Federal District Court Finds Claims Directed to Dog Chew Toy Patent EligibleFew subjects have drawn as much interest among patent stakeholders and practitioners as understanding the framework used to determine a patent claim’s eligibility. Courts continue to address different factual situations in applying the two-step test for patent eligibility under 35 USC § 101 that the Supreme Court set out in Alice Corp. Pty. Ltd. V. CLS Bank Int’l., 537 U.S. 208, 217 (2014).Courts generally ask whether a claim is directed to patent eligible subject matter or a patent-ineligible concept, such as an abstract idea or natural phenomenon. If a claim is drawn to a patent ineligible concept, the court asks whether the claim includes an inventive concept or is simply an abstract idea without significantly more.

So, should a court disregard “well-understood, routine, and conventional” components of a claimed device when deciding whether a claim is directed to a patent-ineligible “natural phenomenon” under the first step of the Alice test?

Not according to the United States District Court for the Northern District of Illinois in FYF-JB LLC v. Pet Factory, Inc., which denied a motion to dismiss a patent infringement suit making this argument in the context of claims covering a dog chew toy. In Pet Factory, the accused infringer of U.S. Patent No. 9,681,643 (the “’643 Patent,” entitled “Tug Toy”), Pet Factory, Inc., argued that claims directed to a dog chew toy that makes noise when tugged or stretched were patent ineligible under § 101. Claim 1, which is one of several asserted claims, reads as follows:

  1. A tug toy comprising:

at least one gripping member and a central portion, wherein said at least one gripping member is attached to said central portion, and

wherein said central portion further includes a noise maker,

wherein said at least one gripping member is adapted to transmit force to said central portion and

wherein said force comprises a first lateral force directed away from the central portion in the direction of a first gripping member.

According to Pet Factory, even though the claims of the ‘643 Patent recited tangible chew toy devices, the devices’ components were “well-understood, routine and conventional.” Aside from these tangible components, Pet Factory argued that the claims recite nothing more than the natural phenomenon of “force and its direction” for purposes of Step 1 of the Alice inquiry. As a result, Pet Factory argued the patent infringement complaint against it brought by patent holder FYF-JB LLC should be dismissed.

The court disagreed, pointing out that whether components of a claimed device are “well-understood, routine and conventional” is not relevant to the determination under Step 1 of Alice of whether the claims are directed to a patent-ineligible concept.  The court noted that “the ‘well-understood, routine, and conventional’ language that Pet Factory cites comes from Alice and Mayo in the context of describing under step two of the Alice test why the addition of routine steps does not transform an otherwise unpatentable method into a patent-eligible application.” Because the claims were “anchored in the tangible form of a tug toy,” the court found the claims patent eligible, although it noted that simply reciting “concrete, tangible components is not necessarily enough to escape the reach of Alice step one.” The court apparently found persuasive cases cited by the patent holder which similarly rejected the notion that patents directed to circular swings that could move in any direction simply involved the natural phenomenon of a pendulum, and thus patent ineligible. Similarly, the court found the claims of the ‘643 Patent “involve force but are not directed to force itself.” They “describe the features of the tug toy, and how the apparatus is designed to transmit force and activate the noise maker.”

The court’s interpretation seems to be that tying a natural phenomenon to the operation of a claimed device is different from claiming the phenomenon itself. This decision suggests that whether a claim’s components are commonplace is not likely to be a relevant consideration under the analysis in Step 1 of Alice. Practitioners also should understand whether their claims are directed to the components of a claimed device, which are free to operate according to principles of a natural phenomenon, or simply to the operation of the phenomenon itself.

If you have questions regarding patent eligible subject matter under 35 USC § 101, please contact a member of Bradley’s Intellectual Property Practice Group.

