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 .
Response to Arguments
Applicant’s arguments, filed 12/04/2025, with respect to the objection of claims 19-20 and 24 for minor informalities have been fully considered and are persuasive. The objection of claims 19-20 and 24 for minor informalities has been withdrawn.
Applicant’s arguments, filed 12/04/2025, with respect to the interpretation of claims 8 and 23 under 35 U.S.C. § 112(f) have been fully considered and are persuasive. The interpretation of claims 8 and 23 under 35 U.S.C. § 112(f) has been withdrawn.
Applicant’s arguments, filed 12/04/2025, with respect to the rejection of claims 8, 13, and 18-20 under 35 U.S.C. §112(b) have been fully considered and are persuasive. The rejection of claims 8, 13, and 18-20 under 35 U.S.C. §112(b) has been withdrawn.
Applicant's arguments, filed 12/04/2025, with respect to the rejection of claims 1-13, 18-20, 22-26, and 49 under 35 U.S.C. § 103 have been fully considered but they are not persuasive. Additionally, since the amendments to independent claims 1, 23, 25, and 49 change the scope of claims 1-4, 6, 8, 10-13, 18, 20, 22-26, and 49 and do not merely incorporate limitations from previous dependent claims, a new grounds of rejection is made in view of previously applied references. Furthermore, since new claims 51-55 were added, a new grounds of rejection is made in view of previously applied references.
Applicant contends that none of the references, alone or in combination, disclose an electrode that is provided on either side of the tragus such that the signal is passed across the tragus, that none of the references disclose that this arrangement is used to modulate cerebral blood flow, and that none of the references disclose modulation of cerebral blood flow of a user for the purpose of treating a circulatory system disease. Examiner respectfully disagrees.
Dietrich teaches modulation of cerebral blood flow (Abstract, where “The invention relates to a method for modulation … of neural tissue and/or neural tissue related functionality with stimulating neural tissue and/or neural tissue related functionality with stimuli by which neural activity related local perfusion changes”) utilizing a stimulation and reference electrode to stimulate the tragus of a user (Figure 2, stimulation electrode 2, reference electrode 3, ¶[0052], where “The stimulation and reference electrodes 2, 3 must have electrical contact with the surface of the patient's skin, and this contact is permitted by contact points 8, 9 which can be designed as small metal balls. The electrodes 2, 3 lie on the inner face of the tragus,” ¶[0068], where “tVNS was performed at the inner side of the left tragus (FIG. 3A)”) and that modulation is utilized to treat a circulatory system disease (¶[0020], where “The method according to the present invention may in particular be used with neurological and/or neuropsychiatric disorder and/or symptoms resulting from underlying cause selected from a group consisting of … cardio-vascular disorders, artrial fibrillation”). Examiner takes the position that modulation of neural tissue or neural tissue functionality with stimuli that trigger or influence related local perfusion changes modulates cerebral blood flow. Local perfusion changes directly represent local cerebral blood flow (See Alyssa Larios, Shivang Sullere, Chenghua Gu, "Cerebral blood flow and energy demand: imaging insights into neurovascular function," Neurophotonics 12(S2), S22810 (2 December 2025). https://doi.org/10.1117/1.NPh.12.S2.S22810, where “the neurovascular network dynamically modulates regional blood volume to concentrate energy-rich blood toward highly active brain areas. This activity-dependent focal increase in cerebral blood flow, called neurovascular coupling (NVC), occurs when activated neurons trigger the dilation of nearby arterioles, leading to a localized increase in perfusion.”) such that a perfusion change, such as increasing perfusion, directly impacts and modulates cerebral blood flow. Furthermore, Dundovic teaches an electrode that is provided on either side of the tragus such that the signal is passed across the tragus (¶[0103], where “the nerve stimulation system 100 includes a securing member configured to be attached to a tragus of the subject so that electrodes are urged into engagement with opposing faces of the tragus,” ¶[0104], where “the securing member is in the form of a clip 110 having opposing arms 111, 112, with electrodes 121, 122 positioned proximate a distal end of the arms on opposing faces, which are biased towards each other,” ¶[0135], where “one of the electrodes 121, 122 acts as ground, with the therapy signals being applied via the other electrode”).
Additionally, Applicant contents that the parameters and regimen of amended claim 1 yields a non-obvious technical effect (CBF-mediated, sustained blood pressure reduction) not suggested by Dietrich, Sharma, Spinelli or Brown individually or in combination. In response to applicant's argument that parameters and regimen of amended claim 1 yields a non-obvious technical effect (CBF-mediated, sustained blood pressure reduction) not suggested by Dietrich, Sharma, Spinelli or Brown individually or in combination, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the combination of Dietrich, Dundovic, and Spinelli, as explained in further detail below, teaches the structure of the claimed invention such that the claimed invention is not patentably distinguished from the prior art.
Claim Objections
Claims 22-23 are objected to because of the following informalities:
Regarding claim 22, in line 1, the claim reads “… wherein earpiece comprises a marking”. The statement seems to be missing the article “the”. Examiner suggests amending the claim to read “… wherein the earpiece comprises a marking” in order to increase clarity.
Regarding claim 23, in lines 10-11, the claim reads “… the earpiece comprising stimulating electrode”. The statement seems to be missing the article “a”. Examiner suggests amending the claim to read “… the earpiece comprising a stimulating electrode” in order to increase clarity.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6, 8, 10-13, 18, 20, 22, 51, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Dietrich et al. (hereinafter “Dietrich”) (U.S. Pub. No. 2009/0287035 A1) in view of Dundovic et al. (hereinafter “Dundovic”) (U.S. Pub. No. 2022/0287616 A1) and Spinelli et al. (hereinafter “Spinelli”) (U.S. Pat. No. 9,415,220 B1, Reference 17 from IDS dated 06/16/2023).
