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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claim(s) 1-6, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armistead (US 2017/0311879) in view of Consentino (US 2013/0131574), Yagi (US 2008/0068638), Smadja (US 2018/0041569), Dorsett (US 2017/0039325), and Stone (US 2019/0148025).
Regarding claim 1, Armistead discloses (Figs. 1-5 and 7B) a processing system comprising:
memory (memory 4260);
a computing system (comprising computing device 7050, device 4000 and remote server 7010) including at least one hardware processor (central controller 4230 of device 4000) coupled to the memory (device 7050 receives therapy/usage data from RPT device 4000 and transmits the data to the server 7010, paragraph [0138], therefore at least some form of memory is inherent), the computing system configured to:
receive, from a mobile device configured to execute an application for communicating with a medical device, answers to at least one question (receives responses in the form of yes or no, see paragraphs [0222]-[0225]) and at least one subjective question, the subjective question including questions relating to subjective feedback for using the medical device (paragraphs [0222]-[0225]);
perform analytics to determine, based on the answers to the at least one question received from the mobile device, a tailored coaching program for a patient using the medical device (based on answer received, server 7010 may adjust settings, e.g. increase humidity if nasal congestion, for RPT device 4000, as well as tailored coaching programs for the patient (server 7010 receives answers and prompts action(s) based on answers received (paragraph [0221]). For example, system issues the query "Do you have a dry mouth on waking?" and the received answer to the query is yes, the data server 7010 prompts the patient 1000 to use a full-face mask, or a chin strap with a nasal mask, to reduce mouth leak, see paragraph [0222]) (See Fig. 2B, paragraphs [0216] and [0222]-[0225]).
Armistead does not disclose the plurality of questions include a plurality of demographic questions and that the questions are stored in the memory. However, Cosentino teaches (Fig. 2) a medical device comprising a computing device (210) and a plurality of demographic questions (questions concerning treatment information, paragraph [0031], which includes demographic information such as blood pressure and weight, see paragraph [0026]), wherein the questions are stored and accessible in the memory of the computing device (paragraphs [0029] and [0031]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of the modified Armistead reference to include demographic questions and so that the questions are stored and accessed from the memory, as taught by Consentino, for the purpose of allowing for more accurate adjustment of the device parameters and to reduce the need for the questions to be downloaded with each use (paragraph [0031] Consentino).
Armistead does not disclose the computing system is configured to
transmit, to the mobile device, a notification indicating that at least one subjective question that is unanswered is available from among a plurality of subjective questions;
responsive to a request received from the mobile device, transmit, to the mobile device, the at least one unanswered subjective question;
receive, from the mobile device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device.
However, Yagi teaches (Fig. 1) a computing system configured to transmit, to a computing device (MFP 1100), a notification indicating that unanswered questions are available (paragraph [0107]). Smadja teaches (Fig. 1) a computing system configured to receive, from a computing device (client computing device 320), a request for the questions (client computing device queries database for unanswered questions, paragraphs [0012] and [0063]); and, responsive to the request, transmit, to the computing device, the questions (paragraph [0012]), and receive, from the computing device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device (paragraph [0012] and [0063]-[0064]).
While Yagi and Smadja discloses these receive and transmit functions occur with a computing device, Yagi and Smadja do not disclose that these computing devices are mobile devices (the computing device 1100 of Yagi comprises a plurality of processing devices such as a fax machine, printer, computer, etc., and the computing device of Smadja is a “client computing device” with no specific disclosure of what type of computing device it actually is). However, Dorsett teaches (Fig. 1) a computing system where a user uses either a PC (a computing device) or a PDA (a mobile computing device) to request unanswered questions, and then uses the mobile computing device to answer the unanswered questions and send the responses to a server 101 (see paragraph [0068]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing system of modified Armistead to transmit to the computing device a notification indicating that unanswered questions are available, as taught by Yagi, for the purpose of providing feedback to the user that unanswered questions require answering; and to further modify the system of modified Armistead to receive, from the computing device, request for the questions and responsive to the request, transmit, to the computing device, at least one demographic question and at least one objective question stored in the memory, as taught by Smadja, for the purpose of providing the technological/software capability for user to receive the unanswered questions on a computing device; and to modify the computing devices of modified Armistead to comprise a mobile computing device, as taught by Dorsett, for the purpose of allowing user to receive and answer questions on the go, as opposed to requiring patient to be at home at their PC to answer and receive the questions.
Modified Armistead does not disclose perform analytics to determine, based on the answers to the at least one subjective question received from the mobile device, the one or more answers to the at least one subjective unanswered question, and answers to a plurality of demographic questions and a plurality of subjective questions received from a plurality of other medical devices and/or a plurality of mobile devices, a tailored coaching program for a patient using the medical device.
However, Stone teaches (Fig. 1) a medical device including a remote processing system (one or more server systems, paragraph [0021]) which is an on-demand cloud computing platform (cloud-based architecture, paragraph [0021]) configured to perform advanced analytics using answers from subjective and demographic questions received from the medical device and answers received from the plurality of other medical devices (collects data in the form of user responses to queries from patients 112a to 112n, each of which using a different medical device, and uses “machine learning algorithms” to formulate an output to benefit patients, see paragraphs [0029], [0053] and [0082]).
Regarding the limitation that the coaching program is “based on the answers received from the medical device and the answers received from the mobile device”, while Stone does not disclose receiving answers from a mobile device and from a medical device, this limitation is taught by the combination of Armistead/Yagi/Smadja/Dorsett, and because the answers are answers to questions that are presented on medical device (the answers from the mobile device are answers that are answers to unanswered questions, that are originally presented on the medical device but left unanswered by user for one reason or another), it would have been obvious for the modified Armistead reference to determine the coaching program based on answers from the medical device and mobile device for the purpose of ensuring answers to all required questions are accounted for (e.g. if coaching program is only based on questions from the medical device, answers to the unanswered questions which are answered on the mobile device would not be incorporated into the analytics process, which would not be preferred).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing system of Armistead to be configured to perform machine learning using data received from a plurality of patients, as taught by Stone, for the purpose of generating a coaching plane that better suits the current needs of the patient due to analysis of responses from a variety of patients (paragraph [0029]).
Regarding claim 2, modified Armistead discloses wherein the medical device is a respiratory treatment apparatus (see Abstract of Armistead)..
