Ex Parte 6813868 et al

Board of Patent Appeals and Interferences

Mar 17, 2010

90007816 (B.P.A.I. Mar. 17, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte BAXA CORPORATION,
Appellant
____________

Appeal 2009-010949
Reexamination Control 90/007,816
Patent 6,813,868 B21
Technology Center 3900
____________

Decided: March 18, 2010
____________

Before WILLIAM F. PATE, III, ROMULO H. DELMENDO, and
DANIEL S. SONG, Administrative Patent Judges.

DELMENDO, Administrative Patent Judge.

DECISION ON APPEAL

1 The patent under reexamination (hereinafter the “‘868 Patent”) issued to
Brian Eugene Baldwin, Robert Eugene Mancuso, II, and Jon Paul Page on
November 9, 2004 from Application 09/928,007 filed August 10, 2001.
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Baxa Corporation, the owner of the patent under reexamination,2
appeals under 35 U.S.C. §§ 134(b) and 306 from a final rejection of claims
1-25 and 28-363 (Appeal Brief filed February 4, 2008, hereinafter “Br.,” at
12; Final Office Action mailed October 2, 2007). We have jurisdiction
under 35 U.S.C. §§ 134(b) and 306.
We AFFIRM.

STATEMENT OF THE CASE
This reexamination proceeding arose from a third-party request for ex
parte reexamination filed by David Leason of Darby & Darby, P.C., New
York, New York, acting on behalf of ForHealth Technologies, Inc.
(“ForHealth”). We have been informed that the ‘868 Patent is the subject of
a patent infringement action styled as Baxa Corp. v. ForHealth
Technologies, Inc., Case No. 6:06-cv-0353 (M.D. Fla.) (Br. 5). According
to Appellant, the district court ordered a stay on May 5, 2006 pending the
outcome of the current reexamination proceeding (Br. 5).
The ‘868 Patent states that the invention relates to an apparatus for
automated syringe handling operations, such as syringe filling, labeling, and
capping operations (col. 1, ll. 12-15).

2 See Title Report entered November 28, 2005.
3 Claims 26 and 27 have been determined to be patentable over the cited
prior art references (Final Office Action, PTOL-466).
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Claims 1, 29, 31, and 35 on appeal read as follows:
1. An apparatus adapted for automated handling,
comprising:
a plurality of syringe bodies, each comprising a barrel
having a dispensing end and an opposing end, a plunger
slidably disposed in the opposing end of the barrel, and a cap
removably and replacably [sic] disposed on the dispensing end
of the barrel, wherein a clean, contained volume is defined
within the barrel between the plunger and the cap and wherein
the dispensing end of the barrel includes a fluid port and an
outer flange and wherein said cap includes an outer member
matingly positionable about the outer flange of the barrel and
either an inner member positionable about or an inner member
positionable within the fluid port of the barrel; and,
a flexible belt fixedly attached to each barrel of said
plurality of syringe bodies, wherein said plurality of syringe
bodies are positionable in a predetermined orientation and at
least one of said dispensing end and said opposing end of each
said barrel of said plurality of syringe bodies is accessible.

29. An apparatus adapted for automated handling,
comprising:
a plurality of syringe bodies each comprising a barrel
having a dispensing end and an opposing end and wherein the
dispensing end of the barrel includes a fluid port and an outer
flange, a cap removably and replacably [sic] disposed on the
dispensing end of the barrel, and a plunger slidably disposed in
the opposing end of the barrel, wherein for each of said
plurality of syringe bodies a clean, contained volume is defined
within said barrel between the plunger and cap, and wherein
said cap includes an outer member matingly positionable about
the outer flange of the barrel and either an inner member
positionable about or an inner member positionable within the
fluid port of the barrel; and,
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a flexible belt fixedly attached to each said barrel of said
plurality of syringe bodies, wherein said plurality of syringe
bodies are positionable in a predetermined orientation and at
least one end of each said barrel of said plurality of syringe
bodies is accessible, wherein said belt is of a predetermined
length between adjacent ones of said plurality of syringe
bodies, said predetermined length being sufficient to define
label flaps upon severance of the belt between said adjacent
ones of the plurality of syringe bodies and wherein at least one
surface of each said predetermined length of said belt is adapted
for printing contents-related information thereon.

