DETAILED ACTION
After further review, claims 11 and 15-16 should have been rejected under 35 U.S.C. 101 and 35 U.S.C. 103. Please see rejections below. Accordingly, the Actions dated 04/08/2025 and 08/25/2025 have been withdrawn.
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 lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 11 objected to because of the following informalities:
Line 43: “the analyst terminal configured” should be changed to “the analyst terminal is configured”.
Appropriate correction is required.
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 11 and 15-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation “an electrocardiogram data processing server” in line 7, whereas an electrocardiogram data processing server was already introduced in claim 11 (lines 3-4). It is unclear whether the Applicant intended to claim the same or a different electrocardiogram data processing server. Consider changing to “the electrocardiogram data processing server”.
Claim 15 recites the limitation “a pre-set target time” in line 2, whereas a pre-set target time was already introduced in a claim that claim 15 depends from (claim 11). It is unclear whether the Applicant intended to claim the same or a different pre-set target time. Consider changing to “the pre-set target time”.
*Claim 16 is also rejected due to its dependency on a rejected claim.
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 11 and 15-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of receiving information, analyzing it, communicating/transmitting results of analysis for displaying, and transmitting a further analysis request to an analyst) without significantly more.
Step 1
Independent claim 11 is directed to an electrocardiogram monitoring system (i.e., system/machine) and thus meets the requirements for step 1.
Step 2A, Prong 1
Claim 11 recites the following limitations which are interpreted as potentially inclusive of an abstract idea:
“generate label information associated with the electrocardiogram signal” – A person may mentally generate label information by recognizing events in the signal
“calculate an expected analysis time based on an analysis condition received from the medical staff terminal” – An expected analysis time is simply an estimate of how long it will take an analyst to analyze the data (Specification – Par. [0064). A person may mentally estimate an expected analysis time based on previous experience or benchmarks
"...indicating whether the expected analysis time is within a pre-set target time wherein the expected analysis time is calculated based on the analysis condition” – A human may mentally/mathematically compare the expected analysis time with a pre-set target time to determine whether the expected time exceeds a target time
Step 2A, Prong 2
Claim 11 recites additional elements which do not amount to a practical application for the abstract idea when analyzed individually or in combination:
an electrocardiogram measuring device configured to measure an electrocardiogram signal from an object and transmit the electrocardiogram signal to an electrocardiogram data processing server – insignificant pre-solution activity, i.e. mere data gathering
an electrocardiogram data processing server, comprising: a processor; a computer readable memory configured to store computer readable instructions executable by the processor; a communication unit; a medical staff terminal; and an analyst terminal -– These are all interpreted as general purpose computers recited at a high level of generality. They amount to no more than applying the abstract idea on a generic computer.
Receive the electrocardiogram signal from the electrocardiogram measuring device; output the electrocardiogram signal and the label information to an output unit of medical staff terminal; … transmit the expected analysis time to the medical staff terminal; transmit result data to the medical staff terminal …; connect to an analyst terminal selected from among a plurality of analyst terminals to allow input of an analysis comment on the electrocardiogram signal; transmit an analysis request signal to the analyst terminal after receiving confirmation of the expected analysis time from the medical staff terminal; connect to the electrocardiogram data processing server via a network; receive … electrocardiogram output data including the electrocardiogram signal and label information; receive an input for the analysis condition including at least a first label and a second label; and transmit the analysis condition to the electrocardiogram data processing server; connect to the electrocardiogram data processing server; and receive interface data for inputting analysis data received from the electrocardiogram data processing server. – These limitations describe transmitting/receiving various pieces of data to various computers in the network. The communication of information among computers is considered ordinary functionality of a computer. “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) … does not integrate a judicial exception into a practical application” (MPEP 2106.05(f)(2)). Hence these limitations amount to generic computers executing insignificant extra-solution activity.
Display electrocardiogram output data including the electrocardiogram signal and label information – insignificant post-solution activity that does not meaningfully limit the claim. Hence the claim is directed to an abstract idea without a practical application.
