In January 2019, the USPTO issued revised guidelines (hereinafter, the “January 2019 Guidelines”) concerning examination of patent claims for compliance with 35 U.S.C. § 101 (e.g., “Section 101”). Section 101 defines which inventions are subject matter eligible for patentability. Inventions excluded from patentability include (1) abstract ideas (e.g., mathematical formulas); (2) laws of nature (e.g., Newton’s second law of motion, F=MA) and (3) physical phenomena (e.g., new minerals).
On May 9, 2019, USPTO personnel presented an informative and useful webinar relating to the revised guidelines. The following discusses salient points of the presentation.
The January 2019 Guidelines provided guidelines for examining applications for compliance with section 101 under a multi-step test examination process, Step 1, Step 2A and Step 2B. The foregoing steps are shown schematically in the presentation, as follows, with steps depicted as “unchanged” from previous guidelines:
(1) Step One Analysis
Step 1 remains unaffected by the revised guidelines and considers whether an examined claim is directed to (1) a process; (2) a machine; (3) manufacture or (4) composition of matter.
The following section discusses relevant considerations for a Step 2A analysis. Step 2A has been revised in two aspects, and hence is a two-prong inquiry.
(2) Prong One of Step 2A Analysis
Step 2A queries whether the examined claim is directed to (1) law of nature; (2) natural phenomenon (including products of nature) or (3) an abstract idea.
A claim is now deemed eligible at Step 2A unless it (1) recites a judicial exception; and (2) does not integrate the judicial exception into a practical application of the judicial exception.
As the following sub-section shows, Prong One of Step 2A analysis depends on whether a claim is directed to a law of nature and natural phenomena or is directed to an “an abstract idea.”
a. Prong One of Step 2A Analysis concerning “Law of Nature and Natural Phenomena”
Prong One of Step 2A, with respect to a “law of nature and natural phenomena,” remains unchanged by the January 2019 Guidelines. If a claim recites a “law of nature and natural phenomena,” then examiner, in the first prong, should examine the claim under the analysis set forth under MPEP 2106.04(b) and (c), which includes the “markedly different characteristics analysis.” Concerning the foregoing analysis, MPEP 2106.04(c) states the following:
[T]his analysis [is used] to identify product of nature exceptions. For example, Chakrabarty relied on a comparison of the claimed bacterium to naturally occurring bacteria when determining that the claimed bacterium was not a product of nature because it had “markedly different characteristics from any found in nature”. Diamond v. Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193, 197 (1980).
If the claim recites a law or nature of natural phenomenon (including a product of nature), then the analysis proceeds to Prong Two of Step 2A.  Prong Two will be discussed later in this article.
b. Prong One of Step 2A Analysis concerning “Abstract Ideas”
Prong One of Step 2A has been revised with respect to evaluation of a claim that is “directed to” an abstract idea.
If a claim limitation is identified as an “abstract idea,” an examiner, in Prong One of Step 2A, does not evaluate whether an examined claim is analogous to an idea identified as abstract in court decisions as it was done in the past. Instead, the examiner, when applying Prong One of Step 2A, first determines whether the claim is grouped within the three categories of “abstract ideas.” The three categories of “abstract ideas” are (1) mathematical concepts (e.g., mathematical formulas); (2) mental processes (e.g., concepts performed in human mind including an observation) and (3) certain methods of organizing human activity (e.g., fundamental economic principles such as hedging, commercial or legal interactions such as contracts, or managing personal behavior or relationships or interactions between people).
If the claim falls within one of the mentioned three categories of “abstract ideas,” then the analysis should now proceed to Prong Two of Step 2A. Prong Two will be discussed as follows.
(3) Prong Two of Step 2A Analysis
Prong Two of Step 2A evaluates whether the claim recites additional elements that integrate the judicial exception into a practical application of the judicial exception. If such integration is present, then the claim is deemed patent-eligible under section 101. Accordingly, a claim is patent-eligible under Section 101 if the judicial exception is integrated into a practical application of that exception.
