Biotechnology Enablement And Written Description 28 Sep10

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Biotechnology Patent Prosecution – Part 2: Enablement and Written Description

Seattle University School of LawBiotechnology and the Law

Gary M. Myles, Ph.D.

Schwabe, Williamson & Wyatt

September 28, 2010

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35 U.S.C. § 112, ¶ 1 Written Description, Enablement, and Best Mode

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 of carrying out his invention.

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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

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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

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Enablement and Claim Breadth• Disclosure:

– Immunization of a mouse with protein x– Isolation of a murine monoclonal antibody directed

against protein x– Demonstration that the murine monoclonal antibody

induced apoptosis in a cell expressing protein x on its surface

– Methodology for generating fully-human antibodies via phage display and transgenic mice

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Enablement and Claim Breadth• Claims (What is enabled? What provides the broadest scope of

protection?):– “An antibody directed against protein x wherein said antibody

induces apoptosis in a cell expressing protein x.”– “A human antibody directed against protein x wherein said

antibody induces apoptosis in a cell expressing protein x.”– “A composition, comprising: an antibody directed against protein

x.”– “A pharmaceutical composition, comprising: an antibody directed

against protein x.”– “A vaccine, comprising: an antibody directed against protein x.”– “A method of inducing apoptosis in a cell expressing protein x,

said method comprising the step of contacting said cell with an antibody directed against protein x… .”

– “A therapeutic method for the treatment of a disease associated with the expression of protein x.”

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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?

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Degeneracy of the Genetic CodeDegeneracy of the Genetic Code

GGT Gly (G)GGC " GGA " GGG "

GAT Asp (D)GAC " GAA Glu (E)GAG "

GCT Ala (A)GCC " GCA " GCG "

GTT Val (V)GTC " GTA " GTG "

G

AGT Ser (S)AGC " AGA Arg (R)AGG "

AAT Asn (N)AAC " AAA Lys (K)AAG "

ACT Thr (T)ACC " ACA " ACG "

ATT Ile (I)ATC " ATA " ATG Met (M)

A

CGT Arg (R)CGC " CGA " CGG "

CAT His (H)CAC " CAA Gln (Q)CAG "

CCT Pro (P)CCC " CCA " CCG "

CTT Leu (L)CTC " CTA " CTG "

C

TGT Cys (C)TGC TGA Ter TGG Trp (W)

TAT Tyr (Y)TAC TAA Ter TAG Ter

TCT Ser (S)TCC " TCA " TCG "

TTT Phe (F)TTC " TTA Leu (L)TTG "

T

GACT

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Amgen v. Chugai (Fed. Cir. 1991)• Amgen’s patent to recombinant EPO

– Claim 7: A purified and isolated DNA sequence consisting essentially of a DNA sequence encoding a polypeptide having an amino acid sequence sufficiently duplicative of that of erythropoietin to allow possession of the biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells, and to increase hemoglobin synthesis or iron uptake.

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Amgen v. Chugai (Fed. Cir. 1991)

• District Court held claim 7 invalid for lack of enablement– Over 3,600 different EPO analogs can be made by

substituting a single amino acid at each position– Elliott deposition: He did not know whether the 50-80

EPO analogs made by Amgen retained the functional properties

– Lack of predictability in the art• After five years of experimenting, Amgen did not know which

analogs retain the claimed functional properties– Amgen did not provide a teaching commensurate with

the claim scope

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Lessons from Amgen• Bottom line: Teach how to make and use the

claimed invention to a PHOSA so that it can be practiced without undue experimentation– Provide a disclosure that is commensurate in scope

with the breadth of the claims– Provide multiple working examples within the claim

scope– Provide adequate teaching of how to test additional

undisclosed variants within the claim scope• Structural Limitations

– Provide algorithms for computing percent identity– Describe conservative amino acid substitutions

• Functional Limitations– Disclose assay systems and methodologies for confirming

claimed functionality

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Practice TipDisclosure of Single Embodiments is Risky

Claim Construction

35 U.S.C. § 112, ¶1

OK if construed reads on:· Your commercial product· Competitor’s commercial product

“Invalid”

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Practice TipDisclose Multiple Embodiments

Claim Construction

35 U.S.C. § 112, ¶1

“Not Invalid”

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Practice TipDraft Nested Claims from Broad to Narrow

1. Broad Independent Claim

2. Narrow Dependent Claim

3. Still Narrower Dependent Claim

4. Narrowest “Picture” Claim

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Enablement

• General Rules– 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))

– Broad scope requires broad disclosure– A deposit may suffice where difficult to disclose

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Enablement

• Historically … – Enablement was the most onerous description

requirement under 35 USC § 112, first paragraph

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U. of California v. Eli Lilly (Fed. Cir. 1997)

• Facts– UC disclosed:

• Cloned and sequenced a cDNA encoding rat insulin• Amino acid sequence of human insulin protein• General method for obtaining the human cDNA

– 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.

