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 1-24 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) data processing of raw sensor values to create smoothed values and to determine which values to display on the user interface. These limitations covers performance of said limitations in the mind but for the recitation of generic computer components. Apart from the recitation of a computer including a processor, there is nothing in the claim elements that precludes it from being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. The claims only recites well understood, routine, and conventional elements in the recitation of components such a display device comprising a transceiver interface, a user interface, and a computer including a processor. These elements are 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. Accordingly, these additional limitations do not integrate the abstract idea into a practical application because it does not 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 noted above, the additional elements of using a processor to perform the steps is no more than mere instructions to apply the exception using a generic computer component. The incorporation of a user interface to output results is merely the incorporation of an insignificant extra-solution activity.
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 5, 6, 12, and 24 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 5 and 6, it is noted that claim 4 recites “a first smoothing algorithm”. Claims 5 and 6 both recite “wherein the smoothing algorithm …” There is insufficient antecedent basis for “the smoothing algorithm”, and it is unclear whether the applicant intends the “first smoothing algorithm” of claim 4 or some other, unrecited algorithm. Correction to “the first smoothing algorithm” is advised. In addition, claim 5 recites “fits the raw values” while claim 6 recites “fits raw values”, further obscuring whether the same set of raw values is intended.
As to claims 12 and 24, both claims recite “at least the light measurement are indicative of an amount of concentration of an analyte in a medium”. It is first noted that “the light measurement” lacks antecedent basis; previous recitations are “light measurements” (plural), and there is a mismatch with the verb “are” that follows it. In addition, “an amount of concentration” is not defined in the specification and has no established common meaning in the art; [0040] of the printed publication states that the sensor measurements may be “indicative of an amount or concentration of an analyte”. For purposes of examination, the “of” has been interpreted as “or” instead.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 recites “wherein the graph includes none of the third and fourth raw values at the third and fourth times, respectively”. Claim 1, from which claim 9 depends, already recites this exact limitation in the last wherein clause: “wherein the graph includes none of the third and fourth raw values at the third and fourth times, respectively”. Accordingly, claim 9 fails to further limit claim 1 in any respect. In contrast, claim 21 has no such issues, as claim 13 lacks the same recitation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1, 4-5, 10-11, 13, 16-17, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raisoni et al. (US 2016/0345874) in view of Kamath et al. (US 2018/0289333).
As to claims 1, 9, 13, and 21, Raisoni teaches a transceiver interface device and corresponding method of use, (130) configured to receive: a first raw value corresponding to a first time; a second raw value corresponding to a second time, which is later than the first time; a third raw value corresponding to a third time, which is later than the second time; a fourth raw value corresponding to a fourth time, which is later than the third time; and a fifth raw value corresponding to a fifth time, which is later than the fourth time ([0238] – sensor communicates glucose levels wirelessly to a transceiver; [0008] – a trend graph comprising a plurality of analyte levels over a first time interval – a trend graph of analyte levels over a time interval inherently comprises values in which each value is obtained at a later point in time than the previous value).
Raisoni fails to expressly teach “use at least the first, second, third, fourth, and fifth raw values to calculate at least a first smoothed value corresponding to the third time and a second smoothed value corresponding to the fourth time; and cause the user interface to display a graph including at least the first smoothed value at the third time, the second smoothed value at the fourth time, and the fifth raw value at the fifth time, wherein the graph includes none of the third and fourth raw values at the third and fourth times, respectively.”
Kamath teaches the above limitations. Kamath teaches that “smoothed” or “filtered” data refer to data that has been modified to make it smoother and more continuous and/or to remove or diminish outlying points and include data filter such as “moving average filters” ([0100]). An moving average filter smooths values by taking a mathematical mean of a sliding window of N data samples or over a range of time, and advances one point at a time (dropping the oldest value and adding the newest one). Applied to a window comprising consecutive values it yields values corresponding to specific times in that window as it advances (e.g. the third and fourth times). In addition, Kamath further teaches that the smoothed values can be used to displace the raw values on the displayed graph ([0338] – Fig. 12 illustrates a graph in which a portion where signal artifacts 122 can be replaced with smoothed data 124), noting that the replacement is not for all data points, but for those associated with noise of a certain amplitude and/or characteristic. It would have been obvious to modify Raisoni with Kamath to smooth out data values at certain points and replace only the values during which noise is of concern, to display more accurate data to the end user.
As to claims 4 and 16, Kamath teaches a first smoothing algorithm and raw values including at least the first, second, third, fourth, and fifth raw values are used to calculate at least the first and second smoothed values (Kamath teaches a variety of smoothing algorithms which is operated on a raw data stream including the moving average noted above in [0100], trimmed linear regression [0065], FIR filtering [0066], and IIR filtering [0067]).
As to claims 5 and 17, Kamath teaches the smoothing algorithm fits the raw values to a first degree polynomial ([0065] – trimmed linear regression, [0145] – defined as a line in which a set of data has a minimal measurement from that line, with fitting data to a line being a first degree polynomial).
As to claims 10 and 22, Raisoni teaches the raw values are blood glucose levels ([0238]).
As to claims 11 and 23, Raisoni teaches an analyte sensor configured to generate sensor measurements (120) and a transceiver configured to receive the sensor measurements via a wireless or wired connection ([0246]), and use the sensor measurements to calculate the first raw value (inherent).
