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 .
Status of Claims
Claims 1-6 as filed are presently pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: see e.g. page 8, paragraph from line 11: “electrocardiogram path 111”; “smartwatch 112”. 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. 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.
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:
“an electrocardiogram measurement unit configured to generate electrocardiogram data by measuring 1- or more-lead electrocardiograms” in claim 1 -- for equivalent structure, see e.g., page 8, paragraph from line 11 of instant specification as filed, electrocardiogram patch 111, smart watch 112, 6-lead electrocardiogram bar or an electrocardiogram measurement device installed in a medical institution.
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 1-6 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.
Regarding claims 1-6, claim limitations:
“a deep learning-based prediction unit configured to generate disease prediction information by diagnosing and predicting disease …” ,
“a deep learning-based prediction unit configured to generate disease prediction information by diagnosing and predicting disease …”,
“a rule-based inference unit configured to generate disease inference information …”,
“an integrated reading unit configured to generate reading information …”, “a first reading unit configured to receive the primary reading information, and to allow … and generate secondary reading information” and
“a second reading unit configured to receive the secondary reading information, and to allow … and generate final reading information” each invoke 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. 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. 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.
Regarding claim 6, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. § 112(b). See MPEP § 2173/05(p)(II). The following portions of claim 6 are indefinite for this reason:
“to allow a nurse, clinical pathologist, or emergency technician to log in, read the primary reading information, and generate secondary reading information” -- this recitation requires the step to log in and read primary reading information ( by a nurse, clinical pathologist, or emergency technician), and to generate secondary reading information; and
“to allow a cardiologist to log in, read the secondary reading information and generate final reading information” -- this recitation requires the step to log in and read secondary reading information ( by a nurse, clinical pathologist, or emergency technician), and to generate final reading information.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Applicant cited Yu et al. US 20210100468 A1.
Regarding claim 1, Yu et al. discloses an electrocardiogram reading system in which a deep learning-based model and a rule-based model are integrated ([0001] "methods and systems for automatically diagnosing ECGs using deep neural networks and rule-based systems", Figs. 1 and 4), the electrocardiogram reading system comprising:
an electrocardiogram measurement unit configured to generate electrocardiogram data by measuring 1- or more- lead electrocardiograms (Fig. 1, Data Acquisition Module 118; [0022] "ECG data may be acquired from a patient via an electrocardiograph (ECG), such as ECG system", [0028], [0029], [0032] is an equivalent thereof electrocardiogram patch 111, smart watch 112, 6-lead electrocardiogram bar or an electrocardiogram measurement device installed in a medical institution disclosed in page 8, paragraph from line 11 of instant specification as filed);
a deep learning-based prediction unit configured to generate disease prediction information by diagnosing and predicting disease from the electrocardiogram data input from the electrocardiogram a measurement unit (Fig. 1, Deep Neural Network Module 108; [0035], "Deep neural network module 108 may further include instructions for implementing the one or more trained deep neural networks to automatically diagnose ECG data ... by mapping the ECG data to a diagnosis") through a deep learning algorithm constructed by being trained on training datasets of 1- or more-lead electrocardiograms and diseases corresponding to these electrocardiograms ([0037], "training data pairs comprise corresponding pairs of ECG data and ground truth diagnoses");
a rule-based inference unit configured to generate disease inference information by inferring disease from the electrocardiogram data input from the electrocardiogram measurement unit through a rule-based algorithm including a knowledge base, constructed with electrocardiogram data and disease information corresponding to the electrocardiogram data, and inference rules (Fig. 1, Rule-Based System Module 110; [0038], "ECG processing system 102 further includes rule-based system module 110, which may store instructions for implementing a rule-based system for diagnosing ECG data based on hard-coded cardiologist heuristics/criteria"; Fig. 2, Rule-Based System 204; [0062], "The features determined by feature extractor 206 may be fed to decision tree 208 ... At each decision node, the features of ECG data 202 determined by feature extractor 206 may be evaluated based on expert criteria, and the result of the evaluation may determine to which sub node the extracted features are propagated'); and
an integrated reading unit configured to generate reading information by performing disease reading through an integrated analysis of the disease prediction information and the disease inference information and provide diagnostic information descriptive of a reason and basis for the diagnosis of the disease (Fig. 2 and Fig. 3; [0063], [0065] describe the two different embodiments of the hybrid diagnosis system; [0072], "hybrid ECG diagnostic system 400 may incorporate adaptive feature mapping of a deep neural network, with an intuitive and transparent decision making model reflecting expert criteria, to produce a diagnosis tailored to a specific use case, and with a greater transparency than may be achieved in deep neural networks alone").
Regarding claim 2, Yu et al. discloses the system of claim 1 wherein the rule-based inference unit sets a readable range for reading performed by the integrated reading unit ([0065] “… rule-based system 304 determines a preliminary diagnosis from ECG data 302 based on hardcoded expert criteria, which is fed into an input layer of decision network 314 of deep neural network” i.e. the rule-based system 304 sets a readable range and/or [0072] “ … ECG data 402 is fed to rule-based system 404, which produces a first preliminary diagnosis based on ECG data 402”, i.e., rule based system 404 sets a readable range).
