PTAB Finds That a Mixture of Three Milk Sugars is a Product of Nature

The Patent Trial and Appeal Board recently affirmed the 35 U.S.C. § 101 rejection of patent claims for a mixture of three human milk oligosaccharides (HMOs), finding the ternary mixture to be ineligible for patenting.¹ This decision provides helpful insight into how compositions involving naturally occurring constituents are evaluated by the Board, and highlights ongoing challenges that inventors and patent applicants may face, even when claiming compositions that are developed in a laboratory.

The Technology

Human milk is primarily water, but also contains sugars, fats, proteins, and minerals. Certain sugars, known as HMOs, are of particular interest for their potential health properties. At least 130 HMOs are known to be present in milk. The invention involved Glycom’s combination of three specific HMOs, namely 6′-SL, LNnT, and LST c.  This three-part mixture was found to have anti-infective properties, rendering it useful for treating viral or bacterial infections.

The claimed mixture was limited to these three HMOs only, and did not include other components, making it distinctly different from naturally occurring milk. Furthermore, the mixture was prepared using a laboratory enzymatic process. So how did the Patent Office conclude that it was a product of nature?

The § 101 Rejection

Following the USPTO’s 2014 Interim Guidance on Patent Subject Matter Eligibility (2014 IEG) depicted in the flow chart below, under Step 1 the Examiner first determined that the claims were directed to one of the four statutory categories, namely as a “composition of matter.”²   

Under revised Step 2A Prong One of Revised Patent Subject Matter Eligibility Guidance (2019 PEG) shown below, the claim was found to recite a judicial exception, namely a natural phenomenon.

In assessing the nature-based product, the examiner found that none of the claimed HMO components exhibited any change in structure or function with respect to how they occur in nature. According to the USPTO guidelines, if a nature-based product as presented in the claim has markedly different characteristics (MDC test) as compared to any naturally occurring counterparts, there is no judicial exception and the claim is eligible (Step 2A Prong One: NO), whereas if the nature-based product does not have markedly different characteristics, then the claim is directed to the “product of nature” judicial exception (Step 2A Prong One: YES) and the analysis proceeds to Step 2A Prong Two.

With reference to Step 2A Prong Two, the examiner found that the judicial exception was not integrated into a practical exception, because the claims did not recite anything beyond the HMOs themselves, and any intended use did not accomplish such an integration (Step 2A Prong Two: NO).

With reference to Step 2B, the examiner found that the claims as a whole did not recite additional elements amounting to something more than the judicial exception (Step 2B: NO), and therefore the claims were not eligible under § 101.

The Board’s Analysis

To begin, the Board agreed with the examiner that the claims recited a composition of matter, thus satisfying Step 1 of the Guidance. The Board also agreed that the claims were directed to a judicial exception at Step 2A Prong One, noting that “[w]hether the HMOs are isolated or subsequently replicated outside the human is irrelevant to whether they are found in nature.”

With regard to the markedly different characteristics (MDC) analysis at Step 2A Prong One, the Board noted that the application specification itself said that “[i]n some cases, the dosage will be at a concentration similar to that found for 6’-SL, LNnT and/or LST c in human breast milk.”

Relatedly, the Board emphasized that “the claims provide no ranges or specify any concentration of the HMOs, leaving the claims subject to the broadest interpretation in light of the Specification.” Accordingly, the Board concluded that the claims could be construed to encompass dosages as low as the levels of HMOs found in natural milk, and therefore the claims recited subject matter that was not markedly different from what is found in nature.

The Board also indicated that the Appellant did not meet the burden of showing a markedly different characteristic sufficient to warrant patent eligibility.

In sum, the Board’s analysis ended at Step 2A Prong One, and did not reach Step 2A Prong Two or Step 2B.

Key Takeaways for Patent Attorneys and Agents

When working with inventions that involve a mixture of natural products, it can be helpful to specify in the claims how the mixture components are different from the way in which they may occur naturally. Relying on the fact that the components have been isolated, purified, or synthesized may not be enough to establish patent eligibility. Consider drafting the patent application with the following guidelines in mind:

• Include specific quantitative descriptions (e.g. concentrations, amounts, related ranges) of mixture components
• Provide evidence of unique or improved biological/pharmacological functionality for the mixture

PERA Implications

Under the currently proposed language of the Patent Eligibility Restoration Act (PERA, Senate Bill 2140), the milk sugar mixture claims that were found ineligible by the Board would likely have been found to meet the patent eligibility requirement (e.g. pursuant to §§101(a), (b)(2)(A)).

Related Reading

As noted above, the Board placed the burden on the Applicant to show that the claimed subject matter markedly different characteristics as compared to a naturally occurring mixture (as part of the Step 2A Prong One analysis). Compare this result with the Board’s position in Ex parte Ma, where the Board seemed to implicitly put the burden of proof on the examiner to show that the claimed formulation lacked markedly different characteristics as compared to a product of nature (also as part of the Step 2A Prong One analysis).

