DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05 November 2025 of Invention I, directed to Claim 1-10.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 2, the recites the limitation “the respective second control input” in Line 6. There is insufficient antecedent basis for this limitation in the claim. It appears that this is a typographical error and was intended to be “the respective first control input” to match the language of Claim 1 and Claim 2 section (a). Appropriate correction or clarification is required. Claims 3-4 are rejected for depending on Claim 2.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Katnani et al. (US Publication No. 2017/0281946) in view of Gillbe (US Publication No. 2010/0152817).
Regarding Claims 1 and 8, Katnani et al. discloses an apparatus for applying an electric field to a target region (Abstract; Paragraph 0008-0010) using at least four first electrode elements (four or more contacts 306, Fig. 3A, 3C, 3D; Paragraph 0062-0063) positioned on a first side of the target region (contacts 306 on electrode/feedthrough 302, Figs. 3A; Paragraph 0062-0063) and at least four second electrode elements (306 on additional feedthroughs/electrodes 302, Fig. 3A, 3C, 3D; Paragraph 0062-0063) positioned on a second side of the target region that is opposite to the first side of the target region (contacts 306 on multiple electrodes/feedthroughs 302, Figs. 3A; Paragraph 0062-0063; see at least two electrodes/feedthroughs in Fig. 3A on opposite sides of target region), the apparatus comprising:
at least four electrically isolated first signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067), wherein each of the first signal generators has a respective first control input (see respective inputs from CPU 308 for each of separate signal generators; see Fig. 3D; Paragraph 0066-0067), and
wherein each of the first signal generators (Paragraph 0066-0067) is configured to, in response to a respective first control signal that arrives at the respective first control input (control signals from CPU 308, Paragraph 0068-0069), apply an electrical signal to a respective one of the at least four first electrode elements and a respective one of the at least four second electrode elements (contacts 306 on multiple feedthroughs/electrodes 302, Fig. 3A, 3C, 3D; Paragraph 0062, 0063, 0065, 0072);
and a controller (control module 304 including CPU 308, Fig. 3A-3D) that is programmed to generate each of the first control signals (Paragraph 0063, 0065-0068),
and comprising the at least four first electrode elements and the at least four second electrode elements (four or more contacts 306 on multiple feedthroughs/electrodes 302, Fig. 3A, 3C, 3D; Paragraph 0062, 0063, 0065, 0072).
Katnani et al. discloses at least four first and second electrode elements (contacts 306 on electrode/feedthrough 302, Figs. 3A), and that “each feedthrough 302 can include 4 electrical contacts 306, as shown in FIG. 3A, although it may readily understood that fewer or more contacts are possible. In some implementations, multiple feedthroughs 302 may be preferable in order to access and stimulate different brain regions or tissues” (Paragraph 0062), and at least four electrically isolated signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067). However, Katnani et al. does not explicitly disclose at least eight first and second electrode elements with at least eight signal generators.
Gillbe teaches an apparatus for applying an electric field to a target region (Abstract; Paragraph 0022-0023) using at least eight first electrode elements (eight electrodes A1-H1, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; sixteen electrode outputs, Paragraph 0018, 0099-0100, 0133, 0188, 0240) positioned on a first side of the target region and at least eight second electrode elements (eight electrodes A2-H2, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; sixteen electrode outputs, Paragraph 0018, 0099-0100, 0133, 0188, 0240) positioned on a second side of the target region that is opposite to the first side of the target region (current path through tissue on opposite sides of target area, see Fig. 3, 8, 11; Paragraph 0116, 0133-0134, 0148), and may include multiple signal generators (Paragraph 0044). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include at least eight first and second electrode elements with at least eight signal generators, since both Katnani et al. and Gillbe teach multiple electrode elements and multiple signal generators, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Katnani et al. further discloses that the electrode elements may be configured as anodes or cathodes (Paragraph 0102). However, Katnani et al. does not explicitly disclose applying an electrical signal between a respective one of the first electrode elements and a respective one of the second electrode elements.
