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 Objections
Claims 1-2, 4, 9, 11, 13, 15, 20, 23, 27, 29, 31-32, 35, 40, and 46-48 are objected to because of the following informalities:
Claim 1 recites “at least one microstructure” in line 6, but should read “at least one microstructure of the plurality of microstructures”
Claim 1 recites “the at least one microstructure” in line 7, but should read “the at least one microstructure of the plurality of microstructures”
Claims 2, 4, 9, 11, 13, 15, 20, 23, 27, 29, 31-32, 35, 40, and 46-47 recite “A system according to” in line 1, but should read “The system according to”
Claim 4 recites “a least one of:” in lines 15-16, but should read “at least one of:”
Claim 11 recites “vi)standardization” in line 14, but should read “vi) standardization”
Claim 11 recites “senor” in line 33, but should read “sensor”
Claim 15 recites “(5) intra-window metric changes.” in line 11, but should read “(5) intra-window metric changes;”
Claim 48 recites “including, in one” in line 2, but should read “including, by one”
Claim 48 recites “at least one microstructure” in line 6, but should read “at least one microstructure of the plurality of microstructures”
Claim 48 recites “the at least one microstructure” in line 7, but should read “the at least one microstructure of the plurality of microstructures”
Appropriate correction is required.
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 1-2, 4, 9, 11, 13, 15, 20, 23, 27, 29, 31-32, 35, 38, 40, and 46-48 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.
Claim 1 recites the limitation "the at least one sensor" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear as to whether this limitation is referring to the previously recited “a sensor” or a separate element. Clarification is requested.
Claim 2 recites “at least one of:” in lines 1-2. Further in line 13, Claim 2 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 4 recites “a least one of:” in lines 15-16. Further in line 23, Claim 4 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 4 recites “at least one of:” in line 25. Further in line 29, Claim 4 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 9 recites “at least one of:” in line 1. Further in line 6, Claim 9 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 9 recites “at least one of:” in line 2. Further in line 5, Claim 9 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 9 recites “at least one of:” in line 7. Further in line 11, Claim 9 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 9 recites “at least one of:” in line 9. Further in line 10, Claim 9 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 11 recites “at least one of:” in line 1. Further in lines 16 and 30, Claim 11 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 11 recites “at least one of:” in line 3. Further in line 5, Claim 11 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 11 recites “at least one of:” in line 8. Further in line 15, Claim 11 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 11 recites “at least one of:” in line 18. Further in line 21, Claim 11 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 11 recites “at least one of:” in line 23. Further in lines 27 and 29, Claim 11 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 11 recites “at least one of:” in line 24. Further in line 26, Claim 11 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 11 recites “at least one of:” in line 32. Further in line 34, Claim 11 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 13 recites “at least one of:” in lines 2-3. Further in line 4, Claim 13 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 13 recites “at least one of:” in line 5. Further in line 7, Claim 13 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 15 recites “at least one of:” in line 4. Further in line 19, Claim 15 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 15 recites “at least one of:” in line 6. Further in line 10, Claim 15 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 15 recites “at least one of:” in line 15. Further in line 18, Claim 15 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 20 recites “at least one of:” in line 3. Further in line 4, Claim 20 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 20 recites “at least one of:” in lines 10-11. Further in line 12, Claim 20 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 23 recites “at least one of:” in lines 1-2. Further in line 9, Claim 23 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 23 recites “at least one of:” in line 10. Further in line 20, Claim 23 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 27 recites “at least one of:” in line 3. Further in line 5, Claim 27 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 27 recites “at least one of:” in line 8. Further in line 15, Claim 27 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 29 recites “at least one of:” in line 1. Further in line 4, Claim 29 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 29 recites “at least one of:” in line 5. Further in line 10, Claim 29 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 31 recites “at least one of:” in line 4. Further in line 7, Claim 31 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 32 recites “at least one of:” in line 1. Further in lines 7 and 10, Claim 32 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 32 recites “at least one of:” in line 2. Further in line 4, Claim 32 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 32 recites “at least one of:” in line 5. Further in line 6, Claim 32 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 32 recites “at least one of:” in line 8. Further in line 9, Claim 32 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 32 recites “at least one of:” in line 12. Further in line 14, Claim 32 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
The term “about” in claim 35 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 35 recites “at least one of:” in line 2. Further in line 9, Claim 35 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 35 recites “at least one of:” in lines 13-14. Further in line 18, Claim 35 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 38 recites “A method according to claim 1” in line 1. It is unclear as to whether claim 38 was intended to recite “method”, since claim 1 recites a “system”, rather than a “method”.
