More Diagnostic Patent Claims Fall—Despite following USPTO Guidelines
WHDA Blogging Team | May 3, 2019
Cleveland Clinic v. True Health Diagnostics
April 1, 2019
Lourie, Moore and Wallach. Opinion by Lourie. (non-precedential)
Summary
In a non-precedential opinion, the CAFC considered diagnostic patent claims ineligible. The CAFC dismissed recitation of detection of a biomarker using conventional tools as an “overly superficial” rephrasing of claims that were previously considered ineligible. The CAFC also indicated that it is not bound by USPTO guidelines, and implied that the relied-upon USPTO Example is inconsistent with Ariosa.
Details
This case relates to a diagnostic to detect heart disease. Myeloperoxidase (MPO) is an early marker of heart disease associated with atherosclerotic plaques. It was known in the prior art that MPO can be detected in surgically removed plaques, but it was not known that MPO is present in elevated levels in the blood of patients having atherosclerotic cardiovascular disease. The inventors disclosed a method of detecting MPO by lab techniques such as colorimetric-based assay, flow cytometry, ELISA etc, and then correlating the detected MPO to heart disease. Notably, the specification states that MPO can be detected “by standard methods in the art,” and that commercially available kits can be modified to detect MPO.
In Cleveland Clinic I, the CAFC held that method claims reciting “a method of assessing risk of having atherosclerotic heart disease” were invalid as reciting a law of nature without anything significantly more. See Cleveland Clinic v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017), cert. denied, 138 S. Ct. 2621, (2018). In that case, the claims only recited a step of “comparing” MPO levels of a subject with MPO levels in a known non-diseased person.
However, this case presents slightly different claims based on same technology. Rather than reciting diagnosis or treatment, the present claims recite methods of detecting and identifying elevated MPO, with more detail. Specifically, the relevant claims are as follows:
Patent 9,575,065:
1. A method of detecting elevated MPO mass in a patient sample comprising:
a) obtaining a plasma sample from a human patient having atherosclerotic cardiovascular disease (CVD); and
b) detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPO in said plasma sample and said anti-MPO antibodies.
Patent 9,581,597:
1. A method for identifying an elevated myeloperoxidase (MPO) concentration in a plasma sample from a human subject with atherosclerotic cardiovascular disease comprising: a) contacting a sample with an anti-MPO antibody, wherein said sample is a plasma sample from a human subject having atherosclerotic cardiovascular disease;
b) spectrophotometrically detecting MPO levels in said plasma sample;
c) comparing said MPO levels in said plasma sample to a standard curve generated with known amounts of MPO to determine the MPO concentration in said sample; and
d) comparing said MPO concentration in said plasma sample from said human subject to a control MPO concentration from apparently healthy human subjects, and identifying said MPO concentration in said plasma sample from said human subject as being elevated compared to said control MPO concentration.
2. The method of claim 1, further comprising, prior to step a), centrifuging an anti-coagulated blood sample from said human subject to generate said plasma sample.
Prosecution
In prosecution of these patents, the Applicant argued by analogy to Example 29 of the May 2016 USPTO eligibility guidelines. Example 29 presents two claims:
1. A method of detecting JUL-1 in a patient, said method comprising:
a. obtaining a plasma sample from a human patient; and
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.
2. A method of diagnosing julitis in a patient, said method comprising:
a. obtaining a plasma sample from a human patient;
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and
c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.
According to the 2016 guidelines, claim 1 is eligible, because it does not recite a law of nature (pass on step 2A). However, in the USPTO’s view, claim 2 is ineligible because it recites a law of nature without reciting something significantly more (fail on steps 2A and 2B).
In prosecution, the Applicant argued that the “detecting” claim of the ‘065 patent is more similar to the “detecting” claim 1 of Example 29 (eligible) than it is to the “diagnosing” claim 2 of Example 29 (ineligible). The Examiner agreed and allowed the application.
As to the ‘597 claims, the Applicant successfully argued in prosecution that the “identifying” claim recites significantly more than a judicial exception, also relying on Example 29. The Applicant argued that it was not known to identify elevated MPO in plasma of patients having atherosclerotic cardiovascular diseases, even though it was previously known to detect MPO in plaques. The Examiner agreed and allowed the application.
