Presenting a live 90-minute webinar with interactive Q&A Patent Subject Matter Eligibility: Navigating the New USPTO Guidance Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework THURSDAY, APRIL 16, 2015 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Amelia Feulner Baur, Ph.D, Founding Partner, McNeill Baur , Bala Cynwyd, Pa. Leslie McDonell, Partner, Finnegan Henderson Farabow Garrett & Dunner , Boston Donna M. Meuth, Associate General Counsel, Eisai , Andover , Mass. The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .
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Disclaimer These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. These materials should not be taken as individualized legal advice and do not reflect the views of MCNEILL BAUR, FINNEGAN or EISAI. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, MCNEILL BAUR, FINNEGAN, EISAI, and the panelists cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with MCNEILL BAUR, FINNEGAN, EISAI, or the panelists. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. April 16, 2015 4
2014 Interim Guidance • Supplements June 2014 Preliminary Examination Instructions ( Alice ) • Supersedes March 2014 Procedure for Subject Matter Eligibility Analysis ( Mayo/Myriad ) • Public comments were requested by March 16, 2015, and are available on-line as they are received by the USPTO. April 16, 2015 5
Highlights • “Directed to” not “involves” • No complicated 12 factor analysis • Structure, Function, and/or Other Characteristics • Streamlined eligibility analysis April 16, 2015 6
PTO Reminds Examiners: • Prior to evaluating a claim for patentability, establish the broadest reasonable interpretation of the claim and analyze the claim as a whole when evaluating for patentability • In accordance with compact prosecution, along with determining eligibility, all claims are to be fully examined under each of the other patentability requirements: 35 USC §§102, 103, 112, and 101 (utility, inventorship, double patenting) and non- statutory double patenting. April 16, 2015 7
Changes to Rubric April 16, 2015 8
Step 2A: Determine What The Claim I s “Directed To” • “‛Directed to’ means the [judicial] exception is recited in the claim, i.e., the claim sets forth or describes the exception.” • “If the claim recites an exception, but when viewed as a whole, clearly does not seek to ‛tie up’ the exception use the ‘streamlined analysis.’” April 16, 2015 9
Step 2A: “ Directed to” a Judicial Exception • If the invention is merely based on or involves an exception, but the exception is not set forth or described in the claim, the claim is NOT directed to a judicial exception and is patent eligible. – In other words, if the exception is not recited in the claim it is patent eligible. – A claim that is based on an abstract concept may involve a judicial exception but the concept is not recited in the claim, the claim is eligible without further analysis. April 16, 2015 10
Step 2A: Evaluate for Marked Difference?? • A “marked difference” test is only used for nature - based product claims (not process claims) • The Interim Guidance states: “To determine whether a claim that includes a nature-based product limitation recites a ‘product of nature’ exception, use the markedly different characteristics analysis to evaluate the nature- based product limitation.” • See February 2015 Training Slides issued by USPTO for more information. April 16, 2015 11
Step 2A: “Directed to” a Judicial Exception • A process claim that involves the use of a nature- based product requires no analysis for marked difference. – “Except in the limited situation where a process claim is drafted in such a way that there is no difference in substance from a product claim (e.g. ‘a method of providing an apple...’)” • A claim that recites an exception is not automatically ineligible April 16, 2015 12
Step 2A: Evaluate for Marked Difference • “Care should be taken not to overly extend the markedly different characteristics analysis to products that when viewed as a whole are not nature- based.” • But: “The markedly different characteristics analysis should be applied only to the nature-based product limitations in the claim.” • “When the nature based product is produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination .” April 16, 2015 13
Markedly Different Characteristics Analysis • Markedly different characteristics can be expressed as the product’s structure, function and/or other properties. – biological or pharmacological functions or activities -- chemical and physical properties – phenotype, including functional and structural characteristics -- structure and form, whether chemical, genetic, or physical • The analysis compares nature-based product to its closest naturally occurring counterpart “in its natural state .” • Even a small change can result in markedly different characteristics from the product’s naturally occurring counterpart. April 16, 2015 14
Step 2B: Evaluate For Significantly More • If marked difference found, no “significantly more” analysis is required. – This is because under new guidance, “the inquiry as to whether the claim amounts to significantly more than a product of nature exception is not relevant to claims that do not recite an exception.” • If no markedly different characteristics found continue to step 2B to determine if any additional elements in the claim add significantly more to the exception. April 16, 2015 15
Significantly More (Mayo Test) • Every claim analyzed individually based on the recited elements. • Individual elements of the claim may not appear to add significantly more to claim but may when combined. • Claim should describe a process or product that applies the exception in a meaningful way so that it avoids monopolizing the exception. April 16, 2015 16
Significantly More Significantly More Not Significantly More Improvements to technology or technical field Generally linking the use of the judicial or improvements to function exception to a particular technological environment or field of use Applying the judicial exception with, or by use Adding insignificant extra-solution activity to of a particular machine or the judicial exception, such as mere data Effecting a transformation or reduction of a gathering particular article to a different state or thing Adding a specific limitation other than what is Other limitations beyond generally linking the well-understood, routine and conventional in a use of the exception to a particular field, or adding unconventional steps that technological environment confine the claim to a particular application Adding the words “apply it” (or an equivalent Other limitations beyond generally linking the use of the exception to a particular to the judicial exception or mere instructions technological environment to implement an abstract idea April 16, 2015 17
Streamlined Eligibility Analysis • “Streamlined analysis can be used for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it. … eligibility will be self - evident.” • For example: – a method of treatment reciting use of a natural product – a prosthesis coated with a natural product. April 16, 2015 18
Examples and Hypotheticals • Natural Products • Combination of Natural Products • Process/Diagnostic Claims April 16, 2015 19
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