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 .
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] recites related application 15/766981 which has now been abandoned the paragraph should be updated to indicate the current status of the application.
Appropriate correction is required.
Claim Objections
Claims 8-16 are objected to because of the following informalities: Claim 8, line 3 should recite similar to –at least in part—in order to fix an inadvertent typographical error. Appropriate correction is required. Claims 9-16 directly or indirectly depend from claim 8 and are also objected to for the reasons stated above regarding claim 8.
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 2-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 2 is/are drawn to an apparatus which is/are a statutory category of invention (Step 1: YES).
The claim limitations within independent 2 that set forth or describe the abstract idea is/are: “receive input comprising signal data originating from one or more sensors positioned outside a chest of an individual and having direct or indirect mechanical contact with the chest of the individual, determine a distribution of energy of at least one heartbeat of the individual based on the signal data, and determine a risk of the cardiac abnormality of the individual based on the determined distribution of energy”. The reasons that the limitations is/are considered an abstract idea is/are the following: The limitations of, “receive input comprising signal data originating from one or more sensors positioned outside a chest of an individual and having direct or indirect mechanical contact with the chest of the individual, determine a distribution of energy of at least one heartbeat of the individual based on the signal data, and determine a risk of the cardiac abnormality of the individual based on the determined distribution of energy” is a process that under its broadest reasonable interpretation covers performance of the limitation in the mind with the assistance of pen and paper but for the recitation of generic computer components. That is, other than reciting “one or more processors configured to”, nothing in the claim element precludes the steps from practically being performed in the mind with the aid of pen and paper. For example but for the “one or more processors configured to”, “receive input comprising signal data originating from one or more sensors positioned outside a chest of an individual and having direct or indirect mechanical contact with the chest of the individual, determine a distribution of energy of at least one heartbeat of the individual based on the signal data, and determine a risk of the cardiac abnormality of the individual based on the determined distribution of energy” in the context of this claim encompasses the user receiving signal data on screen or printout and determining, with the aid of pen and paper, a distribution of energy and a risk of cardiac abnormality based on the determined distribution of energy. There is nothing to suggest an undue level of complexity in the steps of form/forming and set/setting. If a claim limitation, under its broadest reasonable interpretation covers a metal process, i.e. performance of the limitation in the mind, but for the recitation of generic computer components, then it falls with the “Mental Processes” grouping of abstract ideas. Accordingly the claims recite an abstract idea. Although not drawn to the same subject matter, the claimed limitation(s) is/are similar to concepts that have been identified as abstract by the courts, such as: collecting information, analyzing it, and reporting certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016), selecting certain information, analyzing it using mathematical techniques, and reporting or displaying the results of the analysis in SAP America Inc. v. Investpic, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed Cir. 2018). Additionally, the limitations of, “determine a distribution of energy of at least one heartbeat of the individual based on the signal data”, cover an abstract idea that is part of mathematical concepts. “A mathematical formula or equation will be considered as falling with the ‘mathematical concepts” grouping....”. October 2019 Update: Subject Matter Eligibility, “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at Il. A. ii. See for example, Diamond v. Diehr, 450 U.S. 175, 177 n.2, 179 n.5, 191-92 (1981) or Parker v. Flook 437 U.S. 584, 585, 198 USPQ 193, 195 (1978) (calculating a number representing an alarm limit using a mathematical formula). The claimed steps of ““determine a distribution of energy of at least one heartbeat of the individual based on the signal data” recite a mathematical concept (i.e., mathematical formulas or equations, and mathematical calculations). The claimed steps recite performing a mathematical formula or equation to determine a distribution of energy of at least one heartbeat of the individual based on the signal data but for the recitation of generic computer components. The specification recites utilizing the “Welch Method” which includes a discrete Fourier transform for determining a distribution of energy, see para. [0054]-[0056] of published application 2025/0302338. If a claim limitation, under its broadest reasonable interpretation covers a mathematical formula or equation but for the recitation of generic computer components, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly the claims recite an abstract idea. Although not drawn to the same subject matter, the claimed limitation(s) is/are similar to concepts that have been identified as abstract by the courts, such as: a formula for computing an alarm limit in Parker v. Flook 437 U.S. 584, 585, 198 USPQ 193, 195 (1978), the Arrhenius equation in Diamond v. Diehr, 450 U.S. 175, 177 n.2, 179 n.5, 191-92 (1981). Thus, the claim(s) are directed to a judicial exception and fall squarely within the realm of "abstract ideas," which is a patent-ineligible concept (Step 2A: Prong One YES).
