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
Regarding the 101 rejection, the Applicant’s amendments have overcome the 101 rejection. Regarding claim 1 and the rejection under 35 USC 103 the argument is not persuasive. The examiner pointed to memory 1336 which is very broad and includes the aspects identified by the Applicant and also includes data representing previous neural activity (Paragraph [0149]) and historical data (Paragraph [0154]). The rejection noted that without undue experimentation based on the suggestion of Goodall to use previous neural activity, the skilled artisan would have been motivated to store data indicative of past treatment of a person who is the wearer and/or has been implanted with the medical device and to configure the medical device to at least one of provide stimulation 312 to tissue of the person or sense phenomenon associated with the person, see paragraph [0193].
Regarding claim 11 and the rejection under 35 USC 103 the argument is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding claim 24, Applicant argues too much must be done to Goodall to arrive at the claimed invention and is beyond what one of ordinary skill would find obvious. Also data from a substance delivery device is not a physiological parameter. It is merely operational data regarding a device. The examiner respectfully disagrees as Goodall discloses a signal received at secondary signal input includes a signal from a substance delivery device. The examiner notes the substance delivery device is a therapeutic substance delivery system. Paragraph [0113] discloses a delivery device 802 (indicative of delivery of a drug or nutraceutical to the subject) which is part of neural stimulation system 700, and having inputs pertaining to the health of the subject to determine a neural stimulation system 700 response. It would have been obvious to use the secondary signal input (800) for a closed loop monitoring and therapeutic substance delivery device 802 because a therapeutic drug has a physiological effect pertaining to the health of the subject. Said slightly differently, since the drug delivery device has a physiological effect it would have been obvious to use the inputs 802 for the closed-loop monitoring of physiological parameters in order to establish a dosage and/.or schedule for future therapeutic substance(s) to be taken and or/administered by the user (e.g. Paragraphs [0113], [0116], and [0193]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5, 9-12, 20-30, and 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al (US 2017/0113057).
Regarding claim 1, Goodall discloses a system, comprising: a medical device configured to be body worn 320 and/or implanted 300, wherein the medical device is configured to receive and store data 1334. Goodall does not specify the stored data is indicative of past treatment of a person who is the wearer and/or has been implanted with the medical device. One of ordinary skill in the art would have found it obvious to store data indicative of past treatment of the person because Goodall teaches memory 1336 contains stored stimulus patterns and neural stimulus parameter values from which neural stimuli can be computed and prediction circuitry 1342 predicts a future neural activity signal based on a previous neural activity signal, see paragraph [0149]. Without undue experimentation and based on the suggestion in Goodall to use previous neural activity, the skilled artisan would have been motivated to store data indicative of past treatment of a person who is the wearer and/or has been implanted with the medical device and to configure the medical device to at least one of provide tissue stimulation 312 to tissue of the person or sense phenomenon associated with the person, see paragraph [0193].
Regarding claim 2, Goodall discloses: the medical device 300 is a first subsystem of the system; the system includes a second subsystem, a personal computing device 208; the medical device 300 is configured to electronically communicate data indicative of the stored data to the second subsystem; and the second subsystem is configured to receive the communicated data and at least one of provide the data in a human understandable format or analyze the data and develop at least a partial treatment regimen based on the analysis, see paragraph [0101].
Regarding claim 3, Goodall discloses: the second subsystem is configured to analyze the data and develop at least a partial treatment based on the recipient; the second subsystem is configured using a personal account 1510 to communicate the developed at least partial treatment to the medical device 300; and the medical device is configured to receive the communicated developed at least partial treatment and operate in a different manner based on the received communicated developed at least partial treatment, see paragraph [0471].
Regarding claim 5, Goodall discloses: the medical device is an implantable hearing prosthesis, see paragraphs [0095] and [0101].
Regarding claim 9, Goodall discloses: the neural stimulation system 700 includes a clock or timer 816 and producing a stimulus 708 based on a time of day or date, see paragraph [0114]. One of ordinary skill in the art would have found it obvious to configure the medical device 300 to have stored therein data indicative of therapeutic substance(s) taken by the person within at least the past 10 days for the drug delivery device 844, see paragraph [0116].