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U. of California v. Lilly (Fed. Cir. 1997)

• District Court – Held claims invalid under § 112, ¶ 1,

because “the specification, although it provided an adequate written description of rat cDNA, did not provide an adequate written description of the cDNA required by the asserted claims.”

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• 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.”

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• Written description becomes a super-enablement requirement, which is separate and apart from the enablement requirement

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Enzo v. Gen-Probe (Fed. Cir. 2002)• Rader et al. 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.”

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Enzo v. Gen-Probe (Fed. Cir. 2002)

• Rader et al. dissent– UC v. Lilly (1997) was a “deviation from 30

years of precedent”• “Under the correct written description test, one of

skill in the art would have recognized that the ‘525 patent in Lilly had no new matter or priority problems. In terms of the statutory test for adequacy of disclosure, the patent disclosure undoubtedly warranted rejection for lack of enablement.”

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• 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

• J.E.M. AG Supply (2001), S. Ct. acknowledged only enablement as the disclosure quid pro quo of Patent Act

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Enzo v. Gen-Probe (Fed. Cir. 2002)• Rader Dissent, cont.

– In re Ruschig (1967), CCPA first separated new WD requirement from enablement

• To police priority: Whether new claim/amended claim entitled to priority

• Converted § 132 new matter rejection into § 112 WD rejection

• “The function of the description requirement is to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.” Judge Rich

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• Rader Dissent, cont.– In re Kaslow (Fed. Cir. 1983)

• “The test for determining compliance with the WD requirement is whether the disclosure of the application as originally filed reasonably conveys to the artisan that the inventor had possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claim language.”

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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

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• 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

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• 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.”

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Historical Perspective on Continuation Practice

• Pre-GATT– Before June 7, 1995, when US patent term

was 17 years from date of issue, continuations (CONs), and continuations-in-part (CIPs) attractive

– Submarine Patents• Inventor Lemelson• Policy/fairness concerns

17 YRS17 YRS

17 YRS

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Historical Perspective on Continuation Practice

• Post-GATT– Since June 8, 1995, US patent term is 20

years from date of first filing, making CONs and CIPs less attractive

20 YRS from 1st filed application

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The Priority Claim

• 35 U.S.C § 120. Benefit of Earlier Filing Date in the United States– “An application for patent for an invention

disclosed in the manner provided by the first paragraph of section 112 of this title in an application previously filed in the United States … shall have the same effect, as to such invention, as though filed on the date of the prior application.”

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What Does 35 U.S.C. § 120 Mean?

• A claim in a CON or CIP application that claims priority to a parent application is valid under 35 U.S.C. § 112, ¶1 if the priority document: – Is enabling (make and use) of the claim– Provides written description (possession)

support for the claim• Supports a policy of providing broad

protection for pioneering inventions

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In re Hogan (CCPA 1977)

• 1953: Hogan filed a patent application disclosing how to “make and use” (i.e. enabled) a crystalline form of a “solid polymer”

• 1962: Prior art described an amorphous form of the “solid polymer”

• 1971: Hogan filed a continuation application claiming priority to the 1953 patent application and claimed a “solid polymer” that read on both the crystalline and amorphous forms

1953

1962 -- Prior Art

1971

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• Patent Office concluded that claims recited in the 1971 application were invalid as non-enabled by the specification under § 112, ¶1 because the amorphous form was not disclosed in 1953 application

• CCPA reversed and directed the Patent Office to consider whether the 1953 application was enabling in view of the state of the art in 1953

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• CCPA: “[I]f appellant’s 1953 application provided sufficient enablement considering all available evidence … of the 1953 state of the art … the fact of that enablement was established for all time and a later change in the state of the art cannot change it”

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In re Hogan (CCPA 1977)• Disclosure of the amorphous form of the solid polymer

in the 1953 application would have been an impossible burden on inventors and the patent system

• Restricting patentee to the crystalline form disclosed would be a poor way to stimulate invention and would not encourage early disclosure

• To demand such restriction is merely to state a policy against broad protection for pioneer inventions, a policy both shortsighted and unsound from the standpoint of promoting progress in the useful arts, the constitutional purpose of the patent laws

