american conference institute’s pharma/biotech patent ... · property, xencor, inc. (monrovia,...

* From the company that brings you Biotech Patents and Maximizing Pharmaceutical Patent Life Cycles

American Conference Institute’s

Leading patent practitioners, counsel and industry experts will provide you with the most up-to-date information on:

• The STATUS of Tafas v. Dudas and the FATE of the USPTO Claims and Continuation Final Rule

• ANALYZING the interplay between critical rules and proposed legislation that impact patent drafting and prosecution strategies

• RETHINKING your view on restrictions and making them work in favor of your patent strategy

• EMPLOYING evolving canons of claim construction to your advantage

• ENSURING satisfaction of the enablement/written description requirements

• OVERCOMING obviousness rejections in the face of shifting standards

• ADJUSTING timing strategies to maximize options in an ever changing statutoryand rulemaking environment

• DRAFTING claims that cover the proper scope in light of constraints on claim language

February 25-26, 2008 • The Carlton on Madison Avenue • New York, NY

Distinguished Co-Chairs:

Robin M. SilvaPartner, IntellectualProperty Practice GroupMorgan, Lewis &Bockius LLP(San Francisco, CA)

Joyce L. MorrisonVice President, IntellectualProperty, Xencor, Inc.(Monrovia, CA)

USPTO Speaks:

Bruce KisliukDirector, TechnologyCenter 1600United States Patent and Trademark Office(Alexandria, VA)

MASTER CLASS • Wednesday, February 27, 2008

Perfecting Claim Drafting and Prosecution in Life Sciences Patent Applications

Media Partners:

Athersys, Inc.

Hoffmann-La Roche Inc.

Johnson & Johnson

Medarex, Inc.

Novo Nordisk Inc

Schering-PloughCorporation

Vertex PharmaceuticalsIncorporated

Xencor, Inc.

Featuring Exceptional Faculty From:

REGISTER NOW • 888-224-2480 • AmericanConference.com/claimdrafting

Pharma/Biotech PatentCLAIM DRAFTING & PROSECUTION

Pharma/Biotech PatentCLAIM DRAFTING & PROSECUTION

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CLEETHICS

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Creative Strategies for a Rapidly Evolving Patent Landscape

The already complex tasks of claim drafting and patent prosecution inlife sciences are now infinitely more difficult because of the many patentreforms taking place and new ones on the horizon. Patent practitionershave to contend with sweeping new USPTO rules regarding limitationsto continuations and changes to the number of claims permitted in theapplication, evolving case law impacting obviousness standards, writtendescription, enablement, and inequitable conduct, and more proposednew rules. Pending challenges to the rules, patent reform legislation, andproposals from the USPTO create a perfect storm of uncertainty,unpredictability, and complexity.

The impact of these changes is staggering, especially on the life sciencesindustries. To stay ahead of the curve, you must rethink how you draftyour claims. Additionally, you need to develop creative strategies forprosecuting patents, including filing continuations carefully, usingrestrictions differently and changing the timing of filings.

With the needs of pharmaceutical and biotech companies in mind, ACI has developed Pharma/Biotech Patent Claim Drafting andProsecution: Creative Strategies for a Rapidly Evolving PatentLandscape. Our unparalleled faculty of leading in-house representativesand experienced patent practitioners will bring you the latest legalstrategies, tactics, and solutions for successfully protecting innovation inthis new patent regime.

Add value to your attendance by taking advantage of our Master Class:Perfecting Claim Drafting and Prosecution in Life Sciences PatentApplications. In this practical interactive Master Class, you will get theunique opportunity to drill down on everything you learned during themain conference and apply it in a mock patent drafting scenario.

REGISTER NOW by calling 888.224.2480 ; by faxing your registration form to 877.927.1563 ; or registering online atwww.americanconference.com/claimdrafting.

Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/claimdrafting

Day 1 – Monday, February 25, 2008

• Emerging Patent Reforms: What You Need to Know Now• Revisiting Restriction Practice: Weighing the Cost-Benefit of

Making Restrictions Work in Favor of Your Patent Strategy• Innovative Approaches for Identifying Patentable Subject Matter

to Optimize Protection• Evolving Canons of Claim Construction and Application

– the Post-Philips/Festo World • Aligning Your Patent Timing Strategies With Business Objectives

in Order to Maximize Your Patent Lifecycle • Avoiding Allegations of Inequitable Conduct When Prosecuting

Patent Applications

Day 2 – Tuesday, February 26, 2008

• Preventing Obviousness Rejections post-KSR and its Progeny

• Getting it Right the First Time: Best Practices for Demonstrating Utility

• Surviving 35 USC §112 Rejections: Written Description,Enablement and Best Mode

• Drafting Claims to Include Varying Degrees of Scope

• USPTO Speaks

• Wrap Up and Interactive Strategy Session: Pulling it all Together to Secure Effective Coverage of Inventions in the Current Patent Environment

Richard BermanPartner, Arent Fox LLC(Washington, DC)

Anne Brown, Ph.D.Senior Director Intellectual PropertyAthersys, Inc. (Cleveland, OH)

Michele A. Cimbala, Ph.D. Director, Sterne, Kessler, Goldstein& Fox P.L.L.C. (Washington, DC)

Lisa A. Dixon, Ph.D. Senior Patent Counsel II, VertexPharmaceuticals Incorporated(Cambridge, MA)

Thomas J. Dodd Senior Patent Counsel, Johnson & Johnson (New Brunswick, NJ)

Paul F. FehlnerPartner, Baker Botts L.L.P. (New York, NY)

James F. Haley, Jr.Partner, Ropes & Gray LLP (New York, NY)

Kim R. JessumOf Counsel, Stradley Ronon Stevens& Young, LLP (Philadelphia, PA)

Bruce KisliukDirector, Technology Center 1600United States Patent and TrademarkOffice (Alexandria, VA)

Thomas J. KowalskiPartner, Frommer Lawrence & Haug LLP (New York, NY)

Jeffrey A. Lindeman, Ph.D.Partner, Nixon Peabody LLP(Washington, DC)

Deborah Lu, Ph.D.Patent Attorney, Frommer Lawrence& Haug LLP (New York, NY)

Janet M. McNicholas, Ph.D.Member, Bell, Boyd & Lloyd LLC(Chicago, IL)

Joyce L. MorrisonVice President, Intellectual PropertyXencor, Inc. (Monrovia, CA)

Jonathan P. O’Brien, Ph.D. Principal, Miller, Canfield, Paddock and Stone, P.L.C.(Kalamazoo, MI)

Kimberly Prior Senior Counsel, Hoffmann-LaRoche Inc. (Nutley, NJ)

Jane E. RemillardPartner, Lahive & Cockfield, LLP(Boston, MA)

David B. SchramSenior Intellectual Property CounselMedarex, Inc. (Princeton, NJ)

Harry B. ShubinPartner, Millen, White, Zelano & Branigan, P.C. (Arlington, VA)

Robin M. SilvaPartner, Intellectual PropertyPractice Group, Morgan, Lewis &Bockius LLP (San Francisco, CA)

Len S. SmithSenior Intellectual Property CounselNovo Nordisk Inc (Princeton, NJ)

Immac J. Thampoe, Ph.D. (“Casey”)Senior Director – Patent Law Schering-Plough Corporation(Kenilworth, NJ)

George F. WheelerShareholder, McAndrews, Held & Malloy, Ltd. (Chicago, IL)

Warren D. WoessnerFounding Shareholder, Schwegman,Lundberg & Woessner, P.A.(Minneapolis, Minnesota)

Hal WoodrowSenior Patent Counsel, Johnson & Johnson (New Brunswick, NJ)

Donald L. Zuhn, Jr., Ph.D. Partner, McDonnell Boehnen Hulbert& Berghoff LLP (Chicago, IL)

