PTAB addresses issue of amending to "consisting of" in written description context
The issue raised by this appeal is whether amending the claims to recite that the claimed assessment method consists of, rather than comprises, a specific set of tests introduced new matter into the claims.
The Examiner's issue
According to the Examiner, “Applicant appears to disclose that some tests are optionally included or excluded” in assessing cardiovascular health (Ans. 7), and this “is in clear contradiction to the requirements of using ‘consisting of’ terminology within the claims” (id. at 8). Thus, the Examiner finds that the Specification does not provide support for “the newly added claim limitation that the early marker tests are a closed set consisting of measuring arterial elasticity, measuring blood pressure at rest and during exercise, imaging the optic fundus, analyzing urine samples for albumin, and determining wall thickness” (id. at 4-5), or for “the newly added claim limitation that the early cardiac disease tests are a closed set” (id. at 6). (...)
The Examiner “acknowledges there appears to be at least one
embodiment where ten tests are used; however the specification lacks evidence and support that only 10 tests are used and no other possible combination of tests are used” (Ans. 6).
This is a distinction without a difference. There is no dispute that the Specification explicitly discloses each of the ten tests listed in the claims,2 as well as a small number of additional tests, some of which, like the ankle-brachial index, are relevant when assessing high-risk patients (see, e.g., Spec. 4: 17-20, 24). It is well settled that alternative elements which are positively recited in the Specification may be explicitly excluded from the claims. See In re Johnson, 558 F.2d 1008, 1019 (CCPA 1977) (“[The] specification, having described the whole, necessarily described the part remaining.”).