Appeal No. 1999-1157
Application No. 08/482,321
promoter or the trp promoter. According to the specification (pages 22-23) figure 7
is a photograph of a stained gel wherein:
Lanes 1 and 7 contain protein markers of various known sizes;
lane 2 is a control … Lane 3 segregates protein from E. [c]oli
294/pHGH 107 [a lac promoter construct] grown in LB media [which
contains tryptophan, resulting in reduced expression from the trp
promoter due to the trp repressor/operator interactions that occur in
the presence of tryptophan]; Lane 4 segregates protein from E. [c]oli
294/pHGH 107 grown in M9 media [which lacks tryptophan]; Lane 5
segregates protein from E. [c]oli 294/pHGH 207 [a trp
promoter/operator construct] grown in LB media; and Lane 6
segretages protein from E. [c]oli 294/pHGH 207 grown in M9. The
dense band in Lane 6 is human growth hormone, as shown by
comparison to the similar bands in Lanes 2-4. As predicted by the
invention, the organism E. [c]oli 294/pHGH 207 when grown in
tryptophan-rich LB media produces less human growth hormone by
reason of tryptophan repressor/operator interactions, and when grown
in M9 media produces considerably more HGH than E. [c]oli
294/pHGH 107 owing to the induction of the stronger tryptophan
promoter-operator system vs the lac promoter-operator system in
pHGH 107.
Kleid explains (Declaration, page 7) that figure 7 “demonstrates the unexpectedly
better results obtained with the present trp system (Lane 6, yield estimate about
10%) as compared with the original lac system (Lane 3, yield estimate about 2%).”
In response to appellants’ presentation of unexpected results, the examiner
argues (Answer, page 9-10) that:
[a]ppellants’ arguments regarding unexpectedly large yields are not
convincing because no support is found in the specification, as
originally filed. … Because the repressor protein is directly regulated
by the level of tryptophan available one can up regulate transcription
by decreasing tryptophan, an analogous mechanism is not available
in the lac promoter-operator system. The examiner’s position is
supported in the decision of In re O’Farrell (7 USPQ 2d 1673, CAFC
4 Executed April 17, 1989, attached to appellants’ Brief as Exhibit A.
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