Appeal No. 2002-1361 Page 3
Application No. 09/476,822
A reading of the specification reveals the following features
are critical to the invention as described:
1. The pad has a color pH indicator; and
2. The pH of the sampling liquid is 2.5 – 5, after sampling if the
pH remains under 5 for 1-2 hours, H. Pylori is not present, if the pH
rises to above 7 after 1-2 hours, H. Pylori is present. Further, it
would appear the collection container is not critical to the invention.
Examiner’s Answer, page 4.
The burden is on the examiner to set forth a prima facie case of
unpatentability. See In re Glaug, 283 F.3d 1335, 1338, 62 USPQ2d 1151, 1152
(Fed. Cir. 2002). We find that the examiner has not done so.
The examiner’s first concern appears to be that the claims do not
specifically recite that the pad has a color pH indicator. The claims, however,
specify that the pad is a urease detecting pad containing urease substrate. The
specification describes the urease detecting pad as having a pH indicator
element that is in a dry state and that undergoes a color change reflecting the
increase in pH produced by the urease in the sample acting on the urease
substrate. See Specification, pages 28-29. Thus, the examiner’s concern is
unfounded, as the recitation of a urease detecting pad implicitly requires that the
pad contain a color pH indicator.
We are not sure what the examiner is objecting to with the comment that
“[t]he pH of the sampling liquid is 2.5 – 5, after sampling if the pH remains under
5 for 1-2 hours, H. Pylori is not present, if the pH rises to above 7 after 1-2 hours,
H. Pylori is present.” If the examiner is objecting to that the claim does not
specifically recite how the color changes when the pH of the sample increases in
response to the presence of H. Pylori, the specification provides guidance and
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