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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/04/2026 has been entered.
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. As per the amendments filed on 02/04/2026, claim 43 is amended.
Priority
An updated review of priority is performed. 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 in the instant application is 04/17/2020.
Response to Arguments
Applicant’s arguments, see Remarks pages 9-11 (Rejections under 35 U.S.C. 102), filed 02/04/2026, 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 PG Pub 2017/0216602 A1) have been fully considered. Regarding Claims 1, 43 and 83, Applicant argues:
Applicant submits that there is nothing in the cited reference of record that teaches or suggests an anticipatory embodiment where the first electrical signal is a high frequency alternating current (HF AC) having an intermittent pattern with a millisecond active phase, wherein the intermittent patterns of HF AC blocking signal combined with a low frequency stimulation. (page 10, 02/04/2026 Remarks)
This argument is not persuasive. Waataja discloses an apparatus where signals can either be downregulating (blocking) or upregulating (stimulating) ([0116]). 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]). This has been interpreted in previous office actions as a combination of blocking and stimulation signals.
The interpretation of the term “combined” should be considered in the claim 1 limitation “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.” Based on Applicant’s arguments, it is unclear if the Applicant is arguing for an alternative understanding of “combined” (such as a nested signal combining blocking and stimulating frequencies). The combination of the blocking signal applied to an anatomical feature and the stimulation signal applied to another anatomical feature in Waataja is used to regulate nerve activity ([0103], [0108], [0116]). This interpretation of “combined” is supported in the instant specification, e.g.:
“FIG.53 shows the blood glucose change over time in diabetic swine treated with the combination of blocking the hepatic vagus nerve fiber and stimulating the celiac vagus” (pages 23-24)
“When practicing the present method and systems, especially the method using a combination of low frequency stimulation signal with high frequency blocking signal to regulate separate nerve/nerve branch/nerve fiber, other waveforms or patterns could also be used to improve the energy efficiency and effectiveness of electrical signals” (page 43)
Applicant additionally argues:
Rather the '602 application teaches blocking and stimulating but does not arrive at a methodology that includes a first signal having an intermittent pattern with a millisecond active phase AND a low frequency stimulation with a microsecond inactive phase between the blocking signal and stimulating signal. The Examiner rather draws upon various stimulating and blocking protocols and piecemeals portions of the limitations of claims 1, 43, and 83. (page 11, 02/04/2026 Remarks)
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 HFAC/HFAV which contains repetitive microsecond cycles which form a millisecond active phase”).
Claim 1 also contains the limitation “thereby reducing the energy requirements to deliver a therapeutic effect by initiating a microsecond inactive phase between the blocking signal and stimulating signal.” Both the blocking signal (Fig. 9, [0030] – “Within the microsecond cycles are charge and recharge phases separated by pulse delays and microsecond inactive phases following the pulse delay that follows the recharge phase”) and stimulating signal ([0117-0119] – the microsecond inactive phase is a general feature which is applied to both the blocking and stimulating signals) contain microsecond inactive phases, where the microsecond inactive phase is presented throughout Waataja as reducing energy requirements and improving battery life (see [0004], [0005], [0113], [0115], [0129], [0143]).
Applicant additionally argues:
Thus, there is nothing in Waataja that teaches each and every limitation of the currently pending claims […] Waataja at para [0178]. As shown, the paragraph is about energy consumption reduction for low duty cycle where the pulse width is lower than the period of the signal. Conversely, the instant Specification specially describes "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. Specification at para [0150]. Thus, the teachings of Waataja do not teach each and every limitation of the Applicant's claimed invention. (pages 10-11, 02/04/2026 Remarks)
This argument is not persuasive. Claim 1 contains the limitation “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.” Waataja discloses “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” ([0169]), where the reduction in duty cycle reaching 10% (caused by the inclusion of inactive phases) would be seen as an order of magnitude reduction. The same arguments and responses are pertinent to claims 43 and 83. Therefore, the prior art rejections of claims 1, 43, and 83 (and dependent claims 2-5, 10-12. 44-46, 52-57, and 66-67) are maintained.
Applicant’s arguments, see Remarks pages 12-13 (Rejections under 35 U.S.C. 103), filed 02/04/2026, with respect to the 35 U.S.C. § 103 rejections of claims 68 and 77 have been fully considered. Regarding Claim 68, Applicant argues:
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 as discussed above. 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. (pages 12-13, 02/04/2026 Remarks)
This argument is not 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] – “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]). 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.
