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 .
The current application has the effective filing date of 04/21/2022.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
To claim 1, the following limitations are indefinite for reasons mentioned below:
“based on results of analysis processing automatically executed a plurality of times on an electrocardiogram continuously obtained from a subject…” It is unclear whether this limitation refers to: processing electrocardiogram a plurality of times, processing electrocardiogram into plurality of time (periods), or continuously obtaining electrocardiogram a plurality of times, or processing the electrocardiogram signals to determine a plurality of time (periods).
“each lead in the electrocardiogram” lacks proper antecedent basis.
“a second region for presenting an ST level of each lead” and “wherein leads of which the ST level is presented in the second region include a lead included in the electrocardiogram obtained from the subject and a composite lead” appears redundant, because there is no suggestion in claim 1 of acquiring electrocardiogram from other subject or sources. It is the Examiners best guess that these limitations refer to presenting ST level of unipolar lead(s), and a composite lead.
The limitation “composite processing” is not defined in this claim. It is unclear how this differs from “analysis processing” already recited this claim.
The Examiner notes that other interpretations (not discussed here) are possible due to translation from Japanese. The Applicant is sincerely requested to amend the claims for clarity.
Independent claims 19 and 20 are analogous to claim 1, and thus rejected as indefinite for the same rationale.
Dependent claims which recite “analysis processing executed the plurality of times” are also rejected as indefinite for the same reasons discussed under claim 1 above; this includes at least claims 2-4, 19 and 20.
Further to claim 3, the claim recites “a predetermined period”, but this term is indefinite as it is unclear what this time period is in relation to, and/or how it is tied to the “plurality of time” cited in earlier claims. Further, the terms “first analysis processing executed in the predetermine period”, and “last analysis processing executed in the predetermined period” are also indefinite as there is distinct difference between said “first analysis processing” and “last analysis processing.”
To claim 4, the term “in a predetermined period” is indefinite.
To claim 5, “a period after it is determined that ACS is suspected for the patient” lacks antecedent basis, neither claim 1 nor claim 3 (from which claim 5 depends from) discusses detecting ACS. Only claim 1 recites providing a report for making a diagnosis on a possibility of ACS, but there is no distinct recitation a diagnosis is actually made or a period of time from the electrocardiogram signal indicative of ACS is clearly identified.
To claim 8, the term “with use of” is rejected as indefinite, as it fails to clearly disclose how the “radar chart” is being ‘used’. See MPEP 2173.05(q).
Claim 9 recites “a radar chart” twice, and it is unclear whether this refers to the same or different relative to that recited the same claim and claim 8.
To claim 10, the terms “a predetermined period” and “first analysis processing” are indefinite as discussed in previous claims.
To claim 11, the term “with use of” is rejected as indefinite, as it fails to clearly disclose how the “bar graph” is being ‘used’. See MPEP 2173.05(q).
Claim 12 recites “a bar chart” twice, and it is unclear whether this refers to the same or different relative to that recited the same claim and claim11.
To claim 13, the terms “a predetermined period” and “first analysis processing” are indefinite as discussed in previous claims.
To claims 16 and 17, the term “a/the predetermined period” is indefinite as discussed in previous claims.
To claims 17 and 18, “a period after it is determined that ACS is suspected for the patient” lacks antecedent basis, none of the previous claims (from which claim 5 depends from) discusses detecting ACS. Only claim 1 recites providing a report for making a diagnosis on a possibility of ACS, but there is no distinct recitation a diagnosis is actually made or a period of time from the electrocardiogram signal indicative of ACS is clearly identified.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step (1): Independent claims 1, 19 and 20 are directed to an electrocardiograph (i.e. apparatus), a method and non0transitory computer-readable medium storing a program (i.e. apparatus), and thus, the claims all fall under one of the four patent eligible categories.
To Step 2(a) prong 1:
Independent claim 1 recites:
one or more processors that execute a program stored in a memory and thereby function as:
a controller configured to generate a report for making a diagnosis on a possibility of acute coronary syndromes (ACS), based on results of analysis processing automatically executed a plurality of times on an electrocardiogram continuously obtained from a subject, and to output the report, wherein the report includes:
a first region for presenting, with respect to each analysis processing, a waveform of each lead in the electrocardiogram of a predetermined period of time to which the analysis processing has been applied; and
a second region for presenting an ST level of each lead, wherein leads of which the ST level is presented in the second region include a lead included in the electrocardiogram obtained from the subject and a composite lead generated through composite processing based on the electrocardiogram obtained from the subject, and
the controller is configured to generate the report such that the report is shown on a single sheet output from a printer.
