DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/05/2026 has been entered.
Claims 1, 4-11, 14-20 are the current claims hereby under examination.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-11, and 14-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1, 4-11, and 14-20 are directed to a method of communicating physiological signals using a computational algorithm, which is an abstract idea. Claims 1, 4-11, and 14-20 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] determining a connection quality of a wireless connection between the medical device and an external device based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds
[B1] determining, based at least in part on the connection quality of the wireless connection between the medical device and the external device, an amount of the physiological data stored to send to the external device, including selecting between all of the physiological data or a portion of the physiological data collected after a most recent successful transmission of previously collected physiological data as the amount of the physiological data to send to the external device
These elements [A1]-[B1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] collecting, with processing circuitry of a medical device using sensing circuitry, physiological data associated with a patient;
[B2] processing circuitry
[C2] a medical device
[D2] sensing circuitry
[E2] storing, with the processing circuitry, the physiological data in memory
[F2] memory
[G2] an external device
[H2] controlling, with the processing circuitry, communication circuitry to send via the wireless connection, the determined amount of the physiological data stored in memory to the external device
[I2] communication circuitry
These elements [A2]-[I2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2], [D2], and [H2] are each merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the elements [B2], [E2]-[G2], and [I2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Further, the element [C2] merely generally links the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations of collecting data [A2] the associated sensing circuitry used to collect the data [D2], and the recitations of transmitting the selected data [H2] are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is not limited by the claim and may thus be any generic and well-known sensor that acquires physiological data such as electrocardiogram leads. Such sensors are conventional as evidenced by:
US Patent Application Publication Number US 2018/0028144 A1 hereinafter Chen teaches that ECG devices are conventional for recording ECG waveforms (Paragraph 0020).
US Patent Application Publication Number US 2002/0045836 A1 hereinafter Alkawwas teaches that EKG devices are conventional (Paragraph 0005).
Additionally, the recitations of transmitting the selected data is insignificant extrasolution activity to the judicial exception akin to the generic output of results that uses conventional, routine, and well known elements. In particular, generic computers are considered to be capable of wireless communication.
Further, the elements [B2], [E2], [F2] -[I2] do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)). In particular, the external device is not particularly limited and is considered to merely be an additional computer in communication with the claimed computer.
Additionally, the element [C2] merely generally links the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h). Such medical devices are routine and conventional as evidenced by Chen and Alkawwas above.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 4-10 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 10: a Bluetooth low energy connection;
Each of these claim limitations does not integrate the exception into a practical application. In particular, the elements of claims 10 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the Bluetooth low energy connection is a well-known method of wireless communication as evidenced by:
US Patent Application Publication Number US 2017/0039547 A1 hereinafter Bonsi which teaches that Bluetooth low energy protocol is also known as Bluetooth Smart (Paragraph 0006) which illustrates the protocol is known in the art.
US Patent Application Publication Number US 2017/0289787 A1 hereinafter Yu which teaches that Bluetooth low energy connections are conventional (Paragraph 0040).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim 11 recites the same abstract idea as claim 1 and only recites additional elements already addressed in the above rejection of claim 1. Claim 11 is rejected on the same grounds as claim 1 presented above.
Claims 14-19 depend from claim 11, and recite the same abstract idea as claim 11. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
The analysis of claim 20 is as follows:
Step 1: Claim 20 is drawn to a machine.
Step 2A – Prong One: Claim 20 recites an abstract idea. In particular, claim 20 recites the same abstract idea as claim 1.
Step 2A – Prong Two: Claim 20 recites the following limitations that are beyond the judicial exception and have not already been addressed in the above rejections of claims 1 and 11:
[A2] a non-transitory computer readable storage medium
This element [A2] of claim 20 does not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 20 does not recite additional elements that amount to significantly more than the judicial exception itself as descried in the above rejection of claim 1.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-9, 11, 14-19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mahajan US Patent Application Publication Number US 2011/0082377 A1 hereinafter Mahajan in view of Millar US Patent Application Publication Number US 2013/0265173 A1 hereinafter Millar in view of Padmani US Patent Application Publication Number US 2016/0092639 A1 hereinafter Padmani, further in view of Sevindik US Patent Application Publication Number US 2020/0077457 A1 hereinafter Sevindik.
