Ex Parte Alford et alDownload PDFPatent Trial and Appeal BoardNov 27, 201713749237 (P.T.A.B. Nov. 27, 2017) Copy Citation 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. 13/749,237 01/24/2013 Jamu Alford C00004225.USU2/LG10137L33 1910 71996 7590 11/29/2017 SHUMAKER & SIEFFERT , P.A 1625 RADIO DRIVE , SUITE 100 WOODBURY, MN 55125 EXAMINER MEHL, PATRICK M ART UNIT PAPER NUMBER 3777 NOTIFICATION DATE DELIVERY MODE 11/29/2017 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): pairdocketing @ ssiplaw.com medtronic_neuro_docketing @ cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMU ALFORD, STEVEN M. GOETZ, LOTHAR KRINKE, MARK S. LENT, ERIK R. SCOTT, XUAN K. WEI, and JOHN D. WELTER1 Appeal 2016-008766 Application 13/749,237 Technology Center 3700 Before ERIC B. GRIMES, RICHARD J. SMITH, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a system and method for planning neuromodulation therapy and a system for planning and delivering neuromodulation therapy, which have been rejected as obvious and being directed to patent-ineligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Medtronic, Inc. (Appeal Br. 3.) Appeal 2016-008766 Application 13/749,237 STATEMENT OF THE CASE The Specification states that the “number of evolving therapeutic treatments involving modulation of neural tissue using electrical stimulation is rising, such as Deep Brain Stimulation (DBS) for reducing tremor in Parkinson’s disease.” (Spec. 1.) Claims 1—49 are on appeal. Claims 1,21, and 41 are illustrative and read as follows: 1: A neuromodulation therapy planning system, comprising: an ultrasound transducer array comprising at least one ultrasound transducer, the array adapted for external application to a portion of a patient’s body; and a control unit comprising: an ultrasound control unit coupled to the ultrasound transducer array and configured to control delivery of ultrasound waveforms for causing neuromodulation of neural tissue in a patient; a data collection unit to acquire data indicating a response to the neuromodulation; a data analysis unit configured to analyze the acquired data to accumulate correlation data between a response to the neuromodulation and an ultrasound control parameter used to deliver the ultrasound waveforms; and a reporting module configured to report the correlation data to enable identification of at least one therapy parameter to be used to deliver a neuromodulation therapy to the patient by a therapy delivery system that is different than the neuromodulation therapy planning system. 21: A method for planning a neuromodulation therapy, the method comprising: delivering, via an ultrasound transducer array of a neuromodulation therapy planning system, ultrasound 2 Appeal 2016-008766 Application 13/749,237 waveforms for causing neuromodulation of neural tissue in a patient, wherein the ultrasound transducer array is configured to externally apply the ultrasound waveforms to a portion of a body of the patient and comprises at least one ultrasound transducer; acquiring data indicating a response to the neuromodulation; analyzing the acquired data to determine correlation data between a response to the neuromodulation and an ultrasound control parameter used to deliver the ultrasound waveforms; and reporting the correlation data to enable identification of at least one therapy parameter to be used to deliver a neuromodulation therapy to the patient by a therapy delivery system that is different than the neuromodulation therapy planning system, wherein at least one of acquiring, analyzing, and reporting is performed by a control unit. 41: A system for planning and delivering a neuromodulation therapy, the system comprising: a therapy delivery portion; and an external portion different than the therapy delivery portion, the external portion comprising: an ultrasound transducer array comprising at least one ultrasound transducer and adapted for external application to a portion of a patient’s body; and a control unit comprising: an ultrasound control module coupled to the ultrasound transducer array and configured to control delivery of ultrasound waveforms for causing neuromodulation of neural tissue in a patient, a data collection unit to acquire data indicating a response to the neuromodulation, 3 Appeal 2016-008766 Application 13/749,237 a data analysis unit configured to analyze the acquired data to determine a correlation data between a response