Claims to a Dietary Supplement Survive a Motion to Dismiss on a § 101 Patent Subject Matter Eligibility Challenge
| March 26, 2019
Natural Alternatives International, Inc., v. Creative Compounds, LLC
March 15, 2019
Before Moore, Reyna, and Wallach. Opinion by Moore. Opinion concurring-in-part and dissenting-in-part by Reyna.
Summary:
This case is an appeal from a Rule 12(c) dismissal for judgment on the pleadings in the district court. The district court held that all of the asserted claims to a dietary supplement, method of using the supplement and method of manufacturing the dietary supplement are patent ineligible under § 101 because they are directed to natural laws or natural phenomena. The CAFC reversed and remanded stating that the claims are not directed to an exception to § 101 under the first step of the Alice test.
Details:
Natural Alternatives sued Creative Compounds for infringement of U.S. Patent Nos. 5,965,596; 7,825,084; 7,504,376; 8,993,610; 8,470,865; and RE45,947. These patents relate to dietary supplements containing beta-alanine. Beta-alanine can form dipeptides which are also found in the muscles. Dipeptides aid in regulating intra-cellular pH during muscle contraction, and variations in concentrations of dipeptides affect anaerobic capacity. The claims of the patents are to supplements containing beta-alanine to increase the anaerobic working capacity of muscle and other tissue.
The district court accepted Natural Alternatives’ proposed claim constructions, but held that all of the claims under the proposed claim construction are patent ineligible as natural laws or natural phenomena. The CAFC stated that the district court properly accepted Natural Alternatives’ claim constructions due to the stage of the litigation, but the CAFC stated that the proposed claim constructions plausibly establish eligibility of the claims.
1. Method of Treating Claims
Claim 1 of the ‘596 patent and claim 1 of the ‘865 patent are treated as representative of the claims to a method of using beta-alanine. These claims are provided:
Claim 1 of the ‘596 patent:
1. A method of regulating hydronium ion concentrations in a human tissue comprising:
providing an amount of beta-alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue; and
exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the human tissue.
Claim 1 of the ‘865 patent:
1. A method of increasing anaerobic working capacity in a human subject, the method comprising:
a) providing to the human subject an amount of an amino acid to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the tissue, wherein said amino acid is at least one of:
i) beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide;
ii) an ester of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; or
iii) an amide of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; and
b) exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the tissue,
wherein the amino acid is provided through a dietary supplement.
Natural Alternatives’ claim construction of the highlighted “effective” limitations is to “elevate beta-alanine above natural levels to cause an increase in the synthesis of beta-alanylhistidine dipepetide in the tissue.” “Dietary supplement” is construed as “an addition to the human diet, which is not natural of conventional food, which effectively increases athletic performance when administered to the human over a period of time.” “Increasing anaerobic working capacity” is construed as “increasing the amount of work performed by a muscle under lactate producing conditions.”
The district court held that both method claims are directed to natural laws in that “ingesting certain levels of beta-alanine, will increase the carnosine concentration in human tissue and, thereby, increase the anaerobic working capacity in a human.” The CAFC disagreed with the district court stating that “[a]dministering certain quantities of beta-alanine to a human subject alters that subject’s natural state.” The CAFC stated that due to administering beta-alanine, homeostasis is overcome and the body produces more creatine which results in physiological benefits for athletes engaged in intense exercise. The CAFC also emphasized that the claims require administering the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide described benefits. Citing Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the CAFC concluded that “[t]hese are treatment claims and as such they are patent eligible.” “The Method Claims are directed to patent eligible new ways of using an existing product, beta-alanine.”
The CAFC distinguished Mayo by stating that while the Method Claims rely on a relationship between the administration of beta-alanine and beta-alanylhistidine dipeptide synthesis, under Natural Alternatives’ constructions, “the Method Claims require specific steps be taken in order to bring about a change in a subject, altering the subject’s natural state,” and the Method Claims do more than simply recite a natural law. The CAFC concluded that the Method Claims describe using a natural product in unnatural quantities to alter a patient’s natural state, to treat a patient with specific dosages. Thus, the Method Claims are not directed to an exception to § 101 under the first step of Alice.
2. Dietary Supplement Claims
Claim 6 of the ‘376 patent and claim 1 of the ‘084 patent are treated as representative of the claims to a dietary supplement. Claim 6 of the ‘376 patent depends from claims 1 and 5. The claims are provided:
Claims 1, 5 and 6 of the ‘376 Patent:
1. A composition, comprising:
glycine; and
a) an amino acid selected from the group consisting of a beta-alanine, an ester of a beta-alanine, and an amide of a beta-alanine, or
b) a di-peptide selected from the group consisting of a beta-alanine di-peptide and a beta-alanylhistidine di-peptide.
5. The composition of claim 1, wherein the composition is a dietary supplement or a sports drink.
6. The composition of claim 5, wherein the dietary supplement or sports drink is a supplement for humans.
Claim 1 of the ‘084 patent:
1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine.
