BitLaw

Example 30: Dietary Sweeteners

This example illustrates the application of the markedly different characteristics and significantly more analyses to claims reciting hypothetical nature-based products including mixtures. It also illustrates the importance of applying the broadest reasonable interpretation in the eligibility analysis, and how that interpretation assists in the identification of appropriate naturally occurring counterparts of claimed nature-based products. Hypothetical claims 1 and 2 are ineligible, because the claimed nature-based products lack markedly different characteristics from what exists in nature, and the claims fail to amount to significantly more than the exceptions (even though claim 2 recites specific amounts of the components in the nature-based product). Hypothetical claims 3-6 are eligible in Step 2A, because the claimed nature-based products have markedly different characteristics from what exists in nature.

Background

The “Texas mint” plant is a relative of stevia, which has a thin liquid sap containing about 10% texiol (a newly discovered glycoside similar to rebaudioside A). When the Texas mint plant is damaged, e.g., by a leaf or stem breaking, sap is released from the injury site, and over time dries to form irregular crystals of texiol. Texiol is lower in calories and tastes sweeter than table sugar, but it has a bitter aftertaste. Texiol can be used as crystals or as a powder, and is soluble in water at various concentrations. Applicant filed an application defining a “dietary sweetener” as one of the following formulations, noting that all percentages are by weight:

• A dietary sweetener comprising texiol mixed with other components such as water to form a heterogeneous or homogenous mixture, e.g., a solution or suspension. Applicant discloses that trained sensory panels reviewed formulations having varying concentrations of texiol in water, and found that the sensory perceptions of texiol’s sweetness and bitter aftertaste both increased with concentration, e.g., higher concentrations of texiol were perceived as having stronger sweet and bitter tastes. Based on the panel’s review, and from a consumer’s perspective, applicant discloses a preferred dietary sweetener comprising 1-5% texiol and at least 90% water. This preferred sweetener retains the naturally occurring texiol’s sweetness and bitter aftertaste.

• A dietary sweetener comprising texiol mixed with water and Compound N (a natural flavor excreted from mushrooms and having a mild umami taste). Applicant discloses that when combined with texiol in particular amounts, Compound N neutralizes the bitter aftertaste of texiol. Applicant discloses that this neutralization does not involve a chemical reaction. The same sensory panel tasted mixtures having various concentrations of Compound N and texiol, and found that a formulation comprising 1-5% texiol, 1-2% Compound N, and the balance water produced the most palatable results for a dietary sweetener with no bitter aftertaste. When Compound N is added in the specified amount, the changed taste perception occurs whether or not the texiol is fully dissolved, e.g., even when large crystals of texiol are used.

• A dietary sweetener solid gel formulation comprising 5% texiol mixed with water and/or fruit juice and sufficient pectin to provide a solid gel. The Texas mint plant does not contain pectin in nature. Solid gel formulations are useful commercial sweeteners because their solid, jelly-like consistency makes them spreadable onto other foods, such as bread, cake layers, or pastry dough. Solid gels can also be formed into candies such as jellybeans. Applicant discloses that the same sensory panel tasted the gel formulation and found that it had improved organoleptic properties (e.g., a more pleasant mouthfeel) and a solid but easily- spreadable consistency as compared to naturally occurring texiol (either in the sap or crystallized).

• A dietary sweetener comprising texiol in granular form for use by consumers. Naturally occurring texiol forms irregular crystals that aggregate into large chunks of varying size and shape. Due to this variation, sweeteners formed from these irregular crystals do not have consistent and commercially acceptable dissolution rates. For example, a consumer attempting to sweeten iced tea with irregular texiol crystals will typically experience a need to add more than the expected amount of texiol in order to obtain the desired level of sweetness, because the larger particles of texiol dissolve more slowly (if at all) than the smaller particles even with vigorous stirring. The presence of these undissolved crystals may also cause an undesirable gritty mouth feel as the sweetened tea is consumed. To solve the problem of inconsistent and slow dissolution rates, applicant has produced granulated texiol formulations having even and regular particle size distributions, e.g., by grinding or milling coarse texiol crystals into an even and regular powder, or by crystallizing texiol in a controlled manner that forms regularly sized and shaped crystals. Granular texiol having a particle size of X10 of 80 microns and X90 of 300 microns is preferred, because this particle size distribution results in a greatly increased (and consistent) dissolution rate in water- based liquids as compared to naturally occurring texiol crystals. The terms “X10” and “X90” refer to the median diameter of the particles, as measured on a volume basis by a laser diffraction particle sizing system. For “X10”, 10 percent of the particles have a diameter smaller than the specified size, and 90 percent of the particles have a larger diameter, and for “X90”, 90 percent of the particles have a diameter smaller than the specified size, and 10 percent of the particles have a larger diameter.