to the neuromodulation and an ultrasound control parameter used to deliver the ultrasound waveforms, and a reporting module configured to report the correlation data, wherein the control unit is configured to identify at least one therapy parameter to be used to deliver a neuromodulation therapy, wherein the therapy delivery portion comprises a therapy control unit and a therapy delivery module for delivering the neuromodulation therapy, the therapy delivery portion being configurable to deliver the neuromodulation therapy according to the at least one therapy parameter identified via the external portion. The claims stand rejected as follows: Claims 1—49 under 35 U.S.C. § 101 as being directed to patent- ineligible subject matter (Ans. 2); Claims 1, 15, 19-21, 35, and 39^12 under 35 U.S.C. § 103(a) as obvious based on Yoo2 and Gertner3 (Ans. 3); Claims 2—4, 6, 22-24, and 26 under 35 U.S.C. § 103(a) as obvious based on Yoo, Gertner, and Mace4 (Ans. 7); Claims 5 and 25 under 35 U.S.C. § 103(a) as obvious based on Yoo, Gertner, Mace, and’t Hoen5 (Ans. 8); 2 Seung-Schik Yoo, et al., Focused ultrasound modulates region-specific brain activity, 56 NeuroImage 1267-1275 (2011). 3 Gertner, US 2011/0172527 Al, pub. July 14, 2011. 4 Emilie Mace, et al., Functional ultrasound imaging of the brain, 8(8) Nature Methods 662-664 (2011). 5 ‘t Hoen, US 4,670,683, iss. June 2, 1987. 4 Appeal 2016-008766 Application 13/749,237 Claims 7-12, 16, 17, 27-32, 36, 37, and 46^19 under 35 U.S.C. § 103(a) as obvious based on Yoo, Gertner, Deisseroth,6 and Haro7 (Ans. 9); Claims 18 and 38 under 35 U.S.C. § 103(a) as obvious based on Yoo, Gertner, Deisseroth, Haro, and Bova8 (Ans. 12); Claims 13 and 33 under 35 U.S.C. § 103(a) as obvious based on Yoo, Gertner, Deisseroth, Haro, and Ishibashi9 (Ans. 13); Claims 14 and 34 under 35 U.S.C. § 103(a) as obvious based on Yoo, Gertner, and Cupples10 (Ans. 14); Claim 43 under 35 U.S.C. § 103(a) as obvious based on Yoo, Gertner, and Wilser* 11 (Ans. 15); Claim 44 under 35 U.S.C. § 103(a) as obvious based on Yoo, Gertner, and Della Roca12 (Ans. 15); and Claim 45 under 35 U.S.C. § 103(a) as obvious based on Yoo, Gertner, and DiLorenzo.13 (Ans .16.) I The Examiner has rejected all of the claims on appeal on the basis that they are “directed to the natural phenomenon of a correlation between a response to the modulation and an ultrasound control parameter, which is a 6 Deisseroth et al., US 2009/0112133 Al, pub. Apr. 30, 2009. 7 A.M. Rollan Haro et al., Electro-sensitisation of mammalian cells and tissues to ultrasound: a novel tumour treatment modality, 222 Cancer Letters 49-55 (2005). 8 Bova et al., US 2009/0220136 Al, pub. Sept. 3, 2009. 9 Ishibashi et al., US 6,267,734 Bl, iss. July 31, 2001. 10 Cupples et al., US 6,675,038 B2, iss. Jan. 6, 2004. 11 Wilser et al., US 2007/0066902 Al, pub. Mar. 22, 2007. 12 Della Rocca et al., US 2011/0152748 Al, June 23, 2011. 13 DiLorenzo, US 2010/0023089 Al, pub. Jan. 28, 2010. 5 Appeal 2016-008766 Application 13/749,237 mathematical algorithm fundamental in the practice of the art of ultrasound image analysis.” (Ans. 2.) The Examiner finds that “[t]he idea of correlating natural phenomenon data with control parameters can be considered to be fundamental in many fields and sciences” and “[t]he additional extra solution activities/elements including therapy delivery portion, [etc.] ... do not add a meaningful limitation as the generically cited limitations are well- understood, routine and conventional activities/elements used by those of ordinary skill in the art in order to collect data for determining the correlation and output the results.” {Id.) The Examiner also finds that “[t]he claims also do not recite any means/steps of improvements to a technological field with the generic recitations; and/or improvements to the functioning of the computer.” {Id. at 2-3.) The Examiner concludes that the claims “do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself.” {Id. at 2.) We agree with the Examiner that, under Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S.Ct. 1289 (2012), the claims are directed to inventions that are not eligible for patenting. In Mayo, the Court considered a claimed method that required administering a drug to a subject, determining the level of a metabolite of the drug in the subject, and using certain thresholds of metabolite level to indicate a need to increase or decrease dosage of