The Risk of Using “Consisting Essentially of” in Patent ClaimsThe legal meaning of the transition language “consisting essentially of” is well-established in Federal Circuit case law and is generally construed to mean that the composition or formulation (a) necessarily includes the listed ingredients and (b) is open to unlisted ingredients that do not materially affect the basic and novel properties of the composition.  Similarly, when “consisting essentially of” is used in a process claim, the claim requires that the listed steps are performed, but also may include unlisted steps that do not affect the basic and material properties of the process. Accordingly, a “consisting essentially of” claim is typically understood to signal a middle ground between a closed claim that is written in a “consisting of” format and, thus, excluding any items not expressly recited in the claim, and an open claim that is written in a “comprising” format such that any unrecited items are not excluded. However, the middle ground just became a little less secure for patent holders with the Federal Circuit’s opinion in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. In a nutshell, the phrase “consisting essentially of” is indefinite if any identified basic and novel property is indefinite.

To provide some quick background, HZNP and Horizon own patents covering PENNSAID® 2% – the first FDA-approved twice daily topical diclofenac sodium formulation for the treatment of the pain of osteoarthritis of the knees (Horizon patents). The Horizon patents include the method of use and formulation claims. Actavis asserted that the generic copy of PENNSAID® 2% described in Actavis’ Abbreviated New Drug Application No. 207238 would not infringe any valid and enforceable Horizon patent. Horizon sued Actavis for patent infringement of the Horizon patents in the District of New Jersey.

During the claim construction (Markman) phase, the district court held that the formulation claims, which feature a topical formulation having a viscosity of 500 to 5,000 centipoise “consisting essentially of” certain ranges of diclofenac sodium, dimethyl sulfoxide, ethanol, propylene glycol, hydroxypropyl cellulose, and water were indefinite. More specifically, while the district court found that the specification sufficiently identified five basic and novel properties of the claimed invention — i.e., (1) better drying time; (2) higher viscosity; (3) increased transdermal flux; (4) greater pharmacokinetic absorption; and (5) favorable stability — it concluded that a person of ordinary skill in the art would not be able to have reasonable certainty about the scope of these properties.

On appeal, Horizon tried to convince the Federal Circuit that the Nautilus definiteness standard does not apply to the basic and novel properties of the invention. As a refresher, under Nautilus, Inc. v. Biosig Instruments, Inc., the Supreme Court determined that a claim is invalid for indefiniteness if its language, read in light of the specification and prosecution history, fails to inform with reasonable certainty those skilled in the art about the scope of the invention. In shooting down this argument, the majority clarified that by using “consisting essentially of” in a claim, an inventor incorporates into the scope of the claims an evaluation of the basic and novel properties. Thus, the Nautilus definiteness standard applies to the basic and novel properties.

Horizon also tried to persuade the Federal Circuit that the basic and novel properties are to be considered only as factual determinations of validity and infringement — not at the claim construction stage. Again, the majority was not swayed and explained that the determination of the basic and novel properties of an invention at the claim construction stage is critical to afford clear notice of what is claimed. If any property does not inform a person of ordinary skill in the art with reasonable certainty about the scope of the invention, then the phrase “consisting essentially of” is indefinite in light of the indefinite scope of that property.

On the other side of the podium, Actavis argued that the five basic and novel properties were not identified in the specification as important enough to even be considered basic and novel properties. The majority’s opinion explains that each of the five properties are included in the specification as separate subheadings with discussions of both the importance of each of the properties and the advantages of the invention over prior art with respect to these properties such that the intrinsic record sufficiently identifies the properties as the basic and novel properties of the invention. Despite the basic and novel properties being readily identifiable from the specification, the majority agreed with the district court that one of the five identified basic and novel properties, i.e., better drying time, was indefinite. More specifically, since the two different tests in the specification produced inconsistent results, the majority concluded that a person of ordinary skill in the art would not understand which test to use to evaluate this property. And, as set forth above, if the basic and novel properties are indefinite, so is the phrase “consisting essentially of.”

In sum, if a person of ordinary skill in the art cannot ascertain the bounds of the basic and novel properties of the invention recited in a “consisting essentially of” claim, the claim is indefinite because there is no basis upon which to analyze whether an unlisted item has a material effect on the basic and novel properties.

