Ex Parte Fendelander et al

Patent Trial and Appeal BoardJul 26, 2016

11776744 (P.T.A.B. Jul. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 111776,744 07/12/2007 Lahn M. Fendelander 45458 7590 07/28/2016 SCHWEGMAN LUNDBERG & WOESSNER/BSC POBOX2938 MINNEAPOLIS, MN 55402 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 279.M81US1 7321 EXAMINER JANG, CHRISTIAN YONGKYUN ART UNIT PAPER NUMBER 3735 NOTIFICATION DATE DELIVERY MODE 07/28/2016 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): uspto@slwip.com SLW@blackhillsip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LAHN M. FENDELANDER, LIZBETH M. MINO, and AARON R. MCCABE 1 Appeal2013-009081 Application 11/776,744 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and JACQUELINE T. HARLOW, Administrative Patent Judges. PERCURIAM DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134(a) involving claims to systems and methods for administering cardiovascular autonomic neuropathy tests to a patient having an implanted medical device. The claims are rejected as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. 1 According to Appellants, the Real Party in Interest is Cardiac Pacemakers, Inc. (App. Br. 3). Appeal2013-009081 Application 11/776,744 STATEMENT OF THE CASE "The [present] invention relates to the administration of tests for cardiovascular autonomic neuropathy, and more specifically, to the administration of cardiovascular autonomic neuropathy tests in a patient having an implanted medical device" (Spec. 1 :5-7). Claims 13 and 15-24 are on appeal. Claim 13 is illustrative and reads as follows (emphasis added): 13. A method for remotely testing for cardiovascular autonomic neuropathy (CAN) in a diabetic patient, the method compnsmg: (i) providing a monitor device having a patient interface; (ii) providing an implantable medical device (IMD) comprising a cardiac rhythm management ( CRM) device, wherein the IMD includes a plurality of implantable physiological sensors, the IMD being configured to (a) transmit a plurality of outgoing wireless signals to the monitor device, wherein the one or more first wireless signals correspond to an !MD-sensed physiological activity; and (b) receive one or more incoming wireless signals from the monitor device; (iii) providing a plurality of non-implantable physiological sensors, where the non-implantable physiological sensors are each configured to transmit one or more non- implantable physiological sensor signals to the monitor device, wherein the one or more non-implantable physiological sensor signals correspond to a parameter sensed by the non-implantable physiological sensor; (iv) directing the patient through the patient interface to: (a) answer health related questions; 2 Appeal2013-009081 Application 11/776,744 (b) interface with one or more of the non-implantable physiological sensors; and ( c) perform one or more diagnostic procedures; (v) receiving a plurality of IMD and non-implantable physiological sensor signals at the monitor device; (vi) using one or more of the implantable physiological sensors to verify that the patient properly performed one or more diagnostic procedures; and (vii) processing the plurality of IMD and non-implantable physiological sensor signals at the monitor device to determine the presence or progression of CAN. Independent claim 21 recites a system for the implementation of this method. The claims stand rejected as follows: I. Claims 13, 15-17, 19-21, and 24 stand rejected under 35 U.S.C. Â§ 103(a) as obvious based on Zhimov2 and Gutfinger. 3 II. Claims 18, 22, and 23 stand rejected under 35 U.S.C. Â§ 103(a) as obvious based on Zhimov, Gutfinger, and Coyle. 4 I. The Examiner has rejected claims 13, 15-17, 19-21, and 24 under 35 U.S.C. Â§ 103(a) as obvious based on Zhimov and Gutfinger. Because the claims are not separately argued, we focus our discussion on independent claim 13. 2 Zhimov et al., US 2005/0251055 Al, published Nov. 10, 2005. 3 Gutfinger et al., US 7,794,404 Bl, issued Sept. 14, 2010. 4 Coyle et al., US 2005/0119586 Al, published June 2, 2005. 3 Appeal2013-009081 Application 11/776,744 Findings of Fact FF 1. The Specification discloses that "[ t ]he CAN test protocol has the advantage that it can be conducted in a patient's home or other convenient location[s], and does not require a visit to a medical facility and the direct attention of trained medical personnel" (Spec. 7 :22-25 (emphasis added)). FF 2. The Specification discloses: Monitor device 24 may also be capable of communicating with a remote computer 32 (also called a remote station 32) through telecommunications, such as over a conventional phone line 34, through cellular phone communications, via the Internet, or any other wired or wireless form of communication. In some embodiments, monitor