Ex Parte GreenwaldDownload PDFPatent Trial and Appeal BoardJan 16, 201814020740 (P.T.A.B. Jan. 16, 2018) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/020,740 09/06/2013 Scott D. Greenwald H-RM-01979-02/1215-129US0 6937 127558 7590 01/18/2018 Covidien LP/Shumaker & Sieffert P.A. Attn: IP Legal Department 6135 Gunbarrel Avenue Boulder, CO 80301 EXAMINER BORIN, MICHAEL L ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 01/18/2018 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): pairdocketing @ ssiplaw.com medtronic_mitg-pmr_docketing@cardinal-ip.com ip.legal@covidien.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SCOTT D. GREENWALD1 Appeal 2017-001720 Application 14/020,740 Technology Center 1600 Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL appellant states that the real parties-in-interest are Covidien LP and its parent company, Medtronic PLC. App. Br. 3. Appeal 2017-001720 Application 14/020,740 SUMMARY Appellant files this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1—9 and 11—20 as unpatentable under 35 U.S.C. § 101 as being directed to nonstatutory subject matter.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CFAIMED INVENTION Appellant’s invention is directed to a system and method for predicting and measuring a subject’s analgesic state and analgesic adequacy by measuring biopotential signals obtained from a subject through electrodes. Abstract. REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal and recites: 1. A method for assessing a subject’s analgesic state and adequacy using an electroencephalograph (EEG) processor and a monitoring system, the method comprising: obtaining, using the EEG processor, biopotential signals from a plurality of electrical leads connected to the subject at intervals over a period of time; computing, using the EEG processor, from the biopotential signals a first measure representative of the subject’s sedative state; 2 The Examiner also rejected claims 1—9 and 11—20 as unpatentable under 35 U.S.C. § 112, first paragraph, as lacking written descriptive support in the Specification. Final Act. 2. This rejection has been withdrawn by the Examiner. See Advisory Act. 1 (January 20, 2016). 2 Appeal 2017-001720 Application 14/020,740 calculating, using the monitoring system, a first metric representative of variability of the first measure; computing, using the EEG processor, from the biopotential signals a second measure representative of the subject’s muscle activity; calculating, using the monitoring system, a second metric representative of variability of the second measure; calculating, using the monitoring system, from the first and second metrics an index value representative of the subject’s analgesic state and analgesic adequacy; and displaying, using a display, the index value. App. Br. 18. ISSUES AND ANALYSIS We agree with, and adopt, the Examiner’s findings of fact and conclusions that the appealed claims are directed to nonstatutory subject matter. We address the arguments raised by Appellant below. Issue Appellant argues the Examiner erred in finding that the claims are directed to a judicial exception to 35 U.S.C. § 101 because the claims are not directed to an abstract idea, or, alternatively, add significantly more to the abstract idea so as to quality as patentable subject matter. App. Br. 10-16.3 3 Appellant also argues that the claims recites “meaningful limitations” that “sufficiently limit” the practical application and therefore do not preempt a 3 Appeal 2017-001720 Application 14/020,740 Analysis The Examiner finds Appellant’s claims are directed to a process that is a computational method of calculating metrics based on the variability of biopotential signals and calculating from these metrics an index representing subject’s analgesic state and analgesic adequacy. Final Act. 3^4. The Examiner finds the claims are therefore directed to processing information and converting one form of numerical representation into another, i.e., gathering and combining data by organizing information via mathematical relationships. Id. at 4. The Examiner finds that such gathering and combining of mathematical relationships to manipulate existing information to generate additional information are directed to an abstract idea, which is a judicial exception to Section 101. Id. The Examiner further finds that the claimed method is limited by the steps of obtaining biopotential signals from a subject. Final Act. 4. The Examiner finds that the adding of extra-solution activity to the judicial exception, viz., data gathering in conjunction with the abstract idea, is not enough to qualify as “significantly more,” as required by the Supreme Court’s analysis in Mayo (566 U.S. at 77 ). The Examiner also finds that the claims require that the method steps are carried out using an “EEG monitor,” and that no such device is disclosed in Appellant’s Specification. Final Act. 4. As such, the Examiner finds that judicially-created exception to 35 U.S.C. § 101. App. Br. 8—9. This is not a part of the test that the Supreme Court has set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc., for determining subject matter eligibility under 35 U.S.C. § 101. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). We consequently do not reach Appellant’s argument in this respect. 4 Appeal 2017-001720 Application 14/020,740 the “EEG monitor” does not require any particular type or specified particular arrangement of means for computing or calculating and that, therefore, the method’s recitation of “using the EEG monitor” invokes only generic computational implementation. Id. at 4—5. Appellant argues that claims are directed to solving the technical problem of determining subject’s analgesic state and analgesic adequacy in the field of electroencephalographic monitoring. App. Br. 10. As such, Appellant argues, the Examiner’s conclusion that the claims are directed to an abstract idea is insufficient, as a matter of law, to establish that subject matter of claim 1 is directed to ineligible subject matter. Id. Appellant contends that the Examiner has made no finding of fact that supports the conclusion that the claims are directed to a judicial exception to Section 101. App. Br. 11. Nor, Appellant asserts, has the Examiner adduced any objective evidence that the claimed method is a "‘building block[]’ of human ingenuity” or any type of “fundamental economic practice.” Id. at 11—12 (quoting Alice Corp. v. CLS Bank Inti, 134 S.Ct. 2347, 2354, 2356 (2014). Furthermore, argues Appellant, there is no evidence that Appellant is seeking to wholly preempt “‘methods of organizing human activities, an idea of itself, or a mathematical relationship or formula.’” Id. at 12 (quoting Ex parte Anderson, Appeal No. 2016- 002310, 2017 WL 5037099, at *3 (PTAB October 25, 2017)). According to Appellant, the claims do not threaten to create problems relating to preemption but, rather, are directed to specific techniques carried out by machines comprising an EEG processor and a monitoring system for calculating a value representative of the subject’s analgesic state and analgesic adequacy. Id. 5 Appeal 2017-001720 Application 14/020,740 Appellant next argues that, assuming, arguendo, that the claims are directed to a judicially-created exception to Section 101, Step 2 A, the combination of elements recited in claim 1 is more than sufficient to amount to significantly more than just an abstract idea. App. Br. 12. Specifically, Appellant argues that: (1) the claim is directed to a technological solution that is necessarily rooted in the realm EEG technology, and (2) the claim is directed to methods that improve the functionality of an EEG processor and a monitoring system. Id. With respect to (1), Appellant points to our reviewing court’s holding in DDR Holdings, LLC v. Hotels. Com, L.P., that claims that are directed to problems that are ‘“necessarily rooted in computer technology’” and “‘overcome a problem specifically arising in the realm of computer networks’” are patent eligible in view of Alice. App. Br. 12 (citing DDR Holdings, LLCv. Hotels.Com, L.P., 773 F.3d 1245, 1265 (Fed. Cir. 2014)). According to Appellant, the claims on appeal are directed to a specific technological problem arising in the realm of EEG monitoring. Id. Specifically, Appellant contends that the claims are directed to a method that uses an EEG processor and a monitoring system to determine and display an index value representative of the subject’s analgesic state and analgesic adequacy, which, Appellant asserts, are important diagnostic parameters that could not be determined by known EEG systems prior to the present invention. Id. Furthermore, Appellant contends the ability to determine these parameters using EEG equipment was highly desirable for purposes of monitoring and diagnosing a patient. Id. at 12—13. Consequently, argues Appellant, the method recited in the claims for determining analgesic state 6 Appeal 2017-001720 Application 14/020,740 and analgesic adequacy using EEG equipment is a technique rooted the realm of EEG monitoring technology. Id. at 13. With respect to argument (2), Appellant argues that the Specification describes an acute need for a system that can measure and display an indication of analgesic state of a subject. App. Br. 13 (citing Spec. 13). Specifically, Appellant asserts that the Specification explains that anesthetic pharmacological agents can have separate effects on the patient undergoing a surgical procedure, including ‘“sedation or hypnosis (the lack of consciousness or awareness of the surrounding world), analgesia (the blunting or absence of pain) and paralysis (lack of movement).’” Id. According to Appellant: “anesthesiologist will benefit from being able to monitor analgesia separately from other effects, since a mixture of drugs may be required to achieve acceptable levels for all there [sic] of sedation, analgesia, and paralysis at the same time, while overdose of any of these drugs may