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 .
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 .
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 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claims 1 and 9, both claims use the term “cycle” to describe blood sugar measurements. The plain meaning of cycle can mean “a series of events that are regularly repeated in the same order” or “a complete set or series.” A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. See MPEP 2173.02. Thus, the claims should be read as encompassing both meanings so long as the scope is clearly defined. The scope is not clearly defined, however, because it is not clear how a single blood sugar level may be stored when several measurements are repeated since blood sugar variation in the body is a continuous forward process. For at least these reasons, the claims are indefinite. Given that this ambiguity is not resolved in the dependent claims, they too are rejected as depending from an indefinite claim. For purposes of examination, it is understood to be a complete set or series of measurements.
As to claims 2 and 10, the claims state (or similarly state): “…wherein the processor is further configured to configure an initial value of a change in the blood sugar of the user according to the specified event as the first blood sugar level…” This is unclear. A change requires at least two blood sugar measurements, but these measurements are not specified. Given this ambiguity, the claims must be rejected as indefinite. Because Examiner would be speculating as to the proper scope of the claim, it will be not be judged against the prior art at this time.
As to claim 5, “feature value” could be a category, but in claim 5 it is compared to a threshold. Is it a numerical metric or something else? If it is something else, how can this be compared to a threshold? For example, the feature value could be something like severe hypoglycemia. How can this be compared to a threshold? Given that there are at least two interpretations and one that is incompatible with the claims, the claim must be rejected as indefinite. For purposes of examination, it is understood to mean a numerical metric.
The dependent claims are rejected as their limitations do not cure the indefiniteness of the independent claims.
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)(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, 3-4, 7-9, 11-12, and 15-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0301554 A1 to Choi.
As to claims 1 and 9, Choi discloses a wearable electronic device and method comprising:
a first sensor (Fig 2, element 40);
a second sensor (Fig 2, element 10);
a memory (Fig 2, element 20); and
a processor (Fig 2, element 60) operatively connected to the first sensor, the second sensor, and the memory, wherein the processor is configured to:
measure a blood sugar level of a user in a first cycle using the first sensor so as to store a first blood sugar level measured at a first time point according to the first cycle in the memory (see [0053]-[0056] – ensuring that blood sugar is between 70-100 mg/dl before a meal)
detect a specified event, based on measured values received from the second sensor from a second time point after the first time point to a third time point (see [0043] – sensor shows that user is eating at a certain time point),
in case that the specified event is detected, measure the blood sugar level of the user in a second cycle different from the first cycle using the first sensor so as to store at least one second blood sugar level measured from a fourth time point to a fifth time point according to the second cycle in the memory (see [0045] – showing green, yellow, and red for post-prandial glucose excursions of differing amounts so as to show weight-loss effects of such amounts), and
calculate at least one feature value related to blood sugar of the user, based on the first blood sugar level and the at least one second blood sugar level (see [0045] – a peak post-prandial glucose increase amount and [0053]-[0055] – showing that the user is capable of maintaining weight loss while ensuring non-diabetic blood sugar regulation by showing glucose levels increasing approximately ten minutes after eating and decreasing to a normal level (less than 140 mg/dl) after approximately 2-3 hours).
As to claims 3 and 11, Choi further discloses wherein the specified event corresponds to an event indicating that the user starts to eat food (see [0043]).
As to claims 4 and 12, Choi further discloses wherein the second cycle is shorter than the first cycle (see [0053]-[0055] – the pre-prandial cycle spans the time over which the user is not eating and may last several hours).
As to claims 7 and 15, Choi further discloses wherein the processor is further configured to change a measurement cycle of the first sensor from the second cycle to the first cycle in case that a third blood sugar level of the user, which is measured using the first sensor when a specified time elapses after the specified event is detected, is less than or equal to a threshold (see [0053]-[0055] – the process is repeated for each meal).
As to claim 8, Choi further discloses wherein the at least one feature value comprises at least one of a current blood sugar level, a fasting blood sugar level, a rate of change in blood sugar, a direction of change in blood sugar, a blood sugar response area, a slope of a blood sugar rise curve, a maximum blood sugar level, a change in blood sugar before and after eating food, the time required to return to the fasting blood sugar after eating food, a number of blood sugar peaks, or occurrence intervals of food intake events (see treatment of claim 1).
As to claims 16 and 18, Choi further discloses wherein the processor is further configured to:
compare the at least one feature value with a threshold (see [0045]); and
based on a result of comparing the at least one feature value with the threshold, determine whether or not to provide a notification related to the blood sugar of the user (see [0045] – determining which color to present to the user based on the threshold).
As to claims 17 and 19, Choi further discloses wherein the notification comprises at least one piece of information about the user’s health condition and information related to a diet or exercise guide determined based on the at least one feature value (see [0048]).
As to claim 20, Choi further discloses wherein the at least one feature value comprises at least one of a current blood sugar level, a fasting blood sugar level, a rate of change in blood sugar, a direction of change in blood sugar, a blood sugar response area, a slope of a blood sugar rise curve, a maximum blood sugar level, a change in blood sugar before and after eating food, the time required to return to the fasting blood sugar after eating food, a number of blood sugar peaks, or occurrence intervals of food intake events (see [0045]-[0049]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-6 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of US 2020/0203012 A1 to Kamath et al. (“Kamath”).
As to claims 5-6, and 13-14, Choi discloses wherein the processor is further configured to:
compare the at least one feature value with a threshold (see [0053] – determining that glucose is rising within the first ten minutes of the meal (i.e., dBG/dt > 0); but fails to disclose
based on a result of comparing the at least one feature value with the threshold, change a measurement cycle of the first sensor to a third cycle different from the second cycle, wherein the third cycle is shorter than the second cycle.
Kamath teaches that higher resolution data should be measured for the post-meal rise in glucose concentration (see [0312]) such that a third cycle would be shorter than the second cycle (time between measurements decreases)). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the first and second sensor and processor that compares a feature value with a threshold of Choi with the changing of a measurement cycle of the first sensor to a third cycle different from the second cycle, wherein the third cycle is shorter than the second cycle as taught by Kamath in order to achieve the predictable result that is allowing a more detailed analysis of blood glucose changes during the post-meal rise.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-F, 830am-5pm.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791