device 24 is configured to inquire regularly about the patient's general health conditions, such as physical activity and symptoms of disease. Inquiring about the patient's health generally involves displaying one or more health-related questions on an interface such as screen 27 and requesting the patient provide input such as through a touch sensitive screen or buttons 29. The monitor device 24 may also be configured to receive information from the implanted medical device 22 regarding the operation of the device, as well as any information or data stored in the device. The monitor device 24 may be further configured to transmit this information to a remote computer 32, where the information is received and can be further analyzed to determine the patient's medical condition. Id. at 9:22-10:2. FF 3. Zhimov teaches that autonomic neuropathy (AN) "is often associated with a number of disorders such as diabetes and coronary artery disease" and "testing for AN may be a useful health monitoring tool" (Zhimov i-f 5; see also Final Act. 3). FF 4. Zhimov teaches that "[t]he Slow Metronomic Breathing test is designed to assess [to a metronome, which may be displayed on a computer 4 Appeal2013-009081 Application 11/776,744 screen] the parasympathetic branch of the ANS," that "during the test the patient breathes deeply and evenly, in a supine position, at six breaths per minute," and that "[t]o foster patient compliance with the prescribed breathing regimen, the patient should breathe for one minute following pacer movements, similar to a metronome, which may be displayed on a computer screen." (Zhimov i-f 10; see also Final Act. 4). FF 5. Zhimov teaches that "the Othostatic test is used to evaluate the effect of parasympathetic regulation on HR," that "the test provides a good indication of autonomic function and HRV," that "[t]he patient is instructed to lie down in an idle, relaxed, supine position," and that "[t]he patient's heart rhythm is monitored continuously while the patient lies down and stands up" (Zhimov i-f 14; see also Final Act. 4). FF 6. Zhimov teaches that "background data is obtained from a patient," and provides "exemplar questions regarding the patient's background information" or "exemplar questions regarding the patient's health history" that may be used to obtain such data (Zhimov i1 41; see also Final Act. 2). FF 7. Zhimov teaches that "[t]he patient may undergo provocative HRV tests such as the Metronomic Breathing test, Valsalva test and the Orthostatic test," and that "[t]hese tests are called provocative tests because a patient must provoke his nervous system, by standing up or breathing in a certain way, to produce results indicative of his HRV" (Zhimov i1 42; see also Final Act. 2). FF 8. Zhimov teaches that after a test is chosen, an application "then may prompt, using a dialog box for example, the user to enter background 5 Appeal2013-009081 Application 11/776,744 data from a patient as well as physiologic data from a patient into the application" (Zhimov i-f 108; see also Final Act. 2-3). FF 9. Zhimov teaches patient data recording equipment comprising "one or more testing units[], doctor's workstations [] and an internet-based server," in which the "testing unit [] is used for conducting autonomic assessment tests" and may consist of a "personal digital assistant or handheld computer," utilizing an ECG/Pressure acquisition device (EPAD) (Zhimov i-f 50; see also Final Act. 2). The EPAD "provides, for example, functionality to measure a single-channel ECG and airflow pressure" and "may have three input connectors to attach standard ECG lead wires [] with disposable pre-gelled snap electrodes (Zhimov i-f 50; see also Final Act. 2). FF 10. Zhimov teaches that the "EP AD [] also has an input tip to connect to a spirometric mouthpiece" (Zhimov i-f 51; see also Final Act. 2). FF 11. Zhimov teaches that "[ t ]he digitized ECG and pressure signals are coupled to the processor," that the processor "may execute programming instructions by which a patient's heart rate variability is analyzed in response to the measured physiological data," that the physiological data can be transmitted to the PDA "in numerous ways including wireless means," that the PDA "may also receive data from implantable devices such as pacemakers," and that the implantable devices "may communicate with the PDA []in real time or may deliver ECG data upon interrogation by the PDA" (Zhimov i-f 52; see also Final Act. 2). FF 12. Zhimov teaches that new data could be used to "determine an equation for discriminating between those with both coronary artery disease (CAD) and diabetes and those that have neither condition," to "determine another equation for discriminating between those individuals with CAD, 6 Appeal2013-009081 Application 11/776,744 