The document discusses the disclosure requirements for biotechnology patents under 35 U.S.C. § 112, focusing on enablement and written description standards. It outlines the necessity for patent applications to provide sufficient information for a person skilled in the art to make and use the invention without undue experimentation, and highlights significant legal cases that shape these requirements. The text also offers practical tips for drafting patent claims to meet these legal standards effectively.

1. Biotechnology Patents:
Disclosure Requirements under
35 USC § 112
University of Washington
School of Law
Gary M. Myles, Ph.D.
January 29, 2020
(425) 466-8262
gary@mylesip.com
Copyright ©2020, Myles Intellectual Property Law

2. 35 U.S.C. § 112
Enablement and Written Description
• In Re Wright (Fed. Cir. 1993)
• U. of California v. Eli Lilly (Fed. Cir. 1997)
• Enzo v. Gen-Probe (Fed. Cir. 2002), Rader Dissent
• Chiron v. Genentech (Fed. Cir. 2004)
• Rochester v. Searle (Fed. Cir. 2004)
• Ariad v. Lilly (Fed. Cir. 2009), (Fed. Cir., en banc,
2010)

3. • 35 U.S.C. § 112, Specification
– Enablement
– Written Description
– Best Mode
The Statutory Patent Disclosure
Requirements

4. POST-AIA
35 U.S.C. § 112(a)
(a) In General.— 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 … to make and use the same,
and shall set forth the best mode contemplated
by the inventor or joint inventor of carrying out
[[his]] the invention.

5. Enablement – Basic Concepts
 A patent application must provide sufficient
disclosure to enable a person skilled in the art
to make and use the claimed invention
 One skilled in the art would be enabled to
practice the claimed invention if:
• It would NOT require “undue experimentation” to
make and use the claimed invention
• The claims are NOT of “undue breadth” in view of
the scope of the disclosure provided by the
specification

6. Enablement – Basic Concepts
 In re Wands (Fed. Cir. 1988): “The key word is
‘undue,’ not ‘experimentation’ ” Quoting In re
Angstadt (CCPA 1976)
• Quantity of experimentation
• Amount of direction and guidance provided
• Presence or absence of working examples
• Nature of the invention
• State of the prior art
• Relative skill of those in the art
• Predictability of the art
• Breadth of the claims

7. The Problem of Enablement in
Biotechnology
 What is the scope of protection afforded by these
claims?
• A cDNA encoding Protein X, comprising the
nucleotide sequence of SEQ ID NO: 1.
(wherein SEQ ID NO: 1 encodes full-length Protein
X)
• A cDNA encoding Protein X, comprising a nucleotide
sequence that is at least 70% identical to the
nucleotide sequence of SEQ ID NO: 1.
 How easy would it be for a third-party competitor to
escape the literal scope of these claims by “designing
around” with insubstantial nucleotide substitutions?

8. Amgen v. Chugai (Fed. Cir. 1991)
 Teach how to make and use the claimed
invention such that it can be practiced by a
person of skill in the art without undue
experimentation
• Disclosure that is commensurate in scope
with the breadth of the claims
• Multiple working examples within the claim
scope
• Teaching of how to test additional
undisclosed variants within the claim scope

9. Amgen v. Chugai (Fed. Cir. 1991)
 Make and Use Without Undue Experimentation
• Structural Limitations
−Provide algorithms for computing percent
identity
−Describe conservative amino acid
substitutions
• Functional Limitations
−Disclose assay systems and methodologies
for confirming claimed functionality

10. In Re Wright (Fed. Cir. 1993)
 Claim 11
A live, non-pathogenic vaccine for a pathogenic
RNA virus, comprising an immunologically effective
amount of a viral antigenic, genomic expression
having an antigenic determinant region of the RNA
virus, but no pathogenic properties.

11. In Re Wright (Fed. Cir. 1993)
 One Working Example
• A recombinant vaccine that confers
immunity in chickens against Prague Avian
Sarcoma Virus (PrASV), which is an RNA virus
that is a member of the Rous Associated
Virus (RAV) family

12. In Re Wright (Fed. Cir. 1993)
 Federal Circuit
• “… claims are directed to vaccines, and
methods of making and using these
vaccines, which must by definition trigger
an immunoprotective response in the host
vaccinated; mere antigenic response is not
enough”

13. Enablement
 General Rules
• Broad scope requires broad disclosure
• Working examples not required
• Not required to teach “and preferably omits”
what is well known in the art”
(Hybritech v. Monoclonal Antibodies (Fed.
Cir. 1986))

14. Enablement
Historically …
• Enablement was the most onerous
disclosure requirement under 35 USC § 112,
first paragraph

15. UCalifornia v. Eli Lilly (Fed. Cir. 1997)
 UC disclosed:
• Cloned a cDNA encoding rat insulin
• Determined the rat cDNA nucleotide
sequence
• Amino acid sequence of human insulin protein
• General method for obtaining the human
cDNA

16. UC v. Eli Lilly (Fed. Cir. 1997)
 UC claimed:
1. A recombinant plasmid replicable in
procaryotic host containing within its
nucleotide sequence a subsequence having the
structure of the reverse transcript of an mRNA
of a vertebrate, which mRNA encodes insulin.
5. A recombinant procaryotic microorganism
modified so that it contains a nucleotide
sequence having the structure of the reverse
transcript of an mRNA of a human, which
mRNA encodes insulin.