Gillbe teaches an apparatus for applying an electric field to a target region (Abstract; Paragraph 0022-0023) including applying an electrical signal between a respective one of the first electrode elements and a respective one of the second electrode elements (electrodes A1-H1 and A2-H2, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; Paragraph 0027, 0116-0117, 0133-0134, 0139-0141; 0149). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the apparatus to apply an electrical signal between a respective one of the first electrode elements and a respective one of the second electrode elements, as taught by Gillbe, in the apparatus disclosed by Katnani et al., in order to target the tissue region explicitly between the contacts, as also taught by Gillbe (directly controlling current paths to specific tissue areas, Paragraph 0116-0117, 0133-0134, 0139-0141; 0149 of Gillbe).
Regarding Claims 2, 3, and 4, Katnani et al. discloses the apparatus further wherein each of the first signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067) is configured to (a) in response to a respective first control signal that arrives at the respective first control input (see respective inputs from CPU 308 for each of separate signal generators; see Fig. 3D; Paragraph 0066-0067), apply an electrical signal to the respective one of the at least four first electrode elements and the respective one of the at least four second electrode elements (contacts 306 on multiple feedthroughs/electrodes 302, Fig. 3A, 3C, 3D; Paragraph 0062, 0063, 0065, 0068-0069, 0072),
and (b) in response to a respective second control signal that arrives at the respective second control input (see respective inputs from CPU 308 for each of separate signal generators; see Fig. 3D; Paragraph 0066-0067), apply an electrical signal to the respective one of the at least four first electrode elements and the respective one of the at least four second electrode elements (contacts 306 on multiple feedthroughs/electrodes 302, Fig. 3A, 3C, 3D; Paragraph 0062, 0063, 0065, 0068-0069, 0072),
wherein the controller (control module 304 including CPU 308, Fig. 3A-3D) is further programmed to, for each of the first signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067), apply the respective first control signal and the respective second control signal at respective times in an alternating sequence so that the respective first signal generator will generate an output (generating control signals to output waveforms in timing sequence, Paragraph 0063, 0067, 0071, 0074, 0077, 0085, 0093; Claims 8, 20, 21; see Fig. 7A),
wherein the controller is further programmed to interpose a break in time between each first control signal and each second control signal (see 708, 720 and 702, Fig. 7A, periods of time with no stimulation between waveforms 708 and 720).
Katnani et al. discloses at least four first and second electrode elements (contacts 306 on electrode/feedthrough 302, Figs. 3A), and that “each feedthrough 302 can include 4 electrical contacts 306, as shown in FIG. 3A, although it may readily understood that fewer or more contacts are possible. In some implementations, multiple feedthroughs 302 may be preferable in order to access and stimulate different brain regions or tissues” (Paragraph 0062), and at least four electrically isolated signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067). However, Katnani et al. does not explicitly disclose at least eight first and second electrode elements with at least eight signal generators.
Gillbe teaches an apparatus for applying an electric field to a target region (Abstract; Paragraph 0022-0023) using at least eight first electrode elements (eight electrodes A1-H1, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; sixteen electrode outputs, Paragraph 0018, 0099-0100, 0133, 0188, 0240) positioned on a first side of the target region and at least eight second electrode elements (eight electrodes A2-H2, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; sixteen electrode outputs, Paragraph 0018, 0099-0100, 0133, 0188, 0240) positioned on a second side of the target region that is opposite to the first side of the target region (current path through tissue on opposite sides of target area, see Fig. 3, 8, 11; Paragraph 0116, 0133-0134), and may include multiple signal generators (Paragraph 0044). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include at least eight first and second electrode elements with at least eight signal generators, since both Katnani et al. and Gillbe teach multiple electrode elements and multiple signal generators, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Furthermore, Katnani et al. further discloses that the electrode elements may be configured as anodes or cathodes (Paragraph 0102). However, Katnani et al. does not explicitly disclose applying an electrical signal between a respective one of the first electrode elements and a respective one of the second electrode elements, wherein applying the electrical signal comprises applying a positive or negative electrical signal between the respective one of the first electrode elements and the respective one of the second electrode elements, wherein the electrical signal alternates between a positive electrical signal and a negative electrical signal.