Regarding claim 1, Dietrich teaches a device for modulating cerebral blood flow of a user (Abstract, where “The invention relates to a method for modulation … of neural tissue and/or neural tissue related functionality with stimulating neural tissue and/or neural tissue related functionality with stimuli by which neural activity related local perfusion changes”) to treat a circulatory system disease (¶[0020], where “The method according to the present invention may in particular be used with neurological and/or neuropsychiatric disorder and/or symptoms resulting from underlying cause selected from a group consisting of … cardio-vascular disorders, artrial fibrillation”), the device comprising:
a generator configured to produce an electrical stimulation signal (¶[0045], where “Oscillating signals are needed for transdermal stimulation. They are generated by an oscillator 13”);
a controller (¶[0045], where “The stimulation frequency and the stimulation strength are predetermined and generated by the control unit 4”), connected to the generator (¶[0045], where “The stimulation frequency and the stimulation strength are predetermined and generated by the control unit 4. These parameters are set by various control elements 12. Oscillating signals are needed for transdermal stimulation. They are generated by an oscillator 13 located in the control unit 4”), configured to determine the form of the electrical stimulation signal (¶[0023], where “For stimulation a stimulation pulse with at least one of a plateau pulse width of adjustable duration, a rising and decaying trailing phase of adjustable duration and a charge recovery phase of adjustable duration can be used,” ¶[0047], where “Integrated into the control unit 4 there is, in the first instance, a stimulation strength regulator 16 for regulating the amplitude (strength) of the stimulation signal,” ¶[0048], where “The control unit 4 also contains a stimulation frequency regulator 17 for regulating the frequency pattern of the stimulation signal. Thus, signals following one another in rapid succession can be controlled just as can signals that follow one another at a greater interval”); and
an earpiece (Figure 2, ¶[0046], where “As can be seen from FIG. 2, the device 1 is similar in structure to a behind-the-ear hearing aid”), connected to the generator and controller (¶[0046], where “The connection between the electrode head 7 and the part of the housing 5 shown on the left-hand side of FIG. 2 is designed as a bow-shaped extension piece 6, through which all the input and output lines between stimulation electrode unit and control unit are also routed”), the earpiece comprising:
a stimulating electrode (Figure 2, stimulation electrode 2) configured to provide the electrical stimulation signal to the nerves innervating a tragus of the user (¶[0052], where “The stimulation and reference electrodes 2, 3 must have electrical contact with the surface of the patient's skin, and this contact is permitted by contact points 8, 9 which can be designed as small metal balls. The electrodes 2, 3 lie on the inner face of the tragus,” ¶[0068], where “tVNS was performed at the inner side of the left tragus (FIG. 3A)”), and
a reference electrode (Figure 2, reference electrode 3),
wherein the controller is configured to transmit the electrical stimulation signal to the stimulating electrode and the reference electrode (¶[0044], where “The stimulation of the nerve takes place via the stimulation electrode 2. The reference electrode 3 serves as an electrical reference point. Both electrodes 2, 3 form the stimulation electrode unit 11. Electrodes 2 and 3 for transdermal stimulation are known, commercially available and easy to produce,” ¶[0045], where “The stimulation frequency and the stimulation strength are predetermined and generated by the control unit 4,” ¶[0046], where “The connection between the electrode head 7 and the part of the housing 5 shown on the left-hand side of FIG. 2 is designed as a bow-shaped extension piece 6, through which all the input and output lines between stimulation electrode unit and control unit are also routed”),
wherein the electrical stimulation signal comprises a series of electrical pulses (¶[0023], where “For stimulation a stimulation pulse with at least one of a plateau pulse width of adjustable duration, a rising and decaying trailing phase of adjustable duration and a charge recovery phase of adjustable duration can be used,” ¶[0048], where “The control unit 4 also contains a stimulation frequency regulator 17 for regulating the frequency pattern of the stimulation signal. Thus, signals following one another in rapid succession can be controlled”), each pulse repeating with a frequency of 1 Hz to 100 Hz (¶[0050], where “The frequency of the current is between 20 and 30 Hz”) and an amplitude of 0.1 mA to 8 mA (¶[0050], where “The applied current is between 0.25 and 1.5 mA,” ¶[0068], where “Electrical current amplitude was varied individually between 4 and 8 mA”).
Regarding the above-taught frequency and amplitude, Examiner notes that according to In re Wertheim, where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
Although Dietrich teaches the earpiece being configured such that the stimulating and reference electrodes are in contact with the tragus of the user (¶[0052], where “The stimulation and reference electrodes 2, 3 must have electrical contact with the surface of the patient's skin, and this contact is permitted by contact points 8, 9 which can be designed as small metal balls. The electrodes 2, 3 lie on the inner face of the tragus”), Dietrich does not teach that the earpiece is configured such that, when the stimulating electrode is in position on the tragus of the user, the stimulating electrode is in contact with a first face of the tragus and the reference electrode is in contact with a second, opposing face of the tragus, nor each pulse having duration of 10 microseconds to 500 microseconds.
Dundovic teaches a vagus nerve stimulation system for stimulating a vagus nerve in a biological subject, the system including a clip configured to be attached to a tragus of the subject (Abstract), and further teaches that the earpiece (¶[0103], where “the nerve stimulation system 100 includes a securing member configured to be attached to a tragus of the subject”) is configured such that, when the stimulating electrode is in position on the tragus of the user, the stimulating electrode is in contact with a first face of the tragus and the reference electrode is in contact with a second, opposing face of the tragus (¶[0103], where “the nerve stimulation system 100 includes a securing member configured to be attached to a tragus of the subject so that electrodes are urged into engagement with opposing faces of the tragus,” ¶[0104], where “the securing member is in the form of a clip 110 having opposing arms 111, 112, with electrodes 121, 122 positioned proximate a distal end of the arms on opposing faces, which are biased towards each other,” ¶[0135], where “one of the electrodes 121, 122 acts as ground, with the therapy signals being applied via the other electrode.” Examiner interprets that a ground electrode is equivalent to a reference electrode.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dundovic, which teaches that the earpiece is configured such that, when the stimulating electrode is in position on the tragus of the user, the stimulating electrode is in contact with a first face of the tragus and the reference electrode is in contact with a second, opposing face of the tragus, with the invention of Dietrich in order to stimulate the vagus nerve within the tragus and to ensure good electrical contact with the tragus and maximize the effectiveness of modulation of the vagus nerve (Dundovic ¶[0110]).
Neither Dietrich nor Dundovic teaches each pulse having duration of 10 microseconds to 500 microseconds.
Spinelli teaches a device for auricular stimulation that “includes an earpiece having an electrode arrangement configured and arranged to deliver a series of electrical stimulation signals to an auricular location” (Abstract), and further teaches that each pulse has duration of 10 microseconds to 500 microseconds (Col. 21, line 58, which teaches “a pulse width of 200 microseconds”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli, which teaches that each pulse has duration of 10 microseconds to 500 microseconds, with the modified invention of Dietrich since according to In re Wertheim, where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).” Furthermore, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli with the modified invention of Dietrich since the pulse duration can be particularly effective (Spinelli Col. 28, lines 14-15).
