AIPLA

1. AIPLA NUMERICAL LIMITS, ENABLEMENT AND Claim SCOPE trouble ABOVE AND BELOW AIPLA Mid-Winter Institute IP Practice in Japan Committee Pre-meeting tampa, FLorida Jan 29-30, 2012 Nanda Alapati Womble Carlyle, Tysons Corner, VA Nalapati@wcsr.com

2. General ProblemNumerical Limits, Enablement and Claim Scope Examples of one-sided numerical limits in claims: “such that the surface roughness is less than Ra = 0.2 nm” “causes a change in absorption at 545 nm that is greater than 25%” other key words: “at least”, “at most”, “no less than”, “no greater than”, etc. Questions: What scope do you get? What enablement issues are there? How do you avoid trouble?

3. Ancient History on Numerical Limitations and Enablement In re Fisher (CCPA 1970) • Claim: An ACTH preparation containing at least 1.0 IU of ACTH per mg and (other ingredients) • Disclosure: Method of making preparation; examples 1.11 to 2.30 IU • Prior Art – 0.5 IU per mg • CCPA – 112, 1 enablement issue: • 35 USC 112,1 “requires that the scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art” • “In cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws” • In cases involving unpredictable factors, such as most chemical reactions and physiologicalactivity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved. • Here, enablement only up to 2.3 IU, so a claim stating “at least 1.0 IU is not enabled

4. Ancient History on Numerical Limitations and Adequate Written Description In re Wertheim (CCPA 1976) (instant coffee) Original Swiss Specification: range of "25%- 60%” coffee solids, prior to foaming specific examples of "36%" and "50%." Claims on filing US application: claim 1 - "at least 35%“ claim 2 - between "25%- 60%” CCPA: ADW has to do with “possession of invention” "at least" has no upper limit and causes the claim to read literally on embodiments outside the "25% to 60%" range, no ADW a limitation to "between 35% and 60%" meets ADW requirement.

5. More Recent History on Enablement and Claim Construction (1) Liebel-Flarsheim v. Medrad (I) – (Fed. Cir. 2004) During prosecution, Patentee removes claimed “jacket” after seeing D’s syringe Specification only shows ‘jacketed” syringes Dt. Ct. construes claims to require jacket & grants D’s SJ motion on non-infringement Fed Cir reverses & remands – claims say nothing about a jacket; we’re not saying anything about whether the claims are enabled Liebel-Flarsheim v. Medrad (II) – (Fed. Cir. 2004) Dt. Ct. says claims are not enabled Fed Cir Affirms

6. Even More Recent History on Enablement and Claim Construction (2) Automotive Tech v. (every car mfg & airbag sensor mfg) (Fed. Cir. 2007) Technology: sensors for side impact crash used to trigger a side airbag Disclosure: detailed design of mechanical sensors & mentions electronic Claims: MPF – “means responsive to motion…: Claim Construction: Patentee: MPF -- claim element covers both kinds of sensors Dt. Ct. – Agreed Defendant Delphi files SJ on 112,1 enablement invalidity Patentee – okay if only one kind of sensor is enabled Dt. Ct. -- must enable full scope of claim; electronic sensor not enabled Fed Cir: Affirms; claims are invalid under 112,1 for lack of enablement

7. One More Data Point on Claim Construction Gillette v. Energizer Holdings (Fed. Cir. 2005) Accused device: Razor with four blades (Energizer’s quattro”) Gillette’s patent • Razor comprising a “group of three blades” • Quattro has group of three blades + another blade Fed Cir agrees with Gillette – “comprising” is open-ended N.B. – Gillette did NOT raise issue of enablement (may not mattered anyway)

8. Magsil v. Hitachi 687 F.3d 1377 (Fed Cir 2012) USP 5,629,922 – Electron Tunneling Device Using Ferromagnetic Thin Films

9. USP 5,629,922 – (cont’d)

10. USP 5,629,922 – (cont’d)

11. USP 5,629,922 – (cont’d)

12. USP 5,629,922 – (cont’d) Claim 1. A device forming a junction having a resistance comprising: a first electrode having a first magnetization direction, a second electrode having a second magnetization direction, and an electrical insulator between the first and the second electrodes, wherein applying a small magnitude of electromagnetic energy to the junction reverses at least one of the magnetization directions and causes a change in the resistance by at least 10% at room temperature.

13. ‘922 Patent Disclosure and File History • Prior art - Best Improvement was 2.6 % • Examples - Best example was 11.8%

14. ‘922 Litigation (1) • Patentee “wins” claim construction - Dt. Ct - No upper bound on scope of claim re: resistance change • Inventor Discovery - We had no idea how to reach 100% change in resistance at the time of the invention - But, even 604% (one accused product) or even 1000% change is within scope of claims - (In reality it took 12 years before 100% resistance change was realized)

15. ‘922 Litigation (2) • Defendant’s Argument - Look what the inventors said! - Claim invalid under 112,1; see In re Fisher • Patentee’s Argument - This is an open ended claim “at least 10%”; “comprising” language - See Gillette v. Energizer Holdings • Dt. Ct. - Invalid under 112,1 for lacking enablement

16. ‘922 Litigation (3) • Fed Cir Affirms Dt. Ct. “The named inventors were not able to achieve even a 20% change a year after filing the application in 1995, and 604% junctions were not achieved until 2008.” • “[t]his field of art has advanced vastly after the filing of the claimed invention. The specification containing these broad claims, however, does not contain sufficient disclosure to present even a remote possibility that an ordinarily skilled artisan could have achieved the modern dimensions of this art. Thus, the specification (only) enabled a marginal advance over the prior art” • Claiming open-ended numerical limitations is not the same as open-ended “comprising” claims which encompass additional elements (as in Energizer”)

17. Lessons for Patentees • You can get a broad claim allowed, but Fed Cir will require enablement of what you have claimed • Consider dependent claims with ranges - e.g. – “wherein the change is between 10% and 12%, nested ranges • Consider alternative independent claims with practical functional limitations (be sure to put in Adequate Written Description) - e.g. “…changes the resistance by an amount sufficient to be reliably detectable and not within a margin of measurement error.” • Do Not Fall into Claim Construction/Enablement Trap - Stick to language of claim - Properly prepare your witnesses

18. Lessons for Defendants • Scenario -- Your device, product method has numerical limitation well beyond examples in patent - May be multidimensional w/multiple numerical ranges, e.g., density > x and hardness > y • Keep in mind that claimed numerical value may be a ceiling - e.g., if claim says “having a surface roughness Ra < 2 nm; maybe you achieved a surface roughness Ra < 0.1 nm using different technology • Build the Claim Construction /Enablement Trap • Inventor & Expert Discovery - See what they feel is encompassed by the numerical limitation - N.B./Caution – Fed Cir. has sais that inventor’s opinion on 112,1 issues is to be given little weight

19. Conclusion • Fed Cir is NOT amused by Patentee “overclaiming” or unreasonably expanding scope of numerical limitation • Patentees need to be careful what they ask for during prosecution and later during claim construction • May be okay to argue that claim is very broad in licensing negotiation; but not okay in litigation • Defendants should always check to see if the claimed numerical limitation provides a foundation for a 112, 1 Affirmative Defense or Counterclaim

20. The End Questions? Thoughts?