“Integration into a practical application” of the judicial exception analysis for compliance with Section 101 considers whether the additional elements or a combination of additional elements in the claim applies, relies on or use the judicial exception with meaningful limitations, so that the claim is evaluated as “more than a drafting effort designed to monopolize the judicial exception.”  For evaluation of whether the judicial exception is integrated into a practical application, MPEP sections 2106.05(a)–(h), which describe exemplary considerations presented by the Supreme Court and the Federal Circuit, should be consulted. Examples of Prong Two of Step 2A considerations are shown as follows:
Patent practitioners familiar with Prong Two of Step 2A considerations are more likely to avoid Section 101 rejections as the following will show. As indicated in the above discussion, patent practitioners can advance prosecution of software patent claims by advocating that the claim recites an improvement to the functioning of a computer, for example. Thus, this will avoid a Section 101 rejection. Concerning method of treatment claims, patent practitioners, among many considerations, should draft claims that “apply natural relationships” in order to better avoid a Section 101 rejection. For such claims, application of natural relationships could include claim recitations to specific treatment regimens, for example.
Notably, Prong Two of Step 2A does not consider whether the additional elements in a claim are “well-understood, routine, conventional” activity.
(4) Step 2B analysis
If the claim limitation reciting a judicial exception is not integrated into a practical application, then a Step 2B analysis must be further considered since the examined claim is “directed to” the judicial exception.
In that respect, Step 2B has not been changed by the January 2019 Guidelines. Step 2B still considers whether the claim recites additional elements that amount to “significantly more” than the judicial exception. In this Step 2B, additional elements of the claim are both evaluated individually and in combination to determine whether they amount to “significantly more” than the judicial application. For example, a claim which amounts to “significantly more” than the judicial exception, is deemed patent-eligible under Section 101.
(5) Comments concerning the January 2019 Guidelines
The January 2019 Guidelines do present a good step forward for a more streamlined, more consistent examination of a claim for compliance under Section 101. As the following shows, there are some improvements introduced by the January 2019 Guidelines, and, the revisions still do not address some concerns raised by patent practitioners.
Notably, Prong One of Step 2A does not involve evaluating whether a claim is analogous to an idea identified as abstract in relevant court decisions. This previous practice of analogizing to an idea presented in court decisions introduced imprecision as well as allowing for more subjectivity into the claim examination process. Also, by having Prong Two of Step 2A not taking into consideration whether the claims are “well-understood, routine, conventional” activity,” conflating the Section 101 analysis with Section 103 analysis for obviousness considerations is eliminated. Section 103 analysis of a claim, of course, should be appropriately considered separately.
However, the January 2019 Guidelines, at first glance, do not appear to necessarily advance allowance of medical diagnostic claims. Significant progress concerning advancement of such claims will need to be addressed legislatively by revising Section 101 altogether. Any revisions to section 101 will necessarily affect many classes of claims, not just medical diagnostic claims. Such proposals to reform Section 101 are underway, and U.S. Senate hearings concerning such proposed reform of Section 101 will be conducted on June 4, 5 and 11, 2019, as reported by many patent blogs.
In view of the foregoing discussion, it is even more important for clients to consult patent counsel concerning creative strategies towards drafting claims to better avoid a Section 101 rejection.
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 Update on Section 101 Guidelines, May 9, 2019 at page 6, available at https://www.uspto.gov/sites/default/files/documents/boardside_chat_on_101_5.9.19.pdf.
 Id. at page 6.
 Id. at page 9.
 Id. at page 11.
 Id. at page 10.
 Id. at page 12.
 Id. at page 13.
 Id. at page 14.
 Id. at page 16.
 Vanda memo at page 2 (June 7, 2018), available at https://www.uspto.gov/sites/default/files/documents/memo-vanda-20180607.PDF.
 Update on Section 101 Guidelines, supra note 13, at page 17.
 Id. at page 19.
 See, https://www.ipwatchdog.com/2019/05/22/draft-text-proposed-new-section-101-reflects-patent-owner-input/id=109498/, and https://www.patentdocs.org/2019/05/senate-proposal-for-section-101-reform-effect-on-biotechpharma-inventions.html, for example.