Functional Claim Language in Patents

Functional Claim Language

After the ARIAD V. LILLY

Reaffirmance of the Lilly

Written Description

Requirement

By Ronald Ward

June 25, 2010

© 2010 Workman | Nydegger

Disclaimer

These materials are public information and have beenprepared solely for educational purposes to contribute to theunderstanding of American intellectual property law. Thesematerials reflect only the personal views of the author and arenot individualized legal advice. It is understood that eachcase is fact-specific, and that the appropriate solution in anycase will vary. Therefore, these materials may or may not berelevant to any particular situation. Thus, the author andWorkman Nydegger, P.C.. cannot be bound eitherphilosophically or as representatives of their various presentand future clients to the comments expressed in thesematerials. The presentation of these materials does notestablish any form of attorney-client relationship with theauthor or Workman Nydegger, P.C. While every attempt wasmade to insure that these materials are accurate, errors oromissions may be contained therein, for which any liability isdisclaimed.

Agenda

• Overview of 35 USC § 112 ¶ 1 and the

“Lilly” Written Description Doctrine

• Review Ariad v. Lilly (2010) (en banc)

Fed. Cir. Decision

• Survey of Recent “Scope of

Enablement” Rejections at BPAI

• Take-Aways

35 USC 112 First ¶

“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 enableany person skilled in the art . . . to make and use the same . . .”

Traditional Written Description

Doctrine

• The traditional written description requirement polices priority or “new matter” violations.

• Until 1997, original claims were treated as having written description support. But see In re DiLeone, 436 F.2d 1404 (CCPA 1971) (asserting the possibility that a specification could enable the use and practice of a broadly claimed invention and still not describe the invention)

“Lilly” Written Description

Doctrine of 1997• In Regents of the University of California v. Eli

Lilly & Company, 119 F. 3d 1559 (1997) the Fed. Cir. stated:

• In Lilly, a description of rat insulin DNA and the human insulin protein, did not support an ORIGINAL claim to the human insulin DNA.

“An adequate written description of a DNA…requires a precise definition, such as by structure, formula, chemical name or physical properties.”


Doctrine of 1997• The “Lilly” Written Description (LWD) doctrine has

been criticized as confusing, redundant with

enablement, and conflicting with claim

construction case law, which permits broad claims.

• For example, in Lizardtech v. Earth Resource

Mapping, 433 F.3d 1373, 1380 (2006) Rader,

dissenting from denial of rehearing en banc, stated:

“In 1997, when this court strayed from the statute (Section 112) and modified the written description requirement, it created the present confusion.”

Ariad v. Lilly (2010)

• Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598

F.3d. 1336, 1349 (Fed. Cir. 2010)(en banc) reaffirmed

the LWD Doctrine:

• Despite a description of molecules that could

hypothetically reduce NF-kB activity (to reduce

symptoms of certain diseases), the specification did

not support an ORIGINAL genus claim to methods

of inhibiting NF-kB activity.

“We now reaffirm that § 112, first paragraph, contains a written description requirement separate from enablement….”


• Rader and Linn dissented vociferously:

• Rader also argued that the LWD doctrine is confusing, lacks statutory support, conflicts with rules for claim construction and blocking patents. Moreover, enablement effectively polices functional language.

• Linn also argued that the LWD doctrine is indistinguishable from the requirements for enablement.

“As it stands, the court’s inadequate description of its written description requirement acts as a wildcard on which the court may rely when it faces a patent that it feels as unworthy of protection.”


The LWD doctrine has been and will continue to

be applied mainly to chemical and biological

arts:

“Perhaps there is little difference in some fields between describing an invention and enabling one to make and use it, but that is not always true of certain inventions, including chemical and chemical-like inventions.

…

The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts..”


However, nothing inherently limits LWD doctrine

to chemical and biological arts:

“[The court’s written description doctrine] has not just been applied to chemical and biological inventions. See LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1343-47 (Fed. Cir. 2005).”


Doctrine of 2010+• Does the USPTO view the LWD doctrine as being

mostly limited to chemical and biological arts?

• Kappos’ blog post of May 5, 2010, comments

favorably on Ariad, stating:

“The Ariad decision is important…because written description is a critical tool for ensuring that an applicant does not claim more than she is entitled to claim…

And the written description doctrine is particularly useful in examining claims that employ functional language…. I…strongly support our examiners using the written description requirement to prevent issuance of such vastly overbroad recitations.”


