Ex Parte Armstrong

Patent Trial and Appeal BoardSep 27, 2012

11260836 (P.T.A.B. Sep. 27, 2012)

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. 11/260,836 10/27/2005 Randolph K. Armstrong 2294-02100 7420 41332 7590 09/27/2012 CYBERONICS, INC. LEGAL DEPARTMENT, 6TH FLOOR 100 CYBERONICS BOULEVARD HOUSTON, TX 77058 EXAMINER ALTER, ALYSSA MARGO ART UNIT PAPER NUMBER 3762 MAIL DATE DELIVERY MODE 09/27/2012 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte RANDOLPH K. ARMSTRONG ____________________ Appeal 2010-004591 Application 11/260,836 Technology Center 3700 ____________________ Before: PHILLIP J. KAUFFMAN, LYNNE H. BROWNE, and HYUN J. JUNG, Administrative Patent Judges. KAUFFMAN, Administrative Patent Judge. DECISION ON APPEAL Appeal 2010-004591 Application 11/260,836 2 STATEMENT OF CASE Appellant appeals under 35 U.S.C. § 134 from a rejection of claims 1-11 and 13-24. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. THE INVENTION Appellant’s claimed invention “relates generally to implantable medical devices and more particularly to implantable medical devices that have multiple sequenced therapy protocols.” Spec. para. [0001]. Claims 1, 10, 14, 20, and 22 are the independent claims on appeal. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method of operating an implantable medical device (IMD) to provide neurostimulation comprising: (a) storing a plurality of neurostimulation therapy programs comprising a therapy sequence in storage in the IMD before operating any of the neurostimulation therapy programs; (b) operating a first therapy program from the therapy sequence for a first therapy program time; (c) the IMD automatically operating a second therapy from the therapy sequence in the IMD for a second therapy time following the first therapy time; and the IMD automatically repeating the therapy programs in said therapy sequence. REJECTIONS1 Appellant seeks review of the following rejections: 1. Claims 1-11 and 13-24 under 35 U.S.C. § 103(a) as unpatentable over 1 The Examiner withdrew the rejection of claims 1-11 and 13-24 as anticipated by Stypulkowski. Ans. 3. Appeal 2010-004591 Application 11/260,836 3 Stypulkowski2 (US 7,050,856 B2; iss. May 23, 2006). 2. Claims 1-11 and 13-24 under 35 U.S.C. § 102(e) as anticipated by Marchal (US 6,853,862 B1; iss. Feb. 8, 2005). 3. Claims 1-11 and 13-24 under 35 U.S.C. § 103(a) as unpatentable over Boveja (US 6,668,191 B1; iss. Dec. 23, 2003). OPINION3 Claims 1-11 and 13-24 as unpatentable over Stypulkowski In the Office Action that is the subject of this appeal, these claims were rejected as anticipated by, and alternatively as unpatentable over Stypulkowski. Office Action dated Jan. 27, 2009, at p. 2. Then, in the Examiner’s Answer, the Examiner withdraws the rejection of these claims as anticipated by Stypulkowski. Ans. 2-3. Because the anticipation rejection has been withdrawn, it is not before us on appeal. However, in evaluating the obviousness rejection, we are mindful that if Stypulkowski discloses each and every element of the claims at issue, such disclosure would render the claimed subject matter obvious. See In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (“It is well settled that ‘anticipation is the epitome of obviousness.’” (citations omitted)). Claims 1-9 Independent claim 1 is directed to a method of operating an IMD that calls for operating a first therapy program from the therapy sequence, the IMD automatically operating a second therapy from the therapy sequence, 2 This reference was published as US 2003/0135248 A1 on Jul. 17, 2003. 