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 . 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 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.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 21 and 28 are objected to because of the following informalities: there should be an “and” before the last clause in a list of clauses (i.e., before the “upon” step)).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 21, there is insufficient antecedent basis for the recitation of “the received data of the second type.” It is unclear whether this is the same as or different than the calculated data of the second type. For purposes of examination, it will be interpreted as the same.
Claims 22-27 are rejected because they depend on rejected claims.
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 21-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 21-27 are directed to a “device,” which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claims 28-33 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 21 and 28 recite (“set forth” or “describe”) the abstract idea of a mental process and a mathematical concept, substantially as follows:
calculating data of a second type associated with diabetes, wherein the calculated data of the second type is derived from the received data of the first type, wherein: the data of the second type derived from the data of the first type is a first derivative or a second derivative with respect to time of the data of the first type; or the data of the second type derived from the data of the first type includes: deviations from normal glucose patterns, pattern data of glucose values over a time period, predicted glucose values, a duration over which a glucose value is within a predetermined range, weightings of parameters or variables to be considered in determining a glycemic urgency index, or local maxima or minima in the data of the first type; determining the glycemic urgency index based at least on the received data of the first type, the received data of the second type, and the received data of the third type, wherein determining the glycemic urgency index comprises increasing a value of the glycemic urgency index where the accuracy information indicates a low level of accuracy of the glucose concentration measured by the glucose sensor and electronics; and determining whether the glycemic urgency index exceeds a predetermined threshold indicative of the diabetes reaching a health risk state.
The calculating and determining steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of the data of the first and third types, they would be able to process it by e.g. taking a derivative, and combining the data to determine an urgency index. There is nothing to suggest an undue level of complexity in the calculating and determining. Therefore, a person would be able to perform the calculations mentally or with pen and paper.
The calculating and determining steps also involve the mathematical concepts of differentiation and data combination. These steps correspond to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claims 21 and 28 do not include additional elements that integrate the mental process or mathematical concept into a practical application. Therefore, the claims are “directed to” the mental process and mathematical concept. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. a receiver system comprising one or more memories and one or more processors, etc.), and
add insignificant extra-solution activity (the pre-solution activity of: receiving data of a first type and a third type, using generic data-gathering components including a continuous sensor system comprising a glucose sensor and a sensor electronics module, etc.; and the post-solution activity of: providing an indication on a generic data-outputting device in a manner that overrides other processes).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the provided indication need not be seen, heard, or acted on. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 21 and 28 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. the types of accuracy information (claims 23-25 and 30-32), a particular threshold (claims 26 and 33), etc.),
further describe the post-solution activity (e.g. displaying the indication in response to unlock and during lock in a particular situation (claims 22 and 29), etc.), and
describe field-of-use context (e.g. a mobile device and server configuration (claim 27), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. Even if the indication is provided in a manner that overrides e.g. a lock screen, it still need not be seen, heard, or acted on. The additional elements also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 23-26, 28, and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2015/0273147 (“Duke”) in view of US Patent Application Publication 2009/0143661 (“Taub”).
