November 30, 2020

Volume X, Number 335


November 30, 2020

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The Thorny Problem of Patentable Eligible Subject Matter: Part 1 of a 10-Part Series: U.S

Statutory Classes of Patentable Subject Matter

In the US, patentable subject matter is defined by Section 101 of the Patent Act which states:  Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.  35 U.S.C. §101 (Section 101).

The Patent Act of 1793, authored by Thomas Jefferson, contained the original statute defining patentable subject matter which ultimately evolved into modern day Section 101.  At that time, the statute defined patentable subject matter as any new and useful:  art, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.

In 1952, when the patent laws were recodified, Congress replaced the word “art” with the word “process” but otherwise, Jefferson’s original wording remained unchanged.  Although the term “process” was not added until 1952, “processes” historically enjoyed patent protection because they were considered a form of “art” as used in the 1793 Act.  Interestingly, according to the Committee Reports accompanying the 1952 Act, Congress intended statutory subject matter to “include anything under the sun that is made by man”.

Thus, under Section 101, all patents issued in the US must be classified into at least one of the following four statutory classes:

  1. Machines – A concrete thing consisting of parts or devices;
  2. Manufacture – An article produced from raw or prepared materials;
  3. Composition of Matter – A composition of substances or composite articles; and
  4. Processes -An act or a series of acts.

Inventions that do not fall within any of above described statutory classes are not eligible for patenting.

The US Supreme Court (Supreme Court) has long held that Section 101 contains a number of important “implicit” exceptions.  Specifically, laws of nature, natural phenomena and abstract ideas are not patentable.  For example, the Supreme Court has written that a new mineral discovered in the earth, a new plant found in the wild, Einstein’s law E=mc2 or Newton’s law of gravity are not patentable subject matter.  As the Supreme Court stated inGottschalk v. Benson, 409 U.S. 63, 67 (1972), “[P]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.”  Additionally, Section 33(a) of the Leahy-Smith American Invents Act provides that human organisms (such as claims to a human embryo) are not patent eligible subject matter.

U.S. Patent and Trademark Office Guidelines

In view of recent Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc.(Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo), the U.S. Patent and Trademark Office (USPTO) on March 4, 2014, issued a guidance for evaluating subject matter eligibility under Section 101 (Guidance).  The Guidance superseded the June 13, 2013 memorandum issued on the day of the Myriaddecision.  While the Guidance was issued without public notice or opportunity for the public to comment, the USPTO is holding a forum on May 9, 2014 to receive feedback from organizations and individuals regarding the Guidance.

The Guidance is divided into four sections.  Part I discusses the three-part test for determining subject matter eligibility.  Part II explains how to determine whether a claim (as a whole) is “significantly different”.  This portion of the Guidance provides a list of 12 factors – six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference).  Part III provides seven examples explaining the application of the factors.  Part IV provides a new form paragraph for Examiners to use when rejecting claims in accordance with the guidance.

The USPTO has made it clear that the Guidance is to be used for making subject matter eligibility determinations for all four statutory categories of subject matter (namely, a machine, composition, manufacture or process) that recite or involve laws of nature, natural principles, natural phenomena and/or natural products.  The Guidance is not to be used if the subject matter recites or involves an abstract idea (alone or in combination with other judicial exceptions (namely, laws of nature, natural principles, natural phenomena and/or natural products)).

In addition to the Guidance, the USPTO has prepared detailed training materials (containing 93 PowerPoint slides) for Examiners.  During the Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting on April 16, 2014 (BCP meeting), June Cohan and Ali Salimi from the Office of Patent Legal administration, and Daniel Sullivan, a supervisor patent Examiner from Art Unit 1611, provided insight on how the Guidance was developed, including its basis in Supreme Court precedent.  As discussed during the presentation, the first round of training for Examiners on the Guidelines is in progress and a second round of training is currently in development.  Plans for this second round of training include providing additional training materials containing more examples from the seven provided in the current Guidelines.  Moreover, the USPTO plans to update the MPEP.  It will be interesting to see the content of the next round of training materials, particularly after the USPTO receives feed-back from the public during the forum on May 9th.

