Patentability in the U.S., Part 1                     Asia Pacific Legal Institute                           Summer 2005ju...
Basics Examination of Patents•    Utility•    Written Description•    Enablement•    Novelty•    Unobviousnessjuneaupartne...
Utility Requirement• 35 U.S.C. 101      – Specific      – Substantial      – Crediblejuneaupartners.com         (C) Todd J...
Homology & Practical Utility• Brenner v. Manson (Sup.                 •    Nelson v. Bowler (CCPA  Ct. 1966)              ...
Written Description                       Requirement• 35 U.S.C. 112, first (1st) paragraph      – Possessionjuneaupartner...
Homology & Written         Description – “possession”•    Amgen v. Chugai (Fed. Cir.            • Fiddes v. Baird (BPAI   ...
Written Description Guidelines• Can show by relevant identifying characteristics,  i.e.     – Structure or partial structu...
Enablement Requirement• 35 U.S.C. 112 Second (2nd) paragraph      – How to make and how to usejuneaupartners.com   (C) Tod...
Homology & Enablement • Test: does the specification teach a person of   ordinary skill in the art how to make and   use t...
Enablement case law• Case law is very strict; most patents are  held invalid because they do not have  enough examples to ...
CAFC & BPAI are consistent• CAFC cases:      –   EPO: Amgen v. Chugai (1991)      –   RNA virus vaccine: In re Wright (199...
Homology & Enablement• Ex parte Ishizaka (BPAI                   • In re Brana (Fed. Cir.  1992)                          ...
Novelty Requirement    • Each and every      limitation of the claim    • in the proper order    • not in prior art    • A...
The Novelty Statute•    35USC102                              •    e) (1) described in published appln•    a) known/used b...
35 USC 102(a)• known/used by others in USA, or patented/published  anywhere, BEFORE THE INVENTIONjuneaupartners.com      (...
35 USC 102(b)• patented/published anywhere, or public use or sale in  USA, MORE THAN 1 YEAR BEFORE FILING IN USAjuneaupart...
35 USC 102(e)• e) (1) described in published application by another filed  in USA before invention,• e)(2) described in pa...
Novelty-isms• A genus cannot usually invalidate a species• A species always invalidates a genus• You cannot swear behind m...
Unobviousness• A strictly objective way to obtain a subjective  conclusion• PTO Standard:      – Can two or more documents...
Thank you.                         Todd L. Juneau                     todd@juneaupartners.comjuneaupartners.com           ...
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Juneau patentability i

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Juneau patentability i

  1. 1. Patentability in the U.S., Part 1 Asia Pacific Legal Institute Summer 2005juneaupartners.com (C) Todd Juneau 2005 1
  2. 2. Basics Examination of Patents• Utility• Written Description• Enablement• Novelty• Unobviousnessjuneaupartners.com (C) Todd Juneau 2005 2
  3. 3. Utility Requirement• 35 U.S.C. 101 – Specific – Substantial – Crediblejuneaupartners.com (C) Todd Juneau 2005 3
  4. 4. 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 – Court: practical utility is in 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 4
  5. 5. Written Description Requirement• 35 U.S.C. 112, first (1st) paragraph – Possessionjuneaupartners.com (C) Todd Juneau 2005 5
  6. 6. Homology & 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 6
  7. 7. 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 7
  8. 8. Enablement Requirement• 35 U.S.C. 112 Second (2nd) paragraph – How to make and how to usejuneaupartners.com (C) Todd Juneau 2005 8
  9. 9. Homology & 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 9
  10. 10. 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 10
  11. 11. 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 11
  12. 12. 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 known to work”• Note: Elan (ref.) and Mycogen (festo’d) cases will probably not generate enablement/homology case lawjuneaupartners.com (C) Todd Juneau 2005 12
  13. 13. Novelty Requirement • Each and every limitation of the claim • in the proper order • not in prior art • And not subject to statutory bar(s) against patentability, e.g. sales and/or publication(s)juneaupartners.com (C) Todd Juneau 2005 13
  14. 14. The Novelty Statute• 35USC102 • e) (1) described in published appln• a) known/used by others in USA, by another filed in USA before or patented/published anywhere, invention, except not PCTs unless BEFORE THE INVENTION in English language• b)patented/published anywhere, or • e)(2) described in patent by public use or sale in USA, MORE another filed in USA before THAN 1 YEAR BEFORE invention, except patent filing date FILING IN USA is date of US Natl entry (filing• shall not be on basis of PCT c) abandon filing)• d) patented in foreign country • f) did not invent it from an application filed >12 mos. before filing in USA • g)(1) invented by another who did not abandon/suppress/conceal as established in an interference • g)(2) made by another in USA w/o abandon/suppress/conceal BEFORE THE INVENTIONjuneaupartners.com (C) Todd Juneau 2005 14
  15. 15. 35 USC 102(a)• known/used by others in USA, or patented/published anywhere, BEFORE THE INVENTIONjuneaupartners.com (C) Todd Juneau 2005 15
  16. 16. 35 USC 102(b)• patented/published anywhere, or public use or sale in USA, MORE THAN 1 YEAR BEFORE FILING IN USAjuneaupartners.com (C) Todd Juneau 2005 16
  17. 17. 35 USC 102(e)• e) (1) described in published application by another filed in USA before invention,• e)(2) described in patent by another filed in USA before the invention by the applicant, except patent filing date is date of US Natl entry (filing shall not be on basis of PCT filing),• except that PCTs will not be prior art or provide a filing date unless they designate the U.S. and are in the English languagejuneaupartners.com (C) Todd Juneau 2005 17
  18. 18. Novelty-isms• A genus cannot usually invalidate a species• A species always invalidates a genus• You cannot swear behind more than a yearjuneaupartners.com (C) Todd Juneau 2005 18
  19. 19. Unobviousness• A strictly objective way to obtain a subjective conclusion• PTO Standard: – Can two or more documents, from the same technical field, be combined to provide all of the parts of the invention, in the proper order?• Court Standard: – Same as above, but also takes into account “secondary factors” such as unexpected results, failure of others, commercial success, long felt need, and others.juneaupartners.com (C) Todd Juneau 2005 19
  20. 20. Thank you. Todd L. Juneau todd@juneaupartners.comjuneaupartners.com (C) Todd Juneau 2005 20
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