¹ Ex parte Champion (Appeal 2023-003725; November 6, 2024)

² In Diamond v. Chakrabarty, 447 U.S. 303 (1980), the Supreme Court confirmed that the term “composition of matter” refers to “all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.”

PTAB Finds That Chemokine Receptor-Derived (CKRD) Peptides are Not Natural Products

The Patent Trial and Appeal Board (PTAB) reversed the § 101 rejection of claims directed to chemokine receptor-derived (CKRD) peptides, and found the claims to be eligible for patenting.¹ This decision provides helpful insights on how the U.S. Patent and Trademark Office evaluates claims involving peptide fragments derived from naturally occurring proteins under 35 U.S.C § 101.

The Technology

The case involved Protagonists Ltd.’s peptides that were based on the nine amino acid sequence of Trp, Val, Phe, Gly, Ser, Gly, Leu, Cys, Lys. This peptide sequence is derived from a naturally occurring protein, namely a chemokine receptor protein.

As shown in the illustration below, chemokines bind to chemokine receptors, and thereby initiate inflammation as part of an effective immune response. In some cases, however, dysregulation of the chemokine receptor protein signaling can lead to autoimmune disorders or inflammatory diseases such as arthritis.

Here, the inventors discovered it was possible to use a specific portion of the chemokine receptor (just the part that usually binds to the chemokine) as a decoy, so that the chemokine would bind to this peptide segment instead of to the receptor itself. As a result, the chemokine receptor is not activated and the inflammation response is reduced.

The § 101 Rejection

The examiner rejected the claims under 35 U.S.C. §101, arguing they recited a natural phenomenon (e.g., product of nature). With regard to Step 1 (see flowchart below), the examiner found the claims to be directed to compositions of matter, namely peptides.

With regard to Step 2A Prong One (see flowchart below), the § 101 rejection concluded that the claims recited a natural phenomenon, because the peptide corresponded to domains of naturally occurring proteins which are a natural phenomenon. With regard to Step 2A Prong 2, the § 101 rejection concluded that the claims did not recite additional elements that integrated the judicial exception into a practical application.

With regard to Step 2B, the § 101 rejection concluded that the claims did not recite additional elements that were sufficient to amount to significantly more than the judicial exception.

The Board’s Analysis

The PTAB reversed, disagreeing with various aspects of the § 101 rejection.

1. Peptide Fragment is Not Product of Nature: The Board keyed in on the question of whether a peptide that is a fragment of a larger naturally occurring protein is inherently also naturally occurring. In this instance, the Board noted that the § 101 rejection provided no evidence that the claimed peptides were found in nature, even though it was theoretically conceivable that such a peptide may have previously naturally formed as a product of protease cleavage within the human body. According to the Board, “it is the Examiner’s burden to show that claimed subject matter is necessarily naturally occurring and not merely an unusual and rare phenomenon.”
2. Markedly Different Characteristics: The Board found that even if the peptide could be considered as a nature-based product, it had markedly different characteristics than the naturally occurring protein based upon multiple lines of evidence, including binding activity, structure, and effect on inflammation.

In sum, the Board resolved the patent eligibility question under Step 2A Prong 1 by finding that the claimed peptide was not directed to a product of nature, without needing to complete an analysis that fully addressed Step 2A Prong 2 or Step 2B.

Key Takeaways for Patent Attorneys and Agents

This decision highlights important principles for patent practitioners dealing with compositions involving peptide fragments of larger naturally occurring proteins.

• Emphasize experimental evidence showing structural and functional differences from the natural protein source.
• Emphasize experimental evidence showing therapeutic properties of claimed peptides.

PERA Implications

Although the Board found that the claims met the requirements of § 101, under the currently proposed language of the Patent Eligibility Restoration Act (PERA, Senate Bill 2140) it is likely that this case would not have made it to the Board, as the examiner would likely have concluded that the composition claims met the patent eligibility requirement (e.g. pursuant to §§101(a), (b)(2)(A),(b)(2)(B)).

Related Reading

As noted above, the Board placed the burden on the Examiner to show that the claimed subject matter is necessarily naturally occurring and not merely an unusual and rare phenomenon (as part of the Step 2A Prong One analysis). Complement this result with the Board’s position in Ex parte Ma, where the Board seemed to implicitly put the burden of proof on the examiner to show that the claimed formulation lacked markedly different characteristics as compared to a product of nature (also as part of the Step 2A Prong One analysis).

¹ Ex parte Ezerzer(Appeal 2022-004253; February 7, 2024)

A History of the Language of the Patent Eligibility Restoration Act (PERA)

Patent eligibility is determined by Section 101 of Title 35 of the United States Code, which currently reads:

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 therefor, subject to the conditions and requirements of this title.

