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 Objections
Claims 1 and 9 are objected to because of the following informalities: there are grammatical mistakes within the claims.
In claim 1, line 10, it appears “associated with a condition associated with a condition of the patient's heart” should read “associated with a condition of the patient's heart”.
In claim 9, it appears “the at least one segment zoomed in on” should read “the at least one segment is zoomed in on”.
Claim Rejections - 35 USC § 101
3. 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.
4. Claims 1-20 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea (i.e. mental process) without significantly more.
Step 1:
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a system (i.e. machine) and a method (i.e. a process). Thus, they are directed to statutory categories of invention (See MPEP 2106.03).
Step 2A – (Prong 1): Independent claim 1 recites a judicial exception by reciting the limitations of
“receive an ECG that includes a waveform of electrical activity of a patient's heart over a period of time;
analyze the waveform to calculate computerized interpretation metrics;
detect at least one segment of the waveform corresponding to a behavior associated with a condition associated with a condition of the patient's heart;
categorize a type of the condition and a status of the condition selected from a group including at least normal and abnormal with the computerized interpretation metrics;
generate…the waveform and highlight the at least one segment with a color selected from a plurality of colors, each color of the plurality of colors corresponding to the type of condition or the status of the condition; and
generate…textual information that includes the type of the condition and the status of the condition”.
Independent claim 14 recites a judicial exception by reciting the limitations of
“receive an ECG that includes a waveform of electrical activity of a patient's heart over a period of time;
analyze the waveform to calculate computerized interpretation metrics;
detect at least one segment of the waveform corresponding to a behavior associated with a condition of the patient's heart;
categorize a type of the condition and a status of the condition selected from a group including at least normal and abnormal with the computerized interpretation metrics;
generate… the waveform; and
generate… textual information that includes the type of the abnormality and highlight the textual information with a color selected from a plurality of colors, each color of the plurality of colors corresponding to the severity of the abnormality”.
Independent claim 19 recites a judicial exception by reciting the limitations of
“receiving an ECG that includes a waveform of electrical activity of a patient's heart over a period of time;
analyzing the waveform to calculate computerized interpretation metrics;
detecting at least one segment of the waveform corresponding to a behavior associated with a condition of the patient's heart;
categorizing a type of the condition and a status of the condition selected from a group including at least normal and abnormal with the computerized interpretation metrics;
generating… the waveform and highlight the at least one segment with a color selected from a plurality of colors, each color of the plurality of colors corresponding to the type of condition or the status of the condition; and
generating… textual information that includes the type of the condition and the status of the condition”.
These limitations, as drafted, is a process that, under its broadest reasonable interpretation covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) or by a person using a pen and paper. For example, these limitations are nothing more than a clinician receiving a print-out of ECG data of a patient. The clinician can then use the print-out of ECG data to perform an analysis of the waveform and calculate interpretation metrics. Subsequently, the clinician can detect at least one segment of the waveform corresponding to a behavior associated with a condition associated with a condition of the patient's heart and categorize a type of the condition and a status of the condition selected from a group including at least normal and abnormal from the ECG data. Finally, the clinician can highlight/color-code segments of the ECG waveform corresponding to the type/status of the condition and write down a diagnosis/report on the print-out. Therefore, the claims are directed to a judicial exception (see MPEP 2106.04(a)(2)).
Step 2A – (Prong 2):
Regarding claim 1 (and similarly claims 14 and 19), the judicial exception is not
integrated into a practical application. Claim 1 (and similarly claim 14) recite a display, user interface, processor, and memory at a high-level of generality and amounts to nothing more than parts of a generic computer. Claim 19 only recites a display at a high-level of generality and amounts to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B:
The claims do not include additional elements that are sufficient to amount to
significantly more than the judicial exception.
5. Regarding dependent claims 2-13, 15-18, and 20, the limitations of claims 2-13, 15-18, and 20 further define the limitations already indicated as being directed to the abstract idea. While the dependent claims further define the abstract idea, it does not set forth any additional elements that integrate the claims into a practical application or add any additional elements that amount to significantly more than the abstract idea.
Thus, when considered as a whole and in combination, claims 1-20 are directed to an abstracted idea and are therefore rejected.
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 1-8 and 10-20 are rejected under 35 U.S.C 103 as being unpatentable over Grube et al. (US Pub.: 2015/0282726 A1) and further in view of Ziv-Ari et al. (US Pub.: 2020/0178831 A1).
