METHODS AND SYSTEMS FOR NEURAL REGULATION

§102 §103

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 . Status of Claims Claims 1-5, 10-12, 43-46, 52-57, 66-68, 77, and 83 are currently pending and under examination. Claims 6-9, 13-42, 47-51, 58-65, 69-76, and 78-82 are canceled. Priority The instant application (filed on 10/15/2021) is a national stage of PCT/US2020/028810 (filed on 04/17/2020), filed under 35 USC 371. Acknowledgment is made of Applicant's claim for domestic priority based on provisional application 62/920,216, filed on 04/18/2019. Claims 1-5, 10-12, 43-46, 52-57, 66-68, 77, and 83 are adequately supported in PCT/US2020/028810 to receive the filing date of 04/17/2020. Claims 1-5, 10-12, 43-46, 52-57, 66-68, 77, and 83 are not adequately supported in the provisional application. The provisional application lacks the full downregulation frequency range of 200 Hz - 100 kHz in claims 1, 43, 77, and 83. The time range in claim 55, organ and nerve system listings in claims 66-68, and the implantable neuroregulator, blood glucose sensor, and microprocessor in claim 77 are not supported in the provisional application. Therefore, the effective filing date of claims 1-5, 10-12, 43-46, 52-57, 66-68, 77, and 83 is the filing date of the PCT application (04/17/2020). Response to Arguments Applicant’s arguments, see Remarks pages 9-11 (Rejection under 35 U.S.C. 102), filed 06/04/2026, with respect to the 35 U.S.C. § 102 rejections of claims 1-5, 10-12, 43-46, 52-57, 66-67 and 83 over Waataja (US 2017/0216602 A1) have been fully considered. Regarding independent claims 1, 43 and 83, Applicant argues: A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001). MPEP 2131. The Examiner contends that this argument is not persuasive. Claim 1 contains the limitation "wherein the first electrical signal comprises a high-frequency alternating current (HFAC) having an intermittent pattern which comprises a millisecond active phase." Waataja discloses a high-frequency alternating current having an intermittent pattern containing a millisecond active phase (Fig. 9, [0030] - "FIG. 9 is a representation of a pattern of layered electrical signals displaying a low duty cycle HF AC/HF AV which contains repetitive microsecond cycles which form a millisecond active phase"). Office Action, pg. 4. However, the Examiner cites Waataja, Figure 9 as being anticipatory disclosure which by comparison claim 1 has a distinct signal delivery. Referring to Figure 9 in Waataja: FIG. 9 shows three microsecond cycles, each microsecond cycle comprises a charge phase followed by a pulse delay, a recharge phase and a pulse delay; and a microsecond inactive phase. Multiple microsecond cycles form a millisecond active phase. In embodiments, a millisecond active phase is separated from another millisecond active phase by a millisecond inactive phase. In embodiments, the millisecond inactive phase is longer than the millisecond active phase. In embodiments, the millisecond inactive phase can vary in time between each millisecond active phase. In embodiments, the millisecond active phase is at least 0.16 millisecond. Waataja, para [0138]-[0140]. Referring to Figure 44C in the instant application where Example 3 is described as the signal has 90 μs pulse widths incorporated 820 μs inactive periods to decrease the duty cycle by about 5 fold. FIG. 44(c) shows a 1000 Hz signal used in Example 3. The signal has microsecond inactive periods was interwoven with 20 millisecond inactive periods which decreased the duty cycle by 1 order of magnitude. In the instant specification, the intermittent pattern comprise a frequency of 5000 Hz is 200 microseconds including a first pulse delay of 10 microseconds and a second pulse delay of 10 microseconds and a charge phase of 90 microseconds and recharge phase of 90 microseconds. Thus, Waataja does not teach each and every limitation of the Applicants claimed invention. In view of at least the arguments made herein, the rejection of claims 1-5, 10-12, 43-46, 52-57, 66-67 and 83 under U.S.C 102(a)(l) and U.S.C 102(a)(2) as being anticipated by Waataja was made in error and must be withdrawn. (06/04/2026 Remarks, pages 9-11) This argument is not persuasive. Applicant’s argument appears to be directed specifically to claim 1, although the topic pertains to all three independent claims. The arguments are related to limitations which discuss the millisecond active phase, millisecond inactive phase, and microsecond inactive phase: wherein the first electrical signal comprises a high-frequency alternating current (HFAC) having an intermittent pattern which comprises a millisecond active phase, thereby reducing the energy requirements to deliver a therapeutic effect by initiating a microsecond inactive phase between the blocking signal and stimulating signal, thereby reducing the duty cycle by at least 1 order of magnitude when compared against a signal without an inactive phase between the blocking signal and stimulating signal. (claim 1) Waataja Fig. 9 and [0030] disclose an intermittent pattern between the alternating millisecond active and inactive phases and within the millisecond active phase. The term intermittent pattern is broadly claimed where the alternating patterns in Waataja’s signal would be considered intermittent. Intermittent lacks a formal definition in the specification which would support a more specific interpretation. Therefore, it would be improper to import claim limitations from the specification (see MPEP 2111.01), such as the specific waveform in Fig. 44C, given the broadness of the claim language. It is also unclear how the microsecond inactive phase which occurs between adjacent positive/negative