2020000178 (P.T.A.B. Aug. 4, 2020)

Palo Alto Investors

Patent Trials and Appeals BoardAug 4, 2020

2020000178 (P.T.A.B. Aug. 4, 2020)

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. 15/257,620 09/06/2016 Anthony Joonkyoo Yun PALO-001CIP2CON2 7563 93726 7590 08/04/2020 EPA - BOZICEVIC FIELD & FRANCIS LLP BOZICEVIC, FIELD & FRANCIS 201 REDWOOD SHORES PARKWAY SUITE 200 REDWOOD CITY, CA 94065 EXAMINER GETZOW, SCOTT M ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 08/04/2020 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): docket@bozpat.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANTHONY JOONKYOO YUN and PATRICK YUARN-BOR LEE Appeal 2020-000178 Application 15/257,620 Technology Center 3700 Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 117–128, 131, 133, 134, and 139–142. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE and enter a NEW GROUND OF REJECTION under 37 C.F.R. § 41.50(b). 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Palo Alto Investors. Br. 3. Appeal 2020-000178 Application 15/257,620 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to a treatment of inflammation through modulation of the autonomic nervous system. Sole independent claim 117, reproduced below with certain limitations italicized, is representative of the claimed subject matter: 117. An open-loop system for treating inflammation, the system comprising: an implantable electrostimulatory device for treating inflammation, the device comprising: an electrode for directly applying electrical energy to an efferent portion of the vagus nerve of a subject; a battery operatively connected to the electrode; a programmer operatively connected to the electrode and the battery; a radiofrequency receiver connected to the programmer for remote control of the device; and a computer readable medium storing pre- programmed electrical stimulation parameters to increase activity of the efferent portion of the vagus nerve and result in an increase in the parasympathetic activity/sympathetic activity ratio of the subject, wherein the device is configured to be implanted within the subject on the vagus nerve; and an external controller comprising programming and a transmitter coupled to the radiofrequency receiver to activate the device in an open-loop manner to apply the pre- programmed electrical simulation parameters to increase activity of the efferent portion of the vagus nerve and result in an increase in the parasympathetic activity/sympathetic activity ratio of the subject thereby treating the subject for inflammation. Appeal 2020-000178 Application 15/257,620 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Schulman US 6,208,894 B1 Mar. 27, 2001 Boveja US 6,269,270 B1 July 31, 2001 Whitehurst US 7,167,751 B1 Jan. 23, 2007 REJECTIONS2 I. Claims 117, 119–128, 131, 133, 134, and 139–141 are rejected under 35 U.S.C. § 103(a) as unpatentable over Whitehurst and Schulman. II. Claim 118 is rejected under 35 U.S.C. § 103(a) as unpatentable over Whitehurst, Schulman, and Boveja. OPINION Rejection I; Obviousness Based on Whitehurst and Schulman The Examiner finds that Whitehurst discloses many of the limitations of claim 117. Final Act. 2–3. For the limitation “a computer readable medium storing pre-programmed electrical stimulation parameters to increase activity of the efferent portion of the vagus nerve and result in an increase in the parasympathetic activity/sympathetic activity ratio of the subject … thereby treating the subject for inflammation,” the Examiner finds that Appellant’s disclosed stimulation parameters treat various diseases, but there is no disclosure “of any specific parameters that are used to treat inflammation.” Final Act. 3. According to the Examiner, because Schulman’s Table I discloses “parameters that are within the ranges set forth 2 A rejection of claims 143–146 under 35 U.S.C. § 103(a) as unpatentable over Whitehurst, Schulman, and Tracey (US 6,610,713 B2, iss. Aug. 26, 2003) is moot due to these claims being canceled. See Advisory Act. mailed Mar. 7, 2019; see also Final Act. 4. Appeal 2020-000178 Application 15/257,620 4 in applicant's specification,” and because Whitehurst stimulates the vagus nerve, the combined teachings of the references stimulate the vagus nerve using the same parameters set forth in Appellant’s Specification for treating inflammation.” Id.; see also Ans. 5. The Examiner concludes that “treating inflammation” is an intended use that would be accomplished by the Whitehurst/Schulman device. Id. Appellant argues, inter alia, that the references do not disclose a device, implantable on the vagus nerve, preprogrammed with electrical stimulation parameters that, together with programming on the external controller, increase activity of the efferent portion of the vagus nerve, and treat inflammation. Br. 7–8. Appellant