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Analysis of Obviousness in Kao Case and Trade Secret Implications from Tewari De-Ox Systems

This document summarizes key legal findings on patent obviousness and trade secret issues from notable cases discussed at the Prosecution Group Luncheon in May 2011. Specifically, it covers the Federal Circuit's remand on the Kao case regarding the substitution of oxymorphone and the necessity for substantial evidence to support an obviousness rejection based on dissolution profiles. Additionally, it addresses trade secret protections in Tewari De-Ox Systems v. Mountain States, where the 5th Circuit ruled that publicly available information is no longer protectable as trade secrets.

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Analysis of Obviousness in Kao Case and Trade Secret Implications from Tewari De-Ox Systems

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Presentation Transcript

  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

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