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 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.
1. 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:
The “data collection module” of claim 1 is being interpreted as a computer/software system that can receive beat-to-beat interval equivalent data from the biometric data on a subject
The “Lorenz plot generation module” of claim 1 is being interpreted as a computer/software system that can calculate a Lorenz plot from the beat-to-beat interval equivalent data at a predetermined period.
The “abnormal value chronic occurrence evaluation module” of claim 7 is being interpreted as a computer/software that can calculate a feature amount in a region defined in advance on the aggregate Lorenz plot, calculate a degree of occurrence of an arrhythmia-like abnormal value as abnormality degree data based on the feature amount, and output the abnormality degree data.
The “inadequate person determination module” of claim 8 is being interpreted as a software/computer system that can calculate an occurrence frequency of the arrhythmia-like abnormal value from the aggregate Lorenz plots in a third period equal to or longer than the first period, and determine whether the subject is adequate for autonomic nerve function evaluation.
The “autonomic nerve function index calculation module” of claim 9 is being interpreted as a computer/software system that can calculate an autonomic nerve function index based on the beat-to-beat interval equivalent data on the subject adequate for the autonomic nerve function evaluation based on a result of the determination performed by the inadequate person determination module, and output the autonomic nerve function index.
The “warning presentation module” of claim 10 is being interpreted as a computer/software system that can determine reliability of the autonomic nerve function index based on the arrhythmia-like abnormal value, and display the reliability of the autonomic nerve function index on an output device.
The “danger prediction module” of claim 11 is being interpreted as a computer/software system that can calculate, as an accident risk, a probability that the subject is to cause one of an accident or an incident after a predetermined time period, based on the autonomic nerve function index, wherein the warning presentation module is configured to issue an alert for warning about an increase in accident risk to the subject having the accident risk exceeding a predetermined threshold value.
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.
2. Claims 1-15 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.
With respect to claims 1-15, the claims recite the steps of using several different modules to make determinations/predictions from obtained data. However, the specification does not provide any working examples, guidance, or steps as to how this function is achieved. Rather, the specification only mentions the use of computing/software means. For example, looking at claim 6, it recites “an abnormal value chronic occurrence evaluation module configured to calculate a feature amount in a region defined in advance on the aggregate Lorenz plot, calculate a degree of occurrence of an arrhythmia-like abnormal value as abnormality degree data based on the feature amount, and output the abnormality degree data.” However, is it not clear how this specific module is making these calculations or these outputs. This is the same for all of the claims and their various modules; there is no real description for how these modules are performing their claimed functions other than by using computing software.
As noted in the MPEP, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient).
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement
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.
3. Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The independent claims 1, 12, and 14 recite systems comprising “data collection module configured to receive beat-to-beat interval equivalent data from the biometric data on a subject; and a Lorenz plot generation module configured to calculate a Lorenz plot from the beat-to-beat interval equivalent data at a predetermined period, and output the obtained Lorenz plots as an aggregate Lorenz plot a method for generating a treatment recommendation to a patient based on patient data” with these systems comprising processors, sensors, and memories. The limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, a user could look at heart rate data, such as beat to beat interval data, create a Lorenz plot of this data, and make determinations on the health of the user from this plot (as is being done in the dependent claims.) If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. This judicial exception is not integrated into a practical application.
The components are recited at a high-level of generality such that it amounts no more than any structure that gather heart/biometric data and make plots and predictions. Further, the use of sensors, processors, and memories, are merely insignificant extra-solution activity of data gathering. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The additional elements, such as the sensor to gather patient data and a processor and memory to analyze and store data, while being mere structures for data gathering are also well-understood, routine, conventional activity that is widely prevalent or common use in the relevant industry. The use of sensors/processors/memories to gather/analyze/store patient information are well known in the art as disclosed by the following references: US 20150164349 A1 and US 20070032733 A1. Well-understood, routine and conventional activity cannot be significantly more than the abstract idea itself. The claims are not patent eligible.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claim(s) 1-7 and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gopalakrishnan (US 20150164349 A1).