and associated autonomic dysfunction, and those without autonomic dysfunction," and to "determine an equation for discriminating between individuals with CAD, who would have a first state of autonomic function indicative of CAD, and those with diabetes, who would have second state of autonomic function indicative of diabetes" (Zhimov i-f 86; see also Final Act. 2). FF 13. Gutfinger teaches that [ t ]echniques are provided for estimating left atrial pressure (LAP) or other cardiac pressure parameters based on various parameters derived from impedance signals. In particular, effective LAP is estimated based on one or more of: electrical conductance values, cardiogenic pulse amplitudes, circadian rhythm pulse amplitudes, or signal morphology fractionation values, each derived from the impedance signals detected by the implantable device. Predetermined conversion factors stored within the device are used to convert the various parameters derived from the electrical impedance signal into LAP values or other appropriate cardiac pressure values. (Gutfinger, Abstract.) FF 14. Gutfinger teaches an implantable system that "includes a pacer/ICD [] or other cardiac stimulation device that incorporates internal components [] for detecting one or more impedance signals using electrodes mounted to a set of sensing/pacing leads [] and for estimating LAP or other cardiac pressure parameters based on various parameters derived from the impedance signals" and that "LAP is estimated based on one or more of: electrical conductance values, cardiogenic pulse amplitudes, circadian rhythm pulse amplitudes, or signal morphology fractionation index values, each derived from the impedance signals detected by the pacer/ICD" (Gutfinger 10:33-36, 43--47; see also Final Act. 3). 7 Appeal2013-009081 Application 11/776,744 FF 15. Gutfinger teaches that "the pacer/ICD can issue warning signals," that "if the estimated LAP exceeds a threshold indicative of CHF, warning signals may be generated to warn the patient, using either an internal warning device [] or an external bedside monitor/handheld warning device," that the "handheld device receives short-range telemetry signals from the implanted device and provides audible or visual verification of the warning signal," that "the bedside monitor provides audible or visual alarm signals to alert the patient as well as textual or graphic displays," that "diagnostic information pertaining to the deteriorating cardiac condition is transferred to the bedside monitor or is stored within the pacer/ICD for subsequent transmission to an external programmer [] for review by a physician or other medical professional," and that the "bedside monitor may be directly networked with a centralized computing system" ( Gutfinger 11 :2-7, 12-15, 24--31, 35-36; see also Final Act. 3--4). FF 16. Gutfinger teaches that "the physician may have the patient perform the Valsalva maneuver, which reduces effective LAP secondary to reduced venous return" ( Gutfinger 15: 65-16: 1). FF 1 7. Gutfinger teaches that the procedure [] may be initiated by periodically having the pacer/ICD transmit a signal to the bedside monitor providing instructions to the patient to perform the Valsalva maneuver. The pacer/ICD detects the new conductance value during the Valsalva maneuver and updates the baseline value. The pacer/ICD may be additionally programmed to verify that the patient actually performed the Valsalva maneuver by, e.g., analyzing changes in respiration (as detected using otherwise conventional respiration detection techniques) to verify that respiratory patterns consistent with the Valsalva maneuver occur. (Gutfinger 18:41-51; see also Final Act. 3.) 8 Appeal2013-009081 Application 11/776,744 FF 18. Gutfinger teaches that"[ w ]hile shown as being included within pacer/ICD[], it is to be understood that the physiologic sensor[] may also be external to pacer/ICD[], yet still be implanted within or carried by the patient," that "[a] common type of rate responsive sensor is an activity sensor incorporating an accelerometer," and that"[ o ]ther types of physiologic sensors are also known, for example, sensors that sense the oxygen content of blood, respiration rate ... " (Gutfinger 29:11-19; see also Final Act. 5). FF 19. Gutfinger teaches an "external programmer [] for use in programming the pacer/I CD" that "permits a physician or other user to program the operation of the implanted device and to retrieve and display information received from the implanted device such as IEGM data and device diagnostic data," and that "may also be capable of processing and analyzing data received from the implanted device and from the EKG leads to, for example, render preliminary diagnosis as to medical conditions of the patient or to the operations of the implanted device" ( Gutfinger 31: 5-14, 18- 23; see also Final Act. 3). FF 20. Gutfinger teaches that the external programmer includes a CPU that "transmits appropriate signals to a telemetry subsystem[], which provides components for directly interfacing with the implanted devices, and the EKG leads," and that the telemetry subsystem "receives and transmits signals electromagnetically from a telemetry unit of the implanted device" (Gutfinger 31 :59---62, 31 :66-32:2; see also Final Act. 3). 