the drug. Id. at 1295. The Court noted that the claims “set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” Id. at 1296. The 6 Appeal 2016-008766 Application 13/749,237 Court held that the dispositive question was: “do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?” Id. at 1297. The Court held that the claim’s “administering” step, “determining” step, and “wherein” clauses did not transform the claim into a patentable application of a natural law, id. at 1297-98: “The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations.” Id. at 1298. The Court’s analysis in Mayo is directly applicable to the claims here, which are directed to a system (claims 1 and 41) or method (claim 21) for planning (or planning and delivering in claim 41) neuromodulation therapy, where the invention consists of applying ultrasound under certain parameters to cause neuromodulation—similar to the “administering” step of Mayo— then determining a correlation between those parameters and a response to the neuromodulation—similar to the “determining” step of Mayo—and reporting the correlation—similar to the “wherein” clauses of Mayo. Although claim 41 adds a therapy delivery portion to the neuromodulation planning system, this addition represents “well-understood, routine, conventional activity previously engaged in by researchers in the field,” Mayo, 132 S. Ct. at 1294, as demonstrated by Yoo, which is discussed in detail below. Thus, the addition of this conventional step to the natural phenomenon or law of nature (a parameter associated with effective neuromodulation therapy) does not “transform unpatentable natural correlations into patentable applications of those regularities.” Id. at 1298. 7 Appeal 2016-008766 Application 13/749,237 Just as in Mayo, the claims here inform a relevant audience of a law of nature (specifically, a correlation between a neuromodulation therapy parameter and the effect of the therapy) and “any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community.” Id. Thus, the claims are directed to a patent- ineligible natural phenomenon or law of nature. Appellants argue that claim 41 “do[es] not seek to tie up all techniques for accumulating ‘correlation data between a response to the neuromodulation and an ultrasound control parameter used to deliver the ultrasound waveforms’ such that others cannot correlate ‘natural phenomenon data with control parameters.(Appeal Br. 32.) Rather, Appellants argue that “claim 41 requires a very specific system with very specific components. Indeed, the particular system for planning and delivering a neuromodulation therapy recited by claim 41 does not pre-empt all other possible ways that a neuromodulation therapy may be planned and/or delivered and therefore is patent eligible.” {Id. at 34.) Appellants rely on the same argument with respect to claims 1 and 21. {See id. at 35- 37.) This argument is unpersuasive. The Mayo Court stated that “Prometheus argues that, because the particular laws of nature that its patent claims embody are narrow and specific, the patents should be upheld. . . . But the underlying functional concern here is a relative one: how much future innovation is foreclosed relative to the contribution of the inventor.” Mayo, 132 S. Ct. at. 1303. In this case, Appellants have not even claimed to have discovered any particular correlations between ultrasound parameters and neuromodulation therapy effects and yet they seek the right to exclude 8 Appeal 2016-008766 Application 13/749,237 others from discovering such correlations in the future. See id. at 1301 (“[TJhere is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to ‘apply the natural law,’ or otherwise forecloses more future invention than the underlying discovery could reasonably justify.”); see also Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F3dl371, 1379 (Fed. Cir. 2015) (“While preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility. . . . Where a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot.”). Claims 2-20, 22 40, and 42^49 have not been argued separately and therefore fall with claims 1, 21, and 41. 