Regarding claim 21, Duke teaches [a] system, comprising: a continuous sensor system (Fig. 2, a continuous glucose monitoring (CGM) system 50), comprising: a glucose sensor (Fig. 3, glucose sensor 56); and a sensor electronics module (¶ 0035, sensor 56 comprising other components, such as a wireless transmitter 60 and antenna 62 – see Fig. 2) configured to: acquire, via the glucose sensor, sensor data indicative of glucose concentration (¶ 0035 – also see the x-axis of Fig. 1); and transmit, via a wireless link, the sensor data to a receiver system (Fig. 2, transmitting, via e.g. wireless link 64, to computing device 66, also shown in Fig. 3); and the receiver system, comprising: one or more memories storing instructions (Fig. 3, memory 76); and one or more processors coupled to the one or more memories and configured to execute the instructions (Fig. 3, processor(s) 72) to: receive, via the wireless link (¶ 0037), data of a first type, the data of the first type comprising the sensor data indicative of glucose concentration measured by the glucose sensor (Fig. 10, block 152; concentration is indicated by the axes of e.g. Figs. 1, 4, 5, etc. - also see ¶ 0052, describing how the management device 66 maintains a record of historical glucose data accumulated over time, and Figs. 5 and 13, showing glucose concentrations over time); calculate data of a second type associated with diabetes, wherein the calculated data of the second type is derived from the received data of the first type, wherein: the data of the second type derived from the data of the first type is a first derivative or a second derivative with respect to time of the data of the first type; or the data of the second type derived from the data of the first type includes: deviations from normal glucose patterns, pattern data of glucose values over a time period, predicted glucose values, a duration over which a glucose value is within a predetermined range, weightings of parameters or variables to be considered in determining a glycemic urgency index, or local maxima or minima in the data of the first type (Fig. 10 and ¶ 0067, describing the glucose state as including a time rate of change of the glucose concentration); receive data of a third type associated with diabetes, wherein the data of the third type comprises accuracy information indicating an accuracy of the glucose concentration measured by the glucose sensor (¶ 0067, the glucose state is further based on a measure of uncertainty or probability of accuracy – also see ¶ 0048, etc.); determine the glycemic urgency index based at least on the received data of the first type, the received data of the second type, and the received data of the third type (Fig. 10 shows e.g. total current risk being determined in block 162, based on the glucose state (which includes concentration data, rate of change data, and accuracy data - see ¶¶s 0007, 0008, 0067, etc.), adjusted hyperglycemic risk (meal event), behavior information such as exercise (¶ 0062), etc.; ¶ 0060 describes the effect of a temporary elevation in allowed glucose level on e.g. hyperglycemic risk. If a temporary elevation of the glucose concentration is within allowable limits (i.e., within a predetermined range, e.g. allowed rise value 124 in Fig. 5) for a duration (a limited duration as in ¶ 0060 - also see offset time value 126 and acting time value 122), then the hyperglycemic risk is reduced - as in Figs. 5, 8, and 9. The risk surface/probability distribution is calculated/adjusted based on these considerations. The urgency index is time-based at least because it changes over time, based on the user’s glucose state, in response to events such as meals, exercise, etc.), wherein determining the glycemic urgency index comprises increasing a value of the glycemic urgency index when the accuracy information indicates a low level of accuracy of the glucose concentration measured by the glucose sensor (¶¶s 0048, 0050, etc., the risk value increases with increasing uncertainty); upon determining that the glycemic urgency index exceeds a predetermined threshold indicative of the diabetes reaching a health risk state, providing an indication of the determined glycemic urgency index on a display device (¶¶s 0041, 0080-0082; e.g. in ¶ 0041, transmitting to a display the risk associated with the glucose state, and providing a warning if the glucose level is predicted to fall below a particular level; in ¶ 0081, if the risk exceeds a threshold, providing a predictive notification (which is a result of it being determined that the user’s urgent attention is warranted at the time of the notification) before the pump is shut off; ¶¶s 0080-0082, the notification giving the user sufficient time to take a corrective action, thereby responding to the glucose concentration state, etc.) … .
Duke does not appear to explicitly teach overriding other applications or processes operating on the display device, such that the indication of the glycemic urgency index is displayed regardless of the other applications or processes.
Taub teaches providing a visual alarm (i.e., displaying an indication - ¶ 0010) in a persistent manner that overrides other running processes on the device (¶¶s 0072, 0073, requiring the user to perform a series of operations in order to silence the alarm, where the alarm may not turn off unless the user acknowledges understanding of their options).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to visually display the glycemic urgency index of Duke based on the teachings of Taub (which provides a visual alarm that overrides other processes to warn the user of risk (e.g., a low level of user interaction indicates higher risk as described in Taub: Fig. 6, ¶¶s 0075-0077, etc.)), for the purpose of ensuring that the user becomes aware of the risk/urgency (Taub: ¶¶s 0072, 0073).
