Ex Parte DilorenzoDownload PDFPatent Trial and Appeal BoardAug 27, 201411706630 (P.T.A.B. Aug. 27, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DANIEL JOHN DILORENZO ____________ Appeal 2012-004864 Application1 11/706,630 Technology Center 3700 ____________ Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to a method of managing epileptic seizures. The Examiner has rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The Specification is directed to a method of preventing an epileptic seizure by determining the propensity of a patient to experience a future 1 Appellant identifies NeuroVista Corporation as the Real Party in Interest. (App. Br. 2.) Appeal 2012-004864 Application 11/706,630 2 seizure and “communicating to the patient and/or a health care provider a therapy recommendation.” (Spec. 4: ¶ 17.) Some embodiments will provide a recommendation or instruction to take an acute dosage of a specified pharmacological agent (e.g., neuro-suppressant, sedative, AED or anticonvulsant, or other medication which exhibits seizure prevention effects). However, the instructions or recommendations may suggest adjusting the timing or dosage of a chronically prescribed pharmacological agent, performing a specific action such as assuming a safe posture or position, activating an implanted drug dispenser, manually activating a neuromodulation treatment such as vagus nerve stimulation (VNS), deep brain stimulation (DBS), cortical stimulation, or the like. (Spec. 5: ¶ 23.) Claims 1–11 and 23–27 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claims 1 and 23 are representative of the claims on appeal, and read as follows: 1. A method of managing epileptic seizures, the method comprising: determining that a patient has an increased propensity for having a future epileptic seizure within a time period prior to the occurrence of the epileptic seizure; and providing an output communication to the patient that indicates to the patient a therapeutically effective dosage of a pharmacological agent treatment to be administered that will provide a clinically therapeutic threshold amount of the pharmacological agent within the time period prior to the occurrences of the epileptic seizure; wherein the therapeutically effective dosage is less than a dosage that is effective after the seizure has begun. Appeal 2012-004864 Application 11/706,630 3 23. A method of managing epileptic seizures, the method comprising: determining that a patient has an increased propensity of a future epileptic seizure within a time period prior to the occurrence of the epileptic seizure; and providing an output communication to the patient that is indicative of a therapeutically effective dosage of a pharmacological agent treatment that will provide a clinically therapeutic threshold amount of the pharmacological agent within the time period prior to the occurrences of the epileptic seizure. The following grounds of rejection are before us for review: I. claims 1–4, 11, and 23–25 under 35 U.S.C. § 102(b) as anticipated by Echauz;2 II. claims 5–10 are rejected under 35 U.S.C. § 103(a) over Echauz; and III. claims 26 and 27 under 35 U.S.C. § 103(a) as unpatentable over Echauz in view of Sillén.3 I. The Issue: Anticipation by Echauz Does the evidence of record support the Examiner’s finding that Echauz disclosed determining a patient’s propensity of a future seizure as well as communicating a therapy suggestion to the patient? Findings of Fact FF1. We adopt the Examiner’s findings and analysis concerning the scope and content of the prior art. The following facts are repeated for reference convenience. 2 Echauz et al., US 2002/0103512 A1, published Aug. 1, 2002. 3 Sillén et al., US 5,672,154, issued Sept. 30, 1997. Appeal 2012-004864 Application 11/706,630 4 FF2 Echauz disclosed: A method and apparatus for forecasting and controlling neurological abnormalities in humans such as seizures . . . . Forecasting is achieved by indicating the probability of an oncoming seizure within one or more time frames, which is accomplished through an inner-loop control law and a feedback necessary to prevent or control the neurological event by either electrical, chemical, cognitive, sensory, and/or magnetic stimulation. (Echauz, Abstract.) FF3. Echauz disclosed notifying a patient of an imminent seizure. “The probability output of having a seizure for one or more time frames is shown on a portable display . . . . When this probability is higher than an adaptive threshold, a sound, visual, and/or tactile alarm(s) is(are) activated to alert the patient of the oncoming seizure.” (Echauz, 