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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/13/2024, 6/12/2024, and 2/12/2025 has/have been acknowledged and is/are being considered by the Examiner.
The information disclosure statement filed 2/13/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein that has been lined-through has not been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the single-lead electrocardiogram measurement unit provided with two electrodes must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment filed February 13, 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The incorporation by reference of the international patent application PCT/KR2022/012216, and the foreign patent application KR 10-2021-0107769 is ineffective as it was added after the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 08/16/2022, see MPEP 1893.03(b). Therefore the specification amendment of 02/13/2024 to include the incorporation by reference is new matter, per MPEP 608.01(p). Applicant is advised to remove the phrase “, the disclosures of which are hereby incorporated herein by reference in their entireties” from the specification.
Applicant is required to cancel the new matter in the reply to this Office Action.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract is a single run-on sentence that includes phrases which can be implied, such as “Disclosed herein”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a prediction unit configured to predict” in claim 1 and “an electrocardiogram data generation unit configured to determine” in claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 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 1-7 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 limitation “prediction unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure, while it recites a “prediction unit”, it fails to provide the corresponding structure for the claimed “prediction unit configured to predict”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 1 recites the limitation "through a diagnostic algorithm" in line 12. It is unclear if this phrase applies to “input from the single-lead electrocardiogram measurement unit and segmented into specific time units” immediately preceding the phrase or applies to “to predict presence/absence of a disease and degree of the disease from the asynchronous electrocardiogram data” recited in lines 8-10. Is the input through a diagnostic algorithm or is the prediction through a diagnostic algorithm?
Claim 1 recites the limitation "a plurality of asynchronous segmented standard lead electrocardiogram datasets in which asynchronous segment standard lead electrocardiograms at different times in an asynchronous standard lead electrocardiogram segmented into the specific time units from a synchronous standard lead electrocardiogram measured for a same electrical axis and accumulated in a medical institution server are matched to presence/absence of a disease and degree of the disease corresponding to the asynchronous segment standard lead electrocardiograms" in lines 13-23. The metes and bounds of this limitation are unclear. It is unclear what, if any, portions of this limitation apply to the configuration of the prediction unit and what portions are merely limiting how the diagnostic algorithm was previously constructed. It is unknown if formatting or punctuation would clarify this portion of the claim or if there is a need for re-wording such that the intent and limiting effects are clear. For the purposes of this communication, it is believed that this limitation is merely reciting how the diagnostic algorithm was previously constructed and it fails to further define the configuration of the prediction unit.
Claim limitation “electrocardiogram data generation unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure, while it recites an “electrocardiogram data generation unit”, it fails to provide the corresponding structure for the claimed “electrocardiogram data generation unit configured to determine”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 2 recites the limitation "the plurality of pieces of asynchronous electrocardiogram data" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
The term “specific” in claim 2 is a relative term which renders the claim indefinite. The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claim and the specification fail to explain what is meant by the term “specific” in the limitation “specific lead electrocardiogram data”. The metes and bounds of the term are unclear as it is unknown what is “specific” versus “unspecific” in the context of the claim and invention. Clarification is requested.
Claim 2 recites the limitation "the generated standard lead electrocardiogram data" in line 13. There is insufficient antecedent basis for this limitation in the claim. Claim 2 previously recites “generate a plurality of pieces of remaining standard lead electrocardiogram data not corresponding to the identified specific lead electrocardiogram data”, but it is unclear if the recitation of “the generated standard lead electrocardiogram data” is referring to the recited “remaining standard lead electrocardiogram data not corresponding to the identified specific lead electrocardiogram data”, or is instead to refer to a different set of data.
Claim 4 recites the limitation "the diagnostic algorithm generates the plurality of asynchronous segment standard lead electrocardiogram data sets by asynchronously extracting synchronous segment standard lead electrocardiograms obtained by segmenting standard lead electrocardiogram data, stored in a synchronized form, into specific time units" in lines 1-7. The metes and bounds of the claim are unclear as it is unknown what is being claimed with such recitations. It is unknown if formatting or punctuation would clarify this portion of the claim or if there is a need for re-wording such that the intent and limiting effects are clear.