SPEAKER FACULTYNew Rules, New Cases,

New Laws =New Patent Strategies

AGENDA-AT-A-GLANCE


Day 1 – Monday, February 25, 2008

8:00 Registration and Continental Breakfast

9:00 Co-Chairs’ Opening Remarks

Robin M. SilvaPartner, Intellectual Property Practice GroupMorgan, Lewis & Bockius LLP(San Francisco, CA)

Joyce L. MorrisonVice President, Intellectual Property, Xencor, Inc.(Monrovia, CA)

9:15 Emerging Patent Reforms: What You Need to Know Now

Michele A. Cimbala, Ph.D. Director, Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

Thomas J. Dodd Senior Patent Counsel, Johnson & Johnson(New Brunswick, NJ)

Hal WoodrowSenior Patent Counsel, Johnson & Johnson(New Brunswick, NJ)

In this session, a distinguished panel of experts will examine the specific changes to patent rules and standards over the past year and set the stage for the deeper strategic discussions to follow over the next two days.

• Maximizing your options to protect your invention under a torrent of USPTO rules- continuations, RCE practice, limits on claim numbers:

where do these stand? - analysis of Tafas v. Dudas

• Coordinating patent filings with new proposed rulesrequiring more extensive IDS submissions

• Planning for proposed rule changes to Markush practice- how would limiting claims to a single invention

impact claiming overall• Successfully filing appeals under USPTO proposed

new appeal rules• Implications of the Patent Reform Act of 2007 on your

patent prosecution practices- switching to First to File system - granting PTO discretion in ordering search reports- allowing for a post-grant review- open examination permitting anyone to submit prior art- discretion to certify interlocutory appeals of claim

construction decisions- pleading inequitable conduct with specificity - giving the PTO regulatory power to make rule changes

11:00 Morning Coffee Break

11:15 Revisiting Restriction Practice: Weighing theCost-Benefit of Making Restrictions Work inFavor of Your Patent Strategy

Jane E. RemillardPartner, Lahive & Cockfield, LLP(Boston, MA)

David B. SchramSenior Intellectual Property Counsel, Medarex, Inc.(Princeton, NJ)

Harry B. ShubinPartner, Millen, White, Zelano & Branigan, P.C.(Arlington, VA)

• Comparing previous restrictions from the USPTO with how the examiners are restricting claims today- election of species requirements

• Contending with unwanted restrictions from the PTO- challenging the restriction- proceeding with multiple divisionals- rejoinders- selecting what to proceed with if there are

budgetary constraints- preparing the record for appeal

• How much precision is required in claim descriptions to prevent restrictions

• Deciding whether you WANT restrictions in the currentpatent environment- using restrictions to provide relief for obtaining new claims- strategies for requesting restrictions

• Managing the increased financial burden with multiple restrictions - communicating the need for restrictions and the

added cost to the decision makers

12:45 Networking Lunch

2:00 Innovative Approaches for Identifying PatentableSubject Matter to Optimize Protection

Richard BermanPartner, Arent Fox LLC(Washington, DC)

• Deciding on the right subject matter to claim - identifying patentable subject matter and limitations

on the scope• Establishing what you are trying to protect

- compounds- formulations- methods of use

� treatment claims� diagnostic claims� research tool claims

- methods of manufacture

Who You Will Meet

• Patent Attorneys and Agents from:

- Pharmaceutical, Biotechnology andBiopharmaceutical Companies

• Intellectual Property Professionals in the Life Sciences Industries

• Law Firm Patent Counsel and TechnologySpecialists representing pharma/biotech companies


• Claiming by function without raising issues of inherentanticipation and lack of written description

• Streamlining the claims to include only the subject matterothers must use to practice the technology

• Impact on life sciences of recent case law - In re Comiskey (finding claims relating to arbitration

processes unpatentable)- In re Nuitjen (holding signal not patentable if it

was not connected to a specific type of technology)• Defining and filing claims with families