asserts that there is no guidance “to pre-program an implantable device for efferent vagus nerve stimulation with any of the Schulman parameters,” to treat inflammation. Br. 8. Appellant has the better position. Although we appreciate that the stimulation parameters in Schulman’s Table I are “to stimulate tissue, e.g., a nerve, proximate to the implanted location of the microstimulator” (Schulman, 6:31–32), Schulman merely generally describes using nerve stimulation for treating a patient, but does not disclose treating a patient for inflammation. Thus, the Examiner’s finding that the parameters of Table I treat inflammation appears to be inadequately supported by evidence. Patentability determinations “should be based on evidence rather than on mere speculation or conjecture.” Alza Corp. v. Mylan Laboratories, Inc., 464 F. 3d 1286, 1290 (Fed. Cir. 2006). We agree with Appellant that Schulman’s parameters do not provide guidance “to pre-program an implantable device for efferent vagus nerve stimulation” to treat inflammation. Accordingly, we do not sustain the rejection of claim 117 and Appeal 2020-000178 Application 15/257,620 5 claims 119–128, 131, 133, 134, and 139–141 depending therefrom as unpatentable over Whitehurst and Schulman. Rejection (II); Whitehurst, Schulman, and Boveja Claim 118 depends from claim 117. Br. 27 (Claims App.). The Examiner’s use of Boveja does not remedy the deficiency discussed above regarding Rejection (I). See Final Act. 4. Accordingly, for the same reasons, we do not sustain Rejection (II). NEW GROUND OF REJECTION As discussed above, in light of Schulman’s general teaching of treating a patient, the Examiner did not establish that one of ordinary skill in the art would have found it obvious to combine the teachings of Whitehurst with those of Schulman to treat inflammation. However, we find that the claim limitations for which the Examiner relied upon Schulman are found in Whitehurst. Specifically, Whitehurst teaches “electrical stimulation at one or more locations along the vagus nerve 100 and/or its branches is provided to treat, control, and/or prevent … headache (including migraine and chronic daily headache).” Whitehurst, 5:60–6:14. Given that Appellant’s Specification discloses “the treatment of a variety of different conditions, including … inflammatory conditions, e.g., acute respiratory distress syndrome (‘ARDS’), multiple sclerosis, rheumatoid arthritis, juvenile rheumatoid arthritis, juvenile chronic arthritis, migraines, chronic headaches, and the like” (Spec. ¶ 119 – p. 55:14–16), Whitehurst’s disclosure of treating headaches qualifies as a disclosure of treating inflammation, consistent with the Specification. Appeal 2020-000178 Application 15/257,620 6 In addition, we find that Whitehurst discloses the claimed components. Whitehurst discloses that microstimulator 150 contains “electronic circuitry 154 includ[ing] an inductive coil for receiving and transmitting RF data and/or power, an integrated circuit (IC) chip for decoding and storing stimulation parameters and generating stimulation pulses.” Whitehurst, 8:32–39; see also Ans. 3. Whitehurst further discloses that microstimulator 150 includes “a programmable memory 160 for storing a set(s) of data, stimulation, and control parameters.” Id. at 8:43–45; see also Ans. 3. We agree with and adopt the Examiner’s finding that Whitehurst’s programmable memory 160 qualifies as a computer readable medium that stores pre-programmed electrical stimulation parameters. Whitehurst also discloses that microstimulator 150 “may communicate (via an RF link) with an external remote control (e.g., patient and/or physician programmer 220) that is capable of sending commands and/or data to implanted devices and that may also be capable of receiving commands and/or data from implanted devices.” Id. at 12:59–67; see also Final Act. 3. To the extent that this disclosure of Whitehurst does not describe open loop operation, we agree with and adopt the Examiner’s findings that Schulman discloses “an open loop mode” in which a control unit “can be programmed to periodically initiate tasks, e.g., perform real time tasking, such as transmitting commands to microstimulators.” Schulman, 4:49–52; see also Final Act. 3. Schulman discloses that open loop mode and closed loop mode are known alternatives for controlling a microstimulator. See Schulman, 4:45–57. Thus, it would have been obvious to one of ordinary skill in the art to replace closed loop control with open loop control, because one of ordinary skill in the art would have been able to Appeal 2020-000178 Application 15/257,620 7 carry out such a substitution, and the results would reasonably predictably result in a programmed external controller that sends commands to a microstimulator to perform pre-programmed stimulation. Whitehurst further