BitLaw

Example 44: Denveric Acid

This example illustrates the application of Revised Step 2A to product claims reciting nature-based product limitations. The Rocky Mountain cassia tree and denveric acid are hypothetical products, but protamine is a known product used in the medical field. Claim 1 is ineligible because the claimed nature-based product lacks markedly different characteristics from what exists in nature, and the claim as a whole does not integrate the exception into a practical application or provide an inventive concept. Claim 2 recites the same judicial exception as claim 1, but is eligible because the claim as a whole integrates the exception into a practical application. Claims 3 and 4 are eligible because the claimed nature-based products have markedly different characteristics from what exists in nature.

BACKGROUND

Diabetes is a disease characterized by abnormal regulation of glucose and insulin. Glucose is a sugar used by the human body’s cells to produce energy, and insulin is a naturally-occurring protein that helps regulate how the body uses or stores glucose. Many patients with diabetes take medications called insulin-sensitizing agents that help reduce their requirements for insulin, but these medications may have adverse side effects such as gastrointestinal irritation.

Applicant discovered a protein in the bark of the Rocky Mountain cassia tree that it calls “denveric acid.” When administered to a human, denveric acid reduces the human’s need for insulin because it: (a) reduces the rate of gluconeogenesis (glucose production) in the patient; and (b) acts as an insulin- sensitizing agent. Denveric acid has a much lower rate of adverse side effects than known insulin- sensitizing agents, but acts much more quickly in the body than these known agents, thus requiring more frequent dosing.

Applicant has now filed an application claiming several products comprising denveric acid, and discloses several containers that can be used to hold denveric acid solutions, for instance bottles, vials, pre-filled syringes, and delivery devices such as infusion pumps. The application explicitly defines the term “container” as a human-made container, and discloses several exemplary embodiments of the container including a bottle, syringe, or vial. In one embodiment, the application discloses a dosage unit that is a delivery device wearable by a patient. The delivery device has a flexible patch-shaped housing, which when placed on a patient’s body (e.g., the upper arm or abdomen) will conform to the patient’s body contours for comfortable and discreet use. As shown in Fig. 1, the delivery device also comprises a reservoir located inside the housing in which the denveric acid is stored, a needle assembly mounted on one side of the housing, a dosage control button mounted on the opposite side of the housing from the needle assembly, and a delivery valve for dispensing a selected dosage of denveric acid from the reservoir to the needle assembly. The button and valve can be calibrated to deliver different dosage amounts as desired by patients and their physicians. When delivery of a denveric acid bolus is scheduled, the dosage control button activates the delivery valve to dispense the selected dosage of denveric acid to the needle assembly, and triggers a pressure mechanism (not shown) to move the needle assembly toward the patient so that the needles pierce the skin and administer the dosage of denveric acid. The application notes that this wearable delivery device is well-understood, and is routinely used to administer other medications.

Applicant also discloses that denveric acid has particular glycemic control characteristics that may not be suitable for all situations. For instance, denveric acid is considered to be a “short-acting” agent, in that the onset of glycemic control is about 30 minutes post-injection, peak action is about 1 hour post- injection, and duration of action is about 1 to 3 hours post-injection. Sometimes a longer period of control is desired, for instance during the nighttime when a patient desires uninterrupted sleep. Applicant discloses that a slower onset of glycemic control is desirable in some situations, and so a patient may need to administer an “intermediate-acting” denveric acid, which applicant defines as having particular glycemic control characteristics, i.e., an onset of glycemic control about 1 to 3 hours post-injection, a peak action about 3 hours post-injection, and a duration of action of about 3 to 6 hours post-injection. Although applicant does not disclose any denveric acid molecules that are intermediate- acting, applicant explains that those of ordinary skill in the art understand how to modify insulin- sensitizing agents (e.g., by modifying one or more amino acids or by making some other structural modification) in order to make them have the recited functionality. Applicant also discloses that a mixture of denveric acid with protamine, another naturally-occurring protein, in a particular amount (0.75 mg to 1.5 mg of protamine per every mg of denveric acid) changes the glycemic control characteristics to be long-acting, i.e., the mixture has an onset of glycemic control about 90 minutes post- injection, peak action about 6 to 8 hours post-injection, and duration of action about 12 to 18 hours post- injection.

CLAIMS

1. A dosage unit comprising denveric acid in a container.

2. The dosage unit of claim 1, wherein the container is a wearable delivery device having a flexible patch-shaped housing, a needle assembly mounted on one side of the housing, a reservoir located inside the housing in which the denveric acid is stored, a dosage control button mounted on the opposite side of the housing from the needle assembly, and a delivery valve for dispensing a selected dosage of denveric acid from the reservoir to the needle assembly.

