Ex Parte Iyer et alDownload PDFPatent Trial and Appeal BoardFeb 25, 201511276066 (P.T.A.B. Feb. 25, 2015) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ANAND IYER, RODNEY W. SALO, ANTHONY V. CAPARSO, and PAUL A. HAEFNER __________ Appeal 2012-005117 Application 11/276,066 Technology Center 3700 __________ Before DONALD E. ADAMS, LORA M. GREEN, and JEFFREY N. FREDMAN, Administrative Patent Judges. PER CURIAM DECISION ON APPEAL This is a decision on appeal 1 under 35 U.S.C. § 134 from the Examiner’s rejection of claims 1–28 and 40–45. 2 We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The Real Party in Interest is Cardiac Pacemakers, Inc. (App. Br. 2). 2 Claims 29–39 are also pending, but stand withdrawn from consideration (App. Br. 4). Appeal 2012-005117 Application 11/276,066 2 STATEMENT OF THE CASE The Specification discloses “devices and methods to stimulate nerves” (Spec. 1:4–5). The Specification discloses that the method or device of the invention “directs two or more energy waveforms to a desired neural stimulation target . . . [wherein] energy from each waveform alone is not sufficient to stimulate the neural target, but the combination of energy waveforms at the neural stimulation target is greater than the neural stimulation threshold for the target” (id. at 4:7–10). The Specification discloses that “[e]xamples of waveforms that may be used include acoustic waveforms such as ultrasound waveforms,” among others (id. at 4:11–12). Claims 1 and 40 are the independent claims on appeal and read as follows: 1. A device, comprising: at least a first and a second transducer, wherein the first transducer is configured to be positioned to direct a first energy wave toward a neural target, and the second transducer is configured to be positioned to direct a second energy wave toward the neural target; a controller connected to the transducers and configured to generate the first energy wave with a first predetermined phase and a first predetermined amplitude from the first transducer and to generate the second energy wave with a second predetermined phase and a second predetermined amplitude from the second transducer, the first and second amplitudes being selected so that a neural stimulation threshold is reached only during constructive wave interference, and the first and second phases being selected so that the first and second energy waves constructively interfere at the neural target. 40. A method for stimulating a neural target, comprising: generating a first energy wave from a first position toward the neural target, the first energy wave having a first phase and having a first predetermined amplitude insufficient to stimulate the neural target by itself; and Appeal 2012-005117 Application 11/276,066 3 generating a second energy wave from a second position toward the neural target, the second energy wave having a second phase and having a second predetermined amplitude insufficient to stimulate the neural target by itself, the first phase of the first energy wave and the second phase of the second energy wave being selected to provide constructive interference at the neural target for use in delivering an energy capable of stimulating the neural target. The claims stand rejected under 35 U.S.C. § 103(a) as follows: I. Claims 1–6, 9, 16, 22, 23, 24, 40, 41, 42, 44, and 45 over the combination of Vitek 3 and Gafni 4 (Ans. 5–7); and II. Claim 12 over the combination of Vitek, Gafni, and Kuzma 5 (Ans. 7–8); III. Claim 13 over the combination of Vitek, Gafni, and DiLorenzo 6 (Ans. 8); IV. Claim 14 over the combination of Vitek, Gafni, and Ashley 7 (Ans. 8–9); V. Claim 15 over the combination of Vitek, Gafni, and Werneth 8 (Ans. 9); VI. Claim 25–28 over the combination of Vitek, Gafni, and Montegrande 9 (Ans. 10). 3 Vitek et al., US 2006/0058678 A1, published Mar. 16, 2006. 4 Gafni et al., US 2007/0010860 A1, published Jan. 11, 2007. 5 Kuzma et al. US 6,259,951 B1, issued July 10, 2001. 6 DiLorenzo, US 2005/0021104 A1, published Jan. 27, 2005 7 Ashley, US 6,176,857 B1, issued Jan. 23, 2001. 8 Werneth et al., US 2006/0106375 A1, published May 18, 2006. 9 Montegrande, US 7,074,189 B1, issued July 11, 2006. Appeal 2012-005117 Application 11/276,066 4 VII. Claim 7, 8, 10, and 11 over the combination of Vitek, Gafni, and Gafni ‘895 10 (Ans. 7); and VIII. Claim 17, 18, 19, 20, 21, and 43 over the combination of Vitek, Gafni, and Towe 11 (Ans. 9–10). Issue The issue is whether the Examiner established by a preponderance of the evidence that the combination of Vitek and Gafni would have made obvious the claimed device, as well as the claimed method for stimulating a neural target? Findings of Fact FF1. The Examiner finds that “Vitek discloses a method and device comprising multiple transducer elements 12 configured to be positioned to direct multiple energy waves towards a target” (Ans. 5 (citing Vitek, ¶¶ 0020, 0024, and 0027 and Figs. 1A, 1B, 7, and 9)). FF2. The Examiner finds that Vitek discloses “a controller 18 . . . configured to generate multiple energy waves with a predetermined phase and amplitude in order to apply therapy, such as heating of a tissue, to a desired site in the body through constructive interference at the site” (id.). FF3. The Examiner finds that “Vitek discloses that the device may also be used for imaging purposes . . . [and the] power level at which the device would be used for imaging is lower than the power level that would be used for heating a nerve” (id. at 11 (citing Vitek at 4, ¶ 0038)). 