discloses that “stimulation parameters may be chosen to target specific neural populations and to exclude others, or to increase neural activity in specific neural populations and to decrease neural activity in others.” Id. at 8:54–57; see also Ans. 5–6. Whitehurst’s targeted activity is consistent with Appellant’s disclosure that “increasing the parasympathetic activity/sympathetic activity ratio may be achieved by stimulating the parasympathetic system to increase activity in at least a portion of the parasympathetic system … or … may be achieved by inhibiting activity in the sympathetic system.” Spec. ¶ 17. We find that Whitehurst’s targeted stimulation to increase neural activity in certain neural populations and decrease activity of others, would predictably achieve an increase in the parasympathetic activity/sympathetic activity ratio. See Ans. 6. To the extent that an increase in the parasympathetic activity/sympathetic activity ratio is not achieved by Whitehurst’s targeted stimulation, one of ordinary skill in the art would have found it obvious to alter the activity of specific neural populations to achieve the claimed ratio, because Whitehurst discloses that “stimulation and control parameters [may] be adjusted to settings that are safe and efficacious.” Whitehurst, 8:46–48. For the sake of completeness, we address below Appellant’s arguments spanning pages 11–20 of the Brief. Appellant argues that there is insufficient reason or guidance to modify the teachings of Whitehurst and Schulman to arrive at the claimed system. Br. 11. According to Appellant because Schulman is silent as to Appeal 2020-000178 Application 15/257,620 8 vagus nerve stimulation, there is no reason to use any of Shulman’s parameters for vagus nerve stimulation, and the Examiner appears to be improperly employing hindsight to establish the alleged obviousness of the modification. Br. 12. Appellant asserts that a person of ordinary skill would not have been motivated to employ parameters of Schulman, which is used in a device for bypassing a severed neuron pathway, in Whitehurst's vagus nerve stimulating device. Br. 13. These arguments are unavailing. Whitehurst “relates to an implantable stimulator system utilizing one or more implantable microstimulators for vagus nerve stimulation.” Whitehurst, 1:15–17. Schulman “relates to systems … characterized by a plurality of devices … configured for implanting within a patient's body, each device being configured to … affect a parameter, e.g., via nerve stimulation.” Schulman, 1:13–21. The disclosures of Whitehurst and Schulman evidence that it is within the abilities of one of ordinary skill in the art to use various implantable devices for nerve stimulation. Appellant also asserts that “the inherency of a device implantable on the vagus nerve pre-programmed as recited, increasing activity of the efferent portion of the vagus nerve and resulting in an increase in the parasympathetic activity/sympathetic activity ratio has not been established.” Br. 16. Appellant’s inherency arguments are addressed by Whitehurst’s disclosure that “stimulation parameters may be chosen to target specific neural populations and to exclude others, or to increase neural activity in specific neural populations and to decrease neural activity in others.” Whitehurst, 8:54–57. Given that Whitehurst stimulates various portions of Appeal 2020-000178 Application 15/257,620 9 the vagus nerve in order to increase neural activity, Appellant does not explain adequately why Whitehurst is not increasing activity of the efferent portion of the vagus nerve to result in an increase in the parasympathetic activity/sympathetic activity ratio. As discussed above, to the extent that an increase in the parasympathetic activity/sympathetic activity ratio is not achieved by Whitehurst’s targeted stimulation, it would have been obvious to one of ordinary skill in the art to alter the activity of specific neural populations to achieve the claimed ratio. Appellant does not provide persuasive evidence or argument that Whitehurst is incapable of performing the claimed functions. Appellant also argues that the references do not disclose an external controller having programming to activate the device as recited and that Whitehurst’s generic “external controller” does not teach the claimed external controller. Br. 16–19. Appellant contends that Schulman does not remedy this deficiency of Whitehurst. Br. 19–20. Appellant’s arguments are not persuasive. Appellant’s Specification discloses that “[i]n an open-loop system, the physician or patient may at any time manually or by the use of pumps or motorized elements adjust treatment parameters such as pulse amplitude, pulse width, pulse frequency, or duty cycle.” Spec. ¶ 98. Whitehurst discloses that “stimulation parameters may be determined and refined, for