9 Appeal2013-009081 Application 11/776,744 Analysis We begin with claim interpretation, because until a claim is properly interpreted, its scope cannot be compared to the prior art. Claim 13 recites "[a] method for remotely testing for cardiovascular autonomic neuropathy (CAN) in a diabetic patient" (emphasis added). Claim 21 similarly recites "[a] system for remote testing for cardiovascular autonomic neuropathy (CAN) in a diabetic patient" (emphasis added). The Examiner interprets the terms "remotely testing" and "remote testing" broadly, but reasonably, to encompass "testing that is done with any distance .... There is no requirement that a patient 'complete this type of diagnostic at home' as argued by appellant." (Ans. 2-3). In reaching this conclusion, the Examiner observes that Appellants "failed to provide an express definition within the disclosure for the term 'remote"' (id.). In the Appeal Brief, Appellants appear to argue that remotely testing for CAN requires that the testing is performed at home, without the assistance of trained medical personnel (App. Br. 11 ). In the Reply Brief, however, Appellants' clarify this contention, and assert that the terms "remotely testing" and "remote testing" mean "that the testing is conducted outside of the immediate [] presence of a medical specialist in CAN testing" (Reply Br. 6). We do not agree with either of Appellants' proposed constructions. The Specification and claims do not define "remotely testing" or "remote testing" as testing that is conducted either in the home, or outside of the immediate presence of a medical specialist in CAN testing. Rather, the Specification teaches that "[ t ]he CAN test protocol has the advantage that it can be conducted in a patient's home or other convenient location[s]," and 10 Appeal2013-009081 Application 11/776,744 that "[t]he monitor device []may be fhrther configured to transmit this information to a remote computer[], where the information is received and can be further analyzed to determine the patient's medical condition" (FF 1- 2 (emphasis added); see also Ans. 2-3). The Specification is thus consistent with an understanding of "remotely testing" and "remote testing" as referring to testing done at any distance. During prosecution, claim terms are given their broadest reasonable interpretation as they would be understood by persons of ordinary skill in the art in the light of the Specification. See In re Sneed, 710 F .2d 1544, 1548 (Fed. Cir. 1983). We, therefore, conclude that the broadest reasonable interpretation of the terms "remote testing" and "remotely testing" includes no requirement that testing be conducted outside of the immediate presence of a medical specialist in CAN testing. Rather, the broadest reasonable construction of these terms encompasses testing done at any distance. Appellants' contend that neither Zhimov nor Gutfinger teaches a method or a system for remotely testing for CAN in which a plurality of implantable medical devices (IMD) and non-implantable physiological sensor signals are processed to determine the presence or progression of CAN (App. Br. 11 ). Appellants argue that Zhimov describes protocols for testing for AN in the presence of trained medical personnel, and that "[a] patient cannot be expected to properly attach ECG lead wires to complete this type of diagnostic at home, without the assistance of trained medical personnel" (id.). Appellants also assert that Gutfinger's pacer/ICD remote sensing capabilities are used to monitor a narrow range of physiological changes, and Gutfinger does not teach "the use of a plurality of sensors, including an accelerometer, a body sensor, or an implantable respirator 11 Appeal2013-009081 Application 11/776,744 sensor to verify that the patient performed one or more diagnostic procedures as recited in dependent claims 17-20 and 22-24" (id. at 11-12). Appellants thus conclude that "nothing in the proposed combination of Zhirnov []and Gutfinger []teaches or suggests using a pacer/ICD to remotely evaluate the plurality of complex measurements necessary to monitor for CAN" (id. at 11 ). Because we conclude, as set forth above, that the broadest reasonable interpretation of the terms "remotely testing" and "remote testing" encompasses testing done at any distance, we do not find Appellants arguments concerning the location of the testing, or the employment of medical personnel, as taught by Zhirnov, persuasive (see also Ans. 2-3). 