37 C.F.R. § 41.37(c)(l)(iv). II The Examiner has rejected claims 1,15, 19-21, 35, and 39^42 under 35 U.S.C. § 103(a) as obvious based on Yoo and Gertner. The Examiner finds that Yoo discloses a system meeting all of the limitations of claims 1, 21, and 41, except that “Yoo does not explicitly disclose a therapy delivery system that is different than the neuromodulation therapy planning system.” (Ans. 3-5.) The Examiner finds that Gertner discloses a system and method for delivering neuromodulatory therapy using ultrasound, as well as “by different systems such as microwave, light, vibration, ionizing and nonionizing radiation which are different systems than the ultrasound system used for the ‘neuromodulation therapy planning system.’” {Id. at 5-6.) The Examiner concludes that it would have been obvious “to have used the 9 Appeal 2016-008766 Application 13/749,237 system and method of Yoo with the applicability of the feedback correlation for the localization of the modulation of the neural tissue towards the application of a local therapy such as total ablation as taught by Gertner in order to correctly pin point the right local neural region to treat with a minimum damage to the surrounding tissue.” {Id. at 6.) We agree with the Examiner that the system of claim 1 would have been obvious to a person of ordinary skill in the art based on Yoo and Gertner. Yoo discloses “the in vivo feasibility of using focused ultrasound (FUS) to transiently modulate (through either stimulation or suppression) the function of regional brain tissue in rabbits.” (Yoo 1267, abstract.) Yoo’s Figure 1 is reproduced below: Figure 1 shows a diagram of Yoo’s experimental apparatus. {Id., legend to Figure 1.) The apparatus includes an ultrasound transducer array (“Transducer”) and an ultrasound control unit (“Control Computer,” “Function Generator,” etc.). Yoo discloses that [t]he visual and motor areas of the rabbit brain were subjected to sonication to test the neuro-modulatory potential of FUS. . . . [R]eal-time fMRI [functional MRI] was employed to map the visual and motor areas of the brain. A gradient-echo (single shot) echo-planar imaging sequence was used ... to image most 10 Appeal 2016-008766 Application 13/749,237 of the brain in the axial orientation to obtain the T2*-weighted blood-oxygenation-level-dependent (BOLD) fMRI signal. {Id. at 1268, right col.) Since fMRI imaging was used to evaluate the effect of the administered ultrasound, Yoo’s system included a “data collection unit to acquire data indicating a response to the neuromodulation,” as recited in claim 1. Yoo discloses that “[t]he image data were immediately transferred to an adjacent computer via a file-transfer-protocol (FTP) over the Ethernet connection, and the stimulus-related activation in the brain was identified” {id. at 1269, left col.) under different parameters (id. at 1269, right col.). Yoo’s system thus included a data analysis unit to accumulate correlation data between ultrasound parameters and neuromodulation, as recited in claim 1. Yoo’s system also includes a reporting module configured to report the correlation data. For example, Figures 3D through 3F show “[a]n example of forepaw motion recording from an animal. . . recorded upon the completion of 1 s-long sonication in the motor cortex (E) and away from the motor cortex (F).” {Id. at 1271.) The Examiner cited Gertner for its disclosure of a therapy delivery system that is different from the therapy planning system because Yoo does not disclose this aspect of claims 1 and 21. (Ans. 5-6.) However, we conclude that the relevant language merely identifies an intended use of the reported correlation between an ultrasound therapy parameter and a neuromodulation response. “[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Inti, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 11 Appeal 2016-008766 Application 13/749,237 2002). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Here, claim 1 is directed to a neuromodulation therapy planning system that includes, among other things, “a reporting module configured to report the correlation data to enable identification of at least one therapy parameter to be used to deliver a neuromodulation therapy to the patient by a therapy delivery system that is different than the neuromodulation therapy planning system” (emphasis added). Thus, the reporting module is required simply to report the correlation data that is accumulated by the data analysis unit. Viewers of the correlation data can then use it to identify a correlation between a therapy parameter and a response, and to deliver therapy, but the claimed system doesn’t do so. Thus, the recitation of what the reported correlation data is intended to be used for