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Further USPTO Guidance re Patent Subject Matter Eligibility

Posted on Dec 18, 2014 in Blog

In light of the relatively recent Supreme Court decisions in the area of patent subject matter eligibility, the United States Patent and Trademark Office has been attempting to provide guidance to its Patent Examiners to use in determining whether claims are directed to patent eligible subject matter. Further to that end, the Patent Office has released new Interim Guidance on Patent Subject Matter Eligibility, which was published in the Federal Register on December 16, 2014. According to the Patent Office, this new Interim Guidance supersedes the March 4, 2014, Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, and/or Natural Products (March 2014 Procedure) issued in view of the Supreme Court decisions in Myriad and Mayo, and supplements the June 25, 2014, Preliminary Examination Instructions in view of the Supreme Court decision in Alice Corp. (June 2014 Preliminary Instructions).

The new Interim Guidance appears to be a considerable softening of the stance the Patent Office had taken with regard to the analysis Patent Examiners were to employ in determining patent eligible subject matter.

As part of the updated analysis, after making a determination as to whether the claim is directed to one of the four statutory categories (i.e., process, machine, manufacture, or composition of matter) the examiner is now to make a further determination as to whether the claim is “directed to” a law of nature, natural phenomenon, or an abstract idea (i.e., a judicial exception).

According to the Interim Guidance, a claim is “directed to” a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim. According to the Interim Guidance, such a claim requires closer scrutiny for eligibility because of the risk that it will “tie up” the excepted subject matter and pre-empt others from using the law of nature, natural phenomenon, or abstract idea. (See Interim Guidance at page 11). This “directed to” determination is different than the previous March 2014 Guidance, in which examiners were instructed to make a determination as to whether the claims “recite or involve one or more judicial exceptions”. (March 2014 Guidance at page 3).

Under the new Interim Guidance, if the claim is “directed to” a judicial exception, examiners are then to identify the judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea), and make a determination whether there is a “marked difference” between the nature-based product limitation and its naturally occurring counterpart in its natural state. While under the March 2014 Guidance only structural changes were sufficient to show a marked difference, now changes in functional characteristics and other non-structural properties can evidence markedly different characteristics, in addition to structural differences. (See Interim Guidance at page 18). Marked differences can be shown by, for example, biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic or physical (See Interim Guidance at page 19). If the claim includes a nature-based product that has markedly different characteristics than its naturally occurring counterpart, the claim does not recite a “product of nature” exception and is patent eligible subject matter.

This change to the analysis, which allows examiners to look at functional changes, as well as structural changes, when analyzing nature based products for subject matter eligibility should go a long way to easing the concerns of applicants in the pharmaceutical, chemical, and biological arts.

If the Examiner determines that the claim is directed to a judicial exception (i.e., law of nature, natural phenomenon, or an abstract idea), without a marked difference, under the new Interim Guidance the Examiner is then to make a determination whether the claim recites additional elements that amount to “significantly more” than the judicial exception. (See Interim Guidance at page 20).

According to the Interim Guidance, limitations that may be enough to qualify as “significantly more” when recited in a claim with a judicial exception include: improvements to another technology or technical field; improvements to the functioning of the computer itself; applying the judicial exception with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment. If the claim as a whole does recite significantly more than the exception itself, the claim is patent eligible subject matter. (See Interim Guidance at pages 22 – 23).

These new Interim Guidelines appear to be a significant step towards addressing the concerns of inventors and the patent bar that previous Patent Office Guidelines had been overly narrow in determining patent subject matter eligibility. The Patent Office is seeking public comment on the Interim Guidance.


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