Analyzing the claim as whole for a practical application, the claim does not include additional elements/steps that are sufficient to amount to significantly more than the judicial exception. The additionally recited element(s) appended to the abstract idea in claim 2 include: “a memory” and “one or more processors”. As discussed above with respect to integration of abstract idea into a practical, the additional element of “a memory” and “one or more processors configured to” perform the receiving and determining steps amount to no more than mere instruction to apply the exception using generic computer components. The “a memory” and “one or more processors configured to” are purely general-purpose computer components recited as carrying out the general-purpose computer functions of storing data, processing data and displaying to enable the abstract process. As such, this/these recitation(s) is/are nothing more than nominal recitation(s) of a computer covering an abstract concept. See Bancorp Servs. v. Sun Life Assurance Co., 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Circ. 2012). See also Mayo Collaborative Services v. Prometheus Laboratories Inc., 101 USPQ2d 1961 (U.S. 2012), which establishes that a claim cannot simply state the abstract idea and add the words "apply it”, see MPEP 2106.05(f). Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (Step 2A, Prong Two, NO).
Claim 2 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all the additional elements being purely general-purpose computer components recited as carrying out the general-purpose computer functions of storing data, processing data and displaying to enable the abstract process, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Similarly, when considered as an ordered combination, the additional components/steps of the claim(s) add nothing that is not already present when the steps are considered separately (Step 2B: NO). The claims are not patent eligible.
Claim(s) 3-23 depend directly or indirectly from claim(s) 2. Therefore, the dependent claims rely upon the same abstract idea as the independent claim(s), as set forth above. Additionally, the dependent claims do nothing more than further limiting the abstract idea while failing to qualify as "significantly more", and the specificity of an abstract idea does not make it any "less abstract" as it is still directed to concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work subject matter. Therefore, the dependent claim(s) are also not patent eligible for the reasons discussed above. Claim(s) 4-15 and 22 fail(s) to provide significantly more, when considered as an ordered combination, as it/they merely provide further limitation regarding determining a distribution of energy and/or risk of cardiac abnormality, which can still nonetheless be considered mathematical concepts and/or mental processes, i.e. performed by a human using a pen and paper. Claim(s) 3,19-21 and 23 fail(s) to provide significantly more, when considered as an ordered combination, as it/they merely provide further limitation regarding the “data gathering” in particular sensors used for the “data gathering” which merely: add insignificant extra-solution activity, and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to mere data gathering, which is a form of insignificant extra-solution activity (pre-solution activity). All uses of the recited judicial exception require the pre-solution activity of data gathering. Claim(s) 16-18 fail(s) to provide significantly more, when considered as an ordered combination, as it/they merely provide further limitation regarding an alert and/or transmitting the signal data which is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to insignificant application, which is a form of insignificant extra-solution activity (post-solution activity), see MPEP 2106.05(g). As such, this/these recitation(s) is/are nothing more than nominal recitation(s) of a computer covering an abstract concept. See Bancorp Servs. v. Sun Life Assurance Co., 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Circ. 2012). See also Mayo Collaborative Services v. Prometheus Laboratories Inc., 101 USPQ2d 1961 (U.S. 2012), which establishes that a claim cannot simply state the abstract idea and add the words "apply it”.
The instantly rejected claim(s) are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. In the interest of advancing prosecution, the examiner suggests: providing evidence, for example, delineating how the abstract idea and/or additional elements appended to the abstract idea results in an improvement to the technology/technical field, which can show eligibility and/or adding a practical application of the claimed method outside of the computer (e.g. treating a patient). See MPEP § 716.01(c) for examples of providing evidence supported by an appropriate affidavit or declaration. For additional guidance, applicant is directed generally to MPEP § 2106.
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.
Claims 2-10 and 12-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 03/061473 to Elle et al. (Elle) in view of WO 2015/036925 to Meriheina et al. (Meriheina) (both cited by applicant).