Regarding claim 1, Grube teaches an electrocardiogram ("ECG") interpretation system (e.g. Fig. 1 – ECG device/workstation 112) comprising:
a display (e.g. Fig. 1 – display 118);
a user interface (e.g. Fig. 1 – interface 120);
and a processor (e.g. Fig. 1 – processor 114)
and a memory (e.g. Fig. 1 – memory 116), the memory (116) containing instructions that when executed by the processor (114) cause the processor (114) (e.g. paragraphs 0008, 0023) to:
receive an ECG that includes a waveform of electrical activity of a patient's heart over a period of time (e.g. paragraphs 0005, 0026);
analyze the waveform to calculate computerized interpretation metrics (e.g. paragraphs 0026, 0045);
detect at least one segment of the waveform corresponding to a behavior associated with a condition associated with a condition of the patient's heart (e.g. paragraphs 0039, 0043, 0046);
categorize a type of the condition and a status of the condition selected from a group including at least normal and abnormal with the computerized interpretation metrics (e.g. paragraphs 0006, 0031, 0046);
generate, on the display (118), the waveform (e.g. paragraphs 0026-0027)
and highlight the at least one segment with a color selected from a plurality of colors (e.g. paragraphs 0033-0035; 0041);
and generate, on the display (118), textual information that includes the type of the condition and the status of the condition (e.g. paragraphs 0031, 0039, 0047).
However, Grube does not explicitly teach each color of the plurality of colors corresponding to the type of condition or the status of the condition.
Ziv-Ari, in a same field of endeavor of electrocardiogram (ECG) systems, discloses each color of the plurality of colors corresponding to the type of condition or the status of the condition (e.g. paragraphs 0046, 0074).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ECG interpretation system of Grube to incorporate each color of the plurality of colors corresponding to the type of condition or the status of the condition, as taught and suggested by Ziv-Ari, in order to provide the predictable results of assisting a clinician with diagnosing different conditions from an ECG plot more quickly.
Regarding claim 2, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 1 as discussed above, and Grube further teaches wherein the textual information further includes information related to portions of the waveform other than the at least one segment (e.g. paragraphs 0038-0039, 0044).
Regarding claim 3, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 2 as discussed above, and Grube further teaches wherein the textual information that includes the type of the type of condition (e.g. paragraphs 0037, 0039, 0041) and is highlighted in color (e.g. paragraphs 0037, 0039, 0041). Additionally, Ziv-Ari further teaches that the textual information is highlighted in the color of the highlight to the at least one segment (e.g. paragraphs 0037, 0067, 0071).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Grube and Ziv-Ari to incorporate that the textual information is highlighted in the color of the highlight to the at least one segment, as taught and suggested by Ziv-Ari, in order to provide the predictable results of further facilitating discernment and visual associations of the ECG information for a clinician.
Regarding claim 4, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 3 as discussed above, and Grube further teaches wherein the highlight on the waveform includes colorizing the at least one segment in the color (e.g. paragraphs 0035, 0041).
Regarding claim 5, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 4 as discussed above, and Grube further teaches wherein the highlight on the textual information includes colorizing a font of the textual information in the color (e.g. paragraphs 0039-0041).
Regarding claim 6, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 4 as discussed above, and Ziv-Ari further teaches wherein the highlight on the textual information includes colorizing a background behind a font of the textual information in the color (e.g. paragraphs 0071-0072).
Regarding claim 7, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 1 as discussed above, and Grube further teaches wherein the processor (114) is further caused to: detect if a user interacts with the textual information that includes the type of condition or the status of the condition (e.g. paragraphs 0020, 0048); and enlarge the at least one segment on the display (e.g. paragraph 0035).
Regarding claim 8, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 7 as discussed above, and Grube further teaches wherein the at least one segment is thickened (e.g. paragraph 0035).
Regarding claim 10, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 1 as discussed above, and Grube further teaches wherein the processor (114) is further caused to: detect if a user interacts with the at least one segment (e.g. paragraphs 0020, 0035); and enlarge the textual information that includes the type of condition or the status of the condition (e.g. paragraphs 0039-0040).
Regarding claim 11, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 10 as discussed above, and Grube further teaches wherein the textual information that includes the type of condition also includes the status of the condition (e.g. paragraphs 0006, 0031, 0039).
Regarding claim 12, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 10 as discussed above, and Grube further teaches wherein the textual information that includes the type of condition and the status of the condition is generated in larger font (e.g. paragraphs 0039-0040).
Regarding claim 13, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 1 as discussed above, and Grube further teaches wherein the user interface (120) includes a keypad (e.g. paragraphs 0029, 0039), and wherein the processor (114) is further caused to: generate a diagnosis section (e.g. paragraphs 0038-0039); receive comments from the keypad related to a clinical diagnosis (e.g. paragraphs 0026, 0029, 0042); and generate the comments in the diagnosis section (e.g. paragraphs 0029, 0038).
Regarding claim 14, Grube teaches an electrocardiogram ("ECG") interpretation system (e.g. Fig. 1 – ECG device/workstation 112) comprising:
a display (e.g. Fig. 1 – display 118);
a user interface (e.g. Fig. 1 – interface 120);
and a processor (e.g. Fig. 1 – processor 114)
and a memory (e.g. Fig. 1 – memory 116), the memory (116) containing instructions that when executed by the processor (114) cause the processor (114) (e.g. paragraphs 0008, 0023) to:
receive an ECG that includes a waveform of electrical activity of a patient's heart over a period of time (e.g. paragraphs 0005, 0026);
analyze the waveform to calculate computerized interpretation metrics (e.g. paragraphs 0026, 0045);
detect at least one segment of the waveform corresponding to a behavior associated with a condition of the patient's heart (e.g. paragraphs 0039, 0043, 0046);
categorize a type of the condition and a status of the condition selected from a group including at least normal and abnormal with the computerized interpretation metrics (e.g. paragraphs 0006, 0031, 0046);
generate, on the display (118), the waveform (e.g. paragraphs 0026-0027);
and generate, on the display (118), textual information that includes the type of the abnormality (e.g. paragraphs 0006, 0031, 0039, 0047)
and highlight the textual information with a color selected from a plurality of colors (e.g. paragraphs 0039-0040).