Regarding claim 3, modified Armistead discloses wherein the computing system is further configured to receive, from the medical device, answers to questions pre-stored on the medical device and answered by the patient using the medical device (Consentino disclose pre-stored questions, see paragraphs [0029] and [0031], and discloses that when a question is answered that belongs to a certain hierarchy of questions, the next question in the hierarchy is asked of the user, see [0069]-[0070] and [0074]) and answered using the medical device (via GUI of RPT device 4000 of Armistead).
Regarding claim 4, modified Armistead discloses wherein one or more of a plurality of demographic questions and a plurality of subjective questions are stored in the memory and are transmitted to the mobile device after a predetermined condition is satisfied (questions are displayed on medical device 4000 after a therapy quality indicator is determined which requires initial use of the RPT, see paragraph [0222], therefore the predetermined condition is that a user has already used the RPT at least one in order to generator a therapy quality indicator)..
Regarding claim 5, modified Armistead discloses a predetermined condition, but does not disclose the predetermined condition is a predetermined time period after the medical device is setup and/or a predetermined time period that the medical device has been operated by the patient. However, when the method of Armistead is used to treat nasal congestion (one of the queries issued by Armistead is “Are you experiencing nasal congestions?” paragraph [00224]), one of ordinary skill in the art would appreciate that it takes a period of time for a user to recognize their own nasal congestion when using the respiratory system, and therefore suggests it would be obvious to display the questions a predetermined time period after the apparatus has been setup and/or operated for the purpose of obtaining a more accurate response from the patient.
Regarding claim 6, modified Armistead discloses wherein the predetermined condition includes specific operating parameters set for the medical device (Armistead discloses in paragraph [0223] that if system determines declining usage time or increasing on/off events, user is queried “Are you having trouble getting to sleep?” and if user answers yes, system changes the therapy mode as a result).
Regarding claim 18, Armistead dsiclsoes (Figs. 1-5 and 7B) a method performed by a processing system, the method comprising:
receiving, from a mobile device configured to execute an application for communicating with a medical device, answers to at least one question (receives responses in the form of yes or no, see paragraphs [0222]-[0225]) and at least one subjective question, the subjective question including questions relating to subjective feedback for using the medical device (paragraphs [0222]-[0225]);
transmitting, to the mobile device, a notification indicating that at least one subjective question that is unanswered is available from among a plurality of subjective questions;
responsive to a request received from the mobile device, transmitting, to the mobile device, the at least one unanswered subjective question;
receiving, from the mobile device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device; and
performing analytics to determine, based on the answers to the at least one question received from the mobile device, a tailored coaching program for a patient using the medical device (based on answer received, server 7010 may adjust settings, e.g. increase humidity if nasal congestion, for RPT device 4000, as well as tailored coaching programs for the patient (server 7010 receives answers and prompts action(s) based on answers received (paragraph [0221]). For example, system issues the query "Do you have a dry mouth on waking?" and the received answer to the query is yes, the data server 7010 prompts the patient 1000 to use a full-face mask, or a chin strap with a nasal mask, to reduce mouth leak, see paragraph [0222]) (See Fig. 2B, paragraphs [0216] and [0222]-[0225]).
Armistead does not disclose the plurality of questions include a plurality of demographic questions and that the questions are stored in the memory. However, Cosentino teaches (Fig. 2) a medical device comprising a computing device (210) and a plurality of demographic questions (questions concerning treatment information, paragraph [0031], which includes demographic information such as blood pressure and weight, see paragraph [0026]), wherein the questions are stored and accessible in the memory of the computing device (paragraphs [0029] and [0031]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of the modified Armistead reference to include demographic questions and so that the questions are stored and accessed from the memory, as taught by Consentino, for the purpose of allowing for more accurate adjustment of the device parameters and to reduce the need for the questions to be downloaded with each use (paragraph [0031] Consentino).
Armistead does not disclose the computing system is configured to
transmit, to the mobile device, a notification indicating that at least one subjective question that is unanswered is available from among a plurality of subjective questions;
responsive to a request received from the mobile device, transmit, to the mobile device, the at least one unanswered subjective question;
receive, from the mobile device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device.
However, Yagi teaches (Fig. 1) a computing system configured to transmit, to a computing device (MFP 1100), a notification indicating that unanswered questions are available (paragraph [0107]). Smadja teaches (Fig. 1) a computing system configured to receive, from a computing device (client computing device 320), a request for the questions (client computing device queries database for unanswered questions, paragraphs [0012] and [0063]); and, responsive to the request, transmit, to the computing device, the questions (paragraph [0012]), and receive, from the computing device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device (paragraph [0012] and [0063]-[0064]).
While Yagi and Smadja discloses these receive and transmit functions occur with a computing device, Yagi and Smadja do not disclose that these computing devices are mobile devices (the computing device 1100 of Yagi comprises a plurality of processing devices such as a fax machine, printer, computer, etc., and the computing device of Smadja is a “client computing device” with no specific disclosure of what type of computing device it actually is). However, Dorsett teaches (Fig. 1) a computing system where a user uses either a PC (a computing device) or a PDA (a mobile computing device) to request unanswered questions, and then uses the mobile computing device to answer the unanswered questions and send the responses to a server 101 (see paragraph [0068]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing system of modified Armistead to transmit to the computing device a notification indicating that unanswered questions are available, as taught by Yagi, for the purpose of providing feedback to the user that unanswered questions require answering; and to further modify the system of modified Armistead to receive, from the computing device, request for the questions and responsive to the request, transmit, to the computing device, at least one demographic question and at least one objective question stored in the memory, as taught by Smadja, for the purpose of providing the technological/software capability for user to receive the unanswered questions on a computing device; and to modify the computing devices of modified Armistead to comprise a mobile computing device, as taught by Dorsett, for the purpose of allowing user to receive and answer questions on the go, as opposed to requiring patient to be at home at their PC to answer and receive the questions.
Modified Armistead does not disclose perform analytics to determine, based on the answers to the at least one subjective question received from the mobile device, the one or more answers to the at least one subjective unanswered question, and answers to a plurality of demographic questions and a plurality of subjective questions received from a plurality of other medical devices and/or a plurality of mobile devices, a tailored coaching program for a patient using the medical device.
