ASSESSING THE REALISTIC BREADTH OF A PATENT: DESIGN-AROUNDS AND

CLAIM STRATEGY 

Michael Hostetler, PartnerPatents and Innovations Group

Wilson Sonsini Goodrich & Rosati

What is claimed is:

1. A compound of Formula I:

A-B-C-D-E-F-G-J (I)

Conservatively estimated to cover 1060 compounds!

You should be able to:Be able to deconvolute any Markush (easy).•Understand the process of claim interpretation (moderate).•Know how to apply the concepts of written description and •enablement to claim scope (hard).

By The End of this Talk

What are the strongest claims in my patent?•Do I have ‘freedom to operate’?•How can I bust that patent?•

All in the context of evaluating:

In the beginning …

US Patent No. 1,506,316; August 26, 1924Pyrazolone Dye and Process of Making the SameEugene A. Markush; Pharma-Chemical Corporation

Two Common Alternative Ways of Presenting a Markush Group

“selected from the group consisting of … and ….”

“is … or ….”

But cracking the Markush code is just the beginning of “claim construction”

that is

“an interpretation or explanationof a claim.”

Claim Construction: The Basic Idea

Determine “how a person of ordinary skill in the art understands a claim term,” in the context of the patent. Courts have held this is a question of law, informed by underlying facts.

A POSITA is generally “based on the well-settled understanding that inventors are a)typically persons skilled in the field of the invention and that patents are addressed to and intended to be read by others of skill in the pertinent art.” In other words, a patentin the field of medicinal chemistry would be directed to a POSITA in medicinal chemistry, typically those with a PhD and/or industry experience in synthetic organic chemistry.

b) “at the time of the invention, i.e., as of the effective filing date of the patent application.” Terms change meaning, e.g., “solid tumor.

For Technical Terms, Look First at “Intrinsic Evidence”

Does the body of the patent (the “specification”) define the term?

A Patentee is Permitted to be a Lexicographer

Can define a ‘made-up’ term in any way.1)Can define a common term to be broader or narrower than its 2)typical usage.Can even define a term that contradicts the common understanding, 3)although this is risky.

Pro: using a definition usually provides clarity, and limits the ability of a third party from imposing an unwanted definition on a claim term.Con: length and cost of an application. Could limit patentees’ ability to have a more flexible term to hinder design-arounds.

What About Terms Not Defined in the Specification?

Van Nostrand’s Scientific Encyclopedia, Ninth Edition, Volume 1:“A generic name for any organic group or radical formed from a hydrocarbon by elimination of one atom of hydrogen and so producing a univalent unit. The term is usually restricted to those radicals derived from the aliphatic hydrocarbons.”Thus, alkyl includes CH2CH3, CHCH2 and CCH.

Introduction to Organic Chemistry, Second Edition:“A group derived by removing a hydrogen from an alkane. “Thus, alkyl includes CH2CH3, but excludes CHCH2 and CCH.

(and dictionaries disagree!)

Look at Usage in Other Claims and the SpecificationDo the claims use separate terms for alkyl, alkenyl and alkynyl? 1)In the specification, is the term alkyl used only in the context of fully 2)saturated hydrocarbons, or is the usage vague enough to include any hydrocarbon?Does the specification have a separate term for a general hydrocarbon?3)

Look at Usage in the “File History”Does the back-and-forth with the patent office, provide clarity to a term?

“Azacycloalkyl” was not defined in the patent, but during prosecution, the USPTO stated that the term “aza” was indefinite. Patentee responded that “aza” meant as having “at least two nitrogens in th[e] ring.”

If Intrinsic Evidence Appears Unsatisfactory, Examine “Extrinsic Evidence”

Consult dictionaries and other treatises that were available when the patent was filed. But these can be conflicting!

“alkyl” – in 2001, 30 dictionaries/textbooks limited alkyl to saturated •hydrocarbons, but 3 included all hydrocarbons.“solid tumor” – in 1998, half the available dictionaries included •lymphoma, while the other half excluded lymphoma. Some even included leukemia.

Hire a third-party expert

So what to do?If the patent defines a term, then it’s generally ok to use that •term, with the caveat that the file history may alter that definition. Best practice is to read the claims, specification and file history, and make sure term is used consistently.Look at dictionaries/treatises that were available when the •patent application was first filed. But, be willing to check out at least 5-8 different sources.If critical to an infringement analysis, or determining design-•around opportunities, seek legal counsel.

After claim construction:

Enablement: can a POSITA make and use the full scope of the •invention without undue experimentation?Written Description: did the inventor have possession of the full •scope of the invention?

Interrelated but distinct concepts.

Enablement Analysis: The Wands Factors, pt. 1The breadth of the claims.(A)

Broader claims face a higher burden.•

(B) The nature of the invention.Quite simply, what is the field of the invention: •

medicinal chemistry, molecular biology, etc.