In reference to at least claims 2 and 23
Elle discloses a system for identifying a cardiac abnormality comprising: a memory (e.g. inherent within the signal processing unit 11 since data is stored for further analysis by the signal processing unit); and one or more processors (e.g. signal processing unit 11) configured to: receive input comprising signal data originating from one or more sensors (e.g. ai, signal from the sensor for rotary movement, p. 17 Il. 1-9); determine a distribution of energy of at least one heartbeat of the individual based on the signal data (e.g. Ai, p. 8 I. 20-p.11 I. 5, p. 11 Il. 1-11, sum of squares of the differences between Ai and the standard set, p. 11 I. 14-16, Euclidean distance on p. 13 Il. 23-24) and determine a risk of the cardiac abnormality of the individual based on the determined distribution of energy (e.g. “Changes in the frequency distribution can then be seen as a measurement of imminent ischemia” p. 11 Il. 1-2, “A large sum of squares indicates abnormal heart activity.” p. 11, Il. 15-16, p. 13 Il. 25-28).
However, Elle does not explicitly disclose the one or more sensors positioned outside a chest of an individual and having direct or indirect mechanical contact with the chest of the individual.
Meriheina, within the same field of heart monitoring, discloses a heart monitoring system that includes a sensor such as a gyroscope (e.g. 400, “multi-axis gyroscope”, p. 12, ll. 12-30, p. 13, ll. 1-5, 19-27) that is positioned outside a chest of an individual and having direct or indirect mechanical contact with the chest of the individual (e.g. 400, Fig. 4). Meriheina also discloses that it is known that microelectromechanical structures can be applied to quickly and accurately detect very small changes in physical properties and can be applied to quickly and accurately detect very small angular displacements (e.g. “It is known that microelectromechanical (MEMS) structures can be applied to quickly and accurately detect very small changes in physical properties. A microelectromechanical gyroscope can be applied to quickly and accurately detect very small angular displacements.” p. 8, l. 24 – p. 9, l. 12).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Elle to include utilizing one or more sensors positioned outside a chest of an individual and having direct or indirect mechanical contact with the chest of the individual for receiving the signal data related to the heart, as taught by Meriheina, in order to provide a noninvasive technique for monitoring the heart that allows ambulatory and long-term monitoring of the heart outside a clinical environment (‘152, para. [0004]).
In reference to at least claim 3
Elle modified by Meriheina renders obvious a system according to claim 2. Elle further discloses wherein the one or more sensors comprise a gyroscope, or an accelerometer, or both (e.g. “gyroscope for measuring rotary movement”, p. 17, ll. 3-6, “Preferably, the motion sensor comprises an accelerometer that is sensitive to acceleration in at least one direction, p. 17, ll. 1-2, 21-23). Meriheina further discloses wherein the one or more sensors comprise a gyroscope, or an accelerometer, or both (e.g. “multi-axial gyroscope”, p. 12,ll. 12-30, p. 13, ll. 1-2, 20-25).
In reference to at least claim 4
Elle modified by Meriheina renders obvious a system according to claim 2. Elle further discloses wherein the distribution of energy comprises an energy spectral density (ESD) (e.g. “frequency distribution of a signal”, p.8, l. 20-p. 11, l.5, p. 11, ll. 1-11, p. 13, ll. 5-22).
In reference to at least claim 5
Elle modified by Meriheina renders obvious a system according to claim 4. Elle further discloses the processing unit computing the energy spectral density (e.g. p. 81. 20-p.11 I. 5, p. 11 II. 1-11, p. 13 II. 5-22), it was well known in the art before the effective filing date of the invention to perform statistical analysis of sensed data to calculate an average, median or certain values represented over a time period of interest, therefore it would have been well within the level of one having ordinary skill in the art at the time of the invention to include calculating an estimate of the energy over a certain time period, computing an average frequency of the energy spectral density and computing a median frequency of the energy spectral density as the recited calculations are known statistical techniques for processing and analyzing information to determine various values, such as a median value or average value for a set of data, and would have yield the predictable result of providing additional information to aid in further detecting any adverse conditions and determining the patient's cardiac health.