So what are the key takeaways from this part of the Horizon decision? First, for patent practitioners, be conscientious when employing “consisting essentially of” language in claims.  While the majority’s opinion made it clear that “consisting essentially of” claims are not per se indefinite, ambiguities in the specification as to the basic and novel properties of the invention or what constitutes a material alteration of these properties certainly leave such claims vulnerable to an indefiniteness attack. Since “consisting essentially of” language is typically introduced during prosecution in an effort to distinguish over a cited reference, ensure that any such amendment to the transition language is thoroughly vetted as if you are in the Markman phase of a patent infringement trial. Even though “consisting of” language is narrower in scope than “consisting essentially of” language, if the specification lacks requisite clarity with regard to the basic and novel properties of the invention, you would be better off obtaining a closed claim than a middle ground claim susceptible to attack under 35 U.S.C. § 112.

Second, for accused infringers wanting to challenge the validity of a “consisting essentially of” claim for failure to clearly identify the basic and novel properties or what constitutes a material alteration of these properties, be prepared to do so early in the dispute and no later than the Markman phase. If the only asserted claims are “consisting essentially of” claims, you may be able to end the dispute altogether well before summary judgment. If the asserted claims are not limited to the “consisting essentially of” claims, you at least may be able to significantly narrow the issues for subsequent phases of the litigation, thus reducing litigation costs, as well as possibly gaining considerable leverage for settlement purposes.

As discussed in a previous blog post, since Mayo v. Prometheus, critics of medical treatment patents have advocated that such patents should be banned from patenting. While such arguments seemed futile based on the consistent position taken by the U.S. Court of Appeals for the Federal Circuit (CAFC) that treating a disease or other condition is not merely a “mental process” or “natural law,” the CAFC’s recent decision in INO Therapeutics, LLC v. Praxair Distribution Inc. may have changed that. Indeed, if this decision is followed by other panels of the CAFC, it could have a profound effect on the patenting of personalized medicine in the United States.

The Old Rule: Medical Treatment Informed by Diagnostic Testing Could be Patented

For the First Time, a Medical Treatment Patent Is Ruled Invalid Under Mayo/MyriadPrior to INO, the CAFC consistently ruled that methods of medical treatment are patent-eligible subject matter, regardless of whether they are combined with a diagnostic step. In Classen Immunotherapies Inc. v. Biogen IDEC – the seminal case in this line – the CAFC considered the patent eligibility of a claimed method of immunization of a subject that involved first immunizing a number of other subjects according to two immunization schedules and determining which has the least risk of side effects, then immunizing the subject according to the schedule with the lowest risk.

The unanimous panel found the act of immunizing two groups of subjects and comparing the results to determine the best immunization schedule, without applying that schedule to a subject, not eligible for patenting. However, with the extra step of actually immunizing a subject based on the schedule, the majority of the panel held that the claimed method was patent eligible. Notably, while the majority held that a method of medical treatment is eligible for patenting, even if it involves mental steps, a dissenting judge thought the claims were “a monopoly over the scientific method itself.” The CAFC followed this analysis in several later decisions, including in Natural Alternatives International, Inc. v. Creative Compounds, LLC; Endo Pharmaceuticals Inc. v. Mallinckrodt, LLC; and Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd.

In contrast, the CAFC has consistently found patent claims that include only diagnostic steps, without any form of medical treatment, ineligible for patenting. Such cases include Myriad (by the Federal Circuit, before it went to the Supreme Court); PerkinElmer Inc v. Intema Ltd.; Univ. of Utah Research Foundation v. Ambry Genetics Corp.; Cleveland Clinic Foundation v. True Health Diagnostics, LLC; Roche Molecular Systems, Inc. v Cepheid; and Ariosa Diagnostics, Inc. v. Sequenom, Inc.

The INO Rule: Withholding Treatment Dooms the Patent

The invention claimed in INO was directed to a method of treating hypoxia in newborns with nitric oxide while reducing the risk of pulmonary edema (a deadly side effect). The inventors discovered that infants with impaired function of the left ventricle are at elevated risk for pulmonary edema if treated with nitric oxide. The asserted claims of the patents in suit featured a method of diagnosing a hypoxic infant for left ventricular dysfunction (LVD) by echocardiography and administering an appropriate concentration of nitric oxide only in the absence of left ventricular dysfunction.