paired pulses in Waataja Fig. 9 is different in theory than the intermittent period which occurs between adjacent positive/negative paired pulses in instant Fig. 44C (besides the different look due to scaling). In Waataja, the duty cycle of the signal containing some combination of microsecond or millisecond inactive phases is discussed as being as low as 10% or less ([0169]), which would be an order or magnitude lower than a 100% duty cycle without the inactive phases (continuous). Therefore, the rejections of claims 1-5, 10-12, 43-46, 52-57, 66-67 and 83 are maintained. Applicant’s arguments, see Remarks pages 11-13 (Rejection under 35 U.S.C. 103), filed 06/04/2026, with respect to the 35 U.S.C. § 103 rejections of claims 68 and 77 have been fully considered. Regarding Claim 68, Applicant argues: The Examiner argues that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to alter Waataja's method/apparatus for neural regulation by incorporating the stimulation of organ tissue in Thornton. This would have been obvious because both Waataja and Thornton discuss the stimulation of tissue to address medical disorders and Thornton provides a solution/improvement to apply stimulation to organs as well as nerves for treatment of disorders. Therefore, one of ordinary skill would be motivated to improve the method/apparatus of Waataja by incorporating the stimulation of organ tissue in Thornton. Office Action, pg. 20. Applicants disagree. As a threshold matter, claim 43, which includes limitations directed to microsecond inactive phase between the blocking signal and stimulating signal is not taught or described in Waataja. Further, Thornton is used for the teachings or a list of organs. There is nothing in the combined references that would provide one of ordinary skill in the art the rational underpinning to arrive at the Applicant's claimed invention without the Applicants instant Specification. Applicants submit that Waataja is directed to the treatment of modulation of nerve activity is useful for the treatment of gastrointestinal conditions including obesity and other eating disorders, inflammatory conditions such as inflammatory bowel disease and pancreatitis, diabetes, and hypertension. Waataja at para [0004]. However, Applicants queries why a skilled artisan would seek out additional locations for the device to be utilized (such as organs), as suggested by the Examiner. Moreover, the treatment of a variety of diseases states, whether inflammation, obesity or glucose regulation and the use of signaling methods as described, show the complexity of each unique treatment regimen. Thus, the rational underpinning for combining these references has not been established as the Examiner has failed to articulate why a skilled artisan would seek out organs for use in the methods taught by Waataja. Moreover, the ability to attach the system to organs for the treatments, as claimed, could not be done without undue experimentation. Thus, the combination of references was made in error. In view of at least the arguments made herein, the rejection of claim 68 under U.S.C 103 as being unpatentable over Waataja in view of Thornton was made in error and must be withdrawn. (06/04/2026 Remarks, pages 11-12) This argument is not persuasive. The arguments pertaining to independent claim 43 were not found to be persuasive. Waataja discloses multipolar electrodes are arranged to be placed on different anatomical features with either upregulating or downregulating signals, e.g. one nerve is downregulated while another nerve is upregulated ([0103], [0108]). The inclusion of the phrase “two different branches of a nerve, another nerve or anatomical feature” suggests that other anatomical features than nerves would be considered (although this is not explicitly identified as an organ). Waataja further discloses “the systems and methods are useful for treating gastrointestinal disorders, obesity and eating disorders, pancreatitis and other inflammatory conditions, ulcerative colitis, Crohn's disease, diabetes, prediabetes, hypertension, and congestive heart failure” ([0238]). The conditions treated by Waataja are therefore relevant to organ systems. Thornton teaches a system which applies upregulating and downregulating electrical signals to separate nerves or organs in order to treat a disorder ([0037], [0131] – the physical capability to stimulate either is discussed). The application of blocking or stimulatory signals to organs as well as nerves would be seen as obvious in view of Thornton because stimulation of a nerve is ultimately made to have an effect on an organ, where Thornton teaches the stimulation of the organ directly. Note the organs are described as being in proximity to a nerve ([0131] – “The electrode may also be positioned to apply a signal to an organ in proximity to the vagus nerve such as the liver, duodenum, jejunum, ileum, spleen, pancreas, esophagus, or stomach”). Therefore, the prior art rejection of claim 68 is maintained. Regarding Claim 77, Applicant Argues: The Examiner argues that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to alter Thornton's method/apparatus treating metabolic disorders with electrical stimulation by incorporating the energy-saving electrical stimulator in Waataja. This would have been obvious because both Thornton and Waataja discuss the stimulation of tissue to address medical disorders and Waataja provides a solution/improvement for prolonged electrical stimulation due to reduced battery usage. Therefore, one of ordinary skill would be motivated to improve the method/apparatus of Thornton by incorporating the energy-saving electrical stimulator in Waataja. Office Action, pg. 