Step 2B
Claim 11 recites additional elements which do not amount to significantly more than the abstract idea when analyzed individually or in combination for the same reasons identified above. Any limitations which were considered insignificant extra-solution activity are reconsidered in step 2B to determine if they are also well-understood, routine, and conventional.
an electrocardiogram measuring device configured to measure an electrocardiogram signal from an object and transmit the electrocardiogram signal to an electrocardiogram data processing server – Eikefjord, et al. (U.S. Patent No. 5,097,830), Col. 9, lines 28-53: “The first transfer relay switch 16 has a terminal 100 connected by a line 102 to one input of a conventional ECG monitoring circuit 104, such as of the type as used in the Heartstart 1000 defibrillator. … When the relays 16 and 18 are in a patient monitoring position as …, the ECG circuit 104 is coupled by the electrodes 22, 24 to the patient for picking up ECG signals from the patient.”
Receive the electrocardiogram signal from the electrocardiogram measuring device; output the electrocardiogram signal and the label information to an output unit of medical staff terminal; … transmit the expected analysis time to the medical staff terminal; transmit result data to the medical staff terminal …; connect to an analyst terminal selected from among a plurality of analyst terminals to allow input of an analysis comment on the electrocardiogram signal; transmit an analysis request signal to the analyst terminal after receiving confirmation of the expected analysis time from the medical staff terminal; connect to the electrocardiogram data processing server via a network; receive … electrocardiogram output data including the electrocardiogram signal and label information; receive an input for the analysis condition including at least a first label and a second label; and transmit the analysis condition to the electrocardiogram data processing server; connect to the electrocardiogram data processing server; and receive interface data for inputting analysis data received from the electrocardiogram data processing server. – MPEP 2106.05(d)(II)(“i. Receiving or transmitting data over a network”)
display electrocardiogram output data including the electrocardiogram signal and label information – Eikefjord, et al. (U.S. Patent No. 5,097,830), Col. 19, lines 54-58: “This display may be a conventional split screen display with the lower half of the screen containing commands and messages and the upper half of the screen displaying ECG signals.”
Hence the claim is directed to an abstract idea without a practical application and without significantly more.
Dependent claims
Regarding dependent claim 15, the limitations only further define insignificant extra-solution activity of generic computer implementation of the abstract idea.
Regarding dependent claim 16, the limitations only further define the abstract idea.
Therefore, claims 15 and 16 are unpatentable under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Li, et al. (U.S. PGPub No. 2022/0031223) in view of Sadeghi, et al. (U.S. PGPub No. 2024/0105313).
Regarding claim 11, Li teaches (Fig. 2, # 10 – ECG processing system) an electrocardiogram monitoring system (Title, Abstract) comprising:
(Fig. 2, # 13 – ECG sensing device) an electrocardiogram measuring device (Par. [0061] – ECG sensing device 13 is designed to sense the electrical activity of the heart for generating ECG data) configured to measure an electrocardiogram signal from an object and transmit the electrocardiogram signal to (Fig. 2, # 15) – server) an electrocardiogram data processing server (Par. [0068] – to receive ECG data from sensing device 13, … to communicated ECG data to server 15);
(Fig. 2, # 15) an electrocardiogram data processing server (Par. [0062-0063]), comprising:
(Fig. 3B, # 31) a processor (Par. [0070] – server 15 may include one or more processing unit 31);