2:45 Evolving Canons of Claim Construction andApplication – the Post-Philips/Festo World

Warren D. Woessner Founding Shareholder, Schwegman, Lundberg & Woessner, P.A. (Minneapolis, Minnesota)

• Philips Rules – Using intrinsic and extrinsic evidence to construe claims- specifications and prosecution history forward

and backwards- dictionary wars- expert testimony

• Employing “special definitions” to your advantage- the effect of “trash talk” and unconditional surrender

• How to import limitations from the specification into the claims (or keep them out)

• Preserving and applying the remnants of the doctrine of equivalents- claim amendments – effective or just restrictive?- the end of the road for Festo (and the DOE)?- Amgen v. Hoescht – what went wrong?

3:30 Afternoon Refreshment Break

3:45 Aligning Your Patent Timing Strategies With Business Objectives in Order to Maximize Your Patent Lifecycle

Lisa A. Dixon, Ph.D. Senior Patent Counsel II, Vertex Pharmaceuticals Incorporated (Cambridge, MA)

Jonathan P. O’Brien, Ph.D. Principal, Miller, Canfield, Paddock and Stone, P.L.C. (Kalamazoo, MI)

• Clarifying with the business executives the end goal of the patent and adapting timing strategies accordingly

• Conducting a risk/benefit analysis of early vs. later filing• Determining whether a year from the provisional is

sufficient to fully develop the inventive concepts of the technology- identifying alternatives if you need more time

• When to file the first application- key information needed to determine that there

is enough research to get sufficient scope

• Avoiding specific disclosures early on to prevent creatingprior art for the invention

• Adjusting timing strategies based on new and proposed rules • Communicating with the inventors and scientists –

preventing or working around premature publication

4:45 Avoiding Allegations of Inequitable ConductWhen Prosecuting Patent Applications

Jeffrey A. Lindeman, Ph.D.Partner, Nixon Peabody LLP(Washington, DC)

• Does the Federal Circuit’s inequitable conduct analysissquare with the USPTO's Duty of Disclosure?

• Materiality, Intent and the totality of the circumstancesunder the current standard for inequitable conduct

• Rule 1.56 obligations during prosecution and their relation to inequitable conduct findings- disclosure to patent office- materiality and intent requirement- prosecution and litigation issues

• The USPTO’s New & Proposed Rules - considerations for Examination Support Documents,

Information Disclosure Statements, etc.• Analysis of key inequitable conduct decisions, including

- McKesson Information Solutions, Inc. v. Bridge Medical, Inc.- Nilssen v. Osram Sylvania

• Developing practice steps in drafting & prosecutingapplications to avoid allegations of inequitable conduct

5:30 Conference Adjourns to Day 2

Ethi

cs

Pharma/Biotech Patent CLAIM DRAFTING & PROSECUTION


Day 2 – Tuesday, February 26, 2008

7:45 Registration and Continental Breakfast

8:45 Co-Chairs’ Opening Remarks

9:00 Preventing Obviousness Rejections post-KSR and its Progeny

Anne Brown, Ph.D.Senior Director Intellectual Property, Athersys, Inc.(Cleveland, OH)

Janet M. McNicholas, Ph.D.Member, Bell, Boyd & Lloyd LLC(Chicago, IL)

• Deciphering the effect of KSR on application of 35 U.S.C. § 103- how did the Federal Circuit err? - how to apply the “teaching-suggestion-motivation”

test in view of the Court’s objection- how the Supreme Court approves In re Kahn- assessing how KSR affects obviousness of non-combination

inventions, e.g., modifications or similar inventions- how does “predictability” factor in?

� is In re O’Farrell good law? � is “reasonable expectation of success”

still a viable test?� is “obvious to try” now a viable test?