However, Stone teaches (Fig. 1) a medical device including a remote processing system (one or more server systems, paragraph [0021]) which is an on-demand cloud computing platform (cloud-based architecture, paragraph [0021]) configured to perform advanced analytics using answers from subjective and demographic questions received from the medical device and answers received from the plurality of other medical devices (collects data in the form of user responses to queries from patients 112a to 112n, each of which using a different medical device, and uses “machine learning algorithms” to formulate an output to benefit patients, see paragraphs [0029], [0053] and [0082]).
Regarding the limitation that the coaching program is “based on the answers received from the medical device and the answers received from the mobile device”, while Stone does not disclose receiving answers from a mobile device and from a medical device, this limitation is taught by the combination of Armistead/Yagi/Smadja/Dorsett, and because the answers are answers to questions that are presented on medical device (the answers from the mobile device are answers that are answers to unanswered questions, that are originally presented on the medical device but left unanswered by user for one reason or another), it would have been obvious for the modified Armistead reference to determine the coaching program based on answers from the medical device and mobile device for the purpose of ensuring answers to all required questions are accounted for (e.g. if coaching program is only based on questions from the medical device, answers to the unanswered questions which are answered on the mobile device would not be incorporated into the analytics process, which would not be preferred).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing system of Armistead to be configured to perform machine learning using data received from a plurality of patients, as taught by Stone, for the purpose of generating a coaching plane that better suits the current needs of the patient due to analysis of responses from a variety of patients (paragraph [0029]).
Regarding claim 19, modified Armistead does not disclose one or more of the plurality of demographic questions and the plurality of subjective questions are transmitted to the mobile device after a predetermined condition is satisfied, and the predetermined condition is a predetermined time period after the medical device is setup and/or a predetermined time period that the medical device has been operated by the patient. However, when Armistead is used to treat nasal congestion (one of the queries issued by Armistead ‘879 is “Are you experiencing nasal congestions?” paragraph [00224]), one of ordinary skill in the art would appreciate that it takes a period of time for a user to recognize their own nasal congestion when using the respiratory system, and therefore suggests it would be obvious to display the questions a predetermined time period after the apparatus has been setup for the purpose of obtaining a more accurate response from the patient regarding their condition based on the current settings, thereby allowing the device to adjust operation of the device according to the current condition of the patient.
Claim(s) 7 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armistead (US 2017/0311879) in view of Consentino (US 2013/0131574), Yagi (US 2008/0068638), Smadja (US 2018/0041569), Dorsett (US 2017/0039325), and Stone (US 2019/0148025), and further in view of Kakkar (US 2016/0089089).
Regarding claim 7, modified Armistead discloses a computing system, but does not disclose the computing system is further configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device, the one or more answers to the at least one subjective unanswered question, and the answers to a plurality of demographic questions and a plurality of subjective questions received from the plurality of other medical devices and/or the plurality of mobile devices.
However, Kakkar teaches (Figs. 1-2B) a computing system (system 200) configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician (transmits message to patient that threshold, based on answers to questions answered by user, is crossed and schedules meeting with clinician, paragraphs [0079] and [0089]), wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device (paragraphs [0079] and [0089]). Regarding the transmission being based on “the one or more answers to the at least one subjective unanswered question, and the answers to a plurality of demographic questions and a plurality of subjective questions received from the plurality of other medical devices and/or the plurality of mobile devices”, one of ordinary skill would recognize that since these are already taught by the combined Armistead reference, it would have been obvious for the transmission to be based on all three of these answer categories for the purpose of ensuring a user requiring appointment is scheduled or alternatively to determine whether an appointment is necessary.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Armistead to be configured to transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device, the one or more answers to the at least one subjective unanswered question, and the answers to a plurality of demographic questions and a plurality of subjective questions received from the plurality of other medical devices and/or the plurality of mobile devices, as taught by Kakkar, for the purpose of improve patient outcome and preventing potential injury to patient if maligned medical condition is determined.
Regarding claim 20, modified Armistead discloses the method of claim 18, but does not disclose the steps further comprising: transmitting a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined based on answers, received from the mobile device.
However, Kakkar teaches (Figs. 1-2B) a method comprising providing a computing system (system 200) configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician (transmits message to patient that threshold, based on answers to questions answered by user, is crossed and schedules meeting with clinician, paragraphs [0079] and [0089]), wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device (paragraphs [0079] and [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Armistead to include the step of transmitting a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined based on answers, received from the mobile device, as taught by Kakkar, for the purpose of improve patient outcome and preventing potential injury to patient if maligned medical condition is determined.
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armistead (US 2017/0311879) in view of Yagi (US 2008/0068638), Smadja (US 2018/0041569), Dorsett (US 2017/0039325), and Stone (US 2019/0148025).
Regarding claim 8, Armistead discloses a processing system comprising:
memory (memory 4260);
a computing system (comprising computing device 7050, device 4000 and remote server 7010) including at least one hardware processor (central controller 4230 of device 4000) coupled to the memory (device 7050 receives therapy/usage data from RPT device 4000 and transmits the data to the server 7010, paragraph [0138], therefore at least some form of memory is inherent), the computing system configured to:
receive, from a medical device, answers to questions answered by a patient of the medical device via a user interface of the medical device before use of the medical device (receives responses in the form of yes or no to questions asked by device, see paragraphs [0222]-[0225]);
receive, from the medical device, answers to at least one subjective question answered by the patient via the user interface of the medical device before use of the medical device (paragraphs [0222]-[0225]), the at least one subjective question including questions relating to subjective feedback for using the medical device (i.e. “are you having trouble getting to sleep?”, paragraph [0223]);
Armistead does not disclose after receiving the answers to the at least one subjective question answered by the patient via the user interface of the medical device, transmit, to a mobile device configured to execute an application for communicating with the medical device, a notification indicating that unanswered subjective questions are available from among a plurality of subjective questions;
responsive to receiving a request from the mobile device, transmit, to the mobile device, a plurality of subjective questions from among the unanswered subjective questions;
receive, from the mobile device, answers to the plurality of subjective questions transmitted to the mobile device and answered by the patient via a user interface of the mobile device.
However, Yagi teaches (Fig. 1) a computing system configured to transmit, to a computing device (MFP 1100), a notification indicating that unanswered questions are available (paragraph [0107]). Smadja teaches (Fig. 1) a computing system configured to receive, from a computing device (client computing device 320), a request for the questions (client computing device queries database for unanswered questions, paragraphs [0012] and [0063]); and, responsive to the request, transmit, to the computing device, the questions (paragraph [0012]), and receive, from the computing device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device (paragraph [0012] and [0063]-[0064]).
