Comments on: Do the New Rules Exceed USPTO Rulemaking Authority? (pt. 1)

By: Patent Baristas » Brief Highlights Patent Office’s “Suspicious Procedures”

Fri, 11 Jan 2008 21:44:30 +0000

[...] Tafas v. Dudas case to enjoin enactment of the USPTO’s new rules, “Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably Ind…” (Final [...]

By: Patent Baristas » Sides Line Up in Impending Patent Continuations Fight

Patent Baristas » Sides Line Up in Impending Patent Continuations Fight — Tue, 08 Jan 2008 20:01:39 +0000

[...] et al. v. Jon W. Dudas, et al. (1:07cv1008), to enjoin enactment of the USPTO’s new rules, “Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably Ind…,” (Final [...]

By: Simon Elliott

Simon Elliott — Thu, 11 Oct 2007 18:11:03 +0000

I agree with Dave that the new rules can be very harmful to biotech. Unfortunately, under the new rules, new PK and tox data are not automatically grounds for a new CIP or continuation. The comments to the new rules state that the mere fact that you had not discovered something until later is not sufficient justification for filing it in a CIP. Other comments suggest that the applicants are required to do all of the following:(a) start experimental work early, (b) file a request to suspend prosecution and (c) be diligent and efficient in the prosecution of all related cases.

By: Dave

Dave — Tue, 09 Oct 2007 17:26:38 +0000

Absolutely agree. In biotech, the inventor often actually reduces to practice several molecules directed toward the same disease/target. At this point the inventor has only laboratory data, and does not know which molecule out of his several candidates will make the best drug. The data on pharmacokinetics and toxicity (two factors which knock 90% of candidate drugs out of the clinic) is not generated until much later. Because the PK and tox data is required by the FDA to show that the molecule is safe and efficacious, would this be a sufficient showing under the new continuation rules to grant another continuation/CIP ?