1. Utility and Written Description Steve Kunin Deputy Commissioner for Patent Examination Policy Esther Kepplinger Deputy Commissioner for Patent Operations

2. Utility

3. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 35 U.S.C. §101 Patentable Inventions

4. The Patent Office of the United Kingdom Issued Examination Guidelines for Patent Applications relating to biotechnological Inventions (September 2002) Refer to the USPTO’s Utility Examination Guidelines “…although the Guidelines issued by the USPTO did not have direct effect in the UK, the requirement in the United States of America that a “specific, substantial and credible” utility be disclosed, was arguably the sort of disclosure, relating to industrial applicability, which the UK Office would expect to be contained in a UK application.”* * WIPO “Standing Committee on the Law of Patents” Ninth Session, Geneva, May 12 to16, 2003

5. ICOS Corporation/Seven Transmembrane Receptor, (EP-B- 0630405) OJEPT 2002, 293 Decision of the Opposition Division of the European Patent Office (June 20, 2001) “…potential uses of the invention are disclosed in the specification which however are based on a proposed function of the V28 protein as a receptor which is not sufficiently disclosed in the specification” “…the potential uses disclosed in the application are speculative, i.e., are not specific, substantial and credible and as such are not considered industrial applications.”

6. Utility Claim: An isolated and purified nucleic acid (protein) comprising SEQ ID NO: 1. Some asserted utilities for discussion: Forensics Cell identification (non-disease) Microarrays (non-specific) If the array is useful, are the individual members? Laundry lists of potential uses W/no common theme W/common theme

7. Utility- Post Filing Evidence Application asserts the claimed product is useful for treating a laundry list of diseases The list comprises apparently unrelated diseases that would not be expected to all be treatable by the same agent Is there a prima facie case for lack of utility? What evidence can overcome prima facie case of lack of utility?

8. “Laundry” List What constitutes a laundry list? Many pages of potential uses? 2 uses “Its an agonist or an antagonist” Is the assertion that all are treatable acceptable? What evidence can overcome prima facie case of lack of utility?

9. Utility- Post Filing Evidence A) Applicant responds with the argument that it is possible to treat one member of the list B) Applicant responds with evidence that it is possible to treat one member of the list Under what circumstances would this be compelling?

10. Preventing - Curing - Vaccines Are there situations when these terms will invoke a utility issue? If so, what situations?

11. Written Description

12. 35 U.S.C. 112 Specification, first paragraph The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

13. Written Description Is there a necessary link between meeting the written description requirement and the enablement requirement?

14. Written Description Is “homology/identity” plus function acceptable? Should the function be a specific, substantial, and credible use? Is there a difference between “homology/identity” language and the use of hybridization language?

15. Written Description When is “comprising” language appropriate for nucleic acid or protein claims? When should a process of use claim be subject to a written description rejection? Consider only process steps per se? Consider products used in process?

16. Written Description Variants, Fragments, Mutants, Subsequences How much description is necessary? Human, Mammalian, Vertebrate