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 .
Status of Claims
This action is in response to application 18/786318 filled on 07/26/2024.
Claims 5, 8-12, and 16-26 have been canceled.
Claims 1-4, 6-7, 13-15, and 27-37 are currently pending and have been examined.
Detailed Action
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, 6-7, 13-15, and 27-37 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.
Step 1:
Claims 1-4, 6-7, 13-15, and 27-37 are drawn to a method and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claims 1, 30, and 37 recite generating one or more data trends by analyzing the analyte data (As seen in claim 1 and 37). Claim 30 recites generating one or more trends by analyzing data; and classifying at least a portion of the plurality of patients based on risk using the one or more data trends.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity by identifying and reporting events preceding a pattern in a set of user data. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including a computing device and analyte measurement device (in claims 1 and 30) and in addition a transceiver and controller (in claim 37), which are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional element of receiving analyte data and modifying device setting as seen in claim 1 and 30. Claim 37 recites an additional element of outputting a prompt, which are considered limitations directed to insignificant extra-solution activity that do not amount to an inventive concept because the limitations do not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, the claimed receiving limitations are incidental to the performance of the recited abstract idea of identifying and reporting events preceding a pattern in a set of user data. See: MPEP 2106.05(g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
Paragraph 6, where “Generally, the systems and methods described herein may receive data from an analyte measurement device (e.g., blood glucose monitor) and a patient measurement device (e.g., activity tracker) that measures one or more patient health characteristics. The data generated from each of these devices may be automatically uploaded to a patient's computing device (e.g., smartphone, laptop, PC) and/or a database (e.g., cloud based storage). The data may be integrated so as to permit analysis for trends between the analyte data and the other patient data for one or more patients. These trends may be presented to the patient on any device (e.g., analyte measurement device, smartphone, laptop) with selectable levels of complexity (e.g., detailed, concise, summary, long-term, short-term).”
Paragraph 11, where “In other of these variations, a prompt may be transmitted comprising a suggestion from the health care professional device to the computing device using the communication channel. In some variations, the analyte measurement device may include a blood glucose monitor and the patient measurement device may include one or more of an activity tracker, a heart rate monitor, a blood pressure monitor, a scale, an Alc monitor, and a cholesterol monitor. In some variations, the analyte data may comprise blood glucose data and blood glucose testing history.”
Paragraph 52, where “An output device of the user interface may output data analysis and actionable prompts corresponding to the patient and may comprise one or more of a display device and audio device. For example, a video conference between the patient and a health care professional may be facilitated using the display device of the computing device. A display device may permit a user to view trend analysis and/or other data processed by the controller. Data analysis generated by a server (250) may be displayed by the output device (e.g., display) of the computing device (220, 222). Measurement data from one or more measurement devices (210, 212) may be received through the network interface and output visually and/or audibly through one or more output devices of the computing device.”
The claims recite the additional element of receiving analyte data and modifying device setting and outputting a prompt, which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-4, 5-7, 13-15, 27-29, and 31-36 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 6-7, 13-15, and 27-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raisoni et al. (US 2016/0345874 A1) in view of Mayou et al. (US 2015/0120317 A1).
In claim 1, a method of monitoring a chronic condition of a patient, comprising:
Raisoni teaches:
receiving analyte data generated by an analyte measurement device and patient data generated by a patient measurement device ( Para. 311 “In some embodiments where the analyte monitoring device 741 communicates with a transceiver 730, which in turn obtains analyte measurement data from an analyte monitoring sensor”;
generating one or more data trends by analyzing the analyte data against the patient data using a computing device comprising a processor and memory (Para. 319 wherein “ graphical trends of analyte or glucose levels, alarms or alerts for hypoglycemia or hyperglycemia, and log events such as meals, exercise, and medication”); and
Raisoni does not explicitly teach however Mayou teaches:
modifying device settings of one or more of the analyte measurement device and the computing device in response to one or more of the data trends (Para. 87 wherein “The adjustment to the style or manner of reporting may include audio feedback characteristics such as changing frequency, tone, and volume of an alarm (e.g., increasing, decreasing or other changes). The adjustment to the style or manner of reporting may include changing visual characteristics such as resolution of a trend graph, brightness intensity, colors for graphs, interface iconography, interface symbology (e.g., for alerts), magnification level of displayed information, and the like…Alert and/or alarm settings may be adjusted, such as one of multiple high level contextual categories, wherein the system may, over time, adjust the high level contextual categories and/or adapt each individual category setting (e.g., alert level, volume, etc.). The modes may also be applied selectively by the system based on context. For example, while in a meeting at work, the information only mode may be desirable”.