Regarding claim 2, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Spinelli teaches that modulating cerebral blood flow is applied to the user for any of the following purposes: modulating arterial blood pressure, reducing systemic arterial blood pressure, reducing left ventricular hypertrophy, reducing pulmonary arterial blood pressure, treating of hypertension, treating heart failure (Col. 4, lines 33-37, 41-58, where “The present disclosure is believed to be applicable to a variety of different types of devices and processes, and the present disclosure has been found to be particularly suited for stimulation of one or both of the auricular branches of the vagus nerve ... Various embodiments of the present disclosure are directed toward locating a stimulation point for providing electrical stimulus to one or both of the auricular branches of the vagus nerve. Particular aspects relate to facilitating methods for providing therapeutic levels of such stimulation in a reproducible manner. For instance, certain embodiments are directed toward a stimulation-providing device that has a positioning and fixation device that is designed to consistently deliver individualized (operator-independent) electrical stimulation to the auricular nerve with the objective of activating the parasympathetic system and decreasing the sympathetic/parasympathetic balance to decrease and/or slow down the inflammatory process and/or stop degenerative processes triggered by the neural network that controls the heart during periods of stress, such as those that occur during the progression of heart failure, dilation of the ventricles and its reaction to a sudden decrease in regional blood flow in the myocardium,” Col. 26, lines 32-45, where “The use of two earpieces 1802, 1804 with respective stimulation electrodes allow for a variety of different applications and embodiments ... stimulation on each side of the body can be effective for reaching respective and different portions of the heart ... having the capability to stimulate from both sides of the body can be particularly useful for parasympathetically innervated regions of the heart ... In some embodiments, such as in the case of heart failure and ischemia, there is stimulation of both sides”), and/or treating atrial fibrillation.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli, which teaches that modulating cerebral blood flow is applied to the user for at least one of the following purposes: treating heart failure, with the modified invention of Dietrich in order to correct imbalances in autonomic control created by acute and chronic heart failure, to significantly reduce ischemic damage of the heart by tempering the over-reaction of the control system due to the overload of its afferent circuits, to lower the overall mortality rate (Spinelli Col. 1, lines 45-53).
Regarding claim 3, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Dietrich teaches that the stimulating electrode and the reference electrode are configured to provide the electrical stimulation signal transcutaneously to the user (¶[0063], where “direct transcutaneous VNS (tVNS) at the external ear is possible is reasoned from interpreting functional anatomy,” ¶[0068], where “tVNS was performed at the inner side of the left tragus (FIG. 3A) using a stand-alone electrical nerve stimulator connected with carbon fibre wires to an acrylic electrode array housing a sterling silver stimulation electrode and a reference electrode (FIG. 3B)”).
Regarding claim 6, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Dietrich teaches that the earpiece comprises a stimulating electrode and a reference electrode (Figure 2, stimulation electrode 2, reference electrode 3).
Spinelli teaches that the earpiece is a first earpiece (Col. 2, lines 57-60, where “The kit includes a first ear piece having an electrode configured and arranged to deliver a series of electrical stimulation signals to a first auricular location”) and wherein the device further comprises a second earpiece (Col. 2, lines 62-65, where “A second earpiece has an electrode configured and arranged to deliver the series of electrical stimulation signals to a second, different auricular location”) comprising a second stimulating electrode and a second reference electrode (Col. 3, lines 10-13, where “Although various embodiments herein are described in the context of a single one auricular nerve in one ear being stimulated, the various teachings can be applied to the stimulation of both auricular nerves,” Col. 7, lines 53-63, where “Structure/earpieces 104, 106 contain one or more stimulation electrodes 122, 124 configured and arranged to deliver electrical stimulation signals to the auricular branch of the vagus nerve. A control switch 120 can be used to select between the stimulation electrodes. In this manner, the electrical stimulation can be delivered to different stimulation locations relative to the patient. A reference electrode 128 can also be included. This reference electrode can be used to provide feedback information, such as an electrical impedance measurement taken relative to the stimulation electrodes.” Examiner takes the position that the first and second earpiece comprise respective stimulation electrodes and reference electrodes since the first and second earpieces are constructed in the same manner and each have respective stimulation and recording electrodes that correspond to first and second electrodes and first and second reference electrodes.), wherein the first earpiece is configured to be placed in contact with the left tragus of the user (Col. 2, lines 57-60, where “The kit includes a first ear piece having an electrode configured and arranged to deliver a series of electrical stimulation signals to a first auricular location,” Col. 3, lines 5-13, where “both auricular nerves (or nerve regions) are stimulated in the auricular areas of the right and left ears. Depending on the desired/measured effect, the stimulation in each ear can be sequential, simultaneous and/or have other relationships relative to phase, frequency, and amplitude or duty cycle. Although various embodiments herein are described in the context of a single one auricular nerve in one ear being stimulated, the various teachings can be applied to the stimulation of both auricular nerves.” Examiner takes the position that the first electrode is in contact with the left tragus since the auricular nerves are located within the tragus and the electrode is inherently applied to that area in order to stimulate it. Furthermore, since the ear piece is applied to a first auricular location in either the left or right ear, this inherently teaches contact with the left ear.) and the second earpiece is configured to be placed in contact with the right tragus of the user (Col. 2, lines 62-65, where “A second earpiece has an electrode configured and arranged to deliver the series of electrical stimulation signals to a second, different auricular location,” Col. 3, lines 5-13. Examiner takes the position that the second electrode is in contact with the right tragus since the auricular nerves are located within the tragus and the electrode is inherently applied to that area in order to stimulate it. Furthermore, since the ear piece is applied to a second auricular location in either the left or right ear, this inherently teaches contact with the right ear.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli, which teaches that the earpiece is a first earpiece and wherein the device further comprises a second earpiece comprising a second stimulating electrode and a second reference electrode, wherein the first earpiece is configured to be placed in contact with the left tragus of the user and the second earpiece is configured to be placed in contact with the right tragus of the user, with the modified invention of Dietrich since auricular stimulation is a minimally invasive way to stimulate the vagal system and since enabling stimulation of both sides of the system (right and left) in a minimally invasive way facilitates treatment of a significant portion of the neural system that controls the heart (Spinelli Col. 1, lines 65-67 – Col. 2, lines 1-3).
Regarding claim 8, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Dundovic teaches a clip to secure the stimulating electrode and the reference electrode to the tragus of the user (¶[0104], where “the securing member is in the form of a clip 110 having opposing arms 111, 112”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dundovic, which teaches a clip to secure the stimulating electrode and the reference electrode to the tragus of the user, with the modified invention of Dietrich in order to ensure good electrical contact with the tragus and maximize the effectiveness of modulation of the vagus nerve (Dundovic ¶[0110]).
Regarding claim 10, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 8 as described in the rejection above.
Dundovic teaches that the clip has a first gripping portion and a second gripping portion which are biased into contact with each other (¶[0104], where “the securing member is in the form of a clip 110 having opposing arms 111, 112, with electrodes 121, 122 positioned proximate a distal end of the arms on opposing faces, which are biased towards each other”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dundovic, which teaches that the clip has a first gripping portion and a second gripping portion which are biased into contact with each other, with the modified invention of Dietrich in order to ensure good electrical contact with the tragus and maximize the effectiveness of modulation of the vagus nerve (Dundovic ¶[0110]).
Regarding claim 11, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 10 as described in the rejection above.
Dundovic teaches that the stimulating electrode is located on the first gripping portion (Figure 1B, electrode 121, ¶[0104], where “the securing member is in the form of a clip 110 having opposing arms 111, 112, with electrodes 121, 122 positioned proximate a distal end of the arms on opposing faces, which are biased towards each other,” ¶[0135], where “one of the electrodes 121, 122 acts as ground, with the therapy signals being applied via the other electrode”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dundovic, which teaches that the stimulating electrode is located on the first gripping portion, with the modified invention of Dietrich in order to ensure good electrical contact with the tragus and maximize the effectiveness of modulation of the vagus nerve (Dundovic ¶[0110]).