Regarding claim 1, Mahajan discloses a method (Abstract) comprising:
collecting, with processing circuitry of a medical device using sensing circuitry, physiological data associated with a patient (Paragraphs 0063 and 0078: monitoring physiological data using a physiological data monitor, and the data collected by an implantable medical device);
storing, with the processing circuitry, the physiological data in memory (Paragraph 0078: the storage for physiological data);
determining, with the processing circuitry, an amount of the physiological data stored in the memory to send to the external device (Paragraphs 0079 and 0081: selecting portions of data to be transmitted; transmitting only the selected data); including selecting between all of the physiological data stored in the memory or a portion of the physiological data as the amount of the physiological data stored in the memory to send to the external device (Paragraphs 0079-0081: the selected portion of data is transmitted or if no selection occurs then all data is transmitted in order of pre-defined priority; Paragraph 0087: all data may be transmitted Paragraphs 0094-0096: previously transmitted data can be flagged. Thus Mahajan at least suggests that the non-transmitted, or not flagged, data may be of a higher priority for transmission than the flagged, or previously transmitted data.)
controlling, with the processing circuitry, communication circuitry to send via the wireless connection, the determined amount of the physiological data stored in memory to the external device (Paragraph 0081: transmitting the selected data to the external device; Paragraph 0078: a wireless connection may be utilized and established through the communication module).
Mahajan fails to further disclose the method comprising: determining, with the processing circuitry, a connection quality of a wireless connection between the medical device and an external device based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds; and determining an amount of the physiological data to send based at least in part on the connection quality of the wireless connection between the medical device and the external device; and selecting the data collected after a most recent successful transmission of previously collected physiological data.
Millar teaches systems and methods for portable instrumentation, comprising a server computer and a portable instrument that is wirelessly connectable to the server computer. The portable instrument comprises sensors for performing respective physical or electrochemical measurements, and a hand-held computer that is operably connectable to the sensors. The hand-held computer is configured to record and transmit the measurements to the server computer. The hand-held computer evaluates a real-time wireless connection quality between the portable instrument and the server computer. When the wireless connection quality shows a declining trend, the hand-held computer determines a spatial boundary where the portable instrument reaches a dead zone with wireless connection quality below a predetermined threshold. The hand-held computer then requests pre-recorded data from the server computer to be forwarded to the portable instrument before the portable instrument reaches the spatial boundary. The efficiency and reliability of the measurements are thus improved (Abstract). Thus Millar falls within the same field of endeavor as Applicant’s invention.
Millar teaches a system which calculates network quality, and determines the capacity of data that can be transmitted to an external device before it moves out of range. The calculation includes signal degradation as the external device moves farther away. The system compares the transmission capacity to the amount of data recorded in memory and transmits the appropriate amount of data according to the transmission capacity. If the signal quality indicates that available transmission bandwidth is in excess of the amount of related recorded data then no action is required. If the signal quality indicates that the available transmission bandwidth is not in excess of the amount of related recorded data then the system determines an amount of data which can be transmitted. If the amount of data that can be transmitted is less than the amount of related recorded data then a reduced data set can be transmitted (Paragraph 0055). The wireless connection quality is calculated and compared to a threshold of connection quality, when the connection quality is below the threshold the system may transmit a predetermined amount of data. The data transmission is prioritized based on factors including the amount of data capable of being transmitted and the timestamps of data to be transmitted (Paragraphs 0042-0044)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to combine the signal quality and transmission capacity determination described by Millar into the method of Mahajan because Mahajan teaches that the prioritization of data is important because it is unknown when the external device will move out of transmission range and be unable to receive the stored data (Mahajan: Paragraph 0093). Incorporating the quality determination and transmission capacity determination of Millar would allow Mahajan to know exactly how much data is able to be transmitted and allow Mahajan in view of Millar to transmit all of the stored data when the transmission capacity is sufficient (Millar: Paragraph 0055: when the transmission capacity is greater than the recorded data) or select the highest priority data for transmission if the transmission capacity is insufficient for all data (Millar: Paragraph 0055: the selection of a reduced dataset for transmission in combination with Mahajan: paragraphs 0079, 0081, and 0094-0096: the flagging of previously transmitted data and prioritization of transmission is considered to at least suggest the selection of non-transmitted data as the data to be transmitted). The determination of connection quality and associated transmission capacity further eliminates the risk of data loss in the event that data is transmitted but the device losses connection prior to receiving all of the transmitted data.
Mahajan in view of Miller is considered to at least suggest selecting the data collected after a most recent successful transmission of previously collected physiological data as the data for transmission as described above. Mahajan in view of Miller fails to further disclose the connection quality of a wireless connection between the medical device and an external device being based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds.
Padmani teaches a distributed healthcare information management system. Support user management may include generation of permission data that may be distributed from a central server to one or more local systems. The local systems may execute a healthcare information management application such as, for example, a pharmacy workflow management application. In any regard, central support users at the central server may periodically require access to the local systems to perform, among other activities, technical support or troubleshooting in relation to the application executed at the local system. In turn, provision of permission data from the central server to the local system may allow support users to access the local system with specific permission identification's provided specific ones of the support users. In turn, specific user permissions may be established and support user tracking may be carried out at the local systems (Abstract). Thus Padmani is reasonably pertinent to the problem of data transmission presently at hand.