23. Applicants disagree. There is nothing in the combination of references that teach each and every limitation of claim 77 in view of the argument made in the anticipatory rejection. In view of at least the arguments made herein, the rejection of claim 77 under U.S.C 103 as being unpatentable over Thornton in view of Waataja was made in error and must be withdrawn. (06/04/2026 Remarks, page 13) This argument is not persuasive. The argument is interpreted as claim 77 being covered by the same arguments regarding the intermittent patterns discussed in the 102 rejections (because of the shared limitations between claims 1 and 77). These arguments were not found persuasive in the anticipatory rejections and the rejections of claims 1-5, 10-12, 43-46, 52-57, 66-67 and 83 were maintained. Therefore, the rejection of claim 77 would similarly be maintained because Waataja teaches those features of the signal. Summary: The 35 U.S.C. § 102 rejections of claims 1-5, 10-12, 43-46, 52-57, 66-67 and 83 and the 35 U.S.C. § 103 rejections of claims 68 and 77 are maintained. Claim Objections The identified claims are objected to because of the following informalities: • Claim 83: Claim 83 is labeled "currently amended" but was not amended. Appropriate correction is required. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1-5, 10-12, 43-46, 52-57, 66-67, and 83 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Waataja (US 2017/0216602 A1). Regarding Claim 1, Waataja discloses a method for regulating nerve activity of a subject ([0002]) comprising: • applying a first electrical signal to a first nerve/organ and applying a second electrical signal to a second nerve/organ ([103,109] - Two electrodes are disclosed as performing separate actions to different nerves or anatomical features, where actions are described as either blocking or stimulation as they relate to downregulation and upregulation, respectively) wherein the first electrical signal downregulates nerve activity and has a frequency from about 200 Hz to about 100 kHz, or from about 200 Hz to about 50 kHz, or from about 200 Hz to about 25 kHz, or from about 200 Hz to about 15 kHz, or from about 200 Hz to about 10 kHz, or from about 200 Hz to about 5,000 Hz, or from about 200 Hz to about 1,500 Hz, or from about 200 Hz to about 1,000 Hz ([0118] – These ranges are disclosed for downregulation, but the frequency range can be summarized as bounded by 200 Hz to about 100 kHz) and wherein the first electrical signal comprises a high-frequency alternating current (HF AC) having an intermittent pattern which comprises a millisecond active phase (Fig 9, [0030] - These electrodes make use of high frequency alternating currents in [0118], made up of charge/recharge phases, during an “ON” or active phase where each “ON” or active phase is separated by an inactive phase), and • wherein the second electrical signal upregulates nerve activity and has a frequency from about 0.01 Hz to 199 Hz, or from about 0.01 Hz to about 100 Hz, or from about 0.01 Hz to about 50 Hz, or from about 0.01 Hz to about 30 Hz, or from about 0.01 Hz to about 10 Hz ([0119] – These ranges are disclosed for upregulation, but the frequency range can be summarized as bounded by 0.01 Hz to 199 Hz), wherein the intermittent patterns of HFAC blocking signal combined with a low frequency stimulation thereby regulates nerve activity (The higher frequency signal and lower frequency signal can be combined to simultaneously block and stimulate separate nerves to produce an effect, see [103, 109]) using lower pulse amplitudes to regulate nerve activity relative to a continuous blocking signal (A lower pulse duration and amplitude are a feature of the device which contributes to lower energy consumption [0177-0179], in combination with the inactive phase, particularly in comparison to a continuous signal without inactive phases [0005]), thereby reducing the energy requirements (a microsecond inactive phase is presented throughout Waataja as reducing energy requirements and improving battery life, see [0004], [0005], [0113], [0115], [0129], [0143]), to deliver a therapeutic effect by initiating a microsecond inactive phase between the blocking signal and stimulating signal ([0117-0119] – the microsecond inactive phase is a general feature which is applied to both the blocking and stimulating signals) thereby reducing the duty cycle by at least 1 order of magnitude when compared against a signal without an inactive phase between the blocking signal and stimulating signal ([0169] - “a duty cycle including at least one microsecond and/or millisecond inactive phase is a low duty cycle of about 75% or less, 70% or less, 60% or less, 50% or less, 40% or less, 30% or less, 20% or less, and 10% or less,” where a transition from 100% to 10% would be considered an order of magnitude less). Regarding the amplitude modulation, Claim 1 merely states lower pulse amplitudes can be used to regulate nerve activity (“wherein the intermittent patterns of HFAC blocking signal combined with a low frequency stimulation thereby regulates nerve activity using lower pulse amplitudes to regulate nerve activity relative to a continuous blocking signal”). Waataja discloses ramp downs in pulse width and amplitude can result in energy savings ([0178-0179]), where the amplitude ramp down is described in greater detail ([0177] – the amplitude is modulated to address the level of blocking in the downregulating signal). Waataja discloses an apparatus for downregulating ([0118]) and upregulating ([0119]) nerve activity using an electrical signal. The simultaneous use of downregulation and upregulation on different nerves (generally referred to as anatomical