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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Examiner can find no support for the limitation “wherein the first time and the second time are times when variations in blood glucose level become equal or larger than a predetermined value.” There does not appear to be a blood glucose level that is equal or larger than a predetermined value in the specification. For purposes of examination, they are assumed to be times when the blood glucose increases following a meal as this appears to be what is disclosed.
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 1-14 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.
Independent claims 1, 13, and 14 each recite estimating “glucose metabolism” or “lipid metabolism.” Metabolism refers to “physical and chemical processes in an organism by which its material substance is produced, maintained, and destroyed, and by which energy is made available.” For glucose and lipids, the term is modified to replace “material substance” with glucose or lipids, respectively.
If the term is to be understood broadly, then there must be a commensurate disclosure of how the invention relates to this broad meaning. For example, does the metric allow an estimate of the glucose concentration in the blood (mg/dL)? Does it allow an estimate of glucose disposal rate (mg/kg/min)? Does it allow an estimate of glucose sensitivity? Glucose clearance rate (mL/kg/min)? A change in glucose concentration? Is there a scale by which to measure it? Fasting plasma glucose? How the subject would respond to an oral glucose tolerance test? The same questions may be asked of lipid metabolism. As the terms do not appear to have objective boundaries, they must be rejected as indefinite. For purposes of examination, both “glucose metabolism” and “lipid metabolism” will be understood as encompassing anything that leads one to believe a patient is becoming diabetic or pre-diabetic.
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.
Claim(s) 1-8 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0058308 A1 to Robinson in view of an article entitled “Assessment of vascular function in individuals with hyperglycemia: a cross-sectional study of glucose-induced changes in digital volume pulse” by Alaei-Shahmiri et al. (“Alaei-Shahmiri”).
As to claim 1, Robinson discloses an electronic device comprising:
at least one sensor configured to acquire a pulse wave on a measured part of a subject (see Fig 29, element 521), and
a controller configured to estimate glucose metabolism of the subject from an index based on the pulse wave acquired by the sensor (see Fig 29, element 522 and [0112] – “As stated previously, prediabetes and diabetes lead to accelerated aging of the vascular system. Therefore, shape-based methods based using distance metric calculations or other methodologies can be used to determine the “effective age” of a recorded pulse profile. For example, if a 40-year-old individual were to generate a pulse waveform more consistent with that of a 60-year-old individual it can be indicative of significant arterial aging and compliance changes.”) and [0157] – “FIG. 29 shows a system comprising an optical measurement system 521, data acquisition system (e.g., a smart phone) 520 that records information and transmits data to central processing location (not shown) for analysis of the data. The central processing location processes data, determines the diabetes assessment score, and can manage invoicing and payment.” See also [0108] – “It is important to recognize that pulse wave velocity is the most common metric for determining arterial stiffness. However, there exist several other approaches that quantify other elements of the arterial pulse wave and are broadly classified here as pulse wave analysis. Analysis of the aortic pressure waveform provides a measure of central blood pressure and indices of systemic arterial stiffness, such as Augmentation Pressure (AP) and Augmentation Index (Alx). These parameters are rather simplistic methods that use peak heights or ratios of peak heights for the determination of various parameters. FIG. 9 shows a typical method for the calculation of augmentation index. In the figure: central aortic waveform and augmentation index (Alx); (A) forward wave; (B) reflected waveform; (c) summation waveform as the result of early wave reflection in a patient with stiff arteries.”).
Robinson fails to disclose wherein the controller estimates the glucose metabolism based on a first index related to a pulse wave acquired at a first time and a second index related to a pulse wave acquired at a second time after the first time.
However, in a related technique for diabetes assessment, Alaei-Shahmiri found differences between the same index measured by Robinson (augmentation/stiffness index) that were different between those with pre-diabetic hyperglycemia and those with normal glucose metabolism when comparing a first index (here, the augmentation/stiffness index) acquired at a first time when compared to a second index acquired at a second time (see Fig 2 and p. 7 – “DVP derived RI is mainly related to the tone of small arteries which can be altered in the presence of hyperglycemia []. Moreover, blunted response of RI to endothelium-dependent vasoactive agents has been established as a marker of endothelial dysfunction in individuals with high cardiovascular risk, including those with impaired glucose.”). 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 glucose metabolism assessment of Robinson with the monitoring of the level of change in the first and second indices over time as time as taught by Alaei-Shahmiri in order to better assess the tendency toward diabetes of the user.