Natural Alternatives construed “dietary supplement” as “an addition to the human diet, which is not a natural or conventional food, which effectively increases athletic performance and is manufactured to be used over a period of time.”
The district court held that the Product Claims are directed to the natural phenomena of beta-alanine and glycine, and thus, are directed to ineligible subject matter. The CAFC disagreed stating that the Product Claims are not directed to beta-alanine. The claims are directed to specific treatment formulations that incorporate natural products and they have different characteristics and can be used in a manner that natural beta-alanine cannot be used.
The CAFC added that beta-alanine and glycine are incorporated into particular dosage forms. The natural products are isolated and then incorporated into a dosage form with particular characteristics. In addition, the CAFC stated that “the record indicates that the claimed combination of glycine and beta-alanine could have synergistic effects allowing for outcomes that the individual components could not have.” The CAFC added that the factual allegations are sufficient to render judgment on the pleadings inappropriate, and that the Product Claims survive a motion for judgment on the pleadings at the first step of the Alice test.
3. Manufacturing Claims
Claim 1 of the ‘610 patent is treated as representative of the claims to a method of manufacturing a dietary supplement. This claim is provided:
1. Use of beta-alanine in manufacturing a human dietary supplement for oral consumption;
supplying the beta-alanine, which is not part of a dipeptide, polypeptide or oligopeptide, as a single ingredient in a manufacturing step of the human dietary supplement or
mixing the beta-alanine, which is not part of a dipeptide, polypeptide or oligopeptide, in combination with at least one other ingredient for the manufacture of the human dietary supplement,
whereby the manufactured human dietary supplement is for oral consumption of the human dietary supplement in doses over a period of time increases beta-alanyl histidine levels in muscle tissue sufficient to delay the onset of fatigue in the human.
The district court held that this claim is directed to “the natural phenomenon beta alanine and the natural law that ingesting certain levels of beta-alanine will increase the carnosine concentration in human tissue.” The CAFC disagreed stating that the claim is directed to “an application of the law and new use of that product.” The CAFC stated that the supplement is not a product of nature and the use of the supplement to achieve a given result is not directed to a law of nature, and thus, “[w]e do not see, therefore, how a claim to the manufacture of a non-natural supplement would be directed to the law of nature or natural product.” Thus, the CAFC held that the claims are not directed to ineligible subject matter under step one of the Alice test.
Dissent
Judge Reyna stated that the majority relies on an erroneous claim construction because Natural Alternatives’ claim construction improperly imports limitations into the claims. He took issue with the construction for claim 1 of the ‘084 patent. Specifically, Natural Alternatives construed “human dietary supplement” to be “an addition to the human diet, ingested as a pill, capsule, powder or liquid, which is not natural or conventional food, meat or food flavoring or extract, or pharmaceutical product which effectively increases the function of a tissue when administered to the human over a period of time.” Judge Reyna stated that this construction improperly imports the limitation that beta-alanine “effectively increases the function of a tissue when administered to the human over a period of time” because it is not in the plain language of the claim. He also stated that the proposed construction is contradicted by the written description.
Judge Reyna raised the issue of whether the court should reconsider whether a Rule 12(c) motion based on § 101 should be decided before claim construction. He interprets the majority’s remand to mean that upon formal claim construction, the § 101 issue may be revisited and asks “whether anything meaningful has been achieved in these circumstances.”
Comments
In this case, Natural Alternatives provided a favorable proposed claim construction for surviving the § 101 issue and due to the stage of the litigation at the motion to dismiss phase, the court adopted much of this proposed claim construction. Relying on this claim construction, the CAFC found all of the claims to be patent eligible. However, as Judge Reyna pointed out, it is not clear that the district court will adopt such a favorable claim construction at the claim construction stage of the litigation. And the § 101 issue might be raised again.
Prior Art Based on Inherency Does Not Extend to “Probably” Existing Subject Matter, but Is Limited to “Necessarily” Existing Subject Matter.
| March 21, 2019
Personal Web Technologies, LLC v. Apple, Inc.
March 12, 2019
Before Moore, Taranto and Chen. Opinion by Chen.
Summary
In September, 2013, Apple, Inc. (Apple) filed an inter parties review (IPR) proceeding before the U.S. Patent Trial and Appeal Board (PTAB) against Personal Web Technologies, LLC (Personal Web) asserting unpatentability of U.S. Patent No. 7,802,310. The PTAB held that the ‘310 patent was obvious. On appeal, the Federal Circuit overturned the Board’s holding of obviousness on the basis that the Board had relied upon purported “inherent” subject matter in a prior art document without sufficient evidence that the purportedly inherent subject matter “necessarily exists” based on the teachings of the reference.
Details
Procedural Background
In September, 2013, Apple, Inc. (Apple) filed an inter parties review (IPR) proceeding before the U.S. Patent Trial and Appeal Board (PTAB) asserting multiple grounds of unpatentability of U.S. Patent No. 7,802,310 owned by Personal Web Technologies, LLC (Personal-Web). The PTAB held that the ‘310 patent was obvious over U.S. Patent No. 5,649,196 (Woodhill) in view of 7,359,881 (Stefik). Personal-Web appealed the PTAB’s ultimate determination of obviousness.
