Ex Parte GerberDownload PDFPatent Trial and Appeal BoardDec 9, 201311116932 (P.T.A.B. Dec. 9, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MARTIN T. GERBER __________ Appeal 2011-009063 Application 11/116,932 Technology Center 3700 __________ Before LORA M. GREEN, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1,2 under 35 U.S.C. § 134 involving claims to an implantable neurostimulator. The Examiner rejected the claims as failing to comply with the written description requirement, as anticipated, and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. 1 Appellant identifies the Real Party in Interest as Medtronic, Inc. (see App. Br. 3). 2 Appellant identifies a related appeal in US application 11/116,953, which is Appeal 2011-009697 (see App. Br. 3). Appeal 2011-009063 Application 11/116,932 2 Statement of the Case Background The Specification teaches “an implantable neurostimulator for delivering neurostimulation therapy to a patient in both a trial mode and a chronic mode . . . . If the trial mode indicates desirable efficacy, the neurostimulator enters a chronic mode in which the neurostimulator delivers neurostimulation on a permanent basis over an extended period of time, such as several months or years.” (Spec. 6 ¶ 0029). The Claims Claims 27 and 29-54 are on appeal. Claim 27 is representative and reads as follows: 27. An implantable neurostimulator comprising: a neurostimulation generator; a processor that controls the neurostimulation generator to generate neurostimulation in a trial mode as a first operating mode upon initial implantation of the neurostimulator and before generation of electrical stimulation in any chronic mode by the neurostimulation generator, to evaluate efficacy of the neurostimulator; and one or more sensors that sense one or more parameters related to a patient during the trial mode, wherein the processor controls the neurostimulation generator to generate neurostimulation in the chronic mode after completion of the trial mode and only if the trial mode indicates that the neurostimulator provides efficacious therapy to the patient, wherein the processor controls the neurostimulation generator to generate neurostimulation in the chronic mode according to a set of electrical stimulation parameter values that is different than any sets of electrical stimulation parameter values that define neurostimulation generated during the trial mode. Appeal 2011-009063 Application 11/116,932 3 The Issues A. The Examiner rejected claims 27, 29-43, 46-48, and 52-54 under 35 U.S.C. § 112, first paragraph as failing to comply with the written description requirement (Ans. 4-5). B. The Examiner rejected claims 44, 45, 50, and 51 under 35 U.S.C. § 102(e) as anticipated by King3 (Ans. 5-6). C. The Examiner rejected claim 49 under 35 U.S.C. § 103(a) as obvious over King and Swoyer4 (Ans. 6-7). A. 35 U.S.C. § 112, first paragraph The Examiner finds that “claims 27, 29, 44 and 51 require that the stimulation parameter values generated in the chronic mode are different than, or not based on, any sets of parameter values that define neurostimulation during the trial mode” (Ans. 4). The Examiner finds that the “appellant has not pointed out in the response where these features/embodiments where found in the originally filed specification” (Ans. 4). The Examiner finds that “there is no disclosure that the parameters could not be parameters used during the trial period or even based on the parameters used during the trial period. While the parameters may be ‘new’ they are not disclosed as necessarily being different” (Ans. 4-5). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that the Specification fails to provide descriptive support for “a set of electrical stimulation parameter values that is different than any sets of electrical stimulation parameter values that 3 King, J. D. H., US 7,146,223 B1, issued Dec. 5, 2006. 4 Swoyer et al., US 7,065,412, B2, issued Jun. 20, 2006. Appeal 2011-009063 Application 11/116,932 4 define neurostimulation generated during the trial mode” as required by claim 27? Findings of Fact 1. The Specification teaches that the “invention is directed to a chronic implantable neurostimulator that supports both trial and chronic modes of operation. In particular, the neurostimulator is designed to be used as both a trial neurostimulator and a permanent, or chronic, neurostimulator. (Spec. 2 ¶ 0008). 2. The Specification teaches that: The authorization to continue use in a chronic mode may be provided in a variety of ways. For example, the clinician may simply download an authorization code to the implanted neurostimulator, which authorizes the neurostimulator to continue operation. The authorization code may unlock the neurostimulator from a frozen state, or unlock parameters or programs necessary for chronic operation. Alternatively, the clinician may reprogram the implanted neurostimulation device by downloading new parameters or programs that govern the chronic mode. In general, the chronic mode is intended for relatively long term stimulation therapy over an extended, indefinite time period. However, it may be possible for a patient to discontinue the therapy at any time using a patient programmer. (Spec. 3-4 ¶ 0014). 