DETAILED ACTION
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.
Claim 6 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the measure of glucose dysregulation is determined by determining an “area over or under a threshold area value in a time period”. It is unclear what this means, in particular what makes up the parameters of how the area is calculated.
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 1-8, 10-11, 14, 17-18, and 20-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the determining of an analyte pattern type. This limitation covers performance of the limitation in the mind but for the recitation of generic computer components such as the “one or more processors”. Accordingly, it falls within the “Mental Processes” grouping of abstract ideas.
This judicial exception is not integrated into a practical application. In particular, the system only recites two additional elements – the one or more processors and a memory storing instructions recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component, failing to impose any meaningful limits on practicing the abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As stated previously, the additional elements of a generic processor and memory amounts to no more than mere instructions to apply the exception using a generic computer component. This cannot provide an inventive concept. The claims are not patent eligible.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 10-11, 22-26 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kamath et al. (US 2021/0260286).
As to claim 1, Kamath teaches a system for determining a recommended medication dose, the system comprising: an input configured to receive time-correlated analyte data of a patient taken over an analysis period ([0217] – measurements made over a time period during particular times of day); one or more processors ([0302]) coupled with the input and a memory ([0050])storing instructions ([0309]), wherein the instructions, when executed by the one or more processors, cause the one or more processors to: determine an analyte pattern type for each of a plurality of time of day (TOD) periods by executing a pattern analysis algorithm that receives as input time-correlated analyte data of a patient taken over an analysis period ([0217]); select a recommended action based on the analyte pattern type ([0248], [0253]), and store an indicator of the recommended action in a computer memory for output ([0204]).
As to claim 2, Kamath teaches the recommended action is a basal dosing recommendation ([0204]).
As to claim 3, Kamath teaches the instructions further cause the one or more processors to: determine a measure of glucose dysregulation for the plurality of TOD periods, wherein the recommended action is selected based on the analyte pattern type and the measure of glucose dysregulation ([0028]).
As to claim 10, Kamath teaches the instructions further cause the one or more processors to output the recommended action ([0204]).
As to claim 11, Kamath teaches the recommended action is a change to a next dosing recommendation ([0204]).
As to claim 22, Kamath teaches the instructions cause the one or more processors to select the recommended action based on the analyte pattern type and additional input ([0028], [0086], [0088], [0092]).
As to claim 23, Kamath teaches the additional input comprises a user's weight ([0227])
As to claim 24, Kamath teaches the additional input comprises insulin dose data comprising dose amounts and corresponding times of administration ([0204]).
As to claim 25, Kamath teaches the additional input comprises meal logs ([0088]).
As to claim 26, Kamath teaches the additional input comprises exercise logs ([0088]).
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.
Claim(s) 4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. (US 2021/0260286) in view of McGarraugh (US 2010/0121167).
As to claim 4, Kamath fails to teach that the measure of glucose dysregulation is determined by determining a number of times an analyte level crosses above or below a threshold crossing value in a time period. However, McGarraugh teaches a device analyzing glycemic related data in which the occurrence or the frequency of the occurrence of the glucose level of a patient crossing a predetermined threshold within a predetermined time period is detected, wherein the thresholds are based on glucose dysregulation conditions such as a hypo or hyperglycemic conditions ([0074]). It would have been obvious to modify Kamath with McGarraugh to utilize the number of threshold crossings in a time period as a measure of glucose dysregulation as it is an established method of doing so in the art and would be obvious to try.
As to claim 8, Kamath fails to teach instructions further cause the one or more processors to: determine a frequency of a low glucose alarm within a time period, wherein the recommended action is selected based at least on the analyte pattern type and the frequency of the low glucose alarm. McGarraugh teaches the determining of a frequency of an alarm activation associated with a glycemic excursion event ([0075]), in which the frequency is factored into determining the underlying alarm conditions ([0078]) or to change the output of notifications to the user ([0080])
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. (US 2021/0260286) in view of Constantin et al. (US 2019/0252079).
As to claim 5, Kamath fails to teach that the measure of glucose dysregulation is determined by determining a duration of time above or below a threshold value in a time period. However, Constantin teaches a device for providing guidance to a user regarding management of diabetes (Abstract) in which patterns such as the amount of time of glucose staying above or below thresholds is used to determine glycemic outcomes and events as part of its decision support system to determine guidance such as patterns and insulin dose information ([0304]). It would have been obvious to modify Kamath with Constantine to utilize a duration of time above or below a threshold value in a time period as a measure of glucose dysregulation as it is an established method of doing so in the art and would be obvious to try.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. (US 2021/0260286) in view of Crouther et al. (US 2013/0085358).
As to claim 6, Kamath fails to teach that the measure of glucose dysregulation is determined by determining an area over or under a threshold area value in a time period. Crouther teaches the use of a minimum area for measurements to meet a threshold for being considered a dysregulation event in which the area under or above the glucose v. time curve is utilized. It would have been obvious to modify Kamath with Crouther to utilize an area above or below a threshold value in a time period as a measure of glucose dysregulation as it is an established method of doing so in the art and would be obvious to try.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. (US 2021/0260286) in view of Bashan et al. (USP #8,370,077).
As to claim 7, Kamath fails to teach the measure of glucose dysregulation is determined by determining a number of days in a time period with a minimum number of instances of glucose dysregulation. Bashan teaches a system for optimizing a patient’s insulin dosage regimen in which a number of patient hypoglycemic events over a predetermined period of days are assessed and evaluated, including those above a certain number of hypoglycemic events (col. 13 line 63 to col. 14 line 20). It would have been obvious to modify Kamath with Crouther to utilize a number of days in a time period with a minimum number of instances of glucose dysregulation as a measure of glucose dysregulation as it is an established method of doing so in the art and would be obvious to try.
Claim(s) 14, 20, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. (US 2021/0260286) in view of Hayter et al. (US 2022/0249779).
As to claim 14, Kamath fails to teach that the recommended action is a recommendation to add a new medication. Hayter teaches a device for determining a medication dose for a patient using recent and/or historical analyte levels (Abstract), determining the glucose patterns ([0201]) and recommend various actions, including one to add a new medication ([0199]). It would have been obvious to modify Kamath with Hayter to recommend a new medication for patients whose current medication is insufficient.
As to claim 20, Hayter teaches the recommended action further states that a user remains in poor glucose control ([0199] – Statement 1, reflective of poor control)
As to claim 21, Hayter teaches the recommended action further indicates that therapy escalation may be required ([0626]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. (US 2021/0260286) in view of Sieh et al. (US 2010/0016700).
As to claim 17, Kamath fails to teach that the recommended action is an indication that a maximum recommended dose has been reached. However, Sieh teaches a diabetes management system (Abstract) in which when a daily maximum dosage is reached, an output signal can be sent out to stop any further administration of medication until the next day ([0052]). It would have been obvious to modify Kamath with Sieh such that the user can be warned of when a maximum dosage of a medication has been reached, to prevent both overdosing, or as an indication that a new form of medication may now be necessary.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. (US 2021/0260286) in view of Patek et al. (US 2020/0205744).
As to claim 17, Kamath fails to teach the recommended action is an indication that an optimization in titration has been reached. Patek teaches a device for evaluating glycemic dysfunction in which the device outputs optimized insulin boluses ([0141]). It would have been obvious to modify Kamath with Patek to output an indication of an optimization in titration to allow the user to be notified when the ideal dosage has been achieved for future reference.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 11/30/25