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Written Description

PHOSITA

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Adequate Disclosure: Statute

The specification shall contain a WRITTEN DESCRIPTION of the


invention, and of the manner and process of making and using it, in such full,
clear, concise, and exact terms as to ENABLE any person skilled in the art to
which it pertains, or with which it is most nearly connected, to make and use
the same, and shall set forth the BEST MODE contemplated by the inventor
or joint inventor of carrying out the invention.

35 U.S.C. § 112(a) (AIA); cf. 35 U.S.C. § 112 ¶1 (1952 Act)

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“Written description” refers to . . .

• The PHYSICAL PART of the patent document (i.e., the specification without the
claims) which describes the invention (“Summary of the Invention,”
“Background of the Invention,” “Detailed Description”)

• A PATENTABILITY REQUIREMENT (Ruschig; Vas-Cath)


• To satisfy it, an applicant must convey with reasonable clarity to the
PHOSITA, as of the filing date sought, he or she was in POSSESSION of
the FULL SCOPE of the claimed invention.
• Thus, the WD “must clearly allow [the PHOSITA] to recognize that [the
inventor] INVENTED what is claimed.”

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Two applications of WD requirement:
• LIMITATION ON THE PRESENTATION OF NEW OR AMENDED CLAIMS
DURING PROSECUTION (“PRIORITY POLICING”)
• It serves as a check on applicants who wish to retain their original filing date, but,
AFTER FILING:
• AMEND the originally-filed claims;
• ADD NEW CLAIMS to a pending application; or
• File a CONTINUATION APPLICATION which claims the benefit of an earlier
filed application
• Addresses whether the amended claims in the original application or new claims in the
CON HAVE ADEQUATE SUPPORT in the original specification and, therefore,
are, entitled to the original filing date
• Not contentious

• ADEQUATE SUPPORT FOR ORIGINALLY-FILED CLAIMS


• Has the claimed subject matter been DESCRIBED WITH SUFFICIENT
PARTICULARITY such that a PHOSITA would recognize that the applicant
possessed it’s FULL SCOPE as of the filing date?
• Very contentious

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Gentry Gallery v. Berkline
134 F.3d 1473 (Fed. Cir. 1998)

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Gentry Gallery v. Berkline
134 F.3d 1473 (Fed. Cir. 1998)
A sectional sofa comprising:
a pair of reclining seats disposed in parallel relationship with one another in a
double reclining seat sectional sofa section being without an arm at one end . . . ,
each of said reclining seats having a backrest and seat cushions and movable
between upright and reclined positions . . . ,
a fixed console disposed in the double reclining seat sofa section between the
pair of reclining seats and with the console and reclining seats together
comprising a unitary structure,
said console including an armrest portion for each of the reclining seats; said arm
rests remaining fixed when the reclining seats move from one to another of their
positions, and
a pair of control means, one for each reclining seat; mounted on the double
reclining seat sofa section . . . .

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Gentry Gallery v. Berkline Corp.

Enabled: 2 reclining
seats in a sectional
sofa; controls not
located on arms of
chair
Specification
for Gentry
Enabled Described: pair of
patent reclining seats in a
sectional sofa with a
Described fixed console that
houses the control
means

Claim 1 Claimed: pair of


reclining seats in a
sectional sofa, a fixed
console, and a pair of
controls.
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Commentary on Gentry Gallery
In Gentry Gallery, . . . the patentee came up with an improvement in sofa technology that
allowed two sofa sections side by side to recline. It built a fixed console to house the
controls for the sofa recliner section. When it saw that competitors found other places to
put the controls, it retroactively changed its patent claims to cover any location for the
controls.

A patentee who tries to retroactively fix that isn’t entitled to claim that they owned
the invention all along. They weren’t in possession of the invention they now claim
when they filed their patent. The problem isn’t that the PHOSITA couldn’t make or use
the invention; a reasonable sofa designer could easily imagine a number of places to put
the controls. Rather, the problem is that the patentee didn’t actually think of the genus
they now lay claim to at the time they filed their patent application.

