Appeal No. 2006-0730 Page 6
Application No. 10/164,863
SR-BI knockout mice are not a representative animal model for evaluating “[a]
method of treating reproductive disorders involving abnormal levels of lipids in a
female mammal mediated by SR-BI activity.” See e.g., claim 1.
“When rejecting a claim under the enablement requirement of section 112,
the PTO bears an initial burden of setting forth a reasonable explanation as to
why it believes that the scope of protection provided by that claim is not
adequately enabled by the description of the invention provided in the
specification of the application; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the scope of
enablement.” In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513
(Fed. Cir. 1993). “[It] is incumbent upon the Patent Office, whenever a rejection
on this basis is made, to explain why it doubts the truth or accuracy of any
statement in a supporting disclosure and to back up assertions of its own with
acceptable evidence or reasoning which is inconsistent with the contested
statement. Otherwise, there would be no need for the applicant to go to the
trouble and expense of supporting his presumptively accurate disclosure.”
In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). Upon
consideration of the record, we find no evidence to support the examiner’s
arguments.
In our opinion, the examiner fail to meet his burden of providing the
evidence necessary to support his position. The examiner also asserts (Answer,
page 4), “[t]here is no evidence [on this record] that altering SR-BI levels in a
fertile female with normal SR-BI levels and no reproductive disorders will have
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