Maleficent's Argument

Question 1

Introduction

Answer 1

Good morning your honors
May it please the Court [pause for a nod], my name is Tyler Whittemore, I also represent appellee Maleficent Inc
This is a case about weather inventors can ask the public to perform burdensome experimentation to practice aspects of the invention that the inventors themselves did not and could not at the time of filing
This court should affirm the lower courts answer to this question. Claim 10 is not enabled under § 112 The reasoning is twofold:
First, there is not an inherent upper limit to the unbound range of claim 10
Second, it is further true that reaching the full scope of that claimed invention by determining this value would require undue experimentation under a Wands Factor Analysis.
Because the lower court properly found in favor on both of these points this Court should affirm their finding

Question 2

Now for the inherency issue . . .

Answer 2

The ‘016 patent cites a dosage range but . . .
This Court in Magsil v Hitachi, Anderson v Fiber Composites teach that these ranges are not PER SE not enabled but . . . “MUST BE ABLE TO REACH”
A POSITA at the time of filing would know the following facts, which are uncontroverted from (1) EXPERT TESTIMONY and (2) AND INTRINSIC RECORD
(a) Awakenate is a CNS Stimulant (APPX 002 col 3)
(b) Similar stimulants had failed because of overstimulation (3F Expert APPX 007/PATENT at 002)
(c) Or had not stimulated like the placebo did (APPX 007/Patent at 002 col 3)
Given this set of facts the THERAPEU EFFEC VALUE is not inherent because . . .

Question 3

Transition to Wands

Answer 3

Since this value is not inherent, the key inquiry is whether determining it required undue experimentation.
It does.
Under a Wands analysis there are 8 factors this court has laid out, although not all were raised in the court below and none are mandatory

Question 4

Wands factors

Answer 4

((1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.)

Question 5

First, under a Wands analysis the art was unpredictable at the time of filing

Answer 5

(a) Claim 10 is physiological effect (b) Conssitent with this Court’s precedent (Hogan; Tyler v Boston)
(b) Also consistent with expert testimony – page 7 Hubert = “challenging” and stimulation/oversimulation
(c) THUS THIS FACTOR IS IN MALEFICENTS FAVOR

Question 6

Second – how broad the claims are 

Answer 6

(a) Claims all routes of administration – IV, Intramuscular, oral, topical – intrinsic and express
(b) Broadens the amount of experimentation  pg 2 col 4 of spec- the route of administration further changes the minimum and maximum therapeutic dose
(c) Fails to disclose upper end for the formulation range
(d) Conclude: So Three Fairies must teach the full scope of these broad claims . . .

Question 7

But looking at the specification and working examples (two Wands factors I will consider together) these are woefully inadequate

Answer 7

(e) Despite claiming all routes of administration – only oral dose formulation is considered
(f) AK Steel – the full scope of the claims must be enabled without undue experimentation
(g) Working examples also inadeaute, does not teach:
(h) Species of type of rodent
(i) Weights of the animal
(j) What the oral composition administer WAS
(k) Teaches on pg x that the studies “an effect was observed” (R. at 3, col 5) but does not say how
(l) Finally, the specification was inadequate to inform Three Fairies own experts 

Question 8

Thus given the unpredictability of the art, the broad claims, and the scant guidance of the specification those four factors make clear that the FIFTH AND FINAL Wands factor . . .

Answer 8

experimentation, was undue and this should be resolved in Maleficent’s favor.
In Idenix this court held that iterative trial an derror type experimentation is undue -

Question 9

Conclusion

Answer 9

Because a POSITA would not find the uncited range inherent and each of the 5 Wands factors supports the fact that determining this value would require undue experimentation
AFFIRM