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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Element 132 in Fig. 1 is not referenced in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: Sensor in claim 1 is referring to electrodes coated in enzymes (¶[0009]).
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 19 follows.
STEP 1
Regarding claim 19, the claim recites a series of steps or acts, including compensating for the compression of tissue with respect to the first samples. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of compensating for the compression of tissue with respect to the first samples sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The compensation does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the compensation, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of acquiring samples from analyte sensors and evaluating the samples to determine a compression event. Obtaining data (analytes) to determine a compression event is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the acquiring and evaluating steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited sensor is a generic sensor configured to perform pre-solutional data gathering activity and the computer system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and the display of data. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 1-5 and 17-20 are rejected under 35 U.S.C. 102 as being anticipated by Vanslyke et al. (US 20190150803- cited by Applicant ), hereinafter Vanslyke.
Regarding claims 1 and 19, Vanslyke teaches one or more sensors configured to sense a first analyte and a second analyte within tissue of a user;
and a controller operably coupled to the one or more sensors, the controller configured to: evaluate first samples representing measurements of the first analyte using the one or more sensors and second samples representing measurements of the second analyte using the one or more sensors with respect to one another to determine whether the first samples and the second samples indicate compression of the tissue (¶[0188], “the signal from other constituent sensors such as oxygen sensors may be employed in fault discrimination . . . . raw signal values are plotted on axis 124 versus time on axis 126. A raw signal value 132 is illustrated, along with an oxygen sensor value 128. The raw signal value 132 suffers a drop at or near the same time as the oxygen sensor value 128, indicating a compression fault . . . . detecting a blocked signal on both sensors leads to a greater likelihood the fault is caused by compression.” The provided excerpts teach that two signals from constituents sensors can be used to employ fault discrimination due to compression);
and if the first samples and the second samples indicate compression of the tissue, perform an ameliorating action (¶[0393-5], “the display may be blanked and the user woken with the alarm”).
Regarding claim 2, Vanslyke teaches wherein the controller is configured to perform the ameliorating action by compensating for the compression of the tissue with respect to the first samples (¶[0393-95], compensation of the glucose signal is based on extending the value of a known value for a period of time if a previous rate is met).
Regarding claims 3 and 20, Vanslyke teaches wherein the ameliorating action includes blanking the first samples (¶[0395]).
Regarding claim 4, Vanslyke teaches wherein the first analyte is glucose and the second analyte is lactate (¶[0067,0188], constituents under analysis include substance or chemical constituents, which further includes glucose and lactate).
Regarding claim 5, Vanslyke teaches further comprising a force sensor (¶[0453], “a transmitter with integrated force sensor . . . . If force is applied to the transmitter, the cover is pushed downwards and a pressure can be sensed using the pressure sensor”), the controller further configured to:
evaluate an output of the force sensor with respect to a threshold condition (¶[0195], “Changes in the signal that are not related to physiology may be detected by raw signal analysis” and “raw signal value 152 is illustrated with a sudden decrease 154. The sudden decrease 154 may be of greater magnitude than would possibly or ordinarily be encountered in a physiological system, e.g., a raw signal value in a user would not be expected to exhibit such a drop (or conversely, a rise above normal physiological thresholds).”); and evaluate the first samples and the second samples to determine whether the first samples and the second samples indicate the compression of the tissue in response to the output of the force sensor meeting the threshold condition (¶[0105,0454,], “pressure transducer measurements may be used to assist identification of spurious hypoglycemic values associated with compression applied directly to the sensor and transmitter pad” and “combine the pressure transducer data with the previous 60 to 90 minutes glucose trend data to further assist in differentiating actual hypoglycemic events from spurious readings induced by compression at the site of the transmitter and sensor.”)
