Prosecution Group Luncheon

1. Prosecution Group Luncheon May, 2011

2. Obviousness—In re Kao (FC 2011) • BPAI affirms obviousness rejection: using reference formula, POSA can replace reference’s drug with oxymorphone • FC: finding not supported by substantial evidence—remanded • FC: Even if obvious to substitute oxymorphone, finding does not show whether substitution is within “dissolution profile” of claims • Reference’s “dissolution rate” measured in a different way than in claims • USPTO provided no “direct factual support in the record . . . that the claimed range of dissolution rates actually over-laps with the dissolution rate disclosed” in reference • Testimony was that “there is no general correlation” between the two measurement methods • “Board should neither rely upon conclusory reasoning nor its own conjecture in assessing the weight of evidence"

3. Obviousness—In re Kao (FC 2011) • “Secondary Considerations” and nexus with claims • No nexus if “consideration actually results from something other than what is both claimed and novel in the claim” • Nexus is a “two-way” requirement; absent if • (1) “consideration” is result of prior art aspects of claim, or • (2) only a small number of potential embodiments have the asserted “consideration” • Applicant need not provide hard evidence that every embodiment covered by the claim has that nexus • “Providing information" about correlation between renal failure and bioavailablity of oxymorphone • Does not confer patentability w/o “functional relationship between the informing and administering steps”

4. Trade Secret vs. Published Application Tewari De-Ox Systems v. Mountain States (5th Cir. 2011) (TX law) • Under NDA, Tewari showed “zero ppm oxygen meat-packing” • Suit followed when Mountain allegedly began using the method   • Much of the method in Tewari's already published patent appn. • 5th Cir.: information in published application is “generally known and readily available,” no longer protectable via trade secret   • Ct.: Application published at time of confidential disclosure, so where defendant got the information immaterial • Different result if publication was after fiduciary relationship? • Is there TS-protectable information not in the appn?

5. First Action Interview Program • Program expanded to all technology areas • Appns. with 3 independent/20 total claims, directed to single invention—no additional fees required • Applicant must request first action interview (electronically) before an OA entered into PAIR • Examiner must prepare "pre-interview communication“ • References to be cited • Outline of potential rejections/objections  • Per Director Kappos: enhancing interaction between applicant and examiner early on helps both • 1/3 of applications in program previously were allowed in FAOM

6. PTO Administrative Update • Avg. First Action Pendency: 25.9 months (up 0.6) • May continue to rise until oldest cases in backlog (~178,000) are dealt with • Average Total Pendency: 33.8 months (down 0.1) • Filings: 286,700 (up ~13K over FY 2010) • 5 percent increase in filings expected • Applications awaiting first action: ~707,000 • Allowance rate: 46.3% (March) (up 2.3 from 2010) • Kappos: “steady progress toward our goals” despite funding uncertainties