Gillbe teaches an apparatus for applying an electric field to a target region (Abstract; Paragraph 0022-0023) including applying an electrical signal between a respective one of the first electrode elements and a respective one of the second electrode elements (electrodes A1-H1 and A2-H2, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; Paragraph 0116-0117, 0133-0134, 0139-0141; 0149), wherein applying the electrical signal comprises applying a positive or negative electrical signal between the respective one of the first electrode elements and the respective one of the second electrode elements (anode/cathode, Paragraph 0027, 0131, 0132, 0139-0142, 0148-0149, 0181; Claim 1; see Fig. 11 with positive/negative signal outputs), wherein the electrical signal alternates between a positive electrical signal and a negative electrical signal (successive electrical signals in a sequence and/or interleaved for anode/cathode designated electrodes, see Figs. 10-15; Paragraph 0027, 0031, 0040, 0057, 0118, 0121, 0145, 0148-0149, 0158, 0168, 0191; Claim 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the apparatus disclosed by Katnani et al. to apply an electrical signal between a respective one of the first electrode elements and a respective one of the second electrode elements, wherein applying the electrical signal comprises applying a positive or negative electrical signal between the respective one of the first electrode elements and the respective one of the second electrode elements, wherein the electrical signal alternates between a positive electrical signal and a negative electrical signal, as taught by Gillbe, in order to target the tissue region explicitly between the contacts (directly controlling current paths to specific tissue areas, Paragraph 0116-0117, 0133-0134, 0139-0141, 0149 of Gillbe), and achieving balanced composite pulses (Paragraph 0114, 0123, 0131, 0149), as also taught by Gillbe.
Regarding Claims 5, 6, and 7, Katnani et al. discloses the apparatus further wherein the controller (control module 304 including CPU 308, Fig. 3A-3D) is further programmed to generate each of the first control signals in a sequence that causes each of the at least four first signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067) to generate an output with a given waveform (generating control signals to output waveforms in timing sequence, Paragraph 0063, 0067, 0071, 0074, 0077, 0085, 0093; Claims 8, 20, 21; see Fig. 7A), wherein the output of each of the at least four first signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067) is shifted in time with respect to an output of at least one other first signal generator (generating control signals to output waveforms in timing sequence, Paragraph 0063, 0067, 0071, 0074, 0077, 0085, 0093; Claims 8, 20, 21; see Fig. 7A).
Katnani et al. further discloses at least four first and second electrode elements (contacts 306 on electrode/feedthrough 302, Figs. 3A), and that “each feedthrough 302 can include 4 electrical contacts 306, as shown in FIG. 3A, although it may readily understood that fewer or more contacts are possible. In some implementations, multiple feedthroughs 302 may be preferable in order to access and stimulate different brain regions or tissues” (Paragraph 0062), and at least four electrically isolated signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067). However, Katnani et al. does not explicitly disclose at least eight first and second electrode elements with at least eight signal generators.
Gillbe teaches an apparatus for applying an electric field to a target region (Abstract; Paragraph 0022-0023) using at least eight first electrode elements (eight electrodes A1-H1, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; sixteen electrode outputs, Paragraph 0018, 0099-0100, 0133, 0188, 0240) positioned on a first side of the target region and at least eight second electrode elements (eight electrodes A2-H2, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; sixteen electrode outputs, Paragraph 0018, 0099-0100, 0133, 0188, 0240) positioned on a second side of the target region that is opposite to the first side of the target region (current path through tissue on opposite sides of target area, see Fig. 3, 8, 11; Paragraph 0116, 0133-0134), and may include multiple signal generators (Paragraph 0044). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include at least eight first and second electrode elements with at least eight signal generators, since both Katnani et al. and Gillbe teach multiple electrode elements and multiple signal generators, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Furthermore, Katnani et al. does not explicitly disclose wherein the electrical signals alternates between a positive electrical signal and a negative electrical signal, and wherein the controller is further programmed to control the shifting in time to steer an electric field within the target region.