Although the statute broadly indicates that “any” process, machine, manufacture, or composition of matter is eligible for patenting, certain judicially created exceptions have been established by the Supreme Court.

The scope of these judicial exceptions has expanded over the years, and the boundaries defining what may or may not be eligible for patenting has grown increasingly uncertain.

Congress is now taking action to clarify the law on subject matter patent eligibility.

The objective of PERA is to amend the law relating to patent subject matter eligibility, to establish that only certain restricted categories of subject matter (e.g. a mental process performed solely in the mind of a human being) are ineligible for patenting.

In April 2019, U.S. Senators Thom Tillis (R-NC) and Chris Coons (D-DE), Chair and Ranking Member of the Senate Judiciary Subcommittee on Intellectual Property, and Representatives Doug Collins (R-GA-9), Ranking Member of the House Judiciary Committee, Hank Johnson (D-GA-4), and Steve Stivers (R-OH-15) released a bipartisan, bicameral framework on Section 101 patent reform. The text of the April 2019 framework can be found here. [PDF]

The following month, in May 2019, a draft proposal to reform Section 101 was circulated by number of U.S. Senators and Representatives. This proposal included draft statutory language specifically intended for 35 U.S.C. §§ 100 and 101. The text of the May 2019 proposal can be found here. [PDF]

In June 2023, US Senators Chris Coons (D-DE) and Thom Tillis (R-NC) jointly introduced a draft of the Patent Eligibility Restoration Act of 2023 (S.2140) in the Senate. The text of this draft can be found here. [PDF]

In September 2024, U.S. Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA) introduced the Patent Eligibility Restoration Act (PERA) in the House of Representatives.

Nature-Based Food Products May Be Eligible for Patenting Under 35 U.S.C. § 101

According to the U.S. Patent and Trademark Office’s 2014 Interim Guidance on Patent Subject Matter Eligibility (2014 IEG), there are several categories of nature‑based products which may be eligible for patenting, such as chemical mixtures, plant extracts, purified proteins, genetically modified bacteria, agricultural bacterial mixtures, nucleic acids, antibodies, biological cells, and foods.  In this example, we’ll take a closer look at how the Patent Office determines whether certain food products are eligible for patenting.

The Science of Yogurt

Traditionally, yogurt is made by mixing bacteria and milk together to create a culture.  The metabolic activity of the culture results in the production of lactic acid, and in turn, the lactic acid causes proteins within the milk to clump together, thickening the milk to form yogurt.

The Invention

In this example, the inventor has found a new naturally occurring species of bacteria called Lactobacillus alexandrinus.¹ The inventor has discovered that by mixing L. alexandrinus with milk and Streptococcus thermophilus (a naturally occurring bacterial species well known for making yogurt), the resulting culture produces a yogurt having a pleasant tangy flavor. The inventor has also discovered that the two mixed bacteria act synergistically to ferment milk at twice the speed than either bacteria can ferment by itself, and the resultant yogurt is much lower in fat than either bacteria can produce when used by itself.

Based on these discoveries, the inventor would like to patent two products. The product on the left is a kit that can be used for making yogurt. The kit includes a packet of S. thermophilus along with a separate packet of L. alexandrinus. The product on the right is a culture for making yogurt. The culture includes a mixture of the two bacteria along with milk.

According to 35 U.S.C. § 101, products of nature are not eligible for patenting.  So how can the inventor obtain a patent based on these discoveries?  The answer lies in the specific wording that is used for the claims which will be included in the patent application.

Claims in the Patent Application

The inventor files a patent application with the following two claims:

1. A kit for preparing milk yogurt comprising:

          Streptococcus thermophilus and Lactobacillus alexandrinus.

2. A yogurt starter culture comprising:

          milk mixed with Streptococcus thermophilus and Lactobacillus alexandrinus.

The Kit Is Not Eligible for Patenting, Whereas the Culture is Eligible

Under the USPTO’s 2014 IEG, the claims would be reviewed according to this flowchart.

Claim 1

Under Step 1 of the analysis, the kit claim is directed to a statutory category, specifically a composition of matter.  So, the answer to Step 1 is YES.

We know that the kit involves a nature-based product, because it includes bacteria that can be used in the production of food. Under Step 2A, the markedly different characteristics (MDC) test can be used to determine whether a nature-based product is a “product of nature” judicial exception. According to the USPTO guidelines, if the nature-based products as presented in the claim have markedly different characteristics as compared to any naturally occurring counterparts, there is no judicial exception and the claim is eligible (Step 2A: NO), whereas if the nature-based products do not have markedly different characteristics, then the claim is directed to the “product of nature” judicial exception (Step 2A: YES) and the analysis proceeds to Step 2B.

