The USPTO has issued “Interim Examination Instructions For Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101” to be used by patent examiners during examination. These instructions supersede previous guidance on subject matter eligibility.

These instructions  must be “really” important given the extraordinarily “high” number of “unnecessary” quotation marks.  Maybe the USPTO could benefit from subscribing to the “Blog” of “Unnecessary” Quotation Marks.


To pass the threshold eligibility inquiries of § 101 for patent protection, a claimed invention must be directed to statutory subject matter and must be useful. Thus, under § 101 two separate patent eligibility considerations are raised: (1) subject matter and (2) utility.

Subject Matter Eligibility

The following two step analysis is used for determining subject matter eligibility:

  1. Step 1: Is the claim directed to one of the four patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
  2. Step 2: Does the claim wholly embrace a judicially recognized exception, which includes abstract ideas, mental processes or substantially all practical uses (pre-emption) of a law of nature or a natural phenomenon, or is it a particular practical application of a judicial exception?

Processes (methods)

A process claim, to be statutory under § 101, must pass the machine-or-transformation test (M-or-T test) – at least until the Supreme Court reverses this test.

In accordance with the M-or-T test, the claimed process must:

  1. be tied to a particular machine or apparatus (machine implemented); or
  2. particularly transform a particular article to a different state or thing.

A method claim that does not require machine implementation or does not cause a transformation will fail the test and should be rejected under § 101:

However, the mere presence of a machine tie or transformation is not sufficient to pass the test. When a machine tie or transformation has been identified, it must be further determined that the tie is to a particular machine or the particular transformation is of a particular article.

Additionally, the particular machine tie or particular transformation must meet two corollaries to pass the test for subject matter eligibility. First, the use of the particular machine or transformation of the particular article must impose a meaningful limit on the claim’s scope. So, a machine tie in only a field-of-use limitation would not be sufficient. Second, the use of the particular machine or the transformation of the particular article must involve more than insignificant “extra-solution” activity. If the machine or transformation is only present in a field-of-use limitation or in a step that is only insignificant “extra-solution” activity, the claim fails the M-or-T test, despite the presence of a machine or a transformation in the claim.

Insignificant “extra-solution” activity means activity that is not central to the purpose of the method invented by the applicant. For example, gathering data to use in the method when all applications of the method would require some form of data gathering would not impose a meaningful limit on the claim.

You can see the whole set of interim guidelines (pdf) here.

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