The United States Patent and Trademark Office (USPTO) has recently issued further guidance to US Examiners in relation to how the subject matter of US patent applications which relate to laws of nature, natural phenomena or natural products should be assessed for patent eligibility, with a focus on biotechnological inventions (see here). As discussed in more detail below, the Guidance instructs US Examiners to perform a much more detailed assessment in relation to patent eligibility which appears to provide Applicants with much more scope to both understand, and be in a position to rebut, any objections that are raised.

As discussed in our earlier news articles (see here and here), the USPTO previously issued Guidance aiming to address changes in the law relating to subject matter eligibility in view of US Supreme Court decisions in this area including Association for Molecular Pathology v. Myriad Genetics Inc. and Mayo Collaborative Services v. Prometheus Laboratories Inc. All claims which relate to laws of nature/natural principles, natural phenomena and/or natural products are to be examined using the procedure outlined in the Guidance.

The previous Guidance set out a three-part test for Examiners to use in order to assess whether a claim relates to patent-eligible subject matter, as follows:

Step 1
Is the claim directed to one of the four statutory patent-eligible subject matter categories, i.e., a process, machine, manufacture, or composition of matter? If yes;

Step 2A
does the claim recite or involve one or more judicial exceptions, which include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products? If yes or the Examiner is unsure;

Step 2B
does the claim as a whole recite something significantly different than the judicial exception? If no, the claim will be rejected as not patent eligible. Alternatively, if the claim is determined to be significantly different the claim is deemed patent eligible.

In practice, Examiners have been applying this test very strictly. Typically, Applicants have found that Examiners will raise an eligibility objection without providing adequate reasoning as to why the limitations of the claims do not transform the subject matter of the claims into significantly different than the judicial exception, often dismissing Applicants arguments as stating limitations that are simply well-understood, routine, conventional activities in the relevant field of art (per the phrase employed in the previous Guidance which is derived from the case law). Typically, once the objection has been raised it has proven extremely difficult to move the Examiner from their position without imposing significant limitations on the claims. Such limitations may, and often do, significantly compromise the commercial utility of the claims.

Having invited public comments on the previous Guidance, the USPTO has now issued revised Guidance to US Examiners which seems to have taken these issues into consideration. In particular, the new Guidance emphasises that Examiners must:

  1. identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception;
  2. identify any additional elements (specifically point to claim features/limitations/steps) recited in the claim beyond the identified judicial exception; and
  3. explain the reason(s) that the additional elements taken individually, and also taken as a combination, do not result in the claim as a whole amounting to significantly more than the judicial exception. (original emphasis)

Specifically with reference to laws of nature, natural phenomena and natural products, the new Guidance emphasises that Examiners must provide a reasoned rationale as to why the claim is considered to be directed to a law of nature, natural phenomena or product which does not have markedly different characteristics from its naturally occurring counterpart in its natural state.

In addition, as mentioned in point 3 above, the new Guidance also emphasises the need to consider any further claim limitations in combination. The new Guidance states that:

“It is important to remember that a new combination of steps in a process may be patent eligible even though all the steps of the combination were individually well known and in common use before the combination was made (Diehr). Thus, it is particularly critical to address the combination of additional elements, because while individually-viewed elements may not appear to add significantly more, those additional elements when viewed in combination may amount to significantly more than the exception by meaningfully limiting the judicial exception”. (original emphasis)

The new Guidance continues:

“[W]hen the Examiner has concluded that particular claim limitations are well-understood, routine, conventional activities (or elements) to those in the relevant field, the rejection should explain why the US courts have recognized, or those in the relevant field of art would recognize, those claim limitations as being well-understood, routine, conventional activities. Mere knowledge of the particular laboratory technique or use of the particular laboratory technique by a few scientists is not sufficient to make the use of the particular laboratory technique routine or conventional in the relevant field”.

The new Guidance also offers a further set of six hypothetical examples covering a variety of scenarios and claimed subject matters detailing how Examiners should apply the new Guidance, in particular the aspects mentioned above (see here). The examples include hypothetical claims to products such as vaccines and dietary sweeteners as well as diagnostic claims. Of most value for Applicants, the new examples offer a number of helpful scenarios in which claims which recite further limitations, such as the use of a pharmaceutically acceptable carrier, should and should not be objected to by the Examiner. Furthermore, the examples highlight that where it can be demonstrated that the combination of additional features leads to a functional/technical effect which means the invention is markedly different from what occurs in nature then the claimed subject matter should fall outside the exception without needing to evaluate whether or not each additional feature is well-understood, routine or conventional.

In relation to diagnostic methods, new example 29 outlines one potentially important point of practice that we have recently seen emerging; specifically that the USPTO will accept method claims covering an ineligible method provided they are not specifically directed to that method. So, referring to that example, a method of detecting a newly identified protein marker satisfies § 101 even if the method is recited at a high level of generality. However, a method of diagnosing a disease by detecting the newly identified protein marker does not satisfy § 101 when the detection steps are recited at a high level of generality. Thus, adding a “diagnosing …” step to a patent-eligible “method of detecting” claim will render the claim ineligible.

The same example indicates that a personalised medicine method of diagnosing and treating a disease that involves detecting a newly identified protein marker satisfies § 101 even if the detection method is recited at a high level of generality and the recited treatment is a conventional treatment for the condition.

With the distinct possibility that the Sequenom case will be heard by the Supreme Court in due course we expect there to be significant further updates in relation to patent eligibility of diagnostic methods. Nevertheless, the new Guidance now requires US Examiners to offer a much more detailed rationale to support any objection that claims relate to patent ineligible subject matter and the new examples offer a number of helpful scenarios which Applicants can point to in order to rebut such objections and/or guide potential claim amendments.