Utility Analysis and the Impact of In re Fisher

1. Utility Analysis and the Impact of In re Fisher Jeffrey Siew SPE Art Unit 1645 Technology Center 1600 571-272-0787 Jeffrey.Siew@uspto.gov

2. Outline • History • Citations • Definitions • Guideline Example • In Re Fisher • Cancer Immunology Example

3. Historical Background • Brenner vs. Manson, 383 U.S. 519 (1966) • Process for making certain known steroids • Steroid belong to a class of compounds that were undergoing screening for possible tumor inhibiting effects in mice • A homologue was proven effective in that role • Board found no utility • CCPA reversed and stated that “where a claimed process produces a known product it is not necessary to show utility of product so long as product is not alleged to be detrimental to public interest”

4. Brenner (cont.) • Supreme Court reversed CCPA. • A chemical process is not useful under 35 U.S.C. 101 merely because it produces the intended product for which no use is known or because the compound belongs to a class of compounds which is the subject of serious scientific investigation.

5. Citations • Federal Register (http://www.access.gpo.gov/su_docs/aces/aces140.html) • Utility Guidelines • 60 FR 36263 (1995) and at 1177 O.G. 146 (1995) • Utility Examination Guidelines • 66 Fed. Reg. 1092 (Jan. 5, 2001); 1242 O.G. 162 (Jan. 30, 2001) • Manual of Patent Examination and Procedure§2107 (8th Ed. 2001, rev. 5, 2006)

6. Three-pronged Test • Test • Specific • Substantial • Credible

7. Definitions Specific Substantial Credible

8. Specific Utility - Definition • A utility that is specific to the subject matter claimed. A general utility that would be applicable to the broad class of the invention. • A claim to a polynucleotide whose only use is disclosed simply as a “gene probe” or “chromosome marker” would not be considered to be specific in the absence of a disclosure of a specific DNA target. • Similarly, a general statement of diagnostic utility, such as diagnosing an unspecified disease, would ordinarily be insufficient absent a disclosure of what condition can be diagnosed.

9. Substantial Utility - Definition • A utility that defines a "real world" use. • Utilities that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use are not substantial utilities.

10. Substantial Utility - Positive Examples • Both a therapeutic method of treating a known or newly discovered disease and an assay method for identifying compounds that themselves have a "substantial utility“ • An assay that measures the presence of a material which has a stated correlation to a predisposition to the onset of a particular disease condition.

11. Substantial Utility Negative Examples • If the only use for the claimed invention is to carry out further research to identify a “real world” use, the proposed use would not be substantial. For example, • When the product or material lacks a specific or substantial utility, basic research to study its properties or the mechanisms • A method of treating an unspecified disease or condition. C. A method of assaying for or identifying a material that itself has no "specific and/or substantial utility". • A method of making a material • Intermediate product - Final product

12. Substantial Utility-”Throw Away” • “Throw away” utilities do not meet the tests for a specific or substantial utility. • For example, using transgenic mice as snake food is a utility that is neither specificnor substantial.

13. Substantial Utility “Wheel” Nucleic Acid Protein Probe for disease state e.g. cancer gene mutation Assay for specific, substantial, credible use Antibody

14. Credible Utility - Definition • An assertion is credible unless • (A) the logic underlying the assertion is seriously flawed, or • (B) the facts upon which the assertion is based are inconsistent with the logic underlying the assertion. • A credible utility is assessed from the standpoint of whether a person of ordinary skill in the art would accept that the recited or disclosed invention is currently available for such use. • For example, no perpetual motion machines would be considered to be currently available. However, nucleic acids could be used as probes, chromosome markers, or forensic or diagnostic markers.

15. Well Established Utilities - Definition • A specific, substantial, and credible utility which is well known, immediately apparent, or implied by the specification’s disclosure of the properties of a material, alone or taken with the knowledge of one skilled in the art. • "Well established utility" does not encompass any "throw away" utility or a nonspecific utility that would apply to virtually every member of a general class of materials.

