On August 21, 2007, the USPTO published its final rules limiting continuation practice (72 Federal Register 161 at 46716, Tuesday, August 21, 2007 “Rules and Regulations Changes To Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent applications; Final Rule”).
The original proposed rules (71 Federal Register 1 at 48. Tuesday, January 3, 2006) (published eighteen months earlier) elicited an unprecedented amount of comments, and were roundly criticized by many practitioners. The limitations on continuation practice in the final rules are less onerous than those originally proposed. However, the rules might still be challenged under the Administrative Procedures Act (APA).
The new rules: a solution or just new problems?
The final rules allow two Continuations and/or Continuations-in-Part (CIP) but only a single Request for Continued Examination (RCE). For every additional Continuation, CIP or RCE, the applicant must submit justification showing why the amendment, argument, or evidence sought to be entered via the Continuation, CIP or RCE could not have been previously submitted.
No guidance on what is a sufficient justification
It would be natural to expect that the nuances of what constitutes sufficient “evidence” will be worked out over time. However, the rules provide no guidance whatsoever as to what constitutes a sufficient “showing” to support an additional Continuation, CIP or RCE. Without such guidance, it is impossible to determine the extent to which the rules effectively limit current continuation practice.
Hardship in certain areas of technology
The continuation limitations might work excessive hardship on certain areas of technology, such as biotechnology and other medically-related fields in which experimentation may take significant periods of time (such as conducting experiments in animals, or clinical studies). In such an area, Continuations and/or RCEs are almost a standard step in patent prosecution.
Most importantly, Continuations are important for demonstrating enablement in these unpredictable arts. Under 35 U.S.C. § 112, the specification must enable a person of ordinary skill in the art to make and use the claimed invention, without undue experimentation. (See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988.). This objective standard does not require the existence of working examples, (See In re Wright, 27 USPQ2d 1510, 1561 (Fed. Cir. 1999); see also In re Borkowski, 422 F.2d 904, 908 (C.C.P.A. 1970); In re Long, 151 USPQ 640, 642 (C.C.P.A. 1966) so an application can be filed without experimental data.
However, if an Examiner rejects a claim as lacking in enablement, Applicants often can overcome the rejection with post-filing evidence demonstrating that “the disclosure was in fact enabling when filed,”(See In re Brana, 51 F.3d 1560, 1567 (Fed. Cir. 1995); see also Wands, 858 F.2d 731) such as experimental data showing that the teachings in the application were followed to obtain a successful result.
The fact that post-filing evidence is used to prove enablement indicates that an application can statutorily enable the claims, yet the Applicant is also required to meet an evidentiary standard of convincing the Examiner. The time and expense of obtaining such data may be extensive, especially in technologies requiring human or animal model data. Thus, in a family of Applications, claims to (say) a molecule might be prosecuted first, and claims to a method of treatment would be prosecuted later, as additional evidence supporting efficacy is obtained. Continuation practice permits the Applicant time to develop additional data to prove that the specification enables the claims.
Without Continuation practice, the Applicant may have difficulty obtaining the data necessary to prove enablement within the applicable time constraints. Thus, an Applicant’s statutory rights to a patent that satisfied the enablement requirement may be effectively denied by an inability to meet the Examiner’s evidentiary standard. (See, e.g., The Comments of the Biotechnology Industry Organization on the United States Patent & Trademark Office Proposed Rules Changes Concerning Continuation Practice and Claim Limitations, May 2, 2006, Biotechnology Industry Association, at pages 4-5. In that situation, denial of a continuation results in an effective denial of rights of the applicant.
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 ?
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.
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