31. An apparatus as recited in Claim 29, wherein said
belt comprises:
opposing layers adjoined in face-to-face relation between
adjacent ones of said plurality of syringe bodies and wrapped
about opposing sides of the barrels of each of said plurality of
syringe bodies.

35. An apparatus as recited in Claim 31, wherein said at
least one surface of each said predetermined length of said belt
is defined by a sheet label affixed to said belt.
(Claims App’x A.)

The Examiner relied upon the following as evidence of
unpatentability (Examiner’s Answer mailed September 26, 2008, hereinafter
“Ans.,” 3-15):
Rycroft 4,865,592 Sept. 12, 1989
Haber 5,356,393 Oct. 18, 1994
Ortiz 5,884,457 Mar. 23, 1999
Timko EP 0 935 969 A2 Aug. 18, 1999

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The Examiner rejected claims 1-25 and 28-36 under 35 U.S.C. §
103(a) as follows:
I. Claims 1-23, 28-34, and 36 as unpatentable over the
combined teachings of Ortiz, Timko, and Rycroft (Ans.
3-14); and
II. Claims 24, 25, and 35 as unpatentable over the combined
teachings of Ortiz, Timko, Rycroft, and Haber (Ans. 14-15).

ISSUES
Rejection I
The Examiner found that Ortiz describes an automated syringe
handling apparatus having all the elements recited in claim 1 except for “a
flexible belt fixedly attached to each said barrel of said plurality of syringe
bodies” (Ans. 3-5). To resolve this difference, the Examiner relied on, inter
alia, Timko, which was found to teach various advantages in using a flexible
belt or strip that connects plural syringes together (id. at 5-6). According to
the Examiner, these known advantages of a flexible belt or strip would have
prompted a person of ordinary skill in the art to combine Ortiz with Timko
in the manner claimed in the ‘868 Patent (id. at 6). With respect to claim 29,
which is argued separately, the Examiner found that the limitation “at least
one surface of each said predetermined length of said belt is adapted for
printing contents-related information thereon” reads on a surface that is
capable of receiving a label (Ans. 26).
Appellant asserts that the Examiner’s analysis is flawed because Ortiz
teaches away from using a “flexible belt,” as recited in the claims.
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Specifically, Appellant argues that because “significant forces” (rotational
and vertical) are imparted on Ortiz’s syringes during processing, a person of
ordinary skill in the art would not have dispensed with Ortiz’s “high strength
feeding magazine 26” in favor of Timko’s flexible belt or strip (Br. 16-17,
20-21, 30). According to Appellant, “there would be no reasonable apparent
reason to make the combination of Ortiz and Timko” (Br. 27). Appellant
also contends that it is “impractical” to fill Timko’s syringes through the
dispensing end and that the reference teaches away from “a cap removably
and replacably [sic] disposed on the dispensing end of the barrel,” as
required in the claims (Br. 17, 21). Appellant further contends that Timko
would have discouraged “a clean, contained volume . . . within the barrel,”
as recited in the claims, because the prior art syringe must remain
plungerless to accommodate filling (Br. 22). With respect to claim 29,
Appellant contends that the prior art flexible belt has not been shown to “be
capable of being printed on” (Br. 47).
Thus, the dispositive issues for Rejection I are:
A. Did the Examiner articulate some reasoning with
sufficient rational underpinnings to support a conclusion
that a person of ordinary skill in the art would have
combined the teachings of Ortiz and Timko in the
manner claimed (i.e., substitute Ortiz’s feeding magazine
with Timko’s flexible belt to arrive at the claimed subject
matter)?
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B. Do the collective teachings of the prior art references
describe “a cap removably and replacably disposed on
the dispensing end of the barrel,” as recited in claim 1?
C. Do the collective teachings of the prior art references
describe “a clean, contained volume . . . defined within
the barrel,” as recited in claim 1?
D. Does Timko disclose a flexible belt which, upon
severance of the belt between syringes, would provide
label flaps, wherein at least one surface flap would be
“adapted for printing contents-related information
thereon,” as recited in claim 29?