Under the broadest reasonable interpretation and the Examiner’s best guess (in view of plethora of 35 USC 112(b) rejections), claim 1 is directed to generating a report for making a diagnosis on a possibility of acute coronary syndromes (ACS) by obtaining an electrocardiogram, dividing the electrocardiogram into a plurality of time segments, analyzing the time segments, then generating a report comprising a first region of a waveform of each lead, and then a second region of an ST level of each lead, then printing out the report.
These various recited steps can be wholly performed in a person’s head by using a mental observation, analysis and judgement, the person can also use pen and paper to write out the analyzed results in the form of a report. Accordingly, claim 1 is directed to a judicial exception including one or more abstract ideas under the mental processes
Independent claims 19 and 20 are analogous to claim 1, and are thus rejected as patent ineligible for reciting abstract ideas under the same rationale.
As for dependent claims 2-18, these claims recited finding predetermine time periods, ST levels, outputting results in radar graphs, and outputting results in bar graphs, etc. These claims recited further abstract ideas which cover mental processes and/or mathematical relationships/calculations.
Under Step 2(a) prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claims 1, 19 and 20 recites “generating a report for making a diagnosis on a possibility of acute coronary syndromes (ACS), based on results of analysis processing…” Under BRI, this recitation requires outputting a report for making a diagnosis; in here the report is a interpreted as a tool for making the diagnosis- which can be performed by a human via mental processes. This limitation does not positively recite the controller outputting a diagnosis, and also does not disclose the steps for analyzing the electrocardiographs to derive said diagnosis. As such, the report, as drafted in the current independent claims fail to practically integrate the judicial exception under prophylaxis for a disease or medical condition.
Claims 1, 19 and 20 recites the additional elements of “controller”, “processor”, “printer”, “non-transitory computer-readable medium” and “program”; these additional elements do not practically integrate the judicial exception because these elements do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mathematical concepts grouping or the certain methods of organizing human activity grouping.
Under Step 2b: The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of “controller”, “processor”, “printer”, “non-transitory computer-readable medium” and “program”; in the field of medical (sensor) data analysis are well-understood, routine and conventional activities previously known in the industry as indicated in the following references provided in the Applicant’s own IDS:
Wang US 12015/0011902 A1 discloses a system for obtaining ECG, analyzing ECG and outputting graphical displays including radar graphs, see Figs.1-15.
Lindauer et al. US 2012/0323133 A1 discloses an ECG monitoring system that analyzes ECG signals of leads associated with different anatomical location of the body for evidence of ST elevation in the lead signals. See Abstract and Figs. 10-18.
Nelwan et al. US 2012/0083706 A1 discloses a system which measured values of ST segment deviations obtained form a multi-lead ECG; see Abstract and Figs. 4-7
Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 1-20 are thus rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-10, 14-15 and 17-20 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang US 2015/0011902 A1 (cited in Applicant’s IDS).
Note to Applicant: The claims are rejected under the Examiner’s best guess as noted in the 35 USC 112(b) and 35 USC 101 sections above.
