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 .
Claims Pending
Applicant's arguments, filed 06/19/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 06/19/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant’s previous withdrawal of claims 18, 24, and 28-44 is acknowledged.
Claims 1-17, 19-23, and 25-27 are the current claims hereby under examination.
Claim Objections
Claims 4-8, 16-17, and 25 are objected to because of the following informalities:
Dependent Claims 4-8 and 25, recite “first controller is configured to…”, while independent claim 1 recites “a first controller that, in operation…”, which lacks consistency between the claims
Dependent Claims 16-17 recite “user interface is configured to”, while independent claim 1 recites “user interface that, in operation…”, which lacks consistency between the claims
Appropriate correction is required.
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:
Claim 1: The claim limitation “a processor that, in operation…” “…determines whether the first data indicates preterm delivery based on a correlation between the first data and second data that includes, for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “processor” coupled with functional language “that, in operation…” “…determines whether the first data indicates preterm delivery based on a correlation between the first data and second data that includes, for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “processor”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“the information provider 110 may output information for diagnosing preterm birth risk based on correlation between the plurality of corresponding impedances, another data, and the preterm birth risk. Said another data may be at least one of spectral impedances, pH level, metabolites, temperature, pregnancy stage, and human microbiome. In an embodiment, the spectral impedances include impedances at different frequencies. The information provider 110 may comprise a diagnosis engine. The diagnosis engine may comprise an algorithm, an Al (Artificial Intelligence) model, or a machine learning model.” (Page 7, lines 13-21), “In an embodiment, the information provider 110 may be trained with correlation between the plurality of corresponding impedances, pregnancy stage, and the preterm birth risk. The diagnosis engine is organized into a taxonomy based on one or more outcomes of the model and is trained by applying training data to the model. The model is adjusted (e.g., improved) based on how it responds to the training data” (Page 8, lines 2-7), “The classifier may be trained with data of a mother who has a different pregnancy stage. The different pregnancy stage may be the first trimester (e.g., one to twelve week), the second trimester (e.g., thirteen to twenty-six week), or the third trimester (twenty-seven to the birth). The period can be adjusted. One classifier may be trained with data of a mother who has experienced the preterm birth or has not experienced the preterm birth…” (Page 9, lines 2-14), “The processor 120 is configured to analyze and process data. The processor 120 is configured to control overall operations of the system 100. The storage 130 is configured to store the data above and correlation between the data and the preterm birth risk…” “…classifying the impedances into different groups, each representing different status, based on the correlation between the plurality of impedances and the preterm birth risk” (Page 20, lines 4-14), “In block S825, the system 100 classifies the data values that met the data quality requirements and derived from the cervical tissues into different groups based on data including the impedances at different frequencies. The data may further comprise correlation between the impedances and the preterm birth risk.” (Page 29, lines 10-13), or equivalents thereof, which lacks sufficient detail within the applicant’s specification and will be interpreted as a generic computational structure and algorithm capable of the indicated function, as described on the indicated pages of the disclosure filed on 11/22/2021.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are 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(s) to avoid it/them 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(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-17, 19-23, and 25-27 are 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.