District Court
The district court interpreted the claims as being directed to a law of nature, based on the recitations of “detecting elevated MPO mass in a patient sample…”, “….from a human having atherosclerotic cardiovascular disease”, and “identifying an elevated [MPO] concentration in a plasma sample from a human subject with atherosclerotic cardiovascular disease.” The district court concluded that the method is only useful for detecting elevated MPO associated with cardiovascular disease. In other words, the method is only useful for detecting a natural phenomenon.
As such, the district court concluded that the claims do not recite a general laboratory technique and instead are trying to “recast [a] diagnostic patent as a laboratory method patent.” The district court concluded that the claims are directed to detecting the correlation between MPO and the disease, rather than to detecting MPO more generally. Thus, the claims fail step 2A. Further, the additional steps are all well-known and conventional and thus fail step 2B. Specifically, the district court stated that “[i]f merely using existing, conventional methods to observe a newly discovered natural phenomenon were enough to qualify for protection under §101, the natural law exception would be eviscerated.”
CAFC
The CAFC agreed in holding that the claims are ineligible. Cleveland Clinic argued first that the claims are not directed to a natural law, but rather to a technique of using an immunoassay to measure MPO. However, the CAFC considered this distinction to be “overly superficial,” and stated that the claims are directed to a natural law (correlation between MPO and the disease). The CAFC characterized the difference between the claims at issue and the claims of Cleveland Clinic I as a “rephrasing” that does not make the claims less directed to a law of nature.
Cleveland Clinic also argued that the correlation is not a natural law because it can only be detected using certain techniques. However, the CAFC saw through this, and stated that the same is true for many of the natural laws at issue in previous cases. Specifically, the CAFC stated that “[i]nadequate measures of detection do not render a natural law any less natural.”
The CAFC also held that the claims do not recite an additional inventive concept. Cleveland Clinic argued that using a known technique in a standard way to observe a natural law confers an inventive concept. However, the CAFC stated that this reasoning has been dismissed is previous cases such as Athena Diagnostics v. Mayo and Ariosa v. Sequenom. Further to this point, the CAFC stressed that the MPO is detected using known techniques without significant adjustments.
Finally, the CAFC addressed the USPTO guidelines. Cleveland Clinic stated that the district court erred by not giving appropriate deference to Example 29 noted above. The CAFC agreed with True Health in stating the USPTO guidelines are neither persuasive nor relevant to the claims at issue, because the district court reached the correct decision.
The CAFC did not include an extensive discussion of the USPTO guidelines, but stated as follows:
While we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance. And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law.
Further with regard to Example 29, the CAFC stated that its claim 1 is “strikingly similar” to ineligible claim 1 of Ariosa. As such, the CAFC stated that although they have considered Example 29 and related arguments, Ariosa must control. Thus, the CAFC did not follow the USPTO’s guidelines.
Takeaway
- Patent eligibility of diagnostic methods continues to be highly problematic. However, Chris Coons (D-DE) and Thom Tillis (R-NC) have recently been holding meetings on the issue, and released a “framework” on April 17, 2019:
However, in view of competing interests of the life sciences industry and the software industry, as well as reluctance to change a long-standing law, legislative change may be farther away than one might hope.
- One relies on USPTO guidelines at their own risk. Here, less than 3 years after publication, a CAFC panel has declined to follow the USPTO’s guidelines. Since such guidelines do not have the force of law, the courts are not required to follow them. In fact, in this case, the CAFC was somewhat dismissive of the USPTO’s efforts regarding §101. It is quite possible that the much-lauded USPTO guidelines issued on January 4, 2019 might suffer the same fate.
- If trying to claim a diagnostic as a detection method, it is probably better to omit recitation of a specific disease and a high/low comparison in the claims. In the rare case it is possible, it would be ideal to disclose a non-diagnostic use of the detected compound in the specification.
A comparison of an accused product to a commercial product that meets all the claim limitations for finding infringement of the claim
WHDA Blogging Team | April 29, 2019
TEK Global S.R.L. v. Sealant Systems International Inc. (Fed. Cir. 2019) (Prost, C.J.) (Case No. 17-2507)
March 29, 2019
Prost, Chief Judge, Dyk and Wallach, Circuit Judges. Court opinion by Chief Judge Prost.