Regarding claim 10, Goodall discloses recommendation 1372 relates to a user experience, see paragraph [0154]. Complying with a treatment is a user experience one of ordinary skill in the art would have found desirable for the medical device 300 to be configured to identify biomarkers of the person and determine a compliance of past treatment.
Regarding claim 11, Goodall discloses a method: receiving, indirectly or directly, from a body worn 320 and/or implanted medical device 300. Data is received from 320 and 300 and stored in memory 1334. Goodall does not specify the data is indicative of at least one of a treatment history or a current medical condition of a person wearing and/or implanted with the medical device 300. One of ordinary skill in the art would have found it obvious to store data indicative of a treatment history or a current medical condition of the person because Goodall teaches memory 1336 contains stored stimulus patterns and neural stimulus parameter values from which neural stimuli can be computed and prediction circuitry 1342 predicts a future neural activity signal based on a previous neural activity signal, see paragraph [0149]. Without undue experimentation and based on the suggestion in Goodall to use previous neural activity, the skilled artisan would have been motivated to use data indicative of at least one of a treatment history or a current medical condition of a person wearing and/or implanted with the medical device 300 for evaluating at least the data and determining, based on the evaluation, a treatment regimen for the person; and implementing the treatment regimen or providing the treatment regimen to the person, see paragraph [0193].
Regarding claim 12, Goodall discloses: the body worn 320 and/or implanted medical device 300 is configured to sense a physiological phenomenon of the person, see paragraph [0161]. It is inherent at least prior to the action of receiving, stored data indicative of the treatment history of the person enables determination circuitry 1308 to determine the person is completely conscious; and the action of evaluating is executed without real time input from the person regarding the treatment history, see paragraph [0161].
Regarding claim 20, Goodall discloses: the medical device 300 is a hearing prosthesis 4031; the hearing prosthesis was used in conjunction with the person to evaluate the person's hearing, see paragraph [0261]. The data is indicative of a current medical condition, wherein the current medical condition is the person's ability to hear, and the data is based on data obtained when using the hearing prosthesis to evaluate the person's hearing.
Regarding claim 21, Goodall discloses: the treatment regimen is the adjustment and/or the addition of a therapeutic substance to treat hearing disorder related ailments, see paragraph [0113].
Regarding claim 22, Goodall discloses controlling an ear stimulation device based on personal interaction with a computing device, see paragraph [0032]. One of ordinary skill in the art would have found it obvious and desirable to decrease drug dosage for a person taking a therapeutic substance to treat an ailment for at least a month prior to the action of determining; and the action of evaluating and determining results in a treatment regimen for the person that results in a decrease in an average daily amount of the therapeutic substance during the time of implementing the treatment regimen.
Regarding claim 23, Goodall discloses: the body worn 320 and/or implanted medical device 300 is configured to sense a physiological phenomenon of the person, see paragraph [0161]. Goodall further discloses implementing the treatment regimen automatically; the person has a therapeutic substance delivery system attached thereto; the action of implementing the treatment regimen automatically causes the therapeutic substance delivery system to automatically provide a fast acting therapeutic substance in a quantity and/or quality automatically determined in the action of determining the treatment regime, see paragraph [0116]. One of ordinary skill in the art would have found it obvious for at least two weeks prior to the action of implementing the treatment regimen, the person has been receiving therapeutic substance in amounts and/or types substantially different from that provided during the action of automatically providing because Goodall suggests using various types of stimuli to improve outcomes, see paragraph [0186].
Regarding claim 24, Goodall discloses a signal received at secondary signal input 800 includes a signal from a substance delivery device 802. Goodall does not disclose a closed-loop monitoring and therapeutic substance delivery system, wherein: the closed-loop monitoring and therapeutic substance delivery system is configured to monitor one or more physiological parameters of a user of a medical device 300. However, Goodall suggests using inputs pertaining to the health of a subject to determine a neural stimulation system 700 response, see paragraph [0113].
One of ordinary skill in the art would have found it obvious to use the secondary signal input 800 for a closed-loop monitoring and therapeutic substance delivery device 802 because a therapeutic drug has a physiologic effect pertaining to the health of the subject.