Rejection II
The Examiner found that while Ortiz and Timko do not disclose the
use of sheet labels having contents-related information, Haber would have
suggested the use of such labels adjacent or between syringe bodies “for the
purpose of identifying the contents in the syringes, thereby reducing the risk
of patients receiving the wrong medication” (Ans. 14-15). According to the
Examiner, “[t]he teaching of Haber . . . would sufficiently suggest providing
labels between syringe bodies, as to make it obvious to do so between the
syringe bodies of the art combination . . . .” (Ans. 27).
Appellant contends that Haber’s label is not positioned on a belt that
is “between each of said plurality of syringe bodies,” as recited in claim 24.
(Br. 51.)

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Thus, the dispositive issue is:
E. Does Haber suggest the placement of labels with printed
information on areas of the flexible belt adjacent to and
between the syringe bodies?

FINDINGS OF FACT (“FF”)
1. Figures 1 and 2 of the ‘868 Patent are reproduced below:

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Figures 1 and 2 of the ‘868 Patent disclose a plurality of sterile
capped syringes mounted in a flexible or pliable belt or band 30
for automated labeling and/or cap removal, fluid filling, and cap
replacement, wherein the cap may be connected by a Luer lock
(col. 3, ll. 1-2; col. 7, ll. 19-22; col. 7, l. 64 to col. 8, l. 12; col.
17, l. 65).
2. The ‘868 Patent discloses that the flexible belt 30 of Figure 2
may be formed by adhesively bonding two tape strips, which
secure the plurality of syringes (col. 8, l. 58 to col. 9, l. 45).
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3. The ‘868 Patent Specification states (col. 3, ll. 5-10; italics
added):
[I]t is advantageous for the belt to be of a
predetermined length between adjacent ones of the
plurality of syringe bodies, such predetermined
length defining belt segments that are sufficient for
the placement of contents information thereupon
(e.g. via the application of a label thereto or direct
printing thereon).
4. Ortiz’s Figures 4C, 5, 6, and 7C are reproduced below:

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Ortiz’s Figures 4C, 5, 6, and 7C collectively disclose an
apparatus for automated handling of sterile delivery devices
comprising: syringes 12 complete with a hollow barrel 14,
piston plungers, dispensing ends, and a tip 22 (e.g., friction-
fit)/cap 88 complementarily sized to seal dispensing nozzle 16
upon filling of the syringe using fluid fillings station 66 (part of
filling machine 10, not shown); and a feeding magazine 26 for
holding syringes 12 while preventing their rotation (col. 3, l. 49
to col. 4, l. 22; col. 5, ll. 21-28; col. 5, l. 43 to col. 6, l. 59).
5. Ortiz teaches that the prior art disclosure “is not limited to the
use of a feeding magazine 26” but that the syringes “can be
carried, transported and supported on the sterile delivery device
filling machine 10 in any number of manners . . . .” (col. 6, l. 67
to col. 7, l. 5).
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6. According to Ortiz, “it is preferred that the feeding magazine
be constructed of a high-strength, lightweight material, such as
a polymeric material” and that “[p]ortions of the feeding
magazine could be constructed of other high-strength,
lightweight materials . . . .” (col. 7, ll. 6-11; emphasis added).
7. Timko teaches a flexible strip (i.e., belt) that interconnects and
maintains a plurality of syringes “in a selected alignment for
efficient and easy handling during packaging and syringe-filling
processes” (col. 2, ll. 10-14).