Claim 38 recites “at least one of:” in line 1. Further in line 10, Claim 38 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 38 recites “at least one of:” in line 2. Further in line 9, Claim 38 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 38 recites “at least one of:” in line 11. Further in line 17, Claim 38 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
The term “about” in claim 40 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 40 recites “at least one of:” in line 2. Further in line 6, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in line 8. Further in line 19, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in line 9. Further in line 12, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in line 14. Further in line 18, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in line 20. Further in line 22, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in line 24. Further in line 28, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in line 25. Further in line 27, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in line 29. Further in line 31, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in line 33. Further in line 35, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in lines 37-38. Further in line 40, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 40 recites “at least one of:” in line 43. Further in line 45, Claim 40 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 46 recites “at least one of:” in line 2. Further in line 10, Claim 46 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 47 recites “SAMs” in line 17. It is unclear as to what “SAMs” is an abbreviation or acronym for. Clarification is requested.
Claim 47 recites “at least one of:” in line 2. Further in line 9, Claim 47 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 47 recites “at least one of:” in line 3. Further in line 5, Claim 47 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 47 recites “at least one of:” in line 10. Further in line 16, Claim 47 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 48 recites the limitation "the at least one sensor" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear as to whether this limitation is referring to the previously recited “a sensor” or a separate element. Clarification is requested.
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.
Claims 1-2, 4, 9, 11, 23, 27, 29, 31-32, 35, 38, 40, and 46-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kendall et al (WO 2020069567; cited by Applicant).
Regarding Claim 1, Kendall discloses a system for analyzing measurements performed on a biological subject (An electrode arrangement for use with a system for performing measurements on a biological subject; Abstract), the system including one or more processing devices (one or more electronic processing devices 122; [0225]) configured to:
a) acquire subject data at least in part captured by a measurement system (An example of a system for performing measurements on a biological subject will now be described with reference to Figure 1; [0212]) including:
i) at least one substrate (at least one substrate 111; [0213]; substrate 311; [0449]) including a plurality of microstructures (micro structures 112; micro structure 312) configured to breach a functional barrier of the subject (the micro structures only penetrate the barrier a sufficient distance to allow a measurement to be made. For example, in the case of skin, the micro structures are typically configured to enter the viable epidermis and not enter the dermal layer; [0243]); and,
ii) a sensor (sensor 121) operatively connected to at least one microstructure, the at least one sensor being configured to measure response signals from the at least one microstructure (at least one sensor 121, which is operatively connected to at least one micro structure 112, thereby allowing response signals to be measured from respective micro structures 112; [0218]); and,
b) analyze the subject data using at least one model to determine an indicator at least partially indicative of a physiological state of the subject ([0423-0424]; [0539-0541]).
Regarding Claim 2, Kendall discloses wherein the subject data includes at least one of: a) an identifier associated with at least one of :i) the subject; and, ii) a patch including the microstructures; b) sensor data indicative of the measured response signals (the electrode configuration is used with a measuring device, which in one example includes at least one sensor 121, which is operatively connected to at least one micro structure 112, thereby allowing response signals to be measured from respective micro structures 112. In this regard, the term response signal will be understood to encompass signals that are intrinsic within the subject, such ECG (Electrocardiograph) signals, or the like, or signals that are induced as a result of the application of stimulation, such as bioimpedance signals, or the like; [0218]); c) secondary sensor data indicative of measurements performed by one or more secondary sensors; d) secondary sensor data indicative of measurements performed by one or more secondary sensors, wherein the secondary sensors include physiological sensors configured to sense one or more physiological parameters or signals; e) subject trait data indicative of one or more subject traits; f) subject parameters derived from previous measurements; and, g) context data indicative of at least one of: i) environmental parameters; ii) environmental parameters measured by one or more environmental sensors; and, iii) a subject context.