3 Though the Examiner indicates that Appellant has mischaracterized the claimed subject matter, we discern no mischaracterization relevant to our analysis here. See Ans. 5. Appeal 2010-004591 Application 11/260,836 4 and the IMD automatically repeating the therapy programs in the therapy sequence. In other words, claim 1 requires operation of a first therapy program, a second therapy program, and repetition of that sequence. The Examiner found that Stypulkowski discloses a finite set of options for therapy that repeat in a pseudo-random rather than a random pattern, so that the iteration of Stypulkowki’s process would invariably repeat the therapy programs in the therapy sequence as called for in independent claim 1. Ans. 3-4, 6-7. Alternatively, the Examiner concludes that if Stypulkowski does not disclose repeating the therapy programs in the therapy sequence as called for in independent claim 1, modification of Stypulkowski to repeat the therapy programs of the therapy sequence would have been obvious to a person of ordinary skill in the art. Ans. 4, 6-7. For the reasons that follow, we cannot agree with this finding or the alternative conclusion. To begin, the finding is deficient on its face in that it does not identify the therapy programs in Stypulkowski that correspond to the claimed first and second therapy programs. Further, Stypulkowski does not expressly disclose a method of operating a first and a second therapy program and repeating that therapy sequence. Stypulkowski, passim. Stypulkowski discloses that “[e]xperience with deep-brain stimulation (DBS) in the treatment of movement disorders and epilepsy has indicated that, in some cases, patients develop a tolerance or adaptation to the stimulation.” Stypulkowski, col. 1, ll. 30-33. In order to minimize loss of therapeutic efficacy due to a patient developing physiologic tolerance to therapeutic stimulation, Stypulkowski discloses a method of dynamically changing various neural-stimulation-treatment parameters. Stypulkowski, Appeal 2010-004591 Application 11/260,836 5 col. 1, ll. 6-11; see also, Abstract; col. 2, ll. 58-62. Stypulkowski discloses that these parameter variations could produce a virtually infinite number of electrode combinations and stimulus-parameter settings to promote the desired clinical efficacy. Stypulkowski, col. 7, ll. 10-30. In other words, Stypulkowski’s method is designed to vary treatment (stimulation) to avoid repetition that can lead to tolerance or adaptation to that stimulation. See Stypulkowski, col. 7, ll. 10-11. Specifically, Stypulkowski’s method of operating an IMD includes a clinician programming ranges of values for parameters of a patient’s treatment plan. Stypulkowski, col. 5, l. 61-col. 6, l. 1; fig. 6 (steps 602, 604, 606 and 608). Following this programming, neuro-stimulation therapy in accordance with those parameters is provided to the patient. Stypulkowski, col. 6, ll. 8-9; fig. 6 (step 610); see also col. 2, l. 66-col. 3, l. 3. Following this, at least a first stimulation parameter is pseudo- randomly varied, and a second stimulation parameter is changed based upon the pseudo-random variation of the first parameter and a predetermined relationship between the first and second parameters and that variation. Stypulkowski, col. 5, ll. 13-25; col. 6, ll. 9-10, 35-41; fig. 6 (steps 612, 614); see also col. 3, ll. 3-9. The consequence of Stypulkowski’s pseudo-random variation is that two of the stimulation parameters of this therapy program differ from that of the first neuro-stimulation therapy program. After the pseudo-random therapy is completed, the pseudo-random therapy is repeated. Stypulkowski, fig. 6 (see the line with an arrow from after step 614 indicating a loop back to before step 612). Appeal 2010-004591 Application 11/260,836 6 In light of this, Stypulkowski’s initial neuro-stimulation therapy is followed by pseudo-random therapy, and subsequent therapies are pseudo- randomly generated. If the Examiner intended to find that Stypulkowski’s initial neuro- stimulation therapy corresponds to a first therapy program as claimed, and the pseudo-random therapy corresponds to a second therapy as claimed, we cannot agree. In Stypulkowski’s method the first and second therapies are followed by additional pseudo-random therapies rather than a repetition of the first and second therapy sequence as called for in claim 1. If the Examiner intended to find that Stypulkowski’s first pseudo- random therapy (after the initial therapy) corresponds to a first therapy program as claimed, and that a subsequent pseudo-random therapy corresponds to a second therapy as claimed, such finding is also in error. The third iteration of Stypulkowski’s pseudo-random therapy is