Regarding claim 17, Vanslyke teaches wherein the controller is further configured to evaluate the first samples and the second samples to determine whether the first samples and the second samples indicate the compression of the tissue by evaluating the first samples and the second samples by processing the first samples and the second samples using a machine learning model (¶[0207, 0374], “drop and rise is characteristic of the fault of ‘compression’,” “results of such measurements and queries may be fed back into a user profile and used later for personalized fault discrimination routines” and “adaptive or machine learning may be triggered and the system may thus become alerted to faults characteristic or typical of a given patient, enabling even more rapid actionable alerts”).
Regarding claim 18, Vanslyke teaches wherein the controller is configured to evaluate the first samples and the second samples to determine whether the first samples and the second samples indicate the compression of the tissue by processing, using the machine learning model, at least one of force data, exercise data, drug data, and diet data (¶[0207,0248,0259,0268,0374], “drop and rise is characteristic of the fault of ‘compression’,” “various types of data or other information that may constitute or be involved in the determination of clinical context information,” “drug. . . activity level” “measurements and queries may be fed back into a user profile and used later for personalized fault discrimination routines” and “adaptive or machine learning may be triggered and the system may thus become alerted to faults characteristic or typical of a given patient, enabling even more rapid actionable alerts”).
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.
Claims 6-16 are rejected under 35 U.S.C. 103 as being unpatentable over Vanslyke, as applied to claim 1, further in view of Park et al. (US 20180064378), hereinafter Park.
Regarding claim 6, Vanslyke fails to teach wherein the controller is further configured to evaluate the first samples and the second samples to determine whether the first samples and the second samples indicate the compression of the tissue by evaluating whether the first samples and the second samples have an inverse correlation.
Park teaches a blood glucose measurement device based on analyzing differences and/or similarities in the sensor signals to determine appropriate blood glucose measurements (abstract). The signals have a positive correlation with a difference between two spectra and a negative correlation (inverse correlation) with a similarity between the two spectra (¶[0065]). The negative correlation can be used to determine whether there is noise (compression) (¶[0065], “Therefore, when the noise value is small, the difference between a specific skin spectrum and another skin spectrum is assumed to be small and the similarity between the two skin spectra is high”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Vanslyke, such that the first samples and the second samples indicate noise of the tissue by evaluating whether the first samples and the second samples have an inverse correlation, as taught by Park, to aid in performing high-speed analysis and large scale analysis through a processor (¶[0070]).
Regarding claim 7, Vanslyke-Park teach wherein the controller is further configured to adjust values of the first samples if the first samples and the second samples have the inverse correlation (¶[0371], “to compensate for the discriminated fault of compression, a max average algorithm may be employed, particularly where the clinical context indicates that the time of day is night time and the patient is above a certain clinical glucose value.” Faults due to compression are adjusted with a max average algorithm).
Regarding claim 8, Vanslyke teaches wherein the controller is further configured to: calculate a first expected value for a current first sample of the first samples; calculate a second expected value for a current second sample of the second samples (¶[0168], “The processor 42, also referred to as the processor module, is the central control unit that performs the processing, such as storing data, analyzing data streams, calibrating analyte sensor data, predicting analyte values, comparing predicted analyte values with corresponding measured analyte values, analyzing a variation of predicted analyte values, downloading data, and controlling the user interface by providing analyte values, prompts, messages, warnings, alarms, and the like” indicating a plurality of analyte values are predicted/expected);
calculate a first difference between the first expected value and the current first sample; calculate a second difference between the second expected value and the current second sample (¶[0168,0172,0393], “deviation of the measured analyte values from the predicted analyte values” and “Thus, the beginning of a compression episode may be detected based on a drop in glucose, as compared to predicted values or by examining the rate of change”(emphasis added)), but fails to determine that the first samples and the second samples have the inverse correlation in response to the first difference and the second difference having opposite signs.
Park teaches that a negative correlation (opposite sign) between a difference of signals can be obtained to determine the noise, or a positive correlation (positive sign) (¶[0065], “generate a plot of difference degree of spectra which represents differences among the acquired plurality of skin spectra” and “In this case, the noise value between a specific skin spectrum and another skin spectrum has a positive correlation with a difference between the two skin spectra and has a negative correlation with a similarity between the two spectra.”)
