A Patent Claim Is Not Indefinite If the Patent Informs the Relevant Skilled Artisan about the Invention’s Scope with Reasonable Certainty
| April 23, 2020
NEVRO CORP. v. BOSTON SCIENTIFIC
April 9, 2020
Before MOORE, TARANTO, and CHEN, Circuit Judges. MOORE, Circuit Judge
中文标题
权利要求的不确定性判定
中文摘要
内夫罗公司（Nevro）起诉波士顿科学公司和波士顿科学神经调节公司（合称波士顿科学）侵犯了内夫罗公司的七项专利。 内夫罗公司对地方法院的专利无效判决提出上诉。根据专利说明书及其申请历史，联邦巡回法院认定“paresthesia-free,” “configured to,” “means for generating,” 和 “therapy signal” 等术语并未使内夫罗公司的权利要求产生不确定性，因此撤销专利无效判决并发回重审。
小结
- 仅因其为功能用语或仅通过专利权利的诠释不能将功能性语言判定为不确定。
- 功能性语言的确定性重要体现在专利说明书中需要有解释或支持功能术语的相关结构，特别是侧重方法的专利申请，如果这些申请中存在着系统或设备的权利要求， 而这些系统或设备权利要求由方法的权利要求转化而来，对系统或设备的必要描述是需要的。1
- 不确定性的判定标准存在于是否权利要求通过说明书和申请历史以合理的确定性向本领域技术人员告知了本发明的范围。
注1：许多专利申请通常使用诸如“模块”（module）和“单元”（unit）的术语，并将方法权利要求转换为系统或设备的权利要求。但是，在说明书中如果没有相关的结构说明，由于不确定性，通常这些权利要求会被拒绝。因此，专利说明书中有必要对“模块”或“单元”进行必要的描述，例如电子、通讯及软件类的专利申请，可添加一些与通用处理器，集成芯片或现场可编程门阵列有关的描述，以定义“模块”或“单元”并描述相关功能。
Summary
Nevro Corporation (Nevro) sued Boston Scientific Corporation and Boston Scientific Neuromodulation Corporation (collectively, Boston Scientific) for infringement of eighteen claims across seven patents. Nevro Corporation appealed the district court’s judgment of invalidity. The Federal Circuit found that the terms “paresthesia-free,” “configured to,” “means for generating,” and “therapy signal” are not rendering the asserted claims indefinite in view of the specifications and prosecution history, vacating and remanding the district court’s judgment of claim invalidity.
Background
Nevro owns seven patents having method and system claims directed to high-frequency spinal cord stimulation therapy for inhibiting an individual pain. Nevro sued Boston Scientific in the Northern District of California for patent infringement related to U.S. Patent Nos. 8,359,102; 8,712,533; 8,768,472; 8,792,988; 9,327,125; 9,333,357; and 9,480,842.
In a joint claim construction and summary judgment order, the district court held twelve claims invalid as indefinite. Though six asserted claims survived and were found definite, the district court granted Boston Scientific noninfringement. On appeal, the Federal Circuit concluded the district court erred in holding indefinite the claims reciting the terms “paresthesia-free,” “configured to,” and “means for generating.” The Federal Circuit also found the district court erred in its construction of the term “therapy signal,” though determined not indefinite by the district court. The Federal Circuit, therefore, vacated and remanded the district court’s judgment of invalidity of claims 7, 12, 35, 37 and 58 of the ’533 patent, claims 18, 34 and 55 of the ’125 patent, claims 5 and 34 of the ’357 patent and claims 1 and 22 of the ’842 patent.
Discussion
I. “paresthesia-free”
Several of Nevro’s asserted claims relate to methods and systems comprising a means for generating therapy signals that are “paresthesia-free.” Claim 18 of the ’125 patent and Claim 1 of the ’472 patent recite as follow:
18. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
means for generating a paresthesia-free therapy signal with a signal frequency in a range from 1.5 kHz to 100 kHz; and
means for delivering the therapy signal to the patient’s spinal cord at a vertebral level of from T9 to T12, wherein the means for delivering the therapy signal is at least partially implantable.