3. The dosage unit of claim 1, wherein the denveric acid is an intermediate-acting denveric acid.

4. The dosage unit of claim 1, further comprising protamine that is mixed with the denveric acid in the container in an amount of 0.75 mg to 1.5 mg protamine per every mg of denveric acid.

ANALYSIS

Claim 1 is ineligible.

Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification’s identification of “denveric acid” as being a particular protein isolated from the Rocky Mountain cassia tree, and the plain meaning of the other terms, the broadest reasonable interpretation of claim 1 is a product comprising denveric acid (which is naturally occurring) in a container. The preamble language (“A dosage unit”) does not indicate any structural or manipulative difference in the invention recited in the body of the claim (the denveric acid), and instead merely conveys an intended use of the claimed denveric acid. The claim also recites a container, but does not impose any limits on the container.

Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Here, the claim recites denveric acid, which is a protein. Because proteins are composed of matter, the denveric acid is a composition of matter, which is a statutory category of invention. In addition, the container is a concrete thing that was produced by a human from raw or prepared materials, e.g., a plastic bottle, and thus is a manufacture, which is also a statutory category. As explained in the MPEP, it is not necessary to identify a single category into which a claim falls, so long as it is clear that the claim falls into at least one category. MPEP 2106.03(I). Here, because the denveric acid is a composition of matter, and the container is a manufacture, the claim is to at least one statutory category of invention (Step 1: YES).

Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Because claim 1 recites a nature-based product limitation (the denveric acid), the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). Although the claim also recites a non-nature based product limitation (the container), the markedly different characteristics analysis should be applied only to the nature-based product limitation. MPEP 2106.04(c)(I)(A). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring denveric acid. When the claimed denveric acid is compared to this counterpart, the comparison indicates that there are no differences in structure, function, or other characteristics. Therefore, the claimed denveric acid is a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.

Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Claim 1 recites an additional element (the container). Although this limitation indicates that the denveric acid is held in the container, it does not provide any information as to how the denveric acid is contained, or what the container is, but instead covers any possible container that a doctor or pharmacist decides to use. Because denveric acid must be placed in a container in order to store and use it, merely reciting a generic “container” thus fails to meaningfully limit the claim because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the container does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception (Step 2A: YES).

Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, the claim recites a single additional element of a generic container, which is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.

Practice note: A rejection of claim 1 should identify the exception by pointing to the nature-based product in the claim (the denveric acid) and explaining why it is a product of nature exception. The rejection should also explain that the claim as a whole does not integrate the exception into a practical application or amount to significantly more than the exception because the additional limitation is at best the equivalent of merely adding the words “apply it” to the claim. If the examiner believes that it would be helpful to cite a court decision, the rejection could include an explanation of how the claimed denveric acid is like the cloned mammal of Roslin, which was held ineligible because it lacked markedly different characteristics from its naturally occurring counterparts. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1339 (Fed. Cir. 2014). See also Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) (isolated BRCA genes held ineligible). The examiner could also include a citation to MPEP 2106.05(f), which provides a detailed explanation of the “mere instructions to apply an exception” consideration, as well as specific examples of limitations that the courts have evaluated using this consideration.

Claim 2 is eligible.

Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Claim 2 depends from claim 1, and specifies that the container is a wearable delivery device having a flexible patch-shaped housing, a needle assembly mounted on one side of the housing, a reservoir located inside the housing in which the denveric acid is stored, a dosage control button mounted on the opposite side of the housing from the needle assembly, and a delivery valve for dispensing a selected dosage of denveric acid from the reservoir to the needle assembly. It is important to remember during claim interpretation that no limitations can be disregarded and the mere fact that the limitation appears in a “wherein” clause does not automatically mean that it is not given weight. In this case, when the wherein clause is considered in view of the specification, it is clear that the wherein clause has patentable weight, in that the claim requires that the denveric acid be physically located in the reservoir of a wearable delivery device, which also has particular specified components such as the dosage control button, the delivery valve, and the needle assembly.

Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claim 2 depends from claim 1, and thus also recites a composition of matter (the denveric acid) and a manufacture or machine (the container, which in this claim is recited as a wearable delivery device consisting of various manufactured components such as the needle assembly and the dosage control button). Like claim 1, the claim is thus to at least one statutory category of invention (Step 1: YES).

Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. Claim 2 depends from claim 1, and thus recites the same nature-based product limitation (the denveric acid). Although claim 2 also recites a non-nature based product limitation (the delivery device), the markedly different characteristics analysis should be applied only to the nature-based product limitation. MPEP 2106.04(c)(I)(A). As discussed with respect to claim 1, the claimed denveric acid is a product of nature exception because it lacks markedly different characteristics. Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.

Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2) 84 Fed. Reg. at 54-55.