Thornton teaches a system which applies upregulating and deregulating electrical signals to separate nerves or organs in order to treat a disorder ([0037], [0131] – the physical capability to attach to either is demonstrated in the art). The application of blocking or stimulatory signal to organs as well as nerves would be seen as obvious in view of Thornton’s apparatus because direct stimulation of an organ would provide enhanced localization of blocking or stimulatory effects for a prescribed treatment. 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. 25. Applicants disagree.
There is nothing in the combination of references that teach each and every limitation of claim 77. In particular, there is nothing in the cited references that specifically teach a high frequency alternating current having an intermittent pattern having a millisecond active phase, wherein the intermittent patterns of high frequency alternating current (HFAC) blocking signal combined with a low frequency stimulation thereby reduces the peak glucose value; 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. These features are explicitly recited in claims 77. (page 13, 02/04/2026 Remarks)
This argument is not persuasive. Relevant to the above argument, Claim 77 states:
wherein the downregulating signal frequency is a high-frequency alternating current having an intermittent pattern having a millisecond active phase, wherein the intermittent patterns of high frequency alternating current (HFAC) blocking signal combined with a low frequency stimulation thereby reduces the peak glucose value; 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, and wherein initiating a microsecond inactive phase between the blocking signal and stimulating signal thereby reducing the energy requirements to deliver a therapeutic effect.
As has been discussed earlier, Waataja teaches multipolar electrodes arranged to be placed on different anatomical features with either upregulating or downregulating signals ([0103], [0108]) where the blocking signal contains intermittent millisecond active phases (Fig. 9, [0030]) and both blocking and stimulating signals use microsecond inactive phases ([0117-0119]) to reduce energy requirements and improve battery life (see [0004], [0005], [0113], [0115], [0129], [0143]). Waataja further discusses the application of these signals for regulating blood glucose ([0243-0244]).
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 upregulating and downregulating signals are applied to different nerve/organs in concert to regulate glucose levels ([0091]). The system applies responsive changes to adjust the stimulation parameters to regulate glucose level, such as when excessive glucose levels are detected and need to be lowered ([0089]). Thornton is used as the primary reference because the instant claim 77 apparatus is specifically configured to regulate glucose by applying blocking and stimulating signals to particular nerves/organs while Waataja, also concerned with glucose regulation, teaches signals which conserve energy with the inclusion of inactive phases in the blocking and stimulating signals.
Summary: The 35 U.S.C. § 102 rejections of claims 1-5, 10-12, 43-46, 52-57, 66-67 and 83 are maintained. The 35 U.S.C. § 103 rejections of claims 68 and 73 are maintained.
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 PG Pub 2017/0216602 A1, see previously cited).
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.
Therefore, Claim 1 is anticipated by Waataja.
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]).
Therefore, Claim 2 is anticipated by Waataja.
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]).
Therefore, Claim 3 is anticipated by Waataja.
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.
Therefore, Claim 4 is anticipated by Waataja.
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]).
Therefore, Claim 5 is anticipated by Waataja.
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]).
Therefore, Claim 10 is anticipated by Waataja.
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]).
Therefore, Claim 11 is anticipated by Waataja.
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.
Therefore, Claim 12 is anticipated by Waataja.
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 improveing 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.
Therefore, Claim 43 is anticipated by Waataja.
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]).
Therefore, Claim 44 is anticipated by Waataja.
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]).
Therefore, Claim 45 is anticipated by Waataja.
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]).
Therefore, Claim 46 is anticipated by Waataja.
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]).
Therefore, Claim 52 is anticipated by Waataja.
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]).
Therefore, Claim 53 is anticipated by Waataja.
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.
Therefore, Claim 54 is anticipated by Waataja.
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]).
Therefore, Claim 55 is anticipated by Waataja.
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]).
Therefore, Claim 56 is anticipated by Waataja.
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]).
Therefore, Claim 57 is anticipated by Waataja.
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.
Therefore, Claim 66 is anticipated by Waataja.
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.
Therefore, Claim 67 is anticipated by Waataja.
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.
Therefore, Claim 83 is anticipated by Waataja.
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. PG Pub 2017/0216602 A1, see previously cited) in view of Thornton (U.S. PG Pub 2017/0021174 A1, see previously cited).
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]). 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 ([0038]). Thornton teaches “applying an intermittent electrical signal to a target nerve or organ of the subject” ([0037]) in order to treat a disorder.
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 tissue 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 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.
Therefore, Claim 68 is obvious over Waataja in view of Thornton.
Claim 77 is rejected under U.S.C 103 as being unpatentable over Thornton (U.S. PG Pub 2017/0021174 A1, see previously cited) in view of Waataja (U.S. PG Pub 2017/0216602 A1, see previously cited).
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 tissue 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.
Therefore, Claim 77 is obvious over Thornton in view of Waataja.
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 8:30 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights