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 .
Claim Objections
Claims 3, 4, and 9 are objected to because of the following informalities:
Claim 3 line 3 it appears that “a physiological parameter indicative of anxiety” should read “the physiological parameter indicative of anxiety”
Claim 4 line 1 it appears that “housing” should read “the housing”
Claim 9 line 1 it appears that “a physiological parameter indicative of anxiety” should read “the physiological parameter indicative of anxiety”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “an anxiety monitor and treatment system” in line 1 but the recited device includes only the functionality to measure parameters “indicative of anxiety” and prepare them for analysis and/or transmission. The claimed system neither explicitly monitors, detects, or treats anxiety and thus it is unclear how the claimed system is “an anxiety monitor and treatment system”. For the purposes of this examination, the system will be interpreted as any system which monitors parameters indicative of anxiety regardless of whether any anxiety detection or monitoring is performed.
Claim 1 recites “at least one sensor configured to detect a physiological parameter indicative of anxiety” but the meets and bounds of this limitation are unclear. It is unclear what physiological parameters may be considered “indicative of anxiety”. It is further unclear what the meets and bounds of sensors which may measure these parameters are and how they relate to the claimed system. For the purposes of this examination, the limitation will be interpreted as parameters related to stress responses.
Claim 1 recites “prepare the physiological parameter for transmission from the subject” but it is unclear what this preparation entails. It is further unclear “transmission from the subject” entails. For the purposes of this examination, the limitation will be interpreted as wireless communication of the measured parameters to an external device.
Claim 1 recites “prepare the physiological parameter for … analysis of the physiological parameter” but it is unclear what preparing the physiological parameter for analysis entails. For the purposes of this examination, the limitation will be interpreted as converting the raw sensor data into the physiological parameter.
Claims 2-20 are rejected by virtue of their dependence on claim 1.
Claim 3 recites “detachable residency arms at a distal end thereof sized and configured to retain the housing in the stomach until the at least one sensor has detected a physiological parameter indicative of anxiety in the stomach” but it is unclear how long the detection of a physiological parameter indicative of anxiety takes. It is further unclear if the detected parameter indicative of anxiety may be at a normal level (i.e. normal heartbeat rate), or if the limitation is meant to convey that the housing remains in the stomach until the parameter being monitoring indicates anxiety (i.e. an elevated heart rate). For the purposes of this examination, the limitation will be interpreted as only requiring the detection of a parameter which is capable of indicating anxiety, not the parameter actually indicating anxiety.
Claim 7 recites “in response to a determination that the physiological parameter falls outside a threshold value or range for the at least one physiological parameter” but the controller has not been established as capable of comparing the received signal to a threshold. The controller is only capable of “preparing” the received physiological parameter for analysis, not performing the analysis. It is further unclear if the comparison results in an indication of anxiety or only a release of medication For the purposes of this examination, this limiting will be interpreted as the controller carrying out the comparison.
Claim 8 recites “wherein the controller is programmed to preemptively actuate release of the anti-anxiety medication from the drug dispenser into the patient in response to the determination such that the anti-anxiety medication is delivered prior to the patient experiencing the anxiety” but it is unclear how such an actuation in response to a parameter exceeding a threshold would be “preemptive” of the patient experiencing anxiety since the physiological response to anxiety has already exceeded a threshold and thus must be “experienced”. It is further unclear what degree of anxiety constitutes “the patient experiencing the anxiety”. It is unclear how this limitation may be interpreted as it appears to indicate that the device uses present values to prevent the present values from occurring. This claim has not been rejected over the prior art as it is unclear what teachings would serve to anticipate it.