As to claim 2, Alaei-Shahmiri further discloses wherein the controller calculates an amount of change in the second index, taking the first index as a standard (see Fig 2).
As to claim 3, Alaei-Shahmiri further discloses wherein the first time and the second time are times when variations in blood glucose level become equal or larger than a predetermined value (see p. 3 showing that measurements are recorded certain times after the test load).
As to claim 4, Alaei-Shahmiri further discloses wherein the first time is before a meal and the second time is after the meal (see p. 3 showing this).
As to claim 5, Robinson/Alaei-Shahmiri further discloses wherein the first time is before exercise and the second time is during the exercise, or the first time is during the exercise and the second time is after the exercise (the device is capable of being used before exercise and after exercise while making the claimed measurements).
As to claim 6, Robinson/Alaei-Shahmiri further discloses wherein the first time is before bathing and the second time is during the bathing, or the first time is during the bathing and the second time is after the bathing (the device is capable of being used before bathing and after bathing while making the claimed measurements).
As to claim 7, Robinson further discloses wherein the second time is a time when an index related to a pulse wave acquired after the first time becomes an extreme value (see Fig 9 of Robinson showing the peak (extreme value) being used to assess the augmentation/stiffness index see also the same in Alaei-Shahmiri at Fig 1).
As to claim 8, Robinson/Alaei-Shahmiri further discloses wherein the second time is a time when an index related to a pulse wave acquired after a meal becomes an extreme value (see Fig 1 of Alaei-Shahmiri showing how the peaks are used to calculate the augmentation/stiffness index).
As to claim 11, Robinson further discloses wherein the index is an index related to a reflected wave of the pulse wave acquired by the sensor (see [0157] and treatment of claim 1, above).
As to claim 12, Robinson further discloses wherein the at least one sensor is disposed on or in one sensor unit (see Fig 29, element 521).
As to claim 13, Robinson discloses a system comprising a first electronic device (see Fig 29, element 529) and a second electronic device, wherein
the first electronic device comprising :
at least one sensor configured to acquire a pulse wave on a measured part of a subject (see Fig 29, element 432 – a detector is a sensor),
a communication interface configured to communicate with the second electronic device (see Fig 29 (cord is an interface that is configured to communicate with the second electronic device)), and
a controller configured to transmit information related to the pulse wave acquired by the sensor from the communication interface to the second electronic device, so that the second electronic device can estimate glucose metabolism of the subject (see Fig 29, element 522 and [0112] – “As stated previously, prediabetes and diabetes lead to accelerated aging of the vascular system. Therefore, shape-based methods based using distance metric calculations or other methodologies can be used to determine the “effective age” of a recorded pulse profile. For example, if a 40-year-old individual were to generate a pulse waveform more consistent with that of a 60-year-old individual it can be indicative of significant arterial aging and compliance changes.”) and [0157] – “FIG. 29 shows a system comprising an optical measurement system 521, data acquisition system (e.g., a smart phone) 520 that records information and transmits data to central processing location (not shown) for analysis of the data. The central processing location processes data, determines the diabetes assessment score, and can manage invoicing and payment.” See also [0108] – “It is important to recognize that pulse wave velocity is the most common metric for determining arterial stiffness. However, there exist several other approaches that quantify other elements of the arterial pulse wave and are broadly classified here as pulse wave analysis. Analysis of the aortic pressure waveform provides a measure of central blood pressure and indices of systemic arterial stiffness, such as Augmentation Pressure (AP) and Augmentation Index (Alx). These parameters are rather simplistic methods that use peak heights or ratios of peak heights for the determination of various parameters. FIG. 9 shows a typical method for the calculation of augmentation index. In the figure: central aortic waveform and augmentation index (Alx); (A) forward wave; (B) reflected waveform; (c) summation waveform as the result of early wave reflection in a patient with stiff arteries.”), the second electronic device receives the information related to the pulse wave acquired by the sensor transmitted from the first electronic device (see Fig 29 showing the second device receiving the sensor data), but fails to disclose wherein the controller estimates the glucose metabolism based on an index related to a pulse wave acquired at a first time and an index related to a pulse wave acquired at a second time after the first time.