In reference to at least claim 6
Elle modified by Meriheina renders obvious a system according to claim 2. Elle further discloses wherein the one or more processors are further configured to determine, over a predetermined time period, the distribution of energy of the at least one heartbeat (e.g. “frequency distribution of a signal”, p.8, l. 20-p. 11, l.5, p. 11, ll. 1-11, p. 13, ll. 5-22), and wherein the risk of the cardiac abnormality is based at least in part on the distribution of energy (e.g. “Changes in the frequency distribution can then be seen as a measurement of imminent ischemia” p. 11 Il. 1-2, “A large sum of squares indicates abnormal heart activity.” p. 11, Il. 15-16, p. 13 Il. 25-28).
In reference to at least claim 7
Elle modified by Meriheina renders obvious a system according to claim 6. Elle further discloses wherein the predetermined time period comprises one or more heartbeat periods (e.g. various intervals, p. 10, 11. 17-30).
In reference to at least claim 8
Elle modified by Meriheina renders obvious a system according to claim 6. Elle further discloses wherein the one or more processors are further configured to dynamically generate one or more threshold values relating to the distribution of energy, and wherein the risk of the cardiac abnormality is based at last in part on the dynamically generated one or more threshold values (e.g. “Based on this, we envisage that one set of Ai can be determined, which applies to a normal, healthy heart, and then a subsequent sequence A' i can be compared with this standard, e.g. by calculating the sum of squares of the differences Ai - A'i· This yields a single number that measures the deviation from normal activity.”, p. 9, ll. 5-13, p. 11. ll. 14-16, p. 18, ll. 1-7).
In reference to at least claim 9
Elle modified by Meriheina renders obvious a system according to claim 8. Elle further discloses wherein the one or more processors are further configured to dynamically generate the one or more threshold values based at least in part on: (i) a normal value of the individual, (ii) a normal value for a population, or both (i) and (ii) (e.g. “Based on this, we envisage that one set of Ai can be determined, which applies to a normal, healthy heart, and then a subsequent sequence A'i can be compared with this standard, e.g. by calculating the sum of squares of the differences Ai - A'i· This yields a single number that measures the deviation from normal activity.”, p. 9, ll. 5-13, p. 11. ll. 14-16, p. 18, ll. 1-7).
In reference to at least claim 10
Elle modified by Meriheina renders obvious a system according to claim 9. Elle further discloses wherein the normal value for the population of (ii) comprises one or more reference values (e.g. “Based on this, we envisage that one set of Ai can be determined, which applies to a normal, healthy heart, and then a subsequent sequence A'i can be compared with this standard, e.g. by calculating the sum of squares of the differences Ai - A'i· This yields a single number that measures the deviation from normal activity.”, p. 9, ll. 5-13, “Compare the set Ai with a standard set for a healthy heart by calculating the sum of squares of the differences between Ai and the standard set. A large sum of squares indicates abnormal heart activity” p. 11. ll. 14-16, p. 18, ll. 1-7).
In reference to at least claim 12
Elle modified by Meriheina renders obvious a system according to claim 8. Elle further discloses wherein the one or more processors are further configured to determine a change in at least one energy level of the distribution of energy over the predetermined time period (e.g. sum of squares of the differences between Ai and the standard set, p. 11 I. 14-16, Euclidean distance p. 13 II. 23-24).
In reference to at least claim 13
Elle modified by Meriheina renders obvious a system according to claim 12. Elle further discloses wherein the one or more processors are further configured to determine a change in at least one energy level of the distribution of energy over the predetermined time period (e.g. sum of squares of the differences between Ai and the standard set, p. 11 I. 14-16, Euclidean distance on p. 13 II. 23-24).
In reference to at least claim 14
Elle modified by Meriheina renders obvious a system according to claim 13. Elle further discloses wherein the one or more processors are further configured to compare the change in the at least one energy level to the dynamically generated one or more threshold values (e.g. “Based on this, we envisage that one set of Ai can be determined, which applies to a normal, healthy heart, and then a subsequent sequence A' i can be compared with this standard, e.g. by calculating the sum of squares of the differences Ai - A'i· This yields a single number that measures the deviation from normal activity.”, p. 9, ll. 5-13, p. 11. ll. 14-16, p. 18, ll. 1-7).