6: ¶ 88; see also Ans. 4.) FF4. Echauz disclosed therapy in the form of: Stimulations at the patient level include sensory/perceptive and cognitive stimulations, and at the device level include electrical, chemical, magnetic, and certain types of sensory stimulation. . . . The low level supervisory control or implanted closed- loop control 300 is activated manually from the external portable module 500 or automatically via the high level supervisory control 400 through the external portable module. (Echauz, 7–8: ¶¶ 94-95 (emphasis added); see also Ans. 4.) FF5. Echauz disclosed: Prediction times on the order of minutes to an hour can be obtained with this invention . . . , and in the worst cases on the order of seconds . . . . This represents ample time to avoid a seizure by releasing small quantities of a drug (chemical stimulation), by electrically stimulating focal points to ward off Appeal 2012-004864 Application 11/706,630 5 synchronized nerve impulses, by wearing a special helmet that provides a magnetic stimulation, by solving high cognitive problems, or by experimenting with sensory stimulation such as music, flavors, images, tactile sensations, or odors. (Echauz, 8: ¶ 96; see also Ans. 5.) FF6. Echauz disclosed: [A]ctive therapeutic agents are infused or otherwise released in the brain regions where seizures are generated, or to where seizures may spread. As seizures become more likely, the amount, concentration or spatial distribution through which a chemical agent is delivered are all increased. As with electrical or other therapeutic interventions, patterns of delivery can include infusing a drug directly in the epileptic focus, in an area surrounding it, or to regions involved in early spread, or to more central or deep brain regions, which may modulate seizure propagation. These same therapeutic principles apply to distribution of maximal therapy when electrical seizure onset is detected, including distributing therapy to regions where seizures are known to spread and propagate. Last-minute treatment may include release of larger amounts of drug into the cerebrospinal fluid (CSF) space for circulation over wide regions of the brain or into the cerebral circulation. Other types of pharmacological agents may also be used in this scheme, such as agents which are activated by oxidative stress, which may themselves increase the concentration and distribution of an active therapeutic agent as seizure precursors evolve and the probability of seizures increases. (Echauz, 8: ¶ 99; see also Ans. 5.) Principle of Law In order for a prior art reference to serve as an anticipatory reference, it must disclose every limitation of the claimed invention, either explicitly or inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Appeal 2012-004864 Application 11/706,630 6 Analysis Appellant contends that “[s]imply providing an alarm, however, does not ‘indicate[s] to the patient a therapeutically effective dosage of a pharmacological agent treatment to be administered.’” (Reply Br. 2; see also App. Br. 6.) “There is a significant difference between indicating a therapeutically effective dosage, as recited in claim 1, and merely indicating THAT a dosage will be administered.” (Reply Br. 3.) We are not persuaded. Claim interpretation is at the heart of patent examination because a claim cannot be compared to the prior art without ascertaining its proper scope. In this case, Appellant contends that the claims require that the output information include information about the dosage to be administered. Medichem, S.A. v. Rolabo, S.L., 353 F.3d 928, 933 (Fed. Cir. 2003). Specifically, the claims require an output communication to the patient that “indicates to the patient a therapeutically effective dosage of a pharmacological agent treatment to be administered’ (claim 1) or “providing an output communication to the patient that is indicative of a therapeutically effective dosage of a pharmacological agent treatment that will provide a clinically therapeutic threshold” (claim 23). The Examiner interprets the claims to be sufficiently broad to encompass “that merely indicating [that] a dosage is ready via a light or sound indicates to a patient the effective dosage of the treatment.” (Ans. 7.) We do not agree with Appellant’s contention that “merely indicating THAT a dosage will be administered” does not meet the limitation of providing “indicating a therapeutic effective dosage” (Reply Br. 3). Here, the dependent claims contain the limitation that the output communication “specifies the therapeutically effective dosage” (see claims 