Claim 1 recites the limitation “a processor that, in operation…” “…determines whether the first data indicates preterm delivery based on a correlation between the first data and second data that includes, for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery”, which lacks sufficient detail within the specification as to the structure of the algorithm of the processor that performs indicated function. The specification does state “the information provider 110 may output information for diagnosing preterm birth risk based on correlation between the plurality of corresponding impedances, another data, and the preterm birth risk. Said another data may be at least one of spectral impedances, pH level, metabolites, temperature, pregnancy stage, and human microbiome. In an embodiment, the spectral impedances include impedances at different frequencies. The information provider 110 may comprise a diagnosis engine. The diagnosis engine may comprise an algorithm, an Al (Artificial Intelligence) model, or a machine learning model.” (Page 7, lines 13-21 of applicant’s spec.) and “In an embodiment, the information provider 110 may be trained with correlation between the plurality of corresponding impedances, pregnancy stage, and the preterm birth risk. The diagnosis engine is organized into a taxonomy based on one or more outcomes of the model and is trained by applying training data to the model. The model is adjusted (e.g., improved) based on how it responds to the training data” (Page 8, lines 2-7 of applicant’s spec.), and “The classifier may be trained with data of a mother who has a different pregnancy stage. The different pregnancy stage may be the first trimester (e.g., one to twelve week), the second trimester (e.g., thirteen to twenty-six week), or the third trimester (twenty-seven to the birth). The period can be adjusted. One classifier may be trained with data of a mother who has experienced the preterm birth or has not experienced the preterm birth…” (Page 9, lines 2-14 of applicant’s spec.), which indicates a diagnosis engine and a classifier as the structures that perform the indicated function. The specification further states “The processor 120 is configured to analyze and process data. The processor 120 is configured to control overall operations of the system 100. The storage 130 is configured to store the data above and correlation between the data and the preterm birth risk…” “…classifying the impedances into different groups, each representing different status, based on the correlation between the plurality of impedances and the preterm birth risk” (Page 20, lines 4-14 of applicant’s spec.), which indicates an algorithm on a processor that performs a classification. The specification further states “In block S825, the system 100 classifies the data values that met the data quality requirements and derived from the cervical tissues into different groups based on data including the impedances at different frequencies. The data may further comprise correlation between the impedances and the preterm birth risk.” (Page 29, lines 10-13 of applicant’s spec.), which further indicates the functionality of the algorithm. However, simply reciting the presence of a classifier and algorithm on a processor does not provide sufficient detail as to the actual structure of the algorithm itself that is able to make a determination regarding preterm delivery. The applicant does not provide sufficient detail as to the manner itself in which the classifier itself is trained to make the above determination regarding preterm delivery, or weights utilized within the classifier. As such, the claim is rejected.
Claim 1 recites the limitation “determines whether the first data indicates preterm delivery based on a correlation between the first data and second data that includes, for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery”, which is considered to be new matter as the specification made no previous indication as to the explicit use of the data of “a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery”. The applicant does state “FIGs. 8A and 8B illustrate a graph of mean cervical impedances of mothers who experienced preterm delivery and term delivery. FIGs. 8A and 8B indicate that impedance of cervical tissues of mothers who experienced the preterm delivery is relatively different than that of mothers who experienced the term delivery across a frequency range” (Page 21, lines 20-23 of applicant’s spec.), where Fig. 8A and Fig. 8B merely provide a graphical example of impedance data at different frequencies for preterm and term deliveries. The specification further states “The classifier may be trained with data of a mother who has a different pregnancy stage. The different pregnancy stage may be the first trimester (e.g., one to twelve week), the second trimester (e.g., thirteen to twenty-six week), or the third trimester (twenty-seven to the birth). The period can be adjusted. One classifier may be trained with data of a mother who has experienced the preterm birth or has not experienced the preterm birth…” (Page 9, lines 2-14 of applicant’s spec.), however, this merely indicates the existence of impedance data for a singular mother at various pregnancy stages. The applicant made no previous indication as to the use of the data that includes “a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery” in the determination of preterm delivery. As such, the claim is rejected.
Claims 2-17, 19-23, and 25-27 are dependent on claim 1, and as such are also rejected.
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 1-17, 19-23, and 25-27 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 “determines whether the first data indicates preterm delivery based on a correlation between the first data and second data that includes, for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what the applicant considers to be “second data”. For example, the applicant states “first data including impedances that satisfy the data quality requirements”, where the first data is indicated as including impedances. The claim then states “a correlation between the first data and second data that includes, for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery”, where it is unclear as to what exactly the second data involves. Is it the correlation between the first and second data that then includes “for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery”, or is this specifically just referring to the second data? Does the first data also include a range of impedances of mothers? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the second data itself including “for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery”.
