Source: http://cafc.whda.com/
Timestamp: 2019-04-22 08:15:18+00:00

Document:
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.
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.
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 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.
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 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.
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”.
Before Moore, Reyna, and Wallach. Opinion by Moore. Opinion concurring-in-part and dissenting-in-part by Reyna.
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.
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.
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.
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.
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.
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.
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.
Before Moore, Taranto and Chen. Opinion by Chen.
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.
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.
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.
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.
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 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.
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.
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.
Centrak, Inc. v. Sonitor Tech., Inc.
Before Reyna, Taranto and Chen. Opinion by Chen.
The CAFC reversed and remanded a Motion of Summary Judgment finding that the District Court errored in focusing on the length of a written description and dismissing a plausible theory for direct infringement based on the final assembly being done by the defendant within a customer’s system.
CenTrak, Inc. sued Sonitor Technologies, Inc. for alleged infringement of U.S. Patent No. 8,604,909 (’909 patent), which claims systems for locating and identifying portable devices using ultrasonic base stations. The district court granted Sonitor’s MSJ that the relevant claims are invalid for lack of written description and are not directly infringed because Sonitor does not individually provide for all the aspects of the claims.
The claims are directed to ultrasonic base stations which can be mounted in various fixed locations in a facility, such as rooms in a hospital, and the portable devices can be attached to people or assets that move between rooms. Each portable device is configured to detect the ultrasonic location codes from the nearby ultrasonic base stations and “transmit an output signal including a portable device ID representative of the portable device and the detected ultrasonic location code.” While the portable devices receive location codes from ultrasonic base stations via ultrasound, they might transmit location and device information via RF to an RF base station.
The asserted claims generally recite: (1) ultrasonic (US) base stations; (2) portable devices (tags); (3) a server; (4) radio frequency (RF) base stations; and (5) a backbone network that connects the server with the RF base stations.
In regard to lack of written description, Sonitor argued that the two sentences in the specification dedicated to ultrasound, did not show that the inventors had possession of an ultrasound-based RTL system.
Regarding invalidity, the district court ruled that while the specification “contemplated” ultrasound, “[m]ere contemplation . . . is not sufficient to meet the written description requirement.
In regard to infringement, the accused Sonitor Sense system includes three pieces of hardware sold by Sonitor: RF “gateways,” ultrasonic location transmitters, and portable locator tags. Sonitor also provides software for installation on a customer’s server hardware.
Sonitor’s main non-infringement argument was that Sonitor does not make, use, or sell certain elements recited in the claims, including the required backbone network, Wi-Fi access points, or server hardware.
CenTrak argues that the resulting system infringes the ’909 patent when the components Sonitor sells are integrated with a customer’s existing network and server hardware. CenTrak asserted only direct infringement. Since, Sonitor does not sell all of the hardware necessary to practice the asserted claims, so, on appeal, CenTrak only pursued a theory under 35 U.S.C. § 271(a) that Sonitor “makes” infringing systems when it installs and configures the Sonitor Sense system. In short, the crux of CenTrak’s assertion is that there is direct infringement when the party assembles components into the claimed assembly (i.e. the party “makes” the patented invention, even when someone else supplies most of the components).
The district court granted summary judgment of non-infringement. It held that a defendant must be the actor who assembles the entire claimed system to be liable for direct infringement, and CenTrak had not submitted proof that Sonitor personnel had made an infringing assembly.
CenTrak appealed both MSJ grants.
The Court explained that the real question is the level of detail the ’909 patent’s specification must contain, beyond disclosing that ultrasonic signals can be used, to adequately convey to a skilled artisan that the inventors possessed an ultrasonic embodiment. Citing their Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) en banc: “the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” They further noted per Ariad that the issue of whether a claimed invention satisfies the written description requirement is a question of fact.
The opinion details that the parties disputed the complexity and predictability of ultrasonic RTL systems, and the district court erred at the summary judgment stage by not sufficiently crediting testimony from CenTrak’s expert that the differences between IR and ultrasound, when used to transmit small amounts of data over short distances, are incidental to carrying out the claimed invention. The Court specifically noted the testimony from CenTrak’s expert that those details were not particularly complex or unpredictable, and Sonitor does not explain why a person of ordinary skill in the art would need to see such details in the specification to find that the named inventors actually invented the claimed system.
Here, as in ScriptPro, the fact that the bulk of the specification discusses a system with infrared components does not necessarily mean that the inventors did not also constructively reduce to practice a system with ultrasonic components … “the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice” may be sufficient if it “identifies the claimed invention” and does so “in a definite way.” Ariad, 598 F.3d at 1352.
In regard to direct infringement, the Court noted that it is undisputed that Sonitor does not provide certain claimed elements in the accused systems, such as a backbone network, Wi-Fi access points, or server hardware. Moreover, the district court analyzed the evidence CenTrak offered and concluded that no reasonable jury could find that Sonitor “made” the claimed invention by performing installations relying on Centillion Data Systems, LLC v. Qwest Communications International, Inc., 631 F.3d 1279 (Fed. Cir. 2011) for the proposition that to “make” a system, a single entity must assemble the entire system itself.
The CAFC found that Centillion does not rule out CenTrak’s infringement theory. In this case, Cen-Trak argued that the final, missing elements are the configuration that allows the location transmitters to work with the network and the location codes that are entered into the Sonitor server. According to CenTrak, admissible evidence that Sonitor is the “final assembler” raises a triable issue of fact on infringement even though Sonitor does not “make” each of the claimed components of the accused systems.
The Court further held that under Lifetime Industries, Inc. v. Trim-Lok, Inc., 869 F.3d 1372 (Fed. Cir. 2017), and Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1311 (Fed. Cir. 2005), a final assembler can be liable for making an infringing combination—assuming the evidence supports such a finding—even if it does not make each individual component element.
The CAFC found that the District Court errored in both: (1) finding a lack of written description as it relied too heavily on the briefness of the ‘909 patents comments on ultrasonic RTL systems rather than the amount of knowledge needed for a skilled artisan to consider; and (2) finding that there was no dispute of fact as to whether Sonitor was a “final assembler” by virtue of performing the final system installation for its customers. The Court therefore reversed and remanded.
The measure of a sufficient written description is not in its length. Rather, the test is to the amount of disclosure necessary for a skilled artisan to discern that the inventor in fact possessed the invention.
A case for direct infringement can be made even where the defendant does not “make all the parts” if there is sufficient evidence that the accused infringer is a “final assembler” in terms of actuating the combination of elements to infringe.

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