Claim 11 recites “wherein the controller is programmed to preemptively actuate release of the anti-anxiety medication from the drug dispenser into the patient in response to the determination such that the anti-anxiety medication is delivered prior to the patient experiencing the anxiety” but it is unclear how such an actuation in response to a parameter meeting a pre-defined condition would be “preemptive” of the patient experiencing anxiety since the physiological response to anxiety has already met a pre-defined condition and thus must be “experienced” to some degree. It is further unclear what degree of anxiety constitutes “the patient experiencing the anxiety”. It is unclear how this limitation may be interpreted as it appears to indicate that the device uses present values to prevent the present values from occurring. This claim has not been rejected over the prior art as it is unclear what teachings would serve to anticipate it.
Claim 12 recites “at least one sensor” but it is unclear if this limitation is the same as, related to, different from, or a subset of, “at least one sensor” of claim 1. For the purposes of this examination, the limitation will be interpreted as the same sensor of claim 1.
Claim 16 recites “wherein the at least one sensor is a transcutaneous sensor configured to measure electrical conductance of the skin” but if the sensor is not within the ingestible housing (as it is interpreted to be in claim 1) then it is unclear how the ingestible housing relates to the claimed system. It is further unclear if “a transcutaneous sensor” is meant to convey that the sensor detects transcutaneous signals of electrical conductance or if the sensor itself is “transcutaneous” in that is penetrates the user’s skin. For the purposes of this examination, the limitation is interpreted as the sensor detecting transcutaneous signals.
Claim 17 recites “a transcutaneous electrode configured to deliver therapeutic electrical stimulation in response to the detected physiological parameter” but it is unclear if “transcutaneous electrode” is meant to convey that the electrode detects transcutaneous signals or if the sensor itself is “transcutaneous” in that is penetrates the user’s skin. It is further unclear how this limitation relates to the rest of the claimed system. It is unclear if “a transcutaneous electrode” is the same as, related to, or different from “at least one sensor” of claim 1 line 3 and if the electrode has any relation to the controller. For the purposes of this examination, the limitation is interpreted as the electrode detecting transcutaneous signals
Claim 18 recites “a radio configured to communicate with an external device, wherein the controller is configured to control the operation of the radio to send an alert to the external device in response to determining that the subject is experiencing anxiety” but the controller has no such functionality of determining anxiety and thus it is unclear how it controls the radio to send an alert. It is further unclear what structure “radio” is meant to convey. For the purposes of this examination, the limitation will be interpreted as the controller determining anxiety and the radio will be interpreted as any wireless communications means.
Claim 19 recites “a radio configured to communicate with an external device, wherein the controller is configured to control the operation of the radio to preemptively send an alert to the external device in response to receiving the physiological parameter such that alert is sent prior to the subject experiencing anxiety” but it is unclear if the controller sends the alert in response to receiving any signals or only signals indicative of anxiety. It is further unclear how the transmitted alert would “preempt” the anxiety since it is generated in response to current signals and thus if the signals are indicative of anxiety the patient must be experiencing them to some degree. It is further unclear what constitute “the subject experiencing anxiety”. This claim has not been rejected over the prior art as it is unclear what teachings would serve to anticipate it.
Claim 20 recites “wherein the anxiety is a panic attack” but it is unclear what this limitation is meant to convey. It is unclear how signals indicative of anxiety being collected in claim 1 relate to a panic attack and what constitutes a panic attack. It is unclear what distinguishes anxiety from a panic attack and how such a distinction limits the system. The meets and bounds the claim are unclear and it has thus not been rejected over the prior art.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 8-11, 17 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “controller programmed to receive the physiological parameter and prepare the physiological parameter for transmission from the subject , analysis of the physiological parameter, or both” but the specification does not appear to describe what “prepare the physiological parameter for transmission from the subject, analysis of the physiological parameter, or both” entails. This step is merely stated in paragraph 0014 but no description of what such a preparation entails is provided.
Claim 8 recites “the controller is programmed to preemptively actuate release of the anti-anxiety medication from the drug dispenser into the patient in response to the determination such that the anti-anxiety medication is delivered prior to the patient experiencing the anxiety” but the specification recites no such functionality of preempting or predicting anxiety. The specification does not appear to describe how anxiety can be predicted such that the drugs are released prior to the patient experiencing the anxiety.
Claim 9 recites “detecting a physiological parameter indicative of anxiety comprises detecting an individual physiological parameter, a combination of physiological parameters, trends in an individual physiological parameter, or trends in a plurality of physiological parameters” but the specification does not fully support the claimed scope of detecting trends in single of multiple physiological parameters. In particular, paragraph 0019 recites a single example of a detected trend but does not describe how the received sensor information is processed to detect the recited trend. Additionally, the disclosure of a single species of possible trends to be detected is insufficient support for the claimed genus of detecting any and all possible combinations of trends.
Claim 10 recites “wherein the controller is programmed to actuate release of the anti-anxiety medication from the drug dispenser into the patient in response to a determination that the individual physiological parameter, the combination of physiological parameters, trends in the individual physiological parameter, or trends in the plurality of physiological parameters meet a pre-defined condition” but the specification does not describe what pre-defined conditions may be set for each of the possible physiological parameter types. In particular, paragraph 0019 provides a single example of a trend being detected to actuate release of anti-anxiety medication but does not describe what the particular predefined conditions for initiating such an actuation may be. Paragraph 0019 states that the detection of fast or irregular breathing and an increased heart rate and sweating not associated with normal activity or exercise may initiate the release. This example species is considered insufficient to support the claimed genus of any individual or combination of parameters or trends being used in such a manner. Furthermore, the specification does not appear to describe how the example trend is distinguished from being related to normal activity or exercise. Additionally, Paragraph 0018 indicates that such a release of medication is in response to a pre-defined condition indicating anxiety and thus the full scope of releasing medication in response to any pre-defined condition is not supported.
Claim 11 recites “wherein the controller is programmed to preemptively actuate release of the anti-anxiety medication from the drug dispenser into the patient in response to the determination such that the anti-anxiety medication is delivered prior to the patient experiencing the anxiety” but the specification recites no such functionality of preempting or predicting anxiety. The specification does not appear to describe how anxiety can be predicted such that the drugs are released prior to the patient experiencing the anxiety.
Claim 17 recites “a transcutaneous electrode configured to deliver therapeutic electrical stimulation in response to the detected physiological parameter” but the specification does not describe the electrical stimulation or how it would provide therapy to the user. The specification further does not appear to describe how the electrical stimulation is applied in response to a physiological parameter or what the therapeutic response entails for different physiological parameters. The specification does not support the claimed scope of providing therapeutic electrical stimulation.
Claim 19 recites “a radio configured to communicate with an external device, wherein the controller is configured to control the operation of the radio to preemptively send an alert to the external device in response to receiving the physiological parameter such that alert is sent prior to the subject experiencing anxiety” but the specification recites no such functionality of preempting or predicting anxiety. The specification does not appear to describe how anxiety can be predicted such that an alert may be sent prior to the patient experiencing the anxiety.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 12, 15, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruskin, international Patent Application publication Number WO 2019023473 A1 hereinafter Ruskin
Regarding claim 1, Ruskin disclose an anxiety monitor and treatment system (Abstract; Paragraph 0055: the system detects when the patient is in physiologic distress) comprising:
an ingestible housing; at least one sensor configured to detect a physiological parameter indicative of anxiety (Paragraph 0050 and 0055: the ingestible physiological monitor, housed in an enteric capsule, may monitor respiration, heart rate, core temperature, and oxygen saturation which may all be indicative of anxiety); and
a controller operatively coupled to the least one sensor, the controller programmed to receive the physiological parameter and prepare the physiological parameter for transmission from the subject, analysis of the physiological parameter, or both (Paragraph 0055: the controller receives the physiological parameter and may detect physiological events, or analyze the parameter, and transmit alarms; Paragraph 0007).
Regarding claim 12, Ruskin discloses the anxiety monitor and treatment system of claim 1. Ruskin further discloses the system wherein the controller and at least one sensor are contained within the housing (Paragraphs 0048 and 0050: the device is located within a housing).