features) is discussed in sections relating to tripolar electrodes ([0103]) and five polar electrodes ([0109]). In this discussion of multipolar electrodes, Waataja describes systems capable of “blocking a first nerve and stimulating a second and then switching to stimulating the first nerve and blocking the second. Blocking one nerve and stimulating a second followed by blocking both nerves or vice versa” ([0103]). Note “nerve/organ” is being interpreted as being applied to either a nerve or organ. Regarding Claim 2, Waataja anticipates the neuroregulatory system in Claim 1, as indicated hereinabove. Waataja further discloses the first electrical signal comprises at least one microsecond cycle and a microsecond inactive phase, wherein each of the at least one microsecond cycle comprises at least one period, each of the at least one period comprising a pulse comprising a charge/recharge phase, the pulse having a pulse width ([0006] - describes the charge and recharge phases separated by microsecond inactive phases), and wherein the second electrical signal comprises at least one stimulation cycle, wherein each of the at least one stimulation cycle comprises at least one stimulation period, each of the at least one stimulation period comprising a pulse and a stimulation inactive phase, wherein the pulse of the stimulation period comprises a cathodic phase and/or an anodic phase ([0005]), and a pulse delay, the pulse of the stimulation period having a pulse width ([0006] - the second signal has similar features as the first signal as seen in [0228]). Waataja teaches downregulation ([0118]) in the first signal and upregulation ([0119]) in the second signal. The cathodic and anodic phases are represented by the charge and recharge phases described in Waataja (Fig. 6, [0005]). Regarding Claim 3, Waataja anticipates the neuroregulatory system in Claim 1, as indicated hereinabove. Waataja further discloses the first electrical signal further comprises at least one millisecond active phase and wherein each of the at least one millisecond active phase is separated by a millisecond inactive phase ([0010]). Regarding Claim 4, Waataja anticipates the neuroregulatory system in Claim 1, as indicated hereinabove. Waataja further discloses the second electrical signal further comprises at least one stimulation active phase, wherein each of the at least one stimulation active phase comprises at least one stimulation cycle, and wherein each of the at least one stimulation active phase is separated by an idle phase ([0010]). Waataja teaches downregulation ([0118]) in the first signal and upregulation ([0119]) in the second signal using the same terms. Regarding Claim 5, Waataja anticipates the neuroregulatory system in Claim 1, as indicated hereinabove. Waataja further discloses the first electrical signal is low duty cycle of about 75% or less, or preferably 50% or less ([0007], [0169]). Waataja teaches “a low duty cycle of about 75% or less, 70% or less, 60% or less, 50% or less, 40% or less, 30% or less, 20% or less, and 10% or less” ([0169]). Regarding Claim 10, Waataja anticipates the neuroregulatory system in Claim 2, as indicated hereinabove. Waataja further discloses the microsecond inactive phase of the first electrical signal is longer than the period of the first electrical signal ([0006]). Regarding Claim 11, Waataja anticipates the neuroregulatory system in Claim 2, as indicated hereinabove. Waataja further discloses the charge/recharge phase of the first electrical signal further comprises a pulse delay between the charge and/or recharge phases thereof ([0005]). Regarding Claim 12, Waataja anticipates the neuroregulatory system in Claim 2, as indicated hereinabove. Waataja further discloses the pulse of the second electrical signal is monophasic pulse, or biphasic pulse, or combinations thereof ([0005]). The charge and recharge phases constitute the two phases of a biphasic pulse. Waataja’s neuroregulator has the capability of generating a biphasic pulse and modulating the amplitudes of each phase, as evidenced by “each charge recharge phase has an increasing increment of amplitude or an increasing increment of pulse width. In embodiments, a ramp down includes multiple charge recharge phases, each charge recharge phase has a decreasing increment of amplitude or a decreasing increment of pulse width” ([0156]). Given this, it would be reasonable for one of ordinary skill in the art to create a zero-amplitude recharge phase, effectively creating a monophasic pulse. Regarding Claim 43, Waataja discloses a system ([0002]) comprising: • an implantable neuroregulator (Fig. 1, [0053] - The therapy system is an implantable neuroregulator); • at least one first electrode electrically connected to the implantable neuroregulator ([0054]) and adapted to be placed on a first nerve/organ ([0055]); • and at least one second electrode electrically connected to the implantable neuroregulator ([0054]) and adapted to be placed on a second nerve/organ ([0055]), • wherein the implantable neuroregulator comprises a microprocessor ([0063-0065]), the microprocessor configured to independently deliver a first electrical signal to the first nerve/organ through the first electrode and independently deliver a second electrical signal to the second nerve/organ through the second electrode ([0063-0065] - The microprocessor controlling the signals to the electrodes is disclosed); • wherein the first electrical signal has parameters to downregulate nerve activity ([0118]) and the second electrical signal has parameters to stimulate nerve activity ([0119]), and • wherein the first electrical signal has a frequency of about 200 Hz to about 100 kHz ([0118] – These ranges are disclosed for downregulation, but the frequency range can be summarized as bounded by 200 Hz to about 100 kHz), wherein the second electrical signal has a frequency of about 0.01 Hz to 199 Hz ([0119] – These ranges are disclosed for upregulation, but the frequency range can be summarized as bounded by 0.01 Hz to 199 Hz), • wherein the first electrical signal is a high-frequency alternating current (HFAC) having an intermittent pattern with a millisecond active phase (Fig. 9, [0030] – “FIG. 9 is a representation of a pattern of layered electrical signals displaying a low duty cycle HFAC/HFAV which contains repetitive microsecond cycles which form a millisecond active phase”), wherein the intermittent patterns of HF AC blocking signal, combined with a low frequency stimulation, (The higher frequency signal and lower frequency signal can be combined to simultaneously block and stimulate separate nerves to produce an effect, see [103, 109]) - comprises a microsecond inactive phase between the blocking signal and stimulating signal ([0117-0119] – the microsecond inactive phase is a general feature which is applied to both the blocking and stimulating signals), thereby reducing the energy requirements to deliver a therapeutic effect (a microsecond inactive phase is presented throughout Waataja as reducing energy requirements and improving battery life, see [0004], [0005], [0113], [0115], [0129], [0143]) - thereby reducing the duty cycle by at least 1 order of magnitude when compared against a signal without an inactive phase between the blocking signal and stimulating signal ([0169] - “a duty cycle including at least one microsecond and/or millisecond inactive phase is a low duty cycle of about 75% or less, 70% or less, 60% or less, 50% or less, 40% or less, 30% or less, 20% or less, and 10% or less,” where a transition from 100% to 10% would be considered and order of magnitude less). Waataja discloses an apparatus for downregulating ([0118]) and upregulating ([0119]) nerve activity using an electrical signal. The simultaneous use of downregulation and upregulation on different nerves (generally referred to as anatomical features) is discussed in sections relating to tripolar electrodes ([0103]) and five polar electrodes ([0109]). In this discussion of multipolar electrodes, Waataja describes systems capable of “blocking a first nerve and stimulating a second and then switching to stimulating the first nerve and blocking the second. Blocking one nerve and stimulating a second followed by blocking both nerves or vice versa” ([0103]). Note “nerve/organ” is being interpreted as being applied to either a nerve or organ. Regarding Claim 44, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the first electrical signal is low duty cycle of about 75% or less, or about 50% or less ([0169]). Waataja teaches “a low duty cycle of about 75% or less, 70% or less, 60% or less, 50% or less, 40% or less, 30% or less, 20% or less, and 10% or less” ([0169]). Regarding Claim 45, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the first electrical signal comprises at least one microsecond cycle and a microsecond inactive phase, wherein each of the at least one microsecond cycle comprises at least one period, each of the at least one period comprising a pulse comprising a charge/recharge phase, the pulse having a pulse width ([0006] - describes the charge and recharge phases separated by microsecond inactive phases), and wherein the second electrical signal comprises at least one stimulation cycle, wherein each of the at least one stimulation cycle comprises at least one stimulation period, each of the at least one stimulation period comprising a pulse and a stimulation inactive phase, wherein the pulse of the stimulation period comprises a cathodic and/or anodic phase ([0005]), and a pulse delay, the pulse of the stimulation period having a pulse width ([0006] - the second signal has similar features as the first signal as seen in [0228]). Waataja discloses downregulation ([0118]) in the first signal and upregulation ([0119]) in the second signal. The cathodic and anodic phases are represented by the charge and recharge phases described in Waataja (Fig. 6, [0005]). Regarding Claim 46, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the first electrical signal further comprises at least one millisecond active phase and wherein each of the at least one millisecond active phase is separated by a millisecond inactive phase ([0010]). Regarding Claim 52, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the microsecond inactive phase of the first electrical signal is longer than the period of the first electrical signal ([0006]). Regarding Claim 53, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the charge/recharge phase of the first electrical signal further comprises a pulse delay between the charge and/or recharge phase thereof ([0005]). Regarding Claim 54, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the pulse of the second electrical signal is monophasic pulse, or biphasic pulse, or combinations thereof ([0005]). The charge and recharge phases constitute the two phases of a biphasic pulse. Waataja’s neuroregulator has the capability of generating a biphasic pulse and modulating the amplitudes of each phase, as evidenced by “each charge recharge phase has an increasing increment of amplitude or an increasing increment of pulse width. In embodiments, a ramp down includes multiple charge recharge phases, each charge recharge phase has a decreasing increment of amplitude or a decreasing increment of pulse width” ([0156]). Given this, it would be reasonable for one of ordinary skill in the art to create