35. Figures 5A and 5B are said to show clamps 70 and 71 which may be used to support and
bring together multiple components 10 and 12 for joining of ends 14 in a reactive volume
to make a sterile joint .7 B. Ex. 2006, p. 5, 11. 7- 10, p. 8, 11. 6-2 1.
36. Bilstad's Figures 5A and 5B are reproduced below:
7 Bilstad's brief description of Figures 5A and 5B as well as the detailed description of each arc
reproduced:
FIG. 5A is one embodiment of a mechanism for supporting the ends of multiple
components within an active sterile field;
FIG. 5B shows the mechanism of FIG. 5A as the ends of multiple components are
brought into contact with each other within an active sterile field ....
B. Ex. 2006, p. 5,11.7-10.
Connection of the opened ends together while still within the e-beam field 60 may
be achieved in a variety of ways. FIGURES 5A and 5B illustrate one possible mechanism
for bringing the opened ends into aligned contact with each other. The mechanism uses a
pair of automated clamps 70, 71 which engage a portion of components 10, 12, respectively,
j tist behind ends 14, as sho wn in FIGURE 5A. Clamps 70, 71 close about components 10,
12 by actuation in the direction of arrows (AB). Clamps 70, 71 have a pair of rotating tabs
72, 73 which help to maintain the alignment of ends 14 of components 10, 12. Upon
rotation of tabs 72, 73 in the direction of arrows (CD), ends 14 of components 10, 12 are
exposed within the e-beam field (See FIGURE 313) from tube 54. A short delay of
approximately 2-3 seconds allows the e-bearn to sterilize the surface of the ends 14 before
they are opened.
The type of connection to be made will determine how the opened ends of
components 10, 12 are brought into contact with one another. FIGURES SA and 5B
illustrate the use of a spike tube and a membrane tube. With the spike and membrane
configuration, cut-off of the ends 14 is not necessary. After the short delay to allow for
surface sterilization, clamps 70, 71 may be actuated in the direction of arrows (EF). The
spike tube is designed to pierce the membrane tube and continue to enter the membrane tube
until actuation is complete.
B. Ex. 2006, p. 8,11. 6-2 1.
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