3-Part Analysis

The Guidance provides a three-step analysis for determining the subject matter eligibility of a claim.  The analysis involves determining the broadest reasonable interpretation for a claim and asking the following questions:

  1. Does the claim recite one of the four statutory categories of patent eligible subject matter (namely, a machine, a composition, a manufacture or a process)?  If the answer to this question is no, then the analysis is complete and the claim is rejected under Section 101 as drawn to ineligible subject matter.  If the answer to this question is yes, proceed to question 2.
  2. Does the claim recite or involve one or more judicial exceptions (namely, an abstract idea*, law of nature or natural principle, natural phenomena or natural product)?  If the answer to this question is no, then the analysis is complete and the claim qualifies as eligible subject matter.  If the answer to this question is yes, proceed to question 3.

*If an abstract idea, however, is recited or involved, then the Guidance should not be used to determine if the claim qualifies as eligible subject matter.

  1. Does the claim as a whole recite something significantly different from the judicial exception?  If the answer to this no, then the analysis is complete and the claim is rejected under Section 101 as drawn to ineligible subject matter.  If the answer to this question is yes, then the analysis is complete and the claim qualifies as eligible subject matter.

According to the Guidance, it is not enough that a claim is directed to a product or composition that is non-naturally occurring.  Rather, the claimed product or composition must also be significantly different in structure from a naturally occurring product.

What does “significantly different” mean?

According to the Guidance, if a claim recites or involves a judicial exception (a law of nature/natural principle or natural phenomenon and/or something that appears to be natural product), the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.  This raises the question of the meaning of “significantly different”.  According to the USPTO, the Supreme Court has articulated two pathways to eligibility for claims reciting judicial exceptions (such as natural products):

  1. Marked difference from what exists in nature; or
  2. Addition of significantly more to the judicial exception.

The “marked difference” inquiry focuses on the structural differences of a claimed product or composition and whether these structural differences impart one or more unique functions to the product when compared to a naturally occurring product.  Applicants must be cognizant that including limitations in a claim such as “synthetic”, “isolated”, “recombinant”, “cDNA”, “composition”, “primer”, “purified”, and “vector” are not likely to be found to constitute a “marked difference” from what exists in nature.  In fact, in the Examiner training materials, the USPTO made it clear that “[T]hese words may reflect ‘hand of man’ but are not necessarily determinative of eligibility”.

Additionally, a claim reciting a method that involves or recites a judicial exception must recite meaningful limitations that add significantly more (namely, practically apply) to the judicial exception.  A claim that recites limitations that are insignificant or tangentially related and/or are well known or understood and purely conventional or routine steps or features are not likely to be found to have added “significantly more” to a judicial exception.

The Guidance and training materials provide a list of 12 factors (six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference)) to be evaluated for determining if a claim as a whole is “significantly different”.  The Guidance makes it clear that not every factor will be relevant to every claim and does not need to be considered in every analysis.  The 12 factors are provided in the table below.

       intellectual property

*These factors are only relevant to product claims.  The remaining 10 factors (b-f and h-l) are applicable to all claims.

The initial burden is on an Examiner to establish a prima facie case of ineligibility.  Specifically, when rejecting a claim, the Examiner is required to provide a rationale or evidence to reasonably support a determination that a product is not markedly different from what exists in nature.  The evidence that can be used by an Examiner is not limited to that available as of the filing date of the application.  Moreover, as discussed in detail in the Guidance and training materials, an Examiner’s analysis “should carefully consider every relevant factor and related evidence before making a conclusion”.  In fact, the materials make clear that a determination of eligibility is not “a single, simple determination but is a conclusion reached by weighing the relevant factors, keeping in mind that the weight accorded each factor will vary based upon the facts of the application.”