10 Gafni et al., US 6,741,895 B1, issued May 25, 2004 . 11 Towe et al., US 2006/0167500 A1, published July 27, 2006. Appeal 2012-005117 Application 11/276,066 5 FF4. Vitek discloses an “apparatus and methods for delivering diagnostic and/or therapeutic ultrasound energy from a transducer disposed outside a body” (Vitek 1, ¶ 0001). FF5. Vitek discloses a method of treating body tissue with ultrasound energy [that] includes positioning a [body] part . . . within an aperture defined by a transducer device, the transducer device having a plurality of acoustic transducer elements positioned . . . about the aperture, and providing drive signals to cause . . . the transducer elements to emit acoustic energy focused in one or more focal zones in the tissue to be treated. (Id. at 1, ¶ 0007.) FF6. Vitek discloses that the “transducer device 10 is configured to deliver acoustic energy . . . to a target tissue . . . inside a patient” (id. at 2, ¶ 0020). FF7. Vitek discloses that the “acoustic energy 15 may be used to coagulate, necrose, heat, or otherwise treat the target tissue region, which may be a benign or malignant tumor within an organ or other tissue structure” (id.). FF8. Vitek discloses that the controller 18 “may control the amplitude . . . of the acoustic waves transmitted by the transducer elements 12 . . . [and] may also control a phase component of the drive signals to [the] respective transducer elements 12” (id. at 2, ¶ 0024). FF9. Vitek discloses that, “as is well known to those skilled in the art, the location of the focus can be determined by adjusting the phases of the individual elements in such a way that constructive interference is generated at the desired location” (id.). Appeal 2012-005117 Application 11/276,066 6 FF10. Vitek discloses that “[b]esides treating tissue, the same ultrasound device may also be used to deliver diagnostic ultrasound for imaging tissue” (id. at 4, ¶ 0038). FF11. The Examiner finds that “Vitek fails to disclose the use of the device for neural stimulation” ( Ans. at 6). FF12. The Examiner finds that Gafni “discloses the use of heat for the purpose of neural stimulation” (id., citing Gafni 2, ¶ 0014). FF13. Gafni discloses “a physiological temperature stimulation probe with a fast cooling and heating ability” (Gafni 1, ¶ 0009). FF14. Gafni discloses the use of the probe for “brain function mapping during brain surgery” (id. at 2, ¶ 0014). FF15. Gafni discloses that “[i]n one example, a surgeon holds recording electrodes . . . and measures the evoked response to a heat or cold stimulation . . . so that a most strongly responding or least strongly responding brain region is identified” (id. at 2, ¶ 0014). FF16. The Examiner concludes that it “would have been obvious to one having ordinary skill in the art . . . [to] use Vitek’s device for the purpose of neural stimulation, based on Gafni’s teachings, since Vitek’s device is disclosed to be usable for the purpose of applying heat to tissue” (App. Br. at 17). Analysis Appellants argue that Vitek discloses the use of “acoustic energy to coagulate, necrose, heat, or otherwise ‘treat’ the target tissue region, which may be a benign or malignant tumor” (App. Br. 15). Appellants argue that Vitek does not disclose targeting nerves for neural stimulation therapy and Appeal 2012-005117 Application 11/276,066 7 does not disclose a device configured to generate first and second energy waves such that “a neural stimulation threshold is reached only during constructive interference” at the neural target, as required by claim 1 (id. at 17). Appellants argue that one of skill in the art would not have been motivated to modify Vitek’s device to generate heat for neural stimulation, as disclosed by Gafni, because a device designed to destroy tissue would also destroy the nerve” (id. at 17). Appellants argue that “[h]eating to kill tissue is different from heating for the purposes of neural stimulation (id. at 18). Appellants’ arguments are not convincing. Appellants have pointed to no errors in the Examiner’s fact finding, but rather point out that Vitek does not disclose a device configured for neural stimulation. As to obviousness, the Supreme Court has emphasized that “the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” (Id. at 417.) Moreover: Appeal 2012-005117 Application 11/276,066 8 The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981). Here, Vitek discloses an ultrasound device that may generally be used for diagnostic or therapeutic purposes (FF 4 and 10). The fact that Vitek specifically