Regarding claim 15, Ruskin discloses the anxiety monitor and treatment system of claim 1. Ruskin further discloses the system wherein the at least one sensor is an accelerometer, a photoplethysograph (PPG) sensor, an impedance plethysmograph (IPG) sensor, an electrocardiogram (ECG) sensor, a temperature sensor, or combinations thereof (Fig. 1 references 105 (ECG), 135 (pulse Oximeter, 115 (IPG), and 130 (temperature sensor); Paragraph 0058: an accelerometer may be connected).
Regarding claim 18, Ruskin discloses the anxiety monitor and treatment system of claim 1. Ruskin further discloses the system further comprising a radio configured to communicate with an external device (paragraph 0045: the wireless communications module 190), wherein the controller is configured to control the operation of the radio to send an alert to the external device in response to determining that the subject is experiencing anxiety (paragraph 0064: the device may send alerts; Paragraph 0055 the device may transmit an alarm when the patient is in distress. The recitation of detecting when a patient is in distress is considered to render the detection of anxiety as obvious because a state of anxiousness is a type of distress).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ruskin, international Patent Application publication Number WO 2019023473 A1 hereinafter Ruskin as applied to claim 1 above and further in view of Swiston US Patent Application Publication Number US 20170156632 A1 hereinafter Swiston.
Regarding claim 2, Ruskin discloses the anxiety monitor and treatment system of claim 1. Ruskin fails to further disclose the system wherein the housing is configured to remain in the stomach for a period of time sufficient to allow the at least one sensor to detect the physiological parameter indicative of anxiety. In particular, Ruskin is directed towards the system performing measurements in the intestine rather than the stomach, but Ruskin does disclose that the device may be deployed in the stomach (Paragraph 0049).
Swiston teaches systems and methods which enable vital sign monitoring internally from the gastrointestinal tract. The large animal (porcine) experiments and a robust processing disclosed herein demonstrate the feasibility of this approach. Implementing vital sign monitoring as a stand-alone technology or in conjunction with other ingestible devices has the capacity to significantly aid telemedicine, optimize performance monitoring of athletes, military service members, and first-responders, as well as provide a facile method for rapid clinical evaluation and triage (Abstract). Thus, Swiston falls within the same field of endeavor as Applicant’s invention.
Swiston teaches that physiological parameters such as heart rate and breathing rate may be measured in the stomach with a high degree of accuracy (Paragraphs 0088 and 0092).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to adapt the system of Ruskin to take measurements in the stomach rather than the intestines as taught by Swiston because Swiston teaches that accurate measurements may be made in the stomach and taking measurements in the stomach may allow the system to deploy and begin transmitting relevant data more rapidly than if the system has to wait until it reaches the intestines. The above teachings of taking measurements in the stomach is considered to anticipate the limitation of “the housing is configured to remain in the stomach for a period of time sufficient to allow the at least one sensor to detect the physiological parameter indicative of anxiety” since Ruskin in view of Swiston teaches that the system may take measurements indicative of anxiety within the stomach and thus must implicitly remain there long enough to take the measurements.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ruskin, international Patent Application publication Number WO 2019023473 A1 hereinafter Ruskin in view of Swiston US Patent Application Publication Number US 20170156632 A1 hereinafter Swiston as applied to claim 2 above and further in view of Curatolo US Patent Number US 5443843 A hereinafter Curatolo
Regarding claim 3, Ruskin in view of Swiston teaches the system of claim 2. Modified Ruskin fails to further disclose the system wherein the housing comprises detachable residency arms at a distal end thereof sized and configured to retain the housing in the stomach until the at least one sensor has detected a physiological parameter indicative of anxiety in the stomach.