Regarding Claim 4, Kendall discloses wherein the one or more processing devices are configured to: a) analyze the subject data to determine at least one metric; and, b) apply the at least one metric to the model to determine the indicator, wherein the at least one model embodies a relationship between a physiological state and the at least one metric and wherein the at least one metric includes at least one of: i) response signals; ii) pre-processed response signals; iii) values derived from the response signals; iv) subject data; v) an attribute of the subject data; vi) a feature derived from an attribute of the subject data; vii) an attribute of the context data; viii) a feature from an attribute of the context data; ix) an attribute statistically derived from measured response signal values including a least one of: (1) a mean; (2) a median; (3) an average; (4) a variance; (5) a skew; (6) a kurtosis; (7) a percentile; and (8) a cumulative distribution function, x) a feature derived using at least one of: (1) changes of attributes; (2) rates of change of attributes; (3) deviation of attributes from reference attributes; (4) deviations of attributes from a baseline; and, (5) one or more feature engineering algorithms (the electronic processing devices could apply the metric to at least one computational model to determine the indicator, with the computational model embodying the relationship between a health status and the one or more metrics…the nature of the model and the training performed can be of any appropriate form and could include any one or more of decision tree learning, random forest, logistic regression, association rule learning, artificial neural networks, deep learning, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, genetic algorithms, rule- based machine learning, learning classifier systems, or the like. As such schemes are known, these will not be described in any further detail. In one example, this can include training a single model to determine the indicator using metrics from reference subjects with a combination of different health states, or the like, although this is not essential and other approaches could be used; [0423-0424]).
Regarding Claim 9, Kendall discloses wherein at least one of: a) the indicator is at least one of: i) a predictive indicator; ii) a classification; iii) an index value; and, iv) a measurement value (the indicator could be indicative of measured parameters associated with the subject, such as measured level or concentrations of analytes or other bio markers; [0230]); and, b) wherein the one or more processing devices are configured to at least one of: i) record the indicator (At step 1260 data, such as the subject data, the indicators, or the measurement data, are recorded allowing this to be subsequently accessed as needed; [0542]); ii) generate an output including at least one of: (1) a representation of the indicator; and, (2) a recommendation based on the indicator; and, iii) cause an intervention to be performed based on the indicator.
Regarding Claim 11, Kendall discloses wherein at least one of: a) the one or more processing devices are configured to process sensor data at least in part using at least one of: i) blind source separation algorithms; ii) independent component analysis; and, iii) principal component analysis; b) the one or more processing devices are configured to process the subject data by performing at least one of: i) anomaly detection; ii) data cleaning; iii) bias correction; iv) windowing; v) normalization; vi) standardization; vii) base lining; and, viii) signal processing (The system further includes one or more electronic processing devices 122, which can form part of a measuring device, and/or could include electronic processing devices forming part of one or more processing systems, such as computer systems, servers, client devices, or the like as will be described in more detail below. In use, the processing devices 122 are adapted to control the signal generator and/or receive and analyse signals from the sensor 121 and either store or process the signals; [0225]); and, c) the one or more processing devices are configured to: i) perform anomaly detection by analyzing the subject data to identify at least one of: (1) sudden changes in response signal values; (2) outlier response signal changes; (3) outlier response signal values; and, (4) changes in response signal values corresponding to events; and, ii) at least one of: (1) perform data cleaning by at least one of: (a) excluding anomalies from subsequent analysis; (b) excluding sensor data including anomalies; and, (c) performing anomaly correction; and, (2) use pattern matching of anomalies to identify measurement device issues; (3) analyze the anomalies; and, (4) determine at least one metric using the anomaly; and, d) the one or more processing devices are configured to perform bias correction based on at least one of: i) individual senor characteristics; ii) environmental parameters; and, iii) physiological parameters.
Regarding Claim 23, Kendall discloses wherein the at least one model is at least one of: a) a biophysical model; b) a computational model; c) a statistical model; d) a biochemical model; e) obtained using reference metrics derived from subject data measured for one or more referenced subjects having known physiological states; f) obtained and/or fit using at least one of machine learning and statistical inference; and, g) obtained and/or fit using at least one of: i) linear or non-linear regression; ii) logistic regression; iii) clustering algorithms; iv) neural networks; v) random forests; vi) decision trees; vii) Bayesian algorithms; viii) Random effects, fixed effects or mixed effects modelling; ix) Random field modelling; x) gaussian processes; and, xi) ensemble methods (The nature of the model and the training performed can be of any appropriate form and could include any one or more of decision tree learning, random forest, logistic regression, association rule learning, artificial neural networks, deep learning, inductive logic programming, support vector machines, clustering, Bayesian networks, reinforcement learning, representation learning, similarity and metric learning, genetic algorithms, rule- based machine learning, learning classifier systems, or the like. As such schemes are known, these will not be described in any further detail. In one example, this can include training a single model to determine the indicator using metrics from reference subjects with a combination of different health states, or the like, although this is not essential and other approaches could be used; [0424]).