Claim 2 recites an additional element (the delivery device), which requires that the denveric acid be physically located in the reservoir of a wearable delivery device, which also has a housing, needle assembly, a dosage control button, and a delivery valve for dispensing a selected dosage of denveric acid from the reservoir to the needle assembly. Although the background of this example explains that the delivery device is well-understood, and is routinely used to administer other medications, the Step 2A Prong Two analysis excludes consideration of whether a limitation is well-understood, routine, conventional activity (2019 PEG Section III(A)(2), 84 Fed. Reg. at 55). Thus, the following evaluation does not take into account whether or not the delivery device is well-known. See October 2019 Update at Section III.D.

An evaluation of the “particular machine” consideration is then performed, using the three factors set forth in MPEP 2106.05(b). Evaluation of the first factor indicates that the delivery device is not recited at a high level of generality, for instance it is clearly a particular container having specific components (e.g., a reservoir, a needle assembly, a valve, etc.) as opposed to a generic container (denveric acid can be stored in any number of containers, such as vials, test tubes, etc.). Evaluation of the second and third factors indicates that the delivery device is also an integral part of the claim, in that the denveric acid is physically stored in the reservoir of the delivery device, and the amount of denveric acid that is injected is controlled by the delivery valve. Thus, the involvement of the delivery device in the claim is more than just a field of use or other insignificant limitation. The delivery device is therefore a particular machine that applies or uses the denveric acid in a meaningful way that integrates this product of nature exception into a practical application, like the claimed Fourdrinier machine in Eibel Process. See MPEP 2106.05(b), which discusses Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45 (1923) and other cases analyzing the “particular machine” consideration. Accordingly, claim 2 is not directed to the judicial exception (Step 2A: NO). The claim is eligible.

Practice note: This discussion of claim 2 sets forth the full analysis of this claim under the 2019 PEG, which results in eligibility at Step 2A (Pathway B). During examination, however, a claim like this one may not require the full analysis. As explained in MPEP 2106.06, for purposes of efficiency in examination, examiners may use a streamlined eligibility analysis (Pathway A) when the eligibility of the claim is self-evident. Like the artificial hip prosthesis coated with a naturally occurring mineral that is described in the MPEP, claim 2 is also not an attempt to tie up the naturally occurring denveric acid and thus would be suitable for the streamlined analysis. If the claim were a “close call,” however, then a full analysis should be performed in order to ensure that the appropriate result is reached. See MPEP 2106.06(a) for more information about the streamlined analysis for claims like this one.

Claim 3 is eligible.

Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Claim 3 depends from claim 1 (which was interpreted as limited to “denveric acid”), and adds a wherein clause specifying that the denveric acid is an “intermediate- acting denveric acid”. It is important to remember during claim interpretation that no limitations can be disregarded and the mere fact that the limitation appears in a “wherein” clause does not automatically mean that it is not given weight. In this case, when the wherein clause is considered in view of the specification, it is clear that the wherein clause has patentable weight because the claim requires that the denveric acid have the function of being intermediate-acting, which is understood by those in the art to mean that it acts more slowly than naturally-occurring denveric acid. As described in the specification, “intermediate-acting denveric acid” is a denveric acid molecule that has been modified to have particular glycemic control characteristics, e.g., specific onset timing of about 1 to 3 hours post-injection, peak action timing of about 3 hours post-injection, and duration of action of about 3 to 6 hours post-injection. As also described in the specification, those of ordinary skill in the art understand that the functional language in the claim (“intermediate-acting”) imposes some structural difference on the structure (denveric acid) recited in the claim, for instance it may have a modified amino acid sequence or some other structural modification that provides the recited functionality. Accordingly, claim 3 covers a genus of any denveric acid that has the desired functional effect of being intermediate-acting.

Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claim 3 depends from claim 1, and thus also recites a composition of matter (the denveric acid) and a manufacture (the container). Like claim 1, the claim is thus to at least one statutory category of invention (Step 1: YES).

Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. Because this claim recites a nature-based product limitation (the denveric acid), the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). Although the claim also recites a non-nature based product limitation (the container), the markedly different characteristics analysis should be applied only to the nature-based product limitation. MPEP 2106.04(c)(I)(A).

The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring denveric acid. When the claimed denveric acid is compared to this counterpart, the comparison indicates that the claimed denveric acid has a changed functional property, in that it is intermediate-acting. In other words, the glycemic control characteristics of the claimed denveric acid are different than those of naturally-occurring denveric acid. In particular, the claimed denveric acid has intermediate-acting glycemic control characteristics (onset of glycemic control is about 1 to 3 hours post-injection, peak action is about 3 hours post-injection, and duration of action is about 3 to 6 hours post-injection) as compared to naturally occurring denveric acid (onset of glycemic control is about 30 minutes post-injection, peak action is about 1 hour post-injection, and duration of action is about 1 to 3 hours post-injection).