• A dietary sweetener comprising texiol in a controlled release formulation. Applicant discloses that the same sensory panel, upon tasting naturally occurring texiol, reported perceiving an immediate burst of sweetness that rapidly dissipated. Applicant discloses formulations that achieve controlled release (e.g., release of specific amounts of texiol from the formulation at specific time intervals, or over a prolonged period of time) by mixing the texiol with other substances such as polymers and/or changing the form of the texiol so that a controlled perception of sweetness is achieved. For example, in one such formulation, texiol particles are encapsulated in a polymer-emulsifier mixture that delays release of the texiol as compared to unencapsulated (e.g., naturally occurring) texiol particles. These controlled release formulations prolong enjoyment of a texiol-sweetened product such as chewing gum, by altering the time over which texiol’s sweetness is perceived.

Claims

1. A dietary sweetener comprising: texiol; and
   water.

2. A dietary sweetener comprising: 1-5 percent texiol; and
   at least 90 percent water.

3. A dietary sweetener comprising: 1-5 percent texiol;
   at least 90 percent water; and 1-2 percent Compound N.

4. A dietary sweetener comprising: 5 percent texiol;
   water, fruit juice, or a combination of water and fruit juice; and
   sufficient amounts of pectin to provide a solid gel.

5. A dietary sweetener comprising:
   granular particles of texiol having a particle diameter of X10 of 80 microns and X90 of 300 microns.

6. A dietary sweetener comprising texiol in a controlled release formulation.

Analysis

Claim 1: Ineligible

The claim recites a dietary sweetener comprising texiol and water. Based on the specification’s definition of “dietary sweetener”, the broadest reasonable interpretation (BRI) of the claim is a mixture of texiol and water in any amount that will be understood as a sweetener to those of ordinary skill in the art. Thus, the BRI covers the naturally occurring sap of the Texas mint plant, which contains texiol and water. Because texiol and water are composed of matter, the claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed in Step 2A to determine whether it is directed to any judicial exception. As noted above, the BRI of this claim encompasses the naturally occurring sap. Because the sap is naturally occurring, it cannot have markedly different characteristics from how it exists in nature, and therefore the claimed mixture of texiol and water (i.e., the sap) is a “product of nature” exception. Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107, 2116 (2013) (naturally occurring things are “products of nature” which cannot be patented). Thus, the claim is directed to at least one exception (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. In this case, the combination as claimed occurs in nature (as sap) so there are no additional elements to the claimed combination. The claim is to a “product of nature” exception with nothing that adds significantly more (Step 2B: NO). Claim 1 is not eligible.

A rejection of claim 1 should identify the exception(s) by pointing to the nature-based product in the claim (the combination of texiol-water) and explaining that it is a “product of nature” exception because it is naturally occurring. The rejection should also explain that because the combination of the texiol and water is the exception, there are no additional elements in the claim that could amount to significantly more than the exception.

If the examiner believes that it would be helpful to cite an analogous court decision, the rejection could include an explanation of how the claimed mixture is like the cloned mammals of Roslin, which were held ineligible because, as claimed, the cloned mammals lacked markedly different characteristics from their naturally occurring counterparts. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1339 (2014).

Claim 2: Ineligible

The claim recites a dietary sweetener comprising 1-5 percent texiol and at least 90 percent water. Based on the specification’s definition of “dietary sweetener”, the broadest reasonable interpretation (BRI) of the claim is a mixture of texiol and water in the specified amounts. In this case, the BRI does not cover the naturally occurring sap of the Texas mint plant, which contains a different amount of texiol. Because texiol and water are composed of matter, the claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed in Step 2A to determine whether it is directed to any judicial exception. The claimed mixture is a nature-based product that is compared to its closest naturally occurring counterpart, in order to determine if it has markedly different characteristics from this counterpart. As noted above, the BRI of this claim is limited to the recited percentages and thus does not encompass the naturally occurring sap of the Texas mint plant. Accordingly, the closest naturally occurring counterpart is not the sap, but the naturally occurring texiol-water mixture in the sap. By comparing the claimed mixture and its component parts to the naturally occurring texiol-water mixture in the sap, all potential changes in characteristics can be investigated.