• Analyzing post-KSR case law from BPAI, Federal Districtcourts, and the Federal Circuit- genomics

� Ex parte Kubin (applying “obvious to try” test) � assessing the effect of new obviousness standard

on patenting genomics and proteomics � are Bell and Deuel still good law at BPAI?

- chemical� Pfizer v. Apotex (finding skilled artisan would

have been motivated to combine the prior art)� Takeda Chemical Industries, Ltd. v. Alphapharm

Pty., Ltd. (finding not obvious to try combination of compounds)

- other areas – Ex parte Smith, Ex parte Catan, In re Icon Health, Leapfrog Enters v. Fisher Price

• Strategies for prosecution at USPTO - how has Examining Corps been instructed- what is the substance of the Examination Guidelines

for obviousness determinations?- preventing and responding to obviousness rejections- defining the prior art search- determining the appropriate scope of the search- developing a clear picture of the prior art early on- drafting the application to prevent an obviousness

rejection- pros and cons of arguing “unexpected results”

10:15 Morning Coffee Break

10:30 Getting it Right the First Time: Best Practices for Demonstrating Utility

Donald L. Zuhn, Jr., Ph.D. Partner, McDonnell Boehnen Hulbert & Berghoff LLP(Chicago, IL)

• Ensuring specific assertions of utility are included in the application

• What constitutes acceptable support for establishing that the utility is credible?

• What is currently considered not sufficiently substantial?- methods for treating unspecified disorders- gene probes- chromosome markers- further research

• Overcoming utility rejections with genomics

11:15 Surviving 35 USC §112 Rejections: WrittenDescription, Enablement and Best Mode

Len S. SmithSenior Intellectual Property CounselNovo Nordisk Inc(Princeton, NJ)

Kim R. JessumOf Counsel, Stradley Ronon Stevens & Young, LLP(Philadelphia, PA)

• Appropriate scope of written descriptions- review of the Philips decision

� time filing of application� contrasting the need to define everything v. not

defining anything� setting boundaries when defining things specifically� changing definitions as science advances

- impact of Noelle v. Lederman and Ex Parte Kubin- determining when the invention is predictable enough

to be described- method claims – drafting a full written description

so one can make future improvements - problem areas for new claims- narrowing range limitations – describing the original

range in the claim- including in the description a reasonable number

of species to get the claims to genus - indefiniteness arguments under Section 112

• Drafting to encompass future improvements while avoidingprior art

• Handling the tough enablement questions - reviewing the Wands factors- striking the balance between sufficient scope

and sufficient enablement- resolving the uncertainty over what to include



- drafting effective enablement provisions when includingexamples of experiments on multiple species

• Determining timing of relevant skill of the art standards for:- sec. 112(6) equivalents and Warner-Jenkinson/Festo equivalents

• Navigating through the unpredictable and inconsistent case law

• What are the consequences of improper claim structure? • Best practices for addressing the increased difficulty

wrapping up these issues in one round of prosecution • Levels of disclosure for best mode requirement

12:15 Networking Lunch

1:30 Drafting Claims to Include Varying Degrees of Scope

Kimberly Prior Senior Counsel, Hoffmann-La Roche Inc. (Nutley, NJ)

Paul F. FehlnerPartner, Baker Botts L.L.P.(New York, NY)

• Drawing the line between broad and overreaching claims • Balancing the need to carve out the biggest space available

with limitations to claims per the new rules• Resolving the problem of creating prior art that may block

future discoveries from being patented• Specific strategies for drafting claim language which

accounts for the uncertainty and unpredictability of innovation in life sciences

• Working around limited data due to budgetary or other constraints

• Getting a claim and support scope that is commercially viable• Communicating to inventors and business executives

what data you need to ensure proper patent protection• Assessing the impact of PTO guidance on the KSR decision

on the scope of patent coverage• Applying recent case law impacting the scope of patent coverage

- Chiron v.Genentech- Kaplan v. Escher- Falco-Faulkner v. Ingels- Ariad Pharmaceuticals v. Eli Lilly – mechanism of action- Festo update

2:30 USPTO Speaks

Bruce KisliukDirector, Technology Center 1600United States Patent and Trademark Office(Alexandria, VA)

Take this unique opportunity to hear directly from the USPTO.Come prepared with questions about new and proposed rules,current developments at the USPTO and what you need to knowfrom the PTO that impacts your life sciences patent practices.