Curatolo teaches an oral drug delivery system having delayed gastrointestinal transit comprising a non-continuous compressible element and an attached controlled release device and which in the expanded form resists gastrointestinal transit; and a modular system for use therein comprising a non-continuous compressible element and an attached receptacle means for receiving and holding a drug-containing orally administrable controlled release device and which in the expanded form resists gastric transit (Abstract). Thus, Curatolo falls within the same field of endeavor as Applicant’s invention.
Curatolo teaches a system which uses retaining arms to prevent the passage of a device out of the stomach (Col 6 lines 32-65). Curatolo teaches that the retention arms, receptacle to which they are attached, and/or the adhesive which attached the retention arms to the receptacle or directly to a drug delivery device are constructed from materials which soften, dissolve, disintegrate, or degrade in the biological environment of use in order to permit safe passage of the materials through the GI tract (Col 8 lines 1-9). Thus, Curatolo teaches that retention arms may be attached by a degradable material such that when the material degrades, the retention arms are detached from the housing and allow the separated components to pass through the GI tract.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the detachable retention arms taught by Curatolo into the system of Ruskin in view of Swiston because the use of residency arms allows the system to remain in the stomach and monitor the patient for a configurable period of time. This would allow the device to be adapted for particular use cases where longer monitoring durations are desirable. Additionally, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the residency arms taught by Curatolo into the system of Ruskin in view of Swiston such that the residency arms are disposed on a distal end of the ingestible device because there are a finite number of positions in which to implement the residency arms with a reasonable expectation of success. In particular, the residency arms may be implemented on the proximal end, the distal end, some point therebetween, or any combination of these positions. The particular location that the residency arms are implemented does not produce a surprising technical effect and thus it would have been obvious to try implementing the arms on the distal end of the system.
Claims 4-7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ruskin, international Patent Application publication Number WO 2019023473 A1 hereinafter Ruskin as applied to claim 1 above and further in view of Giftakis US Patent Application Publication Number US 2010/0280336 A1 hereinafter Giftakis.
Regarding claim 4, Ruskin discloses the anxiety monitor and treatment system of claim 1. Ruskin fails to further disclose the system further comprising a drug dispenser contained within housing and comprising an anti-anxiety medication.
Giftakis teaches an anxiety episode may be identified as being an anxiety event that is attributable to an anxiety disorder of a patient based on the patient activity associated with the anxiety episode. The patient activity may include, for example, patient motion, patient posture or voice activity. Detection of the activity component during an anxiety episode can help distinguish between a general anxiety state and an anxiety event that differs from the general anxiety state. Examples of anxiety events include, for example, an occurrence of a compulsion or a panic attack. The detected anxiety events can be used to evaluate an anxiety disorder of a patient, evaluate therapy programs implemented by a medical device to treat the anxiety disorder, or control therapy delivery. In some examples, a mood state transition is detected based on patient activity information and therapy delivery is controlled based on the detection of the mood state transition (Abstract). Thus, Giftakis is reasonably pertinent to the problem at hand.
Giftakis teaches an implantable system for managing anxiety disorder which may deliver electrical stimulation and/or therapeutic agents to the patient to manage a psychiatric disorder such as anxiety (Paragraph 0084-0085). Giftakis teaches that anxiety may be monitored by a number of different physiological parameters including heart rate from ECG and/or PPG, respiratory rate, motor activity, and other parameters (Paragraphs 0057, 0059, and 0099-0105). It is noted that while Giftakis teaches a system which is not located in the user’s stomach, its teachings are applicable to any internal device.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the drug delivery system of Giftakis into the system of Ruskin because incorporating a drug delivery system such as the one described by Giftakis would allow the system of Ruskin to perform closed-loop therapy where it may both monitor parameters and deliver treatment which may improve patient outcomes by reducing the delay between a condition being detected and a treatment being administered. It is further noted that while Giftakis is directed towards delivering drugs to the user’s blood stream or surrounding tissues, one of ordinary skill in the art would recognize that delivering drugs into the GI tract is a suitable alternative since the GI tract permits absorption of the delivered drugs into the bloodstream.
