Opinion ID: 4523913
Heading Depth: 2
Heading Rank: 1

Heading: “paresthesia-free”

Text: Several of the asserted claims are directed to embodiments of the claimed invention in which “therapy-induced paresthesia is not a prerequisite to achieving pain reduction.” ’533 patent at 3:16–19. Specifically, claims 18, 34 and 55 of the ’125 patent, claims 5 and 34 of the ’357 patent and claims 7, 12, 35, 37, and 58 of the ’533 patent recite systems or devices comprising a means for generating Case: 18-2220 Document: 69 Page: 4 Filed: 04/09/2020 4 NEVRO CORP. v. BOSTON SCIENTIFIC CORP. therapy signals that are “paresthesia-free.” 3 Claims 11, 21 and 23 of the ’102 patent, claims 1 and 5 of the ’472 patent and claim 18 of the ’988 patent are method claims reciting similar limitations. Claim 18 of the ’125 patent is illustrative of the asserted system and device claims and recites: 18. A spinal cord modulation system for reducing or eliminating pain in a patient, the system com- prising: 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 pa- tient’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. (emphasis added). Claim 1 of the ’472 patent is illustrative of the asserted method claims and recites: 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; 3 As used in this opinion the term “paresthesia-free” refers to “paresthesia-free,” “non-paresthesia-producing” and similar phrases used to express the idea that a claimed therapy or therapy signal does not produce paresthesia. Case: 18-2220 Document: 69 Page: 5 Filed: 04/09/2020 NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 5 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. (emphasis added). The district court determined that “paresthesia-free” has a “clear meaning,” namely that the therapy or therapy signal “does not produce a sensation usually described as tingling, pins and needles, or numbness.” J.A. 9. It found, 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.” J.A. 11. The district court therefore held that the term “paresthesia-free” does not render the asserted method claims indefinite. Id. The district court held indefinite, however, the asserted “paresthesia-free” system and device claims. It held that infringement of these claims depended upon the effect of the system on a patient, and not a parameter of the system or device itself and therefore, “a skilled artisan cannot identify the bounds of these claims with reasonable certainty.” J.A. 10. Nevro appeals, arguing that the district court erred in holding indefinite the asserted “paresthesiafree” system and device claims. Boston Scientific cross-appeals, arguing that the district court erred in holding that the “paresthesia-free” method claims are not indefinite. While the district court made several underlying factual findings, the parties dispute only the district court’s legal conclusion of indefiniteness. Accordingly, we review Case: 18-2220 Document: 69 Page: 6 Filed: 04/09/2020 6 NEVRO CORP. v. BOSTON SCIENTIFIC CORP. the district court’s indefiniteness holdings regarding the “paresthesia-free” claims de novo. BASF Corp. v. Johnson Matthey, Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017). Under 35 U.S.C. § 112, patent claims must “particularly point[ ] out and distinctly claim[ ] the subject matter” regarded as the invention. Claims, viewed in light of the specification and prosecution history, must “inform those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014); see Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed. Cir. 2014). This standard “mandates clarity, while recognizing that absolute precision is unattainable.” Nautilus, 572 U.S. at 910. We conclude that the district court correctly determined that the “paresthesia-free” method claims are not indefinite, but that it erred in holding indefinite the “paresthesia-free” system and device claims. It is undisputed that “paresthesia,” as used in the asserted patents, means “a sensation usually described as tingling, pins and needles, and numbness.” See J.A. 6 (citing e.g., ’472 patent at 1:62–66). It is also undisputed that “a skilled artisan would be able to quickly determine whether a signal creates paresthesia for any given patient.” J.A. 11. In nonetheless holding indefinite the asserted “paresthesia-free” system and device claims, the district court applied the wrong legal standard. The test for indefiniteness is not whether infringement of the claim must be determined on a case-by-case basis. Instead, it is simply whether a claim “inform[s] those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, 572 U.S. at 910. We conclude that both the “paresthesia-free” method claims and the “paresthesiafree” system and device claims satisfy this standard. “Paresthesia-free” is a functional term, defined by what it does rather than what it is. But that does not inherently render it indefinite. See Halliburton Energy Servs., Inc. v. Case: 18-2220 Document: 69 Page: 7 Filed: 04/09/2020 NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 7 M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008). In fact, we have held that 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. When a claim limitation is defined in “purely functional terms,” a determination of whether the limitation is sufficiently definite is “highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area).” Halliburton, 514 F.3d at 1255. We have held that 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). Here, the asserted claims recite parameters for a system or device configured to generate a “paresthesia-free” signal. See, e.g., ’125 patent at Claim 34; ’102 patent at Claim 7. The specification teaches how to generate and deliver the claimed signals using the recited parameters. For example, the specifications of the Alataris patents describe a study comparing the effects of conventional signals and the effects of the claimed therapy signals. To achieve paresthesia-free therapy signals, the specifications teach using “therapeutic signals at a frequency of from about 3 kHz to about 10 kHz” and amplitudes ranging “from about 1 mA to about 4 mA (normally about 2.5 mA).” ’533 patent at 6:51–7:5. Accordingly, a person of ordinary skill would know whether a spinal cord stimulation system, device or method is within the claim scope. Thus, the patents provide reasonable certainty about the claimed inventions’ scope by giving detailed guidance and examples of systems and devices that generate and deliver paresthesia-free signals with high frequency, low amplitude, and other parameters. Enzo Biochem., 599 F.3d at 1335. That Case: 18-2220 Document: 69 Page: 8 Filed: 04/09/2020 8 NEVRO CORP. v. BOSTON SCIENTIFIC CORP. a given signal will eliminate paresthesia in some patients, but not others, does not render the claims indefinite. See id. at 1336 (“[T]he claims are not indefinite simply because the binding strength of a DNA strand will vary based on the strand’s length and sequence . . . .”). Boston Scientific contends that the asserted “paresthesia-free” claims are indefinite because infringement can only be determined after using the device or performing the method. Appellees’ Br. 44–46, 55–56 (citing Halliburton, 514 F.3d at 1254–55; Geneva Pharm., Inc. v. Glax- oSmithKline PLC, 349 F.3d 1373, 1384 (Fed. Cir. 2003)). We do not agree. Definiteness does not require that a potential infringer be able to determine ex ante if a particular act infringes the claims. See, e.g., Star Sci., Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1372–73 (Fed. Cir. 2008); Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1384 (Fed. Cir. 2005). Our decisions in Halliburton and Geneva do not hold otherwise. In Halliburton, we held claims reciting the term “fragile gel” indefinite not because infringement could only be determined after use, but because infringement could not be determined at any time. 514 F.3d at 1254–56. That is not the case here, as “a skilled artisan would be able to quickly determine whether a signal creates paresthesia for any given patient.” J.A. 11. And in Geneva, we held that “[t]he fact that the same dosage amount does not yield synergy under other circumstances is irrelevant” and does not alone render the term “synergistically effective amount” indefinite. 349 F.3d at 1384. Accordingly, we hold the district court erred in holding invalid as indefinite the “paresthesia-free” system and device terms, and we construe “paresthesia-free” in accordance with the plain language of the claims and specification to mean that the therapy or therapy signal “does not produce a sensation usually described as Case: 18-2220 Document: 69 Page: 9 Filed: 04/09/2020 NEVRO CORP. v. BOSTON SCIENTIFIC CORP. 9 tingling, pins and needles, or numbness.” See, e.g., ’472 patent at 1:62–66.