(Fig. 3B, # 35) a computer readable memory configured to store computer readable instructions executable by the processor (Par. [0072] – operating system 36 and ECG platform 37 may be stored in storage 35 and executed on processing unit 31); and
(Fig. 3B, # 34) a communication unit (Par. [0071]),
wherein the computer readable instructions include:
(Fig. 2) receive the electrocardiogram signal from the electrocardiogram measuring device (Par. [0068] – receive ECG data from sensing device, … communicate ECG data to server 15);
(Fig. 4, # 57, 59, 60, 62, 64) generate label information associated with the electrocardiogram signal (see at least Par. [0092-0093]; labels in blocks 57, 59, 60, 62, and 64 are generated by steps 56, 58, 61, and 63)
(Fig. 4) output the electrocardiogram signal and the label information to an output unit of a medical staff terminal (Par. [0106] – the information generated on back end 46 by ECG platform 37 in steps 54, 56, 58, and 61, and optionally, 63, may be communicated by ECG platform 37 to ECG application 29 on front end 45. ECG application 29 may cause the foregoing information to be displayed);
[…];
(Fig. 4, # 45) transmit result data to the medical staff terminal (Par. [0106]; any subset of the above information may read on “result data”) […];
(Fig. 2) connect to an analyst terminal selected from among a plurality of analyst terminals to allow input of an analysis comment on the electrocardiogram signal (Par. [0062-0063]; each of system device 14 and server 15 may be multiple communicatively coupled computing devices, any one of which may be mapped to “an analyst terminal”); and
(Fig. 17, # 219, 220, 222; Fig. 23A,C) transmit an analysis request signal to the analyst terminal (see at least Par. [0142-0144]; optional steps 219, 220, 222 to request/receipt of comments; Par. [0160]) after (Fig. 4, # 66) receiving confirmation […] from the medical staff terminal (Par. [0124-0125]; a user’s manual request for a report via input device 25 constitutes a “confirmation”);
wherein (Fig. 4, # 45) the medical staff terminal (Par. [0075] – Front end 45 running on system device 14) is configured to:
(Fig. 4) connect to the electrocardiogram data processing server via a network (Par. [0058] – local area network (LAN); Par. [0062] – Internet) ;
(Figs. 2 and 4) receive and display electrocardiogram output data including the electrocardiogram signal and label information (Par. [0106] – As is shown in Fig. 4, the information generated on back end 46 by ECG platform 37 in steps 54, 56, 58, and 61, and optionally, 63, may be communicated by ECG platform 37 to ECG application 29 on front end 45. ECG application 29 may cause the foregoing information to be displayed, at step 65, on display 17 of system device 14);
(Fig. 17, # 219, 220, 222) receive an input for the analysis condition including at least a first label and a second label (Par. [0142-0144]; optional steps 219, 220, 222 to request/receipt of comments and other information); and
(Fig. 17, # 220, 222) transmit the analysis condition to the electrocardiogram data processing server (Par. [0143-0144] – transmit quality control data/user input data to ECG platform; and
Wherein (Fig. 2; Figs. 24A-F) the analyst terminal (Par. [0062-0063] – each of system device 14 and server 15 may be multiple communicatively coupled computing devices, and one of which may be mapped to “an analyst terminal”; Par. [0165]) configured to:
(Fig. 4) connect to the electrocardiogram data processing server (Par. [0058] – local area network (LAN); Par. [0062] – Internet) ; and
(Figs. 24C, 24E) receive interface data for inputting analysis data received from the electrocardiogram data processing server (Par. [0167-0168]; Figs. 24C, E describing various interfaces for reviewing and editing uploaded data).
Li does not explicitly disclose that the server is instructed to “calculate an expected analysis time based on an analysis condition received from the medical staff terminal and transmit the expected analysis time to the medical staff terminal” or “[indicate] whether the expected analysis time is within a pre-set target time, wherein the expected analysis time is calculated based on the analysis condition”.