Summary
In a precedential opinion, the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s claim construction in a specific context that an asserted claim including “container connecting conduit” was not subject to 35 U.S.C 112, ¶ 6 (112(f)) because the term “conduit” recites sufficiently definite structure to avoid classification as a nonce term. The Federal Circuit also affirmed the district court’s overruling of the accused infringer’s objections to certain alleged product-to-product comparisons in the patentee’s closing argument with general guidance that, despite the maxim that to infringe a patent claim, an accused product must meet all the limitations of the claim, a comparison of the accused product to a commercial product that meets all the claim limitations may support a finding of infringement of the claim.
Details
I. background
1. Patent in Dispute
TEK Corporation and TEK Global, S.R.L. (collectively, “TEK”) owns U.S. Patent No. 7,789,110 (“’110 patent”), directed to an emergency kit for repairing vehicle tires deflated by puncture.
In a lawsuit by TEK against Sealant Systems International and ITW Global Tire Repair (collectively, “SSI”) at the United States District Court for the Northern District of California (“district court”), claim 26 is the only asserted independent claim:
26. A kit for inflating and repairing inflatable articles; the kit comprising a compressor assembly, a container of sealing liquid, and conduits connecting the container to the compressor assembly and to an inflatable article for repair or inflation, said kit further comprising an outer casing housing said compressor assembly and defining a seat for the container of sealing liquid, said container being housed removably in said seat, and additionally comprising a container connecting conduit connecting said container to said compressor assembly, so that the container, when housed in said seat, is maintained functionally connected to said compressor assembly, said kit further comprising an additional hose cooperating with said inflatable article; and a three-way valve input connected to said compressor assembly, and output connected to said container and to said additional hose to direct a stream of compressed air selectively to said container or to said additional hose.
2. Preceding Proceedings
In claim construction proceedings, SSI argued that “conduits connecting the container” and “container connecting conduit” in claim 26 are subject to 35 U.S.C. 112, ¶ 6, and that the claim requires a fast-fit coupling, which the accused product lacks.
FIG. 1, showing a “view in perspective of a repair kit [1] comprising a container [3] of sealing liquid [and a compressor assembly 2],” is reproduced below
FIG. 4, showing a “underside view in perspective [o]f the FIG. 1 kit [1] partly disassembled,” and a portion of the specification of ’110 patent, relevant to the “fast-fit coupling” are reproduced below:
“Conveniently, hose 4 [i]s fitted on its free end with a fast-fit, e.g. lever-operated, coupling 58.” ’110 patent col. 4 ll. 7–9.
The magistrate judge rejected SSI’s contention, and entered an order respectively construing these terms (“conduits connecting the container” and “container connecting conduit”) as “hoses and associated fittings connecting the container to the compressor assembly and to an inflatable article for repair or inflation” and “a hose and associated fittings for connecting the container to the compressor assembly.”
Following the claim construction, SSI moved for summary judgment of invalidity, arguing that claim 26 was obvious over U.S. Patent Application No. 2003/0056851 (“Eriksen”) in view of Japanese Patent No. 2004-338158 (“Bridgestone”). The district court granted SSI’s motion with determinations that the term “additional hose cooperating with said inflatable article” did not require a direct connection between the additional hose and the inflatable article, and that Bridgestone discloses an air tube (54) that works together with a tire, even though it is not directly connected to the tire, and that air tube (54) therefore represents the element of an additional hose (83) cooperating with the tire. TEK appealed the district court’s order to the Federal Circuit.
The Federal Circuit reversed the district court’s construction of the “cooperating with” limitation and its subsequent invalidity determination, and remanded the case back to the district court, because SSI “has not had an opportunity to make a case for invalidity in light of this court’s claim construction.”
On remand, SSI again moved for summary judgment of invalidity, contending that “it would have been obvious . . . to modify Bridgestone to eliminate the second three-way valve (60) and joint hose (66), resulting in a conventional tire repair kit meeting the limitations of the claims of the 110 Patent.” The magistrate judge denied SSI’s motion, noting that “the Federal Circuit has already considered and rejected obviousness in light of the combination of Eriksen and Bridgestone.”