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Vanslyke, such that the first samples and the second samples have the inverse correlation in response to the first difference and the second difference having opposite signs, as taught by Park, to aid in determining whether the measurements are appropriate thereby making accurate and efficient determinations (¶[0070-71]).
Regarding claim 9, Vanslyke teaches wherein the first expected value is a function of one or more samples of the first samples preceding the current first sample and one or more samples of the second samples preceding the current second sample (¶[0457], “implementations above in which a predicted or forecasted value is suggested, any method of forecasting or prediction using historic and current data values may be applied, including methods relating to pattern analysis, use of clinical context, and the like” the predicted value is a function of historical values).
Regarding claim 10, Vanslyke teaches further comprising a force sensor; wherein the first expected value is a function of an output of the force sensor (¶[0454], “combine the pressure transducer data with the previous 60 to 90 minutes glucose trend data to further assist in differentiating actual hypoglycemic events from spurious readings induced by compression at the site of the transmitter and sensor”).
Regarding claim 11, Vanslyke teaches wherein the first expected value is a function of diet data for the user. (¶[0258], “A patient query may be prompted to determine if a fault was preceded by a meal, so as to attempt to resolve an ambiguous rise in signal value” and “if the query determines that the patient recently ingested a meal, a rise in signal value will likely be attributable to a post-prandial rise rather than an error or fault”)
Regarding claim 12, Vanslyke teaches wherein the first expected value is a function of drug data for the user. (¶[0248], “raw sensor data indicating a potentially faulty situation because of an abnormally low signal value may indicate a fault, but may also be caused by a recent injection or bolus of a medicament such as insulin. By consideration of such clinical context, that which may otherwise be ascribed to a fault may be determined to be actual physiological data, i.e., not a fault”)
Regarding claim 13, Vanslyke teaches wherein the drug data is an amount of subcutaneous insulin delivered to the user. (¶[0248], “raw sensor data indicating a potentially faulty situation because of an abnormally low signal value may indicate a fault, but may also be caused by a recent injection or bolus of a medicament such as insulin. By consideration of such clinical context, that which may otherwise be ascribed to a fault may be determined to be actual physiological data, i.e., not a fault” (emphasis added)).
Regarding claim 14, Vanslyke teaches wherein the first expected value is a function of exercise data for the user (¶[0257], “a user may be queried as to meals ingested, exercise performed, and the like. In some cases, a user query may be prompted by a fault, so as to disambiguate the same. For example, a user could be queried as to whether they were laying on top of their sensor, e.g., to discriminate a compression fault. Other questions will also be understood” (emphasis added)).
Regarding claim 15, Vanslyke teaches wherein the controller is further configured to compensate for the compression of the tissue with respect to the first samples based on the first expected value. (¶[0393-95], compensation due to glucose signal is based on extending the value of a known value for a period of time if a previous rate is met)
Regarding claim 16, Vanslyke-Park teach wherein the controller is further configured to blank the first samples in response to the first samples and the second samples not having the inverse correlation. (¶[0395] of Vanslyke, noisy samples are blanked)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Freeman teaches adaptive filters have been used in many studies to remove the artifact due to CPR chest compression from the ECG signal. The adaptive filters use compression depth and thoracic impedance as reference signals to estimate the artifacts in the ECG signal. The adaptive filter's parameters are updated by calculating the inverse of a cross-correlation matrix or the auto- and cross-spectra of the signal. The artifacts could be reduced when these adaptive filters were applied. US 20240197261
Fathieh teaches that the powerline noise score has an inverse relationship with SNR along with the fitted curve (double exponential function) and the 95% confidence bands. The high-frequency noise score may be defined to be an inverse of the median SNR, calculated over one second, which has been also verified through the inverse relationship given by the correlation. US 20210212582
Freeman teaches adaptive filtering methods use the compression depth as the reference signal to remove the chest compression artifact from the ECG signals. This is based on the assumption that the chest compression artifact is correlated with the reference signal (compression depth) and independent of the desired ECG signal. US 20060025824
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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