(C) The state of the prior art.Is the scientific literature extensive or limited?•No need to disclose techniques in the patent that •

are well known.

Dr. Jack Wands

Enablement Analysis: The Wands Factors, pt. 2(D) The level of one of ordinary skill

This is evaluated to put the invention into context. That is, if a •POSITA has a PhD and several years of post-graduate work experience, then the patent may need less disclosure. At least, that’s the general philosophy.

(E) The level of predictability in the artThe life sciences (chemistry and biology) are considered •unpredictable sciences, which raises the bar on the amount of disclosure needed to prevent undue experimentation. The mechanical and computer sciences are generally considered predictable sciences, and thus need less disclosure.

Enablement Analysis: The Wands Factors, pt. 3(F) The amount of direction provided by the inventor.

Specifically, the information provided in the body of the patent, •other than the examples.

(G) The existence of working examples.Note the emphasis on working, as opposed, to prophetic (or •proposed) examples.

(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.

“Undue experimentation” generally refers to creative •experimentation, where the result is not predictable, as opposed to experimentation done by a lab tech or a lab robot.

Enablement Analysis: Take Home The trend, even in the US, is towards narrower claims:•

Linking the scope with the examples.oPortions of the claims with no supporting examples or oexplanation face a higher chance of non-enablement.

The USPTO is encouraging examiners to be skeptical •with broad chemical and biological claims

Enablement Analysis: Outside the USChina/Japan – generally claim scope is limited to a genus tightly •based on the actual examples presented in the application, plus some obvious variations.

Europe – good ground for attacking broad claims is either under:•lack of sufficient disclosure (similar to enablement), or•lack of inventive step (similar to obviousness): here, non-•working embodiments of the claims (including toxicity issues) could be used to argue that the inventors had not invented the full scope of the claims.

Written Description AnalysisIs there sufficient disclosure to convey, with clarity, to a POSITA, that the inventor(s) had possession of their invention

Patents aren’t granted for academic theories or mere wishes or 1)hypotheses.A “representative number of species” must reflect the variation 2)of species within the genus, and “in arts where the species vary widely and their characteristics are unpredictable, a description of one species will ordinarily be insufficient to lay claim to the genus.”

Applying the Written Description AnalysisAntibodies:In re Alonso, 545 F.3d 1015, 1020, 1021 (2008)

Claimed a genus of monoclonal antibodies•The specification did not characterize the antigens to which the •monoclonal antibodies bound, but only disclosed the molecular weight of one identified antigen.The court found the disclosure to be “clearly insufficient •[because it taught] nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method.”

Applying the Written Description AnalysisChemical compounds:Boston Scientific Corp. v. Johnson & Johnson Inc., 679 F.Supp.2d 539, 555 (2010)

Claimed rapamycin and its analogues•No indication of how many compounds were truly ‘structurally •similar’ to rapamycin in the manner contemplated by the patents.The patentees sought to constrain the genus by relying on •functional limitations (activity).The court found that there was insufficient correlation between the •function and structure of rapamycin and its analogs, i.e., “given the structural complexity of rapamycin, the universe of potential compounds that are structurally similar to rapamycin and classifiable as macrocyclic lactones is potentially limitless”

Assessing Claim StrengthInterpret the claims using the principles of claim construction.•

Intrinsic evidence, followed by extrinsic evidence•Analyze which claims have good enablement.•

Apply the Wands factors•Review the written description•

Did the inventor envision the full scope of the claims•

Identify weaknesses and strengths of each claim, and then it’s •time to apply this assessment to your situation.

Claim Strategy: How Much Should The Competition Fear My Claims

Broad claims in issued patents can be used to provide •uncertainty to a competitor, since patents are presumed valid. In litigation, need to show invalidity by clear and convincing evidence.Very important to have scoped coverage •(progressively narrower claims). Identify likely work-arounds, and provide sufficient •disclosure to support claims.

Claim Strategy: Is My Design-Around Clear of the This Patent?

Construe claims with broadest reasonable meaning.•If a claim term is ambiguous or has multiple dictionary •meanings, consider multiple meanings independently.Compare your design-around to each claim. Every •element/feature of the claim must be found in your design-around in order for the claim to cover your design-around. Are the relevant claims enabled/etc.•Complex analysis, in general, and recommend seeking •legal counsel.

Claim Strategy: How Can I Bust This Patent?

Broad claims, even in issued patents, with no •supporting examples, are most vulnerable.Stay away from busting narrow claims.•Consider undue experimentation factors: was it easy •busting or challenging busting. Evaluate whether someone would risk patent •litigation and potentially endanger the validity of the patent.Remember: patents are presumed valid, so consult •legal counsel.

Conclusions

The analysis of claims requiresClaim construction1.Enablement Analysis2.Written Description Review3.

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