Following a four-day trial, the jury found the asserted claims including claim 26 of the ’110 patent infringed and not invalid. The jury awarded $2,525,482 in lost profits and $255,388 in the form of a reasonable royalty for infringing sales for which TEK did not prove its entitlement to lost profits.
SSI then moved for a new trial on damages (or remittitur) and for JMOL on damages, invalidity, and noninfringement. The district court denied SSI’s motions for a new trial and for JMOL on invalidity and noninfringement. As to SSI’s motion for JMOL on damages, the district court denied the motion with respect to lost profits and granted it with respect to reasonable royalty. The district court also granted TEK’s motion for a permanent injunction. SSI appealed to the Federal Circuit.
II. The Federal Circuit
The Federal Circuit vacated the district court’s final judgment as to validity and reversed its denial of SSI’s motion for partial new trial on validity. In the interest of judicial economy, the Federal Circuit also reached the remaining issues on appeal including claim construction and infringement, and affirmed on those issues in the event the ’110 patent is found not invalid following the new trial.
This article focuses on the issues of the claim construction and infringement.
1. Claim Construction
(a) Fast-fit coupling
Review the district court’s claim construction de novo, and any underlying factual findings based on extrinsic evidence for clear error, the Federal Circuit affirmed the district court’s claim construction, concluding that the intrinsic and extrinsic evidence in this case establishes that the term “conduit” recites sufficiently definite structure to avoid classification as a nonce term and agreed with the district court that SSI did not meet its burden to overcome the presumption against applying 35 U.S.C. 112, ¶ 6.
First, the Federal Circuit noted that SSI did not dispute that the elements connected via the conduits—i.e., the container, the compressor assembly, and the inflatable article (e.g., a tire)—each comprise definite structure, and that SSI did not dispute that the “hose” disclosed in the ’110 patent is structural.
Second, the Federal Circuit concluded that the ’110 patent (intrinsic evidence) clearly contemplates a conduit having physical structure. Indeed, the disclosed conduits serve to physically connect a container of sealing liquid to a compressor and to connect the compressor to tires such that “[t]he liquid is fed into the [tire] for repair by means of compressed air, e.g., by means of a compressor.” ’110 patent col. 1 ll. 13–14. Note that the cited portion in the parentheses is described in the “BACKGROUND ART” section of the specification without reference to any drawing in the patent.
Third, citing the applicant’s statement when adding new claim 26 to its patent application, “[n]ew claim 26 is similar to claim 10 but defines the connections in structural terms rather than ‘means for’ language,” the Federal Circuit agreed with the district court’s determination that the prosecution history establishes that the applicant intended for the term “conduit” to avoid the application of 35 U.S.C. 112, ¶ 6, with note that “[t]he subjective intent of the inventor when he used a particular term is of little or no probative weight in determining the scope of a claim,” but that is not necessarily true when the intent is “documented in the prosecution history.” Markman v. Westview Instruments, Inc., 52 F.3d 967, 985 (Fed. Cir. 1995) (en banc) (emphasis added).
Finally, the Federal Circuit indicated that extrinsic evidence also supports the conclusion. For example, dictionary definitions at or around the time of the invention confirm that the noun “conduit” denoted structure with “a generally understood meaning in the mechanical arts.” Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1583 (Fed. Cir. 1996) (explaining that the dictionary definition of “detent” shows that a person skilled in the art would understand the term to connote structure); Webster’s Third New International Dictionary 474 (1993) (defining “conduit” as “a natural or artificial channel through which water or other fluid passes or is conveyed: aqueduct, pipe”); The New Oxford American Dictionary 358 (2001) (defining “conduit” as “a channel for conveying water or other fluid”).
(b) Outer casing connected to compressor
SSI also argues that because claim 26 requires that the “seat is part of the outer casing[,] . . . the outer casing connects the container to the compressor.”
Regarding the issue, the Federal Circuit indicated that its inquiry is limited to whether substantial evidence supports the jury’s infringement verdict under the issued claim construction, and did not reach whether the accused product infringes the asserted claims under SSI’s posited constructions because the district court expressly rejected SSI’s interpretation when determining that the term should have its plain and ordinary meaning, and because SSI did not appeal the district court’s claim construction order rejecting its interpretation of the plain and ordinary meaning.