Gillbe teaches an apparatus for applying an electric field to a target region (Abstract; Paragraph 0022-0023) including applying an electrical signal between a respective one of the first electrode elements and a respective one of the second electrode elements (electrodes A1-H1 and A2-H2, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; Paragraph 0116-0117, 0133-0134, 0139-0141; 0149), wherein the electrical signals alternates between a positive electrical signal and a negative electrical signal (successive electrical signals in a sequence and/or interleaved for anode/cathode designated electrodes, see Figs. 10-15; Paragraph 0027, 0031, 0040, 0057, 0118, 0121, 0145, 0148-0149, 0158, 0168, 0191; Claim 1), and wherein the controller (controller, Paragraph 0040, 0041, 0044) is further programmed to control the shifting in time to steer an electric field within the target region (directly controlling current paths to specific tissue areas, Paragraph 0116-0117, 0133-0134, 0139-0141, 0149).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the apparatus disclosed by Katnani et al. such that the electrical signals alternates between a positive electrical signal and a negative electrical signal, and wherein the controller is further programmed to control the shifting in time to steer an electric field within the target region, as taught by Gillbe, in order to target the tissue region explicitly between the contacts (directly controlling current paths to specific tissue areas, Paragraph 0116-0117, 0133-0134, 0139-0141, 0149 of Gillbe), since “This provides more precise definition of the current path between the electrodes and therefore better control of the location and coverage area of the composite waveform, ” (Paragraph 0149 of Gillbe); and achieving balanced composite pulses (Paragraph 0114, 0123, 0131, 0149 of Gillbe), as also taught by Gillbe.
Regarding Claims 9 and 10, Katnani et al. discloses the apparatus for applying an electric field to a target region (Abstract; Paragraph 0008-0010) using at least four first electrode elements (four or more contacts 306, Fig. 3A, 3C, 3D; Paragraph 0062-0063) positioned on a first side of the target region (contacts 306 on electrode/feedthrough 302, Figs. 3A; Paragraph 0062-0063) and at least four second electrode elements (306 on additional feedthroughs/electrodes 302, Fig. 3A, 3C, 3D; Paragraph 0062-0063) positioned on a second side of the target region that is opposite to the first side of the target region (contacts 306 on multiple electrodes/feedthroughs 302, Figs. 3A; Paragraph 0062-0063; see at least two electrodes/feedthroughs in Fig. 3A on opposite sides of target region), comprising at least four electrically isolated first signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067), wherein each of the first signal generators has a respective first control input (see respective inputs from CPU 308 for each of separate signal generators; see Fig. 3D; Paragraph 0066-0067), and wherein each of the first signal generators (Paragraph 0066-0067) is configured to, in response to a respective first control signal that arrives at the respective first control input (control signals from CPU 308, Paragraph 0068-0069), apply an electrical signal to a respective one of the at least four first electrode elements and a respective one of the at least four second electrode elements (contacts 306 on multiple feedthroughs/electrodes 302, Fig. 3A, 3C, 3D; Paragraph 0062, 0063, 0065, 0072); wherein the controller (control module 304 including CPU 308, Fig. 3A-3D) is further programmed to generate each of first and second control signals (Paragraph 0063, 0065-0068). Katnani et al. further discloses at least four first and second electrode elements (contacts 306 on electrode/feedthrough 302, Figs. 3A), and that “each feedthrough 302 can include 4 electrical contacts 306, as shown in FIG. 3A, although it may readily understood that fewer or more contacts are possible. In some implementations, multiple feedthroughs 302 may be preferable in order to access and stimulate different brain regions or tissues” (Paragraph 0062), and at least four electrically isolated signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067), wherein the controller (control module 304 including CPU 308, Fig. 3A-3D) is further programmed to generate each of the first control signals in a sequence (generating control signals to output waveforms in timing sequence, Paragraph 0063, 0067, 0071, 0074, 0077, 0085, 0093; Claims 8, 20, 21; see Fig. 7A) that causes each of the at least first signal generators (separate signal generators for electrode contacts, see Fig. 3D; Paragraph 0066-0067) to generate an output with a first given waveform (waveforms, Paragraph 0063, 0071, 0074, 0093), wherein the output of each of the at least first signal generators is shifted in time with respect to an output of at least one other first signal generator (generating control signals to output waveforms in timing sequence, Paragraph 0063, 0067, 0071, 0074, 0077, 0085, 0093; Claims 8, 20, 21; see Fig. 7A).