intentionally designed to be different from prior therapies such as the first iteration of the pseudo-random therapy. Therefore, Stypulkowski’s method will not repeat the first and second therapies. Nor can we agree with the Examiner’s alternative conclusion that it would have been obvious to modify Stypulkowski to repeat a therapy sequence. Such a modification would result in a method that produces the very thing that Stypulkowski seeks to avoid (repetition of the therapy sequence). See App. Br. 11-13. Accordingly, we cannot sustain the rejection of independent claim 1 and its dependent claims 2-9. Appeal 2010-004591 Application 11/260,836 7 Claims 10, 11, and 13 Independent claim 10 is directed to a method that includes the steps of operating a first therapy program, automatically sequencing through additional therapy programs, and subsequently operating and continuing the first therapy program. The Examiner’s finding is deficient in that it does not identify which therapy program in Stypulkowski corresponds to a first therapy program as claimed. Ans. 3-4, 6-7. Further, as explained in the analysis of independent claim 1, supra, Stypulkowski’s method does not repeat therapy programs, and thus does not operate and continue a first therapy program as called for in claim 10. Accordingly, we cannot sustain the rejection of independent claim 10 and its dependent claims 11 and 13 as anticipated by Stypulkowski. Claims 14-21 Independent claims 14 and 20 are similar to independent claim 1 in that each method calls for repeating a therapy sequence. As explained in the analysis of claim 1, supra, Stypulkowski does not disclose repeating a therapy sequence. Accordingly, we cannot sustain the rejection of independent claims 14 and 20 and their respective dependent claims 15-19 and 21 as anticipated by Stypulkowski. Claims 22-24 Independent claim 22 is directed to a method of operating a neurostimulator that includes the step of interrupting the automatic Appeal 2010-004591 Application 11/260,836 8 sequencing of the therapy sequence. The Examiner makes no finding regarding this limitation. See Ans. 3-4, 7; see also App. Br. 13-14 (identifying this omission); Reply Br. 3. Accordingly, we cannot sustain the rejection of independent claim 22 and its dependent claims 23 and 24 as anticipated by Stypulkowski. Claims 1-11 and 13-24 as anticipated by Marchal4 Claims 1-9 The Examiner made the generalized finding that Marchal’s first and second therapies are followed by “an additional therapy,” while in contrast, claim 1 more specifically calls for repeating the therapy programs in the therapy sequence (i.e., the first and second therapy sequences). See Ans. 4, (citing Marchal Figures 3, 8a, 8b), 8 (referring to Figure 8 as a subset of Figure 9). For the reasons that follow, this finding is not adequately supported by the reference. Marchal’s Figure 3 depicts a gastroelectric stimulator, and does not disclose a method of operating an IMD. Marchal, col. 2, ll. 17-18; col. 3, ll. 64-65. Marchal’s Figures 8a and 8b depict operating a therapy sequence (therapy 97) that includes operating a first therapy (therapy A), operating a second therapy (therapy B) and repeating a first therapy (therapy A). Marchal, col. 2, l. 26; col. 5, l. 60; col. 6, ll. 6-9; figs. 8a, 8b. However, this method differs from that of claim 1 in that the second therapy (therapy B) of the therapy sequence (therapy 97) is not repeated. 4 Because this is an anticipation rejection, we do not consider the Examiner’s conclusion that “repetition of steps is considered obvious within routine skill in the art.” See Ans. 4. Appeal 2010-004591 Application 11/260,836 9 Figure 9 depicts a diagram of a method of influencing pancreatic secretions. Marchal, col. 2, ll. 27-28; col. 7, ll. 31-32; fig. 9. In this method, the degree of pancreatic influence 106 is measured 108 and used to adjust the stimulation 106 to achieve the desired pancreatic influence 106. Marchal, col. 7, ll. 42-44; fig. 9. While such a method is iterative, Marchal does not disclose which therapy program is administered. Further, Marchal does not explicitly disclose that Figures 8a and 8b are a subset