1. A method for alleviating patient pain or discomfort, without relying on paresthesia or tingling to mask the patient’s sensation of the pain, comprising:
implanting a percutaneous lead in the patient’s epidural space, wherein the percutaneous lead includes at least one electrode, and wherein implanting the percutaneous lead includes positioning the at least one electrode proximate to a target location in the patient’s spinal cord region and outside the sacral region;
implanting a signal generator in the patient; electrically coupling the percutaneous lead to the signal generator; and
programming the signal generator to generate and deliver an electrical therapy signal to the spinal cord region, via the at least one electrode, wherein at least a portion of the electrical therapy signal is at a frequency in a frequency range of from about 2,500 Hz to about 100,000 Hz.
The district court presented its findings based on extrinsic evidence that “[a]lthough the parameters that would result in a signal that does not create paresthesia may vary between patients, a skilled artisan would be able to quickly determine whether a signal creates paresthesia for any given patient.” While holding that the term “paresthesia-free” does not render the method claims indefinite, the district court held indefiniteness regarding the asserted system and device claims. The Federal Circuit disagreed the indefiniteness holdings because the test of indefiniteness should be simply based on whether a claim “inform[s] those skilled in the art about the scope of the invention with reasonable certainty.” The Federal Circuit states that the district court applied the wrong legal standard and the test for indefiniteness is not whether infringement of the claim must be determined on a case-by-case basis.
The Federal Circuit states that “paresthesia-free,” a functional term defined by what it does rather than what it is, does not inherently render it indefinite. Furthermore, the Federal Circuit instructs that
i. functional language can “promote[] definiteness because it helps bound the scope of the claims by specifying the operations that the [claimed invention] must undertake.” Cox Commc’ns, 838 F.3d at 1232.
ii. the ambiguity inherent in functional terms may be resolved where the patent “provides a general guideline and examples sufficient to enable a person of ordinary skill in the art to determine the scope of the claims.” Enzo Biochem. Inc. v. Applera Corp., 599 F.3d 1325, 1335 (Fed. Cir. 2010).
II. “configured to”
Nevro’s asserted claim 1 of the ’842 patent relates to a spinal cord modulation system, which recites:
1. A spinal cord modulation system comprising:
a signal generator configured to generate a therapy signal having a frequency of 10 kHz, an amplitude up to 6 mA, and pluses having a pulse width between 30 microseconds and 35 microseconds; and
an implantable signal delivery device electrically coupleable to the signal generator and configured to be implanted within a patient’s epidural space to deliver the therapy signal from the signal generator the patient’s spinal cord.
The district court held indefiniteness because it determined that “configured to” is susceptible to meaning one of two constructions: “(1) the signal generator, as a matter of hardware and firmware, has the capacity to generate the described electrical signals (either without further programing or after further programming by the clinical programming software); or (2) the signal generator has been programmed by the clinical programmer to generate the described electrical signals.”
The Federal Circuit pointed out that “the test [of indefiniteness] is not merely whether a claim is susceptible to differing interpretations” because “such a test would render nearly every claim term indefinite so long as a party could manufacture a plausible construction.” Further, the Federal Circuit states that the test for indefiniteness is whether the claims, viewed in light of the specification and prosecution history, “inform those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, 572 U.S. at 910. (emphasis added).
The specifications of the asserted patents and prosecution history, indeed, help Nevro win the argument on “configured” means. Nevro’s asserted patents not only recites that “the system is configured and programmed to,” but also Nevro agreed with the examiner that “configured” means “programmed” as opposed to “programmable.” The limitation specifies the interpretation of the term “configured” and leads to this favorable decision towards Nevro. The “programmed” and “programmable” may sound similar. However, “programmable” would be appliable to a general machine, since any general signal generator would have the capacity to generate the described signals. The term “programmed” sets out its specific settings of the signal generator and limits such broad interpretation.