Regarding claim 12, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 10 as described in the rejection above.
Dietrich teaches the reference electrode (¶[0044], where “The reference electrode 3 serves as an electrical reference point,” ¶[0046], where “The stimulation electrode unit in the form of an electrode head or an ear electrode 7 is inserted into the external auditory canal, such that … the reference electrode 3 come to lie on the skin surface”), however, Dietrich does not teach that the reference electrode is located on the second gripping portion.
Dundovic teaches that an electrode is located on the second gripping portion (Figure 1B, electrode 122, ¶[0104], where “the securing member is in the form of a clip 110 having opposing arms 111, 112, with electrodes 121, 122 positioned proximate a distal end of the arms on opposing faces, which are biased towards each other”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dundovic, which teaches that an electrode is located on the second gripping portion, with the modified invention of Dietrich in order to ensure good electrical contact with the tragus and maximize the effectiveness of modulation of the vagus nerve (Dundovic ¶[0110]).
Regarding claim 13, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Dietrich teaches a physiological sensor configured to measure a value of a physiological parameter (¶[0057], where “The earpiece can additionally be provided with a sensor for measuring the pulse and oxygen saturation. Such sensors are known for measurement of respiratory function and pulse and are commercially available”) and store the value in a memory portion of the device (¶[0057], where “The measured values can be recorded on a memory chip located in the housing 5 behind or in the ear, such that they can later be read out by a physician via a cableless interface and can be evaluated using software”), wherein the value stored in the memory portion is used by the controller to determine the form of the electrical stimulation signal (¶[0023], where “For stimulation a stimulation pulse with at least one of a plateau pulse width of adjustable duration, a rising and decaying trailing phase of adjustable duration and a charge recovery phase of adjustable duration can be used,” ¶[0047], where “Integrated into the control unit 4 there is, in the first instance, a stimulation strength regulator 16 for regulating the amplitude (strength) of the stimulation signal,” ¶[0048], where “The control unit 4 also contains a stimulation frequency regulator 17 for regulating the frequency pattern of the stimulation signal. Thus, signals following one another in rapid succession can be controlled just as can signals that follow one another at a greater interval,” ¶[0057], where “From the change in the pulse rate variability calculated by the software, the physician is able to obtain important information concerning the psychovegetative modulation effect of the stimulation device and is thus also provided with control data over the course of the therapy.”).
Regarding claim 18, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Spinelli teaches that the device is configured to determine the electrical impedance of the tragus (Col. 22, lines 13-18, where “injection of low amplitude pulses of current facilitates the measurement of the ratio between the voltage applied and the current achieved between the reference electrode and the stimulation electrode. The voltage waveform was identical to the one used for stimulation to obtain accurate estimates of the complex impedance that exists between the electrodes”) based on measurements of current, voltage and phase relationship of the electrical stimulation signal are stored in a memory portion of the device (Col. 7, lines 33-43, where “Device 102 includes circuitry 112 that is configured and arranged to generate electrical stimulation signals (e.g., pulses) that are consistent with a desired stimulation profile. A processing circuit 114 can adjust the stimulation profile in response to one or more inputs. Consistent with certain embodiments, the adjustment to the stimulation profile can made by selecting from a set of stimulation profiles, which can be stored in a storage/memory circuit 110. Consistent with other embodiments, the adjustment can be made using an algorithm that determines parameter changes to the stimulation profile,” Col. 5, lines 51-59, where “a first stimulation profile may include a series of square wave pulses having a voltage or current level ‘X’. The feedback signal may detect a certain impedance level at, or near, stimulation point(s) of the electrode arrangement. The stimulation profile can then be adjusted by increasing or decreasing the voltage or current level ‘X’. This process can repeat in response to further feedback and thereby achieve and maintain the stimulation profile within an acceptable level,” Col. 22, lines 13-16, where “injection of low amplitude pulses of current facilitates the measurement of the ratio between the voltage applied and the current achieved between the reference electrode and the stimulation electrode.” Examiner takes the position that since the stimulation profile, which is continuously updated, is stored in a storage/memory circuit and includes a voltage and current level, that voltage and current levels are inherently stored in the memory. Additionally, since the measured ratio of the voltage and current is also determined, a phase relationship is inherently determined and stored since the relationship between voltage and current is a type of phase relationship.) and are used to determine an electrical impedance of the tragus (Col. 22, lines 13-18, where “injection of low amplitude pulses of current facilitates the measurement of the ratio between the voltage applied and the current achieved between the reference electrode and the stimulation electrode. The voltage waveform was identical to the one used for stimulation to obtain accurate estimates of the complex impedance that exists between the electrodes”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli, which teaches that the device is configured to determine the electrical impedance of the tragus based on measurements of current, voltage and phase relationship of the electrical stimulation signal are stored in a memory portion of the device and are used to determine the electrical impedance of the tragus, with the modified invention of Dietrich since the use of impedance as a feedback can be particularly useful for indicating whether or not a stimulation electrode has an adequate electrical connection with the patient (Spinelli Col. 5, lines 60-62).
Regarding claim 20, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Spinelli teaches that the electrical stimulation signal is a pulse waveform comprising a series of substantially square electrical pulses (Col. 5, lines 51-52, where “a first stimulation profile may include a series of square wave pulses having a voltage or current level ‘X’”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli, which teaches that the electrical stimulation signal is a pulse waveform comprising a series of substantially square electrical pulses, with the modified invention of Dietrich in order to achieve and maintain the stimulation profile within an acceptable level (Spinelli Col. 5, lines 57-59).
Dundovic teaches that the pulse waveform is one of: a monophasic waveform (¶[0133], where “The therapy signals can be symmetrical, asymmetrical, monophasic or biphasic.”);
a symmetrical biphase waveform (¶[0227], where “Additionally and/or alternatively, symmetrical balanced biphasic square waveforms can be used”);
an asymmetrical monophasic waveform (¶[0133], where “asymmetrical and/or monophasic therapy signals could be used in some circumstances”); or
an asymmetrical biphase waveform (¶[0227], where “the system is configured to apply asymmetrical balanced biphasic square waveforms”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dundovic, which teaches that that the pulse waveform is one of: a monophasic waveform, a symmetrical biphase waveform, an asymmetrical monophasic waveform, or an asymmetrical biphase waveform, with the modified invention of Dietrich since an asymmetrical balanced biphasic square waveform can be better tolerated by users with less chance of causing a pain response and can be more effectively focused to specific nerve fibres and since symmetrical balanced biphasic square waveforms can be used to reduce charge build-up, thereby resulting in reduced skin irritation for the user (Dundovic ¶[0227]).
Regarding claim 22, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Dietrich teaches that the reference electrode is in contact with an inner surface of the tragus (¶[0052], where “The … reference electrode … 3 must have electrical contact with the surface of the patient's skin, and this contact is permitted by contact points 8, 9 which can be designed as small metal balls. The electrode … 3 lie on the inner face of the tragus, i.e. an anatomical part of the auricle”).