While Yagi and Smadja discloses these receive and transmit functions occur with a computing device, Yagi and Smadja do not disclose that these computing devices are mobile devices (the computing device 1100 of Yagi comprises a plurality of processing devices such as a fax machine, printer, computer, etc., and the computing device of Smadja is a “client computing device” with no specific disclosure of what type of computing device it actually is). However, Dorsett teaches (Fig. 1) a computing system where a user uses either a PC (a computing device) or a PDA (a mobile computing device) to request unanswered questions, and then uses the mobile computing device to answer the unanswered questions and send the responses to a server 101 (see paragraph [0068]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing system of modified Armistead to transmit to the computing device a notification indicating that unanswered questions are available, as taught by Yagi, for the purpose of providing feedback to the user that unanswered questions require answering; and to further modify the system of modified Armistead to receive, from the computing device, request for the questions and responsive to the request, transmit, to the computing device, at least one demographic question and at least one objective question stored in the memory, as taught by Smadja, for the purpose of providing the technological/software capability for user to receive the unanswered questions on a computing device; and to modify the computing devices of modified Armistead to comprise a mobile computing device, as taught by Dorsett, for the purpose of allowing user to receive and answer questions on the go, as opposed to requiring patient to be at home at their PC to answer and receive the questions.
Modified Armistead does not disclose the system is configured to receive answers from a plurality of other medical devices associated with other patients;
perform analytics to determine, based on the answers received from the medical device, the answers received from the mobile device, and the answers received from the plurality of other medical devices associated with the other patients, a tailored coaching program for the patient using the medical device; and transmit the tailored coaching program to the medical device.
Modified Armistead does not disclose the computing system receives answers from a plurality of other medical devices associated with other patients; and perform advanced analytics to determine, based on the answers received from the medical device, the answers received from the mobile device, and the answers received from the plurality of other medical devices associated with the other patients, a tailored coaching program for the patient using the medical device associated the patient and personalised therapy for setting operating parameters of the medical device associated the patient; and transmit the tailored coaching program and the personalised therapy to the medical device.
However, Stone teaches (Fig. 1) a medical device including a remote processing system (one or more server systems, paragraph [0021]) which is an on-demand cloud computing platform (cloud-based architecture, paragraph [0021]) configured to perform machine learning analytics using answers received from the medical device and answers received from the plurality of other medical devices (collects data in the form of user responses to queries from patients 112a to 112n, each of which using a different medical device, and uses “machine learning algorithms” to formulate an output to benefit patients, see paragraphs [0029] and [0053]).
Regarding the limitation that the coaching program is “based on the answers received from the medical device and the answers received from the mobile device”, while Stone does not disclose receiving answers from a mobile device and from a medical device, this limitation is taught by the combination of Armistead/Yagi/Smadja/Dorsett, and because the answers are answers to questions that are presented on medical device (the answers from the mobile device are answers that are answers to unanswered questions, that are originally presented on the medical device but left unanswered by user for one reason or another), it would have been obvious for the modified Armistead reference to determine the coaching program based on answers from the medical device and mobile device for the purpose of ensuring answers to all required questions are accounted for (e.g. if coaching program is only based on questions from the medical device, answers to the unanswered questions which are answered on the mobile device would not be incorporated into the analytics process, which would not be preferred).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing system of Armistead to be configured to perform machine learning using data received from a plurality of patients, as taught by Stone, for the purpose of generating a coaching plane that better suits the current needs of the patient due to analysis of responses from a variety of patients (paragraph [0029]).
Regarding claim 9, modified Armistead discloses wherein the medical device is a respiratory treatment apparatus (see Abstract of Armistead).
Regarding claims 10-11, modified Armistead discloses the computing device is further configured to perform setup operations (starting the RPT device 4000 using previous settings), but does not disclose and the unanswered subjective questions are transmitted to the mobile device after a predetermined condition is satisfied, wherein the predetermined condition is a predetermined time period after the medical device is setup and/or a predetermined time period that the medical device has been operated by the patient. However, when Armistead is used to treat nasal congestion (one of the queries issued by Armistead ‘879 is “Are you experiencing nasal congestions?” paragraph [00224]), one of ordinary skill in the art would appreciate that it takes a period of time for a user to recognize their own nasal congestion when using the respiratory system, and therefore suggests it would be obvious to display the questions a predetermined time period after the apparatus has been setup for the purpose of obtaining a more accurate response from the patient regarding their condition based on the current settings, thereby allowing the device to adjust operation of the device according to the current condition of the patient.
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armistead (US 2017/0311879) in view of Yagi (US 2008/0068638), Smadja (US 2018/0041569), Dorsett (US 2017/0039325), and Stone (US 2019/0148025), and further in view of Consentino (US 2013/0131574).
Regarding claim 12, modified Armistead discloses subjective questions but does not discloses each of the plurality of subjective questions stored in the memory is associated with one or more conditions for distributing the corresponding question from the among the plurality of objective questions to the medical device.
However, Cosentino teaches (Fig. 1-3) a system wherein each of the plurality of objective questions stored in the memory is associated with one or more conditions for distributing the corresponding question from the among the plurality of objective questions to the medical device (questions concerning treatment information, paragraph [0031], which includes demographic information such as blood pressure and weight, see paragraph [0026], where the questions are adiministered based on previous responses to previous questions as well as the identity of patient entered in user interface, see paragraph [0069]-[0070] and [0074]. Questions also include hierarchies, where questions are asked based on the hierarchy and based on the previous response, paragraph [0074]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Armistead to include each of the plurality of objective questions stored in the memory is associated with one or more conditions for distributing the corresponding question from the among the plurality of objective questions to the medical device, as taught by Cosentino, for the purpose of providing optimal care tailored to individual patient parameters.
Regarding claim 13, modified Armistead discloses wherein the one or more conditions include one or more patient characteristics (e.g. patient identification, patient health status, etc., see paragraph [0074] and [0026]) being satisfied based on the answers to the questions pre-stored on the medical device.
Regarding claim 14, modified Armistead discloses the one or more conditions include a specific type of peripheral device being connected to the medical device (Cosentino discloses questions administered once user provides their telephone number as identification code to the medical device, thereby “connecting” a peripheral device (phone) to the medical device (computing system)).