In this example, the claimed kit includes the two bacterial species, each in their own packet. Their presence in the kit does not markedly change their characteristics. Therefore, the answer to Step 2A is YES and we proceed to Step 2B. The kit claim does not recite any additional elements that could amount significantly more than the “product of nature” exception (Step 2B: NO), and therefore the claim does not pass the 35 U.S.C. § 101 test for subject matter eligibility.

Claim 2

As with the kit claim, under Step 1 of the analysis the culture claim is directed to a statutory category, namely a composition of matter. Again, the answer to Step 1 is YES.

According to the markedly different characteristics analysis (MDC) at Step 2A, we know that after mixing, the bacterial species promote faster fermentation and reduced fat yogurt, which are marked differences in terms of bacterial function and activity when compared to the bacteria in their natural state. Hence, the culture is not a “product of nature” judicial exception (Step 2A: NO) and the claim is eligible for patenting under 35 U.S.C. § 101.

Revised Guidance for Step 2A

In 2019, the USPTO published Revised Patent Subject Matter Eligibility Guidance (2019 PEG) to provide increased clarity, predictability, and consistency in how Section 101 is applied during patent examination. The 2019 PEG revised the procedure at Step 2A for determining whether a claim is directed to a judicial exception (e.g. product of nature) by using a two-prong inquiry.

In this food invention example, the outcome of the patent eligibility determination still remains the same following implementation of the 2019 PEG. This is because the Step 2A Prong 1 still applies the markedly different characteristics (MDC) test, and under Step 2A Prong 2, the kit claim does not recite any additional elements beyond the two bacterial species. If the kit claim did recite any additional elements, the question would be whether the additional elements operated to integrate the product of nature into a practical application.

¹ U.S. Patent and Trademark Office, ‘2014 Interim Guidance on Patent Subject Matter Eligibility,’ 79 Fed. Reg. 74618 (Dec. 16, 2014) [Nature Based Example 10, pp. 16-17; PDF] 

PTAB Finds That Base Oil + Essential Oil Formulation is Not a Natural Product

The Patent Trial and Appeal Board (PTAB) reversed the § 101 rejection of claims directed to a formulation that includes an essential oil in an oil base containing fatty acids, and found the claims to be eligible for patenting.¹ This decision provides helpful insights on how the U.S. Patent and Trademark Office evaluates claims involving products of nature under 35 U.S.C § 101.

The Technology

The case involved Joyce Ma’s formulation of an essential oil dispersed in a base mixture of oils having fatty acids. The fatty acids were present in amounts sufficient to mimic the fatty acid composition of a human cell membrane or sebum (a substance produced by the skin). The formulation was created to improve the penetration or absorption of substances applied to tissues and/or otherwise improve the functioning of the body.

For example, in order to mimic the oleic acid (fatty acid) 30.8% concentration present in human sebum, the patent application described selectively combining different oils (e.g. emu oil, coconut oil) which contain oleic acid in the appropriate ratio in order to achieve the desired oleic acid concentration.

The resulting base oil mixture, by virtue of its resulting fatty acid composition, could for example facilitate and/or improve permeability of the formulation and its components into a target location of the body.

The § 101 Rejection

The examiner rejected the claims under 35 U.S.C. § 101, arguing they were directed to a product of nature. According to the Step 2A Prong 1 analysis, the examiner found the claims to read on a natural product, particularly the compositions of a cell membrane or a sebum of a mammalian cell.

According to the Step 2A Prong 2 analysis, the examiner found that the judicial exception was not integrated into a practical application, because the claimed mixture of fatty acids was not markedly different from its naturally occurring counterpart. Here, the examiner relied upon the claim clause “wherein the fatty acids are in amounts that render a fatty acid composition of the base composition substantially identical to a fatty acid composition of a cell membrane or a sebum of a human cell.”

Under the Step 2B analysis, the examiner concluded that the claims did not include additional elements sufficient to amount to significantly more than the judicial exception, because the addition of an essential oil from a natural plant did not alter the fatty acid composition recited in the claims.

The Board’s Analysis

The PTAB reversed, disagreeing with various aspects of the § 101 rejection.

Under the Step 2A Prong 1 analysis, the Board stated that even if the claimed fatty acids in the oil of the base are substantially identical to the fatty acids in a cell membrane or in human sebum, it remained true that the claimed base is a mixture of selected oils, and not a cell membrane or sebum. Hence, the claimed formulation is not a product of nature.

Further, the Board noted that the claimed mixture of oils resulted in a fatty acid composition conferring functional properties different from those of any of the individual oils themselves.

In sum, the Board resolved the patent eligibility question under Step 2A Prong 1 by finding that the claimed formulation was not directed to a product of nature, without needing to complete an analysis that fully addressed Step 2A Prong 2 or Step 2B. The logical path of the Board’s reasoning can be further understood with reference to the USPTO’s 2019 Revised Subject Matter Eligibility Guidance flowchart excerpted below.