The Guidance and the training materials provide a number of examples demonstrating how the factors are to be weighed when conducting a subject matter eligibility analysis.  However, several of the examples have resulted in significant discussion and consternation by practitioners.  Some of these examples include:

  1. Examples directed to compositions containing purified natural products and methods of using these purified natural products for various purposes (See, Example B in the Guidance and the examples on pages 41 and 67-85 of the training materials).  Specific examples include:  a composition containing purified amazonic acid or 2-methyl-2-pentenoic acid, a beverage composition comprising pomelo juice and a preservative or vitamin E and a method of treating colon cancer using purified amazonic acid.
  2. Examples directed to compositions containing a mixture or aggregation of natural products (See, Example D in the Guidance and the example on page 44 of the training materials).  Specific examples include:  an inoculant for plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria and a composition comprising 90% copper and 10% tin.
  3. Examples directed to articles of manufacture containing a natural product (See, Example C in the Guidance).  A specific example includes a fountain-style firework comprising calcium chloride and gunpowder.

But Wait…Didn’t Myriad Just Involve DNA?

During the BCP meeting, the USPTO addressed the question of why the Guidance extends the Myriad decision beyond just nucleic acids.  According to the USPTO, the Guidance was not intended to be limited to just Myriad, but addresses Myriad in the context of at least 10 other Supreme Court decisions addressing subject matter eligibility.  The USPTO justifies this approach arguing that Myriad “explicitly” relied on earlier Supreme Court precedent such as Chakrabarty and Mayo, all of which are interrelated.

Moreover, the USPTO further argues that despite the fact that for over 30 years Office practice was that “isolation” or “purification” of an otherwise unchanged naturally occurring product was sufficient for eligibility, the Supreme Court has given no deference to this past practice.  Specifically, the USPTO states that the:

Supreme Court made it clear in Myriad that isolating a natural product such as a gene, even though it ‘creates a nonnaturally occurring molecule’, is not enough for eligibility.  Instead, eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature.

So, what now??

Applicants prosecuting applications that have one or more claims rejected under Section 101 should consider amending their claims to include limitations that impose meaningful limits on the scope of the claims.  Applicants should avoid adding limitations that are well-understood, purely conventional or routine and consider explaining why a step or the claim as a whole is not routine or conventional.  Other possible suggestions include adding a particular machine or particular transformation (such as a method of treatment) to the claims.

Applicants should consider amending product claims to recite the structural differences between the claimed product and the naturally occurring product.  Additionally, Applicants should explain how these structural differences impart unique functions to the product when compared to a naturally occurring product.  Although such claims would be relatively narrow in scope, Applicants should consider filing one or more continuation applications to await further judicial clarification on the subject matter eligibility in view of the Guidance.

When drafting applications, Applicants should make sure to include multiple claim sets with progressively narrower scope.  Additionally, Applicants should make sure that the specification includes sufficient detail to provide the description necessary to provide any support that may be needed to demonstrate “a marked difference” between a claimed product or composition and a naturally occurring product(s) and/or to impart “meaningful limits” to the scope of the claims.

This is Part 1 of a 10-part series examining patent eligible subject matter in the U.S., BRIC and several non-BRIC countries.

To view Part 2  The Thorny Problem of Patentable Eligible Subject Matter: Canada, click here.

©2020 MICHAEL BEST & FRIEDRICH LLPNational Law Review, Volume IV, Number 120



About this Author

intellectual property, Michael Best Law Firm, Patent Agent, Julie Cox, inventions, life science, pharmaceutical, biotechnology
Patent Agent

Julia Cox is a Patent Agent and a member of the Intellectual Property Practice Group in the Madison office. Dr. Cox has an extensive background in Chemistry, Biochemistry, and Molecular Biology, with broad experience in protein engineering, pharmaceuticals, genetic screening, and biotechnology. She has experience in all phases of foreign and domestic patent prosecution, including advising clients in contemplation of filing a patent, as well as writing and prosecuting patent applications. Dr. Cox focuses her practice on inventions in life science, pharmaceuticals,...

Lisa Mueller, Michael Best, Patent application Attorney, intellectual property lawyer,
Partner, Industry Group Chair, Life Sciences

Lisa provides strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology and chemistry sectors. She brings an in-depth knowledge and extensive experience to her work advising clients on patent protection, freedom to operate and invalidity of blockbuster drugs they aim to produce and distribute.

Lisa’s advice on the full spectrum of global intellectual property portfolio management includes patent prosecution, opposition and other post-grant proceedings