Regarding claim 15, modified Armistead discloses wherein the one or more conditions include specific operating parameters set for the medical device (Armistead discloses in paragraph [0223] that if system determines declining usage time or increasing on/off events, user is queried “Are you having trouble getting to sleep?” and if user answers yes, system changes the therapy mode as a result).
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armistead (US 2017/0311879) in view of Yagi (US 2008/0068638), Smadja (US 2018/0041569), Dorsett (US 2017/0039325), and Stone (US 2019/0148025), and further in view of Lee (US 2018/0153440).
Regarding claim 17, modified Armistead discloses answers to the subjection questions but does not disclose at least one of the answers to the at least one subjective question provides an input indicated on a varying scale between two responses to the at least one subject question.
However, Lee teaches (Figs. 1-2) at least one of the answers to the at least one subjective question provides an input indicated on a varying scale between two responses to the at least one subject question (paragraph [0105]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Armistead to such that at least one of the answers to the at least one subjective question provides an input indicated on a varying scale between two responses to the at least one subject question, as taught by Lee, for the purpose of allowing user to provide feedback to computing device regarding complex issues (i.e. answers are based on a scale as opposed to finite yes/no), thereby improving patient treatment and adaptation of treatment protocol to specific user.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armistead (US 2017/0311879) in view of Yagi (US 2008/0068638), Smadja (US 2018/0041569), Dorsett (US 2017/0039325), and Stone (US 2019/0148025), and further in view of Kakkar (US 2016/0089089).
Regarding claim 16, modified Armistead discloses a computing system, but does not disclose the computing system is further configured to: transmit a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on answers, received from the mobile device.
However, Kakkar teaches (Figs. 1-2B) a computing system (system 200) configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician (transmits message to patient that threshold, based on answers to questions answered by user, is crossed and schedules meeting with clinician, paragraphs [0079] and [0089]), wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device (paragraphs [0079] and [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing system of modified Armistead to be configured to: transmit a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on answers, received from the mobile device., as taught by Kakkar, for the purpose of improve patient outcome and preventing potential injury to patient if maligned medical condition is determined.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8-16 and 18-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,064,554.
Although the claims are not identical, they are not patentably distinct from one another. The application claims are broader in at least one aspect and also recite additional features not claimed in the patent claims.
For claim 1:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Patent claim 22
Application claim 1
A processing system comprising:
memory storing a plurality of demographic questions and a plurality of subjective questions for a patient using a medical device, the plurality of subjective questions including at least one question relating to subjective feedback for comfort level in using the medical device and at least one question relating to subjective feedback for sleep satisfaction when using the medical device;
a computing system including at least one hardware processor coupled to the memory, the computing system configured to:
receive, from the medical device or a mobile device configured to execute an application for communicating with the medical device, answers to at least one demographic question and at least one subjective question;
transmit, to the mobile device, a notification indicating that at least one subjective question that is unanswered is available from among the plurality of subjective questions stored in the memory;
responsive to a request received from the mobile device, transmit, to the mobile device, the at least one unanswered subjective question stored in the memory;
receive, from the mobile device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device; and
perform analytics to determine, based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device, the one or more answers to the at least one subjective unanswered question, and answers to the plurality of demographic questions and the plurality of subjective questions received from a plurality of other medical devices and/or a plurality of mobile devices, a tailored coaching program for the patient and personalised therapy using the medical device.
A processing system comprising:
memory;
a computing system including at least one hardware processor coupled to the memory, the computing system configured to:
receive, from a mobile device configured to execute an application for communicating with a medical device, answers to at least one demographic question and at least one subjective question, the subjective question including questions relating to subjective feedback for using the medical device;
transmit, to the mobile device, a notification indicating that at least one subjective question that is unanswered is available from among a plurality of subjective questions;
responsive to a request received from the mobile device, transmit, to the mobile device, the at least one unanswered subjective question;
receive, from the mobile device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device; and
perform analytics to determine, based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device, the one or more answers to the at least one subjective unanswered question, and answers to a plurality of demographic questions and a plurality of subjective questions received from a plurality of other medical devices and/or a plurality of mobile devices, a tailored coaching program for a patient using the medical device.
Thus, it is apparent, for the broadening aspect, that patent claim 1 includes features that are not in application claim 1. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 1 is anticipated by patent claim 1, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 1 is obvious over patent claim 1 with respect to the broadening aspect.
For dependent claims 2-6, the recited limitations are contained in patent claims 2-6, respectively.
For claim 8:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Patent claim 8
Application claim 8
A processing system comprising:
memory storing a plurality of demographic questions for a patient using a medical device and a plurality of subjective questions relating to use of the medical device, the plurality of subjective questions including at least one question relating to subjective feedback for comfort level in using the medical device and at least one question relating to subjective feedback for sleep satisfaction when using the medical device;
a computing system including at least one hardware processor coupled to the memory, the computing system configured to:
receive, from the medical device, answers to questions pre-stored on the medical device and answered by the patient via a user interface of the medical device before initial use of the medical device;
receive, from the medical device, answers to at least one subjective question answered by the patient via the user interface of the medical device before initial use of the medical device;
after receiving the answers to the at least one subjective question answered by the patient via the user interface of the medical device, transmit, to a mobile device configured to execute an application for communicating with the medical device, a notification indicating that unanswered subjective questions are available from among the plurality of subjective questions stored in the memory;
responsive to receiving a request from the mobile device, transmit, to the mobile device, a plurality of subjective questions from among the unanswered subjective questions stored in the memory;
receive, from the mobile device, answers to the plurality of subjective questions transmitted to the mobile device and answered by the patient via a user interface of the mobile device;
receive answers from a plurality of other medical devices associated with other patients;
perform analytics to determine, based on the answers received from the medical device, the answers received from the mobile device, and the answers received from the plurality of other medical devices associated with the other patients, a tailored coaching program for the patient using the medical device associated the patient and personalised therapy for setting operating parameters of the medical device associated the patient; and
transmit the tailored coaching program and the personalised therapy to the medical device.