As a side note, although the examiner raised the markedly different characteristics (MDC) question, the Board seemed to implicitly put the burden of proof on the examiner to show that the claimed formulation lacked markedly different characteristics as compared to a product of nature. The Board concluded that because the examiner had not provided such evidence, the claims were eligible for patenting.

Key Takeaways for Patent Practitioners

This decision highlights several important points to consider when pursuing claims involving a product of nature:

1. If the invention involves approximating or artificially replicating a feature present in a naturally occurring material, make sure to thoroughly explain this throughout the specification, drawing sharp distinctions between the synthetic or man-made formulation and the product of nature themselves, while emphasizing that the former contains a specific subcomponent that is intended to mimic a specific subcomponent of the latter
2. When claiming combinations of natural products, make sure to fully flesh out the unique properties conferred by the combination as a whole
3. Even in crowded fields like therapeutic formulations, innovative combinations of elements with clear technical descriptions regarding the conceptual underpinnings of the combinations and their desired effects can help establish patent eligibility

PERA Implications

Although the Board found that the claims met the requirements for §101 eligibility, under the currently proposed language of the Patent Eligibility Restoration Act (PERA, Senate Bill 2140) there is a good chance this case would not have made it to the Board, because the examiner would likely have concluded that the formulation claims met the patent eligibility requirement (e.g. pursuant to §§ 101(a), (b)(2)(A),(b)(2)(B)).

¹ Ex parte Ma (Appeal 2023-002362; May 30, 2023)

The Patent Eligibility Restoration Act (PERA) is a Critically Needed, Balanced Solution for Maintaining U.S. Leadership

U.S. courts have developed an increasingly byzantine framework of judicial exceptions to the inventor rights granted by 35 U.S.C. § 101, thereby rendering a number of creative inventions ineligible for patent protection and causing unnecessary confusion in this area of the law.

Products of Nature Cannot Be Patented

There has never been a time in the United States when it was possible to patent a principle of nature. Congress originally permitted the broad patenting of any machine, manufacture, or composition of matter in the Patent Act of 1793. By 1810 U.S. courts were expressly confirming that these rights had certain limits, in that principles of nature could not be patented.¹

Early U.S. Jurisprudence Required Practical Application for Patent Eligibility

In the early 1900’s, the contours of patent-eligibility as it pertained to natural products became further defined, and the consensus in the legal community was that although a principle of nature could not be patented, a practical application of the natural principle was eligible for patenting.² This was generally agreed to be a reasonable and workable approach.

The Supreme Court Improperly Raised the Bar for Patent Eligibility in Funk Brothers

Unfortunately, all of that changed in 1948 when the Supreme Court decided the Funk Brothers case, finding that the creation of unique bacterial mixture inoculants for leguminous plants was only a discovery of natural phenomena.³ Following this decision, a practical application of a natural principle was no longer sufficient to establish patent-eligibility. Instead, an inventive application of the principle was now required, thus significantly departing from a century of precedent.⁴ As a result, rather than simply providing a threshold test for whether an invention fell into a particular category of eligible subject matter, 35 U.S.C. § 101 had become conflated with other statutory requirements for patentability such as nonobviousness under 35 U.S.C. § 103. From a historical perspective, it has been observed that Justice Douglas, who authored the Funk Brothers decision, had a notoriously anti-patent bias.⁵

The Supreme Court’s Error in Funk Brothers has Propagated to Subsequent Decisions

Although the Funk Brothers decision is strongly condemned,^6,7 the Supreme Court has continued to rely upon it when deciding patent-eligibility cases where the invention involves a product of nature. For example, in the Myriad case,⁸ the Supreme Court cited Funk Brothers when finding that an isolated DNA segment is a product of nature and therefore not eligible for patenting under 35 U.S.C. § 101, thus perpetuating this faulty reasoning.

PERA Will Restore Clarity and Predictability for Cases Involving Natural Products

PERA has bipartisan, bicameral support and will restore patent eligibility to certain categories of inventions which are currently considered patent-ineligible, including many inventions that involve natural products.  According to PERA, a number of U.S. judges have expressed the need for better guidance with respect to § 101, and other stakeholders in the patent process have found that the interpretation of current § 101 law is extremely confusing and difficult to interpret and apply with any confidence.⁹

PERA simplifies 35 U.S.C. § 101 by succinctly stating that an unmodified natural material, as that material exists in nature, shall not be eligible for patenting. And importantly, PERA clarifies that a natural material is patent-eligible if it is (a) isolated, purified, enriched, or otherwise altered by human activity, or (B) otherwise employed in a useful invention or discovery.  

