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7.1 – Bilski Process Claims

Bilski Process Claims Featured

Bilski Process Claims

The Interim Bilski Guidance provides factors to consider in determining whether a claim is directed to an abstract idea and is therefore not patent-eligible under 35 U.S.C. § 101. Under the Interim Bilski Guidance, factors that weigh in favor of patent-eligibility satisfy the criteria of the machine-or-transformation test or provide evidence that the abstract idea has been practically applied, and factors that weigh against patent-eligibility neither satisfy the criteria of the machine-or-transformation test nor provide evidence that the abstract idea has been practically applied.  These factors are described below.

Factors Weighing Toward Eligibility:

The recitation of a machine or transformation (either express or inherent), machine or transformation is particular.  The machine or transformation meaningfully limits the execution of the steps.  The machine implements the claimed steps.  The article being transformed is particular.  The article undergoes a change in state or thing (e.g., objectively different function or use).  The article being transformed is an object or substance.  The claim is directed toward applying a law of nature and the law of nature is practically applied.  The application of the law of nature meaningfully limits the execution of the steps.  The claim is more than a mere statement of a concept.  The claim describes a particular solution to a problem to be solved.  The claim implements a concept in some tangible way.  The performance of the steps is observable and verifiable.

Factors Weighing Against Eligibility:

There is no recitation of a machine or transformation (either express or inherent).  There is insufficient recitation of a machine or transformation.  Involvement of machine, or transformation, with the steps is merely nominally, insignificantly, or tangentially related to the performance of the steps, e.g., data gathering, or merely recites a field in which the method is intended to be applied.  The machine is generically recited such that it covers any machine capable of performing the claimed step(s).  The machine is merely an object on which the method operates.  The transformation involves only a change in position or location of article.  The “Article” is merely a general concept.  The claim is not directed to an application of a law of nature.  The claim would monopolize a natural force or patent a scientific fact; e.g., by claiming every mode of producing an effect of that law of nature.  The law of nature is applied in a merely subjective determination.  The law of nature is merely nominally, insignificantly, or tangentially related to the performance of the steps.  The claim is a mere statement of a general concept (see notes below for examples).  The use of the concept, as expressed in the method, would effectively grant a monopoly over the concept.  Both known and unknown uses of the concept are covered, and can be performed through any existing or future-devised machinery, or even without any apparatus.  The claim only states a problem to be solved.  The general concept is disembodied.  The mechanism(s) by which the steps are implemented is subjective or imperceptible.

Examples of general concepts include, but are not limited, to:

  • ƒ Basic economic practices or theories (e.g., hedging, insurance, financial transactions, marketing);
  • ƒ Basic legal theories (e.g., contracts, dispute resolution, rules of law);
  • ƒ Mathematical concepts (e.g., algorithms, spatial relationships, geometry);
  • ƒ Mental activity (e.g., forming a judgment, observation, evaluation, or opinion);
  • ƒ Interpersonal interactions or relationships (e.g., conversing, dating);
  • ƒ Teaching concepts (e.g., memorization, repetition);
  • ƒ Human behavior (e.g., exercising, wearing clothing, following rules or instructions);
  • ƒ Instructing “how business should be conducted.”

For a detailed explanation of the terms machine, transformation, article, extrasolution activity, and field-of-use, please refer to the Interim Patent Subject Matter Eligibility Examination Instructions of August 24, 2009.

When making a subject matter eligibility determination, the relevant factors should be weighed with respect to the claim as a whole to evaluate whether the claim is patent-eligible or whether the abstract idea exception renders the claim ineligible. When it is determined that the claim is patent-eligible, the analysis may be concluded. In those instances where patent-eligibility cannot be easily identified, every relevant factor should be carefully weighed before making a conclusion. Not every factor will be relevant to every claim. While no factor is conclusive by itself, the weight accorded each factor will vary based upon the facts of the application. These factors are not intended to be exclusive or exhaustive as there may be more pertinent factors depending on the particular technology of the claim.

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7.2 – Subject Matter Eligibility Instructions

SME Instructions Featured

Summary:

The Instructions supersede previous guidance on subject matter eligibility that conflicts with the instructions, including MPEP 2106(IV), 2106.01 and 2106.02, as of 8/24/09.  To determine subject matter eligibility, follow the “Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101”.  Product claims are evaluated to determine if the claim is wholly directed to a judicial exception.  Functional/nonfunctional descriptive material (FDM/NFDM) is evaluated for patentable distinction over the prior art. See MPEP 2112.01(III).  All process (method) claims are evaluated with the M-or-T test.