A processing system comprising:
memory;
a computing system including at least one hardware processor coupled to the memory, the computing system configured to:
receive, from a medical device, answers to questions answered by a patient of the medical device via a user interface of the medical device before use of the medical device;
receive, from the medical device, answers to at least one subjective question answered by the patient via the user interface of the medical device before use of the medical device, the at least one subjective question including questions relating to subjective feedback for using the medical device;
after receiving the answers to the at least one subjective question answered by the patient via the user interface of the medical device, transmit, to a mobile device configured to execute an application for communicating with the medical device, a notification indicating that unanswered subjective questions are available from among a plurality of subjective questions;
responsive to receiving a request from the mobile device, transmit, to the mobile device, a plurality of subjective questions from among the unanswered subjective questions;
receive, from the mobile device, answers to the plurality of subjective questions transmitted to the mobile device and answered by the patient via a user interface of the mobile device;
receive answers from a plurality of other medical devices associated with other patients;
perform analytics to determine, based on the answers received from the medical device, the answers received from the mobile device, and the answers received from the plurality of other medical devices associated with the other patients, a tailored coaching program for the patient using the medical device; and
transmit the tailored coaching program to the medical device.
Thus, it is apparent, for the broadening aspect, that patent claim 1 includes features that are not in application claim 8. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 8 is anticipated by patent claim 1, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 8 is obvious over patent claim 1 with respect to the broadening aspect.
For dependent claims 9-15, the recited limitations are contained in patent claims 9-15, respectively.
For claim 18:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Patent claim 8
Application claim 8
A method performed by a processing system including memory storing a plurality of demographic questions and a plurality of subjective questions for a patient using a medical device, the plurality of subjective questions including at least one question relating to subjective feedback for comfort level in using the medical device and at least one question relating to subjective feedback for sleep satisfaction when using the medical device, the method comprising:
receiving, from the medical device or a mobile device configured to execute an application for communicating with the medical device, answers to at least one demographic question and at least one subjective question;
transmitting, to the mobile device, a notification indicating that at least one subjective question that is unanswered is available from among the plurality of subjective questions stored in the memory;
responsive to a request received from the mobile device, transmitting, to the mobile device, the at least one unanswered subjective question stored in the memory;
receiving, from the mobile device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device; and
performing analytics to determine, based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device, the one or more answers to the at least one subjective unanswered question, and answers to the plurality of demographic questions and the plurality of subjective questions received from a plurality of other medical devices and/or a plurality of mobile devices, a tailored coaching program for the patient and personalised therapy using the medical device.
A method performed by a processing system, the method comprising:
receiving, from a mobile device configured to execute an application for communicating with a medical device, answers to at least one demographic question and at least one subjective question, the subjective question including questions relating to subjective feedback for using the medical device;
transmitting, to the mobile device, a notification indicating that at least one subjective question that is unanswered is available from among a plurality of subjective questions;
responsive to a request received from the mobile device, transmitting, to the mobile device, the at least one unanswered subjective question;
receiving, from the mobile device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device; and
performing analytics to determine, based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device, the one or more answers to the at least one subjective unanswered question, and answers to a plurality of demographic questions and a plurality of subjective questions received from a plurality of other medical devices and/or a plurality of mobile devices, a tailored coaching program for a patient using the medical device.
Thus, it is apparent, for the broadening aspect, that patent claim 18 includes features that are not in application claim 18. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 18 is anticipated by patent claim 18, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 18 is obvious over patent claim 18 with respect to the broadening aspect.
For dependent claims 19, the recited limitations are contained in patent claims 19, respectively.
Claims 7, 16 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 18 of U.S. Patent No. 12,064,554 in view of Kakkar (US 2016/0089089).
Regarding claim 7, claim 1 of patent discloses a computing system, but does not disclose the computing system is further configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device, the one or more answers to the at least one subjective unanswered question, and the answers to a plurality of demographic questions and a plurality of subjective questions received from the plurality of other medical devices and/or the plurality of mobile devices.
However, Kakkar teaches (Figs. 1-2B) a computing system (system 200) configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician (transmits message to patient that threshold, based on answers to questions answered by user, is crossed and schedules meeting with clinician, paragraphs [0079] and [0089]), wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device (paragraphs [0079] and [0089]). Regarding the transmission being based on “the one or more answers to the at least one subjective unanswered question, and the answers to a plurality of demographic questions and a plurality of subjective questions received from the plurality of other medical devices and/or the plurality of mobile devices”, one of ordinary skill would recognize that since these are already taught by the combined Armistead reference, it would have been obvious for the transmission to be based on all three of these answer categories for the purpose of ensuring a user requiring appointment is scheduled or alternatively to determine whether an appointment is necessary.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of claim 1 of patent to be configured to transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device, the one or more answers to the at least one subjective unanswered question, and the answers to a plurality of demographic questions and a plurality of subjective questions received from the plurality of other medical devices and/or the plurality of mobile devices, as taught by Kakkar, for the purpose of improve patient outcome and preventing potential injury to patient if maligned medical condition is determined.
Regarding claim 16, claim 8 of patent discloses a computing system, but does not disclose the computing system is further configured to: transmit a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on answers, received from the mobile device.
However, Kakkar teaches (Figs. 1-2B) a computing system (system 200) configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician (transmits message to patient that threshold, based on answers to questions answered by user, is crossed and schedules meeting with clinician, paragraphs [0079] and [0089]), wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device (paragraphs [0079] and [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing system of claim 8 of patent to be configured to: transmit a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on answers, received from the mobile device., as taught by Kakkar, for the purpose of improve patient outcome and preventing potential injury to patient if maligned medical condition is determined.
Regarding claim 20, claim 18 of patent discloses the method of claim 18, but does not disclose the steps further comprising: transmitting a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined based on answers, received from the mobile device.
However, Kakkar teaches (Figs. 1-2B) a method comprising providing a computing system (system 200) configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician (transmits message to patient that threshold, based on answers to questions answered by user, is crossed and schedules meeting with clinician, paragraphs [0079] and [0089]), wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device (paragraphs [0079] and [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 18 of patent to include the step of transmitting a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined based on answers, received from the mobile device, as taught by Kakkar, for the purpose of improve patient outcome and preventing potential injury to patient if maligned medical condition is determined.
Claims 1-6, 8-16 and 18-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,612,707.
Although the claims are not identical, they are not patentably distinct from one another. The application claims are broader in at least one aspect and also recite additional features not claimed in the patent claims.