The Council for Innovation Promotion has published an informational letter further explaining the need for PERA in providing clarity on the patent-eligibility of inventions involving products of nature,¹⁰ and the American Intellectual Property Law Association (AIPLA) supports the passage of this bill as well.¹¹

The Time for Congressional Action is Now

According to Article 1, Section 8, Clause 8 of the U.S. Constitution, Congress has the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”

By passing PERA, Congress will foster the development of next-generation technologies involving natural products, and ensure that the U.S. remains a leader in the global patent system.

¹ Michael Risch, America’s First Patents, 64 Fla. L. Rev. 1279 (2012) [PDF]

² Jeffrey A. Lefstin, Inventive Application: A History, 67 Fla. L. Rev. 565 (2015) [PDF]

³ Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) [PDF]

⁴ See Lefstin

⁵ Martin J. Adelman et al., Session 8C, Competition and Patent Law Session, U.S. Patent Developments, Fordham University Law School (2019) [PDF]

⁶ Jared M. Graff, Funk Brothers, Myriad, & Products of Nature: How a Lack of Understanding Scientific Principles is Damaging the Patent System, Southwestern Law Review, Vol 49, Issue 2, 330 (2020) [PDF]

⁷ Oskar Liivak, Don’t Cite Funk, 72 Cath. U. L. Rev. 43 (2023) [PDF]

⁸ Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) [PDF]

⁹ S. 2140 – Patent Eligibility Restoration Act of 2023, 118th Congress (2023-2024) [PDF]

¹⁰ Myths vs. Facts: The Patent Eligibility Restoration Act (PERA) Diagnostics and Life Sciences [PDF]

¹¹ AIPLA Letter in Support of S. 2140, PERA [PDF]

PTAB Finds that Psilocybin Formulation Is Not a Product of Nature; Further Prosecution Leads to Issued Patent

In a notable decision, the Patent Trial and Appeal Board affirmed the §101 rejection of claims directed to various compositions that included psychedelic mushroom compounds, finding the claims to be ineligible for patenting.¹ This decision and the application’s subsequent file history provide useful guidance on patent eligibility for compositions involving naturally occurring ingredients.

The Technology

The case centered on claims for compositions containing various amounts of three key components:

• psilocybin/psilocin (compounds found in Psilocybe cubensis and other psychedelic mushrooms)
• erinacines/hericenones (compounds from Hericium erinaceus, also known as the Lion’s Mane mushroom)
• niacin (vitamin B3)

Turtle Bear Holdings’ composition was created for the repair and improvement of neurological function by providing synergistic effects on neuronal growth.

The § 101 Rejection

The examiner rejected the claims under 35 U.S.C. §101, arguing they were directed to a natural phenomenon (e.g., product of nature). For ease of reference, Step 2A of the USPTO’s 2019 Revised Subject Matter Eligibility Guidance flowchart is provided below.

Under Step 2A Prong 1 of the analysis, the examiner noted that the components set forth in the claims were naturally occurring ingredients. Specifically, psilocybin and psilocin are naturally found in Psilocybe mushrooms, erinacine and hericenone are naturally found in Hericium mushrooms, and niacin (vitamin B3) is naturally found in mushrooms. Because the claimed composition simply contained a combined mixture of elements which are individually present in nature, the examiner concluded that the claims recited a product of nature, a judicially recognized exception to subject matter eligibility.

Under Step 2A Prong 2, the examiner stated there was no integration because functionally each individual component still retained its individual equivalent structure and individual related function, and there was no functional change in the characteristics of the components individually, or as a whole, as no transformation nor anything additional was recited in the claims to demonstrate a practical application.

Under Step B, the examiner found that the claimed compositions as a whole failed to recite something significantly more or markedly different from the components as they occur in nature individually.

The Board’s Analysis

The Board affirmed that all claims were invalid under 35 U.S.C. §101 for reciting patent-ineligible subject matter.

Under Step 2A Prong 1, the Board noted that because the claimed invention recited nature-based product limitations, the markedly different characteristics (MDC) analysis should be used to determine if the nature-based product limitation is a product of nature exception. Referring to Myriad, the Board found there was no indication on the record that mixing the nature-based ingredients in the claims resulted in a transformation of the products or that the mixtures had properties not possessed by the products in nature. Further, the Board was not persuaded that the claimed compositions were patent eligible simply because they were the result of a mixture of different nature-based products which themselves are not found together in nature. Hence, the Board concluded that under Step 2A Prong 1 the claims recited a judicial exception (i.e. a product of nature).

Under Step 2A Prong 2, the Board found that the specific milligram quantities of the nature-based components recited in the claims were insufficient to integrate the judicial exception into a practical application.

Under Step B, the Board found that the claims did not recite any specific limitation beyond the judicial exception that is not “well understood, routine, conventional” in the field. Relatedly, the Board referred to Funk Brothers, where mixing different bacterial strains wasn’t enough to confer patent eligibility without changing the bacteria themselves.