III. “means for generating”
Several asserted claims of the ‘125 patent recite “means for generating,” in which claim 18 recites as follow:
18. A spinal cord modulation system for reducing or eliminating pain in a patient, the system comprising:
means for generating a paresthesia-free therapy signal with a signal frequency in a range from 1.5 kHz to 100 kHz; and
means for delivering the therapy signal to the patient’s spinal cord at a vertebral level of from T9 to T12, wherein the means for delivering the therapy signal is at least partially implantable.
Nevro argued that the specification discloses a signal generator as the structure. The Federal Circuit agreed with Nevro and explained the difference comparing a general-purpose computer or processor. If the identified structure is a general-purpose computer or processor, it does require a specific algorithm. A signal or pulse generator is not considered as a general-purpose computer or processor, since it has the structure for the claimed “generating” function. Further, “the specification teaches how to configure the signal generators to generate and deliver the claimed signals using the recited parameters, clearly linking the structure to the recited function.” Hence, the Federal Circuit held that the district court erred in holding indefinite claims with the terms “means for generating.”
The terms such as “module” and “unit” are commonly used in many patent applications to convert method claims to system or device claims in electronic applications. However, without structural description in the specification, such claims are usually rejected due to indefiniteness. Hence, some may add some description related to general-purpose processors, integrated chips, or field-programmable gate arrays to define the “module” or “unit” and describe the functions.
IV. “therapy signal”
The Federal Circuit agreed that claims reciting a “therapy signal” are not indefinite, but held that the district court incorrectly construed the term. The Federal Circuit reiterated the context of the specification and prosecution history for understanding the words of a claim. It stated that “[t]he words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history.” Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).
Boston Scientific argued that the asserted claims reciting a “therapy signal” are indefinite because “two signals with the same set of characteristics (e.g., frequency, amplitude, and pulse width) may result in therapy in one patient and no therapy in another.” The Federal Circuit noted that “the fact that a signal does not provide pain relief in all circumstances does not render the claims indefinite.” Geneva, 349 F.3d at 1384.
Takeaway
- Functional language won’t be held indefinite simply for that reason or simply by interpreted in the claims.
- It is of importance to describe a related structure to support the functional terms in the specification, especially for applications having system or device claims converted from method claims.
- The test for indefiniteness is whether the claims, viewed in light of the specification and prosecution history, “inform those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, 572 U.S. at 910.
Tags: 35 U.S.C. § 112 > indefiniteness > Mean-Plus-Function > reasonable certainty
Examples and procedures in the specification may provide necessary objective boundaries for a term of degree in the claims
| September 18, 2019
Guangdong Alison Hi-Tech Co., v. ITC, Aspen Aerogels, Inc. (intervenor)
August 27, 2019
Wallach, Hughes, and Stoll (Opinion author).
Summary
The ALJ at ITC held, later affirmed by the Commission, that the claims of U.S. Patent No. 7,078,359 were not invalid due to indefinites and anticipation and were infringed by Alison’s importation of the accused products. The Federal Circuit affirmed the validity determination.
Details
The ‘359 patent, titled “Aerogel Composite with Fibrous Batting,” is directed to an improvement in aerogel composite products. Specifically, the ‘359 patent specifically discloses an aerogel composite that uses a lofty batting to reinforce the aerogel in a way that maintains or improves the thermal properties of the aerogel while providing a highly flexible, drapeable form. The ‘359 patent is an improvement over prior aerogel composites, which suffer from low flexibility, low durability, and degraded thermal performance. Independent claim 1 of the ‘359 patent is:
1. A composite article to serve as a flexible, durable, light-weight insulation product, said article comprising a lofty fibrous batting sheet and a continuous aerogel through said batting.