Regarding Claim 27, Kendall discloses wherein at least one of: a) the one or more electronic devices are configured to determine an indicator by performing at least one of :i) pattern matching; ii) a longitudinal analysis (the subject data could be used in conjunction with previously collected subject data in order to perform a longitudinal analysis, examining changes in measured values over time. Additionally, and/or alternatively, the subject data could be analysed using a machine learning model or similar. One or more indicators are generated at step 1255, with the nature of the indicators and the manner in which these are generated varying depending upon the preferred implementation and the nature of the analysis being performed; [0541]); and, iii) comparison to a threshold; b) the one or more processing devices are configured to determine a physiological state indicator indicative of at least one of: i) a predicted physiological state of the subject; ii) a presence, absence or degree of a medical condition; iii) a prognosis associated with a medical condition; iv) a presence, absence, level or concentration of a biomarker; v) a presence, absence, level or concentration of an analyte; vi) fluid levels in the subject; vii) blood oxygenation; and, viii) bioelectric activity.
Regarding Claim 29, Kendall discloses wherein at least one of: a) the measurement system includes a signal generator operatively connected to at least one microstructure to apply a stimulatory signal to the at least one microstructure (a signal generator operatively connected to at least one micro structure to apply stimulation, typically by applying a stimulatory signal to the micro structure; [0248-0249]); and, b) the response signals or stimulatory signals are at least one of: i) mechanical; ii) magnetic; iii) thermal; iv) electrical; v) electromagnetic; and vi) optical.
Regarding Claim 31, Kendall discloses wherein the measurement system includes: a) a patch including the substrate and microstructures (The substrate can form part of a patch 110, which can be applied to a subject, although other arrangements could be used for example, having the substrate form part of a housing containing other components; [0217]); and, b) a monitoring device that is configured to at least one of: i) perform the measurements (the system includes a wearable patch including the substrate and microstructures, and a monitoring device (also referred to as a "reader") that performs the measurements; [0427]); ii) generate the subject data; iii) provide the subject data to the one or more processing devices; and, iv) display an output based on the indicator.
Regarding Claim 32, Kendall discloses wherein at least one of: a) the monitoring device is at least one of: i) inductively coupled to the patch (The monitoring device could be attached or integrally formed with the patch, for example mounting any required electronics on a rear side of the substrate. Alternatively, the reader could be brought into contact with the patch when a reading is to be performed. In either case, connections between the monitoring device could be conductive (ohmic) contacts, but alternatively could be indicative coupling, allowing the patch to be wirelessly interrogated and/or powered by the reader; [0427]); ii) attached to the patch; and, iii) placed in contact with the patch at least one of: (1) when measurements are to be performed; and, (2) when sensor data is retrieved from the sensor; and, b) the sensor is at least one of: i) mounted on the patch; and, ii) provided in the monitoring device; and, c) the system includes one or more secondary sensors, and wherein the secondary sensors are at least one of: i) mounted on a patch; ii) provided in the monitoring device; and, iii) in communication with the monitoring device.
Regarding Claim 35, Kendall discloses wherein at least one of: a) at least some of the microstructures include at least one electrode that at least one of: i) extends over a length of a distal portion of the microstructure; ii) extends over a length of a portion of the microstructure spaced from the tip; iii) is positioned proximate a distal end of the microstructure; iv) is positioned proximate a tip of the microstructure; v) extends over at least 25% of a length of the microstructure; vi) extends over less than 50% of a length of the microstructure; vii) extends over about 60pm of the microstructure (at least one electrode at least one of: extends over a length of a distal portion of the micro structure; extends over a length of a portion of the micro structure spaced from the tip; is positioned proximate a distal end of the micro structure; is positioned proximate a tip of the micro structure; extends over at least 25% of a length of the micro structure; extends over less than 50% of a length of the micro structure; extends over about 60 pm, 90 pm or 150 pm of the micro structure; [0051]); and, viii) is configured to be positioned in a viable epidermis of the subject in use; b) the substrate includes electrical connections to allow electrical signals to be applied to and/or received from respective microstructures; c) at least some of the microstructures include an insulating layer extending over at least one of: i) part of a surface of the microstructure; ii) a proximal end of the microstructure; iii) at least half of a length of the microstructure; iv) about 90pm of the microstructure; and, v) at least part of a tip portion of the microstructure.