Regarding claim 3, Yu et al. discloses the system of claim 2 as discussed above, wherein, when the disease prediction information generated by the deep learning-based prediction unit is included in the readable range, the integrated reading unit generates and outputs the reading information and the diagnostic information (see illustration Fig. 4 and [0072] “The first preliminary diagnosis is then transmitted to deep neural network 410, which maps both the first preliminary diagnosis and ECG data 402 to a second preliminary diagnosis. The second preliminary diagnosis is then fed back into rule-based system 404, and used to produce diagnosis 416” -- i.e. prediction information from the deep neural network 410 is included in the readable range), and, when the disease prediction information generated by the deep learning-based prediction unit is not included in the readable range ([0074] “… the second preliminary diagnosis produced by deep neural network 410 may be used to update/modify one or more parameters of feature extractor 406”-- i.e. prediction information from the deep neural network 410may not be fed into the rules based inference unit and therefore not included in the readable range), electrocardiograms are re-measured by the electrocardiogram measurement unit (see illustration Fig. 4, [0072], rule based system 404 receives ECG data 402, [0073] ECG data 402 is a live stream -- electrocardiograms are remeasured), or the disease prediction information is re-generated by readjusting parameters of the deep learning-based prediction unit (see illustration Fig. 4, [0079], “… the first preliminary diagnosis into an input layer of decision network 414, along with the plurality of features mapped from ECG data 402 by convolutional neural network 412, is that deep neural network 410 may adjust/modify the first preliminary diagnosis based the on one or more features identified by convolutional neural network 412 in ECG data 402 … ”).
Regarding claim 4, Yu et al. discloses the system of claim 1 wherein the integrated reading unit performs final reading by using only the disease inference information generated by the rule-based inference unit ([0038] “Rule-based system module 110 may work in concert with deep neural network module 108” - see illustration Fig. 4, ECG data 402 may generate a diagnosis without being fed back to deep neural network 410; and/or [0085] “two exemplary embodiments of diagnoses are shown, first diagnosis 1004, produced using a rule-based system without a deep neural network).
Regarding claim 5, Yu et al. discloses the system of claim 1 wherein a final diagnosis of the corresponding disease for the electrocardiogram data is made by the deep learning-based prediction unit and the rule-based inference unit (see Fig. 4, hybrid system [0072] “In hybrid ECG diagnostic system 400, ECG data 402 is fed to rule-based system 404, which produces a first preliminary diagnosis based on ECG data 402. The first preliminary diagnosis is then transmitted to deep neural network 410, which maps both the first preliminary diagnosis and ECG data 402 to a second preliminary diagnosis. The second preliminary diagnosis is then fed back into rule-based system 404, and used to produce diagnosis 416” and/or [0085] “two exemplary embodiments of diagnoses are shown … second diagnosis 1006, produced using a hybrid ECG diagnostic system”).
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.
Claim 6 is rejected under 35 U.S.C 102(a)(1) as anticipated by or, in the alternative under 35 U.S.C. 103 as being unpatentable over Yu et al.
Regarding claim 6, Yu et al. discloses the system of claim 1 wherein primary reading information is generated by provisionally reading the electrocardiogram data through the deep learning-based prediction unit or the rule-based inference unit (see e.g. Fig. 2, primary reading is generated via rule based system 204, or Fig. 3, primary reading is generated via deep neural network 310 or [0072] “ECG data 402 is fed to rule-based system 404, which produces a first preliminary diagnosis based on ECG data 402”).
Yu et al. may not explicitly disclose wherein the integrated reading unit comprises: a first reading unit configured to receive the primary reading information, and to allow a nurse, clinical pathologist, or emergency technician to log in, read the primary reading information, and generate secondary reading information; and a second reading unit configured to receive the secondary reading information, and to allow a cardiologist to log in, read the secondary reading information and generate final reading information, however, in view of the 35 U.S.C 112(b) rejections above, examiner notes that this limitation would be met by the system of Yu et al. which is capable of this functionality based on disclosure of an input means in [0028] and more than one clients where the data may be transmitted in [0087] which would allow a first user (e.g. a nurse, clinical pathologist, or emergency technician) to log in, read the primary reading information, and generate secondary reading information and allow a second user (e.g., a cardiologist) in another client device to log in, read the primary reading information, and generate final reading information Yu et al, hence claim 6 is anticipated.
Alternatively, addressing the limitation despite the 35 U.S.C 112(b) rejection, Yu et al. does disclose in [0028] “ECG processing system 102 is further communicatively coupled to a display device 114, which is configured to display ECG data and/or diagnoses determined for the ECG data, as well as user input device 116, which may enable a user to enter data into ECG processing system 102 or interact with data within non-transitory memory 106” i.e., the input device 6 allows a user to log in, read information and/or generate information, [0085] “… the display device comprises a graphical user interface wherein the diagnosis may be displayed to a user. In some embodiments, the display device may comprise a device coupled to the ECG system, such as display device 114, which may be viewed by an operator of ECG system. The operator may view the displayed diagnosis, and may take one or more actions based thereon … first diagnosis 1004, produced using a rule-based system without a deep neural network, and second diagnosis 1006, produced using a hybrid ECG diagnostic system … first diagnosis 1004 includes a textual message indicating an assessment … second diagnosis 1006 includes a message, indicating a diagnostic assessment” -- a user may use an input device to log in, view/read information, input information and generate new or additional information, [0086] “… the ECG system may transmit the diagnosis to one or more client systems” - and [0087] the diagnosis may be displayed to a user, such as a doctor or health care professional, and/or distributed to one or more client devices”-- more than one clients allows other users to log in, read and/or view and generate new information from other workstations.
In view of the combined teachings of Yu et al. it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the system to include a first reading unit to allow an operator next to the ECG system to log in, read the primary reading information and generate secondary reading information by adding comments or notes to the first diagnosis 1004 to be transmitted to a second reading unit in a remote location, to allow another user or professional to log in, read the secondary information and generate a final reading after reviewing, so as to enable remote support in diagnosis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Giovanni Bortolan et al., “Rule-Based Method and Deep Learning Networks for Automatic Classification of ECG” see e.g. abstract “… combining a classical rule-based method with a Deep Learning method for automatic classification of ECG”, the entire document is pertinent to the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797