On June 30, 2020, the United States Patent and Trademark Office (USPTO) revised the Manual of Patent Examining Procedure (MPEP) Ninth Edition and updated it to reflect current USPTO patent practice and relevant case law as of October 31, 2019. In particular, these changes update the MPEP to reflect current USPTO practice regarding the patent subject matter eligibility of high tech and life sciences inventions.
The MPEP is a guidance document regarding patent prosecution practices and procedures used extensively by U.S. patent examiners, patent agents and the public. While the MPEP does not have the force and effect of law, USPTO patent examiners routinely follow the guidance it contains. An up-to-date MPEP increases the predictability of patent examination and consequently reduces the cost of patent prosecution.
The June 2020 MPEP revision is the first such revision in over two years and, as a result, includes significant substantive and administrative updates.
One of the most significant updates pertains to Subject Matter Eligibility guidance. Since the 2013 decision of the U.S. Supreme Court in Alice Corp. v. CLS Bank International ("Alice"), which itself built on the Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. ("Mayo"), the USPTO has released numerous guidance documents in order to clarify this area of law. The latest MPEP revision incorporates the USPTO's two most recent documents on this topic: the October 2019 Patent Eligibility Guidance Update, 84 FR 55941 (October 18, 2019) ("the October Guidance") and the 2019 Revised Patent Subject Matter Eligibility Guidance, 84 FR 50 (January 7, 2019) ("the 2019 PEG"). Previously, the October Guidance and the 2019 PEG had been separate documents that superseded the sections of MPEP concerning subject matter eligibility. With this revision, MPEP has been updated and may be relied on to reflect current practices.
The Alice decision confirmed the two-step test that should be used by USPTO patent examiners for determining whether the subject matter of patent claims is patentable under U.S. law. The first step of the test calls for examiners to determine if the claims of a patent application fall within one of the four statutory categories: a process, machine, manufacture, or composition of matter. If yes, the examiners should determine if the claims are directed to a judicial exception, such as a law of nature, a natural phenomenon, or an abstract idea. If no, the claims qualify as eligible subject matter. Otherwise, if it is believed that the claims are directed to a judicial exception, examiners assess whether the claim recites additional elements that amount to significantly more than the judicial exception.
The Revisions: The 2019 PEG and the October Guidance
In the aftermath of the Alice decision, the USPTO identified that there was ambiguity with respect to what constituted a claim "directed to a judicial exception." The 2019 PEG was intended to provide guidance in two areas. First, the 2019 PEG enumerated three groups of abstract ideas, a category of judicial exception that had previously lacked well-defined boundaries. Second, the 2019 PEG provided a more consistent approach for determining whether a claim is "directed to" a judicial exception. We reviewed these changes in an earlier article.
The October Guidance was released in response to public commentary regarding the 2019 PEG and contained additional guidance. Specifically, the October Guidance provided additional guidance for evaluating whether a claim "recites" a judicial exception and, if so, whether the judicial exception is "integrated into a practical application" such that the claim as a whole is not "directed to" the judicial exception.
Both the 2019 PEG and the October Guidance set out that the three enumerated groups of abstract ideas are mathematical concepts, mental processes, and certain methods of organizing human activity. The other judicial exceptions include laws of nature and natural phenomena.
MPEP Revisions Concerning Engineering and Technology Patents
The June 2020 MPEP revision updates guidance concerning abstract ideas, but not for laws of nature or natural phenomena. For laws of nature and natural phenomena, examiners are directed to follow previous guidance.
With regard to abstract ideas, examiners are now directed to: (a) identify the specific limitation(s) in the claim under examination (individually or in combination) that the examiner believes recites an abstract idea; and (b) determine whether the identified limitation(s) falls within the subject matter groupings of abstract ideas enumerated in the 2019 PEG and, now, MPEP (see section 2106.04(a)(2)).
The subject matter groupings enumerated in the 2019 PEG reflect the USPTO's movement away from the case-comparison approach. The three enumerated groupings are rooted in Supreme Court precedent and Federal Circuit decisions. While the previous MPEP revision had identified some of these groupings, the June 2020 revision now contains all relevant categories and sub-categories previously found only in the 2019 PEG and October Guidance.
Notably, the guidance issued under the new "Mental Processes" group provides clarity for software inventions which was somewhat lacking in the previous MPEP edition. In particular, the June 2020 revision clarifies that "a claim with limitation(s) that cannot practically be performed in the human mind does not recite a mental process". However, it should be noted "a claim that requires a computer may still recite a mental process". In order to evaluate whether a claim that requires a computer recites a mental process, an examiner should, "review the specification to determine if the claimed invention is described as a concept that is performed in the human mind and applicant is merely claiming that concept performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept".
The updated MPEP also includes updated guidance for determining whether a claim integrates a judicial exception into a practical application. For example, whether the invention effects "an improvement in the functioning of a computer, or an improvement to other technology or technical field" is now set out as a consideration. This consideration was present in the previous MPEP edition, but at a later step of the analysis. The updated MPEP places this consideration in earlier stages of the Alice analysis, where the examiner is directed to exclude consideration of whether the additional elements represent well-understood, routine, conventional activity. This may serve to improve the chances of claims for software-related inventions to qualify as eligible subject matter.
MPEP Revisions Concerning Life Sciences Patents
The June 2020 revision contains several updates that are particularly relevant to life sciences patents. Specifically, examiners are now directed to consider whether claims include improvements to technology, and whether the claims apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical treatment. The consideration of an improvement to technology or technical field applies equally to computer implemented inventions.
Claims are to be considered patent eligible if they integrate the judicial exception into a practical application by, e.g., improving the relevant existing technology. However, it should be noted that an improvement in the judicial exception itself, may not constitute an improvement to technology.
Examiners are also instructed to consider treatment/prophylaxis. Claims that practically apply natural relationships, including judicial exceptions, are eligible if they meet a three-part test. Examiners must consider:
- The particularity or generality of the treatment or prophylaxis
- Whether the limitation(s) have more than a nominal or insignificant relationship to the exception(s)
- Whether the limitation(s) are merely extra-solution activity or a field of use
Under the first point, the treatment or prophylaxis limitation must be particular, and not encompassing of all applications of judicial exceptions. Steps that merely instruct one to "apply" the exception in a generic way are not sufficient. Under the second point, the treatment/prophylaxis must be known, or taught to treat or prevent the condition in question. A treatment that is a mere correlation, or has a nominal connection to the condition may not be adequate. Under the third point, the treatment/prophylaxis must impose meaningful limits on the judicial exception and cannot be extra-solution activity or field-of-use. This point illustrates the need of integrating the abstract idea into a practical application. For example, merely administering a vaccine to domestic cats in accordance with a vaccine schedule, and analyzing the data to determine a lowest risk vaccination schedule would not be patent eligible. However, adding another claim wherein a second group of cats are vaccinated in accordance with the lowest-risk vaccination schedule, could be eligible.
The 2019 PEG was issued in accordance with judicial precedent and to increase consistency and predictability in examination practice. In "Adjusting to Alice: USPTO patent examination outcomes after Alice Corp. v. CLS Bank International", the USPTO's Office of the Chief Economist reported a 25% decrease in the likelihood of Alice-affected technologies receiving a first Office Action rejection, in the year following the Alice decision. Furthermore, in that same one-year period, "uncertainty in patent examination for Alice-affected technologies decreased by 44%". The USPTO clearly believes that its guidance updates and the recent MPEP revision serve to increase clarity and predictability.
Originally published 21 July, 2020
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