Regarding claim 5, Ruskin in view of Giftakis teaches the system of claim 4. Modified Ruskin further reasonably suggest the system wherein the drug dispenser is non-refillable. Neither Ruskin nor Giftakis include recitations drawn towards the capability of refilling an internal device which would require specific structural components and descriptions as to how the internal device is refilled. Thus, Ruskin in view of Giftakis is considered to reasonably suggest that the ingestible device is non-refillable. Furthermore, configuring such a device to be non-refillable would be an obvious variation of Ruskin in view of Giftakis because the device of modified Ruskin is not intended to be permanent as taught by Ruskin paragraph 0066 where Ruskin indicates the device is intended to have a set lifetime after which it may disassemble and be excreted.
Regarding claim 6, Ruskin in view of Giftakis teaches the system of claim 4. Modified Ruskin fails to further disclose the system wherein the controller is operably coupled to the drug dispenser.
Giftakis teaches a system wherein the drug dispenser is operably connecter to the controller (Paragraphs 0084-0085: implicitly disclosed by the recitations stating that the pump may be controlled to deliver the agent at a specific rate and bolus amount and may be controlled to have a lock-out time interval).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the system of modified Ruskin such that the controller in in communication with the drug dispenser because such communication allows the system to control various parameters of the drug delivery including rate of delivery, amount of drug to deliver, and a lock-out time to prevent overdosing the patient as taught by Giftakis (paragraphs 0084-0085).
Regarding claim 7, Ruskin in view of Giftakis teaches the system of claim 4. Modified Ruskin fails to further disclose the system wherein the controller is programmed to actuate release of the anti-anxiety medication from the drug dispenser into the patient in response to a determination that the physiological parameter falls outside a threshold value or range for the at least one physiological parameter.
Giftakis teaches that anxiety episodes may be determined by comparing a parameter such as heart rate, respiration rate, and/or motion to a predefined threshold and/or range and when the parameters exceeds the threshold or range, an anxiety event is occurring (Paragraphs 0072, 0100, and 0132-0133). Giftakis further teaches dispensing a therapeutic agent upon detecting an anxiety state (Paragraph 0084)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the system of modified Ruskin to administer the therapeutic agent in response to a determination that a parameter falls outside of a threshold value or range as taught by Giftakis because such a determination allows the system to detect when anxiety events are occurring so that the therapeutic drug is delivered at appropriate times.
Regarding claim 9, Ruskin in view of Giftakis teaches the system of claim 4. Modified Ruskin further discloses the system wherein detecting a physiological parameter indicative of anxiety comprises detecting an individual physiological parameter, a combination of physiological parameters, trends in an individual physiological parameter, or trends in a plurality of physiological parameters (Paragraph 0055: the ingestible physiological monitor may monitor respiration, heart rate, core temperature, and oxygen saturation which may all be indicative of anxiety).
Regarding claim 10, Ruskin in view of Giftakis teaches the system of claim 9. Modified Ruskin fails to further disclose the system wherein the controller is programmed to actuate release of the anti-anxiety medication from the drug dispenser into the patient in response to a determination that the individual physiological parameter, the combination of physiological parameters, trends in the individual physiological parameter, or trends in the plurality of physiological parameters meet a pre-defined condition.
Giftakis teaches that anxiety episodes may be determined by comparing a parameter such as heart rate, respiration rate, and/or motion to a predefined threshold and/or range and when the parameters exceeds the threshold or range, an anxiety event is occurring (Paragraphs 0072, 0100, and 0132-0133). Giftakis further teaches dispensing a therapeutic agent upon detecting an anxiety state (Paragraph 0084)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the system of modified Ruskin to administer the therapeutic agent in response to a determination that a pre-defined condition is met as taught by Giftakis because such a determination allows the system to detect when anxiety events are occurring so that the therapeutic drug is delivered at appropriate times.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ruskin, international Patent Application publication Number WO 2019023473 A1 hereinafter Ruskin in view of Giftakis US Patent Application Publication Number US 20100280336 A1 hereinafter Giftakis as applied to claim 4 above and further in view of Swiston US Patent Application Publication Number US 20170156632 A1 hereinafter Swiston and Curatolo US Patent Number US 5443843 A hereinafter Curatolo
Regarding claims 13 and 14, Ruskin in view of Giftakis teaches the system of claim 4. Modified Ruskin fails to further disclose the system wherein the housing is configured to reside in the stomach for period of time sufficient to allow release of the anti-anxiety medication into the patient, and wherein the housing comprises detachable residency arms at a distal end thereof sized and configured to retain the housing in the stomach until release of the anti-anxiety medication into the patient.