of Figure 9. Marchal, passim; contra Ans. 8. As such, the Examiner has not established by a preponderance of the evidence that Marchal discloses operating a first therapy program from the therapy sequence, the IMD automatically operating a second therapy from the therapy sequence, and the IMD automatically repeating the therapy programs in the therapy sequence as called for in independent claim 1. See App. Br. 14; Reply Br. 4-6. Accordingly, we cannot sustain the rejection of independent claim 1 and its dependent claims 2-9 as anticipated by Marchal. Claims 10, 11, and 13 Independent claim 10 is directed to a method that includes the steps of operating a first therapy program, automatically sequencing through additional therapy programs, and subsequently operating and continuing the first therapy program. The Examiner finds that this limitation is “clearly and explicitly recited in column 5, lines 25-40 of the Marchal reference.” Ans. 8. We cannot agree. This cited portion of the reference discloses that a stimulation signal 52 can consist of a first stimulation signal 90 and a second stimulation signal Appeal 2010-004591 Application 11/260,836 10 92 different from the first, and that there can also be additional stimulation signals 52 with parameters different from the first and second signals 90, 92. Marchal, col. 5, ll. 25-40; fig. 6a. Thus, Marchal discloses a sequence of three different therapy programs. Marchal does not disclose subsequently operating and continuing the first therapy program (first stimulation signal 90) as called for in claim 10. See App. Br. 14; Reply Br. 4-6. Accordingly, we cannot sustain the rejection of independent claim 10 and its dependent claims 11 and 13 as anticipated by Marchal. Claims 14-19 Independent claim 14 calls for repeating a therapy program sequence. As detailed in the analysis of claim 1, supra, Marchal only discloses repeating a first therapy (therapy A) and does not disclose repeating a therapy sequence as called for in independent claim 14. See App. Br. 15; contra. Ans. 4. Accordingly, we cannot sustain the rejection of claim 14 and its dependent claims 15-19. Claim 20 and 21 Independent claim 20 calls for repeating a first therapy program after implementing a plurality of therapy programs. As detailed in the analysis of claim 1, supra, Marchal discloses repeating a first therapy (therapy A) after a second therapy (therapy B) as opposed to repeating a first therapy (therapy A) after implementing a plurality of therapy programs as called for in independent claim 21. See App. Br. 15; contra. Ans. 4, 8. Accordingly, we cannot sustain the rejection of claim 20 and its dependent claim 21. Appeal 2010-004591 Application 11/260,836 11 Claims 22-245 Independent claim 22 is directed to a method of operating a neurostimulator that includes the step of interrupting the automatic sequencing of the therapy sequence. The Specification does not provide a lexicographical definition of “interrupt,” which is commonly understood to mean “to break the continuity of (something) in time.”6 The Specification states that a person may cause the controller to interrupt the sequencing process so that it continues to operate the current therapy rather than progressing to the next sequential therapy. Spec. para. [0033]. In another variation, a user interrupts the sequencing to return to a preceding therapy. Spec. para. [0034]; see also App. Br. 9 (identifying this as the claimed subject matter). These examples are consistent with the ordinary meaning in that the action of the person breaks the continuity of the automatic sequence. Claim 22 does not specify the cause of the interruption, and we do not import into the claim the example from the Specification that a person causes the interruption. See, e.g., In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.). Therefore, claim 22 calls for the continuity of the automatic sequence to be broken. 5 Appellants argue claims 22-24 as a group, and we select claim 22 as representative. App. Br. 15; see 37 C.F.R. § 41.37(c)(1)(vii)(2011). 