The skilled artisan would have found it desirable and without undue experimentation to configure the closed-loop monitoring and therapeutic substance delivery system to use results from the monitored one or more physiological parameters to establish a dosage and/or schedule for future therapeutic substance(s) to be taken by and/or administered to the user, see paragraphs [0113], [0116] and [0193].
Regarding claim 25, Goodall discloses: the system is further configured to have access to data indicative of therapeutic substance(s) previously used and/or currently used by the user, see paragraph [0116]. One of ordinary skill in the art would have found it obvious based on providing a safe and effective dosage to configure the closed-loop monitoring and therapeutic substance delivery system to use results from the monitored one or more physiological parameters in conjunction with the data indicative of therapeutic substance(s) to establish the dosage and/or schedule for future therapeutic substance(s) to be taken by and/or administered to the user, see paragraph [0116].
Regarding claim 26, Goodall discloses: the system includes a component configured to be implanted and/or body worn that monitors the one or more physiological parameters; and the system further includes a therapeutic substance delivery device to deliver the future therapeutic substance(s), see paragraph [0116].
Regarding claim 27, Goodall discloses: the system includes a first subsystem 300, the first subsystem being configured to execute the monitoring and obtaining of the data; and the delivery device is in signal communication with the first subsystem and/or another subsystem, a personal computing device 208, in signal communication with the first subsystem. One of ordinary skill in the art would have found it obvious to configure the delivery to receive data based at least in part on data based on the dosage and/or schedule and operate accordingly to deliver the future therapeutic substance(s) to the recipient.
Regarding claim 28, Goodall discloses a substance delivery device 802. One of ordinary skill in the art would have found it obvious to configure the delivery device 802 to operate accordingly to deliver the therapeutic substance(s) according to the dosage and/or schedule only if the recipient approves the operation using personal computing device 208 to ensure compliance with the dosage and treatment protocols.
Regarding claim 29, Goodall discloses the system includes a first subsystem 300, the first subsystem being configured to execute the monitoring and obtaining of the data; and at least the first subsystem or a second subsystem, a personal computing device 208 that is a part of the system and is in signal communication with the first subsystem. One of ordinary skill in the art would have found it obvious, based on recommended dosing, to configure the computing device 208 to provide output indicative of the dosage and/or schedule; and to configure the delivery device 802 to enable manual initiation of dispensement of the therapeutic substance based on the output.
Regarding claim 30, Goodall discloses: the system includes a monitoring device 208 configured to monitor the one or more physiological parameters; and the system includes a therapeutic substance delivery device 802 configured to deliver therapeutic substance to the user, the therapeutic substance delivery device 802 being a physically separate device from the monitoring device.
Regarding claim 42, Goodall teaches the method of claim 11, wherein: prediction circuitry 1342 predicts a future neural activity signal based on previous neural activity, see paragraph [0149]. Goodall does not specify the person is experiencing a deleterious medical episode having begun within 10 hours of the action of receiving; administration of a fast acting therapeutic substance; and a quantity and/or quality of the therapeutic substance that is or will be administered as part of the administration is based at least in part on the evaluation.
However, Goodall suggests using inputs pertaining to health of the subject to determine a neural stimulation system response, see paragraphs [0113], [0116] and [0193]. One of ordinary skill in the art would have found it obvious to administer a quantity and/or quality of a fast acting therapeutic substance to a person experiencing a deleterious medical episode having begun within 10 hours of the action of receiving based on the inputs pertaining to the health of the subject because Goodall teaches using inputs pertaining to health of the subject to determine a neural stimulation system response for delivering a drug or nutraceutical, see paragraphs [0113], [0116] and [0193] because a therapeutic drug has a physiologic effect pertaining to the health of the subject. Without undue experimentation and based on the suggestion of Goodall to use previous neural activity, the skilled artisan would have been motivated to administer a quantity and/or quality of a fast acting therapeutic substance to a person experiencing a deleterious medical episode having begun within 10 hours of the action of receiving based on the inputs pertaining to the health of the subject in order to improve the provide a treatment regime to improve the health or wellness of the subject.