Padmani teaches a system where stored data is timestamped and when information requests are received it may be determined that only a portion of the stored data needs to be transmitted by comparing the stored data timestamps to the timestamp of the last successful transmission and only transmitting the data that has not been previously transmitted before based on the timestamp occurring after the last successful transmission (Paragraph 0098).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of Mahajan in view of Miller to select and/or prioritize non-flagged, non-transmitted data for transmission when there is insufficient transmission capacity to transfer all of the data based on the teachings of Padmani which indicate that data that has been previously transmitted may be excluded from subsequent transmissions and is thus of a lower priority than new data.
Mahajan in view of Miller further in view of Padmani fails to further disclose the connection quality of a wireless connection between the medical device and an external device being based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds.
Sevindik teaches a communication system including a wireless control station and one or more data payload conveying wireless stations (Abstract). Thus, Sevindik is reasonably pertinent to the problem at hand.
Sevindik teaches that the quality of wireless transmission may be evaluated by comparing various transmission metrics including routine-trip time, bandwidth, and packet loss to respective threshold values (Paragraph 0078).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of Mahajan in view of Miller further in view of Padmani to perform the connection quality analysis by comparing one or more metrics to respective threshold as taught by Sevindik because such a quality determination method is a simple substitution of one known element (the quality determination method of Millar) for another known element (the quality determination method of Sevindik) with no surprising technical effect (the signal quality is evaluated and transmission size and/or priority is determined therefrom).
Regarding claim 11, Mahajan discloses a medical device configured for wireless communication (Abstract), wherein the medical device comprises:
sensing circuitry configured to collect physiological data associated with a patient (Paragraphs 0063 and 0078: monitoring physiological data, and the data collected by an implantable medical device; Fig. 1 references 110A-D and 210);
memory configured to store the physiological data (Paragraph 0078: the storage for physiological data);
communication circuitry configured for wireless communication (Paragraph 0062: the communication module); and
processing circuitry electrically coupled to the communication circuitry (Paragraph 0058: the processor can communicate with the communication module), wherein the processing circuitry is configured to:
determine, an amount of the physiological data stored in the memory to send to the external device (Paragraphs 0079 and 0081: selecting portions of data to be transmitted; transmitting only the selected data); including selecting between all of the physiological data stored in the memory or a portion of the physiological data as the amount of the physiological data stored in the memory to send to the external device (Paragraphs 0079-0081: the selected portion of data is transmitted or if no selection occurs then all data is transmitted in order of pre-defined priority; Paragraph 0087: all data may be transmitted Paragraphs 0094-0096: previously transmitted data can be flagged. Thus Mahajan at least suggests that the non-transmitted, or not flagged, data may be of a higher priority for transmission than the flagged, or previously transmitted data)
control the communication circuitry to send via a wireless connection, the determined amount of the physiological data stored in memory to the external device (Paragraph 0081: transmitting the selected data to the external device; Paragraph 0078: a wireless connection may be utilized).
Mahajan fails to further disclose the device configured to: determine a connection quality of a wireless connection between the medical device and an external device based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds; and determining an amount of the physiological data to send based at least in part on the connection quality of the wireless connection between the medical device and the external device; and selecting the data collected after a most recent successful transmission of previously collected physiological data.
Millar teaches a system which calculates network quality, and determines the capacity of data that can be transmitted to an external device before it moves out of range. The calculation includes signal degradation as the external device moves farther away. The system compares the transmission capacity to the amount of data recorded in memory and transmits the appropriate amount of data according to the transmission capacity. If the signal quality indicates that available transmission bandwidth is in excess of the amount of related recorded data then no action is required. If the signal quality indicates that the available transmission bandwidth is not in excess of the amount of related recorded data then the system determines an amount of data which can be transmitted. If the amount of data that can be transmitted is less than the amount of related recorded data then a reduced data set can be transmitted (Paragraph 0055). The wireless connection quality is calculated and compared to a threshold of connection quality, when the connection quality is below the threshold the system may transmit a predetermined amount of data. The data transmission is prioritized based on factors including the amount of data capable of being transmitted and the timestamps of data to be transmitted (Paragraphs 0042-0044)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to combine the signal quality and transmission capacity determination described by Millar into the device of Mahajan because Mahajan teaches that the prioritization of data is important because it is unknown when the external device will move out of transmission range and be unable to receive the stored data (Mahajan: Paragraph 0093). Incorporating the quality determination and transmission capacity determination of Millar would allow Mahajan to know exactly how much data is able to be transmitted and allow Mahajan in view of Millar to transmit all of the stored data when the transmission capacity is sufficient (Millar: Paragraph 0055: when the transmission capacity is greater than the recorded data) or select the highest priority data for transmission if the transmission capacity is insufficient for all data (Millar: Paragraph 0055: the selection of a reduced dataset for transmission in combination with Mahajan: paragraphs 0079, 0081, and 0094-0096: the flagging of previously transmitted data and prioritization of transmission is considered to at least suggest the selection of non-transmitted data as the data to be transmitted). The determination of connection quality and associated transmission capacity further eliminates the risk of data loss in the event that data is transmitted but the device losses connection prior to receiving all of the transmitted data.