In particular, Ruskin is directed towards the system performing measurements in the intestine rather than the stomach, but Ruskin does disclose that the device may be deployed in the stomach (Paragraph 0049).
Swiston teaches that physiological parameters such as heart rate and breathing rate may be measured in the stomach with a high degree of accuracy (Paragraphs 0088 and 0092).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to adapt the system of modified Ruskin to take measurements and release medication in the stomach rather than the intestines because Swiston teaches that accurate measurements of the parameters utilized in modified Ruskin may be made in the stomach and taking measurements in the stomach may allow the system to deploy, begin collecting relevant data, and administer therapeutics more rapidly than if the system has to wait until it reaches the intestines.
Ruskin in view of Giftakis further in view of Swiston fails to further teach the system wherein the housing is configured to reside in the stomach for period of time sufficient to allow release of the anti-anxiety medication into the patient, and wherein the housing comprises detachable residency arms at a distal end thereof sized and configured to retain the housing in the stomach until release of the anti-anxiety medication into the patient
Curatolo teaches a system which uses retaining arms to prevent the passage of a device out of the stomach (Col 6 lines 32-65). The device is adapted to allow time for a drug to release in the stomach over a period of time (Col 4 line 58 – Col 5 line 21) Curatolo teaches that the retention arms, receptacle to which they are attached, and/or the adhesive which attached the retention arms to the receptacle or directly to a drug delivery device are constructed from materials which soften, dissolve, disintegrate, or degrade in the biological environment of use in order to permit safe passage of the materials through the GI tract (Col 8 lines 1-9). Thus, Curatolo teaches that retention arms may be attached by a degradable material such that when the material degrades, the retention arms are detached from the housing and allow the separated components to pass through the GI tract and that the retention arms hold the system within the stomach to allow for the delivery of a drug.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the detachable retention arms taught by Curatolo into the system of Ruskin in view of Swiston because the use of residency arms allows the system to remain in the stomach and monitor the patient for a configurable period of time such that the system may deliver therapeutic agents while monitoring occurs in the stomach. This would allow the device to be adapted for particular use cases where longer monitoring durations are desirable. Additionally, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the residency arms taught by Curatolo into the system of Ruskin in view of Swiston such that the residency arms are disposed on a distal end of the ingestible device because there are a finite number of positions in which to implement the residency arms with a reasonable expectation of success. In particular, the residency arms may be implemented on the proximal end, the distal end, some point therebetween, or any combination of these positions. The particular location that the residency arms are implemented does not produce a surprising technical effect and thus it would have been obvious to try implementing the arms on the distal end of the system.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ruskin, international Patent Application publication Number WO 2019023473 A1 hereinafter Ruskin as applied to claim 1 above and further in view of Zdeblick US Patent Application Publication Number US 2017/0270779 A1 hereinafter Zdeblick in view of Goodall US Patent Application Publication Number US 2019/0046794 A1 hereinafter Goodall and evidenced by Kushki US Patent Application Publication Number US 2016/0000365 A1 hereinafter Kushki
Regarding claims 16 and 17, Ruskin discloses the anxiety monitor and treatment system of claim 1. Ruskin fails to further disclose the system wherein the at least one sensor is a transcutaneous sensor configured to measure electrical conductance of the skin and further comprising a transcutaneous electrode configured to deliver therapeutic electrical stimulation in response to the detected physiological parameter.