This change in glycemic control characteristics is a marked difference in functional characteristics as compared to the natural counterpart, and therefore the claimed denveric acid is not a “product of nature” exception. Because no judicial exception is recited, the claim cannot be directed to an exception (Step 2A: NO). The claim is eligible.

Practice note: Although claim 3 is eligible, it may be unpatentable for other reasons, and thus it is important to practice compact prosecution by examining each claim for compliance with every statutory requirement for patentability in the initial review of the application. For instance, the examiner should evaluate whether the claim is indefinite because those of ordinary skill in the art cannot determine the boundaries of this claim in the absence of a structural description of intermediate-acting denveric acid. See MPEP 2173.05(g). The examiner should also consider whether claim 3 lacks written description, which will depend on what is disclosed in the application, and whether there is a known correlation between denveric acid structure and function that could support the functionally-claimed genus of intermediate-acting denveric acid. See MPEP 2163(II)(A)(3)(a).

Claim 4 is eligible.

Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Claim 4 depends from claim 1, and adds protamine that is mixed with the denveric acid in an amount of 0.75 mg to 1.5 mg protamine per every mg of denveric acid. Based on the specification’s definition of “denveric acid” as being a particular protein isolated from the Rocky Mountain cassia tree, and the plain meaning of the other terms, the broadest reasonable interpretation of claim 4 is a mixture of denveric acid (which is naturally occurring) with protamine (which is naturally occurring), in a specified ratio (0.75 to 1.5 mg protamine per 1 mg denveric acid). As described in the specification, this mixture of denveric acid and protamine has particular glycemic control characteristics, e.g., specific onset timing of about 90 minutes post-injection, peak action timing of about 6 to 8 hours post-injection, and duration of action of about 12 to 16 hours post-injection.

Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claim 4 depends from claim 1, and thus also recites a composition of matter (the denveric acid and protamine mixture) and a manufacture (the container). Like claim 1, the claim is thus to at least one statutory category of invention (Step 1: YES).

Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. The claimed mixture of denveric acid and protamine is a nature-based product limitation, and thus the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). Although the claim also recites a non- nature based product limitation (the container), the markedly different characteristics analysis should be applied only to the nature-based product limitation. MPEP 2106.04(c)(I)(A).

Because the claim is to a nature-based product produced by combining multiple components (the denveric acid and the protamine), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. MPEP 2106.04(c)(I)(A). Because denveric acid and protamine do not occur together in nature, there is no naturally occurring counterpart mixture for comparison, and so the claimed mixture is compared to its naturally occurring components (denveric acid and protamine). There is no indication that mixing these components changes the structure of the denveric acid or protamine. However, the mixture has a changed functional property, in that the glycemic control characteristics of the mixture are different than the mere “sum” of the glycemic control characteristics of the individual components.

In other words, the denveric acid by itself has relatively short-acting glycemic control characteristics (onset of glycemic control is about 30 minutes post-injection, peak action is about 1 hour post-injection, and duration of action is about 1 to 3 hours post-injection), and the protamine by itself has no glycemic control characteristic, but when combined in the claimed ratio, the resultant mixture has intermediate glycemic control characteristics (onset of glycemic control is about 90 minutes post-injection, peak action is about 6 to 8 hours post-injection, and duration of action is about 12 to 18 hours post-injection). The claimed mixture here is thus unlike the bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the 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, 569 U.S. at 591 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”). Because the claimed mixture here has a different effect (the changed glycemic control characteristics) than its natural counterparts, it has markedly different characteristics, and therefore is not a “product of nature” exception. Because no judicial exception is recited, the claim cannot be directed to an exception (Step 2A: NO). The claim is eligible.

Practice note: When evaluating markedly different characteristics, the examiner should ensure that the claimed nature-based product possesses appropriate characteristics because it is the claim that must define the invention to be patented. Cf. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338 (Fed. Cir. 2014) (unclaimed characteristics could not contribute to eligibility); Roche Molecular Sys., Inc. v. CEPHEID, 905 F.3d 1363, 1370 (Fed. Cir. 2018) (same). The examiner can identify the characteristics possessed by the claimed product by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product. It is not necessary for the claim to explicitly recite a characteristic that is markedly different, so long as the broadest reasonable interpretation of the claim reflects that the claimed product possesses at least one appropriate characteristic that is markedly different. See MPEP 2106.04(c)(II)(B). Thus, although claim 4 does not recite the glycemic control characteristics of the claimed mixture, a person of ordinary skill in the art would recognize that broadest reasonable interpretation of the claimed mixture encompasses only mixtures which have particular glycemic control characteristics that are markedly different.