have adverse effects.” Id. at 13—14 (citing Spec. ^fl[ 4—5). Consequently, Appellant argues that the claimed invention, provides an improvement to the field of EEG monitoring by calculating and displaying an index measuring a parameter that could not be measured by EEG equipment prior to the claimed invention and therefore recite something significantly more than an abstract idea. App. Br. 14. Finally, Appellant points to our reviewing court’s holding in SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319 (Fed. Cir. 2010). App. Br. 15. Appellant argues that the Federal Circuit’s holding in SiRF supports Appellant’s argument that claims directed to mathematical manipulation of a signal are patent eligible under Section 101 if the claims are tied to particular technological area. Id. According to Appellant, the Federal Circuit held that 7 Appeal 2017-001720 Application 14/020,740 a method capable of computing the position of the satellite signal receiver based on signals from a plurality of satellites is patent-eligible under 35 U.S.C. § 101 because the presence of a satellite signal receiver was integral to the claims and provided a ‘“meaningful limit on the scope of the claims’” because it ‘“play[[ed]] a significant part in permitting the claimed method to be performed.’” Id. (quoting SiRF, 601 F.3d at 1332—33). Similarly, asserts Appellant, the combination of elements recited in claim 1 imposes meaningful limits on the scope of the claim because the claim recites, inter alia, an EEG processor and a monitoring system operating on a biopotential obtained from a plurality of electrical leads connected to the subject, similarly to how the claims in SiRF require a satellite signal receiver and use signals from a plurality of satellites. Id. at 16. Furthermore, Appellant argues, processing a biopotential signal generated from a plurality of electrical leads plays a significant part in permitting the claimed invention to function. Id. The Examiner responds that, in the method recited in the claims, parameters are calculated by an “EEG processor,” i.e., by a processor located in EEG equipment. Ans. 3 (citing App. Br. 14). The Examiner finds that there are no limitations or disclosures in the Specification demonstrating any difference between the claimed processor and a generic computer processor. Id. The Examiner finds the claimed method requires merely generic computer implementation and thus fails to transform the abstract idea into a patent-eligible invention. Id. In response to the Appellant’s reliance upon SiRF, the Examiner notes that, whereas the court acknowledged that, whereas limiting performance of the mathematical calculation to a general purpose CPU, absent more, is not 8 Appeal 2017-001720 Application 14/020,740 sufficient to transform the recited judicial exception into a patent-eligible invention, in SiRF the claimed programmed CPU acted in concert with the recited features of the mobile device to enable the mobile device to determine and display its absolute position through interaction with a remote server and multiple remote satellites. Id. (see SiRF, 601 F.3d at 1332—33). The Examiner finds that the court in SiRF held that these meaningful limitations placed upon the application of the claimed mathematical operations showed that the claim is not directed to performing mathematical operations on a computer alone. Id. The Examiner finds, however, that in the appeal before us, there is no demonstration that displaying a particular numeric value, or index value, on a monitor improves an existing technology. Ans. 4. The Examiner finds that, although Appellant asserts that previous systems known in the art were not capable of displaying an index value, inability to display a value not previously addressed in the art is not a demonstrated improvement of technology. Id. We are not persuaded by Appellant’s arguments. In Mayo, the Supreme Court set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts. For review, see Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015). First, we determine whether the claims at issue are directed to a patent- ineligible concept. Id. (citing Mayo, 566 U.S. at 77). If the answer is yes, then we next consider the elements of each claim both individually and ‘“as an ordered combination’” to determine whether additional elements 9 Appeal 2017-001720 Application 14/020,740 ‘“transform the nature of the claim’” into a patent-eligible application. Id. (citing Mayo, 566 U.S. at 79). We agree with the Examiner that the limitations of claim 1 reciting: computing, using the EEG processor, from the biopotential signals a first measure representative of the subject’s sedative state; calculating, using the monitoring system, a first metric representative of variability of the first measure; computing, using the EEG processor, from the biopotential signals a second measure representative of the subject’s muscle activity; calculating, using the monitoring system, a second metric representative of variability of the second measure; calculating, using the monitoring system, from the first and second metrics an index value representative of the subject’s analgesic state and analgesic adequacy; and displaying, using a display, the index value represent no more than the manipulation of data obtained in the form of an electrical signal, i.e., the transformation of one set of numbers (the values of the obtained signals) into another via certain algorithms and then displaying those values. See Spec. ]Hf 38—39, 46, 50-51 for the various algorithms. As such, we agree with the Examiner that these limitations are directed to a patent-ineligible judicially-created exception to Section 101. See Parker v. Flook, 437 U.S. 584, 590 (1978) (“[A] process is not unpatentable simply because it contains a law of nature or a mathematical algorithm”). Proceeding to the second step of the Mayo analysis, Appellant argues that the limitations add significantly more to the claim than just the abstract 10 Appeal 2017-001720 Application 14/020,740 idea. Specifically, Appellant argues that the claimed invention, “provides an improvement to the field of EEG monitoring by calculating and displaying an index measuring a parameter that could not be measured by EEG equipment prior to the claimed invention” and therefore recite something significantly more than an abstract idea.” See App. Br. 14. We are not persuaded. Appellant’s Specification does not disclose the claim term “EEG processor.” The Specification employs the term “processor” six times. See Spec. 21, 35, 37. However, in each of those recitations, the Specification discloses no more than generic processing by the processor or its position in the flow of information through Appellant’s claimed invention. For example, the Specification discloses at paragraph [0021]: “A processor will compute a measure that is representative of the subject’s sedative state and/or muscle activity.” Paragraph [0035] discloses: “Turning now to the method of the invention as implemented by the processor 20, the first and second output signals 50, 60 received by processor 20 are preferably digital, composed of consecutive regularly- spaced discrete samples.” And paragraph [0037] discloses: “For each epoch of data, the processor 20 derives a measure of variability from the time series CerebralActivityi and EMGi. In the preferred embodiment, the standard deviation is utilized as the measure of variability. However, it should be realized that other variability metrics may be used....” None of these passages in the Specification disclose anything more than routine processes that could not be performed on a generic computer or processor via methods of EEG collection that are well-known and routine in the art. As such, we find that they do not add “significantly more” to the claim 11 Appeal 2017-001720 Application 14/020,740 sufficient to rise it above the judicial exception to Section 101 barring abstract ideas. Nor are we persuaded by Appellant’s reliance upon SiRF. In SiRF, the Federal Circuit held that “the claims at issue are properly directed to patentable subject matter as they explicitly require the use of a particular machine (a GPS receiver) and could not be performed without the use of such a receiver.” SiRF, 601 F.3d at 1333. In this instance, Appellant’s claims and Specification recite no more than generic processes (i.e., receiving digital input, calculating a measure of variability) that could be performed on any generic computer. We are therefore not persuaded by Appellant’s contention that the claims are patentable because the “claims are tied to particular technological area.” See App. Br. 15. Finally, we find that the limitation of claim 1 reciting: “obtaining, using the EEG processor, biopotential signals from a plurality of electrical leads connected to the subject at intervals over a period of time,” is also directed to a judicially-created exception to Section 101: a phenomenon of nature. Measuring EEGs is simply the obtaining of, by methods that are routine and well-known in the art, the massed, integrated electrical activity of the brain, which exist whether they are measured or not. The mere measurement of a phenomenon of nature is not patent-eligible. See Mayo, 566 U.S. 97 (“If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself’). In this instance, the phenomenon of nature, an EEG, measured by well-understood and thoroughly conventional means, is the subjected to a series of manipulations 12 Appeal 2017-001720 Application 14/020,740 via an abstraction, i.e., certain algorithms, performed on a generic processor. We agree with the Examiner that none of these steps adds significantly more to the judicial exceptions recited in the claims. We consequently affirm the Examiner’s rejection. DECISION The Examiner’s rejection of claims 1—9 and 11—20 as unpatentable under 35U.S.C. § 101 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1). AFFIRMED 13 Copy with citationCopy as parenthetical citation