Regarding claim 43, Goodall teaches the method of claim 42, a signal received at secondary signal input 800 includes a signal from a substance delivery device 802. Goodall does not disclose after the action of beginning administering, further receiving additional data from the medical device, the additional data indicative of current physiological information about the user of a medical device 300. However, Goodall suggests using inputs pertaining to the health of a subject to determine a neural stimulation system 700 response, see paragraph [0113].
One of ordinary skill in the art would have found it obvious to use the secondary signal input 800 for a closed-loop monitoring and therapeutic substance delivery device 802 because a therapeutic drug has a physiologic effect pertaining to the health of the subject.
The skilled artisan would have found it desirable and without undue experimentation to configure the closed-loop monitoring and therapeutic substance delivery system to use results from the monitored one or more physiological parameters to establish a dosage and/or schedule for future therapeutic substance(s) to be taken by and/or administered to the user, see paragraphs [0113], [0116] and [0193].
Regarding claim 44, Goodall teaches the method of claim 11, wherein: prediction circuitry 1342 predicts a future neural activity signal based on previous neural activity including epileptic seizure, see paragraphs [0149] and [0208]. Goodall does not specify administration of a fast acting anti-seizure and/or seizure therapeutic substance; and a quantity and/or quality of the therapeutic substance that is or will be administered as part of the administration is based at least in part on the evaluation. However, Goodall suggests using inputs pertaining to health of the subject to determine a neural stimulation system response, see paragraphs [0113], [0116] and [0193]. One of ordinary skill in the art would have found it obvious to administer a quantity and/or quality of a fast acting anti-seizure and/or seizure therapeutic substance to a person experiencing an epileptic seizure relative to prior temporal periods of the person because Goodall teaches using inputs pertaining to health of the subject to determine a neural stimulation system response for delivering a drug or nutraceutical, see paragraphs [0113], [0116] and [0193] because a therapeutic drug has a physiologic effect pertaining to the health of the subject. Without undue experimentation and based on the suggestion of Goodall to use previous neural activity, the skilled artisan would have been motivated to administer a quantity and/or quality of a fast acting anti-seizure and/or seizure therapeutic substance to a person experiencing an epileptic seizure relative to prior temporal periods of the person based on the inputs pertaining to the health of the subject in order to improve the provide a treatment regime to improve the health or wellness of the subject.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al (US 2017/0113057) in view of Smyth (US Publication 2021/0001113).
Regarding claim 45, Goodall teaches the method of claim 11, wherein: the medical device is a implanted hearing prosthesis, see paragraphs [0095] and [0101]; and the method includes evoking a hearing percept in the person using the implanted hearing prosthesis by direct stimulation to tissue beneath the skin of the person, see paragraphs [0095] and [0101].
In the alternative, that the wearable neural stimulation device that is implanted in not a implanted hearing prosthesis which evokes a hearing percept by direct stimulation to tissue beneath the skin of the person.
Smyth teaches that it is known to use implanted hearing prosthesis which evokes a hearing percept by direct stimulation to tissue beneath the skin of the person as set forth in Figure 1 and Paragraph [0025]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Goodall, with an implanted hearing prosthesis which evokes a hearing percept by direct stimulation to tissue beneath the skin of the person as taught by Smyth, since such a modification would provide the predictable results of providing a hearing sense in instances when there are no natural hearing capabilities.
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al (US 2017/0113057) in view of Fischell et al (US Publication 2003/0195588).
Regarding claim 46, Goodall teaches the closed-loop monitoring and therapeutic substance delivery system of claim 24, except wherein: the closed-loop monitoring and therapeutic substance delivery system is a vestibular balance disorder management and/or treatment system. Fischell et al teaches that it is known to use a neural stimulation device that treats vestibular structures as set forth in abstract and Paragraphs [0009], [0017] and [0023]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Goodall, with the closed-loop monitoring and therapeutic substance delivery system is a vestibular balance disorder management and/or treatment system as taught by Fischell et al, since such a modification would provide the predictable results of beneficial effects on dizziness, vertigo, seasickness and travel sickness.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Averina et al (US Publication 2019/0008467) discloses including patient medical history and treatment used to control the therapy circuit.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
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