As in Classen and its progeny, the claims involved a medical intervention based on the result of the diagnostic step. Unlike Classen, the trial court in Mallinckrodt held that the use of previously known treatment methods based on the diagnosis does not add “significantly more” to the understanding of the natural law. You can read more about the trial court decision here.

Two of the three judges on the CAFC panel agreed with the trial court. The majority felt that invention in INO was different from those in Classen, Endo, Natural Alternatives, and Vanda in one significant way: in INO, the diagnostic step determined to which patients nitric oxide should be administered and to which patients it should be withheld, whereas in the other decisions, treatment was administered in some form, although the form differed depending on the results of the test.

The majority cited numerous, separate reasons that the distinction caused the invention to fall under the Mayo/Myriad ban. First, the majority explained that “[t]he effect of [nitric oxide] gas on a newborn with LVD is a matter of human physiology.” The majority then stressed that the use of nitric oxide was not new and, therefore, “the patented method does not propose a new way of treating LVD patients.” Although the patentee argued that the claim in its entirety was new, the majority dismissed this “whole claim” approach, opining that “…the focus of the invention is screening for a particular adverse condition that, once identified, requires iNO treatment be withheld.”

The majority contrasted this case with Vanda and Endo, because in the latter cases, the diagnostic test determined the dosage at which a specific treatment is given. Because treatment is administered regardless of the test results, the majority believes these are properly interpreted to be “methods of treatment.” The INO invention, on the other hand, involves either administration of a specific drug at a specific dosage or non-administration of that drug.

It would seem that the majority’s decision is based on the premise that (1) the claimed treatment with nitric oxide of infants without LVD cannot be considered in the patent eligibility analysis because nitric oxide treatment was already known and (2) the claimed withholding of nitric oxide treatment of infants with LVD is not really a method of treatment because no treatment is administered. In fact, the majority explained that a claim not to treat is akin to not disturbing the naturally occurring processes within the LVD patient’s body and “risks monopolizing the natural processes themselves.” Therefore, the claimed method is merely “instruction” to apply the “law of nature” of how nitric oxide affects human physiology.

Judge Newman – the most senior judge on the CAFC – dissented. Her dissenting opinion took a familiar direction, pointing out that the claimed invention was not a “law of nature” as “it was designed by and is administered by humans.” She further pointed out that all medical treatments rely on the response of human physiology to an artificial intervention. She finally pointed out that the Supreme Court has repeatedly cautioned against dissecting claims into component parts and considering only specific parts in the patent eligibility analysis. As noted by Judge Newman in her dissent, while the claimed method may in fact be invalid under the tests of novelty or obviousness, to declare it patent-ineligible is contrary to preceding decisions from the Supreme Court and the CAFC.

Where Does this Leave Personalized Medicine?

This decision leaves many key questions about patent eligibility unanswered and the future uncertain for personalized medicine patents. Prior to INO, the Vanda decision was regarded as a beacon in the foggy post-Mayo world when it came to patenting personalized medicine. It introduced an unaccustomed level of certainty to the question of subject matter eligibility since Mayo. In fact, published USPTO guidance relies on Vanda to teach that “it is not necessary for method of treatment claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under 35 U.S.C. § 101.”

INO calls all of that into question for a number of reasons. First, the majority did not explain why the Mayo/Myriad ban applies to treatment regimens where a treatment is completely contraindicated by test results but not to regimens where the dosage is changed.

Second, the majority opined that Vanda claimed “an improved set of specific doses” but that INO did not. But in Vanda, the lower dosage in the claim was not more effective to treat the disorder; rather, it had less side effects. This appears to be eerily similar to the claims in INO, except that the INO claims effectively require a “zero dosage” for infants with LVD.

Third, the majority gives no explanation of the relevance of the fact that the use of nitric oxide without reference to LVD was already known. Indeed, the treatment steps in Vanda and Endo were also already known if severed from the diagnostic steps.

In summary, although the majority opinion repeatedly attests that there is no inconsistency between INO and the CAFC’s previous opinions, INO seems to be at odds with established precedent and appears to signal another period of uncertainty and inconsistency regarding the patentability of personalized medicine in the United States. Inventors of personalized medicine inventions would be wise to consider maintaining their innovations as a trade secret or explore markets outside of the United States to protect their inventions.