Dundovic teaches that earpiece comprises a marking or shape to indicate to the user a correct orientation of the earpiece (¶[0116], where “the system includes a hook extending over and behind an ear of the subject, to at least partially support the clip … The hook can be attached to any part of the clip, but in one example is configured to extend laterally from the clip so that the hook can loop over and behind the ear of the subject … this provides a secondary attachment mechanism, helping reduce the likelihood of the clip being dislodged, and preventing the clip falling to the ground in the event of dislodgment, in turn helping to reduce the chance of damage to the clip. Furthermore, this also helps guide correct positioning of the clip,” ¶[0126], where “a proximal outer face of the arms includes a depression configured to guide positioning of a subject so that they can engage the arms and bias the arms apart, for example by grasping the proximal ends of the arms between a thumb and forefinger”) such that the stimulating electrode is in contact with an outer surface of the tragus (Figures 1C and 1D, which show an electrode 121 attached to an outward facing surface of the tragus 101, ¶[0108], where “In this example, a subject's ear 100 is shown, including a tragus 101, … the clip 110 is positioned so that the tragus 101 is provided between the electrodes 121, 122, with the electrodes 121, 122 being urged into engagement with opposing faces of the tragus by virtue of biasing of the arms 111, 112”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dundovic, which that the earpiece comprises a marking or shape to indicate to the user a correct orientation of the earpiece and that the electrode is configured to be placed in contact with an outward facing surface of the tragus, with the modified invention of Dietrich in order to guide positioning of a subject (Dundovic ¶[0126]) and to ensure that the electrodes are aligned with the vagus nerve, in turn optimising the effect of the applied therapy signals (Dundovic ¶[0116]), to apply therapy signals to the tragus, resulting in an electric field being generated surrounding the vagus nerve within the tragus to create or inhibit action potentials within the tragus and modulate the vagus nerve (Dundovic ¶[0109]), and to ensure good electrical contact with the tragus and maximize the effectiveness of modulation of the vagus nerve (Dundovic ¶[0110]).
Regarding claim 51, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Dundovic teaches that the first face of the tragus is an outward facing surface of the tragus (Figures 1C and 1D, which show an electrode 121 attached to an outward facing surface of the tragus 101, ¶[0108], where “In this example, a subject's ear 100 is shown, including a tragus 101, … the clip 110 is positioned so that the tragus 101 is provided between the electrodes 121, 122, with the electrodes 121, 122 being urged into engagement with opposing faces of the tragus by virtue of biasing of the arms 111, 112”) and the second face of the tragus is an inward facing surface of the tragus (Figures 1C and 1D, which show an electrode 122 attached to an inward facing surface of the tragus 101, ¶[0104], where “the securing member is in the form of a clip 110 having opposing arms 111, 112, with electrodes 121, 122 positioned proximate a distal end of the arms on opposing faces, which are biased towards each other,” ¶[0135], where “one of the electrodes 121, 122 acts as ground, with the therapy signals being applied via the other electrode,” where Examiner interprets that a ground electrode is equivalent to a reference electrode, ¶[0108], where “In this example, a subject's ear 100 is shown, including a tragus 101, … the clip 110 is positioned so that the tragus 101 is provided between the electrodes 121, 122, with the electrodes 121, 122 being urged into engagement with opposing faces of the tragus by virtue of biasing of the arms 111, 112”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Dundovic, which teaches that the first face of the tragus is an outward facing surface of the tragus and the second face of the tragus is an inward facing surface of the tragus, with the modified invention of Dietrich in order to stimulate the vagus nerve within the tragus and to ensure good electrical contact with the tragus and maximize the effectiveness of modulation of the vagus nerve (Dundovic ¶[0110]).
Regarding claim 53, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Spinelli teaches that the electrical stimulating signal is one of a sinusoidal, square (Col. 5, lines 51-52, where “a first stimulation profile may include a series of square wave pulses having a voltage or current level ‘X’”), triangular, or white noise waveform.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli, which teaches that that the electrical stimulating signal is one of a square waveform, with the modified invention of Dietrich in order to achieve and maintain the stimulation profile within an acceptable level (Spinelli Col. 5, lines 57-59).
Claims 4, 52, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Dietrich, Dundovic, and Spinelli as applied to claim 1 above, and further in view of Cartledge et al. (hereinafter “Cartledge”) (U.S. Pub. No. 2019/0351230 A1, IDS reference 10 from IDS dated 06/16/2023).
Regarding claim 4, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
None of Dietrich, Dundovic, nor Spinelli teaches that the stimulating electrode and the reference electrode are configured to provide the electrical stimulation signal percutaneously to the user.
Cartledge teaches an electrostimulation device and methods of electrical stimulation of anatomic structures such as nerves, blood vessels, muscles, connective tissue, glands, individual organs, and organ systems that use transcutaneous and percutaneous methods of stimulating nerves (¶[0003]), and further teaches that the stimulating electrode and the reference electrode are configured to provide the electrical stimulation signal percutaneously to the user (¶[0272], where “The electrodes can be only ground/negative, only positive, or both … there can be two positive anterior electrodes 1632 each having a pyramidal shape and one posterior ground electrode 1622 having a plate-like shape … In an exemplary embodiment where percutaneous connectivity is desired, the electrodes can be/have needles that pierce the surface of the skin,” ¶[0417], where “The systems and methods described herein primarily relate to transcutaneous embodiments. This, however, does not preclude the possibility of percutaneous electrical vagus nerve stimulation devices. Instead of or in addition to the inner ear electrostimulation, the generator can be combined with a needle probe that receives the electrical stimulation from the generator”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Cartledge, which teaches that the stimulating electrode and the reference electrode are configured to provide the electrical stimulation signal percutaneously to the user, with the modified invention of Dietrich so that the ground for the signal can reside in the earbud and the needle can be inserted anywhere in the person's body to access the vagus nerve, e.g., in the neck (Cartledge ¶[0417]).
Regarding claim 52, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Although Dietrich teaches a stimulating electrode and a reference electrode (Figure 1, stimulation electrode 2, reference electrode 3), none of Dietrich, Dundovic, nor Spinelli explicitly teaches that the stimulating electrode comprises a positive electrode and the reference electrode comprises a negative electrode.
Cartledge teaches that the stimulating electrode comprises a positive electrode and the reference electrode comprises a negative electrode (¶[0030], where “user coupler includes an electrode that serves as the electrically positive contact point. Additionally, there is a least one other electrode serving as the ground or electrically negative point that tracks through the conduit and back to the generator to complete the circuit.” Examiner interprets that a ground electrode is equivalent to a reference electrode.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Cartledge, which teaches that the stimulating electrode comprises a positive electrode and the reference electrode comprises a negative electrode, with the modified invention of Dietrich in order to complete the circuit (Cartledge ¶[0030]).
Regarding claim 54, Dietrich in combination with Dundovic and Spinelli teaches all limitations of claim 1 as described in the rejection above.