is not a limitation of the claimed system, it is simply a recitation of an intended use for those data. Since the correlation data does not limit the claimed system in any way, the prior art need not disclose such use of correlation data in order to anticipate or make obvious the system of claim 1. Claim 21 is similar: it recites “reporting the correlation data to enable identification of at least one therapy parameter to be used to deliver a neuromodulation therapy to the patient by a therapy delivery system that is different than the neuromodulation therapy planning system.” Thus, the step of reporting correlation data allows, but doesn’t require, someone to identify a therapy parameter that can, but doesn’t have to be, used to deliver therapy. Thus, as with claim 1, the step of reporting correlation data in claim 21 12 Appeal 2016-008766 Application 13/749,237 recites an intended use of those data but does not require any particular use in order to meet the limitations of the claim. Appellants argue, with respect to claims 1 and 21, that “the Examiner has not cited any passage of Yoo that actually discloses using correlation data between a response to neuromodulation and an ultrasound control parameter used to deliver the ultrasound waveforms to identify at least one therapy parameter to be used to deliver a neuromodulation therapy.” (Appeal Br. 9.) Appellants also argue that “Gertner fails to cure the deficiencies of Yoo,” because “none of the techniques described by Gertner are related to identification of at least one therapy parameter to be used to deliver a neuromodulation therapy to a patient by a therapy delivery system that is different than a neuromodulation therapy planning system that also causes neuromodulation in the patient.” {Id. at 10-11.) As discussed above, however, the claim language that Appellants rely on does not recite a structural limitation of the system of claim 1 or an active step of the method of claim 21; it merely recites an intended use of that system and method. Appellants’ argument is therefore unpersuasive. Claim 41 differs from claim 1 in that it requires a “therapy delivery portion [that] comprises a therapy control unit and a therapy delivery module for delivering the neuromodulation therapy.” Gertner discloses a system for delivering neuromodulatory therapy using ultrasound; specifically, “a system to modulate an autonomic nerve in a patient utilizing transcutaneous energy delivery, the system including] ... a therapeutic energy device comprising a transducer for delivering energy from outside the patient.” (Gertner 116.) Gertner states that “[i]n some embodiments, the therapeutic energy device is configured to deliver focused ultrasound.” {Id. at 119.) 13 Appeal 2016-008766 Application 13/749,237 Yoo states that its results suggest that “the FUS-mediated modulation of neuronal activity may also open new avenues of clinical applications for the treatment of various neurological and psychiatric illnesses.” (Yoo 1275, left col.) Thus, it would have been obvious to use Gertner’s therapy delivery system to administer neuromodulatory therapy using the parameters that Yoo determined to be effective using its separate system. Claim 41 also states that “the therapy delivery portion [is] configurable to deliver the neuromodulation therapy according to the at least one therapy parameter identified via the external portion.” As with claims 1 and 21, however, this limitation reflects nothing more than an intended use of the claimed system. It requires that the therapy delivery portion of the claimed system can be configured to deliver therapy according to a parameter identified using the external portion of the claimed system but it does not structurally limit the therapy delivery portion beyond requiring it to be capable of being programmed to use different parameters. Gertner states that its system “includes a processor comprising an input for receiving information regarding energy and power to be delivered to a treatment region.” (Gertner 116.) Thus, Gertner’s system meets the structural limitations of claim 41. Appellants argue that “claim 41 further recites that ‘the control unit is configured to identify at least one therapy parameter to be used to deliver a neuromodulation therapy’” and “the Examiner fails to identify any portions of Yoo or Gertner that disclose or suggest a control unit that identifies the at least one therapy parameter to be used to deliver a neuromodulation therapy.” (Appeal Br. 14.) 