Mahajan in view of Miller is considered to at least suggest selecting the data collected after a most recent successful transmission of previously collected physiological data as the data for transmission as described above. Mahajan in view of Miller fails to further disclose the connection quality of a wireless connection between the medical device and an external device being based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds.
Padmani teaches a system where stored data is timestamped and when information requests are received it may be determined that only a portion of the stored data needs to be transmitted by comparing the stored data timestamps to the timestamp of the last successful transmission and only transmitting the data that has not been previously transmitted before based on the timestamp occurring after the last successful transmission (Paragraph 0098).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of Mahajan in view of Miller to select and/or prioritize non-flagged, non-transmitted data for transmission when there is insufficient transmission capacity to transfer all of the data based on the teachings of Padmani which indicate that data that has been previously transmitted may be excluded from subsequent transmissions and is thus of a lower priority than new data.
Mahajan in view of Miller further in view of Padmani fails to further disclose the connection quality of a wireless connection between the medical device and an external device being based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds.
Sevindik teaches that the quality of wireless transmission may be evaluated by comparing various transmission metrics including routine-trip time, bandwidth, and packet loss to respective threshold values (Paragraph 0078).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of Mahajan in view of Miller further in view of Padmani to perform the connection quality analysis by comparing one or more metrics to respective threshold as taught by Sevindik because such a quality determination method is a simple substitution of one known element (the quality determination method of Millar) for another known element (the quality determination method of Sevindik) with no surprising technical effect (the signal quality is evaluated and transmission size and/or priority is determined therefrom).
Regarding claims 4 and 14, Mahajan in view of Millar in view of Padmani further in view of Sevindik teaches the method and device of claims 1 and 11. Modified Mahajan fails to further disclose the method or device wherein determining the amount of the physiological data stored in the memory to send to the external device further comprises: determining, with the processing circuitry, that the connection quality of the wireless connection between the medical device and the external device is acceptable for sending all of the physiological data stored in the memory to the external device; based on one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfying the one or more corresponding thresholds; and in response to determining that the connection quality of the wireless connection between the medical device and the external device is acceptable for sending all of the physiological data stored in the memory to the external device, determining, with the processing circuitry, to send all of the physiological data stored in the memory to the external device.
Millar teaches a system which calculates network quality, and determines the capacity of data that can be transmitted to an external device before it moves out of range. The calculation includes signal degradation as the external device moves farther away. The system compares the transmission capacity to the amount of data recorded in memory and transmits the appropriate amount of data according to the transmission capacity. If the signal quality indicates that available transmission bandwidth is in excess of the amount of related recorded data then no action is required. If the signal quality indicates that the available transmission bandwidth is not in excess of the amount of related recorded data then the system determines an amount of data which can be transmitted. If the amount of data that can be transmitted is less than the amount of related recorded data then a reduced data set can be transmitted (Paragraph 0055).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to further combine the signal quality and transmission capacity determination described by Millar into the method and device of modified Mahajan because Mahajan teaches that the prioritization of data is important because it is unknown when the external device will move out of transmission range and be unable to receive the stored data (Mahajan: Paragraph 0093). Incorporating the quality determination and transmission capacity determination of Millar would allow modified Mahajan to know exactly how much data is able to be transmitted while the device is in range. Mahajan in view of Millar would further be able to determine if there is sufficient capacity for only a portion of the data, or all of the data which would be beneficial to the process of Mahajan which could prioritize data transmission order based on the available network transmission capacity (Mahajan: Paragraphs 0081 and 0093-0095)
Modified Mahajan fails to further teach the determination being based on one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfying the one or more corresponding thresholds.
Sevindik teaches that the quality of wireless transmission may be evaluated by comparing various transmission metrics including routine-trip time, bandwidth, and packet loss to respective threshold values (Paragraph 0078).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method and device of modified Mahajan to perform the connection quality determination by comparing one or more metrics to respective threshold as taught by Sevindik because such a quality determination method is a simple substitution of one known element (the quality determination method of Millar) for another known element (the quality determination method of Sevindik) with no surprising technical effect (the signal quality is evaluated and transmission size and/or priority is determined therefrom).