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8. Timko’s Figures 1-4 are reproduced below:

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Timko’s Figures 1-4 collectively disclose an apparatus for
packaging and handling syringes during manufacturing and
pharmaceutical filling operations, the apparatus comprising: a
continuous flexible strip (i.e., belt) 40 for holding syringes 22,
the syringe 22 including a barrel portion 24 and a needle cover
32 on a dispending end (col. 2, l. 55 to col. 3, l. 2; col. 3, ll. 18-
30).
9. Timko teaches that the embodiment of Figure 3 includes a
supporting strip 40’ obtained by snap-fitting two strips 50 and
52, which are made from the same substantially flexible
materials, preferably plastic (col. 4, ll. 3-9).
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10. According to Timko, “[t]he embodiment of Figure 3 has the
advantage of being useable with a large variety of syringes 22”
and “also provides a somewhat more secure connection
between the supporting strip 40’ and the syringes 22 compared
to the embodiment of Figures 1 and 2” (col. 4, ll. 24-30).
11. Timko states that Figure 4 is the most preferred embodiment,
where two flexible plastic strips 78 and 80 are bonded together
(either with an adhesive or by melt fusion) to secure the
syringes (col. 4, l. 35 to col. 5, l. 7).
12. Timko teaches that “placing the supporting strip about barrel
portion 24 is especially advantageous because it provides a
more secure connection” (col. 5, ll. 45-47).
13. Timko further states: “Under most circumstances, the syringes
22 preferably are removed from the supporting strip without the
use of any external tools” (col. 5, ll. 54-56).
14. Timko teaches numerous advantages in using the flexible strip
or belt, as follows (col. 6, l. 31 to col. 7, l. 7; italics added):
Once a syringe assembly 20 is completed it
provides the advantage of being readily usable in a
pre-filling operation. For example, high-speed
pharmaceutical linear filling systems can readily
receive an assembly 20 of a plurality of syringes
22. Further, the preselected relative alignment of
the syringes 22 leaves them well suited for
oriented presentation into the pre-filling system.
Further, the syringes 22 can be sterilized in large
quantities after they have been assembled into the
syringe assemblies 20.
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Another advantage to the assembly 20 is its
ready usefulness for packaging a large number of
syringes 22 for shipment or handling. Figure 5
illustrates how a first syringe assembly 100 can be
nested together with a second syringe assembly
102 . . . .
Figure 6 illustrates a preferred orientation of
the two assemblies 100 and 102 within a package
104. The continuous, flexible support strip allows
a large number of syringes to be placed with the
package 104 in a folded pattern. The folded
pattern 106 of Figure 6 is preferred generally S-
shaped. This allows for easy packaging that
minimizes the amount of bulk packaging material
that needs to be used in handling a large number of
syringes 22. The stability of the alignment of the
syringes provided by the supporting strip 40
protects the syringes under most circumstances and
reduces the mount [sic] of packaging material
required. Further, the continuous supporting strip
makes it easy for a selected amount of syringes 22
to be removed from a package without disturbing
the entire arrangement of syringes on a repeated
basis.

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15. Haber’s Figure 9 is reproduced below:

Haber’s Figure 9 depicts a syringe assembly including syringe
2c and plunger 14c and an adhesive label 114 with indicia
affixed adjacent or near the syringe body (col. 6, ll. 3-18; col. 3,
ll. 59-63).

PRINCIPLES OF LAW
“During reexamination, as with original examination, the PTO must
give claims their broadest reasonable construction consistent with the
specification . . . . Therefore, we look to the specification to see if it provides
a definition for claim terms, but otherwise apply a broad interpretation.” In
re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007).
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“[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.” KSR
Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007) (citing United States v.
Adams, 383 U.S. 39, 50-51 (1966)).

