1

Defenses Not Based on Prior Art

Indefiniteness

Nonenablement

Written description

Inventorship

Laches

Equitable estoppel

Statute of limitations

Inequitable conduct

Failure to mark

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

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.

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

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

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

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

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?

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?

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

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

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

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

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

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