Texiol is naturally occurring, and water is naturally occurring, so neither would be eligible as claimed on its own. Although the combination as claimed is novel and does not occur in nature, there is no indication that mixing them in the recited amounts (i.e., 1-5 percent texiol and at least 90 percent water) changes the structure, function, or other properties of the texiol or water in any marked way. Instead, the texiol retains its naturally occurring structure and properties (e.g., its sweetness and bitter aftertaste), and is merely located in water, which also retains its naturally occurring structure and properties (e.g., its liquid form at room temperature). These characteristics are also the same as the naturally occurring texiol and water in the sap, which is also a sweet liquid at room temperature. Thus, the claimed mixture as a whole does not display markedly different characteristics compared to the closest naturally occurring counterpart. Accordingly, each component (the texiol and the water) is a “product of nature” exception, and the claim is directed to at least one exception (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions. Because the component elements (the texiol and water “product of nature” exceptions) do not occur together in nature as claimed (i.e., in the recited amounts) and are not markedly changed by their combination into a mixture, each component is considered as an additional element to the other to determine whether their combination results in significantly more than the products of nature. This consideration of the texiol as an additional element to the water, and vice-versa, provides an opportunity to explore whether this combination of “products of nature” amounts to significantly more than the products themselves. As discussed above, mixing the sweetener with water does not markedly change the characteristics of either component, because each component continues to have the same properties in the mixture as it had alone. Prior to applicant’s invention and at the time of filing the application, mixing a sweetener with water (or vice-versa) was well-understood, routine and conventional in the field, as evidenced by, e.g., the ubiquity of simple syrup and stevia-based liquid sweeteners. The recitation of specific amounts of texiol and water does not affect this analysis, because it was also well-understood, routine and conventional at the time to mix specific amounts of sweeteners with water (or vice-versa) and to vary the amounts of the combination, e.g., to achieve commercially acceptable sweetness levels and provide sweeteners for different purposes. Thus, the mixing of texiol and water, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.

A rejection of claim 2 should identify the exceptions by pointing to the nature-based product limitations in the claim (texiol and water) and explaining why they lack markedly different characteristics from their naturally occurring counterparts, e.g., because there are no marked changes in structure, function or other characteristics. The rejection also should explain that mixing texiol and water does not amount to significantly more than the exceptions, because mixtures of sweeteners and water are well-understood, routine and conventional in the field.

If the examiner believes that it would be helpful to cite an analogous court decision, the rejection could include an explanation of how the claimed mixture is like the novel bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the mixture (like each component in the texiol mixture) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”). While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk Brothers, 333 U.S. at 128 n.1.

Practice Note: In this set of facts, the specificity of the amounts of each component in this mixture did not result in markedly different characteristics of the sweetener. However, under different facts, other mixtures or combinations with specific amounts may result in markedly different characteristics or, when viewed as a whole, may result in adding significantly more to the claimed product of nature. If that is the case, it would be a best practice to indicate why the claim is eligible by explaining which characteristics are markedly different, and not simply noting that the percentages or ratios do not occur in nature.

Claim 3: Eligible

The claim recites a dietary sweetener comprising 1-5 percent texiol, at least 90 percent water, and 1- 2 percent Compound N. Based on the specification’s definition of “dietary sweetener”, the broadest reasonable interpretation (BRI) of the claim is a mixture of texiol, water, and Compound N in the specified amounts. Because texiol, water, and Compound N are composed of matter, the claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed in Step 2A to determine whether it is directed to any judicial exception. The claimed mixture is a nature-based product that must be compared to its closest naturally occurring counterpart to determine if it has markedly different characteristics than the counterpart. Because texiol, water and Compound N do not occur together in nature, there is no naturally occurring counterpart mixture for comparison. However, texiol does occur naturally in combination with water, in the sap of the Texas mint plant. Accordingly, the closest naturally occurring counterparts to which the claimed mixture is compared are Compound N, and the naturally occurring texiol-water combination. Each of these components is naturally occurring, so none would be eligible as claimed on its own. There is no indication that mixing these components changes the structure of the components, and no chemical reaction occurs between or among the components. However, the mixture has a changed organoleptic property (e.g., taste), because its flavor profile (sweet and lacking bitterness) is different than the mere sum of the flavors of the individual components, e.g., texiol’s sweetness and bitter aftertaste, and Compound N’s mild umami flavor. This altered property is a marked difference in characteristics, because it results in the claimed mixture being distinct from its natural counterparts in a way that is relevant to the nature of the invention as a dietary sweetener, e.g., because the taster no longer perceives the bitter aftertaste of naturally occurring texiol. Cf. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1339 (2014) (claimed cloned mammals do not have markedly different characteristics from their naturally occurring counterparts). Thus, the claimed dietary sweetener has markedly different characteristics as compared to its natural counterparts, and is not a “product of nature” exception. Accordingly, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not performed. Thus, the examiner would not need to evaluate the significantly more considerations for this claim. If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance, indicating that the claim is not directed to any judicial exception.