Regarding claims 5 and 15, Mahajan in view of Millar in view of Padmani further in view of Sevindik teaches the method and device of claims 1 and 11 respectively. Modified Mahajan fails to further disclose the method or device wherein determining the amount of the physiological data stored in the memory to send to the external device further comprises: determining, with the processing circuitry, that the connection quality of the wireless connection between the medical device and the external device is not acceptable for sending all of the physiological data stored in the memory to the external device; and in response to determining that the connection quality of the wireless connection between the medical device and the external device is not acceptable for sending all of the physiological data stored in the memory to the external device based on one or more of bandwidth, packet loss, jitter, or latency of the wireless connection not satisfying the one or more corresponding thresholds, determining, with the processing circuitry, to send the portion of the physiological data collected after the most recent successful transmission of the previously collected physiological data to the external device.
Millar teaches a system which calculates network quality, and determines the capacity of data that can be transmitted to an external device before it moves out of range. The calculation includes signal degradation as the external device moves farther away. The system compares the transmission capacity to the amount of data recorded in memory and transmits the appropriate amount of data according to the transmission capacity. If the signal quality indicates that available transmission bandwidth is in excess of the amount of related recorded data then no action is required. If the signal quality indicates that the available transmission bandwidth is not in excess of the amount of related recorded data then the system determines an amount of data which can be transmitted. If the amount of data that can be transmitted is less than the amount of related recorded data then a reduced data set can be transmitted (Paragraph 0055).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to further combine the signal quality and transmission capacity determination described by Millar into the method and device of Mahajan because Mahajan teaches that the prioritization of data is important because it is unknown when the external device will move out of transmission range and be unable to receive the stored data (Mahajan: Paragraph 0093). Incorporating the quality determination and transmission capacity determination of Millar would allow Mahajan to know exactly how much data is able to be transmitted while the device is in range. Mahajan in view of Millar would further be able to determine if there is sufficient capacity for only a portion of the data, or all of the data which would be beneficial to the process of Mahajan which could prioritize data transmission order based on the available network transmission capacity such as making the previously transmitted data a low priority (Mahajan: Paragraphs 0081 and 0093-0096)
Mahajan in view of Miller is considered to at least suggest selecting the data collected after a most recent successful transmission of previously collected physiological data as the data for transmission as described above. Mahajan in view of Miller fails to further teach the determination being based on one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfying the one or more corresponding thresholds
Padmani teaches a system where stored data is timestamped and when information requests are received it may be determined that only a portion of the stored data needs to be transmitted by comparing the stored data timestamps to the timestamp of the last successful transmission and only transmitting the data that has not been previously transmitted before based on the timestamp occurring after the last successful transmission (Paragraph 0098).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method and device of modified Mahajan to select and/or prioritize non-flagged, non-transmitted data for transmission when there is insufficient transmission capacity to transfer all of the data based on the teachings of Padmani which indicate that data that has been previously transmitted may be excluded from subsequent transmissions and is thus of a lower priority than new data.
Modified Mahajan fails to further teach the determination being based on one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfying the one or more corresponding thresholds.
Sevindik teaches that the quality of wireless transmission may be evaluated by comparing various transmission metrics including routine-trip time, bandwidth, and packet loss to respective threshold values (Paragraph 0078).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method and device of modified Mahajan to perform the connection quality determination by comparing one or more metrics to respective threshold as taught by Sevindik because such a quality determination method is a simple substitution of one known element (the quality determination method of Millar) for another known element (the quality determination method of Sevindik) with no surprising technical effect (the signal quality is evaluated and transmission size and/or priority is determined therefrom).
Regarding claims 6 and 16, Mahajan in view of Millar in view of Padmani further in view of Sevindik teaches the method and device of claims 1 and 11 respectively. Modified Mahajan further at least suggests the method and device wherein determining the amount of the physiological data stored in the memory to send to the external device further comprises:
receiving, with the processing circuitry and from the external device, a request for the physiological data stored in the memory (Paragraphs 0055 and 0062 at least suggest that the IMD can receive a data request from an outside device as paragraph 0055 states “In an example, the external communication device 120 can receive data from the IMD 105 and display that, such as on a computer display. In an example, the external communication device 120 can also receive wireless communications initiated by the IMD 105 for the purpose of downloading stored episode data for use by a physician in diagnosis or device programming” which appears to suggest that the external device may initiate the data request, or the IMD may initiate the data transfer. Furthermore, paragraph 0062 states that the memory of the IMD may be accessed by the external device which suggests that the IMD may receive data requests from the external device. These recitations of Mahajan are considered sufficient to render obvious the claimed request of data from the external device to the memory); and
determining, with the processing circuitry and based on the request, whether to send all of the physiological data stored in the memory to the external device or to send the portion of the physiological data collected after the most recent successful transmission of previously collected physiological data to the external device (Paragraphs 0081 and 0093-0096: the selected physiological data is transmitted or all the data is transmitted).