instance, by patient feedback.” Id. at 13:21–33. Thus, Whitehurst appears to disclose an open- loop system consistent with Appellant’s Specification. Moreover, as discussed above, because Schulman discloses “an open loop mode” in which a control unit “can be programmed to periodically initiate tasks, e.g., perform real time tasking, such as transmitting commands to Appeal 2020-000178 Application 15/257,620 10 microstimulators” (Schulman, 4:48–52; see also Final Act. 3) the combination of references discloses an open-loop system. Whitehurst further discloses that “external controller 220 controls the operation of each of the implanted microstimulators 150,” and that microstimulator 150 “may communicate with an external remote control (e.g., patient and/or physician programmer 220) that is capable of sending commands and/or data to implanted devices and that may also be capable of receiving commands and/or data from implanted devices.” Whitehurst, 12:50–67. Whitehurst also discloses that sensing means may be used to activate “microstimulator(s) targeting one area of the vagus nerve, and then, when appropriate, the microstimulator(s) targeting the same or another area of the nerve, in order to control symptoms …. Alternatively, this orchestration may be programmed, and not based on a sensed condition.” Id. at 14:10–17. Given that Whitehurst discloses that external controller 220 controls the operation of the microstimulator and given that the microstimulator is activated (by the external controller) to control symptoms, and that activation can be programmed, a preponderance of the evidence supports the finding that Whitehurst’s external controller (programmer) 220 is programmed to activate the device (microstimulator). In addition, as discussed above, Schulman discloses that a control unit “can be programmed to periodically initiate tasks, e.g., perform real time tasking, such as transmitting commands to microstimulators.” Schulman, 4:48–52; see also Final Act. 3. Schulman’s control unit “could be implemented in a housing configured for carrying on the patient's body outside of the skin defined envelope, e.g., in a wrist band.” Id. at 2:16–18. Thus we find that the combination of Whitehurst and Schulman teaches an Appeal 2020-000178 Application 15/257,620 11 external controller that is programmed to activate the microstimulator device. We also find that both Whitehurst and Schulman disclose that the external controller has a transmitter coupled to the radiofrequency receiver to activate the device. See Whitehurst, 12:56–67; Fig. 5; see also Schulman, Abstract; Fig. 2 Accordingly, for the reasons discussed above, we enter a NEW GROUND OF REJECTION of independent claim 117 as unpatentable over Whitehurst and Schulman. Appellant does not separately argue claims 119– 125, 131, 133, and 134. Nonetheless, we find that Whitehurst’s disclosure of two electrodes – “electrodes 156 and 158” (Whitehurst, 7:34–42) meets the claimed “plurality of electrodes” (claim 121) and “two electrodes” (claim 122). Whitehurst’s incorporation by reference of Loeb (US 5,312,439, iss. May 17, 1994) meets the claimed “electrode is bipolar” (claim 120) in that Loeb discloses a bipolar electrode (Loeb, 6:15). See Whitehurst, 6:64–7:41. Because the plain meaning of “multi” is “more than one”3 Whitehurst’s two electrodes meet the claimed “electrode is multipolar” (claim 119). For claim 123, Whitehurst’s disclosure of programming for “intermittent stimulation” (Whitehurst, 8:32–53), meets the claimed “programming that … causes the device to: a) activate … and b) terminate the delivery of the electrical signal.” For claim 124 “the electrical signal comprises a plurality of pulses,” is met by Whitehurst’s “implantable stimulator 150 is commanded to produce a series of electrical stimulation pulses.” Whitehurst, 11:38–40. For claim 125 “the programming is configured for a physician to select appropriate parameters of the electrical 3 “Multi-.” Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/multi-. Accessed 16 Jul. 2020 Appeal 2020-000178 Application 15/257,620 12 signal and direct the electrode to implement the parameters,” is met my Whitehurst’s “a microstimulator may communicate with an external remote control (e.g., patient and/or physician programmer) that is capable of sending commands and/or data to a microstimulator.” Whitehurst, 9:24–27. For claim 131 “a magnet that, when brought into proximity of the battery, modulates the battery,” is met by Schulman’s “battery 104 … that can be recharged via an AC magnetic field produced external to the patient's body.” Schulman 6:18–21. Accordingly, for the reasons discussed above, we enter a NEW GROUND OF REJECTION of claims 119–125, 131, 133, and 134 as unpatentable over Whitehurst and Schulman. For claims 126–128, Appellant argues that these claims are