Regarding claim 28, Duke teaches [a] method for a receiver system (Figs. 2 and 3, computing device 66), comprising: receiving, via a wireless link (¶ 0037), data of a first type, the data of the first type comprising sensor data received from a continuous sensor system (Fig. 2, a continuous glucose monitoring (CGM) system 50) and indicative of glucose concentration (Fig. 10, block 152; concentration is indicated by the axes of e.g. Figs. 1, 4, 5, etc. - also see ¶ 0052, describing how the management device 66 maintains a record of historical glucose data accumulated over time, and Figs. 5 and 13, showing glucose concentrations over time) measured by a glucose sensor and electronics (Fig. 3, glucose sensor 56; ¶ 0035, sensor 56 comprising other components, such as a wireless transmitter 60 and antenna 62 – see Fig. 2); calculating data of a second type associated with diabetes, wherein the calculated data of the second type is derived from the received data of the first type, wherein: the data of the second type derived from the data of the first type is a first derivative or a second derivative with respect to time of the data of the first type; or the data of the second type derived from the data of the first type includes: deviations from normal glucose patterns, pattern data of glucose values over a time period, predicted glucose values, a duration over which a glucose value is within a predetermined range, weightings of parameters or variables to be considered in determining a glycemic urgency index, or local maxima or minima in the data of the first type (Fig. 10 and ¶ 0067, describing the glucose state as including a time rate of change of the glucose concentration); receiving data of a third type associated with diabetes, wherein the data of the third type comprises accuracy information indicating an accuracy of the glucose concentration measured by the glucose sensor and electronics (¶ 0067, the glucose state is further based on a measure of uncertainty or probability of accuracy – also see ¶ 0048, etc.); determining the glycemic urgency index based at least on the received data of the first type, the received data of the second type, and the received data of the third type (Fig. 10 shows e.g. total current risk being determined in block 162, based on the glucose state (which includes concentration data, rate of change data, and accuracy data - see ¶¶s 0007, 0008, 0067, etc.), adjusted hyperglycemic risk (meal event), behavior information such as exercise (¶ 0062), etc.; ¶ 0060 describes the effect of a temporary elevation in allowed glucose level on e.g. hyperglycemic risk. If a temporary elevation of the glucose concentration is within allowable limits (i.e., within a predetermined range, e.g. allowed rise value 124 in Fig. 5) for a duration (a limited duration as in ¶ 0060 - also see offset time value 126 and acting time value 122), then the hyperglycemic risk is reduced - as in Figs. 5, 8, and 9. The risk surface/probability distribution is calculated/adjusted based on these considerations. The urgency index is time-based at least because it changes over time, based on the user’s glucose state, in response to events such as meals, exercise, etc.), wherein determining the glycemic urgency index comprises increasing a value of the glycemic urgency index where the accuracy information indicates a low level of accuracy of the glucose concentration measured by the glucose sensor and electronics (note that this element is not limiting because the condition need not occur. Nonetheless, for purposes of facilitating compact prosecution, it has been found) (¶¶s 0048, 0050, etc., the risk value increases with increasing uncertainty); upon determining that the glycemic urgency index exceeds a predetermined threshold indicative of the diabetes reaching a health risk state (note that this element is not limiting because the condition need not occur. Nonetheless, for purposes of facilitating compact prosecution, it has been found), providing an indication of the determined glycemic urgency index on a display device (¶¶s 0041, 0080-0082; e.g. in ¶ 0041, transmitting to a display the risk associated with the glucose state, and providing a warning if the glucose level is predicted to fall below a particular level; in ¶ 0081, if the risk exceeds a threshold, providing a predictive notification (which is a result of it being determined that the user’s urgent attention is warranted at the time of the notification) before the pump is shut off; ¶¶s 0080-0082, the notification giving the user sufficient time to take a corrective action, thereby responding to the glucose concentration state, etc.) … .
Duke does not appear to explicitly teach overriding other applications or processes operating on the display device, such that the indication of the glycemic urgency index is displayed regardless of the other applications or processes.
Taub teaches providing a visual alarm (i.e., displaying an indication - ¶ 0010) in a persistent manner that overrides other running processes on the device (¶¶s 0072, 0073, requiring the user to perform a series of operations in order to silence the alarm, where the alarm may not turn off unless the user acknowledges understanding of their options).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to visually display the glycemic urgency index of Duke based on the teachings of Taub (which provides a visual alarm that overrides other processes to warn the user of risk (e.g., a low level of user interaction indicates higher risk as described in Taub: Fig. 6, ¶¶s 0075-0077, etc.)), for the purpose of ensuring that the user becomes aware of the risk/urgency (Taub: ¶¶s 0072, 0073).
