The PTO has now issued what it terms the "final version" of the Utility Examination Guidelines to be used by Examiners in their review of patent applications for compliance with the utility requirements, together with an extensive "underlying analysis" explaining the legal basis for these Guidelines.
The original proposed Utility Examination Guidelines were issued in December 1994, primarily in response to a groundswell of complaints that Examining Group 1800 (biotechnology) was imposing a nearly impossible burden on biotech and pharmaceutical applicants to establish section 101 utility. These Guidelines were formally published for comment on January 3, 1995. The proposed Guidelines were incorporated nearly verbatim as section 608.01(p)A of the revised MPEP circulated in March, and were assumed to be final. Highlights of those Guidelines were presented in the May 1995 issue of our Intellectual Property Report. However, the "final version" of these Guidelines, now published in the July 14, 1995 volume of the Federal Register (60 FR 36263-265), does make some significant changes that are worth noting. Moreover, the "underlying analysis" has been expanded consistent with the broader scope of the final Guidelines, and updated to include extensive citations to the recent Federal Circuit decision in In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995), decided after the proposed Guidelines were published.
First of all, while the original Guidelines were directed toward utility rejections of biotechnology and pharmaceutical inventions, the final Guidelines are said to be applicable to all Examining Groups and the Board of Patent Appeals and Interferences, regardless of field of technology. Nevertheless, the utility concerns addressed and the "underlying analysis" are still focused primarily on the fields of biotechnology and human therapy.
Secondly, the original Guidelines specifically addressed only utility rejections under 35 U.S.C. § 101, and there was a practice by some examiners to maintain their lack of utility rejections by simply converting the statutory basis from section 101 to section 112, first paragraph. This practice is precluded by the final Guidelines, which are expressly applicable to, and essentially equate, lack of utility rejections under both section 101 and section 112, first paragraph.
However, section 112, first paragraph, deficiencies other than those based on lack of utility (how to use), must still be separately addressed. These other deficiencies include lack of specification support for the claims, inadequate written description of the invention, lack of enabling disclosure, and failure to set forth the best mode contemplated by the inventor. In particular, the "underlying analysis" cautions that a rejection for lack of enabling disclosure may still be proper even though a credible utility is found. For example, a claimed process for treating certain disease conditions by use of a particular compound may be credible, but undue experimentation may still be required before persons skilled in the art can actually practice the invention, i.e., achieve the credible utility. In that circumstance, a rejection under section 112, first paragraph, for inadequate enabling disclosure would be proper even though the utility requirement of section 101 is met.
The final Guidelines and revised "underlying analysis" have been fine tuned in many other respects as well. In particular, the Court's reasoning and holding in In re Brana has been integrated throughout. In re Brana recognizes the reality that pharmaceutical inventions, at the time that patent applications are filed, necessarily require further research and development even before administration to humans for testing. The Court therefore warns that any PTO requirement to prove utility in human therapy as a condition of patentability would be so costly as to "prevent many companies from obtaining patent protection on promising new inventions, thereby eliminating an incentive to pursue, through research and development, potential cures in many critical areas such as the treatment of cancer."
The original guidelines have significantly decreased the incidence of unsupported lack of utility rejections from Group 1800, and have been applied by many examiners in Group 1200 as well. The changes made in the final Guidelines should help in overcoming utility rejections under both sections 101 and 112 in all fields of technology, and bring the utility requirements closer to reality, especially in the fields of biotechnology and human therapy. The underlying legal analysis is of particular importance since the Guidelines themselves do not have the force of law (or even regulation), and an examiner's failure to follow the Guidelines cannot, per se, provide a basis for a petition or appeal. Any improper utility rejection must still be addressed by applicants on substantive grounds, but the PTO underlying legal analysis should provide a very helpful and persuasive starting point.