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Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
Juneau patentability ii
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Juneau patentability ii

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  1. Patentability in the U.S., Part 2 Todd L. Juneau Asia Pacific Legal Institute Summer 2005juneaupartners.com (C) Todd Juneau 2005 1
  2. Disclosure Requirements• Utility• Written Description• Enablement• Sequence Listings• Deposit Requirement• Information Material to Patentability (IDS)juneaupartners.com (C) Todd Juneau 2005 2
  3. Utility Requirement – Three Parts• 35 U.S.C. 101 – Definition of “Specific” • specific to the subject matter claimed. – Definition of “Credible” • whether a person of ordinary skill in the art would accept that the recited or disclosed invention is currently available for such use.juneaupartners.com (C) Todd Juneau 2005 3
  4. Utility Requirement …• Definition of “Substantial” by what is not substantial: – A. Basic research, e.g. a study of the properties of the product itself or the mechanisms involved. – B. A method of treating an unspecified disease or condition. (Note, this is in contrast to the general rule that treatments of specific diseases or conditions meet the criteria of 35 U.S.C. § 101.) – C. A method of assaying for or identifying a material that itself has no "specific and/or substantial utility". – D. A method of making a material that itself has no specific,substantial and credible utility.juneaupartners.com (C) Todd Juneau 2005 4
  5. Utility Requirement• What is not substantial… : – A claim to an intermediate product for use in making a final product that has no specific, substantial and credible utility. – Note that “throw away” utilities do not meet the tests for a specific or substantial utility.juneaupartners.com (C) Todd Juneau 2005 5
  6. Homology & Practical Utility• Brenner v. Manson (Sup. • Nelson v. Bowler (CCPA Ct. 1966) 1980) – Pharmaceutical activity is – Claim: a process for sufficient practical utility; preparing a steroid specific therapy is not – Prior art: steroids had required to be shown similar structure • Ex parte Aggarwal (BPAI• Specification: no utility 1992) was given – Utility is not shown unless there is substantial activity in – Court: practical utility is a screen accepted as required to justify a patent, predictive of human activity not just an object for for the type of compound used further researchjuneaupartners.com (C) Todd Juneau 2005 6
  7. Utility Advice• Accepted: • Not accepted: – One or more methods – None stated – Cure or Prevention of treatment – Research materials w/ no – Vaccines commercial reason – Characterized Protein – Compounds without or DNA sequences or asserted or suggested antibodies with activity working examples of – Affecting enzyme activity with no specific disease known or suggested condition cited correlated activity with itjuneaupartners.com (C) Todd Juneau 2005 7
  8. Written Description Requirement• 35 U.S.C. 112, first (1st) paragraph: Possession – Requires having the complete mental picture of the compound and what it will be used forjuneaupartners.com (C) Todd Juneau 2005 8
  9. Written Description – “possession”• Amgen v. Chugai (Fed. Cir. • Fiddes v. Baird (BPAI 1991) 1993) – Requires mental picture of the structure, isolation. – Knowing the amino acid – Merely defining biological sequence of a protein and properties is not enough. the general genetics of amino and nucleic acids• Fiers (Fed. Cir. 1993); Lilly DOES NOT establish (Fed. Cir. 1997) possession of the gene – Conception of a DNA encoding for the protein. fragment requires ability to envision the chemical structure and how to obtain it; i.e. an actual DNA sequence is required.juneaupartners.com (C) Todd Juneau 2005 9
  10. Written Description Guidelines• Can show by relevant identifying characteristics, i.e. – Structure or partial structure – Physical or chemical properties – Function when coupled with known or disclosed correlation between function and structure – Combination of the above• Adopted in Enzo v. GenProbe (Fed.Cir. 2002)juneaupartners.com (C) Todd Juneau 2005 10
  11. Enablement Requirement• 35 U.S.C. 112 Second (2nd) paragraph – How to make, and – How to usejuneaupartners.com (C) Todd Juneau 2005 11
  12. Enablement • Test: does the specification teach a person of ordinary skill in the art how to make and use the claimed invention? • Wands factors (In re Wands, Fed. Cir. 1988) – Predictability vs. undue experimentation; – Examples and guidance in specification; – State of prior art; – Breadth of claims.juneaupartners.com (C) Todd Juneau 2005 12
  13. Enablement case law• Case law is very strict; most patents are held invalid because they do not have enough examples to support broad claims. The Fed. Circuit usually states: “the examples are not predictive of the entire genus”• In re Alton: “mosaic” approach vs.• In re Rushig “blaze marks”juneaupartners.com (C) Todd Juneau 2005 13
  14. CAFC & BPAI are consistent• CAFC cases: – EPO: Amgen v. Chugai (1991) – RNA virus vaccine: In re Wright (1993) – Peptides in plants: In re Goodman (1993) – Chimeric gene: In re Vaeck (1991)• BPAI cases – Oral vaccine: Ex parte Forman (1986) – DNA vector coding for a protein or “biologically functional equivalents” Ex parte Maizel (1992)juneaupartners.com (C) Todd Juneau 2005 14
  15. Homology & Enablement• Ex parte Ishizaka (BPAI • In re Brana (Fed. Cir. 1992) 1995) – Claim: a sequence of – Claim: isoquinolinediones nucleotides which “are as cancer drugs effectively homologous” – Spec: in vivo data using – Spec: homology possibly NCI tumor model as low as 50% – Court: USPTO was wrong – Court: rejected as ‘unclear to reject as non-enabling scope’ since “similarly structured prior art compounds were• Note: Elan (ref.) and Mycogen known to work” (festo’d) cases will probably not generate enablement/homology case lawjuneaupartners.com (C) Todd Juneau 2005 15
  16. Sequence Listing• Nucleic and Amino Acid Requirement – all unbranched nucleotide sequences with ten or more bases and all unbranched, non-D amino acid sequences with four or more amino acids, provided that there are at least 4 "specifically defined" nucleotides or amino acids. The rules apply to all sequences in a given application, whether claimed or not – Paper Copy of Listing and CRF – May be submitted after filing, it is not new matter – CD-R or CD-ROM – Use the PatentIn software to create and checkjuneaupartners.com (C) Todd Juneau 2005 16
  17. Deposit Requirement• Budapest Treaty governs locations• Supports Written Description• Deposit Requirements – Written Request under Budapest Treaty – Deposited during pendency – Viable – Replacement upon loss – Duration of 30 yearsjuneaupartners.com (C) Todd Juneau 2005 17
  18. Duty of Candor• 37 CFR 1.56 – individuals associated with the preparation and prosecution of patent applications – are required to act in good faith (honesty) – During examinationjuneaupartners.com (C) Todd Juneau 2005 18
  19. Duty of Disclosure• Individuals associated with the preparation and prosecution of patent applications• are required to provide to the USPTO, using a special form (PTO-1449),• any information material to patentability.• Note: copies of U.S. patents and publications are no longer required to be submitted• Failure to submit information can, and frequently does, invalidate the entire patentjuneaupartners.com (C) Todd Juneau 2005 19
  20. Thank you. Todd L. Juneautodd@juneaupartners.com

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