demonstration that one skilled in the art would understand that there is a possibility that a detectable
amount of a 1,3,5-oxadiazine might be present in the product of a reaction that was specifically
designed to produced 5-methoxy-2-nitroimino-hexahydro-1,3,5-triazine, and which actually produces
5-methoxy-2-nitroimino-hexahydro-1,3,5-triazine, does not reasonably convey to one skilled in the art
that the inventors had invented the potentially “coproduced” 1,3,5-oxadiazine intermediate.
vi. Shiokawa Had Role in Creation of 1,3,5-Oxadiazine Claims
Shiokawa alleges that “[t]he only reason the ‘146 patent is limited to 1,3,5-oxadiazines is
because of the examiner’s rigid approach to restriction that is based on structural characteristics only,
without regard to the disclosed biological properties of the compounds. (Shiokawa Corrected
Preliminary Motion 1, p. 9, emphasis in original). Moreover, Shiokawa states that:
A patent applicant cannot know exactly how the PTO will choose to restrict the generic
claims, a requirement made to simplify the examiner’s work load in a given case.
Sometimes no generic formula in the specification corresponds exactly to the claims
allowed after restriction.
(Shiokawa Corrected Preliminary Motion 1, pp. 24-25).
Shiokawa has failed to demonstrate that an examiner’s restriction requirement is relevant to the
fact based determination of whether the ‘146 patent contains an adequate written description of the
claimed 1,3,5-oxadiazines. Specifically, Shiokawa has not identified any plausible connection between
the examiner’s restriction requirement and their addition of claims to an unsupported invention. Nor are
we aware of any such connection.
Additionally, Shiokawa conveniently overlooks their role in the creation and patenting of the
1,3,5-oxadiazine claims. During the prosecution of the ‘780 application (‘146 patent), the examiner
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