4:00 Afternoon Refreshment Break

4:15 Wrap Up and Interactive Strategy Session:Pulling it all Together to Secure EffectiveCoverage of Inventions in the Current Patent Environment

James F. Haley, Jr.Partner, Ropes & Gray LLP(New York, NY)

George F. WheelerShareholder, McAndrews, Held & Malloy, Ltd.(Chicago, IL)

Moderator:

Immac J. Thampoe, Ph.D. (“Casey”) Senior Director – Patent Law Schering-Plough Corporation(Kenilworth, NJ)

Industry leaders will identify, analyze, and debate the changesthat have taken hold in the patent industry over the past year.We’ll take a look at the practical impact on patent practices of the USPTO rules, Supreme Court and Federal Circuit casesas well as pending reforms and case law on the horizon. Thisexpert panel will then tie all of the changes together and discussstrategies for protecting your patents today and in the future.Delegate questions and comments are welcome. Points ofdiscussion will include:

• Adapting patent strategies based on divergent needs• Differentiating strategies based on the stage of development

of the invention and the overall business goals for developingthe patent portfolio

• What to do differently with existing and new patent portfolios

• Maximizing the usefulness of the first office action • Getting the full range of potential continuations• Using divisional applications to your advantage• Taking advantage of restrictions• Utilizing provisional and pct applications• Prosecuting families of applications successfully• Filing appeals as an alternative strategy

5:30 Conference Concludes

SAVE THE DATE:

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MASTER CLASS • Wednesday, February 27, 2008

Perfecting Claim Drafting and Prosecution in Life Sciences Patent Applications

9:00 a.m. – 12:30 p.m. (Registration Open 8:30 a.m.)

Thomas J. KowalskiPartner, Frommer Lawrence & Haug LLP(New York, NY)

Deborah Lu, Ph.D.Patent Attorney, Frommer Lawrence & Haug LLP(New York, NY)

With so many unknowns today in the patent industry, draftingclaims and prosecuting patents in life sciences has becomeincreasingly more complex and expensive. In this uniqueinteractive Master Class, you will get the opportunity to takeeverything you have learned over the past two days and apply itin mock patent drafting scenario. Your Master Class leaders willtake a model invention and walk through all of the steps ofgetting your patent approved for the invention from the initialspecifications and drafting the claims to an RSE. You will learnhow to incorporate recent case law and new and proposedUSPTO rules into your patent applications. In addition, yourexperienced faculty will show you the strategic choices you needto make to include the claims you need and successfullyprosecute the application. Points of discussion will include:

• Evaluating the invention and identifying essentially what you need to protect

• Working with inventors and business executives todetermine the right strategy and get the information you need before you start the process

• Deciding when and what to file, especially taking intoaccount recent USPTO rules

• Drafting the claims to include what you need to protect- using the right descriptions and language that will

stand up under scrutiny- including what is necessary for this invention

in the specification- filing families and Markush claims

• Using restrictions to your advantage as part of the process• Conducting the prior art search

- knowing how much you should do- where and what to look for

• Looking toward the future to get the most protectionpossible for this invention

• Creating the best record possible• Going through the examination process

- working with examiners- responding to requests - filing support documents - providing the examiner with all the necessary information

• Determining whether to appeal or file an RSE• Considerations for specification drafting for international

patent protection

EARN

CLEETHICS

CREDITS

American Conference Institute’s


February 25-26, 2008 • The Carlton on Madison Avenue • New York, NY

MASTER CLASS

Wednesday, February 27, 2008

Perfecting ClaimDrafting and Prosecutionin Life Sciences Patent Applications

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