Regarding claims 7 and 17, Mahajan in view of Millar in view of Padmani further in view of Sevindik teaches the method and device of claims 1 and 11 respectively. Modified Mahajan further discloses the method and device wherein controlling the communication circuitry to send the determined amount of the physiological data stored in memory to the external device further comprises: in response to determining to send all of the physiological data stored in the memory to the external device, controlling, with the processing circuitry, the communication circuitry to send, via the wireless connection, all of the physiological data stored in the memory to the external device (Paragraphs 0081 and 0095: transmitting all the data currently stored on the IMD).
Regarding claims 8 and 18, Mahajan in view of Millar in view of Padmani further in view of Sevindik teaches the method and device of claims 1 and 11 respectively. Modified Mahajan further discloses the method and device wherein controlling the communication circuitry to send the determined amount of the physiological data stored in memory to the external device further comprises: in response to determining to send the portion of the physiological data collected after the most recent successful transmission of the previously collected physiological data to the external device, controlling, with the processing circuitry, the communication circuitry to send, via the wireless connection, the portion of the physiological data collected after the most recent successful transmission of the previously collected physiological data to the external device (Paragraphs 0079-0081: the selected portion of data is transmitted or if no selection occurs then all data is transmitted in order of pre-defined priority; Paragraph 0087: all data may be transmitted Paragraphs 0094-0096: previously transmitted data can be flagged. Thus Mahajan at least suggests that the non-transmitted, or not flagged, data may be of a higher priority for transmission than the flagged, or previously transmitted data)
Padmani teaches a system where stored data is timestamped and when information requests are received it may be determined that only a portion of the stored data needs to be transmitted by comparing the stored data timestamps to the timestamp of the last successful transmission and only transmitting the data that has not been previously transmitted before based on the timestamp occurring after the last successful transmission (Paragraph 0098).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method and device of modified Mahajan to select and/or prioritize non-flagged, non-transmitted data for transmission when there is insufficient transmission capacity to transfer all of the data based on the teachings of Padmani which indicate that data that has been previously transmitted may be excluded from subsequent transmissions and is thus of a lower priority than new data.
Regarding claims 9 and 19, Mahajan in view of Millar in view of Padmani further in view of Sevindik teaches the method and device of claims 1 and 11 respectively. Modified Mahajan fails to further disclose the method or device further comprising: comparing, with the processing circuitry, timestamps associated with the physiological data stored in the memory with a timestamp associated with the most recent successful transmission of the previously collected physiological data to the external device to determine the portion of the physiological data collected after the most recent successful transmission of the previously collected physiological data to the external device.
Padmani teaches a system where stored data is timestamped and when information requests are received it may be determined that only a portion of the stored data needs to be transmitted by comparing the stored data timestamps to the timestamp of the last successful transmission and only transmitting the data that has not been previously transmitted before based on the timestamp occurring after the last successful transmission (Paragraph 0098).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the timestamps for stored data and timestamps for successful data transmission as well as their comparison to determine what portion of data should be transmitted as taught by Padmani into the method and device of modified Mahajan because Mahajan already contemplates denoting what data has been transmitted and what data hasn’t (Mahajan: paragraph 0096: the flagged data) and the timestamp labeling and comparison of Padmani would provide an additional metric to determine the priority level assigned to stored data by denoting what could be considered “old” data versus “new” data which is considered important by Mahajan (Mahajan: paragraphs 0093-0094: priority based transmission)
Regarding claim 20, Mahajan discloses a non-transitory computer-readable storage medium comprising program instructions (Abstract: the memory) that, when executed by processing circuitry of a medical device, cause the processing circuitry to:
collect, using sensing circuitry, physiological data associated with a patient (Paragraphs 0063 and 0078: monitoring physiological data using a physiological data monitor, and the data collected by an implantable medical device);
store the physiological data in memory (Paragraph 0078: the storage for physiological data);
determine, an amount of the physiological data stored in the memory to send to the external device (Paragraphs 0079 and 0081: selecting portions of data to be transmitted; transmitting only the selected data); including selecting between all of the physiological data stored in the memory or a portion of the physiological data as the amount of the physiological data stored in the memory to send to the external device (Paragraphs 0079-0081: the selected portion of data is transmitted or if no selection occurs then all data is transmitted in order of pre-defined priority; Paragraph 0087: all data may be transmitted Paragraphs 0094-0096: previously transmitted data can be flagged. Thus Mahajan at least suggests that the non-transmitted, or not flagged, data may be of a higher priority for transmission than the flagged, or previously transmitted data)
control communication circuitry to send, via a wireless connection, the determined amount of the physiological data stored in memory to the external device (Paragraph 0081: transmitting the selected data to the external device; Paragraph 0078: a wireless connection may be utilized).