2. Infringement (Product-to-Product Comparison)
SSI argued that the district court legally erred by allowing TEK, over SSI’s objections, to compare the accused product to TEK’s commercial embodiment during its closing argument.
While the Federal Circuit agreed with SSI’s assertion that to infringe, the accused product must meet all the limitations of the claim, the Court noted, “when a commercial product meets all the claim limitations, then a comparison [of the accused product] to that [commercial] product may support a finding of infringement.”
Regarding this case, the Federal Circuit stated that it cannot say that the district court abused its discretion by allowing the jury to hear the indirect product-to-product comparison, given that SSI’s own expert, Dr. King, acknowledged that he understood the TEK device to be an “embodying device” and to “practice[] the ’110 Patent,” and that certain statements made by SSI’s former executive, TEK’s counsel, and the inventor also suggest that TEK’s device is the commercial embodiment of the ’110 patent.
The Federal Circuit affirmed that the district court overruled SSI’s objections to certain alleged product-to-product comparisons in TEK’s closing argument because it determined that “SSI and its expert invited a product-to-product comparison by identifying TEK’s product as an embodiment of the invention, then drawing a contrast (albeit an unconvincing one) with SSI’s product.”
The Federal Circuit also affirmed that the district court, in its discretion, determined that the indirect comparison between TEK’s product and SSI’s product, in the context that it occurred, was not cause for a new trial. For the support of the affirmance, the Federal Circuit referred to the district court’s instruction directing the jury not to perform a product-to-product comparison to decide the issue of infringement (“You’ve heard evidence about both TEK’s product and SSI’s product. However, in deciding the issue of infringement, you may not compare SSI’s Accused Product to TEK’s product. Rather, you must compare SSI’s Accused Product to the claims of the ’110 Patent when making your decision regarding patent infringement.”). In the Federal Circuit’s view, the district court’s cautionary instructions are sufficient to mitigate any potential jury confusion or substantial prejudice to SSI due to the apparent product-to-product comparison.
In light of the above considerations, the Federal Circuit concluded that the district court did not abuse its discretion, and thus declined to reverse its denial of SSI’s motion for a new trial on infringement.
Takeaway
• The term “conduit” is now a member of examples of structural terms that have been found not to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6. See MPEP 2181 [R-08.2017].
• Despite the maxim that to infringe a patent claim, an accused product must meet all the limitations of the claim, a comparison of the accused product to a commercial product that meets all the claim limitations could support a finding of infringement of the claim.
A case for importing limitation from specification into the claim
WHDA Blogging Team | April 6, 2019
Forest Laboratories, LLC v. Sigmapharm Laboratories, LLC
March 14, 2019
Before Prost, Dyk, and Moore (Opinion by Moore)
Summary
A district court’s narrowing claim interpretation that read a limitation from the specification into the claim may have helped a patent about an antipsychotic drug survive invalidity challenges. The Federal Circuit agreed with the district court’s claim interpretation, reasoning that repeated emphasis on the limitation in the specification and prosecution history supports the reading of the limitation into the claim. The Federal Circuit also agreed that, as a solution to an unrecognized problem, the claimed invention may not be obvious, particularly when there were no alternate, independent bases on which the prior art could be combined to make the claimed invention. Unfortunately, the district court’s lack of express findings on an unrelated proffered motivation to combine prompted the Federal Circuit to nevertheless vacate the district court’s nonobviousness determination and remand the case.
Details
Forest Laboratories, LLC makes and sells the drug, SAPHRIS®, for treating bipolar disorders and schizophrenia. The active ingredient in SAPHRIS® is the compound, asenapine. This compound is the subject matter of U.S. Patent No. 5,763,476 (“476 patent”), also owned by Forest Laboratories.
SAPHRIS® on average costs almost $1,500 for 60 tablets, and there are currently no generic alternatives. When a group of drug makers sought approval from the FDA to make generic versions of SAPHRIS®, Forest Laboratories accused them of infringing the 476 patent.