Claim 4: Eligible

The claim recites a dietary sweetener comprising 5 percent texiol, water and/or fruit juice, and sufficient amounts of pectin to provide a solid gel. Based on the specification’s definition of “dietary sweetener” and the plain meaning of “solid gel”, the broadest reasonable interpretation of the claim is a mixture of texiol, pectin, and water that has the form of a solid gel (i.e., has a jelly-like spreadable consistency). Because the gel is composed of matter, the claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed gel is a nature-based product that must be compared to its closest naturally occurring counterpart to determine if it has markedly different characteristics than the counterpart. Because texiol, pectin, and water do not occur together in nature (the Texas mint plant does not contain any pectin), there is no naturally occurring counterpart mixture for comparison. However, pectin does occur naturally in combination with water (e.g., in apples), and texiol occurs naturally in combination with water in the thin liquid sap of the Texas mint plant. Accordingly, the closest naturally occurring counterparts to which the claimed gel is compared are the naturally occurring water-pectin and texiol-water combinations. There is no indication that mixing the texiol-water combination with the water-pectin combination changes the structure of the water or pectin. However, the texiol in the claimed mixture does have changed properties as compared to naturally occurring texiol in the plant sap, in that the claimed texiol is present in a solid yet spreadable gel form and has improved organoleptic properties (e.g., a more pleasant mouthfeel). These altered properties are a marked difference in characteristics, because they result in the claimed formulation being distinct from its natural counterparts in a way (jelly-like spreadable consistency and more pleasant mouthfeel) that is relevant to the nature of the invention as a dietary sweetener, e.g., because the claimed formulation can be spread onto other foods such as pastry dough, or formed into candies such as jellybeans. Cf. Roslin, 750 F.3d at 1339 (claimed cloned mammals do not have markedly different characteristics from their naturally occurring counterparts). Because the claimed dietary sweetener formulation thus has markedly different characteristics as compared to its natural counterpart, it is not a “product of nature” exception. Accordingly, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not performed. Thus, the examiner would not need to evaluate the significantly more considerations for this claim. If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance, indicating that the claim is not directed to any judicial exception.

Claim 5: Eligible

The claim recites a dietary sweetener comprising granular particles of texiol having a specific particle size distribution, where X10 is 80 microns and X90 is 300 microns. Based on the specification’s definition of “dietary sweetener” and the plain meaning of “X10” and “X90”, the broadest reasonable interpretation of the claim is a texiol formulation having a specific particle size distribution, i.e., 10 percent of the particles have a diameter smaller than 80 microns, 10 percent of the particles have a diameter greater than 300 microns, and the remaining 80 percent have a diameter between 80 and 300 microns. Because texiol is composed of matter, the claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed texiol formulation having a specific particle size distribution is a nature-based product that must be compared to its closest naturally occurring counterpart (texiol in its natural irregular crystal state) to determine if it has markedly different characteristics than the counterpart. As disclosed by applicant, the specific particle size distribution results in the claimed texiol formulation having a changed property, i.e., an increased (and consistent) dissolution rate, as opposed to the slow and inconsistent dissolution rate of naturally occurring texiol. This altered property is a marked difference in characteristics, because it results in the claimed formulation being distinct from its natural counterpart in a way (release of sweetness over time) that is relevant to the nature of the invention as a dietary sweetener, e.g., because the claimed formulation will dissolve evenly and rapidly in a cool liquid. Cf. Roslin, 750 F.3d at 1339 (claimed cloned mammals do not have markedly different characteristics from their naturally occurring counterparts). Because it has markedly different characteristics as compared to its natural counterpart, the claimed formulation is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not performed. Thus, the examiner would not need to evaluate the significantly more considerations for this claim. If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance, indicating that the claim is not directed to any judicial exception.

Claim 6: Eligible

The claim recites a dietary sweetener comprising texiol in a controlled release formulation. Based on the specification’s definition of “dietary sweetener” and the plain meaning of “controlled release formulation”, the broadest reasonable interpretation of the claim is a texiol formulation that has altered time release properties so that its sweetness is now released in a controlled manner over time due to (a) a change in form or structure or (b) being mixed with other substances (e.g., by being encapsulated in a polymer-emulsifier mixture). In either case, the texiol formulation is composed of matter, and thus the claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed formulation is a nature-based product that must be compared to its closest naturally occurring counterpart to determine if it has markedly different characteristics than the counterpart. There is no naturally occurring mixture for comparison, and so the claimed formulation is compared to naturally occurring texiol in its natural state. As disclosed by applicant, the claimed formulation has altered time release properties, in that it releases the sweetness of texiol in a controlled manner over time, as opposed to the naturally occurring texiol, which releases all of its sweetness at one point in time. These altered properties are a marked difference in characteristics, because they result in the claimed formulation being distinct from its natural counterpart in a way (release of sweetness over time) that is relevant to the nature of the invention as a dietary sweetener. Cf. Roslin, 750 F.3d at 1339 (claimed cloned mammals do not have markedly different characteristics from their naturally occurring counterparts). Because it has markedly different characteristics as compared to its natural counterpart, the claimed formulation is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not performed. Thus, the examiner would not need to evaluate the significantly more considerations for this claim. If the examiner believes that the record would benefit from clarification, remarks could be added to an Office action or reasons for allowance, indicating that the claim is not directed to any judicial exception.