a zero-amplitude recharge phase, effectively creating a monophasic pulse. Regarding Claim 55, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the first electrical signal and the second electrical signal each independently has an on time of about 30 seconds to about 30 minutes ([0122]). Regarding Claim 56, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the first electrical signal and the second electrical signal each independently has a current amplitude in a range from about 0.01 mAmps to about 20 mAmps ([0120]). Regarding Claim 57, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses wherein the first electrical signal and the second electrical signal each independently has a voltage in a range from about 0.01 volts to about 20 volts ([0121]). Waataja teaches “the amplitude is at least 1 volt. In other embodiments, the amplitude ranges from about 1 to 20 volts, 1 to 15 volts, 1 to 10 volts, 1 to 8 volts, or 1 to 5 volts.” ([0121]). Regarding Claim 66, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the subject has a disease or disorder selected from the group consisting of obesity, being overweight, pancreatitis, dysmotility, bulimia, gastrointestinal disease with an inflammatory basis, ulcerative colitis, Crohn's disease, low vagal tone, gastroparesis, diabetes, prediabetes, Type II diabetes, chronic pain, hypertension, gastroesophageal reflux disease, peptic ulcer disease and combinations thereof (Claim 15, [0242]). The only list element different between Waataja and the instant application is chronic pain, which would be interpreted by one of ordinary skill in the art as an extremely generalized condition which could originate from any other condition listed. Regarding Claim 67, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja further discloses the first nerve and the second nerve are independently from a nerve selected from the group consisting of the vagus nerve, anterior vagus nerve, posterior vagus nerve, hepatic branch of vagus nerve, celiac branch of vagus nerve, renal nerve, renal artery, sympathetic nerves, baroreceptors, glossopharyngeal nerve, and combinations thereof ([0251]). Note Waataja refers to the vagus nerve as the “vagus nerve and its individual branches” ([0242]) which would include the anterior vagus nerve, posterior vagus nerve, hepatic branch of vagus nerve, and celiac branch of vagus nerve. Regarding Claim 83, Waataja discloses a system ([0002]) comprising: • an implantable neuroregulator (Fig. 1, [0053] - The therapy system is an implantable neuroregulator); • at least one first electrode electrically connected to the implantable neuroregulator ([0054]) and adapted to be placed on a first nerve/organ ([0055]); and • at least one second electrode electrically connected to the implantable neuroregulator ([0054]) and adapted to be placed on a second nerve/organ ([0055] - where [0103] discusses placing electrodes on separate nerves), - wherein the implantable neuroregulator comprises a microprocessor ([0063-0065]), - the microprocessor configured to independently deliver a first electrical signal to the first nerve/organ through the first electrode and independently deliver a second electrical signal to the second nerve/organ through the second electrode ([0063-0065] - the microprocessor controlling the signals to the electrodes is disclosed) - wherein the first electrical signal has parameters to downregulate nerve activity ([0118]), and - the second electrical signal has parameters to stimulate nerve activity ([0119]), and - wherein the first electrical signal has a frequency of about 200 Hz to about 100 kHz ([0118] – These ranges are disclosed for downregulation, but the frequency range can be summarized as bounded by 200 Hz to about 100 kHz), - wherein the second electrical signal has a frequency of about 0.01 Hz to 199 Hz ([0119] – These ranges are disclosed for upregulation, but the frequency range can be summarized as bounded by 0.01 Hz to 199 Hz), - wherein the first electrical signal is a high-frequency alternating current (HFAC) having an intermittent pattern with a millisecond active phase (Fig. 9, [0030] – “FIG. 9 is a representation of a pattern of layered electrical signals displaying a low duty cycle HFAC/HFAV which contains repetitive microsecond cycles which form a millisecond active phase”), wherein the intermittent patterns of HFAC blocking signal, combined with a low frequency stimulation (The higher frequency signal and lower frequency signal can be combined to simultaneously block and stimulate separate nerves to produce an effect, see [103, 109]), comprises a microsecond inactive phase between the blocking signal and stimulating signal ([0117-0119] – the microsecond inactive phase is a general feature which is applied to both the blocking and stimulating signals), - thereby reducing the duty cycle by at least 1 order of magnitude, when compared against a signal without an inactive phase between the blocking signal and stimulating signal ([0169] - “a duty cycle including at least one microsecond and/or millisecond inactive phase is a low duty cycle of about 75% or less, 70% or less, 60% or less, 50% or less, 40% or less, 30% or less, 20% or less, and 10% or less,” where a transition from 100% to 10% would be considered an order of magnitude less). - thereby reducing the energy requirements to deliver a therapeutic effect (a microsecond inactive phase is presented throughout Waataja as reducing energy requirements and improving battery life, see [0004], [0005], [0113], [0115], [0129], [0143]). Waataja discloses an apparatus for downregulating ([0118]) and upregulating ([0119]) nerve activity using an electrical signal. The simultaneous use of