Advanced Patent Prosecution Workshop: Claim Drafting & Amendment Writing


Yesterday, I attended PLI’s Advanced Patent Prosecution Workshop 2011 in New York where an esteemed panel of experts offered hands-on claim drafting and amendment writing techniques.  The program was organized into four technological sections: Biotechnology, Chemical/Pharmaceutical, Electrochemical and Electronics/Computers. I attended the Chemical/Pharmaceutical segment whereJohn Todaro of Merck & Co. discussed advanced issues in drafting of patent specifications.

Here are some highlights from his presentation….

-Draft the claims or Summary of the Invention first, because of the primary role of the patent specification in claim construction

-General Considerations in Drafting the Specification:

  1. Distinguish invention from the prior art
  2. Define claim terms
  3. Provide broadest possible claim scope, while complying with section112 requirements
  4. Consider ex-US patent law issues

Control the length of the application – too long = excess fees. Cost issue is important, think about when drafting the application.

-Written Description – important to disclose subgeneric descriptions:

  1. Genus, subgenus and exemplary species
  2. Generic and subgeneric descriptions
  3. Quantitative Ranges (“up to 50 wgt %, 1-25 wgt %, 1-10 wgt %, etc.)

-Written Description requirement requires sufficient description to show one skilled in the art that the inventors had possession of the claimed invention

AriadCase – confirmed that written description requirement is separate from enablement & confirms the possession of the invention test of written description

-Enablement (“How to Make”)– you don’t have to reinvent the wheel, start at the level of the person skilled in the art!  What is known to one skilled in the art? (Commercially available reagents, known synthetic procedures, well known textbook in English, granted U.S. Patents)

“How To Use” & Utility – the specification discloses as a matter of fact a practical utility for the invention.  You should have some sort of data in the specification to prove sufficient utility.

-Full Scope Enablement – make sure you’ve enabled the full scope of what you claimed.

Some key ex-US issues in drafting the specification:

  1. China: Article 26 interpretation on claim scope and biological test data
  2. EPO: Article 123(2) added Matter Rule does not permit taking one feature from the specification and generalizing it in a claim (amendment must be “directly & unambiguously derivable” from the disclosure)
  3. Canada: :Eli Lilly v. Apotex– utility of the invention must either be demonstrated or based on a “sound prediction” that it will work for its intended purpose

-Best Mode Requirement – at the time of filing, did the inventor possess a best mode? If so, is the best mode disclosed such that one skilled in the art can practice it. (Eli Lilly & Co. case).  Perhaps Best Mode won’t be around for long??

Definitions in the Specification – “patent profanity”, need to think about what NOT to put in the specification as well as what needs to be in there.

-Disclosure Dedication Rule – subject matter disclosed but not claimed is dedicated to the public and cannot be recaptured under the DOE (Johnson & Johnson Assocs. Case)

-Abstract – purpose of the abstract is to provide a summary of the invention so that public is apprised.  However, abstract can play a role in claim construction.

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