Dmitry Karshtedt, Mark A. Lemley & Sean B. Seymore, The Death of the Genus Claim,
35 HARVARD JOURNAL OF LAW & TECHNOLOGY __ (2021)

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Written Description Problem #1

Described in Application as Filed Claimed in Application as Filed

pine widgets pine widgets


mahogany widgets mahogany widgets
birch widgets birch widgets
poplar widgets poplar widgets
walnut widgets walnut widgets

Can the applicant amend the application to add a claim for oak widgets?

No, even if the applicant actually enabled oak widgets in the application as filed!

(Indeed, oak widgets were probably enabled because the embodiments are all
hardwoods)

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Claimed in amended application

Enabled
(all hardwoods) oak

Described

Original
Claims

pine PHOSITA
mahogany
birch
poplar
walnut

Does the applicant convey with reasonable clarity to the PHOSITA


that, as of the filing date sought, that he or she was in POSSESSION
of the full scope of what is now claimed?
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Written Description Problem #2
• DESCRIBED: A device with wooden widgets
• ENABLED: A device with wooden widgets
• EXEMPLIFICATION: Devices with oak widgets, cedar widgets
• CLAIMED AS FILED:

1. A device comprising wooden widgets.


2. The device of claim 1, wherein said wooden widget is oak.
3. The device of claim 1, wherein said wooden widget is cedar.

** During prosecution, the applicant tries to add the following claim:

4. The device of claim 1, wherein said wooden widget is mahogany.

Permissible?
No. Since mahogany was never mentioned in the original disclosure,
claim 4 will be rejected for lack of written description.

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Lack of Written Description

Enabled subject matter:


Everything the PHOSITA can make
and use from reading the written
Enabled Added description at the time of filing
Claim
Adequately described subject matter:
Described Everything the inventor shows that
he or she possessed at the time of
Original filing
Claim

Actual
Work

PHOSITA

“The added claim lacks adequate support in the application as filed.”

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Written Description Problem #3

CLAIMED AS FILED:

1. A process comprising stirring X and Y in a solvent which is


methanol or ethanol.

DURING PROSECUTION, THE APPLICANT TRIES TO AMEND THE


CLAIM:

1. A process comprising stirring X and Y in a solvent.

• The amended claim is broader than the original one. This


broadening amendment will draw a “lack of written description”
rejection if the amendment is not supported by the original
disclosure.
• Here the amended claim might also draw a “lack of enablement”
rejection.

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Written Description Problem #4
CLAIMED AS FILED:

1. A process comprising stirring X and Y in a solvent which is methanol or


ethanol.

DURING PROSECUTION, THE APPLICANT TRIES TO ADD THE


FOLLOWING GENERIC CLAIM:

2. A process comprising stirring X and Y in a solvent which is an alcohol.

• Addition of the generic claim will draw a “lack of written description”


rejection if it is not supported by the original disclosure.

• Here the amended claim might also draw a “lack of enablement” rejection.

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Written Description Problem #5

CLAIMED AS FILED:

1. A process comprising stirring X and Y in a solvent.

DURING PROSECUTION, THE APPLICANT TRIES TO MAKE A


NARROWING AMENDMENT:

1. A process comprising stirring X and Y in a solvent which is ethanol.

• The narrowing amendment will draw a “lack of written


description” rejection if it’s not supported by the original disclosure
(i.e., if ethanol isn’t specifically mentioned).

• The same holds true if the applicant tries to add a species claim
directed to ethanol.

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Applying the WD requirement to
Claims as Originally Filed
• It was long thought that an original claim stood on its own.
• Indeed, some CAFC judges and commentators argue that applying the WD requirement
to originally filed claims is improper.

Prof. Mueller (ret.) Prof. Holbrook (Emory)

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Applying the WD requirement to
Claims as Originally Filed

Prof. Mueller: “The reason for exemption of originally-filed claims from written description
scrutiny is clear: such claims are part of the disclosure, and by presenting them with the
application as filed, the applicant is signifying her possession of the claimed subject
matter as of that filing date. The claims must, after all, signal ‘the subject matter which the
applicant regards as his invention.’ The filing of a claim in the original application precludes
the possibility that the applicant will wrongly obtain an advantage in examination of that
claim.”