Regarding claims 23-25 and 30-32, Duke-Taub teaches all the features with respect to the corresponding claims 21 and 28, as outlined above. Regarding claims 23-25, Duke-Taub further teaches wherein the accuracy information comprises a noise level in the glucose concentration measured by the glucose sensor, wherein the accuracy information comprises a confidence level of the glucose concentration measured by the glucose sensor, and wherein the accuracy information comprises a signal quality of data acquired by the glucose sensor (Duke: ¶ 0048, suggesting that the probability of accuracy is e.g. reduced based on a noise level (the noise level describing e.g. the quality of the signal), and calculating an uncertainty measure (i.e., a low confidence level) indicative of quality).
Claims 30-32 are rejected in like manner.
Regarding claims 26 and 33, Duke-Taub teaches all the features with respect to the corresponding claims 21 and 28, as outlined above. Regarding claim 26, Duke-Taub further teaches wherein the predetermined threshold indicates that a user is in a hypoglycemic state or a hyperglycemic state (Duke: ¶¶s 0041, 0047, 0049, 0080-0082, etc., e.g. providing a warning if the estimated glucose level is hypoglycemic or hyperglycemic; or using a risk surface split into e.g. hyperglycemia-based and hypoglycemia-based surfaces).
Claim 33 is rejected in like manner.
Claims 22 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Duke-Taub in view of US Patent Application Publication 2014/0243749 (“Edwards”) and US Patent Application Publication 2010/0295684 (“Hsieh”).
Regarding claims 22 and 29, Duke-Taub teaches all the features with respect to the corresponding claims 21 and 28, as outlined above. Regarding claim 22, Duke-Taub does not appear to explicitly teach wherein: the indication of the determined glycemic urgency index is displayed on a user interface of the display device in response to a user unlocking the display device, and when the glycemic urgency index exceeds the predetermined threshold, the indication of the glycemic urgency index is displayed on the user interface of the display device so that the indication is visible to the user before a lock screen of the display device has been passed.
Edwards teaches a cell phone having an application that can unlock the phone to make it usable, and also teaches providing information to a user in the event of a medical emergency without requiring a password or unlock sequence (suggesting that normally, a password or unlock sequence is required - ¶ 0213).
Hsieh teaches displaying in-case-of-emergency information even when a device is in a lock state (¶ 0044), and describes sending an alert to the device if e.g. blood glucose level limits are met (¶¶s 0035-0038).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to require unlocking the phone of Duke (¶ 0038) to view an urgency indication, as in Edwards, for the purpose of protecting user information in non-emergency situations (Edwards: ¶ 0213). It would have been obvious to display the urgency indication before a lock screen is passed when the urgency index exceeds a threshold, e.g., in case of medical emergency, as in Edwards and Hsieh, for the purpose of enabling a user to respond to the emergency (Edwards: ¶ 0213; Hsieh: ¶¶s 0035-0038 and 0044).
Claim 29 is rejected in like manner (note that there are conditional elements that need not occur (e.g. “when”), making them non-limiting. Nonetheless, for purposes of facilitating compact prosecution, they have been found).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Duke-Taub in view of US Patent Application Publication 2013/0198685 (“Bernini”).
Regarding claim 27, Duke-Taub teaches all the features with respect to claim 21, as outlined above. Duke-Taub further teaches wherein the receiver system comprises a mobile device (Duke: ¶ 0038, a smart phone or cell phone), but does not appear to explicitly teach that it is in communication with one or more server computers via a wireless network.
Bernini teaches a mobile device being in communication with one or more servers (Figs. 1 and 2, devices 140, 150, 160, and/or 200 in communication with network 100, ¶¶s 0046-0048, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enable the phone/mobile device of the combination to communicate with a server computer via a wireless network, as in Bernini, for the purpose of enabling various functions or communication with a variety of other useful devices (Bernini: ¶¶s 0046-0048, for display, processing, and storage functions, etc.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791