downregulation and upregulation on different nerves (generally referred to as anatomical features) is discussed in sections relating to tripolar electrodes ([0103]) and five polar electrodes ([0109]). In this discussion of multipolar electrodes, Waataja describes systems capable of “blocking a first nerve and stimulating a second and then switching to stimulating the first nerve and blocking the second. Blocking one nerve and stimulating a second followed by blocking both nerves or vice versa” ([0103]). Note “nerve/organ” is being interpreted as being applied to either a nerve or organ. Claim Rejections - 35 USC § 103 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: Determining the scope and contents of the prior art. Ascertaining the differences between the prior art and the claims at issue Resolving the level of ordinary skill in the pertinent art. Considering objective evidence present in the application indicating obviousness or non-obviousness. Claim 68 is rejected under U.S.C 103 as being unpatentable over Waataja (U.S. 2017/0216602 A1) in view of Thornton (U.S. 2017/0021174 A1). Regarding Claim 68, Waataja anticipates the neuroregulatory system in Claim 43, as indicated hereinabove. Waataja discloses multipolar electrodes are arranged to be placed on different anatomical features with either upregulating or downregulating signals, e.g. one nerve is downregulated while another nerve is upregulated ([0103] – “If two tripolar electrode assemblies are on two different branches of a nerve, another nerve or anatomical feature, then any of the above configurations could be applied with different temporal patterns. Examples include, but not limited to, blocking a first nerve and stimulating a second and then switching to stimulating the first nerve and blocking the second”, [0108]). The inclusion of the phrase “two different branches of a nerve, another nerve or anatomical feature” suggests that other anatomical features than nerves would be considered (although this is not explicitly identified as an organ). Waataja further discloses “the systems and methods are useful for treating gastrointestinal disorders, obesity and eating disorders, pancreatitis and other inflammatory conditions, ulcerative colitis, Crohn's disease, diabetes, prediabetes, hypertension, and congestive heart failure” ([0238]). The conditions treated by Waataja are relevant to the organ systems in the instant claim. For instance, gastrointestinal disorders are directly relevant to function of the duodenum, jejunum, ileum, small bowel, colon, and stomach while pancreatitis is relevant to the pancreas. However, Waataja does not explicitly disclose organs to be stimulated in the instant claim. Thornton, in the same field of endeavor of electrical upregulation and downregulation to address medical disorders ([0039]), teaches the first organ and the second organ are selected from the group of duodenum, jejunum, ileum, small bowel, colon, stomach, esophagus, liver, spleen, pancreas, and combinations thereof ([0037], [0131] – the physical capability to stimulate either nerves or organs is discussed). Thornton teaches “applying an intermittent electrical signal to a target nerve or organ of the subject” ([0037]) in order to treat a disorder. The stimulation of a nerve is ultimately produced to have an effect on an organ, where Thornton teaches the stimulation of the organ directly. Note the organs are described as being in proximity to a nerve ([0131] – “The electrode may also be positioned to apply a signal to an organ in proximity to the vagus nerve such as the liver, duodenum, jejunum, ileum, spleen, pancreas, esophagus, or stomach”). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Waataja’s method/apparatus for neural regulation by incorporating the stimulation of organ tissue in Thornton. This would have been obvious because both Waataja and Thornton discuss the stimulation of nerves to address medical disorders and Thornton provides a solution/improvement to apply stimulation to organs as well as nerves for treatment of disorders for enhanced localization along the nerve/organ pathway of blocking or stimulatory effects. Therefore, a person of ordinary skill in the art would be motivated to improve the method/apparatus of Waataja by incorporating the stimulation of organ tissue in Thornton. Claim 77 is rejected under U.S.C 103 as being unpatentable over Thornton (U.S. 2017/0021174 A1) in view of Waataja (U.S. 2017/0216602 A1). Regarding Claim 77, Thornton discloses a system for treating a condition associated with impaired blood glucose regulation ([0011]) comprising: -an implantable neuroregulator ([0015]); -at least one first electrode electrically connected to the implantable neuroregulator and adapted to be placed on one or more hepatic nerve branch of a vagus nerve or any segment of the posterior anterior vagus nerve cranial to the hepatic branch of a subject ([0038]-[0039] - the downregulating signal can be applied to the hepatic nerve branch of the vagus nerve); -at least one second electrode electrically connected to the implantable neuroregulator and adapted to be placed on one or more celiac nerve branch of the vagus nerve or any segment of the posterior vagus nerve cranial to the celiac branch of the subject ([0038]-[0039] - the upregulating signal is applied to the celiac nerve branch of the vagus nerve); -blood glucose sensor configured to measure the blood glucose of the subject and convey a blood glucose value to the system ([0089] - A blood glucose sensor measures blood glucose as part of the system), - wherein the implantable neuroregulator comprises a microprocessor ([0079]), wherein the microprocessor is configured to