The term “specific” in claim 4 is a relative term which renders the claim indefinite. The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claim and the specification fail to explain what is meant by the term “specific” in the limitation “specific time units”. The metes and bounds of the term are unclear as it is unknown what is “specific” versus “unspecific” in the context of the claim and invention. Clarification is requested.
Claim 5 recites the limitation "a presence/absence of a disease" in lines 2-3. It is unknown if this is referring to the same “presence/absence” and “disease” as that recited in claim 1, or is intended to refer to a different “presence/absence” and “disease”.
Claim 5 recites the limitation "the standard lead electrocardiogram data, in which time-series information has been deleted from standard lead electrocardiogram data measured synchronously" in lines 5-7. The metes and bounds of this limitation are unclear, as it is unknown if the diagnostic algorithm is intended to delete the time-series information from the standard lead electrocardiogram data, or if the algorithm is based on information input to it, which has time-series information previously deleted.
Claim 6 recites the limitation "reflected therein" in lines 3 and 9. It is unclear how this phrase is to further limit the claim as recited in context. In lines 2-3 the claim recites that “the diagnostic algorithm is trained with individual characteristic information of an examinee reflected therein”. It is unclear if the diagnostic algorithm has the individual characteristic information reflected therein or if the training has the individual characteristic information reflected therein. Further, in lines 5-9 the claim recites “the prediction unit predicts the presence/absence of the disease and the degree of the disease from the asynchronous electrocardiogram data measured by the single-lead electrocardiogram measurement unit with the individual characteristic information reflected therein”. It is unclear if the presence/absence of the disease and the degree of the disease has the individual characteristic information reflected therein or the asynchronous electrocardiogram data measured by the single-lead electrocardiogram measurement unit has the individual characteristic information reflected therein.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-7 are directed to a system.
Step 2A, Prong One
Regarding claims 1 and 2, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitation(s) of “to predict presence/absence of a disease and degree of the disease from the asynchronous electrocardiogram data, input from the single-lead electrocardiogram measurement unit and segmented into specific time units, through a diagnostic algorithm previously constructed by being trained on a plurality of asynchronous segmented standard lead electrocardiogram datasets in which asynchronous segment standard lead electrocardiograms at different times in an asynchronous standard lead electrocardiogram segmented into the specific time units from a synchronous standard lead electrocardiogram measured for a same electrical axis and accumulated in a medical institution server are matched to presence/absence of a disease and degree of the disease corresponding to the asynchronous segment standard lead electrocardiograms” in claim 1 and “determine individual characteristics of the plurality of pieces of asynchronous electrocardiogram data measured by the single-lead electrocardiogram measurement unit, identify specific lead electrocardiogram data, and generate a plurality of pieces of remaining standard lead electrocardiogram data not corresponding to the identified specific lead electrocardiogram data” and “outputs and predicts the presence/absence of the disease and the degree of the disease by using the measured asynchronous electrocardiogram data and the generated standard lead electrocardiogram data as input or using the generated standard lead electrocardiogram data as input” in claim 2, as best understood, is/are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, these limitations are nothing more than receiving a signal and predicting the presence or absence and degree of the disease based on a mental analysis of the received signal.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, claim 1 also recites a single-lead electrocardiogram measurement unit provided with two electrodes and a prediction unit and claim 2 also recites an electrocardiogram data generation unit. The single-lead electrocardiogram measurement unit amounts to nothing more than the pre-solution activity of data gathering. The prediction unit and electrocardiogram data generation unit are recited at a high-level of generality and amount 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 practical application.
Step 2B
The claims 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 abstract idea into a practical application, the additional elements of a single-lead electrocardiogram measurement unit provided with two electrodes, a prediction unit, and an electrocardiogram data generation unit amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. The additional elements recited above are well known in the field of physiological monitoring. Moreover, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, is discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984. See MPEP § 2106.05(d). In this case, elements of general computer are being used to implement the abstract idea of claim 1.