Claim 1 limitation “a processor that, in operation…” “…determines whether the first data indicates preterm delivery based on a correlation between the first data and second data that includes, for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery”, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The corresponding structure provided by the applicant in the specification indicates a diagnosis engine and a classifier (Page 7, lines 13-21 of applicant’s spec.) (Page 8, lines 2-7 of applicant’s spec.) (Page 9, lines 2-14 of applicant’s spec.)(Page 20, lines 4-14 of applicant’s spec.) (Page 29, lines 10-13 of applicant’s spec.), which fails to effectively define the metes and bounds of the claim, as it is unclear as to the exact weights or biases the applicant is using for the classifier or how the classifier itself is trained to make a determination regarding preterm delivery. For examination purposes, this will be interpreted as a generic algorithm on a generic processor capable of the indicated function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 9 recites the limitation “the data” (line 3). There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as -the first data-.
Claims 2-17, 19-23, and 25-27 are dependent on claim 1, and as such are also rejected.
Claim Rejections - 35 USC § 101 - Withdrawn
Applicant’s amendments, filed 06/14/2024, have been fully considered, and the previous rejection withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The claims are generally directed towards a system for diagnosing preterm birth risk. The system comprises a plurality of electrodes for contacting cervical tissues that generates first and second signals, a controller that controls the frequency of the electrodes, and a second controller that controls the detection of second signals electrodes. The system further comprises a processor with instructions that cause the processor to output a preterm birth risk, where the processor receives impedances, classifies the data to corresponding birth risk results, and outputs information for diagnosing the birth risk. The system further comprises a user interface to notify the user of any information.
Claim(s) 1-8, 13-17, 19, 22-23, and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cantor (US Pub No. 20170035347) hereinafter Cantor, and further in view of Gaw (US Pub. No. 20110313311) hereinafter Gaw, Franco (US Pub. No. 20080171950) hereinafter Franco, and Anumba et al. (“Value of cervical electrical impedance spectroscopy to predict spontaneous preterm delivery in asymptomatic women: the ECCLIPPx prospective cohort study”, 2020) hereinafter NPL.
(Examiner's Note: The NPL was published online on August 15, 2020)
Regarding claim 1, Cantor teaches A system for providing information for diagnosing preterm birth risk (Par. 28, 54. (“. Thus, for example, a change in the trend of data for impedance measured …” “…may indicate infection or other health issue that can be treated by the clinician”)), comprising:
two or more transmit electrodes (Par. 44, injecting electrode pair – 34’) that, in operation, contact cervical tissue of a patient (Par. 44), and apply a plurality of first signals at different frequencies to the cervical tissues (Par. 43, 44 (measurements taken at different frequencies));
two or more detect electrodes (Par. 44, measuring electrode pair – 34”) that, in operation, contact the cervical tissue of a patient (Par. 44), and detect a plurality of second signals generated in response to the first signals (Par. 43,44) (Par. 40, (“An alternating current is applied to the cervix and potential that can be correlated to electrical impedance through the tissue of the cervix is measured at one or more frequencies”)), the second signals corresponding to the first signals, respectively (Par. 44, (“the second pair 34″, referred to as measuring electrodes, measures potential the through the cervix tissue”));
a processor (Par. 53, “The external module receives and records the transmitted data in step 108. Periodically the recorded data is downloaded to a remote display module, such as a computer…”) that in operation:
receives first data including impedances (Par. 52, step 108)(Par. 53 (data acquisition)),
determines based on a correlation between the first data and second data (Par. 53, “Data representing impedance and optionally temperature and pH for each transmitted packet of data can be analyzed by being compared either to a data base consisting of typical values or to a data base consisting of previously recorded data for the individual at step 110 to determine an increase, no change or decrease in the trend of the data values.”) (Par. 54, “If, after comparing the newly received packet of data with the database for any or all of the measured parameters of impedance, temperature and pH to develop a trend…”),
outputs information (Par. 54, “In step 112 a change in the trend of the data values for any or all of the parameters of impedance, temperature and pH for each transmitted packet of data over a predetermined period, for example 8 hours, can indicate an impending change in the cervix and will trigger a signal 113 to the user and the clinician to more closely monitor data output or to personally examine the individual. In the meantime monitoring and recording of the parameters is continued at 114”);
a user interface that, in operation, notifies a user (Par. 57, (“The data can be displayed by the interface device 14…” “…will receive immediate notification of a problem with the pregnancy or a possible device malfunction”)).