Regarding Claim 38, Kendall discloses wherein at least one of: a) the microstructures include at least one of: i) plate microstructures (a plurality of plate micro structures extending from the substrate; [0030]); ii) at least partially tapered plate microstructures; iii) plate microstructures having a substantially rounded rectangular cross sectional shape; iv) spaced apart substantially parallel plate microstructures; v) spaced apart rows of microstructures; vi) pairs of spaced apart microstructures; and, vii) groups of microstructures; and, b) at least one of: i) at least some microstructures are angularly offset; ii) at least some microstructures are orthogonally arranged ;iii) adjacent pairs of microstructures are orthogonally arranged; iv) adjacent pairs of microstructures are angularly offset; v) pairs of microstructures are arranged in rows, and the pairs of microstructures in one row are orthogonally arranged relative to pairs of microstructures in other rows; and, vi) pairs of microstructures are arranged in rows, and the pairs of microstructures in one row are angularly offset relative to pairs of microstructures in other rows.
Regarding Claim 40, Kendall discloses wherein at least one of: a) the microstructures have a spacing that is at least one of: i) less than 1 mm; ii) about 0.5 mm; iii) about 0.2 mm; iv) about 0.1 mm; and, v) more than 10 pm (a spacing between groups of micro structures is at least one of: less than 50 mm; more than 20 mm; less than 20 mm; less than 10 mm; more than 10 mm; less than 1 mm; more than 1 mm; about 0.5 mm; and, more than 0.2 mm; [0037]); b) at least some of the microstructures have at least one of: i) a length that is at least one of: (1) less than 300 pm; (2) about 150 pm; (3) greater than 100 pm; and, (4) greater than 50 pm; ii) a maximum width that is at least one of: (1) greater than the length; (2) about the same as the length; (3) less than 300 pm; (4) about 150 pm; and, (5) greater than 50 pm; and, iii) a thickness that is at least one of: (1) less than 50 pm; (2) about 25 pm; and, (3) greater than 10 pm; c) at least some of the microstructures have a tip that at least one of: i) has a length that is at least one of: (1) less than 50% of a length of the microstructure; (2) at least 10% of a length of the microstructure; and, (3) about 30% of a length of the microstructure; and, ii) has a sharpness of at least one of: (1) at least 0.1 pm; (2) less than 5 pm; and, (3) about 1 pm; d) the microstructures have a density that is at least one of: i) less than 5000 per cm2; ii) greater than 100 per cm2; and, iii) about 600 per cm2; e) at least some microstructures include an electrode having a surface area of at least one of: i) less than 200,000 pm2; ii) about 22,500 pm2; and, iii) at least 2,000 pm2; f) the microstructures include anchor microstructures used to anchor the substrate to the subject and wherein the anchor microstructures at least one of: i) include anchoring structures; ii) have a length greater than that of other microstructures; and, iii) enter the dermis.
Regarding Claim 46, Kendall discloses wherein the microstructures include a material including at least one of: a) a bioactive material; b) a reagent for reacting with analytes in the subject; c) a binding agent for binding with analytes of interest; d) a probe for selectively targeting analytes of interest; e) a material to reduce biofouling; f) a material to attract at least one substance to the microstructures; g) a material to repel at least one substance from the microstructures; h) a material to attract at least some analytes to the projections; and, i) a material to repel at least some analytes from the projections (the micro structures include a material including at least one of: a bioactive material; a reagent for reacting with analytes in the subject; a binding agent for binding with analytes of interest; a material for binding one or more analytes of interest; a probe for selectively targeting analytes of interest; an insulator; a material to reduce biofouling; a material to attract at least one substance to the micro structures; a material to repel at least one substance from the micro structures; a material to attract at least some analytes to the micro structures; and, a material to repel at least some analytes from the micro structures; [0057]).