6 Interrupt: To break in upon (an action, process, or condition, esp. speech or discourse); to break the continuity of (something) in time; to break off, to hinder the course or continuance of, cause to cease or stop (usually temporarily); v. trans., def. 1.a., OXFORD ENGLISH DICTIONARY (1989) (available at http://www.OED.com). We discern nothing in the Specification inconsistent with this ordinary meaning. Appeal 2010-004591 Application 11/260,836 12 The Examiner found that Marchal discloses that sequencing can be interrupted by the patient. Ans. 8 (citing Marchal, col. 4, ll. 4-6; col. 5, ll. 60-67; fig. 8b); see also Ans. 4 Marchal discloses that processor 58 can make changes in the stimulation signal 52 based upon input 70 from a sensor 54 that measures a patient parameter (e.g., temperature). Marchal, col. 4, ll. 1-19; fig. 4. This change of stimulation signal 52 by processor 58 from the sequence to another therapy (altered stimulation signal 52) is an interruption as called for in claim 22. Appellant argues that “[a]djusting a stimulation signal is not the same as interrupting an automatic sequencing.” Reply Br. 6. This conclusory assertion is unaccompanied by a cogent explanation of how adjusting stimulation as disclosed by Marchal differs from an interruption as claimed, and is unpersuasive of error in the Examiner’s finding. Accordingly, we sustain the rejection of claims 22-24 as anticipated by Marchal. Claims 1-11 and 13-24 as unpatentable over Boveja Claims 1-11 and 13-21 Independent claim 1 calls for storing a plurality of neurostimulation therapy programs comprising a therapy sequence in storage in the IMD. Independent claims 10, 14, and 20 similarly call for the programs to be stored in the IMD. The Examiner found that Boveja’s medical device is capable of being implanted. Ans. 5, 9. The Examiner provides no citation to the reference or Appeal 2010-004591 Application 11/260,836 13 technical reasoning in support of this finding. Id. For the reasons that follow, this finding is not supported by a preponderance of the evidence. Boveja does not explicitly disclose that external stimulator 42 may be implanted. Boveja, passim. Boveja’s system and method utilizes an implanted-lead receiver and an external stimulator 42 that stores the predetermined programs. Boveja, Abstract; col. 1, ll. 49-57; col. 10, ll. 38-40. External stimulator 42 may be clipped on a belt or stored in a pocket or other carrying device. Boveja, col. 10, ll. 38-42; fig. 10. External stimulator 42 includes a light emitting diode that turns “on” to indicate that its external coil 46 is correctly positioned relative to coil 48. Boveja, col. 10, l. 66-col. 11, l. 2. The fact that such an indicator must be seen by a patient suggests that the device is not intended to be implanted in a patient. Therefore, we agree with Appellant that Boveja does not disclose storing a plurality of neurostimulation therapy programs comprising a therapy sequence in an IMD as called for in independent claim 1. See App. Br. 15. As such, we do not sustain the rejection of independent claims 1, 10, 14, and 20 and their respective dependent claims 2-9, 11, 13, 15-19, and 21. Claims 22-24 Appellant presents no argument for claims 22-24. App. Br. 15-16, passim; Reply Br. passim. For that reason, we affirm the rejection of these claims. See Ex Parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (citing Hyatt v. Dudas, 551 F.3d 1307, 1313-14 (Fed. Cir. 2008) for the proposition that the Board may treat arguments appellant failed to make as waived). Appeal 2010-004591 Application 11/260,836 14 DECISION We reverse the Examiner’s decision to reject claims 1-11 and 13-24 under 35 U.S.C. § 103(a) as unpatentable over Stypulkowski. We reverse the Examiner’s decision to reject claims 1-11 and 13-21 under 35 U.S.C. § 102(e) as anticipated by Marchal. We affirm the Examiner’s decision to reject claims 22-24 under 35 U.S.C. § 102(e) as anticipated by Marchal. We reverse the Examiner’s decision to reject claims 1-11 and 13-21 under 35 U.S.C. § 103(a) as unpatentable over Boveja. We affirm the Examiner’s decision to reject claims 22-24 under 35 U.S.C. § 103(a) as unpatentable over Boveja. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED-IN-PART mls