14 Appeal 2016-008766 Application 13/749,237 This argument fails for the same reason as the argument advanced by Appellants with respect to claims 1 and 21: it recites nothing more than an intended use. The claim language relied on by Appellants requires that the control unit is configured to identify an ultrasound parameter, nothing more. That parameter can, but need not, be used to deliver neuromodulation therapy, and the therapy delivery portion of the claimed system can, but need not, use the parameter identified by the control unit. The cited claim language therefore, like the language in claims 1 and 21 that is cited by Appellants, does not structurally limit the claim because it merely recites an intended use. Claims 15, 19, 20, 35, 39, 40, and 42 have not been argued separately and therefore fall with claims 1, 21, and 41. 37 C.F.R. § 41.37(c)(l)(iv). The Examiner rejected claims 2-4, 6, 22-24, and 26 under 35 U.S.C. § 103(a) based on Yoo, Gertner, and Mace, and rejected claims 5 and 25 under 35 U.S.C. § 103(a) based on Yoo, Gertner, Mace, and ’t Hoen. Appellants have waived arguments based on Mace or ’t Hoen by not advancing arguments specific to the teachings of these references. (See Appeal Br. 14-16.) We therefore affirm these rejections for the reasons discussed above. See 37 C.F.R. § 41.37(c)(l)(iv) (“Except as provided for in [rules not relevant here], any arguments or authorities not included in the appeal brief will be refused consideration by the Board for purposes of the present appeal.”); Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to contest a ground of rejection to the Board,. . . the PTO may affirm the rejection of the group of claims that the examiner rejected on that ground without considering the merits of those rejections.”). 15 Appeal 2016-008766 Application 13/749,237 III The Examiner has rejected claims 7-12, 16, 17, 27-32, 36, 37, and 46^19 as obvious based on Yoo, Gertner, Deisseroth, and Haro. All of these claims depend from one of claims 1, 21, or 41. With respect to claims 7-9, 27-29, 36, and 37, Appellants argue that the additional references do not overcome the deficiencies of Yoo and Gertner. (Appeal Br. 16-26.) These arguments are unpersuasive because, as discussed above, we conclude that claims 1,21, and 41 would have been obvious based on Yoo and Gertner. We therefore affirm the rejection of claims 7-9, 27-29, 36, and 37 under 35 U.S.C. § 103(a). With respect to claims 10, 46, and 47, Appellants again argue that Yoo and Gertner do not suggest using a therapy parameter for delivering neuromodulation therapy using a therapy delivery system that is different from the neuromodulation therapy planning system. (Appeal Br. 17-19.) Appellants rely on the same argument with respect to claims 11, 30, 31, 48, and 49. (Appeal Br. 19-22.) As discussed above, however, the claim language that Appellants rely on does not recite a structural limitation of the system of claim 1 or an active step of the method of claim 21; rather, the language merely recites an intended use of the system and method. Appellants’ argument is therefore unpersuasive. With respect to claim 11, Appellants also argue that the Examiner has provided no citations to Deisseroth or Haro in an attempt to disclose or suggest that “the data analysis unit is further configured to identify, based at least in part on the data indicating the response to the modulation acquired for each of the plurality of neural sites, the trajectory for delivery of the therapy delivery device,” as recited by claim 11. 16 Appeal 2016-008766 Application 13/749,237 (Appeal Br. 21.) Appellants rely on the same argument with respect to claim 31. {Id. at 21-22.) With respect to claim 12, Appellants argue that the Examiner has provided no citations to Deisseroth or Haro in an attempt to disclose or suggest that “the data analysis unit is further configured to identify, based at least in part on the data indicating the response to the modulation acquired for each of the plurality of neural sites, at least one therapy parameter to be used to deliver the electrical stimulation therapy by the therapy delivery system to the patient,” as recited by claim 12. (Appeal Br. 23.) Appellants rely on the same argument with respect to claim 32. (Mat23-24.) These arguments are unpersuasive, because the Examiner found (emphasis