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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9, 14, 16-21, 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu (WO 2020/086934 A2 – cited by Applicant).
Regarding Claim 1, Xu teaches: A glucose monitoring system (abstract), comprising:
a sensor control device comprising an analyte sensor coupled with sensor electronics (paragraph 0160-0163), the sensor control device configured to transmit data indicative of an analyte level of a subject (figures 3; 8; paragraph 0164;0168; and
a reader device comprising:
a wireless communication circuitry configured to receive the data indicative of the analyte level and a glycated hemoglobin level for the subject (paragraph 168; figure 8; paragraph 0187-0192);
a non-transitory memory (paragraph 0069);
at least one processor communicatively coupled to the non-transitory memory and the analyte sensor (paragraph 0190-0192) and configured to:
calculate a plurality of personalized glucose metrics for the subject using at least one physiological parameter and at least one of the received data indicative of the analyte level or the received glycated hemoglobin level (paragraph 0189-0193); and
display, on a display of the reader device, a report comprising a plurality of interfaces including at least two or more of the received data indicative of the analyte level, the received glycated hemoglobin level, or the calculated plurality of personalized glucose metrics (paragraph 0098-0106; figure 5B),
wherein the plurality of interfaces comprising the report are based on a user type (given the broadest reasonable interpretation, it can be said that it is inherent that the interfaces are based on a user type – i.e. a user monitoring glucose levels).
Regarding Claim 2, Xu teaches: The system of claim 1, wherein the plurality of personalized glucose metrics includes one or more of an adjusted A1c, a calculated A1c, an adjusted calculated A1c, a personalized glucose, a personalized average glucose, or a personalized time in range (paragraph 0187; figure 5B).
Regarding Claim 3, Xu teaches: The system of claim 2, wherein the at least one processor is further configured to calculate a plurality of personalized glucose targets corresponding to the calculated plurality of personalized glucose metrics (figure 5B; paragraph 0187-0198).
Regarding Claim 4, Xu teaches: The system of claim 3, wherein the plurality of interfaces further includes the plurality of personalized glucose targets (figure 5B; paragraph 0189).
Regarding Claim 5, Xu teaches: The system of claim 3, wherein the plurality of personalized glucose targets includes one or more of a target glucose range or a target average glucose (paragraph 0189).
Regarding Claim 6, Xu teaches: The system of claim 5, wherein the personalized target glucose range includes a personalized lower glucose limit (paragraph 0100).
Regarding Claim 7, Xu teaches: The system of claim 5, wherein the personalized target glucose range includes a personalized upper glucose limit (paragraph 0100).
Regarding Claim 8, Xu teaches: The system of claim 1, wherein the at least one physiological parameter is selected from the group consisting of: a red blood cell glucose uptake, a red blood cell lifespan, a red blood cell glycation rate constant, a red blood cell generation rate constant, a red blood cell elimination constant, and an apparent glycation constant (claim 17).
Regarding Claim 9, Xu teaches: The system of claim 8, wherein the plurality of interfaces further includes the at least one physiological parameter for the subject (figure 5B; paragraph 0189).
Regarding Claim 14, Xu teaches: The system of claim 1, wherein the plurality of interfaces comprising the report are predetermined based on the user type (given the broadest reasonable interpretation, it can be said that it is inherent that the interfaces are predetermined based on a user type – i.e. a user monitoring glucose levels).
Regarding Claim 16, Xu teaches: The system of claim 4, wherein the at least one processor is further configured to output a notification if at least one of the plurality of personalized glucose metrics is at or above the corresponding plurality of personalized glucose target (paragraph 0180; claim 13 and 24).
Regarding Claim 17, Xu teaches: The system of claim 16, wherein the notification comprises a visual notification (paragraph 0180).
Regarding Claim 18, Xu teaches: The system of claim 16, wherein the notification comprises an audio notification (paragraph 0180).
Regarding Claim 19, Xu teaches: The system of claim 16, wherein the notification is an alarm (paragraph 0180).
Regarding Claim 20, Xu teaches: The system of claim 16, wherein the notification is a prompt (paragraph 0180; a visual/audible alarm/alert can be considered a prompt).
Regarding Claim 21, Xu teaches: The system of claim 1, wherein the reader device wirelessly receives the glycated hemoglobin level for the subject from an electronic medical records system (paragraph 0084; the device can obtain data wirelessly – it is capable of obtaining data from an electronic medical records system).
Regarding Claim 24, Xu teaches: The system of claim 1, the reader device wirelessly receives the glycated hemoglobin level for the subject from a home test kit (paragraph 0072-0075; 0084; the device can obtain data wirelessly – it is capable of obtaining data from a home test kit).
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.
Claim(s) 10-13, 15, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Harper et al. (US 20110193704 A1 – cited by Applicant), hereinafter Harper.
Regarding Claim 10, Xu teaches: The system of claim 1. While examiner notes that it is inherent that the user type includes a health care professional, Examiner notes that Xu does not explicitly mention a user type.
Harper teaches different user interfaces for different users, including health care professionals (paragraph 0088). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the user type includes a health care professional in order to have personalized displays for different users.
Regarding Claim 11, Xu in view of Harper teach: The system of claim 10, wherein the plurality of interfaces includes a glucose monitoring data interface, a glycated hemoglobin interface, a personalized a1c interface, a personalized glucose interface, a personalized average glucose, and a personalized time in range interface (paragraph 0187-0198; figure 5B).
Regarding Claim 12, Xu teaches: The system of claim 1. While examiner notes that it is inherent that the user type includes the subject, Examiner notes that Xu does not explicitly mention a user type.
Harper teaches different user interfaces for different users, including health care professionals (paragraph 0087-0089). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the user type includes a health care professional in order to have personalized displays for different users.
Regarding Claim 13, Xu in view of Harper teach: The system of claim 12, wherein the plurality of interfaces includes a glucose monitoring data interface, a glycated hemoglobin interface, a mean glucose interface, and a time in range interface (paragraph 0187-0198; figure 5B).
Regarding Claim 15, Xu teaches: The system of claim 1, but does not mention wherein the plurality of interfaces comprising the report can be selected by the user.
Harper teaches that different reports can be selected by the user (paragraph 0080-0091). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system to include wherein the plurality of interfaces comprising the report can be selected by the user to a low the user to view multiple interfaces/reports.
Regarding Claim 22, Xu teaches: The system of claim 1, wherein the reader device wirelessly receives the glycated hemoglobin level for the subject from a cloud-based database (paragraph 0072-0075).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Pan (US 20200054220 A1).
Regarding Claim 23, Xu teaches: The system of claim 1, but does not mention wherein the reader device wirelessly receives the glycated hemoglobin level for the subject from a QR code.
Pan teaches the use of QR codes to store physiological parameters (paragraph 0022-0023; 0044-0046). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system to include wherein the reader device wirelessly receives the glycated hemoglobin level for the subject from a QR code to securely transfer sensitive patient data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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