It would have been obvious to one of ordinary skill in the art at the time of filling to combine the wireless analyte monitoring and tracking of a patient as taught in Raisoni with the adaptive interface that can adjust a device based on analyzing data trends as taught in Mayou. The well-known elements described are merely a combination of old elements, and in combination, each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 2, Raisoni teaches the method of claim 1, further comprising outputting at least one prompt to modify patient behavior in response to one or more of the data trends (Para. 24 wherein displaying a window with one or more recommended actions associated with the selected icon).
As per claim 3, Raisoni in view of Mayou teach the method of claim 2. Raisoni does not explicitly teach however Mayou teaches, wherein the prompt may comprise encouragement to comply with one or more of a testing, diet, and exercise regimen (Para. 6). The motivation to combine reference is the same as seen in claim 1.
As per claim 4, Raisoni in view of Mayou teach the method of claim 2. Raisoni does not explicitly teach however Mayou teaches the method of claim 1, further comprising outputting at least one prompt to modify the device settings in response to one or more of the data trends (Para. 87). The motivation to combine reference is the same as seen in claim 1.
As per claim 6, Raisoni in view of Mayou teach the method of claim 2. Raisoni does not explicitly teach however Mayou teaches the method of claim 1, wherein modifying the device settings comprises modifying one or more of frequency, timing, and content of patient notification (Para. 71 and 87). The motivation to combine reference is the same as seen in claim 1.
As per claim 7, Raisoni teaches the method of claim 1, further comprising notifying a set of one or more predetermined contacts based on a characteristic of the one or more data trends (table 2 wherein alerts can trigger physicians).
As per claim 13, Raisoni teaches the method of claim 1, further comprising outputting at least one prompt to modify health care professional device settings in response to one or more of the data trends (Para. 368).
As per claim 14, Raisoni teaches the method of claim 1, further comprising establishing a communication channel between the computing device and a health care professional device in response to one or more of the data trends being a high risk condition (table 2).
As per claim 15 Raisoni in view of Mayou teach the method of claim 14. Raisoni does not explicitly teach however Mayou teaches the method of claim 14, further comprising receiving the analyte data, the patient data, and the one or more data trends at the health care professional device, and outputting a prompt to modify patient behavior and the device settings at the health care provider device (Para. 7, 87, and 148). The motivation to combine reference is the same as seen in claim 1.
As per claim 27, Raisoni in view of Mayou teach the method of claim 1. Raisoni does not explicitly teach however Mayou teaches the method of claim 1, further comprising receiving a patient query and outputting at least one prompt to modify at least one of patient behavior and device settings in response to one or more of the data trends (Para. 177-179). The motivation to combine reference is the same as seen in claim 1.
As per claim 28, Raisoni teaches the method of claim 1, further comprising transferring the analyte data from the analyte measurement device to the computing device at predetermined intervals (Para. 10 and 256).
As per claim 29, Raisoni teaches the method of claim 1, further comprising outputting the one or more data trends using the computing device (Para. 262).
As per claim 30, Raisoni teaches the method of managing a patient population, comprising:
receiving analyte data generated by a plurality of analyte measurement devices and patient data generated by a plurality of patient measurement devices, the analyte data and the patient data corresponding to a plurality of patients (Para.311 and 317);
generating one or more data trends by analyzing the analyte data against the patient data for the plurality of patients using a computing device comprising a processor and memory (Para. 311 and 317);
Raisoni does not explicitly teach however Mayou teaches:
classifying at least a portion of the plurality of patients based on risk using the one or more data trends (Para. 92 and 173); and
selecting a patient for treatment from a health care professional based on the patient classification (Para. 104 and 109). The motivation to combine references is the same as seen in claim 1.
As per claim 34, Raisoni in view of Mayou teach the method of claim 33. Raisoni does not explicitly teach however Mayou teaches further comprising:
generating one or more prompt trends by analyzing the one or more patient trends against the set of prompts (Para. 101);
classifying the prompts based on prompt effectiveness, wherein effectiveness is based on one or more of the prompt trends (Para. 101); and
outputting a selected prompt from the set of prompts to the patient computing device based on the effectiveness of the selected prompt (Para. 101). The motivation to combine references is the same as seen in claim 1.
As per claim 35, Raisoni in view of Mayou teach the method of claim 30. Raisoni does not explicitly teach however Mayou teaches further comprising generating a support group for the selected patient based at least in part on the patient classification, wherein the support group comprises at least one other patient from the plurality of patients (Para. 173). The motivation to combine references is the same as seen in claim 1.
As per claim 36, Raisoni in view of Mayou teach the method of claim 35. Raisoni does not explicitly teach however Mayou teaches further comprising generating a prompt for the selected patient to join the support group (Para. 98). The motivation to combine references is the same as seen in claim 1.
Claim 31-33 and 37 recites similar features as seen in claims above and hence is rejected for similar rationale as noted above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAROUN P KANAAN whose telephone number is (571)270-1497. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/Primary Examiner, Art Unit 3687