Regarding claim 1, Wang discloses an electrocardiograph (Abstract and Fig.15: electronic patient monitoring device 50, [0022, 0064]) comprising:
one or more processors (see [0064] processor 60) that execute a program ([0066] “non-transitory storage medium storing instructions executable by an electronic data processor (e.g., processor 60) to perform the disclosed cardiac ischemia detection”) stored in a memory and thereby function as:
a controller (processor 60) configured to generate a report for making a diagnosis on a possibility of acute coronary syndromes (ACS) (“for making a diagnosis on a possibility of acute coronary syndromes (ACS)” is taken as intended use of the “report” limitation; the “report” is shown in exemplary graphical representation in Figs. 4-5. Also see [0035-0041], the graphical representation highlights ST elevations which can be used to diagnose ACS), based on results of analysis processing automatically executed a plurality of times (this is interpreted as plurality of analysis processes, this is taught in Fig. 15: iterative loop 70, see [0065] “The iterative loop 70 is re-executed each time the ECG acquisition sub-system 52 and ST values calculator 72 generate a new set of ST values.”) on an electrocardiogram continuously obtained from a subject ([0024-0029] Table 1, 12 lead ECG), and to output the report ([0044] “A graphical presentation is employed, in which both the ischemia criteria and the ST segment measurements to be tested are graphically presented simultaneously”), wherein the report includes:
a first region (Fig. 4-I is an exemplary upper window 6 graphical display) for presenting, with respect to each analysis processing, a waveform of each lead in the electrocardiogram of a predetermined period of time to which the analysis processing has been applied ([0042] twelve ECG traces for the twelve leads; also see Fig.5-I and [0045-0046]); and
a second region (Fig. 4-II is an exemplary lower window 8 graphical display) for presenting an ST level of each lead, wherein leads of which the ST level is presented in the second region ([0042] ST map; also see Fig.5-II and [0045-0046]) include a lead included in the electrocardiogram obtained from the subject and a composite lead generated through composite processing based on the electrocardiogram obtained from the subject (see [0042] leads include limb/unipolar leads and augment/composite leads, e.g. aVR, aVF, and aVL; alternatively see Table 1 ), and
the controller is configured to generate the report (e.g. Figs. 4 and 5 are exemplary reports) such that the report is shown on a single sheet output from a printer. ([0065] “The rendering is suitably displayed on a display device 84 (e.g., LCD screen) of the electronic patient monitoring device 50 and/or printed on a printing device.”)
Regarding claim 2, Wang discloses the electrocardiograph according to claim 1, wherein the report (Figs. 4-5) further includes a region for presenting a list of findings of abnormal electrocardiograms detected in the analysis processing executed the plurality of times. ([0067-0068] highlighting of the (possibly) ischemia-indicative overlap)
Regarding claim 3, Wang discloses the electrocardiograph according to claim 1, wherein the controller is further configured to include, in the analysis processing executed the plurality of times: analysis processing executed immediately before a predetermined period or first analysis processing executed in the predetermined period; and last analysis processing executed in the predetermined period. ([0034] “measuring the voltage difference between the value at the J-point or a point 60 or 80 milliseconds (ms) after the J-point and the isoelectric baseline”)
Regarding claim 4, Wang discloses the electrocardiograph according to claim 1, wherein the controller is further configured to include, in the analysis processing executed the plurality of times, at least one of analysis processing in which a maximum ST level is detected or analysis processing in which a finding of an abnormal electrocardiogram is detected, among analysis processing executed in a predetermined period. (Figs. 4-II and 5-II, [0045] ST area 26 where the polygonal ST area having vertices defined by measured ST values on axes representing electrocardiograph leads, ST values plotted to form a (irregular) hexagon allows for comparison with each other)
Regarding claim 5, Wang discloses the electrocardiograph according to claim 3, wherein the predetermined period is a period after it is determined that ACS is suspected for the subject. ([0038, 0065])
Regarding claim 6, Wang discloses the electrocardiograph according to claim 5, wherein it is determined that ACS is suspected for the subject based on a result of analysis processing or an ACS score of the subject. (ACS is suspected base on the output of graphical representation, i.e. [0006] “conditional upon determining that the measured ST values satisfy the ischemia criteria, highlighting an overlapping region between the polygonal ST area and the ischemia criteria area in the rendering.” Also see [0005: last sentence] and [0045-0046, 0065, 0067-0068]. Alternatively, also see Fig. 15: ischemia map rendering engine 82)
Regarding claim 7, Wang discloses the electrocardiograph according to claim 1, wherein the waveform presented in the first region is a representative waveform of a single heartbeat. (Fig.1, one cardiac cycle)
Regarding claim 8, Wang discloses the electrocardiograph according to claim 1, wherein the second region presents the ST level of each lead with use of a radar chart including axes corresponding to respective leads. (Figs. 4-II and 5-II)