Doctrine of 2010+• Ariad majority expresses policy concerns with

functional language, stating:

• Dissent’s response:

“The problem [of demonstrating that the applicant has invented species sufficient to support a claim to a genus] is especially acute with genus claims that use functional language… [T]he functional claim may simply claim a desired result, and may do so without describing species that achieve that result.”

“I agree that such claims should be invalid—but enablement polices those claims effectively.”

Does Enablement Effectively

Police Functional Language?

Ex parte Miyazaki, 89 USPQ2d1207 (BPAI 2008)

(precedential) is the real wildcard. A “sheet feeding area” was deemed beyond the scope of

what was enabled in the specification.

26. A large printer comprising:

a sheet feeding area operable to feed a plurality ofpaper rolls ranging in width from 210 mm to 1120 mm, asubstantially flat sheet of paper ranging in length from 420mm to 1580 mm and at least one stiff carton ranging inlength from 420 mm to 730 mm.

Miyazaki (BPAI 2008)

Miyazaki says do not apply § 112, ¶ 6 to

functional language during prosecution:

Although…the recitation of a “sheet feeding area” does not recite sufficient structure…, we decline to use this fact in the midst of prosecution…to rebut the presumption that § 112, sixth paragraph does not apply…. As such, the claim element “sheet feeding area operable to feed” is a purely functional recitation in that there is

-no structure presented in the claim element itself, and we are not required to import structure from the Specification into the claim under 35 U.S.C. § 112, sixth paragraph.

- Nor is there any evidence that one of ordinary skill in the art

could understand such a term to have a definite structural meaning.

Miyazaki (BPAI 2008)

• Miyazaki further applies the reasoning in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946) to find claims reciting functional language unenabled:

• Halliburton was concerned with “conveniently functional language at the exact point of novelty.” Congress responded with § 112, ¶ 6.

“Hence, according to reasoning in Halliburton

[any claim that includes purely functional claim

language] is unpatentable… for lack of an

enabling disclosure commensurate with the

scope of the claims.”

“Scope of Enablement”

Rejections at BPAI

Ex parte Rodriguez (BPAI 2009) (precedential)

1. An apparatus comprising:

a system configuration generator configured to generate a random

system configuration file of a structurally variable and complex system;

a system builder configured to (i) build a system level netlist and (ii)

generate system parameters in response to said random system configuration

file; and

a simulation verification environment configured to verify said

structurally variable and complex system in response to said system level netlist,

wherein said simulation verification environment is configured to provide

automatic random verification of said structurally variable and complex system

in response to said random

system configuration file.


Rejections at BPAI

Ex parte Blattner (BPAI 2009)


Rejections at BPAI

Ex parte Biles (BPAI 2009)

1. A data processing apparatus, comprising:

a plurality of registers for storing items of architectural state;

a plurality of functional units, each functional unit for performing a processingoperation with reference to at least one of said items of architectural state;

at least one of said functional units having a register cache associated therewithhaving one or more cache entries, each cache entry for storing a copy of one of said itemsof architectural state and a register identifier identifying the register containing that item ofarchitectural state; and

control logic for determining a subset of said items of architecturalstate to be copied in said register cache, said subset comprising atleast one item of architectural state which, having regard to theprocessing operation of the functional unit with which said registercache is associated, is likely to be referred to multiple times.


Rejections at BPAI

Ex parte Avinash (BPAI 2009)

1. An image processing system comprising:

a temporal processing unit adapted to generate a first derived

member of a first dataset from two or more acquired members of said

first dataset,

said temporal processing unit further adapted to generate a

first derived member of a second dataset from two or more acquired

members of said second dataset,

said temporal processing unit further adapted to compare said

first derived member of said first dataset and said first derived member

of said second dataset and generate a comparison signal

therefrom.


Rejections at BPAI

Ex parte Duvaut (BPAI 2009)

1. A Digital Subscriber Line (DSL) communications system configured to

provide a power spectral density (PSD) mask for spectral shaping of a dual bit

map (DBM) mode downstream transmission, the PSD mask represented by an

equation:

where PSDDBMsOL represents the PSD mask, KADSL_OL represents a constant value,

C represents a constant value, f represents a frequency of the downstream

transmission, f0 represents a constant value, fLP3dB represents a 3 decibel (dB)

low pass frequency and fHP3dB represents a 3 dB high pass frequency.