Claim(s) 2-3 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raisoni et al. (US 2016/0345874) in view of Kamath et al. (US 2018/0289333), and further in view of Garcia et al. (US 2017/0074757) and Rodriguez-Llorente et al. (US 2014/0073964).
As to claims 2 and 14, the above combination teaches the transceiver interface device is further configured to receive a sixth raw value corresponding to a sixth time, which is later than the fifth time, and the computer is further configured to: use at least the second, third, fourth, fifth, and sixth raw values to calculate at least a third smoothed value corresponding to the fourth time and a fourth smoothed value corresponding to the fifth time (as stated above, the measurement of signals over time results in raw values which are all respectively later than all the other values that comes before it, and the use of a rolling average results in smoothed values corresponding to the respective time).
The above combination fails to expressly teach after displaying the graph including at least the first smoothed value at the third time, the second smoothed value at the fourth time, and the fifth raw value at the fifth time, update the graph by replacing the second smoothed value at the fourth time with the third smoothed value, by replacing the fifth raw value at the fifth time with the fourth smoothed value, and to include additionally the sixth raw value at the sixth time. This limitation is in essence the retrospective revision of values that have been already revised once.
Garcia teaches that its method of calibrating sensor data may include, “following the correlating, displaying a graph or table indicating currently measured and historical values of the analyte concentration as calibrated based at least in part on the correlating; and, following the recalibration, updating the display of the graph or table indicating currently measured and historical values of the analyte concentration according to the recalibration. The updating may change the display of the historic values of the analyte concentration”. Garcia thus teaches a displayed graph carrying both the current and historic values, a subsequent recomputation, and and update that changes what is shown at the historic times, while the newly acquired value is added as the current value. Rodriguez-Llorente teaches that when noise levels in measured data is relatively high, the rate algorithm may continue posting previous values to disregard the noise. In short, Rodriguez-Llorente allows for the use of use of a previous smoothed value to take the place of the next value as well. It would have been obvious to modify the above combination with Garcia and Rodriguez-Llorente to allow for continued replacement of previously displayed values whenever more accurate values are available, as well as the use of previously used smoothed values over newer ones if it would still result in a more accurate data value.
As to claim 3 and 15, the above combination results in a teaching of the transceiver interface device is further configured to receive a seventh raw value corresponding to a seventh time, which is later than the sixth time, and the computer is further configured to: use at least the third, fourth, fifth, sixth, and seventh raw values to calculate a fifth smoothed value corresponding to the fifth time and a sixth smoothed value corresponding to the sixth time; and update the graph by replacing the fourth smoothed value at the fifth time with the fifth smoothed value, by replacing the sixth raw value at the sixth time with the sixth smoothed value, and to include additionally the seventh raw value at the seventh time. It is noted that this is merely a duplication of a step already recited by the previous claim but with the next measured value factored in.
Claim(s) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raisoni et al. (US 2016/0345874) in view of Kamath et al. (US 2018/0289333), and further in view of Shah et al. (US 2017/0325749).
As to claims 6 and 18, the above combination fails to expressly teach the smoothing algorithm fits raw values to a second degree polynomial. Shah teaches the use of a Savitzky-Golay filtering algorithm to estimate the glucose derivative ([0087]). A Savitzky-Golay filter uses a least-squares fit of a polynomial of selected degree to a moving window of successive data points, with a quadratic smoothing among the most commonly used configurations. Moreover, Shah also explicitly teaches operation on windows of glucose data ([0086] – looking at measurements over windows of time). Accordingly, it would have been obvious to modify the above combination with Shah to utilize a known algorithm for smoothing data, as it would’ve been obvious to try.
Claim(s) 12 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raisoni et al. (US 2016/0345874) in view of Kamath et al. (US 2018/0289333), and further in view of Emken et al. (US 2015/0099956).
As to claims 12 and 24, the above combination fails to expressly teach the sensor measurements include light measurements and temperature measurements, and at least the light measurement are indicative of an amount of concentration of an analyte in a medium.
Emken teaches an optical sensor for determining analyte concentrations in vivo ([0022]) in which higher levels of analyte levels correspond to a greater amount of emission light of the indicator molecules ([0037]), the sensor also including an analog temperature measurement signal indicative of the temperature of the sensor ([0078]) and use the temperature value to determine error flags in individual measurements ([0091]). It would have been obvious to modify the above combination with Emken to utilize a known sensor system for measuring in vivo analyte values as it would be obvious to try.
Allowable Subject Matter
Claims 7-8 and 19-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As to claims 7 and 19, the prior art of record fails to teach and/or fairly suggest, in combination with all other limitations, determining whether at least one of the first and second smoothed values (a)(i) corresponds in time to a raw value that triggered a first alarm for being above a first threshold value and (ii) is not above the first threshold value or (b)(i) corresponds in time to a raw value that triggered a second alarm for being below a second threshold value and (ii) is not below the second threshold value; and in response to determining that at least one of the first and second smoothed values (a)(i) corresponds in time to a raw value that triggered the first alarm and (ii) is not above the first threshold value or (b)(i) corresponds in time to a raw value that triggered the second alarm and (ii) is not below the second threshold value, recalculating the first and second smoothed values such that such that (1) none of the first and second smoothed values (i) corresponds in time to a raw value that triggered the first alarm and (ii) is not above the first threshold value and (2) none 52 of the first and second smoothed values (i) corresponds in time to a raw value that triggered the second alarm and (ii) is not below the second threshold value.
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 8/24/26
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