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• Basic message of Hogan

– Cannot use the post-filing state of the art to invalidate a patent claim that was fully supported under 35 U.S.C. § 112, ¶ 1 at the time of filing

– This is true whether claims issued from an original filing or from a CON claiming priority to an earlier patent application under 35 U.S.C. § 120

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Rasmusson v. SmithKline (Fed. Cir. 2005)

• State of the Art– Testosterone and dihydrotestosterone

(DHT) are androgens (a class of hormones)

– High levels of DHT are associated with prostate cancer

– 5αR converts testosterone to DHT; therefore, inhibitors of 5αR had been sought for the treatment of prostate cancer

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• State of the Art– Two types of 5αR inhibitors:

• “Multipurpose” – block both DHT and testosterone

• “Selective” – decrease levels of DHT (e.g., finasteride).

– In 1987, finasteride was known to be a selective 5αR inhibitor.

– Evidence existed in the art supporting the use of multipurpose inhibitors to treat prostate cancer.

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• Rasmusson application – Ninth (filed 2Jun95) in a series of applications

(earliest filed 3Apr87)– Disclosed but provided no data on finasteride

activity against prostate cancer

• SmithKline had two patents and related reissue applications with priority to 27Jun90

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• Interference Count: Method of treating prostate cancer in a human with finasteride

• BPAI found Rasmusson was not entitled to priority claim to earlier filed applications for lack of enablement and WD

• BPAI also found SmithKline patent not

anticipated by related published Rasmusson EP application

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• Federal Circuit Upholds Invalidity of Rasmusson Claims– Reason to doubt the objective truth of the

statement that finasteride could be used to treat prostate cancer

– For priority date, Rasmusson needed to provide experimental proof that his invention could be effective in treating cancer

– “Mere plausibility” or “Respectable Guess at Likelihood of Success” or “Mere Proposal of an Unproved Hypothesis” is not the test for enablement under §112.

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• Novelty and the Enablement Requirement– An invention is novel unless

• a single prior art reference discloses every element (expressly or implicitly) of a challenged claim, and

• the reference enables one skilled in the art to make the invention– Enablement standard for an anticipatory reference is different

from the enablement standard for a patent disclosure under §112

– §102 does not require an anticipatory disclosure to enable how to “use” as required by §112 for patentability.

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• Federal Circuit– Proof of efficacy is not required to in order for

a reference to be enabled for purposes of anticipation.

– Remanded to determine whether EP ‘383 anticipates the SKB patents and applications as well as Rasmusson’s application.

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Chiron v. Genentech (Fed. Cir. 2004)

Feb. 1984 Parent App. Filed

Discl. 1 MAbNo Chimeric

No Humanized

May 1984First Chimeric

Antibody Publication

1985 CIP App. Filed


No Humanized

1986 CIP App. Filed


No Humanized

1995 CIPApp. Filed

Discl. 1 MAbChimeric & Humanized

Ab Technology

May 1986First Humanized


Intervening Art

1977First Monoclonal


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• ‘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

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• 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

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Feb. 1984 Parent App. Filed


No Humanized(HELD: NO WD)

May 1984First Chimeric


1985 CIP App. Filed


No Humanized(HELD:

NON-ENABLED)

1986 CIP App. Filed


No Humanized(HELD:

NON-ENABLED)

1995 CIP (‘561 Patent) App. Filed

Discl. 1 MAbChimeric & Humanized

Ab Technology(HELD:

ANTICIPATED)

May 1986First Humanized


Chiron sues GenentechFor Infringement

based on sale of Herceptin(Humanized Ab)

Intervening Art

1977First Monoclonal


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• 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

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• 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

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After-Arising Technologies: Lingering Questions Post-Chiron

OriginalApplication

Invalid

After-Arising Technology

CIP

Continuation

???

???

• Would the outcome in Chiron had been different if:• The original application had matured into a patent?• If the subsequent application had been a CON rather than a CIP?

Prior Art

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Ex parte Kubin (BPAI 2007)

• Invention – A cDNA encoding a human cell surface protein (“NAIL”)

expressed on Natural Killer cells

• Disclosure– Existence (but not sequence) of the polypeptide (“p38” or “NAIL”)

– mAb specific for NAIL

– Prophetic example of how to clone NAIL cDNA using the mAb

– Cloning of mouse homolog (unrecognized as ortholog)

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• Examiner Rejects Claim 73 under Written Description Requirement73. An isolated nucleic acid molecule

comprising a polynucleotide encoding a polypeptide at least 80% identical to amino acids 22-221 of SEQ ID NO:2, wherein the polypeptide binds CD48.