Zdeblick teaches a mobile device for detecting an electrical signal generated by an ingestible event marker is disclosed. The mobile device includes a detection subsystem to receive an electrical signal generated by an ingestible event marker from a detection arrangement. A processing subsystem is coupled to the detection subsystem to decode the electrical signal. A radio subsystem is configured to transmit the decoded electrical signal to a wireless node. A system includes the mobile device and the detection arrangement. A method includes receiving the electrical signal generated by the ingestible event marker at the mobile device, decoding the electrical signal to extract information associated with the ingestible event marker, and transmitting the information to a wireless node (Abstract). Thus, Zdeblick is reasonably pertinent to the problem at hand.
Zdeblick teaches a system wherein an ingestible event marker (IEM) communicates information to a wearable system which then transmits the data to a mobile device. The wearable system may come in the form of hearing aids capable of receiving data from the IEM (Paragraphs 0139-0140; Fig. 19)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the wearable receivers as taught by Zdeblick into the system of Ruskin and configure the IEM of Ruskin to communicate with the wearable receivers because implementing wearable receivers and configuring the ingestible device to communicate with them may reduce the power requirements of the ingestible device since wireless communication will only need to take place over a short distance. Additionally, transmitting the received data to a wearable system provides an opportunity to configure the system to perform electrically intensive operations such as signal processing and algorithmic decision making in the wearable device and/or in another external device which can then send the results back to the IEM. This would further reduce power requirements of the IEM and may allow for a smaller battery to be used thus decreasing the size of the capsule the user must swallow and limiting the presence of harmful materials inside the body.
Ruskin in view of Zdeblick fails to further disclose the system wherein the at least one sensor is a transcutaneous sensor configured to measure electrical conductance of the skin and further comprising a transcutaneous electrode configured to deliver therapeutic electrical stimulation in response to the detected physiological parameter
Goodall teaches an ear stimulation device and related systems and methods for operating an ear stimulation device in connection with a computing device are described. Multiple factors are used in controlling the ear stimulation device, including a variety of factors relating to or influencing the state of the user (Abstract). The state of the user may include mood disorders including anxiety (Paragraph 0127). Thus, Goodall is reasonably pertinent to the problem at hand.
Goodall teaches that stimulation of the ear can be used to treat, prevent, or otherwise address mood disorders such as anxiety (Paragraph 0127). Goodall teaches a wearable system for the ear which includes neural stimulators configured to provide transcutaneous electrical stimulation to the ear (Paragraph 0174). The stimulators may include electrodes capable of providing transcutaneous electrical stimulation (Paragraph 0175). The device further includes a skin conductivity and/or skin capacitance sensor (Paragraph 0178).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the system of Ruskin in view of Zdeblick to include the transcutaneous electrodes for delivering electrical stimulation and the skin capacitance sensor of Goodall because Goodall teaches that transcutaneous electrical stimulation may be used to treat anxiety (Goodall paragraph 0127) and would thus add an additional treatment modality for the system of modified Ruskin to utilize when anxiety is detected which may improve patient outcomes since some patients may respond better to one treatment than another. Additionally, the conductance sensor may be used to ensure good contact for the stimulation electrode and/or may be used as an additional anxiety metric itself since skin conductance may be used to monitor anxiety as evidenced by Kushki (Kushki paragraph 0005: heart rate and skin conductance measurements provided the highest correlation with stress levels)
Claims 8, 11, and 19 are not rejected over the prior art but nonetheless rejected under 35 USC 112 as described above because each of these claims are drawn towards taking preemptive actions prior to a patient experiencing anxiety but it is unclear how the device preempts such experiences
Claim 20 is not rejected over the prior art but nonetheless rejected under 35 USC 112 as described above because it is unclear what limitation of the system is limited by “the anxiety is a panic attack” and what such a limitation is meant to entail.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791