17. UC v. Lilly (Fed. Cir. 1997)
 Federal Circuit Upholds District Court
• Claim 1 invalid
−A description of rat insulin cDNA is not a
description of the broad classes [genra] of
vertebrate or mammalian insulin cDNA
−A description of a chemical genus ‘requires a
precise definition, such as by structure,
formula, [or] chemical name.’ Quoting, Fiers
v. Revel 984 F.2d at 1171
• Claim 5 invalid
−“whether or not [Example 6] provides an
enabling disclosure, it does not provide a
written description of the cDNA encoding
human insulin.”

18. UC v. Lilly (Fed. Cir. 1997)
Written description becomes a super-
enablement requirement, which is
separate and apart from the enablement
requirement

19. Enzo v. Gen-Probe (Fed. Cir. 2002)
 Rader dissent
• UC v. Lilly (1997) was a “deviation from 30
years of precedent”
• Fed. Cir., for the first time, “purported to
apply WD as a general disclosure doctrine in
place of enablement, rather than as a
priority doctrine.”

20. Enzo v. Gen-Probe (Fed. Cir. 2002)
 Rader Dissent
• History of the Written Description
Requirement
−“Written description” first appears in
Patent Act of 1793
−Evans v. Eaton (1822), S. Ct. construed
description requirement to be an
enablement requirement
−JEM AG Supply (2001), S. Ct.
acknowledged only enablement as the
disclosure quid pro quo of Patent Act

21. Chiron v. Genentech (Fed. Cir. 2004)
Feb. 1984 Parent
App. Filed
Discl. 1 MAb
No Chimeric
No Humanized
May 1984
First Chimeric
Antibody
Publication
1985 CIP
App. Filed
Discl. 6 MAb
No Chimeric
No Humanized
1986 CIP
App. Filed
Discl. 6 MAb
No Chimeric
No Humanized
1995 CIP
App. Filed
Discl. 1 MAb
Chimeric & Humanized
Ab Technology
May 1986
First Humanized
Antibody
Publication
Intervening Art
1977
First Monoclonal
Antibody
Publication

22. Chiron v. Genentech (Fed. Cir. 2004)
 ‘561 patent issues with claims directed to
monoclonal antibodies that bind to HER-2
(an antigen associated with breast cancer)
 Chiron sues Genentech for infringement over
sales of Herceptin®, a humanized Ab that
binds to HER-2

23. Chiron v. Genentech (Fed. Cir. 2004)

24. Chiron v. Genentech (Fed. Cir. 2004)
Claims construed to encompass chimeric
and humanized antibodies to HER-2, in
addition to the murine antibodies
disclosed in the 1984, 1985, 1986, and
1995 applications
Parties stipulate that if Chiron is not
entitled to a priority claim under 35
U.S.C § 120, the intervening art
anticipates the ‘561 patent claims

25. Chiron v. Genentech (Fed. Cir. 2004)
Feb. 1984 Parent
App. Filed
Discl. 1 MAb
No Chimeric
No Humanized
(HELD: NO WD)
May 1984
First Chimeric
Antibody
Publication
1985 CIP
App. Filed
Discl. 6 MAb
No Chimeric
No Humanized
(HELD:
NON-ENABLED)
1986 CIP
App. Filed
Discl. 6 MAb
No Chimeric
No Humanized
(HELD:
NON-ENABLED)
1995 CIP (‘561 Patent)
App. Filed
Discl. 1 MAb
Chimeric & Humanized
Ab Technology
(HELD:
ANTICIPATED)
May 1986
First Humanized
Antibody
Publication
Chiron sues Genentech
For Infringement
based on
sale of Herceptin
(Humanized Ab)
Intervening Art
1977
First Monoclonal
Antibody
Publication

26. Chiron v. Genentech (Fed. Cir. 2004)
 Fed. Cir.’s Reasoning
• The 1985 and 1986 applications do not enable
the ‘561 patent claims because:
−Chimeric Abs were “nascent technology
requiring a ‘specific and useful teaching.’ ”
−Undue experimentation required to make and
use the claimed chimeric antibodies
−Enabling disclosure must be commensurate in
scope with claims
◦ Claim reads on chimeric and murine Abs,
yet applications do not disclose chimeric
Abs

27. Chiron v. Genentech (Fed. Cir. 2004)
 Fed. Cir.’s Reasoning, cont.
• The 1984 application does not provide
written description support for the ‘561
patent claims because:
− No disclosure, hence possession, of chimeric or
humanized Ab technologies
− Enablement requirement does not apply to after-
arising technologies