In regards to claim 1, Gopalakrishnan discloses a biometric data evaluation server (Abstract and Par. 0009 teach a biometric system that can measure heart data) including a processor and a memory for evaluating biometric data (Par. 0060 teaches a processor and memory), the biometric data evaluation server comprising:
a data collection module configured to receive beat-to-beat interval equivalent data from the biometric data on a subject (Par. 0050 teaches providing heart rate signals and R-R intervals to a computing device, i.e. a data collection module); and
a Lorenz plot generation module configured to calculate a Lorenz plot from the beat-to-beat interval equivalent data at a predetermined period), and output the obtained Lorenz plots as an aggregate Lorenz plot (Par. 0052 teaches taking the data and using algorithms to create a Lorenz plot of the heart rate data).
In regards to claims 2 and 4, Gopalakrishnan discloses the biometric data evaluation server in accordance with claim 14 wherein the predetermined period includes a first period and a second period shorter than the first period, and wherein the Lorenz plot generation module is configured to calculate the Lorenz plot from the beat-to-beat interval equivalent data in units of the second period, subject the Lorenz plots calculated in units of the second period to aggregation processing in units of the first period to calculate the aggregate Lorenz plot corresponding to the first period, and output the aggregate Lorenz plot corresponding to the first period (Par. 0068 teaches that the heart beat data can be taken over periods, some being shorter than others; Par. 0052 teaches the Lorenz plotting and Par. 0010 further teaches plotting HRV on a display)
In regards to claims 3 and 5, Gopalakrishnan discloses the biometric data evaluation server in accordance with claim 2 wherein the Lorenz plot generation module is configured to determine presence or absence of a lack in the beat-to-beat interval equivalent data from the Lorenz plot calculated in units of the second period, and exclude a lacking portion of the beat-to-beat interval equivalent data in units of the second period, to thereby perform the aggregation processing to calculate the aggregate Lorenz plot corresponding to the first period (Par. 0070 teaches that irregular heart rate data or absence of P waves in the heart beats can be taken into account when making analyses. Par. 0052 teaches the Lorenz plotting and Par. 0010 further teaches plotting HRV on a display)
In regards to claim 6, Gopalakrishnan discloses the biometric data evaluation server in accordance with claim 2 wherein the Lorenz plot generation module is configured to calculate, as the aggregation processing, statistics in units of the first period for each of matrix components of Lorenz plot matrices representing a plurality of the Lorenz plots calculated in units of the second period (Par. 0052 teaches plotting R-R statistics woth adaptive weighting factors).
In regards to claim 7, Gopalakrishnan discloses the biometric data evaluation server in accordance with claim 2, further comprising an abnormal value chronic occurrence evaluation module configured to calculate a feature amount in a region defined in advance on the aggregate Lorenz plot, calculate a degree of occurrence of an arrhythmia-like abnormal value as abnormality degree data based on the feature amount, and output the abnormality degree data (Par. 0081-0086 teaches using a computing means to take in the heart rate variability (i.e. Lorenz plot data) and heart beat data to then determine if an arrhythmia is occurring).
In regards to claim 12, Gopalakrishnan discloses a biometric data evaluation system for evaluating biometric data (Abstract and Par. 0009 teach a biometric system that can measure heart data), the biometric data evaluation system comprising:
a biometric data evaluation server including a processor and a memory (Par. 0060); and
a moving object including a biometric sensor (Par. 009 and 0019 teaches a biometric sensor worn on a watch, i.e. moving object),
wherein the moving object includes a data collection device configured to cause the biometric sensor to detect biometric data including beat-to-beat interval equivalent data from a subject (Par. 0048 teaches collecting biometric data from the user; Par. 0050 teaches providing heart rate signals and R-R intervals), and
transmit the biometric data to the biometric data evaluation server (Par. 0050), and
wherein the biometric data evaluation server includes:
a data collection module configured to receive the biometric data, and receive the beat-to-beat interval equivalent data (Par. 0048 teaches collecting biometric data/heart rate/beat data from the user); and
a Lorenz plot generation module configured to calculate a Lorenz plot from the beat-to-beat interval equivalent data at a predetermined period, and output the obtained Lorenz plots as an aggregate Lorenz plot (Par. 0052 teaches taking the data and using algorithms to create a Lorenz plot of the heart rate data).