discloses the use of the device for targeting and killing tumors as a specific application, does not suggest that one of skill in the art would not appreciate the potential for the application of the device for other purposes, such as inducing heat for neural stimulation and brain mapping purposes as disclosed by Gafni (FF 12 and 14). Appellants argue that modification of Vitek’s device for neural stimulation would render Vitek’s device “unsatisfactory for its intended purpose” (App. Br. 16 (citing In re Gordon, 733 F.2d 900 (Fed. Cir. 1984))). Appellants argue that “[a]n amplitude . . . to treat tumors would not be used to deliver neural stimulation” because it would kill the neural tissue (id). Appellants argue that “[i]f Vitek was modified to deliver ultrasound to stimulate a neural target, the modified ultrasound to deliver neural stimulation would no longer be suitable to treat a benign or malignant tumor through necrosis and coagulation” (id. at 17). The Examiner responds that “Vitek discloses that the device may also be used for imaging purposes . . . [wherein the] power level at which the device would be used for imaging is lower than the power level that would Appeal 2012-005117 Application 11/276,066 9 be used for heating a nerve” (Ans. 11 (citing Vitek at 4, ¶ 0038). The Examiner further reasons that “Vitek’s device is . . . clearly configured to be operated at a power range that goes from high enough to kill tumors to low enough to not affect tissue,” and thus could be used for neural stimulation (id.). We conclude that the Examiner has the better position. Vitek suggests that a particular device could be used for different purposes, i.e. killing target tissue and imaging target tissue. Thus, one of skill in the art would understand that the Vitek device could also be configured for another purpose, i.e. stimulation of neural tissue, without rendering the device unsuitable for other purposes. Thus, we affirm the rejection of claim 1 as being obvious over the combination of Vitek and Gafni. Claims 2–6, 9, 16, 22, 23, and 24 have not been argued separately from claim 1 and therefore fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii). Appellants also argue the rejection of claim 40. As set forth above, claim 40 is directed to a method for stimulating a neural target that comprises generating first and second energy waves having predetermined amplitudes that are insufficient to stimulate the neural target by itself, wherein the phases of the first and second energy waves are “selected to provide constructive interference at the neural target for use in delivering an energy capable of stimulating the neural target.” Appellants argue that they “request consideration of claim 40 separately from the device recited in claim 1,” because claim 40 is directed Appeal 2012-005117 Application 11/276,066 10 to a method (App. Br. 19). Appellants argue that they “incorporate by reference arguments advanced with respect to claim 1” (id.). Appellants’ arguments are not persuasive for the reasons discussed above. Thus, we affirm the rejection of claim 40 as being obvious over the combination of Vitek and Gafni. Appellants also argue the rejection of claim 44. Claim 44 depends from claim 40 and further requires that “the neural target includes at least one specific neural fiber in the nerve and excludes other neural fibers in the nerve.” Appellants argue that “the Examiner fails to address the language recited in claim 44 . . . [and therefore] fails to consider all words in the claims” (App. Br. 19). The Examiner responds that the “use of constructive interference permits a very focused application of the energy . . . [to] target a specific tissue without . . . apply[ing] treatment beyond the area of interest” (Ans. 14). The Examiner concludes that it “would then be obvious that a specific fiber can be targeted while others are not treated” (id.). We conclude that the Examiner has the better position. Gafni discloses nerve stimulation for brain mapping (FF 14). It would have been obvious to one of skill in the art that greater precision in brain mapping could be achieved by targeting specific neural fibers within the nerve. Thus, we affirm the rejection of claim 44 as being obvious over the combination Vitek and Gafni. Appellants also argue the rejection of claim 45. Claim 45 depends from claim 40 and further requires that the method comprises “positioning a first transducer at the first position external to a patient and positioning a Appeal 2012-005117 Application 11/276,066 11 second transducer at the second position external to the patient.” Appellants argue that the Examiner fails “has failed to cite portions of the references relied upon to provide the method recited in claim 44 . . . [and] fails to consider all words in the claims” (App. Br. 19). The Examiner responds that “Vitek’s device comprises multiple transducers positioned outside of a patient’s body” (Ans. 14). The Examiner finds that Vitek’s “Figure 1 A, referred to in the rejection of