Mahajan fails to further disclose the processing circuitry configured to: determine a connection quality of a wireless connection between the medical device and an external device based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds; and determining an amount of the physiological data to send based at least in part on the connection quality of the wireless connection between the medical device and the external device; and selecting the data collected after a most recent successful transmission of previously collected physiological data.
Millar teaches a system which calculates network quality, and determines the capacity of data that can be transmitted to an external device before it moves out of range. The calculation includes signal degradation as the external device moves farther away. The system compares the transmission capacity to the amount of data recorded in memory and transmits the appropriate amount of data according to the transmission capacity. If the signal quality indicates that available transmission bandwidth is in excess of the amount of related recorded data then no action is required. If the signal quality indicates that the available transmission bandwidth is not in excess of the amount of related recorded data then the system determines an amount of data which can be transmitted. If the amount of data that can be transmitted is less than the amount of related recorded data then a reduced data set can be transmitted (Paragraph 0055). The wireless connection quality is calculated and compared to a threshold of connection quality, when the connection quality is below the threshold the system may transmit a predetermined amount of data. The data transmission is prioritized based on factors including the amount of data capable of being transmitted and the timestamps of data to be transmitted (Paragraphs 0042-0044)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to combine the signal quality and transmission capacity determination described by Millar into the device of Mahajan because Mahajan teaches that the prioritization of data is important because it is unknown when the external device will move out of transmission range and be unable to receive the stored data (Mahajan: Paragraph 0093). Incorporating the quality determination and transmission capacity determination of Millar would allow Mahajan to know exactly how much data is able to be transmitted and allow Mahajan in view of Millar to transmit all of the stored data when the transmission capacity is sufficient (Millar: Paragraph 0055: when the transmission capacity is greater than the recorded data) or select the highest priority data for transmission if the transmission capacity is insufficient for all data (Millar: Paragraph 0055: the selection of a reduced dataset for transmission in combination with Mahajan: paragraphs 0079, 0081, and 0094-0096: the flagging of previously transmitted data and prioritization of transmission is considered to at least suggest the selection of non-transmitted data as the data to be transmitted). The determination of connection quality and associated transmission capacity further eliminates the risk of data loss in the event that data is transmitted but the device losses connection prior to receiving all of the transmitted data.
Mahajan in view of Miller is considered to at least suggest selecting the data collected after a most recent successful transmission of previously collected physiological data as the data for transmission as described above. Mahajan in view of Miller fails to further disclose the connection quality of a wireless connection between the medical device and an external device being based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds.
Padmani teaches a system where stored data is timestamped and when information requests are received it may be determined that only a portion of the stored data needs to be transmitted by comparing the stored data timestamps to the timestamp of the last successful transmission and only transmitting the data that has not been previously transmitted before based on the timestamp occurring after the last successful transmission (Paragraph 0098).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of Mahajan in view of Miller to select and/or prioritize non-flagged, non-transmitted data for transmission when there is insufficient transmission capacity to transfer all of the data based on the teachings of Padmani which indicate that data that has been previously transmitted may be excluded from subsequent transmissions and is thus of a lower priority than new data.
Mahajan in view of Miller further in view of Padmani fails to further disclose the connection quality of a wireless connection between the medical device and an external device being based on whether one or more of bandwidth, packet loss, jitter, or latency of the wireless connection satisfies one or more corresponding thresholds.
Sevindik teaches that the quality of wireless transmission may be evaluated by comparing various transmission metrics including routine-trip time, bandwidth, and packet loss to respective threshold values (Paragraph 0078).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of Mahajan in view of Miller further in view of Padmani to perform the connection quality analysis by comparing one or more metrics to respective threshold as taught by Sevindik because such a quality determination method is a simple substitution of one known element (the quality determination method of Millar) for another known element (the quality determination method of Sevindik) with no surprising technical effect (the signal quality is evaluated and transmission size and/or priority is determined therefrom).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mahajan US Patent Application Publication Number US 2011/0082377 A1 hereinafter Mahajan in view of Millar US Patent Application Publication Number US 2013/0265173 A1 hereinafter Millar in view of Padmani US Patent Application Publication Number US 2016/0092639 A1 hereinafter Padmani , further in view of Sevindik US Patent Application Publication Number US 2020/0077457 A1 hereinafter Sevindik as applied to claim 1 above and further in view of Cho US Patent Application Publication Number US 2018/0295657 A1 hereinafter Cho.