Regarding Claim 47, Kendall discloses wherein at least some of the microstructures are coated with a coating that at least one of: a) modifies surface properties to at least one of: i) increase hydrophilicity; ii) increase hydrophobicity; and, iii) minimize biofouling; b) attracts at least one substance to the microstructures; c) repels at least one substance from the microstructures; d) acts as a barrier to preclude at least one substance from the microstructures; and, e) includes at least one of: i) polyethylene; ii) polyethylene glycol; iii) polyethylene oxide; iv) zwitterions; v) peptides; vi) hydrogels; and, vii) SAMs (the coating at least one of: interacts with analytes; undergoes a change in properties upon exposure to analytes; undergoes a shape change to selectively anchor micro structures; modifies surface properties to at least one of: increase hydrophilicity; increase hydrophobicity; and, minimize bio fouling; attracts at least one substance to the micro structures; repels at least one substance from the micro structures; provides a physical structure to at least one of: facilitate penetration of the barrier; strengthen the micro structures; and, anchor the micro structures in the subject; dissolves to at least one of: expose a micro structure; expose a further coating; and, expose a material; provides stimulation to the subject; contains a material; selectively releases a material; acts as a barrier to preclude at least one substance from the micro structures; and, includes at least one of: polyethylene; polyethylene glycol; polyethylene oxide; zwitterions; peptides; hydrogels; and, self- assembled monolayer; [0064]).
Regarding Claim 48, Kendall discloses a method for analyzing measurements performed on a biological subject (Abstract), the method including, in one or more processing devices (one or more electronic processing devices 122; [0225]):
a) acquiring subject data at least in part captured by a measurement system (An example of a system for performing measurements on a biological subject will now be described with reference to Figure 1; [0212]) including:
i) at least one substrate (at least one substrate 111; [0213]; substrate 311; [0449]) including a plurality of microstructures (micro structures 112; micro structure 312) configured to breach a functional barrier of the subject (the micro structures only penetrate the barrier a sufficient distance to allow a measurement to be made. For example, in the case of skin, the micro structures are typically configured to enter the viable epidermis and not enter the dermal layer; [0243]); and,
ii) a sensor (sensor 121) operatively connected to at least one microstructure, the at least one sensor being configured to measure response signals from the at least one microstructure (at least one sensor 121, which is operatively connected to at least one micro structure 112, thereby allowing response signals to be measured from respective micro structures 112; [0218]); and,
b) analyzing the subject data using at least one model to determine an indicator at least partially indicative of a physiological state of the subject ([0423-0424]; [0539-0541]).
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.
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kendall in view of Lackey et al (U.S. Publication No. 2005/0070778; cited by Applicant).
Regarding Claim 13, Kendall discloses wherein the system includes one or more secondary sensors (The sensor 121 can be operatively connected to all of the micro structures 112, with connections being collective and/or independent. For example, one or more sensors could be connected to different micro structures to allow different measured response signals to be measured from different groups of micro structures 112; [0221]). However, Kendall fails to specifically disclose wherein the one or more processing devices are configured to at least one of: a) synchronize the sensor data and secondary sensor data; and, b) process the sensor data in accordance with secondary sensor data to at least one of: i) perform bias correction; ii) identify events; and, iii) perform anomaly detection.
In a similar technical field, Lackey teaches systems and techniques for monitoring hydration including measuring an electrical impedance of a region of a subject to generate an impedance measurement result, and measuring impedance with a probe in the form of a patch adhesively secured to the subject (Abstract), wherein the one or more processing devices are configured to at least one of: a) synchronize the sensor data and secondary sensor data (During a synchronization stage, clocks in two or more of probe 100, data collection apparatus 1105, and data management system 1110 are synchronized to enable synchronous data transmission along one or more of links 1125, 1130, 1135. For example, in one implementation, data collection apparatus 1105 transmits synchronization characters to data management system 1110 over wired data link 1130. Data management system 1110 can receive the synchronization characters and compares the received characters with a synchronization pattern. When the received characters correspond sufficiently with the synchronization pattern, data management system 1110 can exit the synchronization stage and exchange other data synchronously with data collection apparatus 1105 over link 1130. Such a synchronization process can be repeated periodically; [0106]); and, b) process the sensor data in accordance with secondary sensor data to at least one of: i) perform bias correction; ii) identify events; and, iii) perform anomaly detection.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the synchronization teachings of Lackey into those of Kendall in order to enable synchronous data transmission and compare received data with a synchronization pattern (Lackey [0106]).