5 We also find unpersuasive Appellants' assertion that Gutfinger' s pacer/ICD remote sensing capabilities are used to monitor a narrow range of physiological changes, and that Gutfinger does not teach "the use of a plurality of sensors, including an accelerometer, a body sensor, or an implantable respirator sensor to verify that the patient performed one or more diagnostic procedures" (App. Br. 11 ). Claim 13 requires the provision of a plurality of non-implantable and implantable sensors. Claim 13 does not, however, specify the particular sensors that must be provided, or define the parameters they must sense. "[L ]imitations are not to be read into the claims from the specification." In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) ("[A]ppellant's arguments fail from the 5 We note that Gutfinger teaches that at least one sensor may be implanted or may be external and carried by a patient, disclosing both options (FF 18). 12 Appeal2013-009081 Application 11/776,744 outset because ... they are not based on limitations appearing in the claims."). Furthermore, to be complete, we note that, Gutfinger teaches implantable accelerometer and respiration sensors (FF 18), as well a body sensor because the pacer/ICD verifies that the patient performed the Valsalva maneuver (FF 16-17). We also note that the Examiner relies on the Coyle reference, instead of Zhimov or Gutfinger, to teach verifying that a patient properly performed a procedure, for dependent claims 18, 22, and 23, which Appellants did not separately argue (see Final Act. 5; App. Br. 12-13). Appellants next contend that "nothing in the proposed combination of Zhimov []and Gutfinger []teaches or suggests using a pacer/ICD to remotely evaluate the plurality of complex measurements necessary to monitor for CAN" (App. Br. 11; see also Reply Br. 5). This argument is unavailing because, as discussed above, Gutfinger teaches an implantable sensor to verify that the patient performed diagnostic procedures, including the Valsalva manuever (FF 16-18), and Zhimov teaches that a patient is directed to perform a diagnostic procedure, such as a Metronomic, Orthostatic, or Valsalva maneuver, in order to monitor and deter the presence or progression of cardiovascular autonomic neuropathy (FF 3-5, 7). We agree with the Examiner that it would have been obvious "to combine the teachings of Gutfinger with the method and apparatus of Zhimov in order to verify that the procedure was properly carried out" and therefore, the combined teachings of Zhimov and Gutfinger would yield predictable results of "ensuring more accurate results" (Final Act. 3). 13 Appeal2013-009081 Application 11/776,744 We are also not persuaded by Appellants' contention that CAN requires a plurality of testing protocols, many of which require a patient to undertake specific actions that are conventionally performed under the direct supervision of trained medical personnel, and that the combination of cited references does not teach such testing protocols can be monitored remotely (App. Br. 12). Appellants' contentions concerning "remote testing" are addressed above, and there is no persuasive evidence or argument on this record to support a conclusion that Gutfinger' s teaching of using an implantable sensor to monitor and verify that a patient performs detection techniques cannot be combined with Zhimov's teaching of using non- implantable medical sensors to monitor and detect CAN (see FF 3-20). See In re Geisler, 116 F.3d at 1371 (Argument by counsel cannot take the place of evidence). Conclusion of Law A preponderance of the evidence of record supports the Examiner's conclusion that Zhimov and Gutfinger render claims 13 and 21 obvious. Claims 15-17, 19, 20, and 24 have not been argued separately and therefore fall with claims 13 and 21. II. The Examiner has rejected claims 18, 22, and 23 under 35 U.S.C Â§ 103(a) as obvious based on Zhimov, Gutfinger, and Coyle. Appellants present no additional argument based on the teachings of Coyle, and rely on the same arguments addressed above with regard to Zhimov and Gutfinger (see App. Br. 12-13). For the reasons discussed above, therefore, we affirm the rejection of claims 18, 22, and 23. 14 Appeal2013-009081 Application 11/776,744 SUMMARY We affirm the rejection of claims 13 and 21under35 U.S.C. Â§ 103(a) based on Zhimov and Gutfinger. Claims 15-17, 19, and 20 fall with claim 13, and claim 24 falls with claim 21. We affirm the rejection of claims 18, 22, and 23 under 35 U.S.C. Â§ 103(a) based on Zhimov, Gutfinger, and Coyle. 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. Â§ 1.136(a)(l )(iv). AFFIRMED 15