added): Regarding Claims 10-12 [and] 30-32 . . . Gertner teaches the use of intravascular probes (FIG.8B 5050 and 5055, and [0338]) used as [a] homing beacon to direct the externally applied energy for the imaging/therapeutic technology, therefore for determining the trajectory for the therapy delivery. Yoo and so does Gertner too, discloses the determination of the target site with predictive approaches ([0257] for Gertner) or with functional/physiological responses as discussed above for claim 1 and claim 21 for the determination of the activation region to be the target position of a therapeutic treatment. Moreover Yoo, and Gertner too, disclose imaging techniques allowing for determining the position of the target site which can be applied to different directions to optimize the direction for the delivering the therapy ([300] for Gertner). . . . However, Yoo and Gertner fail to disclose a plurality of neural sites and an identification of a target site for therapy delivery for each of the neural sites. Deisseroth et al. discloses multiple small ultrasound transducers (FIG.4B and [0023]) targeting one or more regions, with a comparative analysis to pinpoint to the desired target locations ([0046], ([0047]) for therapy delivery which can be achieved using multiple electric electrode for electrical stimulation therapy ([0049]) as for discussed for claims 8 and 38 above. 17 Appeal 2016-008766 Application 13/749,237 Therefore, it would have been obvious to a person of ordinary skills in the art at the time of the invention to have adapted the system and method of Gertner with combining more than one ultrasound transducers to target a plurality of neural sites as taught by Deisseroth to have each of them combined for comparative effective analysis to target one or more regions in order to define better delivery trajectories and better neural sites. (Ans. 11-12.) Thus, the Examiner found that the limitations added by claims 11, 12, 31, and 32 were disclosed by Deisseroth. Appellants have not pointed to any evidence, or provided any persuasive argument, showing that the Examiner’s finding in this respect is in error. We therefore affirm the rejection of claims 11, 12, 31, and 32 under 35 U.S.C. § 103(a). With respect to claims 16 and 17, Appellants argue that the Examiner has provided no citations to Deisseroth or Haro in an attempt to disclose or suggest that “the control unit is further configured to identify the at least one therapy parameter to be used to deliver the neuromodulation therapy by the therapy delivery system and the therapy delivery system comprises an implantable electrical stimulation system configurable to deliver the therapy using the identified therapy parameter,” as recited by claim 16. (Appeal Br. 24-25.) This argument is unpersuasive, because the Examiner found (emphasis added): Deisseroth et al. discloses a device and a method associated with the use of the device for noninvasive neuromodulation based on ultrasounds (Title) with a plurality of electrodes (FIGS.2B #251 to 255, FIG.4A #415 and 430) with the control unit coupled to the plurality of electrodes (FIG.l 102) and configured to control electrical stimulation delivery ([0049]) via the plurality of implantable electrical electrodes for causing modulation of neural activity (Fig.l and Figs.2B and 4B). Deisseroth discloses also that electrical nerve stimulation is well-established with 18 Appeal 2016-008766 Application 13/749,237 surgical implantable electrodes for deep brain stimulation ([0007] lines 1-4). (Ans. 9-10.) Thus, the Examiner found that the limitations added by claims 16 and 17 were disclosed by Deisseroth. Appellants have not pointed to any evidence, or provided any persuasive argument, showing that the Examiner’s finding in this respect is in error. We therefore affirm the rejection of claims 16 and 17 under 35 U.S.C. § 103(a). IV The Examiner has rejected claims 13, 14, 18, 33, 34, 38, and 43^45 as obvious based on Yoo, Gertner, Deisseroth, Haro, and one of Bova, Ishibashi, Cupples, Wilser, Della Roca, or DiLorenzo. (Ans. 12-16.) Appellants argue that these claims are patentable for the same reason as one of claims 1, 12, 17, 32, 33, or 41. (Appeal Br. 26-30.) These arguments are unpersuasive for the reasons discussed above. SUMMARY We affirm all of the rejections on appeal. 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 19 Copy with citationCopy as parenthetical citation