For claim 1:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Patent claim 6
Application claim 1
A processing system comprising:
memory storing a plurality of demographic questions for a patient using a medical device and a plurality of subjective questions relating to use of the medical device;
a computing system including at least one hardware processor coupled to the memory, the computing system configured to:
receive, from the medical device, answers to questions pre-stored on the medical device and answered by the patient via a user interface of the medical device before initial use of the medical device;
transmit, to the medical device associated with the patient, at least one demographic question from among the plurality of demographic questions stored in the memory and at least one subjective question from among the plurality of subjective questions stored in the memory;
in response to transmitting the at least one demographic question and the at least one subjective questions, receive, from the medical device, answers to the at least one demographic question and at least one subjective question transmitted to the medical device and answered by the patient via the user interface of the medical device;
transmit, to a mobile device configured to execute an application for communicating with the medical device, a notification indicating that unanswered demographic and subjective questions are available from among the plurality of demographic questions and the plurality of subjective questions stored in the memory;
after transmitting the notification, receive, from the mobile device, a request for the unanswered demographic and subjective questions;
responsive to the request, transmit, to the mobile device, at least one demographic question and a plurality of subjective questions from among the unanswered demographic and subjective questions stored in the memory, the plurality of subjective questions transmitted to the mobile device including at least one question relating to subjective feedback for comfort level in using the medical device and at least one question relating to subjective feedback for sleep satisfaction when using the medical device;
receive, from the mobile device, answers to the at least one demographic question and the at least one subjective question from among the unanswered questions transmitted to the mobile device and answered by the patient via a user interface of the mobile deice, wherein at least one of the answers to the at least one subjective question provides an input indicated on a varying scale between two responses to the at least one subject question; receive answers from a plurality of other medical devices associated with other patients;
perform advanced analytics to determine, based on the answers received from the medical device, the answers received from the mobile device, and the answers received from the plurality of other medical devices associated with the other patients, a tailored coaching program for the patient using the medical device associated the patient and personalised therapy for setting operating parameters of the medical device associated the patient; and transmit the tailored coaching program and the personalised therapy to the medical device.
A processing system comprising:
memory;
a computing system including at least one hardware processor coupled to the memory, the computing system configured to:
receive, from a mobile device configured to execute an application for communicating with a medical device, answers to at least one demographic question and at least one subjective question, the subjective question including questions relating to subjective feedback for using the medical device;
transmit, to the mobile device, a notification indicating that at least one subjective question that is unanswered is available from among a plurality of subjective questions;
responsive to a request received from the mobile device, transmit, to the mobile device, the at least one unanswered subjective question;
receive, from the mobile device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device; and
perform analytics to determine, based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device, the one or more answers to the at least one subjective unanswered question, and answers to a plurality of demographic questions and a plurality of subjective questions received from a plurality of other medical devices and/or a plurality of mobile devices, a tailored coaching program for a patient using the medical device.
Thus, it is apparent, for the broadening aspect, that patent claim 6 includes features that are not in application claim 1. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 1 is anticipated by patent claim 6, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 1 is obvious over patent claim 1 with respect to the broadening aspect.
For dependent claims 2-6, the recited limitations are contained in patent claims 7-16, respectively.
For claim 8:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Patent claim 6
Application claim 8
A processing system comprising:
memory storing a plurality of demographic questions for a patient using a medical device and a plurality of subjective questions relating to use of the medical device;
a computing system including at least one hardware processor coupled to the memory, the computing system configured to:
receive, from the medical device, answers to questions pre-stored on the medical device and answered by the patient via a user interface of the medical device before initial use of the medical device;
transmit, to the medical device associated with the patient, at least one demographic question from among the plurality of demographic questions stored in the memory and at least one subjective question from among the plurality of subjective questions stored in the memory;
in response to transmitting the at least one demographic question and the at least one subjective questions, receive, from the medical device, answers to the at least one demographic question and at least one subjective question transmitted to the medical device and answered by the patient via the user interface of the medical device;
transmit, to a mobile device configured to execute an application for communicating with the medical device, a notification indicating that unanswered demographic and subjective questions are available from among the plurality of demographic questions and the plurality of subjective questions stored in the memory;
after transmitting the notification, receive, from the mobile device, a request for the unanswered demographic and subjective questions;
responsive to the request, transmit, to the mobile device, at least one demographic question and a plurality of subjective questions from among the unanswered demographic and subjective questions stored in the memory, the plurality of subjective questions transmitted to the mobile device including at least one question relating to subjective feedback for comfort level in using the medical device and at least one question relating to subjective feedback for sleep satisfaction when using the medical device;
receive, from the mobile device, answers to the at least one demographic question and the at least one subjective question from among the unanswered questions transmitted to the mobile device and answered by the patient via a user interface of the mobile deice, wherein at least one of the answers to the at least one subjective question provides an input indicated on a varying scale between two responses to the at least one subject question; receive answers from a plurality of other medical devices associated with other patients;
perform advanced analytics to determine, based on the answers received from the medical device, the answers received from the mobile device, and the answers received from the plurality of other medical devices associated with the other patients, a tailored coaching program for the patient using the medical device associated the patient and personalised therapy for setting operating parameters of the medical device associated the patient; and transmit the tailored coaching program and the personalised therapy to the medical device.
A processing system comprising:
memory;
a computing system including at least one hardware processor coupled to the memory, the computing system configured to:
receive, from a medical device, answers to questions answered by a patient of the medical device via a user interface of the medical device before use of the medical device;
receive, from the medical device, answers to at least one subjective question answered by the patient via the user interface of the medical device before use of the medical device, the at least one subjective question including questions relating to subjective feedback for using the medical device;
after receiving the answers to the at least one subjective question answered by the patient via the user interface of the medical device, transmit, to a mobile device configured to execute an application for communicating with the medical device, a notification indicating that unanswered subjective questions are available from among a plurality of subjective questions;
responsive to receiving a request from the mobile device, transmit, to the mobile device, a plurality of subjective questions from among the unanswered subjective questions;
receive, from the mobile device, answers to the plurality of subjective questions transmitted to the mobile device and answered by the patient via a user interface of the mobile device;
receive answers from a plurality of other medical devices associated with other patients;
perform analytics to determine, based on the answers received from the medical device, the answers received from the mobile device, and the answers received from the plurality of other medical devices associated with the other patients, a tailored coaching program for the patient using the medical device; and
transmit the tailored coaching program to the medical device.
Thus, it is apparent, for the broadening aspect, that patent claim 6 includes features that are not in application claim 8. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 8 is anticipated by patent claim 6, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 8 is obvious over patent claim 6 with respect to the broadening aspect.