claim 45, clearly shows the different transducers being positioned at different locations” (id.). The Examiner’s reasoning is persuasive. Thus, we affirm the rejection of claim 45 as being obvious over the combination of Vitek and Gafni. The Examiner has also rejected dependent claims 12, 13, 14, 15, and 25–28 as obvious over the combination of Vitek and Gafni, and further in combination with one of Kuzma (claim 12, Rejection II), DiLorenzo (claim 13, Rejection III), Ashley (claim 14, Rejection IV), Werneth (claim 15, Rejection V), and Montegrande (claims 25–28, Rejection VI). Because Appellants have not provided any separate argument based on Kuzma, DiLorenzo, Ashley, Werneth, or Montegrande (App. Br. 21–22), we also affirm these rejections for the reasons set forth above with respect to claim 1. Conclusion of Law The preponderance of the evidence supports the Examiner’s conclusion that the the combination of Vitek and Gafni would have made Appeal 2012-005117 Application 11/276,066 12 obvious the claimed device, as well as the claimed method for stimulating a neural target. Issue The Examiner has rejected claims 7, 8, 10, and 11 under 35 U.S.C. § 103(a) as obvious over the combination of Vitek, Gafni, and Gafni ’895 (Ans. 7–8) (Rejection VII). We focus our analysis on claim 7. Claim 7 depends from claim 1 indirectly, and further requires that the device comprises a sensor configured to sense a physiological parameter indicative that the desired neural target has been stimulated, wherein the controller is configured to perform a scanning procedure, the scanning procedure including controlling a phase of each energy wave to cause the energy waves to constructively interfere at a plurality of locations within a neural target region, wherein the controller is configured to receive feedback from the sensor to indicate that the energy waves constructively interfere at the neural target within the neural target region. The issue presented is: Has the Examiner established by a preponderance of the evidence that the combination of Vitek, Gafni, and Gafni ‘895 would have made obvious a device “configured to perform a scanning procedure . . . to cause the energy waves to constructively interfere at a plurality of locations within a neural target region” and comprising “a sensor configured to sense a physiological parameter indicative that the desired neural target has been stimulated,” as required by claim 7? Appeal 2012-005117 Application 11/276,066 13 Additional Findings of Fact FF17. The Examiner finds that the “Vitek and Gafni combination discloses the apparatus substantially as claimed but fails to disclose a physiological sensor” (Ans. 7). FF18. The Examiner finds that “Gafni ’895 discloses a probe for nerve stimulation comprising a physiological sensor for sensing and indicating a physiological response to stimulation has taken place” (id. (citing Gafni ’895, Abstract and col. 17, ll. 40–41). FF19. Gafni ’895 discloses a “vaginal probe . . . for stimulation of the nerves of the vagina . . . [wherein the probe] shaft (22) may have sensors for measuring the reaction of the nerves to stimulation” (Gafni ’895, Abstract). FF20. The Examiner concludes that it “would have been obvious to one having ordinary skill in the art . . . to modify the device of the Vitek and Gafni combination by providing a sensor, as taught by Gafni ‘895, for the purpose of sensing indication of a physiological response to the stimulation” (Ans. 7). Analysis Appellants contend that “the Examiner fails to address the language recited in claim 7 (including the controller that is configured to perform a scanning procedure, [and] including controlling a phase of each energy wave to cause the energy waves to constructively interfere at a plurality of locations within a neural target region)” (App. Br. 20–21). The Examiner responds that claim 7 does not require that “the plurality of locations be targeted simultaneously” (Ans. 15). Appeal 2012-005117 Application 11/276,066 14 We agree with the Examiner’s reasoning. It would have been obvious to one of skill in the art to configure a neurostimulation device to perform a scanning procedure to cause constructive interference at multiple locations in order to ensure the desired result of neurostimulation is achieved. Appellants also argue that the Examiner “has not shown a controller configured to . . . receive feedback from the sensor to indicate that the energy waves constructively interfere at the neural target within the neural target region” (App. Br. 21). Appellants argue that the “feedback mechanism in Vitek uses imaging to measure the size, shape, location and intensity of the focal zone . . . [and that] thermally mapping focal zones is different than sensing that the neural target has been stimulated” (id.). Those arguments are not persuasive. As recognized by the Examiner, Gafni ’895 discloses the use of a device to cause neural stimulation, such that the device also includes sensors to measure neural stimulation (FFs 18 and 19). It would