For our purpose, claim 1 of the 476 patent is of particular interest:
1. A pharmaceutical composition comprising as a medicinally active compound: trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5,-c]pyrrole or a pharmaceutically acceptable salt thereof; wherein the composition is a solid composition and disintegrates within 30 seconds in water at 37°C.
It is worth noting that claim 4 of the 476 patent recites a “method for treating tension, excitation, anxiety, and psychotic and schizophrenic disorders, comprising administering sublingually or buccally” the asenapine.
Among the issues on appeal, the Federal Circuit’s discussions on claim construction and nonobviousness of claim 1 are informative.
As to claim construction, the question was whether claim 1 should be limited to sublingually or buccally administered compositions, or as the accused infringers would argue, should cover any composition that meets the claimed disintegration profile.
The district court determined that claim 1 should be limited to sublingual or buccal compositions. And the Federal Circuit agreed.
Unlike claim 4, claim 1 does not expressly recite “sublingual or buccal” administrations. The original claim 1 did recite “[a] sublingual or buccal pharmaceutical composition…suitable for use in sublingual or buccal compositions”, but all the “sublingual or buccal” language was removed during prosecution.
At first glance, then, the district court’s claim interpretation would seem to contradict not only the plain language of the claims, and also the intrinsic evidence vis-à-vis the prosecution history.
However, both the district court and the Federal Circuit were able to draw for their claim interpretation from the specification and prosecution history of the 476 patent.
The 476 patent specification repeatedly uses “sublingual or buccal” to modify the “invention”. For example, the 476 patent is titled “sublingual or buccal pharmaceutical composition”, and statements like “the invention relates to a sublingual or buccal pharmaceutical composition” are peppered throughout the specification. The 476 patent also extolls sublingual and buccal treatments, and criticizes conventional peroral or oral treatments.
The Federal Circuit noted that “[w]hen a patent…describes the features of the ‘present invention’ as a whole, this description limits the scope of the invention” (quoting Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007). In addition, both the district court and the Federal Circuit cited UltimatePointer, LLC v. Nintendo Co., 816 F.3d 816 (Fed. Cir. 2016) to support their claim interpretation. In UltimatePointer, the court limited the claim term “handheld device” to a “direct-pointing device” (for example, a Wiimote), even though the claim language did not expressly contain such a limitation. “[T]he repeated description of the invention as a direct-pointing system, the repeated extolling of the virtues of direct pointing, and the repeated criticism of indirect pointing clearly point to the conclusion that the ‘handheld device’…is limited to a direct-pointing device.” Id. at 823-24.
The prosecution history of the 476 patent likewise repeatedly used “sublingual or buccal” to modify the claimed composition. Most notably, in interpreting the original claim 1, the Examiner took the position that the language “‘suitable for sublingually or buccal administration,’ does not result in a structural difference between the claimed invention and the prior art,” and the “the composition as claimed may be used for either mode of administration (sublingually or orally, rectally, etc.).” In response, the patentee amended claim 1 to define “suitability” to mean that “the composition is a solid composition and disintegrates within 30 seconds in water at 37°C”. This feature distinguished the claimed invention over the prior art:
The Office Action indicated that any composition whose physical characteristics make the composition unique to sublingual or buccal administration…would be allowable. Applicants submit that the distinguishing feature of disintegration time is exactly such a characteristic…It is this feature of rapid disintegration which distinguishes a sublingual composition from a peroral one and which makes the compositions of the present invention suitable to avoid the adverse effects observed with peroral administration….
To obtain the good effects of the compositions of the present invention, it is necessary that the medicine be delivered by sublingual or buccal administration.
The district court inferred from those statements the inventors’ intention to limit the claims to sublingual or buccal compositions. The Federal Circuit reached the same conclusion even without considering the prosecution history. Looking only at the specification, and in a rather attenuated logic, the Federal Circuit determined that since the specification describes the claimed disintegration time as defining “rapid disintegration”, and also describes “rapid disintegration” as a feature of sublingual/buccal composition, the claimed disintegration time must therefore limit the claim to “sublingual or buccal” compositions.
Based on the above interpretation, the district court and the Federal Circuit agreed that claim 1 of the 476 patent was not obvious.
Even though asenapine, the use of asenapine to treat schizophrenia, and sublingual and buccal administrations of drugs were separately known in the art, there was no motivation to combine the prior art to arrive at the 476 patent’s sublingual or buccal formulation.