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• Kubin argues– Disclosure of the functional domains of the

NAIL sequence and generic disclosure of conservative amino acid substitutions satisfies Eli Lilly’s “representative number of species” requirement

– Examiner requires disclosure of every amino acid sequence variant falling within the scope of the claim (microscopic approach)

– Examiner’s rejection is contrary to PTO Written Description Guidelines


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Ex parte Kubin (BPAI 2007)• Written Description Requirement: PTO Guidelines

– Example 11 – a sequence that shares percent identity with another sequence

• Exemplary claims:

– Claim 1: An isolated nucleic acid that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2.

– Claim 2: An isolated nucleic acid that encodes a polypeptide with at least 85% amino acid sequence identity to SEQ ID NO: 2; wherein the polypeptide has activity X.

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Ex parte Kubin (BPAI 2007)• Written Description Requirement: PTO Guidelines

– Example 11 – a sequence that shares percent identity with another sequence

• Exemplary specification fails to disclose domains that are critical to activity X

• Acknowledges that skilled artisan can use computer to identify all nucleic acids encoding a polypeptide sharing 85% sequence identity with SEQ ID NO: 2

• Concludes that specification satisfies written description requirement for claim 1, but not for claim 2

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• Board affirmed Examiner’s rejection based on Written Description requirement of 35 U.S.C. §112, first paragraph– No express disclosure of any “variant” by

• Disclosure of NAIL protein domains– Signal peptide, extracellular domain (CD48 binding domain),

transmembrane domain, cytoplasmic domain• Generic disclosure of conservative amino acid substitutions

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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.

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• District Court– Held claims infringed and not invalid for

anticipation, lack of enablement, and lack of written description

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• Federal Circuit– In Rochester v. Searle, held similar method

claims invalid for lack or written description“A method 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.”

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• Federal Circuit– Rochester v. Searle, cont.– Patent disclosure did not disclose any suitable

compounds– Moreover, “Rochester did not present any

evidence that the ordinarily skilled artisan would be able to identify any compound based on [the specification’s] vague functional description.”

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• 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

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• 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.” Capon

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• 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

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• 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.”

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• Ariad appeals to Federal Circuit for en banc review– Whether 35 U.S.C. § 112, ¶ 1, contains a written

description requirement separate from an enablement requirement

– If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

• On August 21, 2009, Federal Circuit grants en banc review, vacating the court’s April 3, 2009 opinion

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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

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• A separate written description requirement “plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described.”

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• And “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.”

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• “Generic claim language appearing in ipsis verbis in the original specification does not satisfy the written description requirement if it fails to support the scope of the genus clamed.”

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• “A generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”

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Practice Tips

• Specification– Support broad claims with multiple actual and

prophetic examples representative of the full claim scope

– Including a description of “nascent technologies” in all original and all subsequently filed provisional and CIP applications

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Practice Tips

• Specification– For scope, need: structure, formula, chemical

name, or physical properties• Domains, multiple species, active variants

– Functional language requires more to show “possession”

• Particularly when single species disclosedVALID: An isolated protein comprising SEQ ID NO:3VALID: An isolated variant having at least 95% identity

to SEQ ID NO:3.INVALID: An isolated variant having at least 95%

identity to SEQ ID NO:3 that binds receptor Z.

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Practice Tips

• Claiming Priority– § 120’s usefulness and reliability has been

eroded by CAFC interpretations of § 112 enablement and written description requirements in Chiron and other post-Hogan cases

– Avoid CIPs (and CONs) to mitigate effect of a failed 35 U.S.C. § 120 priority claim

– Prosecute claims in originally-filed application … then RCE … then CON; avoid relying on subsequently filed applications

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Practice Tips

• New Matter– If new matter to be disclosed in a CIP is

patentably distinct from that in the original application, file a new patent application

– If the new matter is in fact the same invention as disclosed in the original application, update by incorporating description of nascent technology

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Practice Tips

• Claim Drafting– Broad claims Better claims≠– The goal is to get valid claims that will read

on an infringing device• Because the infringing device is

unforeseeable, draft nested dependent claims that progressively narrow toward the disclosed embodiment(s)

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In Summary …

• 35 U.S.C. § 112, ¶ 1 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

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Thank You!

Gary M. Myles, Ph.D.Schwabe, Williamson & Wyatt

[email protected](206) 407-1513

mailto:[email protected]

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ICU v. Alanis (Fed. Cir. 2009)

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Goeddel v. Sugano (Fed. Cir. 2010)

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Laryngeal v. Avbin (Fed. Cir. 2010)

Documents

Biotechnology Enablement And Written Description 28 Sep10