NUMERICAL LIMITS, ENABLEMENT AND CLAIM SCOPE TROUBLE ABOVE AND BELOW AIPLA 1 AIPLA MID-WINTER INSTITUTE IP PRACTICE IN JAPAN COMMITTEE PRE-MEETING TAMPA, FLORIDA JAN 29-30, 2012 NANDA ALAPATI WOMBLE CARLYLE, TYSONS CORNER, VA

General Problem Numerical 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? 2

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 physiological activity, 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 3

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. 4

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 5

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 6

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) 7

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

USP 5,629,922 – (cont’d) 9

10

11

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. 12

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

‘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) 14

‘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. -I nvalid under 112,1 for lacking enablement 15

‘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”) 16

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 17

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 18

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 19

The End Questions? Thoughts? 20