However, Sadeghi teaches a method for predicting the interpretation time for medical image examination in order to improve efficiency and enhance workflow management (Abstract, Par. [0006]). Although Sadeghi’s detailed disclosure pertains to echocardiographic data, Sadeghi explicitly states that the method may be used for other types of medical data (Par. [0079]). In particular, Sadeghi teaches:
(Fig. 3, # 161; Fig. 6, # 605 and/or 607) calculate an expected analysis time based on an analysis condition received from the medical staff terminal (Par. [0042] – a plurality of data inputs are used and applied to the algorithm to determine a predicted image examination interpretation time 161; Par. [0077]) and (Figs. 4-5, displayed “Estimated Interpretation Time”) transmit the expected analysis time to the medical staff terminal (Par. [0071] – the predicted interpretation times 161 for each selected imaging type is provided as output 160 to the clinical management system for presentation to a user (such as a cardiologist)) and
(Fig. 7) indicating whether the expected analysis time is within a pre-set target time (Par. [0072] – the clinical management system 200 selects a combination of examinations to recommend to the cardiologist wherein the cumulative predicted interpretation times for the suggested examinations do not exceed the cardiologist’s available reading time”), wherein (Fig. 3, # 161) the expected analysis time is calculated based on the analysis condition (Par. [0042]; predicted interpretation time 161 based on data inputs 130 any of which would read on “analysis condition”).
Additionally, a user input may be entered to indicate that the algorithm is in a learning phase or a prediction phase (Par. [0075]). This user input may be considered a “confirmation of the expected analysis time” since it indicates that the algorithm has been optimized an is generating legitimate predictions.
Therefore, since Li discloses an ECG interpretation system that includes requesting further analysis from a healthcare professional, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Li by calculating an estimated time that the healthcare professional would require to perform a requested analysis, indicate that the expected analysis time is less than a pre-set target analysis time, and transmit the request when the expected analysis time is confirmed as taught by Sadeghi. Such a modification would improve efficiency and enhance workflow management (Sadeghi Abstract, Par. [0006]) as well as allow the requesting user to better manage expectations regarding turn-around time and cost.
Therefore, claim 11 is unpatentable over Li, et al. and Sadeghi, et al.
Regarding claim 15, Li, in view of Sadeghi, renders obvious the electrocardiogram monitoring system of claim 11, as indicated hereinabove. Sadeghi also teaches the limitation of instant claim 15, that is wherein (Fig. 7, # 704) when the expected analysis time is less than a pre-set target time, the computer readable instructions further include transmitting a notification signal regarding the expected analysis time to the medical staff terminal via the communication unit (Par. [0072] – Based on the total reading time, predicted interpretation times for each impending examination, and other filters (such as time remaining before breaching a service level agreement), the clinical management system 200 selects a combination of examinations to recommend to the cardiologist wherein the cumulative predicted interpretation times for the suggested examinations do not exceed the cardiologist’s available reading time. Then, the clinical management system 200 provides the list of suggested examinations that can be read in the total reading time that is provided to the cardiologist; Par. [0074] – the list of selected examinations may be in the form of highlighted selected examinations on a list of all pending examinations or may be a stand-alone listing, or the selected examinations may be in any other form to reasonably inform the cardiologist of a recommended group of examinations that fit within the cardiologist’s available time for interpretation.).
Therefore, claim 15 is unpatentable over Li, et al. and Sadeghi, et al.
Regarding claim 16, Li, in view of Sadeghi, renders obvious the electrocardiogram monitoring system of claim 15, as indicated hereinabove. Li also teaches the limitation of instant claim 16, that is wherein the computer readable instructions further include:
(Fig. 16A, # 66, 67, 69, and 70) receiving a modification input regarding a section to be analyzed from the medical staff terminal via the communication unit (Par. [0137-0138] – At step 66, a user using ECG application 29 may interact with interactive display. User may determine additional clusters and/or beat groups, may identify, associate, and/or merge similar clusters and/or beat groups, may delete clusters and/or beat groups that are inaccurate, irrelevant, or mislabeled.), and
(Fig. 16A, # 70) re-calculating […] regarding the section to be analyzed in response to the modification input regarding the section to be analyzed (Par. [0138] – upon receiving user input 69, ECG platform 37 on back end 46 may, at step 70, cause recomputer 40 to use input data 69 to retrain, modify and/or adjust delineator 39, embedder 48 and/or grouper).
As explained hereinabove with regards to the rejection of claim 11, Sadeghi was relied upon to teach the limitation involving calculating the expected analysis time.
Therefore, claim 16 is unpatentable over Li, et al. and Sadeghi, et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796