26 and 27). Appeal 2012-004864 Application 11/706,630 7 Appellants seek to read this limitation from the dependent claims into the independent claims. However, a claim construction that results in a dependent claim having the same scope as the independent claim from which it depends, and which thus renders the dependent claim superfluous, is “presumptively unreasonable.” Beachcombers, Int’l Inc. v. Wildewood Creative Prods., Inc., 31 F.3d 1154, 1162 (Fed. Cir. 1994). Accordingly, we agree with the Examiner’s interpretation that the sounding on of an alarm to indicate to the patient that the dosage, presumably a therapeutic dosage, is ready to be administered meets the claim limitation of providing an output communication We agree with the Examiner’s finding that Echauz discloses a method and apparatus for evaluating a patient’s likelihood of having a seizure (FF 1– 6), as well as providing an alarm that indicates a seizure is imminent (FF3), In addition, the alarm sounds in sufficient time to activate treatment either automatically or manually (FF 3–5). Echauz disclosed that “[t]he intensity of intervention, modality of therapy and spatial distribution of therapy are all adjusted as the probability of seizures increases over time.” (Echauz, 8: ¶ 97.) Furthermore, Echauz disclosed that the earlier the treatment is initiated the lower the stimulus or chemical dose required (FF6). We conclude that the preponderance of evidence of record supports the Examiner’s finding that the claims are anticipated. Appellant does not present arguments for the separate patentability of claims other than claim 1 (App. Br. 7). Thus, all claims fall with the corresponding representative claim. 37 C.F.R. § 41.37(c)(1). Appeal 2012-004864 Application 11/706,630 8 II. The Issue: Obviousness over Echauz Does the preponderance of evidence of record support the Examiner’s conclusion that Echauz renders obvious the percent dose reduction of a patient treatment protocol? Analysis Appellant contends that Echauz “provides no examples of any therapeutically effective dosage relative to a dosage that is effective after the seizure has begun.” (App. Br. 9.) We are not persuaded. Echauz recognizes that the earlier treatment is administered, the lower the dosage of the treatment agent that may be required to prevent the seizure from progressing into a full blown seizure (FF6). The Examiner finds that “Echauz discloses that the largest amounts [of drug] (100%) are required at seizure onset (paragraph 99).” (Ans. 7.) An obviousness inquiry “requires[] consideration of common knowledge and common sense.” DyStar Textilfarben GmbH & Co. v. C.H. Patrick Co., 464 F.3d 1356, 1367 (Fed. Cir. 2006). We agree with the Examiner’s position that one of ordinary skill in the art versed in the treatment of seizures (e.g., a physician) would know the pharmacological dosage required for administration during a full blown seizure. The Examiner concludes that “using any number of lesser treatments to prevent a seizure as long as an increased propensity for a seizure is detected. Thus, Echauz actually discloses all percent[ages] between zero and 100.” (Ans. 7; see also 5–6.) Modifying the pharmaceutical dosage would be recognized as a result effective variable that may be adjusted to within the claimed range of in order to achieve optimal prevention of a seizure within the earliest detection a seizure onset (FF 1–6). See In re Applied Materials, Inc., 692 F.3d 1289, Appeal 2012-004864 Application 11/706,630 9 1295 (Fed. Cir. 2012) (overlap of prior art range with claimed range “provides sufficient motivation to optimize the ranges”); In re Boesch, 617 F.2d 272, 276 (CCPA 1980) (“discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art”). We agree with the Examiner’s position that one of ordinary skill in the art would know the dosages to administer to a patient during a seizure. That information in conjunction with the recognition that the earlier the dose is administered the lower the dosage to prevent the patient from reaching a full blown seizure would provide the dosage range for treatments (FF6, see also Ans. 7). We find no error with the Examiner’s conclusion that determining the optimal dosage for a particular drug is a result effective variable where the optimization lies within a known range. Accordingly, we affirm the rejection of claims 5–10. III. The Issue: Obviousness over Echauz and Sillén Does the preponderance of evidence of record support the Examiner’s conclusion that the combination of Echauz and Sillén renders obvious an output device for communicating information