Continued Prosecution Post-Appeal

Following the Board’s decision, Turtle Bear Holdings filed a Request for Continued Examination (RCE). After filing new claims (directed to pharmaceutical formulations or dosages of instead of compositions), submitting expert declarations from the inventor, conducting examiner interviews, and emphasizing that the claimed formulations or dosages (i) showed markedly different characteristics that are not observed with the individual components themselves and (ii) integrated the judicial exception into a practical application, Turtle Bear Holdings successfully obtained an issued patent (U.S. 11,590,120).

Key Takeaways for Practitioners

This case highlights challenges which may be encountered when pursuing patents on natural products, even when the invention involves combining individual natural ingredients in unique ways or in specific quantities.  Having expert declarations or other evidence showing that the claimed products exhibit markedly different characteristics that are not observed with the individual components themselves, and presenting claims that specify practical applications of the combination of natural elements, can be helpful in establishing patent eligibility.

PERA Implications

Under the currently proposed language of the Patent Eligibility Restoration Act (PERA, Senate Bill 2140), the composition claims that were found ineligible by the Board would likely have been considered to meet the patent eligibility requirement (e.g. pursuant to §§101(a), (b)(2)(A)).

Related Reading

As noted above, the Board was not persuaded that the claimed compositions were patent eligible just because they recited mixtures of different nature-based products that are not found together in nature. Compare this result with the Board’s conclusion in Ex parte Murty, where the Board found the requirements of Step 2A Prong 1 were not met (thus establishing patent eligibility), because there was no evidence that the specifically claimed combination of ingredients, as distinguished from the individual ingredients, existed in nature.

¹ Ex parte Stamets (Appeal 2020-006595; November 25, 2020)

PTAB Finds That Cannabis Delivery System Is Not a Natural Product

The Patent Trial and Appeal Board recently reversed the §101 rejection of claims directed to a composition that includes a cannabis component, an oily medium of triglycerides and mixed glycerides, a surfactant, a solubilizing co-solvent, and antioxidants, finding the invention to be eligible for patenting.¹ This decision provides valuable insight into how composition claims involving naturally occurring ingredients can survive Section 101 scrutiny.

The Technology

The case involved claims to a composition for delivering cannabinoids and/or standardized marijuana extracts via the gastrointestinal system. Murty Pharmaceuticals’ composition is administered as a self-emulsifying system that avoids first-pass metabolism via targeted chylomicron/lipoprotein delivery, thereby promoting lymphatic transport.

Typically, orally administered cannabinoid formulations undergo first pass hepatic metabolism and do not reach the systemic circulation in consistent concentrations. In contrast, the claimed formulation is intended to support optimal bioavailability because the cannabis components are protected from acid catalyzed degradation.

The § 101 Rejection

The examiner rejected the claims under 35 U.S.C. §101, arguing they were directed to a natural phenomenon (e.g., product of nature) according to the Step 2A Prong 1 analysis, because the only composition requirements set forth in the composition were naturally occurring ingredients. In other words, the claimed composition simply contained a combined mixture of elements which are individually present in nature. Therefore, the examiner concluded that under Step 2A Prong 1, the claims recited a product of nature, a judicially recognized exception to subject matter eligibility.

The §101 rejection did not include a Step 2A Prong 2 analysis.

Under the Step 2B analysis, the examiner concluded that the characteristic of avoiding hepatic first pass metabolism did not add significantly more to the judicial exception, because such a physiological result would be achieved by simply administering that combination of naturally occurring ingredients.  Accordingly, the examiner found that the claims recited ineligible subject matter.

The Board’s Analysis

The PTAB reversed, disagreeing with various aspects of the §101 rejection.

1. No Natural Product: The Board emphasized that the claims do not recite a natural product, but rather a composition formed from combining several ingredients. Importantly, the Board noted there was no evidence that this specific combination, as distinguished from the individual ingredients, exists in nature. Accordingly, the Board found that the requirements of Step 2A Prong 1 were not met.
2. Markedly Different Characteristics: The Board found that even if the individual ingredients could be considered collectively as a natural product, the claimed combination demonstrated markedly different characteristics from the individual components. Specifically, the combination created a “self-emulsifying system operable to avoid hepatic first pass metabolism via targeted chylomicron/lipoprotein delivery, thereby promoting lymphatic transport.” According to this interpretation, a markedly different characteristic (MDC) provided by the combination of elements would mean that the claims did not recite a product of nature and hence were patent eligible, thereby taking the analysis from Prong One > Pathway B as depicted in the USPTO’s 2019 Revised Subject Matter Eligibility Guidance flowchart excerpted below.
3. Integration of Judicial Exception into a Practical Application: The Board noted that the examiner did not provide a detailed analysis under Step 2A Prong 2. For example, the rejection did not expressly find that claims failed to recite additional elements that integrate the judicial exception into a practical application. According to the Board, the claims as a whole recited combinations of ingredients that purportedly provide benefits relating to the delivery of the pharmacologically active agent.

