Enabling, and Avoiding Anticipation of, Genus Claims

1. Enabling, and Avoiding Anticipation of, Genus Claims J. Ryan Yates

2. Primetime Enablement is growing in importance and isn’t getting easier to decipher What is the appropriate scope to give to inventors?

3. Statute • Written description • Full, clear, concise, exact terms • Enablement • Only needs to enable one skilled in the art, or • With which [the invention] is most nearly connected (what’s the difference?) • No mention of a possession test in statute • Best mode (outside the scope of my research)

4. Enablement vs. written description • Enablement • Does this prevent overclaiming so patentees aren’t over-rewarded? • Written description • Does disclosure fully portray what is “possessed” to others? • WD and enablement: two different things, or do they “rise and fall together” (Lizardtech)? • In what instances can one satisfy one but not the other?

5. Omitted Element Test • PTO Guidelines – if claims require an element not adequately described in the specification • Gentry Gallery – if element essential in disclosure is missing from claims, claims fail WD requirement • Differences? • Do they address possession/WD or enablement? • For legal consistency, hopefully they truly “rise and fall together” all the time

6. Tronzo • ‘589 parent – touts conical shape • ‘262 CIP – all hemispherical shapes • In the meantime… inventor himself published in Britain • Cutoff from broader claim?

7. Policy: what does Tronzo incentivize? • Since Tronzo makes clear that an earlier species patent invalidates a later genus, we are encouraging “later claiming” • What if the patent had not explicitly touted the advantages of the conical shape??? • Would a good test of undue experimentation be whether other species would be “obvious to try”? • Is this what we want? • Inventor in development must make choice: • Patent now, or • Go for it all, holding off until a broader patent is possible • In Newman concurrence, Newman wants to eliminate this quandary from the inventor’s mind

8. On the other hand… • If Newman’s argument were good law: • What kind of worthlessness would people be filing (Pearson)? • There’s no incentive for the prosecutor to fight hard for wider scope the first time. • Is the reward of an expanded CIP necessary for innovation? • The law currently allows claiming priority only on the matter that is NOT new.

9. Lizardtech’s good facts • ERM knew of another seamless DWT! (Shui) • Was experimentation on other seamless DWT’s really “undue” if ERM was able to produce so fast • Did LT argue this fact? Maybe LT didn’t know ERM had seamless alternative until appeals court • LT seems to try arguing that Tronzo was different because the broader claims came in a CIP, rather than the original app, as here – court ignores this argument • Is part of the policy behind preventing broader CIPs eliminated when it’s the original that has the broad claim at issue?

10. Lizardtech’s bad facts • Only one embodiment present • But what about fact that it’s “predictable” tech (Hawkins)? • What if it’s the BEST embodiment? (Frostick) • What if this embodiment ITSELF is very broad within seamlessness generally? (Ko) • Court already gave LT benefit of the doubt in one respect – by limiting claim 21 to seamlessness • Omitted element test of Gentry Gallery would seem to invalidate 21 on the basis that a POSITA would understand seamless to be essential

11. More ways LT can attack • Could LT come up w/ other embodiments quickly (Edsenga)? Does work by LT itself represent work by those “skilled in the art”? • Seamless DWTs in contemporaneous textbooks (Cohen), or even LT itself can try publishing a book (Frostick) • Would it make a difference if ERM had a memo acknowledging LT’s “possession” of seamless DWTs broadly (Heller)? • Look at file wrapper to see if Examiner rejected on enablement basis, but later retracted (Pearson)

12. New or Amended Claims • Can’t go beyond subject matter initially filed • If new claims supported by express, implicit, or inherent disclosure ► ok • Correct obvious (to POSITA) error ► ok

13. Examiner process • Initial burden on Examiner to demonstrate lack of WD or enablement • Identify claim construction • Identify distinguishing features of invention • Compare what is possessed to what is claimed • POSITA standard – POSITA must IMMEDIATELY ENVISAGE possession across entire scope of claim • More skill in the art = less disclosure allowed

14. Possession Incorporate enough of the following: • Actual reduction to practice • Detailed drawings • Normally, this alone is enough • Sufficient relevant identifying characteristics • Apply POSITA standards, of course

15. Predictability • For mature tech w/ high skill in art, disclosing method and function is adequate • For unpredictable (like biotech), more is needed. • Partial structure w/o more characterization is inadequate • Representative amount of species will vary

16. AIPLA comments • Interpret “distinguishing features” according to Fiers: • "Conception of a substance claimed per se without reference to a process requires conception of its structure, name, formula, or definitive chemical or physical properties." • When comparing essential features to claims, focus on nature of characterizing info

17. relevant identifying characteristics include: • complete or partial structure; • other physical and/or chemical properties; • functional characteristics coupled with known or disclosed correlation between function and structure; or, • some combination of these characteristics.

18. Slippery Slope – biotech standards for limiting broadness • Limited to embodiment only • Distinctions btw types of organisms • Prokaryotic vs. eukaryotic • Enzo Biochem v. Calgene • Limited to genus the embodiments belong to • 2 species were enough in Vaeck • Isolate DNA and protein sequences • UC v. Eli Lilly • Neither describing the method to get the sequence nor describing the protein encoded by the DNA is enough Which is best?

19. Enablement for biotech • Complexity of the gene determines how many sequences are enough • Ethical considerations • Injunctions are tougher to get • Genentech v. Novo Nordisk • Court wouldn’t even let skill in the art fill in the missing gaps… fluke? • Enzo Biochem v. Calgene • Pioneering technology means more must be disclosed • However, might policy cut the other way?