have been obvious to include sensors in a neural stimulation device to assess the result of the neural stimulation. Thus, we affirm the rejection of claim 7 over the combination of Vitek, Gafni, and Gafni ‘895. Claims 8, 10, and 11 have not been argued separately from claim 7 and therefore fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii). Conclusion of Law The preponderance of the evidence supports the Examiner’s conclusion that the combination of Vitek, Gafni, and Gafni ‘895 would have made obvious a device “configured to perform a scanning procedure . . . to cause the energy waves to constructively interfere at a plurality of locations Appeal 2012-005117 Application 11/276,066 15 within a neural target region” and comprising “a sensor configured to sense a physiological parameter indicative that the desired neural target has been stimulated,” as required by claim 7. III. Issue The Examiner has rejected claims 17, 18, 19, 20, 21, and 43 under 35 U.S.C. § 103(a) over the combination of Vitek, Gafni, and Towe (Ans. 9– 10) (Rejection VIII). We focus our analysis on claim 17. Claim 17 depends from claim 1 and further requires that the device comprises “a nerve cuff structure, the first transducer and the second transducer being connected to the nerve cuff structure.” The issue presented is: Has the Examiner established by a preponderance of the evidence that the combination of Vitek, Gafni, and Towe would have made obvious the modification of the neural stimulation device made obvious by Vitek and Gafni to include a nerve cuff? Additional Findings of Fact FF21. The Examiner finds that the “Vitek and Gafni combination discloses the method and apparatus substantially as claimed but fails to disclose a nerve cuff” (Ans. 10). FF22. The Examiner finds that “Towe discloses a device comprising a nerve cuff having ultrasound transducers attached thereon [that] circumscribes a nerve or a vessel adjacent to the nerve and stimulat[es] a nerve” (id. (citing Towe, ¶¶ 0006, 0049)). Appeal 2012-005117 Application 11/276,066 16 FF23. Towe discloses “devices and methods that employ ultrasound to achieve neural stimulation” (Towe 1, ¶ 0001). FF24. Towe discloses that “one or more ultrasound transducers can be located on a nerve cuff electrode. Locating ultrasound transducers on a nerve cuff electrode enables focused ultrasound that can target specific fibers” (id. at 4, ¶ 0049). FF25. Towe discloses that, “[i]n one embodiment, a nerve cuff is used that includes an array of ultrasound transducers . . . around the circumference of the nerve cuff and each ultrasound transducer can be electrically addressed” (id.). FF26. The Examiner concludes that it “would have been obvious to one having ordinary skill in the art . . . to modify the device of the Vitek and Gafni combination by providing a nerve cuff, as taught by Towe, in order to be able to generate nerve stimulation” (Ans. 10). Analysis Appellants contend that the Examiner “fails to articulate why one would modify Vitek to stimulate a nerve in the first place and fails to articulate how the nerve cuff would be added” (App. Br. 23). Appellants argue that the devices shown in Vitek’s Figures 6–9 are external devices (id.). Appellants argue that the “Examiner does not explain how a nerve cuff [is] added to an external device, or how . . . power [is] delivered to the external device to destroy tissue/tumors and delivered to the ‘additional’ nerve cuff to stimulate a nerve” (id.). Appellants’ arguments are not persuasive. As recognized by the Examiner (FF 22), Towe discloses a device comprising a nerve cuff having Appeal 2012-005117 Application 11/276,066 17 attached ultrasound transducers for nerve stimulation. Towe also discloses that locating ultrasound transducers on a nerve cuff enables focused ultrasound that can target specific fibers (FF 24). Thus, it would have been obvious to one of skill in the art to modify the device made obvious by Vitek and Gafni to include a nerve cuff to enable focused ultrasound stimulation of specific fibers. Appellants’ arguments that the Examiner has not explained how the device would be modified are not persuasive because the cited references suggest that such a modification would have been within the skill level of the ordinary artisan. Thus, we affirm the rejection of claim 17 as being obvious over the combination of Vitek, Gafni, and Towe. Claims 18, 19, 20, 21, and 43 have not been argued separately from claim 17 and therefore fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii). Conclusion of Law The preponderance of the evidence supports the Examiner’s conclusion that the combination of Vitek, Gafni, and Towe would have made obvious the modification of the neural stimulation device made obvious by Vitek and Gafni to include a nerve cuff. SUMMARY We affirm the rejection of claims 1–28 and 40–45 under 35 U.S.C. § 103(a). Appeal 2012-005117 Application 11/276,066 18 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED JRG Copy with citationCopy as parenthetical citation