Cantor fails to explicitly teach a source, that, in operation, generates the first signals at the different frequencies.
However, Gaw teaches a source, that, in operation, generates the first signals at the different frequencies (Par. 242, signal generator -111) (Par. 254, 303 (multiple frequencies)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Cantor with that of Gaw to include a source, that, in operation, generates the first signals at the different frequencies through the combination of references as it would have yielded the predictable result of identifying tissue anomalies (Gaw (Par. 1, 253)).
Modified Cantor fails to explicitly disclose a first controller that, in operation, controls the source to provide the two or more transmit electrodes with the first signals at the different frequencies.
However, Gaw further teaches a first controller (Par. 243, processing system – 102) (Par. 246, 250 (“In one example, the processing system can be formed from first and second processing systems,”)) that, in operation, controls the source to provide the two or more transmit electrodes (Par. 251, (“drive electrodes”)) with the first signals at the different frequencies (Par. 252 (the signal generator is applying the signal)) (Par. 254, 255 (measurements at different frequencies));
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Cantor and Gaw with that of Gaw to include a first controller that, in operation, controls the source to provide the two or more transmit electrodes with the first signals at the different frequencies through the combination of references as applying different frequencies is known in the art (Gaw (Par. 254)) and it would have yielded the predictable result of detecting tissue anomalies (Gaw (Par. 253)).
Modified Cantor fails to explicitly disclose a second controller that, in operation: controls detection of the second signals from the two or more detect electrodes at the different frequencies, obtains a plurality of corresponding impedances of the cervical tissue of the patient based on the first and the second signals, and applies data quality requirements for diagnosing the preterm birth risk, the data quality requirements including checking that each of the impedances is within a predetermined frequency range.
However, Gaw further teaches a second controller that, in operation (Par. 244, processing system -102 (the processing system generates signals and determines impedance)) (Par. 246, 250 (“In one example, the processing system can be formed from first and second processing systems,”)) (Fig. 4, computer system – 420) (Par. 292, “In particular in this instance an impedance measuring device 400 is connected to a switching device in the form of a multiplexer 410, which is controlled by a processing system or computer system 420, such as a personal computer or the like. In this instance the multiplexer 410 is coupled to an electrode array 430 having a number of electrodes 431 provided thereon”):
controls detection of the second signals from the two or more detect electrodes at the different frequencies (Fig. 5A, step 520-550) (Par. 316 (measurements made at electrode arrangements)) (Par. 310-312 (determination of impedance based on multiple frequencies)) (Par. 254, 303 (multiple frequencies)),
obtains a plurality (Fig. 5A, (impedance values taken)) of corresponding impedances of the cervical tissue of the patient based on the first and the second signals (Par. 310-312, 315 (determination of impedance based on measurements)), and
applies data quality requirements for diagnosing the preterm birth risk, the data quality requirements including checking that each of the impedances is within a predetermined frequency range (Par. 319, “Once all the electrode configurations are complete for a specific site, the measuring device 400 or the computer system 420 is used to analyse the impedance values and determine if the impedance measurements are indicative of a tissue anomaly.”) (Par. 324 (determination on whether an anomaly is present based on a threshold)) (Par. 328, “if the reference is exceeded and the result is determined to be indicative of a tissue anomaly at step 580, then the site is identified as a tissue anomaly at step 590, in which case an appropriate indicator can be generated. The indicator could be indicative of the difference, the measured impedance values, impedance parameters, or the like....”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Cantor and Gaw with that of Gaw to include a second controller that, in operation: controls detection of the second signals from the two or more detect electrodes at the different frequencies, obtains a plurality of corresponding impedances of the cervical tissue of the patient based on the first and the second signals, and applies data quality requirements for diagnosing the preterm birth risk, the data quality requirements including checking that each of the impedances is within a predetermined frequency range through the combination of references as measuring different frequencies is known in the art (Gaw (Par. 254)) and it would have yielded the predictable result of determining the presence of tissue anomalies (Gaw (Par. 325,328)).