PTAB Finds That Probiotic Formulation Is Not a Product of Nature

The Patent Trial and Appeal Board recently reversed the §101 rejection of claims directed to a composition that includes the bacterial strain Lactobacillus plantarum 2830 and a galactooligosaccharide produced by that strain, finding the claims to be eligible for patenting.¹ This decision provides important guidance on patent eligibility for compositions involving naturally occurring microorganisms.

The Technology

Both probiotics and prebiotics can be consumed or administered to individuals to promote gastrointestinal health. OptiBiotix (ProBiotix) Health’s invention relates to a probiotic-prebiotic combination, where the probiotic bacterium L. plantarum 2830 is combined with a prebiotic galactooligosaccharide (GOS). The GOS acts to modify the absorption of cholesterol for the treatment of heart disease, diabetes, or obesity.

L. plantarum 2830 naturally contains β-galactosidase, and normally uses this enzyme to digest lactose. However, the inventors discovered that by manipulating certain reaction conditions, they could get the enzyme to work in reverse and generate an oligosaccharide version of the lactose (i.e. a GOS) instead.

The § 101 Rejection

The examiner rejected the claims under 35 USC §101, arguing that both the bacterial strain and the GOS were natural products that existed together in nature. The examiner stated that neither the L. plantarum 2830 strain itself nor the GOS had been altered in any way, but rather that the GOS is produced when the strain is placed in an alternative environment. Relatedly, the examiner found that the GOS is not structurally distinct from other GOS found in nature.

The Board’s Analysis

The Board agreed with the examiner that the Lactobacillus plantarum 2830 bacterial strain derived from nature. However, the Board did not agree with the examiner’s conclusion that the claimed GOS was a natural product as well.

The Board noted that the GOS produced by L. plantarum 2830 by the reverse β-galactosidase reaction was not naturally produced, and further that L. plantarum 2830 and the GOS do not naturally occur in combination. Key to their analysis was that:

1. The GOS is only produced under artificial conditions not found in nature
2. The reverse β-galactosidase reaction requires manipulated temperatures and lactose concentrations

The Board also considered the question of whether the combination of the L. plantarum 2830 and the GOS, as a nature-based product containing multiple components, exhibited markedly different characteristics when compared to the L. plantarum 2830 strain alone. Under the markedly different characteristics analysis (Step 2A Prong One), the Board looked at two interpretations of the claimed composition:

• the bacterial strain and the GOS made within it by the bacteria’s own enzyme reaction
• the bacterial strain and the GOS combined

Under the first interpretation, the Board concluded that such a composition is markedly different from the strain that exists in nature, because GOS would not be present in the strain in its natural environment. The Board also noted there is a structural difference between the strain in its natural environment and the claimed composition.

Under the second interpretation, the Board concluded that no markedly different characteristic was demonstrated, and then turned to the question of whether the claim as a whole integrated a judicial exception into a practical application (Step 2A Prong Two). Relevant to this aspect of the analysis, for the combined strain and the GOS, the applicant provided evidence of improved cholesterol reduction compared to combinations using GOS from other sources, demonstrating that the combination of elements recited in the claim integrated the judicial exception into a practical application.

With reference to the USPTO’s 2019 Revised Subject Matter Eligibility Guidance reflected in the flowchart provided below, it can be seen that under Step 2A Prong One, the claims involved a product of nature (L. plantarum 2830). According to the first interpretation, a markedly different characteristic (MDC) was provided the overall combination of elements and hence a natural product was not claimed, thereby taking the analysis from Prong One -> Pathway B. According to the second interpretation, a MDC was not present and hence a natural product was claimed, yet the claim as a whole provided sufficient integration, thereby taking the analysis from Prong One > Prong Two > Pathway B. Under either interpretation the claim recited patent eligible subject matter under 35 U.S.C. §101.

Key Takeaways for Practitioners

This decision highlights several important points for the patent eligibility of compositions involving natural products:

1. Products produced by natural organisms may not be interpreted as natural products when they are made under artificial conditions
2. Evidence of unique structural characteristics or improved functionality can help establish eligibility
3. Multiple claim interpretations should be considered in the eligibility analysis

The case provides valuable guidance for drafting and prosecuting claims involving natural products, particularly in the microbiology space.

PERA Implications

Although the Board found that the claims met the requirements of §101, under the currently proposed language of the Patent Eligibility Restoration Act (PERA, Senate Bill 2140) it is likely that this case would not have made it to the Board, as the examiner would likely have concluded that the composition claims met the patent eligibility requirement (e.g. pursuant to §§101(a), (b)(2)(A),(b)(2)(B)).

¹ Ex parte O’Hara (Appeal 2023-003678; December 10, 2024) [PDF]