16. Utility Example 9DNA Fragments Lack of Specific and Substantial Utility

17. Utility Guidelines Example 9 • Claim • A cDNA consisting of the sequence set forth in SEQ ID NO: 1.

18. Example 9: DNA Fragment (cont.) • Specification Disclosure: • >4000 nucleic sequences from a human epithelial cell cDNA library • The nucleic acid sequences are alleged to be fragments of full length genes. • The specification discloses using the nucleic acid sequences as probes to obtain the full length genes and to recombinantly make the corresponding proteins, for further study the cellular mechanisms and activities.

19. Example 9 (cont.) • Is there a "well established utility" for the claimed invention? • The specification and the prior art does not disclose or evidence any activity for the cDNA or its encoded proteins such that another non-asserted utility would be well established.

20. Example 9 (cont.) • Has the applicant made any assertion of utility for the claimed invention? • Yes Each cDNA may be used as a probe to obtain the full length gene that corresponds to the cDNA molecule, which full length gene can be used to make the corresponding protein, which can then be used to study the cellular mechanisms and activities in which the protein is involved.

21. Example 9 (cont.) • Is the asserted utility specific? The use of the claimed nucleic acid is not particular to the sequence being claimed because it would be applicable to the general class of cDNAs. Any partial nucleic acid prepared from any cDNA may be used to as a probe in the preparation and or identification of a full-length cDNA. Therefore, the utility is NOT specific.

22. Jeffrey Siew: Item 1) that is it is only good for identifying and studying its properties in an attempt to discover a specific and substantial use Example 9 (cont.) • Is the asserted utility substantial? Because the protein has no disclosed or well established specific or substantial utility, it is an object of “use testing”. Since the asserted utility for the protein does not define a "real world" context of use, a method of making that protein also could not define a "real world" context of use.

23. Example 9 (cont.) • Claim 1 lacks a specific and substantial utility or a well established utility.

24. In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005) • Nucleic acid comprising any of SEQ ID NO:1 to 5. • SEQ ID NO:1 to 5 are ESTs characterized as being from corn leaves. • Proposed Uses: chromosome marker, measure mRNA levels, primers, find polymorphisms, isolate promoters, control expression, locate other organism molecules.

25. Fisher (cont.) • Board found no specific and substantial utility. CAFC affirmed. • CAFC agreed that Brenner v. Manson, 383 U.S. 519 (1966) is controlling precedent • Board’s reasoning tracked guidelines • Fisher court stated “the office simply followed the Utility Guidelines and MPEP which mandate the specific and substantial utility test set forth in Brenner..” and clearly noted Example 9. • PTO standards for utility assessment comport with court’s interpretation of utility requirement of §101

26. Fisher (cont.) • CAFC agreed that Fisher’s proposed uses were the sort of “use-testing” that fails under the Manson standard: • Underlying genes which ESTs were transcribed have no known functions • ESTs would constitute no more than research intermediates on which scientific research could be performed with no assurance of any useful discovery • EST can only be used to detect presence of genetic material having same structure as itself and not provide any information about overall structure or function of gene • Fisher’s ESTs did not satisfy substantial utility requirement

27. Consider the following claim • An isolated polypeptide consisting of an amino acid sequence selected from the group consisting of • A) the amino acid sequence shown in SEQ ID NO: 2.

28. The specification teaches • SEQ ID NO: 2 is a RAS like protein and share some structural similarity to Nadrin protein which is neuron specific developmental regulated GSPase activating protein. • The spec states that RAS like protein was found via PCR to be expressed in human lymphocytes. The spec cites virtual Northern blot analysis using blast alignments indicate certain hits with ESTs • Proposed utilities: assays in high throughput screening to determine biological activity of protein and as reagent in assays to determine expression in different stages of development. Possible treatment inflammation and disorders as related to Nadrin polypeptide.

29. The claims lack a specific and substantial utility.

30. Thank You