Modified Cantor fails to explicitly disclose a processor.
However, Cantor does disclose a computer (Par. 53 (computer)).
Gaw further teaches a processor (Par. 242, processor – 105).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Cantor and Gaw with that of Gaw to include a processor through the combination of references as it would have yielded the predictable result of explicitly providing the required computational structures (Gaw (Par. 242, 246, 247)).
Modified Cantor fails to explicitly disclose receives first data including impedances that satisfy the data quality requirements.
However, Cantor does teach receives first data including impedances (Par. 52, step 108)(Par. 53 (data acquisition)).
Gaw further teaches data including impedances that satisfy the data quality requirements (Par. 319, “Once all the electrode configurations are complete for a specific site, the measuring device 400 or the computer system 420 is used to analyse the impedance values and determine if the impedance measurements are indicative of a tissue anomaly.”) (Par. 324 (determination on whether an anomaly is present based on a threshold)) (Par. 328, “if the reference is exceeded and the result is determined to be indicative of a tissue anomaly at step 580, then the site is identified as a tissue anomaly at step 590, in which case an appropriate indicator can be generated. The indicator could be indicative of the difference, the measured impedance values, impedance parameters, or the like....”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Cantor and Gaw with that of Gaw to include receives first data of Cantor including impedances that satisfy the data quality requirements through the combination of references as it would have yielded the predictable result of determining the presence of tissue anomalies (Gaw (Par. 325,328)).
Modified Cantor fails to explicitly disclose determines whether the first data indicates preterm delivery based on a correlation between the first data and second data that includes, for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery.
However, Franco teaches determines whether the first data indicates preterm delivery based on a correlation between the first data and second data that includes (Par. 32, “In one implementation, labor or pre-term labor predictions are made based on changes in the patient's cervical impedance or a rate of change of the patient's cervical impedance. In certain examples, these evaluations are made by comparing the patient's impedance measurements to a database of impedance values. The database of impedance values may be compiled based on the patient's historical cervical measurements taken from her past pregnancies or from statistical impedance data taken from women who have similar physiological profiles as the patient.”), a range of impedances of mothers (Par. 32, “The database of impedance values may be compiled based on the patient's historical cervical measurements taken from her past pregnancies or from statistical impedance data taken from women who have similar physiological profiles as the patient.”).
NPL teaches second data that includes, for each of a plurality of frequencies (Page 7, “statistical analysis”, (impedance at differing frequencies measured)), a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery (Page 7 “Following analysis of transfer impedance at the 14 studied frequencies, the top five frequencies that showed reduced transfer impedance magnitude in the spontaneous PTB group in this study (19.5–312.5 kHz) were used for further investigation…” “…Given that a model performs optimally in the dataset employed to generate it, validation in another dataset from a similar population provides a better reflection of the usefulness of the model. We therefore employed these inputs, taken from a random subset (30% of all cases; n = 110) of the spectra measured from both the PTB group and term-delivery group, as a training set to produce a final set of model parameters – the EIS index…” (PTB group and term delivery group)).