However, in a related technique for diabetes assessment, Alaei-Shahmiri found differences between the same index measured by Robinson (augmentation/stiffness index) that were different between those with pre-diabetic hyperglycemia and those with normal glucose metabolism when comparing a first index (here, the augmentation/stiffness index) acquired at a first time when compared to a second index acquired at a second time (see Fig 2 and p. 7 – “DVP derived RI is mainly related to the tone of small arteries which can be altered in the presence of hyperglycemia []. Moreover, blunted response of RI to endothelium-dependent vasoactive agents has been established as a marker of endothelial dysfunction in individuals with high cardiovascular risk, including those with impaired glucose.”). 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 glucose metabolism assessment of Robinson with the monitoring of the level of change in the first and second indices over time as time as taught by Alaei-Shahmiri in order to better assess the tendency toward diabetes of the user.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Alaei-Shahmiri and further in view of an article entitled “Effect of ezetimibe monotherapy on lipid metabolism and arterial stiffness assessed by cardio-ankle vascular index in type 2 diabetic patients.” by Miyashitaet al. (“Miyashita”).
As to claim 14, Robinson discloses an electronic device comprising:
at least one sensor configured to acquire a pulse wave on a measured part of a subject (see Fig 29, element 521), and
a controller configured to estimate glucose metabolism of the subject from an index based on the pulse wave acquired by the sensor (see Fig 29, element 522 and [0112] – “As stated previously, prediabetes and diabetes lead to accelerated aging of the vascular system. Therefore, shape-based methods based using distance metric calculations or other methodologies can be used to determine the “effective age” of a recorded pulse profile. For example, if a 40-year-old individual were to generate a pulse waveform more consistent with that of a 60-year-old individual it can be indicative of significant arterial aging and compliance changes.”) and [0157] – “FIG. 29 shows a system comprising an optical measurement system 521, data acquisition system (e.g., a smart phone) 520 that records information and transmits data to central processing location (not shown) for analysis of the data. The central processing location processes data, determines the diabetes assessment score, and can manage invoicing and payment.” See also [0108] – “It is important to recognize that pulse wave velocity is the most common metric for determining arterial stiffness. However, there exist several other approaches that quantify other elements of the arterial pulse wave and are broadly classified here as pulse wave analysis. Analysis of the aortic pressure waveform provides a measure of central blood pressure and indices of systemic arterial stiffness, such as Augmentation Pressure (AP) and Augmentation Index (Alx). These parameters are rather simplistic methods that use peak heights or ratios of peak heights for the determination of various parameters. FIG. 9 shows a typical method for the calculation of augmentation index. In the figure: central aortic waveform and augmentation index (Alx); (A) forward wave; (B) reflected waveform; (c) summation waveform as the result of early wave reflection in a patient with stiff arteries.”).
Robinson fails to disclose wherein the controller estimates the glucose metabolism based on a first index related to a pulse wave acquired at a first time and a second index related to a pulse wave acquired at a second time after the first time.
However, in a related technique for diabetes assessment, Alaei-Shahmiri found differences between the same index measured by Robinson (augmentation/stiffness index) that were different between those with pre-diabetic hyperglycemia and those with normal glucose metabolism when comparing a first index (here, the augmentation/stiffness index) acquired at a first time when compared to a second index acquired at a second time (see Fig 2 and p. 7 – “DVP derived RI is mainly related to the tone of small arteries which can be altered in the presence of hyperglycemia []. Moreover, blunted response of RI to endothelium-dependent vasoactive agents has been established as a marker of endothelial dysfunction in individuals with high cardiovascular risk, including those with impaired glucose.”). 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 glucose metabolism assessment of Robinson with the monitoring of the level of change in the first and second indices over time as time as taught by Alaei-Shahmiri in order to better assess the tendency toward diabetes of the user.
The main difference between the claimed invention and Robinson/Alaei-Shahmiri is that these two references are chiefly concerned about glucose metabolism, especially as it relates to diabetes progression, and not lipid metabolism. However, Miyashita teaches that diabetics with abnormal lipid metabolism are acutely at risk for macroangiopathy, blockages in the vessels. The progression of such abnormal lipid metabolism can be measured using a similar metric for pulse waveform analysis as those disclosed by Robinson. Miyashita calls this the cardio-ankle vascular index (see pp. 1070-71). Miyashita teaches that this index can show a increase in the level of lipid metabolism in that lower lipids are present when the index is lower (see Fig 1). Thus, It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the combination of Robinson and Alaei-Shahmiri to additionally include the cardio-ankle vascular index at a first time and a second time in order to achieve the predictable result of determining the level of lipid metabolism progression of the user.
Allowable Subject Matter
Claims 9-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791