In regards to claim 13, Gopalakrishnan discloses the biometric data evaluation system in accordance with claim 12 wherein the predetermined period includes a first period and a second period shorter than the first period, and wherein the Lorenz plot generation module is configured to calculate the Lorenz plot from the beat-to-beat interval equivalent data in units of the second period, aggregate the Lorenz plots calculated in units of the second period in units of the first period to calculate the aggregate Lorenz plot corresponding to the first period, and output the aggregate Lorenz plot corresponding to the first period (Par. 0068 teaches that the heart beat data can be taken over periods, some being shorter than others; Par. 0052 teaches the Lorenz plotting and Par. 0010 further teaches plotting HRV on a display)
In regards to claim 14, Gopalakrishnan discloses a biometric data evaluation method performed by a computer including a processor and a memory to evaluate biometric data (Par. 0009 and 0060), the biometric data evaluation method comprising:
a data collection step of receiving, by the computer, beat-to-beat interval equivalent data from the biometric data on a subject (Par. 0050 teaches providing heart rate signals and R-R intervals to a computing device, i.e. a data collection module); and
a Lorenz plot generation step of calculating, by the computer, a Lorenz plot from the beat-to-beat interval equivalent data at a predetermined period, and output the obtained Lorenz plots as an aggregate Lorenz plot (Par. 0052 teaches the Lorenz plotting and Par. 0010 further teaches plotting HRV on a display).
In regards to claim 15, Gopalakrishnan discloses the biometric data evaluation method in accordance with claim 14 wherein the predetermined period includes a first period and a second period shorter than the first period, and wherein the Lorenz plot generation step includes calculating the Lorenz plot from the beat-to-beat interval equivalent data in units of the second period, aggregating the Lorenz plots calculated in units of the second period in units of the first period to calculate the aggregate Lorenz plot corresponding to the first period, and outputting the aggregate Lorenz plot corresponding to the first period (Par. 0068 teaches that the heart beat data can be taken over periods, some being shorter than others; Par. 0052 teaches the Lorenz plotting and Par. 0010 further teaches plotting HRV on a display)
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.
5. Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gopalakrishnan in view of Burton (US 20070032733 A1).
In regards to claims 8-11, Gopalakrishnan discloses the biometric data evaluation server in accordance with claim 7, except for it further comprising an inadequate person determination module configured to calculate an occurrence frequency of the arrhythmia-like abnormal value from the aggregate Lorenz plots in a third period equal to or longer than the first period, and determine whether the subject is adequate for autonomic nerve function evaluation; using an autonomic nerve function index calculation module configured to calculate an autonomic nerve function index based on the beat-to-beat interval equivalent data on the subject adequate for the autonomic nerve function evaluation based on a result of the determination performed by the inadequate person determination module, and output the autonomic nerve function index; using a warning presentation module configured to determine reliability of the autonomic nerve function index based on the arrhythmia-like abnormal value, and display the reliability of the autonomic nerve function index on an output device; and using a danger prediction module configured to calculate, as an accident risk, a probability that the subject is to cause one of an accident or an incident after a predetermined time period, based on the autonomic nerve function index, wherein the warning presentation module is configured to issue an alert for warning about an increase in accident risk to the subject having the accident risk exceeding a predetermined threshold value.
However, in the same field of endeavor, Burton teaches a system for monitoring HRV in subjects to detect cardiac abnormalities (Abstract) wherein the system can look at heart rate and HRV data and to determine if the autonomic activity is as desired or if it is abnormal, the system then determine that autonomic activity is abnormal and issue a warning via a display to the user (Par. 0074-0088) in order to help prevent arrhythmias (Par. 0076).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Gopalakrishnan and modified them by having the system observe the autonomic nerve/system for abnormalities, as taught and suggested by Burton, in order to help prevent arrhythmias (Par. 0076 of Burton).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
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/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792