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 .
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 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.
Status of Claims
Claims 1-10 are pending and under consideration for patentability; claims 3, 4, 6, and 8 were amended via a Preliminary Amendment dated 22 September 2023.
Information Disclosure Statement
The Information Disclosure Statements submitted on 10 October 2023 and 02 April 2024 have been acknowledged and considered by the Examiner.
Claim Objections
Claims 1, 2, 4, 6, 7, 8, and 10 are objected to because of the following informalities.
Claims 1, 2, 4, 6, 7, 8, and 10 contain minor typographical and/or grammatical errors.
Claim 1, lines 6-7: Applicant is advised to change “waveform data in an electrocardiogram” to “the waveform data in the electrocardiogram”
Claim 2, lines 3-4: Applicant is advised to change “waveform data in electrocardiograms” to “the waveform data in the electrocardiograms”
Claim 2, line 6: Applicant is advised to change “waveform data” to “the waveform data”
Claim 4, line 3: Applicant is advised to change “waveform data” to “the waveform data”
Claim 4, line 4: Applicant is advised to change “an electrocardiogram” to “the electrocardiogram”
Claim 4, line 10: Applicant is advised to change “waveform data” to “the waveform data”
Claim 6, line 7: Applicant is advised to change “waveform data in an electrocardiogram” to “the waveform data in the electrocardiogram”
Claim 7, line 7: Applicant is advised to change “waveform data in an electrocardiogram” to “the waveform data in the electrocardiogram”
Claim 8, line 5: Applicant is advised to change “waveform data in an electrocardiogram” to “the waveform data in the electrocardiogram”
Claim 10, line 6: Applicant is advised to change “the predetermined first period” to “a predetermined first period”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3-8 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Duann et al. (US 2008/0097537 A1).
Regarding claims 1, 6, and 7, Duann describes an electrocardiogram analysis assistance device, non-transitory computer readable storage medium, and method ([0011]) comprising
a peak estimation model employing waveform data of partial segments of waveform data in an electrocardiogram as input information and employing peak information indicating whether or not a predetermined type of peak related to analysis of the electrocardiogram is present in the waveform data as output information ([0025], [0031])
an analysis waveform acquisition unit that acquires waveform data in an electrocardiogram for analysis ([0022])
an analysis waveform select and extract unit that selects and extracts waveform data of a predetermined first period from the waveform data acquired by the analysis waveform acquisition unit as analysis divided waveform data, while each time shifting a predetermined shift period that is a shorter period than the first period ([0022] - [0023], continually recording the ECG data)
a derivation unit that derives the peak information by inputting the analysis divided waveform data selected and extracted by the analysis waveform select and extract unit into the peak estimation model ([0024])
Regarding claim 3, Duann describes wherein the predetermined type includes at least one type from out of a first type indicting normal ([0027]), a second type indicating atrial fibrillation ([0024]), and a third type indicating premature ventricular contraction ([0024]).
Regarding claim 4, Duann describes
a segmentation estimation model that employs waveform data of partial segments of waveform data in an electrocardiogram as input information and employs segment type information indicating whether or not a segment corresponding to the waveform data is one segment of predetermined types of segment as output information ([0024])
a second analysis waveform select and extract unit that selects and extracts waveform data of a second period that is a longer period than the first period from waveform data acquired by the analysis waveform acquisition unit as second analysis divided waveform data ([0024]; [0048] and figure 3, modules may be reorganized as necessary)
a second derivation unit that derives the segment type information by inputting the second analysis divided waveform data selected and extracted by the second analysis waveform select and extract unit into the segmentation estimation model ([0024]; [0048] and figure 3, modules may be reorganized as necessary)
an estimation unit that estimates a condition indicated by the electrocardiogram for analysis by synthesizing the peak information derived by the derivation unit together with the segment type information derived by the second derivation unit ([0025] - [0026]; [0048] and figure 3, modules may be reorganized as necessary)
Regarding claim 5, Duann describes wherein the predetermined types of segment include at least two segments from out of a normal segment that is a segment that is normal ([0027]) and an atrial fibrillation segment that is a segment with an atrial fibrillation ([0024]).
Regarding claim 8, Duann describes an electrocardiogram analysis assistance system ([0011]) comprising
the electrocardiogram analysis assistance device of claim 1 (please refer to citations within claim 1, above)
a terminal device that transmits waveform data in an electrocardiogram for analysis to the electrocardiogram analysis assistance device and that receives and presents information obtained by the electrocardiogram analysis assistance device in response to the transmission of the waveform data ([0030])
Claim 9 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Koivisto et al. (US 2018/0035919 A1).
Regarding claim 9, Koivisto describes a peak estimation model generation method ([0056], [0084]) comprising
acquiring first training waveform data in electrocardiograms for training ([0105])
selecting and extracting waveform data of a predetermined first period from the acquired first training waveform data as first training divided waveform data ([0106])
generating a peak estimation model by performing machine learning employing the selected and extracted first training divided waveform data as input information and employing peak information corresponding to the first training divided waveform data and indicating whether or not a predetermined type of peak related to electrocardiogram analysis is present as output information ([0104] - [0105])
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.
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 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Duann in view of Koivisto.
Regarding claim 2, Duann describes the electrocardiogram analysis assistance device of claim 1 but does not explicitly disclose
a training waveform acquisition unit that acquires waveform data in electrocardiograms for training
a training waveform select and extract unit that selects and extracts waveform data of the first period from the waveform data acquired by the training waveform acquisition unit as training divided waveform data
wherein the peak estimation model is a model trained by machine learning employing the training divided waveform data selected and extracted by the training waveform select and extract unit as input information and employing the peak information corresponding to the training divided waveform data as output information
However, Koivisto also describes an electrocardiogram analysis assistance device ([0010]), including
a training waveform acquisition unit that acquires waveform data in electrocardiograms for training ([0105])
a training waveform select and extract unit that selects and extracts waveform data of the first period from the waveform data acquired by the training waveform acquisition unit as training divided waveform data ([0106])
wherein the peak estimation model is a model trained by machine learning employing the training divided waveform data selected and extracted by the training waveform select and extract unit as input information and employing the peak information corresponding to the training divided waveform data as output information ([0104] - [0105])
As Koivisto is also directed towards an electrocardiogram analysis assistance device and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a machine learning algorithm and training steps similar to those described by Koivisto when using the device described by Duann, as doing so advantageously allows the resulting device to analyze the ECG peaks and potential underlying conditions faster and more accurately.
Regarding claim 10, Duann describes a segmentation estimation model generation method ([0024]) comprising
acquiring second waveform data in electrocardiograms ([0024])
selecting and extracting waveform data of a second period that is a longer period than a predetermined first period from the acquired second training waveform data as second training divided waveform data ([0024])
generating a segmentation estimation model employing the selected and extracted second training divided waveform data as input information and employing segment type information indicating whether or not a segment corresponding to the second training divided waveform data is a segment out of predetermined types of segment as output information ([0024])
Although Duann does not explicitly disclose wherein the waveform data is used for training and machine learning, Koivisto describes a model generation method, including wherein waveform data is used for training and machine learning ([0104] - [0105]). As Koivisto is also directed towards a model generation method and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a machine learning algorithm and training steps similar to those described by Koivisto when using the device described by Duann, as doing so advantageously allows the resulting device to analyze the ECG peaks and potential underlying conditions faster and more accurately.
Statement on Communication via Internet
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“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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 by telephone 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796