Cantor, Gaw, Franco, and NPL are considered to be analogous art to the claimed invention as they are involved with electrical signals and biological tissue.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Cantor and Gaw with that of Franco and NPL to include determines whether the first data of Cantor indicates preterm delivery based on a correlation between the first data and second data of NPL that includes, for each of a plurality of frequencies, a range of impedances of mothers who experienced preterm delivery and a range of impedances of mothers who experienced term delivery of NPL through the combination of references as cervical impedance measurements are known indicators of preterm birth for mothers (NPL (Page 2, (Conclusion))(Page 17, Par. 1-2)) and it would have yielded the predictable result of minimizing birth complications (Franco (Par. 23)).
Modified Cantor fails to explicitly disclose outputs information indicating whether the first data is determined to indicate preterm delivery or term delivery based on the correlation with the second data set.
However, Franco further teaches outputs information indicating whether the first data is determined to indicate preterm delivery or term delivery based on the correlation with the second data set (Par. 32, “In one implementation, labor or pre-term labor predictions are made based on changes in the patient's cervical impedance or a rate of change of the patient's cervical impedance. In certain examples, these evaluations are made by comparing the patient's impedance measurements to a database of impedance values. The database of impedance values may be compiled based on the patient's historical cervical measurements taken from her past pregnancies or from statistical impedance data taken from women who have similar physiological profiles as the patient.” (the prediction being made is the output)).
NPL further teaches second data (as indicated above).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Cantor, Gaw, Franco, and NPL with that of Franco and NPL to include outputs information indicating whether the first data of Cantor is determined to indicate preterm delivery or term delivery based on the correlation with the second data set of NPL through the combination of references as cervical impedance measurements are known indicators of preterm birth for mothers (NPL (Page 2, (Conclusion))(Page 17, Par. 1-2)) and it would have yielded the predictable result of minimizing birth complications (Franco (Par. 23)).
Modified Cantor fails to explicitly disclose a user interface that, in operation, notifies a user whether the first data is determined to indicate preterm delivery or term delivery.
Cantor does disclose a user interface that, in operation, notifies a user (Par. 57, (“The data can be displayed by the interface device 14…” “…will receive immediate notification of a problem with the pregnancy or a possible device malfunction”)).
Franco teaches whether the first data is determined to indicate preterm delivery or term delivery (Par. 32, “In one implementation, labor or pre-term labor predictions are made based on changes in the patient's cervical impedance or a rate of change of the patient's cervical impedance. In certain examples, these evaluations are made by comparing the patient's impedance measurements to a database of impedance values. The database of impedance values may be compiled based on the patient's historical cervical measurements taken from her past pregnancies or from statistical impedance data taken from women who have similar physiological profiles as the patient.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Cantor, Gaw, Franco, and NPL with that of Franco to include a user interface of Cantor that, in operation, notifies a user whether the first data of Cantor is determined to indicate preterm delivery or term delivery through the combination of references and it would have yielded the predictable result of alerting the patient regarding potential complications and reducing potential complications (Franco (Par. 23)).
Regarding claim 2, modified Cantor fails to explicitly teach wherein the first and second signals are voltages.
However, Gaw further teaches wherein the first and second signals are voltages (Par. 243).
Therefore, it would have been further obvious to modify the signals of Cantor, Gaw, Franco, and NPL with that of Gaw to include wherein the first and second signals are voltages as current and voltage can both be used for signals (Gaw(Par. 243)) and it would have yielded the predictable result of customizing the signal provided for each subject to best detect tissue anomalies (Gaw(Par. 244)).
Regarding claim 3, modified Cantor fails to explicitly teach wherein the first and second signals are currents.
However, Gaw further teaches wherein the first and second signals are currents (Par. 243).
Therefore, it would have been further obvious to modify the signals of Cantor, Gaw, Franco, and NPL with Gaw to include wherein the first and second signals are currents as current and voltage can both be used for signals (Gaw (Par. 243)) and it would have yielded the predictable result of customizing the signal provided for each subject to best detect tissue anomalies (Gaw (Par. 244)).
Regarding claim 4, modified Cantor fails to explicitly disclose the limitations of the claim.