separately patentable from claim 117 because the references do not disclose the claimed ranges of pre-programed electrical parameters for providing the recited stimulation of the vagus nerve. Br. 23. Appellant reiterates that, because Schulman is silent as to stimulating the vagus nerve even if the parameters of Table 1 of Schulman overlap the claimed ranges, Schulman does not suggest a device having such parameters that increases activity in an efferent portion of the vagus nerve to increase the parasympathetic/sympathetic ratio and treat a subject for inflammation. Id. Appellant again argues that even if Schulman’s parameters fall within the claimed range, there is no reason to have employed such parameters for vagus nerve stimulation “because there is no nexus between Schulman's parameters and the Whitehurst device.” Br. 24. Appellant’s arguments are not persuasive. Claim 126 recites a current wave of 1 Hz to 2500 Hz, claim 127 recites a voltage of 0.1 V to 50 V, and claim 128 recites a pulse width of 1 microsecond to 2000 microseconds. Br. Appeal 2020-000178 Application 15/257,620 13 28 (Claims App.). Schulman’s Table I discloses a frequency (current wave) of 1 to 5000 PPS = 1 to 5000 Hz, a voltage of 3–24 volts, and a pulse width of 5 to 2000 microsecond. Schulman, 6:45–65 (Table I). Thus, Schulman’s parameters are within the claimed ranges. As discussed above, Schulman’s Table 1 parameters are used “to stimulate tissue, e.g., a nerve, proximate to the implanted location of the microstimulator.” Schulman, 6:30–42; Table 1. As also discussed above, that Schulman does not disclose that the nerve is the vagus nerve is immaterial because Whitehurst already stimulates the vagus nerve. Further, the reasoning discussed above supports the combination because the fact that both references are directed to nerve stimulation provides a nexus between Schulman's parameters and the Whitehurst device. For these reasons, we enter a NEW GROUND OF REJECTION of claims 126–128 as unpatentable over Whitehurst and Schulman. For claims 139–141, Appellant asserts that these claims are separately patentable from claim 117 at least because the parameters in Table 1 of Schulman, upon which the Examiner relies, are not used for vagus nerve stimulation. Br. 20–22. Appellant contends that “it would not be obvious to pre-program such parameters onto a device implantable on the vagus nerve.” Br. 22. In addition, Appellant asserts that there is no reason one of ordinary skill would have employed these parameters for vagus nerve stimulation at least because, “there is no nexus between Schulman's parameters and the Whitehurst device.” Id. Appellant’s arguments are not persuasive. Schulman discloses that the parameters in Table 1 correspond to a desired pulse sequence and voltage to energize a discharge capacitor, which stimulates a nearby nerve, Appeal 2020-000178 Application 15/257,620 14 by generating “a sequence of drive pulses through electrodes 112 to stimulate tissue, e.g., a nerve, proximate to the implanted location of the microstimulator.” Schulman, 6:30–42; Table 1. That Schulman does not disclose that the nerve is the vagus nerve is immaterial because Whitehurst already stimulates the vagus nerve. As discussed above, the reasoning to support the combination is sufficient and both references being directed to nerve stimulation provides a nexus between Schulman's parameters and Whitehurst’s device. For these reasons, we enter a NEW GROUND OF REJECTION of claims 139–141 as unpatentable over Whitehurst and Schulman. Claim 118 Claim 118 depends from claim 117 and recites that the electrode is monopolar. Boveja discloses a “unipolar” arrangement of a tip electrode, which is understood to be the same as a monopolar electrode. Boveja, 3:64– 67. Similar to Whitehurst, Boveja also discloses bipolar stimulation. Id. It would have been obvious to one of ordinary skill in the art to use a monopolar electrode as a simple substitution of one known element for another to obtain predictable results with respect to stimulation. For these reasons, we enter a NEW GROUND OF REJECTION of claim 118 as unpatentable over Whitehurst, Schulman, and Boveja. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 117, 119– 128, 131, 103 Whitehurst, Schulman 117, 119– 128, 131, Appeal 2020-000178 Application 15/257,620 15 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 133, 134, 139–142 133, 134, 139–142 118 103 Whitehurst, Schulman, Boveja 118 117–128, 131, 133, 134, 139– 142 103 Whitehurst, Schulman 117, 119– 128, 131, 133, 134, 139–142 118 103 Whitehurst, Schulman, Boveja 118 Overall Outcome 117–128, 131, 133, 134, 139– 142 TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection Appeal 2020-000178 Application 15/257,620 16 designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. REVERSED; 37 C.F.R. § 41.50(b)