Dietrich teaches that the controller selects the electrical stimulating signal (¶[0045], where “The stimulation frequency and the stimulation strength are predetermined and generated by the control unit 4. These parameters are set by various control elements 12. Oscillating signals are needed for transdermal stimulation. They are generated by an oscillator 13 located in the control unit 4. The input and output signals that are delivered via an input/output circuit 15 of the stimulation electrode unit 11 are processed in a logic and control circuit 14. The current is supplied from a battery 10”) with a series of repeating pulses (¶[0023], where “For stimulation a stimulation pulse with at least one of a plateau pulse width of adjustable duration, a rising and decaying trailing phase of adjustable duration and a charge recovery phase of adjustable duration can be used,” ¶[0048], where “The control unit 4 also contains a stimulation frequency regulator 17 for regulating the frequency pattern of the stimulation signal. Thus, signals following one another in rapid succession can be controlled”).
Although Dietrich teaches a stimulating electrode and a reference electrode (Figure 1, stimulation electrode 2, reference electrode 3) and that the controller selects the electrical stimulating signal, none of Dietrich, Dundovic, nor Spinelli explicitly teaches that a net electrical current flow is from the stimulating electrode to the reference electrode.
Cartledge teaches that a net electrical current flow is from the stimulating electrode to the reference electrode (¶[0030], where “user coupler includes an electrode that serves as the electrically positive contact point. Additionally, there is a least one other electrode serving as the ground or electrically negative point that tracks through the conduit and back to the generator to complete the circuit.” Examiner interprets that a ground electrode is equivalent to a reference electrode. Furthermore, Examiner takes the position that the current inherently flows from the positive stimulation electrode to the negative reference electrode since the flow of a positive charge travels from positive to negative.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Cartledge, which teaches that a net electrical current flow is from the stimulating electrode to the reference electrode, with the modified invention of Dietrich in order to complete the circuit (Cartledge ¶[0030]).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dietrich in view of Dundovic, Spinelli, and Sharma et al. (hereinafter “Sharma”) (U.S. Pub. No. 2020/0094054 A1).
Regarding claim 23, see the rejection of claim 1 above. However, claim 23 adds “a system for modulating cerebral blood flow of a user to treat a circulatory system disease, the system comprising: a transceiver connected to the controller of the device, configured to send information from the device to an external computer system and to receive information from the external computer system, and the information received from the external computer system is used by the controller to determine the form of the electrical stimulation signal.”
Dietrich teaches treatment of a circulatory system disease (¶[0020], where “The method according to the present invention may in particular be used with neurological and/or neuropsychiatric disorder and/or symptoms resulting from underlying cause selected from a group consisting of … cardio-vascular disorders, artrial fibrillation”).
None of Dietrich, Dundovic, nor Spinelli teaches a system for modulating cerebral blood flow of a user, the system comprising: a transceiver connected to the controller of the device, configured to send information from the device to an external computer system and to receive information from the external computer system, and the information received from the external computer system is used by the controller to determine the form of the electrical stimulation signal.
Sharma teaches auricular nerve stimulation techniques for addressing patient disorders and associated systems and methods (Abstract), and further teaches a system for modulating cerebral blood flow of a user (Abstract, where “Auricular nerve stimulation techniques for addressing patient disorders, and associated systems and methods. A representative system includes a signal generator having instructions to generate an electrical therapy signal”), the system comprising:
a transceiver connected to the controller of the device, configured to send information from the device to an external computer system and to receive information from the external computer system (¶[0027], where “A communications transceiver 116 provides for communication between the signal generator 110 and the external controller 130”), and the information received from the external computer system is used by the controller (¶[0029], where “the signal generator 110 is controlled by the external controller 130 via a controller link 132. The external controller 130 can include a cellular phone or other mobile device (e.g., a smartwatch), and can access a specific phone-based app 131 to provide controls to the signal generator 110 … practitioner (and/or others) may direct or otherwise affect the internal controller 108 remotely via the external controller 130”) to determine the form of the electrical stimulation signal (¶[0027], where “The signal generator 110 can include a signal transmission port 115 for communicating with the earpieces 120, e.g., transmitting an electrical therapy signal to the earpieces 120, and optionally, receiving feedback or other communications from the earpieces 120,” ¶[0092], where “therapy signal can include waveforms.” Examiner takes the position that the therapy signal is a waveform which is a form of the electrical stimulation signal, and that the therapy signal is determined since the therapy signal is being transmitted to the earpieces and being utilized as feedback.)
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Sharma, which teaches a system for modulating cerebral blood flow of a user, the system comprising: a transceiver connected to the controller of the device, configured to send information from the device to an external computer system and to receive information from the external computer system, and the information received from the external computer system is used by the controller to determine the form of the electrical stimulation signal, with the modified invention of Dietrich in order to create a desired effect on the target neural population and provide communication between the signal generator and the external controller (Sharma ¶[0027]).
Regarding claim 24, Dietrich in combination with Dundovic, Spinelli, and Sharma teaches all limitations of claim 23 as described in the rejection above.
None of Dietrich, Dundovic, Spinelli, nor the above-taught embodiment of Sharma teaches that information from the device received by the external computer system is compared to a secondary set of information stored on the external computer system to determine a set of actions to be performed by at least one of the device or the external computer.
In another embodiment of Sharma, it teaches that information from the device received by the external computer system is compared to a secondary set of information stored on the external computer system to determine a set of actions to be performed by at least one of the device or the external computer (¶[0032], where “The signal generator 410 can be controlled by an external controller 430 via a wireless controller link 432. The external controller 430 can accordingly be used to set and/or adjust the signal delivery parameters in accordance with which the signal generator 410 provides therapeutic electrical signals to the earpieces 420,” ¶[0033], where “The external controller 430 can also communicate with a backend device 440 … the external controller 430 can exchange data with the backend 440. For example, the external controller 430 can provide the backend 440 with information about the patient's condition (e.g., obtained from feedback sensors included in the system 400), and/or a schedule of the signal delivery parameters selected by the patient or practitioner over the course of time … the backend 440 can be used to provide updates to the phone-based app or other software contained on the external controller 430. The allocation of processing tasks and/or data storage between the internal controller 108 (FIG. 2), the external controller 430 and the backend 440 can be selected to suit the preferences of the patient, practitioner, and/or others.” Examiner takes the position that the information received by the external computer system, here the external controller and backend, is inherently compared to a secondary set of information stored on the external computer system to determine a set of actions to be performed by the device. The external controller teaches adjustment of the signal delivery parameters, which is a set of actions to be performed by the device, here the signal generator. Additionally, the external controller receives updated information from the backend, and this information can then be utilized to control the signal generator. The information processed through the external controller and backend is inherently compared with other data, which implies a secondary set of information stored in the backend as there will need to be data to compare the incoming data to, and determines a set of actions, through task allocation, as the data is utilized by the external device to control the signal generator.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of another embodiment of Sharma, which teaches that information from the device received by the external computer system is compared to a secondary set of information stored on the external computer system to determine a set of actions to be performed by at least one of the device or the external computer, with the modified invention of Dietrich in order to exchange data and select processing tasks that suit the preferences of the patient, practitioner, and/or others (Sharma ¶[0033]).