In addition, Gillbe teaches an apparatus for applying an electric field to a target region (Abstract; Paragraph 0022-0023) using at least eight first electrode elements (eight electrodes A1-H1, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; sixteen electrode outputs, Paragraph 0018, 0099-0100, 0133, 0188, 0240) positioned on a first side of the target region and at least eight second electrode elements (eight electrodes A2-H2, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; sixteen electrode outputs, Paragraph 0018, 0099-0100, 0133, 0188, 0240) positioned on a second side of the target region that is opposite to the first side of the target region (current path through tissue on opposite sides of target area, see Fig. 3, 8, 11; Paragraph 0116, 0133-0134), and may include multiple signal generators (Paragraph 0044), and embodiments with more than two leads/arrays (Paragraph 0134), including applying an electrical signal between a respective one of the first electrode elements and a respective one of the second electrode elements (electrodes A1-H1 and A2-H2, Fig. 11; see current paths Fig. 3; multiple leads/arrays Figs. 8-9; Paragraph 0116-0117, 0133-0134, 0139-0141; 0149), wherein the electrical signals alternates between a positive electrical signal and a negative electrical signal (successive electrical signals in a sequence and/or interleaved for anode/cathode designated electrodes, see Figs. 10-15; Paragraph 0027, 0031, 0040, 0057, 0118, 0121, 0145, 0148-0149, 0158, 0168, 0191; Claim 1), and wherein the controller (controller, Paragraph 0040, 0041, 0044) is further programmed to control the shifting in time to steer an electric field within the target region (directly controlling current paths to specific tissue areas, Paragraph 0116-0117, 0133-0134, 0139-0141, 0149).
However, neither Katnani et al. nor Gillbe explicitly discloses additionally at least eight electrically isolated second signal generators with respective control inputs, and applying an electrical signal between a respective one of at least eight third electrode elements and a respective one of at least eight fourth electrode elements, wherein the controller is further programmed to generate each of the second control signals in a sequence that causes each of the at least eight second signal generators to generate an output with a second given waveform, wherein the output of each of the at least eight second signal generators is shifted in time with respect to an output of at least one other second signal generator.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include additionally at least eight electrically isolated second signal generators with respective control inputs, and applying an electrical signal between a respective one of at least eight third electrode elements and a respective one of at least eight fourth electrode elements, wherein the controller is further programmed to generate each of the second control signals in a sequence that causes each of the at least eight second signal generators to generate an output with a second given waveform, wherein the output of each of the at least eight second signal generators is shifted in time with respect to an output of at least one other second signal generator, since both Katnani et al. and Gillbe teach multiple electrode elements and multiple signal generators, and this would require simply a duplication of the signal generators and the arrays’ first and second electrode elements and their stimulation/control functions (as taught by Katnani et al. and Gillbe as explained above). Therefore, the duplication of the signal generators and the arrays’ first and second electrode elements and their functions would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Conclusion
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796