ANALYSIS
I.
Because Rycroft is cumulative to Timko, we focus on the Examiner’s
combination of Ortiz with Timko.
Appellant does not specifically refute the Examiner’s findings that
Ortiz describes an apparatus for automated, sterile handling of a plurality of
syringes, wherein the apparatus includes: a plurality of syringes 12 having
hollow barrels 14, plungers 18, a friction-fit or Luer lock (i.e., removable
and replaceable) tip 22 complementarily sized to seal tip removing section
(i.e., dispensing nozzle) 16 (Ans. 3-5, 16; Br. 15-17, 20-21; FF 4-6). Nor
does Appellant identify any error in the Examiner’s finding that the
dispensing end of Ortiz’s syringe necessarily includes an inner fluid port and
an outer flange to accommodate a Luer lock connection (Ans. 5; Br. 15-17,
20-21). Furthermore, it is undisputed that Timko describes a “flexible belt,”
as recited in claim 1 (Br. 17; FF 7-14).
Rather, Appellant’s position is that the Examiner’s proposed
combination of references fails because Ortiz teaches away by discouraging
the use of a flexible belt through the disclosure of the need for a high-
strength feeding magazine 26 for rotational and vertical locking of the
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syringes during filling (Br. 20-21). Specifically, Appellant asserts that
Ortiz’s cap removing, fluid filling, and sealing operations impart “significant
forces” on the syringes (Br. 17). Furthermore, Appellant argues that “no
reason whatsoever was given by the Examiner for combining the post-
processing filled syringes of Ortiz with the flexible belt of Timko” (Br. 25).
We disagree. As pointed out by the Examiner (Ans. 6), Timko
teaches a myriad of advantages in using a flexible belt, such as the
characteristic of being well-suited for oriented presentation to a pre-filling
system and/or the ability to provide syringes in a nested package
configuration (FF 7, 14). These advantages constitute ample reasons that
would have prompted a person of ordinary skill in the art to combine Ortiz
and Timko in the manner claimed in the ‘868 Patent.
As to the argument that Ortiz discourages a flexible belt, contrary to
Appellant’s belief, Ortiz does not say that a flexible belt would be unsuitable
for the tip removing, fluid filling, and sealing operations, although the
feeding magazine would appear to hold the syringes in rotationally and
vertically locked positions (FF 4-6). Indeed, as correctly found by the
Examiner (Ans. 15), Ortiz does not limit the device for consolidating and
feeding the syringes in any way, much less discourage the use of a flexible
belt (FF 5). Rather, Ortiz merely describes an implementation that differs
from the flexible belt implementation, and thus, does not teach away from
the invention claimed. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Timko, on the other hand, explicitly teaches that a flexible belt allows
a plurality of syringes to be maintained “in a selected alignment for efficient
and easy handling during packaging and syringe-filling processes” (FF 7).
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In addition, Timko teaches that the flexible belt may secure the syringes by
snap-fitting, adhesively bonding, or melt fusing two flexible strips, thus
resulting in a secure connection (FF 8-12). Thus, a person of ordinary skill
in the art would have reasonably expected that such a secure connection
would sufficiently counteract the nominal rotational and/or vertical forces
that may act on the syringe during the filling operation. In re O’Farrell, 853
F.2d 894, 904 (Fed. Cir. 1988) (“For obviousness under §103, all that is
required is a reasonable expectation of success.”).
In this case, Appellant has failed to direct us to any evidence or
persuasive technical reasoning why Timko’s flexible belt would be
incapable of withstanding the forces required to process Ortiz’s syringes.
That failure is not surprising because Timko’s flexible belt is
indistinguishable from that described and claimed in the ‘868 Patent (FF 1-2,
7-14).
Moreover, a person of ordinary skill in the art is not an automaton but
a person with ordinary creativity and full knowledge of the prior art. We
find that such a person of ordinary skill in the art would have had no
difficulty in selecting appropriate polymeric materials that have the right
balance of properties (flexibility, rigidity, and strength) to make the
combination work. KSR, 55 U.S. at 421 (“A person of ordinary skill is also
a person of ordinary creativity, not an automaton.”); Sinclair & Carroll Co.
v. Interchemical Corp., 325 U.S. 327, 335 (1945) (“Reading a list and
selecting a known compound to meet known requirements is no more
ingenious than selecting the last piece to put in the last opening in a jig-saw
puzzle.”); Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329
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(Fed. Cir. 2009) (“KSR expanded the sources of information for a properly
flexible obviousness inquiry to include . . . the background knowledge,
creativity, and common sense of the person of ordinary skill.”).
Equally unavailing are Appellant’s arguments that focus on the
differences between the claimed subject matter and Timko’s apparatus. For
example, Appellant argues that it is impractical to fill Timko’s syringes
through their dispensing ends, that Timko teaches away from a removable
and replaceable cap, and that Timko teaches away from a “clean, contained
volume” within the syringe because a plunger is not shown (Br. 17, 21-22).
But these arguments fail to take into account that the Examiner’s rejection is
based on the collective teachings of the prior art references. The Examiner
has relied on the teachings of Ortiz for these limitations (FF 4-6). In re
Keller, 642 F.2d 413, 425-26 (CCPA 1981) (nonobviousness cannot be
established by attacking references individually where the rejection is based
on a combination of prior art references).
As to separately argued claim 29, the claim recites the limitation
“wherein at least one surface of each said predetermined length of said belt
is adapted for printing contents-related information thereon.” The Examiner
has construed this limitation to read on a predetermined length of belt that
can accommodate a label of any size (Ans. 26). Appellant, on the other
hand, appears to be contending that the surface of the belt must be capable of
receiving direct printing thereon (Br. 47).
Again, we agree with the Examiner. The Specification of the ‘868
Patent describes the use of labels and direct printing as alternative
embodiments of the invention in which printed contents information is
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provided (FF 3). While Patentees are free to claim less than what they
disclose in the Specification, claim 29 does not limit the claimed subject
matter to “direct printing.” Indeed, a cursory review of claim 35 (which
further limits claim 29 through intervening claim 31) confirms that the label
embodiment is in fact within the scope of claim 29.
For these reasons, we detect no basis upon which to reverse the
Examiner’s rejection.