Claims 25-26 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Dietrich in view of Dundovic, Spinelli, Sharma, and Brown et al. (hereinafter “Brown”) (U.S. Pub. No. 2017/0296807 A1).
Regarding claim 25, see the rejection of claim 1 above. However, claim 25 adds “a method for modulating cerebral blood flow of a user to treat a circulatory system disease, the method comprising: producing, using a generator, an electrical stimulation signal; determining, using a controller connected to the generator, the form of the electrical stimulation signal based on an input provided to the controller by the user; and transmitting the electrical stimulation signal to a stimulating electrode and a reference electrode, wherein the stimulating electrode and the reference electrode are configured to provide the electrical stimulation signal to the nerves innervating a tragus of the user, wherein the method is applied to the user at least once a day for at least 3 consecutive days.”
Dietrich teaches a method for modulating cerebral blood flow of a user (Abstract, where “The invention relates to a method for modulation … of neural tissue and/or neural tissue related functionality with stimulating neural tissue and/or neural tissue related functionality with stimuli by which neural activity related local perfusion changes”) to treat a circulatory system disease (¶[0020], where “The method according to the present invention may in particular be used with neurological and/or neuropsychiatric disorder and/or symptoms resulting from underlying cause selected from a group consisting of … cardio-vascular disorders, artrial fibrillation”), the method comprising:
producing, using a generator, an electrical stimulation signal (¶[0045], where “Oscillating signals are needed for transdermal stimulation. They are generated by an oscillator 13”);
determining, using a controller (¶[0045], where “The stimulation frequency and the stimulation strength are predetermined and generated by the control unit 4”) connected to the generator (¶[0045], where “The stimulation frequency and the stimulation strength are predetermined and generated by the control unit 4. These parameters are set by various control elements 12. Oscillating signals are needed for transdermal stimulation. They are generated by an oscillator 13 located in the control unit 4”), the form of the electrical stimulation signal (¶[0023], where “For stimulation a stimulation pulse with at least one of a plateau pulse width of adjustable duration, a rising and decaying trailing phase of adjustable duration and a charge recovery phase of adjustable duration can be used,” ¶[0047], where “Integrated into the control unit 4 there is, in the first instance, a stimulation strength regulator 16 for regulating the amplitude (strength) of the stimulation signal,” ¶[0048], where “The control unit 4 also contains a stimulation frequency regulator 17 for regulating the frequency pattern of the stimulation signal. Thus, signals following one another in rapid succession can be controlled just as can signals that follow one another at a greater interval”); and
transmitting the electrical stimulation signal to a stimulating electrode and a reference electrode (¶[0044], where “The stimulation of the nerve takes place via the stimulation electrode 2. The reference electrode 3 serves as an electrical reference point. Both electrodes 2, 3 form the stimulation electrode unit 11. Electrodes 2 and 3 for transdermal stimulation are known, commercially available and easy to produce,” ¶[0045], where “The stimulation frequency and the stimulation strength are predetermined and generated by the control unit 4,” ¶[0046], where “The connection between the electrode head 7 and the part of the housing 5 shown on the left-hand side of FIG. 2 is designed as a bow-shaped extension piece 6, through which all the input and output lines between stimulation electrode unit and control unit are also routed”), wherein the stimulating electrode and the reference electrode are configured to provide the electrical stimulation signal to the nerves innervating a tragus of the user (¶[0052], where “The stimulation and reference electrodes 2, 3 must have electrical contact with the surface of the patient's skin, and this contact is permitted by contact points 8, 9 which can be designed as small metal balls. The electrodes 2, 3 lie on the inner face of the tragus,” ¶[0068], where “tVNS was performed at the inner side of the left tragus (FIG. 3A)”).
Spinelli teaches determining, using the controller, the form of the electrical stimulation signal based on an input provided to the controller by the user (Col. 7, lines 33-37, where “Device 102 includes circuitry 112 that is configured and arranged to generate electrical stimulation signals (e.g., pulses) that are consistent with a desired stimulation profile. A processing circuit 114 can adjust the stimulation profile in response to one or more inputs,” Col. 8, lines 25-27, 34-47, where “the system can include circuits, sensors and devices 108 to provide input and/or feedback to the device 102 … feedback can be provided to facilitate the treatment of a patient. This can include, as non-limiting examples, … patient feedback 130, … These and other inputs can be used for a variety of purposes including, but not limited to, selection of a stimulation profile,” Col. 9, lines 8-12, where “a response surface can be created that represents the systolic arterial pressure (e.g., reflecting the degree of parasympathetic activation achieved by the stimulation of the auricular nerve) as a function of input variables,” Col. 9, lines 51-54, where “the input variables could include aspects of the electrical stimulus including, but not necessarily limited to, pulse width, pulse shape, voltage level, current level and/or duty cycle”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli, which teaches determining, using the controller, the form of the electrical stimulation signal based on an input provided to the controller by the user, with the modified invention of Dietrich in order to adjust the stimulation profile in response to one or more inputs (Spinelli Col. 7, lines 36-37).
None of Dietrich, Dundovic, nor Spinelli teaches that the method is applied to the user at least once a day for at least 3 consecutive days.
Sharma teaches that the method is applied to the user at least once a day (¶[0060], where “The electrical therapy signal is typically delivered to the patient over the course of one or more sessions that have a limited duration. For example, an individual session typically lasts no longer than sixty minutes and is typically at least two seconds in duration. In more particular embodiments, the duration ranges from about two seconds to about thirty minutes, and in a further particular embodiment, the duration is from five minutes to twenty minutes, or about fifteen minutes. The patient can receive treatment sessions at most once per day, at most twice per day”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Sharma, which teaches that the method is applied to the user at least once a day, with the modified invention of Dietrich in order to provide effective therapy to the patient without causing paresthesia and/or other potentially undesirable sensory responses in the patient (Sharma ¶[0061]).
None of Dietrich, Dundovic, Spinelli, nor Sharma teaches that the method is applied to the user for at least 3 consecutive days.
Brown teaches a method of stimulating a cranial nerve with an electric signal by administering to the patient a stimulator device that provides the electric signal, where the device may be any device configured to electrically stimulate nerves near the patient's auricular area (¶[0014]), and further teaches that the method is applied to the user for at least 3 consecutive days (¶[0053], where “The auricular peripheral nerve stimulator system allows for continuous, intermittent neural stimulation for … about 3 days, about for days, or about 5 days”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Brown, which teaches that the method is applied to the user for 3 consecutive days, with the modified invention of Dietrich in order to allow for physician applied ambulatory treatment of acute pain (Brown ¶[0074]).
Regarding claim 26, Dietrich in combination with Dundovic, Spinelli, Sharma, and Brown teaches all limitations of claim 25 as described in the rejection above.