Regarding claim 9, Wang discloses the electrocardiograph according to claim 8, wherein the second region includes a radar chart for presenting ST levels of limb leads and a radar chart for presenting ST levels of chest leads including the composite lead. (see Figs. 4-II and 5-II: limb leads and chest leads)
Regarding claim 10, Wang discloses the electrocardiograph according to claim 8, wherein the second region presents, with respect to each lead: an ST level detected in analysis processing executed immediately before a predetermined period or first analysis processing executed in the predetermined period; and a maximum ST level detected in analysis processing executed in the predetermined period, such that these ST levels can be compared with each other. (Figs. 4-II and 5-II, [0045] ST area 26 where the polygonal ST area having vertices defined by measured ST values on axes representing electrocardiograph leads, ST values plotted to form a (irregular) hexagon allows for comparison with each other)
Regarding claim 14, Wang discloses the electrocardiograph according to claim 8, wherein the ST level is a representative value of an ST level based on an amplitude or a timing. ([0033] “ST segment measurement values can be reported in millivolt (mV), microvolt (uV) or millimeter (mm)” This is taken as “amplitude” in the claim)
Regarding claim 15, Wang discloses the electrocardiograph according to claim 14, wherein the representative value of the ST level based on the amplitude is a maximum ST level. (Figs. 4-II and 5-II, [0045] ST area 26 where the polygonal ST area having vertices defined by measured ST values on axes representing electrocardiograph leads, highest value vertices is taken to encompass “maximum ST level” in this claim)
Regarding claim 17, Wang discloses the electrocardiograph according to claim 10, wherein the predetermined period is a period after it is determined that ACS is suspected for the subject. (see rejection to claim 10 above.)
Regarding claim 18, Wang discloses the electrocardiograph according to claim 17, wherein it is determined that ACS is suspected for the subject based on a result of analysis processing or an ACS score of the subject. (ACS is suspected base on the output of graphical representation, i.e. [0006] “conditional upon determining that the measured ST values satisfy the ischemia criteria, highlighting an overlapping region between the polygonal ST area and the ischemia criteria area in the rendering.” Also see [0005: last sentence] and [0045-0046, 0065, 0067-0068]. Alternatively, also see Fig. 15: ischemia map rendering engine 82)
Claims 19 and 20 are rejected by Wang under the same rationale as discussed to claim 1 above.
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 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claim 1 above.
To claim 11, Wang discloses the electrocardiograph according to claim 1, wherein the second region presents the ST level of each lead with user of graphical representations such as shown in Figs. 4-II and 5-II, Wang does not disclose wherein the second region presents the ST level of each lead with use of a bar graph. However, since bar graph is a common graphical representation tool for visual comparisons, it would have been an obvious design choice to a person of ordinary skill in the art at the time of invention to replace the hexagonal radar graphs taught in Wang with bar graphs to convey the same information.
As for claims 12 and 13, Wang teaches graphical representation for presenting ST levels of limb leads and a bar graph for presenting ST levels of chest leads including the composite lead and an ST level detected in analysis processing executed immediately before a predetermined period or first analysis processing executed in the predetermined period; and a maximum ST level detected in analysis processing executed in the predetermined period, such that these ST levels can be compared with each other. (Figs. 4-II and 5-II, [0045] ST area 26, ST values plotted to form a (irregular) hexagon allows for comparison with each other) Based on the design choice modification discussed in claim 11 above, it would have been obvious to further show these noted details in the bar graphs as modified.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claim 1 above and in view of Zhou et al. US 9,462,955 B2.
Regarding claim 16, Wang discloses the electrocardiograph according to claim 14, but does not disclose wherein the representative value of the ST level based on the timing is an ST level at a timing when a predetermined period has elapsed from the start of an ST segment.
Zhou, another prior art reference in analogous art of ECG monitoring system for analyzing ST segment data (Fig. 7: one cardiac cycle) and presenting the analyzed data in radar graphs (as shown in Figs. 10-18), and wherein the representative value of the ST level based on the timing is an ST level at a timing when a predetermined period has elapsed from the start of an ST segment (col.6, ll.1-36 and col.9, ll.26-42). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Wang to include the representative value of the ST level based on the timing in view of Zhou, because Zhou has shown in that timing values can be represented in an ST radar graph map similar to that in Wang to represent ACS.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Gadgil et al. US 12,682,520 discloses a method for presenting cardiac information including ST data map as shown in Figs. 5-7.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
August 7, 2026
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