However, Gaw further teaches wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals at the different frequencies concurrently (Par. 254-255).
Therefore, it would have been further obvious to modify the system of Cantor, Gaw, Franco, and NPL with that of Gaw to include wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals at the different frequencies concurrently as Bioimpedance Spectroscopy is known in the art (Par. 254) and would have yielded the predictable result of customizing the signal provided for each subject to best detect tissue anomalies (Par. 244).
Regarding claim 5, modified Cantor fails to explicitly disclose the limitations of the claim.
However, Gaw further teaches wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals 0, 90, 180, or 270 degrees out of phase with each other (Par. 254-255 (concurrently includes 0 degrees out of phase)).
Therefore, it would have been further obvious to modify the system of Cantor, Gaw, Franco, and NPL with that of Gaw to include wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals 0, 90, 180, or 270 degrees out of phase with each other for the reasoning as indicated above in claim 4.
Regarding claim 6, modified Cantor fails to explicitly disclose the limitations of the claim.
However, Gaw further teaches wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals at the different frequencies sequentially (Par. 254-255).
Therefore, it would have been further obvious to modify the system of Cantor, Gaw, Franco, and NPL with that of Gaw to include wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals at the different frequencies sequentially for the reasoning as indicated above in claim 4.
Regarding claim 7, modified Cantor fails to explicitly disclose the limitations of the claim.
However, Gaw further teaches wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals 0, 90, 180, or 270 degrees out of phase with each other (Par. 254-255).
Therefore, it would have been further obvious to modify the system of Cantor, Gaw, Franco, and NPL with that of Gaw to include wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals 0, 90, 180, or 270 degrees out of phase with each other for the reasoning as indicated above in claim 4.
Regarding claim 8, modified Cantor fails to explicitly disclose the limitations of the claim.
However, Gaw further teaches wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals with a combination of concurrent signals and sequential signals (Par. 254-255).
Therefore, it would have been further obvious to modify the system of Cantor, Gaw, Franco, and NPL with that of Gaw to include wherein the first controller is configured to control the source to provide the two or more transmit electrodes with the first signals with a combination of concurrent signals and sequential signals for the reasoning as indicated above in claim 4.
Regarding claim 13, modified Cantor fails to explicitly disclose the limitations of the claim.
However, Gaw further teaches wherein the data quality requirements include checking if each of the corresponding impedances is in a selected range (Par. 319, “Once all the electrode configurations are complete for a specific site, the measuring device 400 or the computer system 420 is used to analyse the impedance values and determine if the impedance measurements are indicative of a tissue anomaly.”) (Par. 324 (determination on whether an anomaly is present based on a threshold)) (Par. 328, “if the reference is exceeded and the result is determined to be indicative of a tissue anomaly at step 580, then the site is identified as a tissue anomaly at step 590, in which case an appropriate indicator can be generated. The indicator could be indicative of the difference, the measured impedance values, impedance parameters, or the like....”).
Therefore, it would have been further obvious to modify the system of Cantor, Gaw, Franco, and NPL with that of Gaw to include wherein the data quality requirements include checking if each of the corresponding impedances is in a selected range as it would have yielded the predictable result of ensuring that any measured impedance was in a healthy range or one that indicated an anomaly (Gaw (Par. 325)).
Regarding claim 14, modified Cantor further discloses wherein the first data further comprises at least one of each of the impedances at the different frequencies, a patient's information including age and pregnancy stage, pH level, metabolites, temperature, and human microbiome (Par. 51).
Regarding claim 15, modified Cantor further discloses wherein the data quality requirements include checking if the at least one of each of the impedances at the different frequencies, the patient's information, pH level, metabolites, temperature, and human microbiome are within a selected range (Par. 53 (comparison to base data of typical values)).
Regarding claim 16, modified Cantor further discloses wherein the user interface (interface device – 14) is configured to notify the information with numerical values (Par. 57).
Regarding claim 17, modified Cantor further discloses wherein the