Regarding claim 10, Mahajan in view of Millar in view of Padmani further in view of Sevindik teaches the method of claim 1. Modified Mahajan further discloses the method wherein the wireless connection comprises a Bluetooth connection (Paragraph 0078).
Mahajan fails to further disclose the device utilizing a Bluetooth Low Energy connection.
Cho teaches an electronic device includes a wireless communication module, a memory configured to store a first application configured to manage connection to at least one external device and a second application configured to process data received from the at least one external device and to manage the data, a processor electrically connected to the wireless communication module and the memory. The processor is configured to connect to a first external device through the wireless communication module by using the first application, to obtain first connection information for connection between the first application and the first external device, and to connect the first external device to the second application through the wireless communication module by using the first connection information (Abstract). Thus, Cho falls within the same field of endeavor as Applicant’s invention.
Cho teaches that Bluetooth low energy is an acceptable form of wireless communication for communicating data to an external device (Paragraphs 0058 and 0060).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of modified Mahajan to operate using Bluetooth low energy communication as taught by Cho because modified Mahajan already utilizes Bluetooth communication (Paragraph 0078) and implementing Bluetooth low energy would be a simple substitution for one known element for another with no surprising technical effect.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not found to be persuasive.
In regards to the rejections previously presented under 35 USC 103:
Applicant argues that Mahajan fails to the selection of non-transmitted data as the portion of data transmitted because Mahajan utilizes the flag placed on transmitted data memory management and does not contemplate using the flag for selection of transmission data.
This argument is not found to be persuasive because Mahajan teaches the flags may influence data priority since the flagged data may be the first to be deleted and is thus the lowest priority, the data priority is utilized in selecting what data is transmitted (Paragraphs 0079-0081 and 0096). Thus Mahajan is considered to at least suggest the prioritization and therefor selection of non-flagged data. Furthermore, Applicant’s arguments do not address the teachings of Mahajan in combination with the teachings of Millar and are thus not found to be persuasive. Nonetheless, Padmani explicitly teaches the omission of previously transmitted data from future transmissions and thus explicitly teaches the selection/prioritization of non-transmitted data.
In regards to the rejections previously presented under 35 USC 101:
Applicant argues that the specification does not describe the invention as being performed by the human mind. Applicant further argues that the control of the communication circuitry cannot be performed in the human mind. Applicant argues that the claim as a whole improves the functioning of a computer by decreasing the amount of time to transfer data between the IMD and the external device and decreases the chances of an error occurring in the wireless communication. Applicant further asserts that the reduced data transfer time reduces the amount of power consumed by the device and therefor improves the functioning of the computing device.
Applicant’s arguments to the extent to which they apply to the present rejection are not found to be persuasive. In particular, the specification is not read into the claims. The specification not explicitly considered the claimed method as being capable of being performed in the human mind does not preclude the claims themselves from reciting an abstract idea. The recited abstract idea of determining a connection quality by comparing metrics to thresholds and subsequently determining how much data to send based on whether the thresholds are met is readily performed in the human mind. It is noted that the claims do not require the method or device to determine the wireless quality metrics themselves. Rather the claims only require that such metrics are compared to thresholds. A human mind may readily make such a comparison of a provided metric to a threshold. The human mind is further well suited for determining and selecting how much data should be transmitted based on the threshold comparisons. The recitations of collecting the data using a medical device with sensing circuitry, storing the data, and performing the data transmission are all elements beyond the abstract idea. However, none of these elements require anything more than a generic computer in communication with generic sensors. In particular, the collecting of data is insufficient extra-solution activity and the wireless transmission of the selected data is analogous to simply displaying the results of the algorithm. Just as the function of displaying results is insufficient extra-solution activity because it requires nothing more than the abstract idea being implemented onto a computer, so too does the recitation of transmitting the selected data. Such a recitations is merely the output of the results of the algorithm and requires nothing more than a generic computer performing generic computing functions of wireless communication.
Applicant’s arguments directed towards the claims being an improvement to the functioning of a computer and/or an improvement in the technology are not found to be persuasive because the claims do not indicate any improvement in the functioning of the computer itself. Thew computer does not process information or transmit data faster or more accurately. Rather the supposed improvements described in Applicant’s arguments are merely the anticipated results of the algorithm being performed on any computer. The selection of data for transmission based on wireless communication quality does not alter the function of the computer itself and the resultant benefits are merely the result of optimizing the amount of data being transferred over a wireless connection based on its quality. Such an optimization is not considered to improve the function of the computer itself. Moreover, the invention is not considered to represent an improvement in any technological field because the method and systems are known in the art as evidenced by the above presented prior art rejections.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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