The Federal Circuit noted a “problem/solution” basis for finding nonobviousness. “[W]here a problem was not known in the art, the solution to that problem may not be obvious”. “[S]olving an unrecognized problem in the art can itself be [a] nonobvious patentable invention, even where the solution is obvious once the problem is known.”
Here, the invention grew out of concerns over severe cardiotoxic side effects of oral asenapine, which caused cardiac arrest in some patients. This prompted the inventors to consider alternative routes of administration. However, the dangers of oral asenapine were unknown in the art at the time of invention. Large-scale clinical studies were even being conducted with conventional oral asenapine tablets.
In addition, the inventors found that the cardiotoxicity of oral asenapine was likely due to accumulation of unmetabolized asenapine. However, sublingual or buccal administrations were expected to produce more, not less, unmetabolized asenapine.
The district court found, and the Federal Circuit accepted, that since nothing in the prior art indicated that oral asenapine had problems, the person skilled in the art would not have been motivated to change the route of administration. Moreover, “it would not have been predictable or expected that sublingual administration would provide a solution to the problem of cardiotoxic effect.”
The accused infringers attempted to argue, as an alternate motivation to combine, the benefit of having more treatment options. However, the Federal Circuit dismissed this argument, because “a generic need for more antipsychotic treatment options did not provide a motivation to combine these particular prior art elements.”
The Federal Circuit did disagree with the district court on one thing—unexpected results. The district court found it unexpected that sublingual administrations of asenapine lacked the cardiotoxicity of the oral formulations, because the skilled person would have expected the contrary. However, if the problem was not known, then how could the solution to the problem be “unexpected”? There would have been no expectations. As the Federal Circuit explained, “[A] person of ordinary skill could not have been surprised that the sublingual route of administration did not result in cardiotoxic effects because the person of ordinary skill would not have been aware that other routes of administration do result in cardiotoxic effect”.
The fight, however, is not completely over. The accused infringers offered a different “motivation to combine” argument, based on whether sublingual or buccal administration would have addressed patient compliance problems. The Federal Circuit did not think the district court made sufficient express findings on this proffered motivation to combine, and for this reason, vacated the district court’s nonobviousness determinations and remanded the case.
The district court and the Federal Circuit’s “problem/solution” approach to nonobviousness in this case raised an interesting question. How does that approach reconcile with the established case law that any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the prior art? The whole of MPEP 2144(IV) is dedicated to explaining how the motivation to combine can be for a purpose or problem different from that of the inventor.
The Federal Circuit answered that question in a recent, non-precedential decision in In re Conrad (Fed. Cir., March 22, 2019): “[C]ases found that the inventor’s discovery of and solution to an unknown problem weighed in favor of non-obviousness because the proffered reason to modify the prior art did not present a specific, alternate basis that was unrelated to the rationale behind the inventor’s reasons for making the invention.” Where the person skilled in the art would combine the prior art “for a reason independent from solving the problem identified by [the inventor]”, the fact that the invention solved an unrecognized problem may not lend as much patentable weight as it did in Forest Laboratories.
Takeaway
In this case, the narrower interpretation worked to the patentee’s advantage, particularly because the accused infringers had already conceded on the question of infringement. But such narrowing of the claim scope after the fact may not always be desirable. One may have preserved the validity of the patent, but is left with a negligible pool of potential infringers against whom to assert the patent.
Be mindful of how the invention is defined in the specification and during prosecution. Be careful with scope-limiting language such as “The present invention is…”, and absolute language such as “necessary”, “essential”, and “the distinguishing feature”.
Question the Examiner’s rationale for combining prior art. I have on several occasions seen Examiners use “more options” to rationalize a proposed combination of prior art. This may be a cop-out, because the Examiner may not have a specific, alternate basis for combining the prior art that is unrelated to the inventor’s reasons for making the invention. In that case, the nonobviousness of the invention may be formulated as the discovery of a solution to the “recognition of an unknown problem”.
Claims to a Dietary Supplement Survive a Motion to Dismiss on a § 101 Patent Subject Matter Eligibility Challenge
Andrew Melick | 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.
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