Rejections at BPAI

Ex parte Atkin (BPAI 2009)

9. A system for converting a unidirectional domain name to a bidirectional domain

name comprising:

a label definer adapted to establish a plurality of labels within a

unidirectional domain name by using a pre-determined full stop punctuation mark

as a delimiter between said labels, said labels having an original label display order

as encountered from left to right;

an inferencer adapted to, within each said label, resolve the direction of

indeterminate characters by assigning a strong direction left or right to each

indeterminate character; and

a character reorderer adapted to reorder said characters within each

said label of said unidirectional domain name into character display order using

the fully resolved characters previously inferenced, thereby converting said uni-

directional domain name to a bidirectional domain name in which said original

label display order is preserved, and bidirectionality of characters within each

label is produced.


Rejections at BPAI

Ex parte Ripper (BPAI 2009)


Rejections at BPAI

Ex parte Novaes (BPAI 2010)


Rejections at BPAI

Ex parte Chaterlea (BPAI 2010)

Take-Aways

• The LWD doctrine mainly applies to biotech and chemical, but can occasionally apply outside that realm. See, e.g., Lizardtech.

• Ask inventors for more detailed disclosures of invention, including structure and/or algorithms.

• During prosecution you might be forced to change functional language to “means for” language. Make sure the specification will support this change.

• Consider including a set of means for claims as insurance against a “scope of enablement” rejection.

• In litigation, try getting § 112 ¶ 6 to apply to a broad recitation by arguing the same policy concerns raised in Miyazaki, i.e., purely functional language undermines the purpose of § 112 ¶ 6.

Citations and Further Reading

• Citations– Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d. 1336, 1349 (Fed. Cir. 2010)(en banc)

– In re DiLeone, 436 F.2d 1404 (CCPA 1971)

– Regents of the University of California v. Eli Lilly & Company, 119 F. 3d 1559 (Fed. Cir. 1997)

– LizardTech v. Earth Res. Mapping, 424 F.3d 1336, 1343-47 (Fed. Cir. 2005)

– LizardTech v. Earth Res. Mapping, 433 F.3d 1373, 1380 (Fed. Circ. 2006) (rehearing en banc denied)

– Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946)

– Ex parte Miyazaki, 89 USPQ2d1207 (BPAI 2008) (precedential)

– Ex parte Rodriguez, 92 USPQ2D 1395 (BPAI 2009) (precedential)

– Ex parte Blattner, Appeal No. 2008-004648 (BPAI 2009)

– Ex parte Biles, Appeal No. 2008-004383 (BPAI 2009)

– Ex parte Avinash, Appeal No. 2009-1542 (BPAI 2009)

– Ex parte Duvaut, Appeal No. 2009-0867 (BPAI 2009)

– Ex parte Atkin, Appeal No. 2008-4352 (BPAI 2009)

– Ex parte Ripper, Appeal No. 2009-1856 (BPAI 2009)

– Ex parte Novaes, Appeal No. 2008-004794(BPAI 2010)

– Ex parte Chaterlea, Appeal No. 2009-001115 (BPAI 2010)

– David Kappos, Written Description--Little Used Perhaps, But Extremely Useful to Ensure Claims are Appropriately Scoped, David Kappos’ Public Blog (May 5, 2010) (available at http://www.uspto.gov/blog/director/entry/written_description_little_used_perhaps)

• Further Reading– Christopher Holman, Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly

and its Progeny in the Courts and PTO,17 Alb. L.J. Sci. & Tech. 1, 26-78 (2007) (available at http://law.bepress.com/expresso/eps/1723/)

– Donald Chisum, Written Description of the Invention: Ariad (2010) and the Overlooked Invention Priority Principle, 2010 Patently‐O Patent L.J. 72 (available at http://www.patentlyo.com/Chisum.Priority.pdf)

– Karen G. Hazzah, Ex parte Rodriguez (precedential): 112 is the new 101, All Things Pros (December 14, 2009) (available at http://allthingspros.blogspot.com/2009/12/ex-parte-rodriguez-precedential-112-is.html)

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