Spinelli teaches that modulating cerebral blood flow is applied to the user for any of the following purposes: modulating arterial blood pressure, reducing systemic arterial blood pressure, reducing left ventricular hypertrophy, reducing pulmonary arterial blood pressure, treating of hypertension, treating heart failure (Col. 4, lines 33-37, 41-58, where “The present disclosure is believed to be applicable to a variety of different types of devices and processes, and the present disclosure has been found to be particularly suited for stimulation of one or both of the auricular branches of the vagus nerve ... Various embodiments of the present disclosure are directed toward locating a stimulation point for providing electrical stimulus to one or both of the auricular branches of the vagus nerve. Particular aspects relate to facilitating methods for providing therapeutic levels of such stimulation in a reproducible manner. For instance, certain embodiments are directed toward a stimulation-providing device that has a positioning and fixation device that is designed to consistently deliver individualized (operator-independent) electrical stimulation to the auricular nerve with the objective of activating the parasympathetic system and decreasing the sympathetic/parasympathetic balance to decrease and/or slow down the inflammatory process and/or stop degenerative processes triggered by the neural network that controls the heart during periods of stress, such as those that occur during the progression of heart failure, dilation of the ventricles and its reaction to a sudden decrease in regional blood flow in the myocardium,” Col. 26, lines 32-45, where “The use of two earpieces 1802, 1804 with respective stimulation electrodes allow for a variety of different applications and embodiments ... stimulation on each side of the body can be effective for reaching respective and different portions of the heart ... having the capability to stimulate from both sides of the body can be particularly useful for parasympathetically innervated regions of the heart ... In some embodiments, such as in the case of heart failure and ischemia, there is stimulation of both sides”), and/or treating atrial fibrillation.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli, which teaches that modulating cerebral blood flow is applied to the user for at least one of the following purposes: treating heart failure, with the modified invention of Dietrich in order to correct imbalances in autonomic control created by acute and chronic heart failure, to significantly reduce ischemic damage of the heart by tempering the over-reaction of the control system due to the overload of its afferent circuits, to lower the overall mortality rate (Spinelli Col. 1, lines 45-53).
Regarding claim 55, Dietrich in combination with Dundovic, Spinelli, Sharma, and Brown teaches all limitations of claim 25 as described in the rejection above.
Sharma teaches that the method is applied to the user for a minimum of 5 minutes per day and a maximum of 2 hours per day (¶[0060], where “The electrical therapy signal is typically delivered to the patient over the course of one or more sessions that have a limited duration ... the duration ranges from about two seconds to about thirty minutes”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Sharma, which teaches that the method is applied to the user for a minimum of 5 minutes per day and a maximum of 2 hours per day, with the modified invention of Dietrich since according to In re Wertheim, where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).” Furthermore, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Sharma with the modified invention of Dietrich in order to provide effective therapy to the patient without causing paresthesia and/or other potentially undesirable sensory responses in the patient (Sharma ¶[0061]).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Dietrich in view of Sharma, Spinelli, Brown, and Terry, Jr. et al. (hereinafter “Terry”) (U.S. Pat. No. 5,707,400 A, IDS reference 11 from IDS dated 06/16/2023).
Regarding claim 49, see the rejection of claims 1 and 25 above. However, claim 49 adds “a method of treating hypertension, left ventricular hypertrophy, heart failure and/or atrial fibrillation in a patient, the method comprising: operating a device for modulating cerebral blood flow of a user, the device comprising: administering to the patient a pharmaceutically active composition for the treatment of hypertension, heart failure and/or atrial fibrillation.”
Dietrich teaches operating a device for modulating cerebral blood flow of a user (Abstract, where “The invention relates to a method for modulation … of neural tissue and/or neural tissue related functionality with stimulating neural tissue and/or neural tissue related functionality with stimuli by which neural activity related local perfusion changes,” ¶[0001], where “The present invention generally relates to the fields of neuroenhancement, neurostimulation and neuralmodulation and to implantable, minimally-invasive and non-invasive medical and holistic devices capable to modulate, augmentate and/or stimulate neural tissue and/or neural tissue related functionality by triggering and/or influencing neural activity and uses thereof”).
Spinelli teaches a method of treating hypertension, left ventricular hypertrophy, heart failure and/or atrial fibrillation in a patient (Col. 4, lines 45-58, where “Particular aspects relate to facilitating methods for providing therapeutic levels of such stimulation in a reproducible manner. For instance, certain embodiments are directed toward a stimulation-providing device that has a positioning and fixation device that is designed to consistently deliver individualized (operator-independent) electrical stimulation to the auricular nerve with the objective of activating the parasympathetic system and decreasing the sympathetic/parasympathetic balance to decrease and/or slow down the inflammatory process and/or stop degenerative processes triggered by the neural network that controls the heart during periods of stress, such as those that occur during the progression of heart failure, dilation of the ventricles and its reaction to a sudden decrease in regional blood flow in the myocardium”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Spinelli, which teaches a method of treating heart failure, with the modified invention of Dietrich in order to correct imbalances in autonomic control created by acute and chronic heart failure, to significantly reduce ischemic damage of the heart by tempering the over-reaction of the control system due to the overload of its afferent circuits, to lower the overall mortality rate (Spinelli Col. 1, lines 45-53).
Sharma teaches administering to the patient a pharmaceutically active composition (¶[0081], where “the foregoing electrical therapy signal can be provided as part of an overall treatment regimen that also includes administering a pharmacological/biological substance to the patient … the treatment regimen can include administering an effective amount of a pharmaceutical”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Sharma, which teaches administering to the patient a pharmaceutically active composition, with the modified invention of Dietrich since utilizing a pharmacological/biological supplement increases the efficacy and/or duration of the electrical therapy and since the electrical therapy can improve on the results obtained via a pharmacological treatment (Sharma ¶[0081]).
None of Dietrich, Dundovic, Spinelli, Sharma, nor Brown teach a pharmaceutically active composition for the treatment of hypertension, heart failure and/or atrial fibrillation.
Terry teaches a method of treating patients suffering from refractory hypertension includes identifying a patient suffering from the disorder and applying a stimulating electrical signal to the patient's vagus nerve predetermined to modulate the electrical activity of the nerve and to alleviate the hypertension (Abstract), and further teaches a pharmaceutically active composition for the treatment of hypertension, heart failure and/or atrial fibrillation (Col. 1, lines 41-43, 47-50, where “current treatment of choice of physicians for patients suffering from refractory hypertension is a regimen of anti-hypertensive drugs … Commonly prescribed classes of pharmaceuticals include diuretics, adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, vasodilators, and calcium channel blockers”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Terry, which teaches a pharmaceutically active composition for the treatment of hypertension, heart failure and/or atrial fibrillation, with the modified invention of Dietrich in order to decrease the systemic vascular resistance by interfering with the sympathetic nervous system (Terry Col. 1, lines 45-47).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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.
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/SEFRA D. MANOS/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792