regarding the patient treatment protocol? Findings of Fact FF7. Sillén disclosed “a device for giving patients individualized situation-dependent medication advice . . . . When the knowledge-based system (6) finds that a medicine should be taken the computer emits a signal providing information on the type of medicine and the dose.” (Sillén, Abstract.) Appeal 2012-004864 Application 11/706,630 10 FF8. Sillén disclosed “[w]hen the system is operating the reminder function block 1 cause the computer to emit a signal when a pharmaceutical preparation is to be taken (or some other activity is to be performed), and which indicates the type of preparation to be taken as well as the dosage.” (Sillén, col. 2, l. 66 to col. 3, l. 3; see also Ans. 6.) Principle of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis The Examiner finds, and Appellant does not dispute, that Sillén teaches a “computer [that] emits a signal when medication delivery or some other action is to occur and which then indicates the type of preparation to be taken as well as the dosage.” (Ans. 6; see also App. Br. 9.) Appellant, however, asserts that Because the stimulation [in Echauz] is automated, the patient has no need to receive an output communication that indicates to the patient a therapeutically effective dosage of a pharmacological agent treatment to be administered. There is therefore no rational reason to combine the personal reminder teachings from Sillen with the method of automated chemical stimulation from Echauz. (App. Br. 10.) We are not persuaded by Appellant’s contention. As discussed above, we agree with the Examiner’s finding that Echauz discloses a method and apparatus for evaluating a patient’s likelihood of having a seizure (FF 1–6), as well as providing an alarm that indicates a seizure is imminent (FF 3). The alarm is sounded in sufficient time to administer treatment either Appeal 2012-004864 Application 11/706,630 11 manually or automatically (FF 4–5). Echauz also discloses that the earlier the treatment is initiated the lower the stimulus or chemical dose required (FF 6). We also agree with the Examiner’s finding that Sillén teaches a computer that signals to the patient the type and dosage of medicine to be administered (FF 7–8). Applying the KSR standard of obviousness to the findings of fact (FF 1–8), we agree with the Examiner’s conclusion that the combination of references provides an apparatus for the detection of seizures and delivery of therapy, and “[w]hen the system is operating, the computer emits a signal when medication delivery or some other action is to occur and which then indicates the type of preparation to be taken as well as the dosage.” (Ans. 6.) An obviousness inquiry “requires[] consideration of common knowledge and common sense.” DyStar Textilfarben,464 F.3d at 1367; see KSR, 550 U.S. at 421(“Rigid preventative rules that deny fact finders recourse to common sense, however, are neither necessary under our case law nor consistent with it.”) Here, Echauz disclosed alerting the patient in sufficient time in order to activate treatment either automatically or manually (FF 4–5). Additionally, Echauz disclosed that “[a]s seizures become more likely, the amount, concentration or spatial distribution through which a chemical agent is delivered are all increased” (FF6). In other words, Echauz recognizes that the earlier treatment is administered the lower the dosage of the treatment agent that may be required. This applies to electrical as well as chemical treatment. We agree with the Examiner’s rationale that it would have been obvious to one of ordinary skill in the art to “to modify the alert of Echauz to further indicate the type of preparation and the dosage as taught by Sillen to give the patient individualized, situation- Appeal 2012-004864 Application 11/706,630 12 dependent medication advice [and] to optimize the patient’s sense of well- being.” (Ans. 6.) Here, common sense explains that providing information with respect to administration and dosage of medicines allows the patient to be more involved in their treatment protocol and thereby achieving and maintaining improved overall health. We affirm the rejection of claims 26 and 27. SUMMARY We affirm the rejection of claims 4, 11, and 23–25 under 35 U.S.C. § 102(b) by Echauz. We affirm the rejection of claims 5–10 under 35 U.S.C. § 103(a) over Echauz. We affirm the rejection of claims 26 and 27 under 35 U.S.C. § 103(a) over Echauz in view of Sillén. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED cdc Copy with citationCopy as parenthetical citation