Factual Background
The ‘310 patent is directed to “Controlling Access to Data in a Data Processing System.” In the prior art, problems arose due to conventional naming techniques in which data files are typically identified by a name and/or pathname or location. In particular, with convention systems, when a data item is transferred from a first device to a second device, if the same data item exists in the second device a duplicate copy will be created on the second device.
According to the invention of the ‘310 patent, a data file or element is given a unique name by creating a “unique identifier” that is added to the data item’s identification along with its user-defined name, location, etc. In particular, this unique identifier is created by applying a cryptograph hash function to the data item, but creates a unique identifier for the specific data item. Accordingly, if the data item is different (e.g., modified), it will have a different unique identifier. However, if the data item is the same (e.g., not modified), it will have the same unique identifier.
The key patent claim at issue – independent claim 24 – is set forth below for reference. And, a key element of this claim at issue in this litigation is highlighted below.
24. A computer-implemented method implemented at least in part by hardware comprising one or more processors, the method comprising:
(a) using a processor, receiving at a first computer from a second computer, a request regarding a particular data item, said request including at least a content-dependent name for the particular data item, the content-dependent name being based, at least in part, on at least a function of the data in the particular data item, wherein the data used by the function to determine the content-dependent name comprises at least some of the contents of the particular data item, wherein the function that was used comprises a message digest function or a hash function, and wherein two identical data items will have the same content-dependent name; and
(b) in response to said request:
(i) causing the content-dependent name of the particular data item to be compared to a plurality of values;
(ii) hardware in combination with software determining whether or not access to the particular data item is unauthorized based on whether the content-dependent name of the particular data item corresponds to at least one of said plurality of values, and
(iii) based on said determining in step (ii), not allowing the particular data item to be provided to or accessed by the second computer if it is determined that access to the particular data item is not authorized.
In holding that the claim was obvious over U.S. Patent No. 5,649,196 (Woodhill) in view of 7,359,881 (Stefik), the PTAB held that the Woodhill reference inherently taught the highlighted features above.
Discussion
The Federal Circuit reversed the Board’s decision on the basis that the Board’s inherency finding determination of the above-noted highlighted feature lacked substantial evidence.
- The Federal Circuit’s Discussion of the Law
The Federal Circuit explained that “[w]hile it is possible that Woodhill’s system utilizes an un-stated Binary Object Identifier lookup table to locate binary objects of a previous version of a file that is going to be restored …, mere possibility is not enough.” The Court further indicated that “[i]nherency . . . may not be established by probabilities or possibilities” and that “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.”
The Federal Circuit explained that for inherency “a party must ‘show that the natural result flowing from the [disclosure] as taught would result in [the claimed subject matter]” – i.e., in this case that the “natural result flowing from the operation as taught would result in the performance of the questioned function.”
The Federal Circuit held that because the claimed subject matter “does not necessarily exist in the” Woodhill reference, reliance on inherency for that feature in the obviousness analysis was improper.
2. The Federal Circuit’s Discussion of the Evidence
In concluding that the Board’s inherency finding determination was not based on substantial evidence, the Federal Circuit explained that the Woodhill reference did not inherently include “causing the content-dependent name of the particular data item to be compared to a plurality of values” for the following reasons.
The Woodhill reference teaches a distributed management system in which files are apportioned into binary objects. The system uses binary object identifiers to determine whether a binary object has changed from one version of a file to the next, and only those binary objects whose content has changed needs to be backed up, thereby reducing the amount of data being backed up. In Woodhill, the binary object identifier is based on the contents of the binary object, such that the binary object identifier changes when the contents is changed.
At the PTAB, the Board had agreed with Apple’s argument that in order to determine which data needs to be restored in Woodhill by an update request, the system “must be able to” reference local data files using the binary object identification information received and, thus, that Woodhill must maintain some sort of file system or other mapping that allows the binary object identification record to serve as a lookup for the requisite file data that is to be restored. Thus, the Board asserted that Woodhill must inherently teach the disputed feature.
However, the Federal Circuit explained that “an equally plausible” understanding of Woodhill is that the system uses conventional file names and locations to locate files and the binary object information to locate a given binary object within the file. The Federal Circuit further explained that the only disclosed use of the binary object identifier in Woodhill is to perform a one-to-one comparison with the binary object identifier in the backed-up version of the object, which occurs after the object has been identified.
Takeaways
- This case emphasizes that inherency requires the “necessary” existence of subject matter that is not expressly shown or described in a reference. Accordingly, this case may be helpful in contesting rejections where asserted subject matter is not emphatically necessarily present, but deemed to be probable or likely by the Patent Office.
- This case also demonstrates that one way to
argue against a finding of inherency is to set forth an “equally plausible”
alternative that is supported by the reference.
That is, by demonstrating that an “equally plausible” alternative
subject matter may exist, it can be argued that the Patent Office cannot
conclude that the asserted subject matter inherently exist.