• The turning point was Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559 (Fed. Cir.
1997); subsequently reaffirmed in Ariad.

• WD as applied to originally-filed claims is sometimes referred to as Lilly WD.

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Ariad v. Eli Lilly
598 F.3d 1336 (Fed. Cir. 2010) (en banc)
80. [A method for modifying effects of external influences on a eukaryotic cell, which
external influences induce NF-κB-mediated intracellular signaling, the method
comprising altering NF-κB activity in the cells such that NF-κB-mediated effects of
external influences are modified, wherein NF-κB activity in the cell is reduced]
wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB
recognition sites on genes which are transcriptionally regulated by NF-κB.

• This GENUS claim covers all methods for modulating the NF-κB pathway and is phrased in
terms of the desired result.
• This GENUS claim also covers the use of ALL substances which achieve the claimed result.
• It’s written in functional language, i.e., language that defines something by what it does, rather
then by what it is.
• The functional result here is: reducing NF-κB binding to NF-κB binding sites in response to
external influences.

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Ariad v. Eli Lilly
598 F.3d 1336 (Fed. Cir. 2010) (en banc)
PRINCIPAL EN BANC QUESTIONS:

1. Does § 112(a) contain a WD requirement that’s distinct from enablement?

2. If there is a separate WD requirement, what is its scope and purpose?

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Ariad v. Eli Lilly
598 F.3d 1336 (Fed. Cir. 2010) (en banc)
ISSUES TO DISCUSS:

• Answers to en banc questions

• “Gun jumping”

• Ariad’s effect on biotech and big pharma

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Lilly WD Hypothetical #1
• Inventor discovers the biological pathway responsible for the production of cholesterol which
involves a liver enzyme (X)

• Inventor hypothesizes that substances which can inhibit the enzyme will thus lower
cholesterol

• Before engaging in any experimentation, the inventor files a patent application claiming:

1. A method of lowering cholesterol in humans comprising


inhibiting the activity of X in cells.

This genus claim (written with functional language) would fail the WD requirement under Ariad.
Why?

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Lilly WD Hypothetical #2
¡ Consider a patent application which, as filed, teaches and exem plifies
plastic chopsticks. Claim 1 recites “non-wooden chopsticks.” The
rem aining claim s recite different types of plastic chopsticks. No m ention of
carbon fiber in the patent docum ent. The patent issues with no claim
am endm ents.

¡ The accused product is carbon fiber chopsticks.

¡ Accused infringer raises (lack of) W D as an invalidity defense, asserting


that the patentee didn’t possess carbon fiber chopsticks at the tim e of filing.
There is no enablem ent challenge.

Prof. Holbrook: This is a claim construction/infringem ent issue; not a validity


issue. Claim 1 should be narrowly construed to exclude carbon fiber
chopsticks.

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Lilly WD Hypothetical #3
¡ The application as filed teaches and exem plifies plastic chopsticks.

¡ Claim 1 recites “non-wooden chopsticks.” The rem aining claim s recite


different types of plastic chopsticks. There is no broadening language in
the patent docum ent that encom passes non-wooden chopsticks.

¡ The exam iner balks at claim 1, identifying a genus-species issue— claim 1


covers ALL non-wooden chopsticks— m ore than what’s described in the
patent docum ent (just plastic chopsticks). There’s no enablem ent issue.

¡ W hat type of rejection should the exam iner m ake?

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Lilly WD Hypothetical #3

Prof. Holbrook (Emory) Prof. Karshtedt (GW)

Prof. Anderson (American)

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Lilly WD Hypothetical #3
¡ Prof. Anderson: Judge Lourie would say that claim 1 should be rejected for
lack of W D. Quoting Ariad: “[C]onsider the case where the specification
discusses only com pound A and contains no broadening language of any
kind. This m ight very well enable one skilled in the art to m ake and use
com pounds B and C; yet the class consisting of A, B and C has not been
described.”

¡ Prof. Holbrook: “I think there is an enablem ent problem [like Sitrick].


Insufficient disclosure to support the genus claim .”

¡ Prof. Karshtedt: “[T]he claim s would fail [for lack of] W D under current
doctrine (even as initially filed), but perhaps not under enablem ent.”

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