In reference to at least claim 15
Elle modified by Meriheina renders obvious a system according to claim 14. Elle further discloses wherein the one or more processors are further configured to determine the risk of the cardiac abnormality of the individual based at least in part on the comparison (e.g. “Changes in the frequency distribution can then be seen as a measurement of imminent ischemia” p. 11 Il. 1-2, “A large sum of squares indicates abnormal heart activity.” p. 11, Il. 15-16, p. 13 Il. 25-28).
In reference to at least claim 16
Elle modified by Meriheina renders obvious a system according to claim 14. Elle further discloses wherein the one or more processors are further configured to generate an output comprising an alert when the change in the at least one energy level is greater than the dynamically generated one or more threshold values (e.g.” this change can trigger an alarm for taking the required measures. I.e. when the frequency distribution dips below a predetermined value, the alarm is triggered.”, p. 11, ll. 2-4, p. 13, ll. 25-28, “an alarm transmitter designed to emit an alarm signal when the deviation from said standard distribution exceeds a certain level.”, p. 18, ll. 5-7).
In reference to at least claim 17
Elle modified by Meriheina renders obvious a system according to claim 2. Elle further discloses wherein the one or more processors are further configured to generate an alert based at least in part on a determination of an increase of the risk of the cardiac abnormality (e.g.” this change can trigger an alarm for taking the required measures. I.e. when the frequency distribution dips below a predetermined value, the alarm is triggered.”, p. 11, ll. 2-4, p. 13, ll. 25-28, “an alarm transmitter designed to emit an alarm signal when the deviation from said standard distribution exceeds a certain level.”, p. 18, ll. 5-7).
In reference to at least claim 18
Elle modified by Meriheina renders obvious a system according to claim 2. Elle further discloses an external data transfer system configured to (i) receive the signal data from the one or more sensors and (ii) transmit the signal data to the one or more processors (e.g. “The registered movement is transmitted to a calculation unit located externally of the patient”, p. 17, ll. 8-9). Meriheina also discloses an external data transfer system configured to (i) receive the signal data from the one or more sensors and (ii) transmit the signal data to the one or more processors (e.g. “processed locally in the mobile computing device, and/or to be transmitted to a remote location for further processing, or to be analyzed, for example by a physician.”, p. 12, ll. 26-30).
In reference to at least claim 19
Elle modified by Meriheina renders obvious a system according to claim 2. Elle further discloses wherein the signal data comprises rotation signal data (e.g. “gyroscope for measuring rotary movement”, p. 17, ll. 3-6, “Preferably, the motion sensor comprises an accelerometer that is sensitive to acceleration in at least one direction, p. 17, ll. 1-2, 21-23). Meriheina further discloses wherein the one or more sensors comprise a gyroscope, or an accelerometer, or both (e.g. “multi-axial gyroscope”, p. 12,ll. 12-30, p. 13, ll. 1-2, 20-25).
In reference to at least claim 20
Elle modified by Meriheina renders obvious a system according to claim 19. Meriheina further discloses wherein the rotation signal data relates to rotational movement of the chest of the individual (e.g. “cardiovascular rotation”, p. 3, ll. 17-20, p. 8, ll. 11-13, p. 19, ll. 15-28, p. 12,ll. 12-30, p. 13, ll. 1-2, 20-25).
In reference to at least claim 21
Elle modified by Meriheina renders obvious a system according to claim 20. Meriheina further discloses wherein the rotational movement of the chest of the individual relates to cardiac rotation (e.g. “cardiovascular rotation”, p. 3, ll. 17-20, p. 8, ll. 11-13, p. 19, ll. 15-28, p. 12,ll. 12-30, p. 13, ll. 1-2, 20-25).
In reference to at least claim 22
Elle modified by Meriheina renders obvious a system according to claim 2. Elle further discloses wherein the cardiac abnormality comprises one or more of: cardiac ischemia, myocardial infarction, carditis, myocarditis, pericarditis, perimyocarditis, or myopericarditis (e.g. “Changes in the frequency distribution can then be seen as a measurement of imminent ischemia” p. 11 Il. 1-2, “A large sum of squares indicates abnormal heart activity.” p. 11, Il. 15-16, p. 13 Il. 25-28).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached on Mon-Fri 7:30AM - 3:30PM ET.
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/JENNIFER L GHAND/Examiner, Art Unit 3796
Prosecution Insights