For subject matter eligibility instructions regarding product claims, there is a two step analysis newly developed to help determine if the subject matter contained in the application is patentable per 35 U.S.C. § 101.  This two step analysis is described below:

The Two-Step 35 U.S.C. § 101 Analysis

Step 1:  Is the claim directed to one of the four patent-eligible subject matter categories?  This includes process, machine, manufacture or composition of matter.  If the subject matter is not in one of the four categories, the claim is not eligible.  An example of non eligible claims can be transitory signals, humans, a company, a set of instruction, etc…

Step 2:  A claim satisfying Step 1 is subject-matter eligible under 101 unless it wholly embraces a judicially recognized exception.  These judicially recognized exceptions include: abstract idea, law of nature and natural phenomena.  Some examples include mental processes, mathematical algorithms or scientific principles.  If the claim is directed to one of these judicially recognized exceptions the claim is not patent eligible.  However, a particular practical application of a judicial exception is eligible.

Product Claim Analysis:

To perform a proper product claim analysis, one must begin with the broadest reasonable interpretation (BRI) of the claim in view of the specification consistent with the interpretation those skilled in the art would reach.  Then review the claims in view of the two steps listed above.

Computer-Readable Media

The functional/non-functional distinction is not an inquiry under 101. The 101 inquiry is whether a claim directed to one of the four statutory categories is wholly directed to a judicial exception.  A tangible medium including a computer program should be evaluated to determine if there is a functional relationship between the computer program and the medium for purposes of distinguishing over prior art, not for subject matter eligibility.

For subject matter eligibility instructions regarding product claims, there is a two step analysis newly developed to help determine if the subject matter contained in the application is patentable per 35 U.S.C. § 101.  This two step analysis is described below:

Process Claim Analysis:

To perform a proper process claim analysis, one must begin with the broadest reasonable interpretation (BRI) of the claim in view of the specification consistent with the interpretation those skilled in the art would reach.

Then look at the claim in view of the machine or transformation (M-or-T) test.  For this test, the claimed process must be tied to a particular machine or apparatus or particularly transform a particular article to a different state or thing.  There are two corollaries in that the particular machine or transformation must involve meaningful limits and a more than insignificant “extra-solution” activity.

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7.3 – 35 U.S.C. §112 Paragraph 2 Compliance

 112 Paragraph 2 Compliance Featured

There are three steps in conducting a 35 U.S.C. § 112 Paragraph 2 compliance test.  These steps are shown below:

Step 1:

Give the claim the broadest reasonable interpretation (BRI) consistent with the specification as it would be interpreted by one of ordinary skill in the art.

Step 2:

Determine whether the claim language is definite.  This can be done through reviewing the terms of degree, subjective terms, confirming clear support in specification, look for improper dependent claims, functional claiming, means-plus-function claim limitations (or other non structural claim term), Markush claims and supplemental information for examining computer-implemented functional claim limitations.

Step 3:

Compact Prosecution Procedures for Resolving §112 Issues

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7.4 – KSR Obviousness Inquiry

KSR Obviousness Featured

KSR Obviousness Featured

2007 KSR Guidelines

From the KSR Guidelines, every obviousness rejection requires three main actions: an appropriate finding of facts, a reasoned explanation and a legal conclusion of obviousness.

This is so regardless of the rationale or line of reasoning used to formulate the rejection.  No examiner may choose to disregard the Supreme Court’s decision in KSR or the associated examiner guidance materials when determining whether or not an obviousness rejection should be made.  Any determination of whether or not a claimed invention is obvious requires the examiner to consider and weigh all evidence that has properly been made of record.

The KSR Guidelines Reaffirm Graham v. Deere obviousness methodology

This methodology includes: the scope and content of the prior art, the difference between the prior art and the claimed invention, the level of ordinary skill in the art and any secondary considerations.The following are important cases regarding obviousness rulings:

Combining Prior Art Elements:

  • In re Omeprazole Patent Litigation
  • Crocs, Inc. v. U.S. Int’l Trade Comm’n
  • Sundance, Inc. v. DeMonte Fabricating Ltd.
  • Ecolab, Inc. v. FMC Corp.
  • Wyers v. Master Lock Co.
  • DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.

Substituting One Known Element for Another:

  • In re ICON Health & Fitness, Inc.
  • Agrizap, Inc. v. Woodstream Corp.
  • Muniauction, Inc. v. Thomson Corp.
  • Aventis Pharma Deutschland v. Lupin Ltd.
  • Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd.
  • Procter & Gamble Co. v. Teva Pharms. USA
  • Altana Pharma AG v. Teva Pharms. USA

Obvious to Try:

  • In re Kubin
  • Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.
  • Ortho-McNeil Pharm., Inc. v. Mylan Labs, Inc.
  • Bayer Schering Pharma A.G. v. Barr Labs., Inc.
  • Sanofi-Synthelabo v. Apotex, Inc.
  • Rolls-Royce, PLC v. United Techs. Corp.
  • Perfect Web Techs. v. InfoUSA

Consideration of Evidence:

  • PharmaStem Therapeutics, Inc. v. Viacell, Inc.
  • In re Sullivan
  • Hearing Components, Inc. v. Shure Inc.
  • Asyst Techs., Inc. v. Emtrak, Inc.