Regarding Claim 20, Kendall fails to specifically disclose wherein at least one of: a) the one or more processing devices are configured to standardize the subject data to establish a baseline, the standardization being performed based on at least one of: i) historical subject data; and, ii) physiological parameters; b) the one or more processing devices are configured to perform baselining by using a baseline to at least one of: i) adjust subject data; ii) flag subject data of interest; c) the one or more processing devices are configured to perform baselining by at least one of: i) comparison to a baseline; and, ii) using a baselining computational model.
In a similar technical field, Lackey teaches systems and techniques for monitoring hydration including measuring an electrical impedance of a region of a subject to generate an impedance measurement result, and measuring impedance with a probe in the form of a patch adhesively secured to the subject (Abstract), wherein at least one of: a) the one or more processing devices are configured to standardize the subject data to establish a baseline, the standardization being performed based on at least one of: i) historical subject data; and, ii) physiological parameters; b) the one or more processing devices are configured to perform baselining by using a baseline to at least one of: i) adjust subject data; ii) flag subject data of interest; c) the one or more processing devices are configured to perform baselining by at least one of: i) comparison to a baseline; and, ii) using a baselining computational model (A baseline measurement is a standard response to hydration monitoring. The standard response can be indicative of the absence of a disease state or of the absence of progression in a disease state. Changes in the baseline impedance measurements can result from changes in factors unrelated to a disease state. For example, changes in the baseline impedance measurements can result from different skin thicknesses, body compositions, or other differences between two locations. Measurements made at the different locations can be normalized to account for such differences in baseline measurements. Such a normalization can include adjustments in gain and/or adjustments in offset. Gain adjustments may be based on the absolute value of the impedance measurement(s), the impedance difference(s) observed at the old and the new locations, or combinations thereof. Offset adjustments can generally be made after gain adjustments and can be based on absolute impedance values and/or other factors. Alternatively, analysis thresholds used to identify disease states can be adjusted; [0061-0062]; [0148]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the baseline teachings of Lackey into those of Kendall in order to measure changes with the baseline in order to identify disease states and progression (Lackey [0061-0062]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kendall in view of Stivoric et al (U.S. Patent No. 7,285,090; cited by Applicant).
Regarding Claim 15, Kendall fails to specifically disclose wherein the one or more processing devices are configured to: a) segment the subject data into a number of windows; and, b) analyze the subject data using the windows and wherein at least one of: i) the one or more processing devices are configured to analyze the data by analyzing at least one of: (1) at least one metric for each window; (2) a plurality of metrics for each window; (3) a plurality of metrics for each of a plurality of windows; (4) inter-window metric changes; and, (5) intra-window metric changes, ii) the one or more processing devices are configured to normalize subject data for each window; iii) the one or more processing devices are configured to segment the subject data based on at least one of: (1) fixed time intervals; (2) events; (3) events detected using secondary sensors; and, (4) identified anomalies; and, iv) the one or more processing devices are configured to: (1) generate an indicator for each window; and, (2) generate an indictor using metrics from multiple windows.
In a similar technical field, Stivoric teaches an apparatus for detecting, receiving, deriving and displaying human physiological and contextual information (Abstract), wherein the one or more processing devices are configured to: a) segment the subject data into a number of windows; and, b) analyze the subject data using the windows and wherein at least one of: i) the one or more processing devices are configured to analyze the data by analyzing at least one of: (1) at least one metric for each window; (2) a plurality of metrics for each window; (3) a plurality of metrics for each of a plurality of windows; (4) inter-window metric changes; and, (5) intra-window metric changes, ii) the one or more processing devices are configured to normalize subject data for each window; iii) the one or more processing devices are configured to segment the subject data based on at least one of: (1) fixed time intervals; (2) events; (3) events detected using secondary sensors; and, (4) identified anomalies; and, iv) the one or more processing devices are configured to: (1) generate an indicator for each window; and, (2) generate an indictor using metrics from multiple windows (At this stage, the models make predictions on, for example, a minute by minute basis. Inter-minute effects are next taken into account by creating an overall model that integrates the minute by minute predictions. A well known or custom windowing and threshold optimization tool may be used in this step to take advantage of the temporal continuity of the data; [0224]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the windowing teachings of Stivoric into those of Kendall in order to take advantage of the temporal continuity of the data and make predictions on specific periods of data (Stivoric [0224]).
Conclusion
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/CHANEL J YOON/Examiner, Art Unit 3791
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