3. The Specification teaches that In the chronic mode, neurostimulator 24 is reactivated and enabled for continued delivery of neurostimulation therapy. In this case, neurostimulator 24 may receive simply the authorization command to invoke a set of parameters or a program stored in the neurostimulator to support the chronic mode. Alternatively, neurostimulator 24 may receive a new Appeal 2011-009063 Application 11/116,932 5 parameter or program via the clinician programmer 34 or patient programmer 36, or be entirely reprogrammed. (Spec. 13-14 ¶ 0060). 4. The Specification teaches that if “the results of the trial period are favorable, the physician may activate the chronic mode of neurostimulator 24 . . . patient programmer 36 or physician programmer 34 may be used to download at least some updated parameters, settings, and other operational information to modify stimulation therapy based upon information received from the trial period” (Spec. 21 ¶ 0088). 5. The Specification teaches that “authorization may serve to unlock additional features of the implanted stimulator. As examples, a clinician or administrator, or a manufacturer of the implanted stimulator, may provide an authorization to activate features such as a voiding diary, different algorithms, different stimulation patterns and the like” (Spec. 21 ¶ 0089). Principles of Law “[I]t is the specification itself that must demonstrate possession. And while the description requirement does not demand any particular form of disclosure, . . . or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement” Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). Analysis The Examiner finds that “there is no disclosure that the parameters could not be parameters used during the trial period or even based on the parameters used during the trial period” (Ans. 4). Appeal 2011-009063 Application 11/116,932 6 Appellant contends that the “disclosure also describes unlocking features not available in the trial mode including, e.g., a voiding diary, different algorithms, different stimulation patterns, and the like” (App. Br. 11). We find that Appellant has the better position. As we interpret claim 27, the phrase “a set of electrical stimulation parameter values that is different than any sets of electrical stimulation parameter values that define neurostimulation generated during the trial mode” cannot simply refer to trial mode parameters which are newly loaded, but requires that the parameter are, in fact, different than any parameters used in the trial mode. The Specification teaches that the “neurostimulator 24 may receive a new parameter or program” which is reasonably understood as a parameter not previously tested, as well as “be entirely reprogrammed” which even more clearly indicates the use of programming not previously used in the trial mode (see Spec. 14 ¶ 0060; FF 3). The Specification also teaches the activation of new features after transition from trial mode to chronic mode, including different stimulation patterns (FF 5), which provides substantial descriptive support for the use of entirely different parameters in the chronic mode relative to the trial mode. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that the Specification fails to provide descriptive support for “a set of electrical stimulation parameter values that is different than any sets of electrical stimulation parameter values that define neurostimulation generated during the trial mode” as required by claim 27. Appeal 2011-009063 Application 11/116,932 7 B. 35 U.S.C. § 102(e) over King The Examiner finds that “King discloses an implantable neurostimulator 10 that includes a neurostimulation generator 12 and a processor that controls the neurostimulation” (Ans. 5). The Examiner finds that King teaches “the processor controls the neurostimulation generator to generate neurostimulation in a chronic mode . . . according to the stimulation set found to have the highest efficacy (Col. 6, lines 33-37). This stimulation program is newer relative to programs used in the trial mode, since it is the most recent program to be utilized” (Ans. 5). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that King anticipates claims 44, 45, and 50? Findings of Fact 6. King teaches that a “Spinal Cord Stimulation (SCS) system 10 . . . comprises an Implantable Pulse Generator (IPG) 12, a lead extension 14, an electrode lead 16, and an electrode array 18. The IPG 12 generates stimulation current for implanted electrodes that make up the electrode array 18” (King, col. 3, ll. 51-55). 7. King teaches that the “steps of selecting a trial set of stimulation parameters (block 24) and providing stimulation in accordance with the selected trial set of stimulation parameters (block 26) are repeated until all of the trial stimulation parameter sets have been tested” (King, col. 5, ll. 8-11). Appeal 2011-009063 Application 11/116,932 8 8. King teaches that after “all of the trial stimulation parameter sets have been tested, the trial stimulation parameter sets are ranked (block 30) based upon the patient’s evaluation (and/or based upon alternative evaluation of selected physiological parameters of the patient) of the effectiveness of each trial stimulation parameter set” (King, col. 5, ll. 12-17). 9. King teaches that “two possible stimulation sets are then evaluated to see if one comprises the most effective stimulation set . . . If so . . . then that set is selected as the best parameter stimulation set for the stimulation that is to be provided (block 46) whenever the operating program of the SCS system (or other neural system) determines stimulation is needed” (King, col. 6, ll. 31-37). Principles of Law “A single prior art reference that discloses, either expressly or inherently, each limitation of a claim invalidates that claim by anticipation.” Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005). Analysis Claim 44 We begin with claim interpretation, since before a claim is properly interpreted, its scope cannot be compared to the prior art. The limitations at issue is “wherein the processor controls the electrical stimulation generator to generate electrical stimulation in the chronic mode according to a new program relative to programs that define neurostimulation generated during the trial mode” in claim 44. While we have found above that the Specification provides support for entirely different stimulation patterns during trial or chronic mode Appeal 2011-009063 Application 11/116,932 9 stimulation periods, the Specification does not exclude simply selecting “new in time” parameters as a “new program” in claim 44. Indeed, Appellant acknowledges that “the Examiner’s ‘new in time’ chronic mode parameters and/or programs interpretation of Appellant’s disclosure is one possibility contemplated” (App. Br. 10). Therefore, we broadly interpret the “new program” requirement of claim 44 to encompass the situation where the processor has a program which is newer than the last program tested during the trial mode. King teaches an implantable electrical stimulator with a stimulation generator, sensors and processors (FF 6) where the processor is first configured in a trial mode to test and rank stimulation parameters (FF 7-8), and where two stimulation sets are tested with the most effective stimulation set used when “the SCS system (or other neural system) determines stimulation is needed” (King, col. 6, ll. 36-37; FF 9). Since King compares two stimulation sets, where the first set is the most effective stimulation set, King will inherently use this newer “new program” stimulation set in the place of the second, less effect stimulation set. Appellant contends that “King does not disclose whether the IPG will be newly programmed to deliver stimulation according to the selected best parameter set or whether the device will continue to deliver stimulation according to this stimulation set already programmed into the device during the testing stage” (App. Br. 16). We are not persuaded. Where the first set tested is more effective than the second set, the processor will then be programmed to use the first set. To the extent that both programs may have been present in the Appeal 2011-009063 Application 11/116,932 10 processor during the trial mode, the processor no longer used the first set when testing with the second set, so the first set is a “new program” consistent with our claim interpretation above. To the extent that the software or program impacts the structure of the processor, rather than the intended use of the processor, programming the processor with the first set of parameters represents the use of a program newer-in-time than the second set of parameters, when the first set of parameters replaces the second set of parameters. Claims 45 and 50 Appellant contends that “King does not disclose controlling ‘the electrical stimulation generator to stop operating after the trial period until authorization to continue operating is received,’ as required by claim 45. Rather, King continues the trial mode until a ‘best’ stimulation parameter set is identified” (App. Br. 17). The Examiner finds that “King discloses that the stimulation is provided according to the best parameter set whenever the system determines stimulation is needed. Therefore, the neurostimulator will stop operating (i.e., delivering neurostimulation) until authorization is received to deliver neurostimulation” (Ans. 11). We find that Appellant has the better position. Claim 45 requires the “electrical stimulation generator to stop operating after the trial period until authorization to continue operating is received.” The Examiner does not identify, and we do not find, any specific teaching in King where authorization to continue operating is taught. In the absence of such a teaching, the claims are not properly anticipated. Appeal 2011-009063 Application 11/116,932 11 Conclusion of Law The evidence of record supports the Examiner’s conclusion that King anticipates claim 44. The evidence of record does not support the Examiner’s conclusion that King anticipates claims 45 and 50. C. 35 U.S.C. § 103(a) over King and Swoyer Appellant does not separately argue the claim in this obviousness rejection. Having affirmed the rejection of claim 44 over King for the reasons given above, we find that the further combination with Swoyer renders claim 49 obvious for the reasons given by the Examiner (Ans. 6-7). SUMMARY In summary, we reverse the rejection of claims 27, 29-43, 46-48, and 52-54 under 35 U.S.C. § 112, first paragraph as failing to comply with the written description requirement. We affirm the rejection of claim 44 under 35 U.S.C. § 102(e) as anticipated by King. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claim 51 as this claim was not argued separately. We reverse the rejection of claims 45 and 50 under 35 U.S.C. § 102(e) as anticipated by King. We affirm the rejection of claim 49 under 35 U.S.C. § 103(a) as obvious over King and Swoyer. 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-IN-PART lp Copy with citationCopy as parenthetical citation