However, Grube does not explicitly teach each color of the plurality of colors corresponding to the severity of the abnormality.
Ziv-Ari, in a same field of endeavor of electrocardiogram (ECG) systems, discloses each color of the plurality of colors corresponding to the severity of the abnormality (e.g. paragraphs 0046, 0074).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ECG interpretation system of Grube to incorporate each color of the plurality of colors corresponding to the severity of the abnormality, as taught and suggested by Ziv-Ari, in order to provide the predictable results of assisting a clinician with diagnosing different conditions from an ECG plot more quickly.
Regarding claim 15, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 14 as discussed above, and Grube further teaches wherein the processor (114) is further caused to highlight the at least one segment with the color selected from a plurality of colors (e.g. paragraphs 0033-0035; 0041).
Regarding claim 16, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 15 as discussed above, and Grube further teaches wherein the highlight on the waveform includes colorizing the at least one segment in the color (e.g. paragraphs 0035, 0041).
Regarding claim 17, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 16 as discussed above, and Grube further teaches wherein the user interface (120) includes a cursor (e.g. paragraphs 0020, 0035), and wherein the processor (114) is further caused to: detect if the cursor is aligned with the at least one segment (e.g. paragraphs 0020, 0035); and enlarge the textual information that includes the type of the abnormality (e.g. paragraphs 0039-0040).
Regarding claim 18, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 17 as discussed above, and Grube further teaches wherein the textual information that includes the type of the abnormality is bolded (e.g. paragraphs 0039, 0048).
Regarding claim 19, Grube teaches a method of interpreting an electrocardiogram ("ECG") (e.g. paragraph 0019) comprising:
receiving an ECG that includes a waveform of electrical activity of a patient's heart over a period of time (e.g. paragraphs 0005, 0026);
analyzing the waveform to calculate computerized interpretation metrics (e.g. paragraphs 0026, 0045);
detecting at least one segment of the waveform corresponding to a behavior associated with a condition of the patient's heart (e.g. paragraphs 0039, 0043, 0046);
categorizing a type of the condition and a status of the condition selected from a group including at least normal and abnormal with the computerized interpretation metrics (e.g. paragraphs 0006, 0031, 0046);
generating, on a display (e.g. Fig. 1 – display 118), the waveform (e.g. paragraphs 0026-0027) and highlight the at least one segment with a color selected from a plurality of colors (e.g. paragraphs 0033-0035; 0041);
and generating, on the display (118), textual information that includes the type of the condition and the status of the condition (e.g. paragraphs 0006, 0031, 0039, 0047).
However, Grube does not explicitly teach each color of the plurality of colors corresponding to the type of condition or the status of the condition.
Ziv-Ari, in a same field of endeavor of electrocardiogram (ECG) methods, discloses each color of the plurality of colors corresponding to the type of condition or the status of the condition (e.g. paragraphs 0046, 0074).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Grube to incorporate each color of the plurality of colors corresponding to the type of condition or the status of the condition, as taught and suggested by Ziv-Ari, in order to provide the predictable results of assisting a clinician with diagnosing different conditions from an ECG plot more quickly.
Regarding claim 20, Grube in view of Ziv-Ari teaches the method of claim 19, and Grube further teaches further including highlighting the textual information that includes the type of the condition and the status of the condition with the color (e.g. paragraphs 0037, 0039, 0041). Additionally, Ziv-Ari further teaches and colorizing the at least one segment in the color (e.g. paragraphs 0037, 0067, 0071).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Grube and Ziv-Ari to incorporate colorizing the at least one segment in the color, as taught and suggested by Ziv-Ari, in order to provide the predictable results of further facilitating discernment and visual associations of the ECG information for a clinician.
Claims 9 is rejected under 35 U.S.C 103 as being unpatentable over Grube and further in view of Ziv-Ari and further in view of Fischell et al. (US Pub.: 2006/0265020 A1).
Regarding claim 9, Grube in view of Ziv-Ari teaches the ECG interpretation system of claim 7 as discussed above. However, Grube in view of Ziv-Ari does not explicitly teach wherein the at least one segment zoomed in on.
Fischell, in a same field of endeavor of electrocardiogram (ECG) systems, discloses wherein the at least one segment zoomed in on (e.g. paragraphs 0128, 0178).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Grube and Ziv-Ari to incorporate wherein the at least one segment zoomed in on, as taught and suggested by Fischell, in order to provide the predictable results of allowing a clinician to inspect desired portions of an ECG waveform for subtle abnormalities more easily.
Conclusion
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/D.T./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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