1. Defenses Not Based on Prior Art  Indefiniteness  Nonenablement  Written description  Inventorship  Laches  Equitable estoppel  Statute of limitations  Inequitable conduct  Failure to mark 1

2. Indefiniteness  Nautilus v. Biosig Instr., 134 S. Ct. 2120 (2014)  Court held that Fed. Cir. standard of “amenable to construction”/”insolubly ambiguous” standard “lacks the precision” required by §112 and was not “probative of the essential” definiteness inquiry  It held that §112 test requires “that a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with “reasonable certainty”  After Nautilus, plausibly construing the terms is not enough to defeat an indefiniteness challenge 2

3. Indefiniteness After Nautilus  Interval Licensing v. AOL, 766 F.3d 1364 (Fed. Cir. 2014)  Key claim language was “unobtrusive manner,” a degree term  Court said a claim “must provide objective boundaries for those of skill in the art.” It held that the phrase “unobtrusive manner” was “highly subjective” and was not supported by adequate guidance in the written description. 3

4. Nonenablement  The patent disclosure is to be "in such full, clear, concise, and exact terms to enable any person skilled in the art to which it pertains, or which it is most clearly connected, to make and use the [invention]."  POSA at time of invention must have been able to use patent specification to make and use full scope of invention without undue experimentation  Cold fusion example 4

5. Enablement cont’d  Full scope of the invention  Scope of disclosure must be commensurate with scope of claims  Courts generally require enablement for a substantial number of the species in the genus  Undue experimentation  Some amount of experimentation to make and use the invention is allowable. Following factors are relevant to whether experimentation is undue:  The time and cost of any necessary experimentation;  How routine any necessary experimentation is in the field  Whether the patent discloses specific working examples of the claimed invention  The amount of guidance presented in the patent  The nature and predictability of the field  The level of ordinary skill in the field  The scope of the claimed invention  Judgment call as to what is undue experimentation -- no bright line  Routine experimentation, even if time-consuming and expensive, is not undue  If a POSA can figure out which species will and which won’t work with just routine experimentation, it’s not undue 5

6. Enablement cont’d  Example  DeKalb v. Northrup King et. al.  DeKalb claimed to be first to succeed in using microprojectile bombardment to transform a particular line of corn cells to produce fertile transgenic corn plants  Technique for creating insect and weed resistant plants  DeKalb patent claims directed to a method for producing fertile transgenic corn plants by “bombarding intact regenerable [corn] cells”  Spec. only described how to transform A188xB73, a particular genotype known to be readily transformable  Claims not limited to particular genotype  Enablement issue: could a POSA produce fertile transgenic corn plants for full scope of invention based on the specification?  If one could show that DeKalb was unable to produce ftcp's for most of the cell lines it tried, that would be good evidence of nonenablement 6

7. Enablement cont’d  GenSci contended the Osteotech patent was not enabled because Osteotech had failed to describe more than a single embodiment of its invention  Osteotech responded that all of the carriers it tried since early days worked  Based on anticipation of a nonenablement argument, Osteotech developed another osteogenic bone graft material using a different polyhydroxy carrier selected from the groups identified in the claims  GenSci failed to show that any of the claimed carriers did not work 7

8. Enablement cont’d  Example  ‘168 patent  Can you construct a nonenablement argument for claims 1 and 6 of the ‘168 patent?  What discovery might you want to do from Hess related to nonenablement? 8

9. Written Description  The written description requirement ensures that the issued claims correspond to the scope of the written description in the original application  The written description requirement is satisfied if a POSA reading the original patent application would have recognized that it describes the full scope of the claimed invention as it is finally claimed in the issued patent and that the inventor actually possessed that full scope by the filing date of the original application  If the claims are construed to cover the accused device, then a POSA would have to conclude based on the application that the inventor had thought of, and was trying to claim, the accused device  Example  ‘168 patent  If '168 patent claims extend to the Beta-Cath system, what argument would you make for lack of written description?  What discovery related to written description might you want to take from Hess? 9

10. Inventorship  To be an inventor, one must make a significant contribution to the conception of at least one or more of the patent claims. Whether the contribution is significant is measured against the scope of the full invention.  Improper inventorship  Joint inventorship  Requirements  Contribute in some significant manner to conception  Make contribution to claimed invention that is not insignificant in quality when compared to dimension of full invention  Do more than merely explain to the real inventors well-known concepts and/or the current state of the art  Law requires only that a co-inventor make a contribution to the conception of the subject matter of a claim  Only minimal level of collaboration between named inventors and putative co- inventors is required  Joint inventors each have right to practice patent 10

11. Laches  Patentee delayed filing suit for an unreasonably long and inexcusable period of time and putative infringer has been or will be prejudiced in a significant way due to the delay  6 year delay creates presumption delay was unreasonable and prejudice resulted  Facts that can excuse an otherwise unreasonable delay  Prejudice  Evidentiary  Economic  Example: Pieczenik knew about infringing activities since 2001, yet waited to sue until 2010 11

12. Equitable Estoppel  Elements are (1) misleading communication by patent holder, (2) reliance by infringer, and (3) material harm to infringer if patent holder allowed to assert claim inconsistent with patent holder's prior misleading communication  Misleading information  Material harm  Evidentiary  Economic  Example 12

13. Statute of Limitations  Under § 286, damages recoverable only for the 6 year period prior to filing suit  Example: Pieczenik could only recover damages for, at most, the period from 2004 to 2010 13

14. Inequitable Conduct  History of inequitable conduct  Equitable defense decided by court  Elements  A person meaningfully involved in the prosecution of the patent withheld material information or submitted materially false information or statements to the PTO during examination of the patent, and  Materiality  But-for test  Threshold level of materiality must be met  That person did so with an intent to deceive the Examiner into issuing the patent  Intent to deceive  Person making false statements knew they were false, or  Person made a deliberate decision to withhold information knowing that it was material  Threshold level of intent must be met  Materiality and intent are weighed to determine if the unenforceability remedy is warranted  Burden of proof  Consequences of finding of inequitable conduct 14

15. Failure to Mark  For product patent, damages accrue on date infringer has both infringed and been notified of the infringement  Marking is constructive notice  Patent holder had burden of showing that it marked substantially all products made under patent  If failed to mark substantially all of its products, damages accrue with actual notice  Not later than date complaint filed  Patent holder has burden 15