For dependent claims 9-15, the recited limitations are contained in patent claims 7-16, respectively.
For claim 18:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Patent claim 6
Application claim 8
A processing system comprising:
memory storing a plurality of demographic questions for a patient using a medical device and a plurality of subjective questions relating to use of the medical device;
a computing system including at least one hardware processor coupled to the memory, the computing system configured to:
receive, from the medical device, answers to questions pre-stored on the medical device and answered by the patient via a user interface of the medical device before initial use of the medical device;
transmit, to the medical device associated with the patient, at least one demographic question from among the plurality of demographic questions stored in the memory and at least one subjective question from among the plurality of subjective questions stored in the memory;
in response to transmitting the at least one demographic question and the at least one subjective questions, receive, from the medical device, answers to the at least one demographic question and at least one subjective question transmitted to the medical device and answered by the patient via the user interface of the medical device;
transmit, to a mobile device configured to execute an application for communicating with the medical device, a notification indicating that unanswered demographic and subjective questions are available from among the plurality of demographic questions and the plurality of subjective questions stored in the memory;
after transmitting the notification, receive, from the mobile device, a request for the unanswered demographic and subjective questions;
responsive to the request, transmit, to the mobile device, at least one demographic question and a plurality of subjective questions from among the unanswered demographic and subjective questions stored in the memory, the plurality of subjective questions transmitted to the mobile device including at least one question relating to subjective feedback for comfort level in using the medical device and at least one question relating to subjective feedback for sleep satisfaction when using the medical device;
receive, from the mobile device, answers to the at least one demographic question and the at least one subjective question from among the unanswered questions transmitted to the mobile device and answered by the patient via a user interface of the mobile deice, wherein at least one of the answers to the at least one subjective question provides an input indicated on a varying scale between two responses to the at least one subject question; receive answers from a plurality of other medical devices associated with other patients;
perform advanced analytics to determine, based on the answers received from the medical device, the answers received from the mobile device, and the answers received from the plurality of other medical devices associated with the other patients, a tailored coaching program for the patient using the medical device associated the patient and personalised therapy for setting operating parameters of the medical device associated the patient; and transmit the tailored coaching program and the personalised therapy to the medical device.
A method performed by a processing system, the method comprising:
receiving, from a mobile device configured to execute an application for communicating with a medical device, answers to at least one demographic question and at least one subjective question, the subjective question including questions relating to subjective feedback for using the medical device;
transmitting, to the mobile device, a notification indicating that at least one subjective question that is unanswered is available from among a plurality of subjective questions;
responsive to a request received from the mobile device, transmitting, to the mobile device, the at least one unanswered subjective question;
receiving, from the mobile device, one or more answers to the at least one subjective unanswered question transmitted to the mobile device; and
performing analytics to determine, based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device, the one or more answers to the at least one subjective unanswered question, and answers to a plurality of demographic questions and a plurality of subjective questions received from a plurality of other medical devices and/or a plurality of mobile devices, a tailored coaching program for a patient using the medical device.
Thus, it is apparent, for the broadening aspect, that patent claim 6 includes features that are not in application claim 18. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 18 is anticipated by patent claim 6, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 18 is obvious over patent claim 6 with respect to the broadening aspect.
For dependent claims 19, the recited limitations are contained in patent claims 19, respectively.
Claims 7, 16 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 of U.S. Patent No.11,612,707 in view of Kakkar (US 2016/0089089).
Regarding claim 7, claim 6 of patent discloses a computing system, but does not disclose the computing system is further configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device, the one or more answers to the at least one subjective unanswered question, and the answers to a plurality of demographic questions and a plurality of subjective questions received from the plurality of other medical devices and/or the plurality of mobile devices.
However, Kakkar teaches (Figs. 1-2B) a computing system (system 200) configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician (transmits message to patient that threshold, based on answers to questions answered by user, is crossed and schedules meeting with clinician, paragraphs [0079] and [0089]), wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device (paragraphs [0079] and [0089]). Regarding the transmission being based on “the one or more answers to the at least one subjective unanswered question, and the answers to a plurality of demographic questions and a plurality of subjective questions received from the plurality of other medical devices and/or the plurality of mobile devices”, one of ordinary skill would recognize that since these are already taught by the combined Armistead reference, it would have been obvious for the transmission to be based on all three of these answer categories for the purpose of ensuring a user requiring appointment is scheduled or alternatively to determine whether an appointment is necessary.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of claim 6 of patent to be configured to transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the medical device or the mobile device, the one or more answers to the at least one subjective unanswered question, and the answers to a plurality of demographic questions and a plurality of subjective questions received from the plurality of other medical devices and/or the plurality of mobile devices, as taught by Kakkar, for the purpose of improve patient outcome and preventing potential injury to patient if maligned medical condition is determined.
Regarding claim 16, claim 6 of patent discloses a computing system, but does not disclose the computing system is further configured to: transmit a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on answers, received from the mobile device.
However, Kakkar teaches (Figs. 1-2B) a computing system (system 200) configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician (transmits message to patient that threshold, based on answers to questions answered by user, is crossed and schedules meeting with clinician, paragraphs [0079] and [0089]), wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device (paragraphs [0079] and [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing system of claim 6 of patent to be configured to: transmit a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined by the computing system based on answers, received from the mobile device., as taught by Kakkar, for the purpose of improve patient outcome and preventing potential injury to patient if maligned medical condition is determined.
Regarding claim 20, claim 6 of patent discloses the method of claim 18, but does not disclose the steps further comprising: transmitting a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined based on answers, received from the mobile device.
However, Kakkar teaches (Figs. 1-2B) a method comprising providing a computing system (system 200) configured to: transmit a message to the mobile device or the medical device indicating that the patient needs to schedule a meeting with a clinician (transmits message to patient that threshold, based on answers to questions answered by user, is crossed and schedules meeting with clinician, paragraphs [0079] and [0089]), wherein transmitting the message is determined by the computing system based on the answers to the at least one demographic question and the at least one subjective question received from the mobile device (paragraphs [0079] and [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 6 of patent to include the step of transmitting a message to the mobile device and the medical device indicating that the patient needs to schedule a meeting with a clinician, wherein transmitting the message is determined based on answers, received from the mobile device, as taught by Kakkar, for the purpose of improve patient outcome and preventing potential injury to patient if maligned medical condition is determined.
Conclusion
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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