Regarding the indefinites, the ALJ and the Commission rejected the Alison’ indefinite argument arguing that the phrase “lofty fibrous batting” in claim 1 is indefinite. The Federal circuit affirmed based on the “reasonable certainty” indefiniteness standard. Specifically, as set forth in Nautilus, Inc. v. Biosig Instruments, Inc., a patent’s claims are definite if the claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable certainty. A patentee need not define his invention with mathematical precision in order to comply with the definiteness requirement. Patents with claims involving terms of degree must provide objective boundaries for those of skill in the art in the context of the invention. Intrinsic evidence such as the claims, figures, written description, or prosecution history of a patent can provide the necessary objective boundaries. In this case, the Federal Circuit acknowledges that the phrase “lofty … batting” is a term of degree. However, the Federal Circuit held that the written description of the ‘359 patent provides objective boundaries for the term. The ‘359 patent specification first expressly defines “lofty … batting” as “a fibrous material that shows the properties of bulk and some resilience (with or without full bulk recovery).” The specification explains that “bulk” refers to the air or openness created by the web of fibers in a lofty batting. It further explains that a batting is “sufficiently resilient” if it “can be compressed to remove the air (bulk) yet spring back to substantially its original size and shape.” Furthermore, the specification details functional characteristics of a “lofty … batting.” Furthermore, the specification provides specific examples of commercial products that can qualify as a lofty batting, and a detailed discussion of seven examples of aerogel composites manufactured in accordance with the claimed invention, along with corresponding test results. Furthermore, during the prosecution, in the Statement of Reasons for allowance, the examiner distinguished the prior art based on the phrase “lofty fibrous batting.” Thus, the Federal Circuit categorize this case in the same class as previous cases like Sonix and Enzo, where examples and procedures in the written description provided sufficient guidance and points of comparison to render claim terms not indefinite.
The Federal Circuit also specifically rejected several Alison’ arguments in support of its indefiniteness challenge. First, Alison argued that the ‘359 patent provides no objective boundary between “some resilience,” which would infringe, and “little to no resilience,” which would not. In other words, in Alison’ view, the ‘359 patent fails to disclose precisely how much resilience is enough to satisfy the claim. The Federal Circuit dismissed this argument by holding that Alison was seeking a level of numerical precision beyond that required when using a term of degree. Next, Alison argued that the ‘359 patent offers two independent approaches, a thermal properties’ approach and a compressibility and resilience approach, to assess loftiness, without indicating which approach to use. The Federal Circuit dismissed this argument by holding that Alison has not provided any evidence that the different methods of measurement described in the ‘359 patent lead to different results. Lastly, Alison argued that the Commission’s indefiniteness analysis is irreconcilable contradiction with its claim construction. The ALJ provided a single reason for holding the claim term not indefinite because the specification states that “a lofty batting is sufficiently resilient if after compression for a few seconds it will return to at least 70% of its original thickness.” Yet, in construing the term, the ALJ declined to limit “lofty … batting” to this specific example of “resilience” in the specification, namely, “it will return to at least 70% of its original thickness.” The Federal Circuit dismissed this argument by holding that examples in the specification may be used to inform those skilled in the art of the scope of the invention with reasonable certainty, thus demonstrating that the term is not indefinite, without being directly construed into the claim.
Regarding the anticipation, Alison uses the same reference Ramamurthi, which was considered by the patent examiner during prosecution and later by the Board in denying Alison’s IPR petition. One of Alison’s argument is that Ramamurthi recites “glass wool” as a preferred fiber, which should be synonymous with the “fiber glass” expressly identified as a lofty batting by the ‘359 patent. However, the Commission rejected Alison’s anticipation argument based on Aspen’s detailed expert testimony, which demonstrated that “fiberglass” and “glass wool” each describe broad categories of materials that are not inherently “lofty.” the Federal Circuit held that the Commission’s determination is supported by substantial evidence, and rejected to reweight the evidence.
In conclusion, the Federal Circuit affirmed that the claims of the ‘359 patent are valid.
Take away
- In drafting specification, the drafter should provide some detailed examples of the invention, which can provide sufficient guidance and points of comparison to render certain claims terms definite.
- In defining claims terms in the specification, numerical precision is not necessarily needed to satisfy the definiteness requirement.