II.
We are in complete agreement with the Examiner’s analysis and
conclusion (Ans. 14-15). Haber teaches the concept of affixing a label near
or adjacent a syringe to convey information (FF 15). Given that teaching,
the placement of a label on any available space near or adjacent the syringes,
including spaces between the syringes on the flexible belt, would have been
within the ordinary skill of a person skilled in the art. In this case, the
specific location of the labels with indicia has not been shown to
unexpectedly affect the characteristics or operation of the claimed apparatus
in any way.
For these reasons, we also uphold Rejection II.

CONCLUSION
On this record, we find that:
the Examiner articulated some reasoning with sufficient rational
underpinnings to support a conclusion that a person of ordinary skill in the
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art would have combined the teachings of Ortiz and Timko in the manner
claimed;
the collective teachings of the prior art references describe “a cap
removably and replacably disposed on the dispensing end of the barrel,” as
recited in claim 1;
the collective teachings of the prior art references describe “a clean,
contained volume . . . defined within the barrel,” as recited in claim 1;
Timko discloses a flexible belt which, upon severance of the belt
between syringes, would provide label flaps, wherein at least one surface
flaps would be “adapted for printing contents-related information thereon,”
as recited in claim 29; and
Haber suggests the placement of labels with printed information on
areas of the flexible belt adjacent and between the syringe bodies.

DECISION
The Examiner’s decision to reject:
I. Claims 1-23, 28-34, and 36 as unpatentable over
the combined teachings of Ortiz, Timko, and
Rycroft; and
II. Claims 24, 25, and 35 as unpatentable over the
combined teachings of Ortiz, Timko, Rycroft, and
Haber,
is affirmed.
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).
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AFFIRMED

bim

FOR PATENT OWNER:
MARSH FISCHMANN & BREYFOGLE, LLP
3151 S. VAUGHN WAY, SUITE 411
AURORA, CO 80014

FOR THIRD-PARTY REQUESTER:
DAVID LEASON, ESQ.
DARBY & DARBY, P.C.
P.O. BOX 5257
NEW YORK, NY 10150