Regarding dependent claims 3-7, the limitations of claims 3-7 further define the limitations already indicated as being directed to the abstract idea.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-7, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Fornwalt et al. (U.S. 2021/0076960) in view of Albert et al. (U.S. 2021/0169392). Regarding claim 1, Fornwalt discloses a health condition prediction system (“A method and system for predicting the likelihood that a patient will suffer from atrial fibrillation is provided.”, Abstract) using an asynchronous electrocardiogram, the system comprising: a prediction unit (computing device 104) configured to predict presence/absence of a disease and degree of the disease from asynchronous electrocardiogram data received by the system (“the computing device 104 can receive ECG data, such as 12-lead ECG data, and generate an AF risk score based on the ECG data”, paragraph [0091]), input from an electrocardiogram measurement unit and segmented into specific time units 404/408/412 (“The input data structure to the model 400 can include a first branch 404 including leads I, II, V1, and V5, acquired from time (t)=0 (start of data acquisition) to t=5 seconds (e.g., the first voltage data, the sixth voltage data, the ninth voltage data, and the twelfth voltage data); a second branch 408 including leads V1, V2, V3, II, and V5 from t=5 to t=7.5 seconds (e.g., the second voltage data, the fourth voltage data, the seventh voltage data, the tenth voltage data, and the thirteenth voltage data); and a third branch 412 including leads V4, V5, V6, II, and V1 from t=7.5 to t=10 seconds (e.g., the third voltage data, the fifth voltage data, the eighth voltage data, the eleventh voltage data, and the fourteenth voltage data) as shown in FIG. 3.“, paragraph [0111]), through a diagnostic algorithm 400 previously constructed by being trained on a plurality of asynchronous segmented standard lead electrocardiogram datasets in which asynchronous segment standard lead electrocardiograms at different times in an asynchronous standard lead electrocardiogram segmented into the specific time units from a synchronous standard lead electrocardiogram measured for a same electrical axis and accumulated in a medical institution server are matched to presence/absence of a disease and degree of the disease corresponding to the asynchronous segment standard lead electrocardiograms (“the model 400 can be tailored to whatever ECG configuration is used by a given organization”, paragraph [0111]). However, while Fornwalt discloses electrocardiogram data from a single lead (“In some embodiments, the ECG can include a single lead.”, paragraph [0096]), Fornwalt fails to disclose a physical single-lead electrocardiogram measurement unit provided with two electrodes, and configured to obtain asynchronous electrocardiogram data by measuring electrocardiograms for at least two electrical axes at different times. Albert teaches an electrocardiograph device that includes two electrodes 2210/2220 in a single form-factor (read: single-lead electrocardiogram measurement unit provided with two electrodes) configured to obtain asynchronous electrocardiogram data by measuring electrocardiograms for at least two electrical axes at different times (“By contacting the plurality of electrode leads with the right arm RA and the left arm LA, a Lead I ECG may be measured. The user US may also contact the first electrode lead 2210 with the right arm RA and the left leg LL to measure a lead II ECG. The user US may also contact the first electrode lead 2210 with the right arm RA and the left leg LL to measure a lead III ECG.”, paragraph [0204] and “In one embodiment, Lead I and Lead II are measured sequentially (e.g., the user first places electrodes for Lead I, obtains a measurement, and then places the electrodes for Lead II and obtains the corresponding measurement). In such a case, processing logic may further time align Lead I and Lead II. In another embodiment, Lead I and Lead II are measured concurrently (e.g., the user places electrodes for Lead I and Lead II and obtains both measurements contemporaneously, concurrently, or substantially simultaneously).”, paragraph [0360]). Albert teaches that the use of the single-lead electrocardiogram measurement unit provided with two electrodes, and configured to obtain asynchronous electrocardiogram data by measuring electrocardiograms for at least two electrical axes at different times, provides the benefit of decreasing the number of leads necessary to obtain an ECG (“In another embodiment, a 12-lead ECG may be generated using three electrodes (e.g., by a device including three electrodes).”, paragraph [0052]), thereby increasing the ease of use of the system. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the single-lead electrocardiogram measurement unit provided with two electrodes, and configured to obtain asynchronous electrocardiogram data by measuring electrocardiograms for at least two electrical axes at different times, of Albert to provide the ECG input to the prediction unit of Fornwalt, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 2, Fornwalt discloses an electrocardiogram data generation unit 132 configured to determine individual characteristics of the plurality of pieces of asynchronous electrocardiogram data measured by the single-lead electrocardiogram measurement unit, identify specific lead electrocardiogram data, and generate a plurality of pieces of remaining standard lead electrocardiogram data not corresponding to the identified specific lead electrocardiogram data (“The input data structure to the model 400 can include a first branch 404 including leads I, II, V1, and V5, acquired from time (t)=0 (start of data acquisition) to t=5 seconds (e.g., the first voltage data, the sixth voltage data, the ninth voltage data, and the twelfth voltage data); a second branch 408 including leads V1, V2, V3, II, and V5 from t=5 to t=7.5 seconds (e.g., the second voltage data, the fourth voltage data, the seventh voltage data, the tenth voltage data, and the thirteenth voltage data); and a third branch 412 including leads V4, V5, V6, II, and V1 from t=7.5 to t=10 seconds (e.g., the third voltage data, the fifth voltage data, the eighth voltage data, the eleventh voltage data, and the fourteenth voltage data) as shown in FIG. 3. The arrangement of the branches can be designed to account for concurrent morphology changes throughout the standard clinical acquisition due to arrhythmias and/or premature beats.”, paragraph [0111]); wherein the diagnostic algorithm outputs and predicts the presence/absence of the disease and the degree of the disease by using the measured asynchronous electrocardiogram data and the generated standard lead electrocardiogram data as input or using the generated standard lead electrocardiogram data as input (“The demographic information can be concatenated with the ECG information, and the model 400 can generate a risk score 420 based on the demographic information and the ECG information. Concatenating the ECG information with the separately generated demographic information can allow the model 400 to individually disseminate the voltage data from the first branch 404, the second branch 408, and the third branch 412, as well as the demographic data 416, which may improve performance over other models that provide the voltage data and the demographic data 416 to the model at the same channel.”, paragraph [0114]).
Regarding claim 3, Fornwalt discloses that the electrocardiogram data generation unit generates a plurality of pieces of synchronized standard lead electrocardiogram data (“the model 400 may need to synchronize which voltage information or data is acquired at the same point in time in order to understand the data”, paragraph [0111]).
Regarding claim 4, it is respectfully submitted that the recitation “the diagnostic algorithm generates the plurality of asynchronous segment standard lead electrocardiogram data sets by asynchronously extracting synchronous segment standard lead electrocardiograms obtained by segmenting standard lead electrocardiogram data, stored in a synchronized form, into specific time units” recites the intended use or function of the diagnostic algorithm rather than further limiting any structural aspect of the system and therefore fails to further define the claimed invention over that of the prior art. Furthermore, Fornwalt discloses that the diagnostic algorithm generates the plurality of asynchronous segment standard lead electrocardiogram data sets by asynchronously extracting synchronous segment standard lead electrocardiograms obtained by segmenting standard lead electrocardiogram data, stored in a synchronized form, into specific time units (“Because the ECG leads are not all acquired at the same time, the leads may be aligned to demonstrate to the neural network model which data was collected at the same time.”, paragraph [0111]).
Regarding claim 5, it is respectfully submitted that the recitation “the diagnostic algorithm is constructed to output and predict a presence/absence of a disease and degree of the disease corresponding to standard lead electrocardiogram data by using the standard lead electrocardiogram data, in which time-series information has been deleted from standard lead electrocardiogram data measured synchronously, as input” recites the intended use or function of the diagnostic algorithm rather than further limiting any structural aspect of the system and therefore fails to further define the claimed invention over that of the prior art.
Regarding claim 6, it is respectfully submitted that the recitation “the diagnostic algorithm is trained with individual characteristic information of an examinee reflected therein; and the prediction unit predicts the presence/absence of the disease and the degree of the disease from the asynchronous electrocardiogram data measured by the single-lead electrocardiogram measurement unit with the individual characteristic information reflected therein” recites the intended use or function of the diagnostic algorithm and prediction unit rather than further limiting any structural aspect of the system and therefore fails to further define the claimed invention over that of the prior art.
Regarding claim 7, it is respectfully submitted that the recitation “the individual characteristic information includes demographic information including gender and age of the examinee, basic health information including weight, height and obesity of the examinee, disease-related information including past history, drug history and family history of the examinee, and test information regarding a blood test, genetic test, vital signs, including blood pressure and oxygen saturation, and biosignals of the examinee” further limits something, the individual characteristic information, that is not previously positively recited. As such, such a limitation fails to further define the claimed invention over that of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796