independently deliver a first electrical signal to the hepatic nerve branch through the first electrode ([0038]-[0039]) and independently deliver a second electrical signal to the celiac branch through the second electrode ([0038]-[0039]), wherein the first electrical signal has parameters to downregulate nerve activity and the second electrical signal has parameters to stimulate nerve activity ([0038]-[0039]); -The downregulating and upregulating signals in Thornton result in a reduction in overall glucose ([0038-0039]). -and wherein the microprocessor is configured to apply a coordinated change to the first electrical signal and/or the second electrical signal in response to the blood glucose value ([0089] - The system can apply responsive changes to adjust the stimulation parameters). Thornton does not disclose a particular set of high and low frequencies or signal waveforms featuring inactive periods, stating “when selected to downregulate activity on the nerve, the electrical signal is applied at a frequency of about 200 Hz to 5000 Hz. When the signal is selected to upregulate activity on the nerve, the electrical signal is applied at a frequency of about 1 Hz to 200 Hz” ([0096]). Thornton discloses an interest in a pulse generator which conserves energy to prolong battery life ([0079]). Additionally, Thornton does not disclose wherein initiating a microsecond inactive phase between the blocking signal and stimulating signal thereby reducing the energy requirements to deliver a therapeutic effect. Waataja, in the same field of endeavor of electrical upregulation and downregulation of nerves, teaches wherein the first electrical signal has a frequency of about 200 Hz to about 100 kHz ([0118]), wherein the second electrical signal has a frequency of about 0.01 Hz to 199 Hz ([0119]), wherein the downregulating signal frequency is a high-frequency alternating current having an intermittent pattern having a millisecond active phase (Fig. 9, [0030] – “FIG. 9 is a representation of a pattern of layered electrical signals displaying a low duty cycle HFAC/HFAV which contains repetitive microsecond cycles which form a millisecond active phase”), wherein the intermittent patterns of high frequency alternating current (HF AC) blocking signal combined with a low frequency stimulation (The higher frequency signal and lower frequency signal can be combined to simultaneously block and stimulate separate nerves to produce an effect, see [103, 109]) thereby reduces peak glucose value ([0243-0244]). These electrodes make use of the low frequency alternating currents, made up of charge/recharge phases during an “ON” or active phase where each “ON” or active phase is separated by an inactive period (both signals appear to use the same scheme, [0228]). Note a microsecond inactive phase is presented throughout Waataja as reducing energy requirements and improving battery life ([0004], [0005], [0113], [0115], [0129], [0143]). Waataja teaches an apparatus for downregulating ([0118]) and upregulating ([0119]) nerve activity using an electrical signal. The simultaneous use of downregulation and upregulation on different nerves (generally referred to as anatomical features) is discussed in sections relating to tripolar electrodes ([0103]) and five polar electrodes ([0109]). In this discussion of multipolar electrodes, Waataja describes systems capable of “blocking a first nerve and stimulating a second and then switching to stimulating the first nerve and blocking the second. Blocking one nerve and stimulating a second followed by blocking both nerves or vice versa” ([0103]). Waataja teaches “the systems and methods of the disclosure are useful to downregulate and/or upregulate activity on the nerve including but not limited to vagus nerve, renal nerve, renal artery, sympathetic nerves, splanchnic nerve, celiac plexus, and glossopharyngeal nerves” ([0019]) where the vagus nerve can include the “vagus nerve and its individual branches” ([0242]). Waataja describes “in embodiments, more than one microsecond cycle forms a millisecond cycle, each millisecond cycle being separated by a millisecond inactive phase. The length of time of the microsecond and/or millisecond inactive phases provides for the ability to vary how often electrical signal treatment is applied to the nerve during an on time, provides for downregulation and/or upregulation of neural activity, and provides energy savings as compared to electrical signal therapy not having inactive phases” ([0005]). Waataja further describes “Application of neural modulation in some circumstances can be accompanied by a loss of effectiveness. This loss of effectiveness can in part be due to compliance of the patient with charging of the implanted device and/or effects on the nerve. It is desirable to identify electrical signal therapies that can minimize loss of effectiveness and decrease energy requirements of the device” ([0004]). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thornton’s apparatus treating metabolic disorders with electrical stimulation by incorporating the energy-saving electrical stimulator in Waataja. This would have been obvious because both Thornton and Waataja discuss the stimulation of nerves to address medical disorders and Waataja provides a solution/improvement for prolonged electrical stimulation capabilities due to reduced battery usage. Therefore, a person of ordinary skill in the art would be motivated to improve the apparatus of Thornton by incorporating the energy-saving electrical stimulator in Waataja. Conclusions Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Benjamin A. Schmitt/ Examiner Art Unit 3796 /LYNSEY C Eiseman/Primary Examiner, Art Unit 3796