28. U. of Rochester v. Searle (Fed. Cir. 2004)
 Rochester Discloses
• COX-2 gene and protein
• COX-2 is expressed in response to
inflammatory stimuli and is associated with
arthritis
• Screening of compounds to see if they are
capable of selectively inhibiting COX-2
• No actual disclosure of any COX-2 inhibitors

29. U. of Rochester v. Searle (Fed. Cir. 2004)
 Rochester claims
• Methods for selectively inhibiting [COX-2]
activity in a human host, comprising
administering a non-steroidal compound that
selectively inhibits activity of the [COX-2]
gene product to a human host in need of
such treatment
 Searle sued for sale of COX-2 inhibitors
Celebrex® and Bextra®, marketed for
treatment of inflammation

30. U. of Rochester v. Searle (Fed. Cir. 2004)

31. U. of Rochester v. Searle (Fed. Cir. 2004)
 Fed. Cir. upholds invalidity of claims for lack of
written description.
• “[T]he ‘850 patent does not disclose any
compounds that can be used in its claimed
methods. The claimed methods thus cannot
be practiced based on the patent’s
specification, even considering the
knowledge of one skilled in the art.”

32. Ariad v. Lilly (Fed. Cir. 2009)
Ariad Claims:
95. [A method for reducing, in eukaryotic
cells, the level of expression of genes which
are activated by extracellular influences
which induce NF-κB-mediated intracellular
signaling, the method comprising reducing
NF-κB activity in the cells such that
expression of said genes is reduced], carried
out on human cells.

34. Ariad v. Lilly (Fed. Cir. 2009)
 Ariad Disclosed:
• Three classes of molecules
(by function, not structure)
−Specific Inhibitors
−Dominantly interfering molecules
−Decoy molecules

35. Ariad v. Lilly (Fed. Cir. 2009)
 Federal Circuit
• “Regardless of whether the asserted claims
recite a compound, Ariad still must describe
some way of performing the claimed
methods. … the specification suggests
only the use of the three classes of
molecules*** to achieve NF-κB reduction.”
*** The three classes of molecules include
−Specific Inhibitors
−Dominantly interfering molecules
−Decoy molecules

36. Ariad v. Lilly (Fed. Cir. 2009)
 Federal Circuit
“Thus, to satisfy the written description
requirement for the asserted claims, the
specification must demonstrate that Ariad
possessed the claimed methods by sufficiently
disclosing molecules capable of reducing NF-κB
activity.” Citing, Capon v. Eshhar (Fed. Cir. 2005)

37. Ariad v. Lilly (Fed. Cir. 2009)
 Federal Circuit
“A vague functional description and an
invitation for further research does not
constitute written disclosure of a specific
inhibitor.
* * *
written description requires more than a
‘mere wish or plan for obtaining the
claimed chemical invention.’ ” UC v. Eli Lilly

38. Ariad v. Lilly (Fed. Cir. 2009)
 Federal Circuit
• Judge Linn’s Concurrance
“I write separately to emphasize … my belief
that our engrafting of a separate written
description requirement onto 35 USC 112,
paragraph 1 is misguided.
* * *
[S]ection 112, paragraph 1 requires no more
of the specification than a disclosure that is
sufficient to enable a person having
ordinary skill in the art to make and use the
invention.”

39. Ariad v. Lilly (Fed. Cir. 2010) (en banc)
 Federal Circuit
• Opinion joined by every member of the
Court except Linn and Rader
• Reaffirms that there is a separate written
description and enablement requirement
under 35 USC § 112, first paragraph

40. Ariad v. Lilly (Fed. Cir. 2010) (en banc)
 “Particularly for the biological arts,” having a
separate written description requirement
“ensures that when a patent claims a genus by
its function or result, the specification recites
sufficient materials to accomplish that
function.”

41. In Summary …
 35 U.S.C. § 112 (a) -- Specification
• Enablement
− Teach one skilled in the art
− Make and use the claimed invention
− Without undue experimentation
− Disclose nascent technology
• Written Description
− Demonstrate Applicant’s possession of the
claimed invention
− Provide disclosure of structure, formula,
chemical name, or physical properties

42. Practice Tip
Disclosure of Single Embodiments is Risky
Claim Construction
35 U.S.C. § 112 (a)
OK if construed reads on:
· Your commercial product
· Competitor’s commercial product
“Invalid”

43. Practice Tip
Disclose Multiple Embodiments
Claim Construction
35 U.S.C. § 112 (a)
“Not Invalid”

44. Practice Tip
Draft Nested Claims from Broad to Narrow
1. Broad Independent Claim
2. Narrow Dependent Claim
3. Still Narrower Dependent Claim
4. Narrowest “Picture” Claim

45. Stay Tuned …
Thank You!
Gary M. Myles, Ph.D.
gary@mylesip.com
(425) 466-8262