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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
The species are as follows:
Species A: drawn to figures 2 and 5, disclosing an electrocardiogram (ECG) evaluation device comprising a selection unit that selects ECG lead data from a plurality of leads, and supplies the selected data to an individual evaluation unit.
Species B: drawn to figures 6-8, disclosing an ECG evaluation device comprising a selection unit that extracts target data from selected lead data and performs evaluation using one of the three waveform selection modes based on the attribute/mode correspondence information.
Species C: drawn to figures 9 and 10, disclosing an evaluation device comprising an acquisition, selection, and evaluation means configured to an acquire ECG data, select ECG lead data, and perform evaluation of the selected data.
There is a serious and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
Searching the different inventions/species would require, at a minimum employing different search queries to evaluate the patentability of the unique limitations recited in one invention/species and not in the other(s). This constitutes a different field of search for the inventions(s)/species, and thus establishes a serious search burden. See MPEP 808.02.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Species A-C lack unity of invention because even though the inventions of these groups require the technical feature of selecting and evaluating ECG lead data, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Sasano et al. (JP 2021109049A1), hereinafter Sasano and in view of Krusor et al. (US 20210096712A1), hereinafter Krusor. The shared technical feature lacks novelty because:
Sasano discloses an electrocardiogram evaluation device comprising (Fig. 1, element 100):
at least one memory configured to store instructions (Fig. 1, element 102, para. 0010 (stores programs and data)); and
at least one processor configured to execute the instructions (Fig. 1, element 101, para. 0010 (controls the device)) to:
acquire electrocardiogram data regarding an electrocardiogram of a subject (Fig. 2, element S201, para. 0014 (acquires electrocardiograms));
select, from the electrocardiogram data, lead data of one or more leads (Fig. 2, element S202) corresponding to a target disease of examination (para. 0009 (heart disease), 0016 (presence or absence of the target disease for each lead), Fig. 3);
evaluate the electrocardiogram regarding the target disease based on the selected lead data (Fig. 2, element S203, para. 0018 (determination result by the model based on the respective leads)).
Sasano does not teach displaying a waveform based on the lead data on a display device in a manner that a section of interest in the evaluation is indicated on the waveform.
However, Krusor discloses an electrocardiogram evaluation device comprising (Fig. 2, element 200):
at least one processor configured to execute the instructions (Fig. 2, element 251, para. 0069 (processor executes the instructions)) to:
display a waveform based on the lead data on a display device (Fig. 3, element 302) in a manner that a section of interest in the evaluation is indicated on the waveform (Fig. 3, element 320 (para. 0071 (individual lead display), Fig. 3, element 330 (para. 0071 (selected lead display))
Sasano and Krusor are considered to be analogous to the clamed invention because they are in the same field of analyzing electrocardiogram data devices. Sasano discloses an output device (Fig. 1, 104, para. 0011 (display)), but displays only the probability that the subject has the target disease (para. 0017). Krusor discloses a display device that includes the waveforms of the lead data. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sasano to incorporate the teachings of Krusor and provide a display device showing the lead data waveforms. Doing so would allow a health professional to properly look at the waveforms from the corresponding lead data, to increase the accuracy of a target disease diagnosis.
During a telephone conversation with Carl J. Pellegrini on 03/30/2026 a provisional election was made without traverse to prosecute the invention of Species C, claims 1, and 9-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 2-4, and 6-8 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 fails to further limit claim 1. Claim 12 appears to further limit the display device of claim 1. However, the display device is not positively recited in claim 12. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, and 9-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Independent claims 1, 9, and 10 recite an electrocardiogram evaluation device, a method, and a computer storage medium. Thus, they are directed to statutory categories of invention.
Step 2A, prong 1:
Claims 1, 9, and 10 recite the following claim limitations:
acquire electrocardiogram data regarding an electrocardiogram of a subject;
select, from the electrocardiogram data, lead data of one or more leads corresponding to a target disease of examinations;
evaluate the electrocardiogram regarding the target disease based on the selected lead data;
These limitations under their broadest reasonable interpretation, cover concepts that can be practically preformed in the human mind. A human, provided ECG lead data, could observe and evaluate the ECG waveform to identify and detect a target disease. For example, these limitations are nothing more than a medical professional, selecting specific ECG leads known to correspond to specific disease conditions, analyzing the waveform data from these leads, and determining the presence or absence of a target disease. Applicant’s specification further discloses that certain lead positions correspond to particular diseases (e.g. l lead, ll lead, and V1 lead correlating with atrial fibrillation (see paragraph [0023])). A medical professional could select and evaluate specific lead data to assess different target diseases. Thus, the claims recite limitations which fall within the ‘mental processes’ grouping of abstract ideas.
Step 2A, prong 2:
Claims 1, 9, and 10 recite the following additional elements:
at least one memory configured to store instructions; (claim 1)
at least one processor configured to execute the instructions; (claim 1)
display a waveform based on the lead data on a display device in a manner that a section of interest in the evaluation is indicated on the waveform (claim 1)
storage medium storing a program that, when executed by a computer, implement a method (claim 10)
Claim 1’s recitation of “at least one processor configured to execute the instructions” fails to recite any additional element or combination of additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. As recited the processor, which upon review of the applicant’s specification is an example of a computer (see paragraph [18]) is a conventional component that does not impose any meaningful structural limitations on the apparatus used to implement the judicial exception. The recitation of a processor in the claim does not integrate the judicial exception into a practical application because the claim merely uses the processor as a tool to perform the abstract idea.
The additional elements of storying the instructions in memory and/or displaying the waveform of the selected lead data in waveform on a display device, amount to nothing more than functions performed by a generic computer. Merely storing instructions/data in a memory and displaying results on a display device does not integrate a judicial exception into practical application.
Claim 10's recitation of a storage medium with computer-usable instructions that, when executed by a computer, implement a method are merely reciting the storage medium at a high-level of generality, and the storage medium merely instructs the computer to carry out the steps of the method. In other words, the computer components are being used as a tool to carry out the method (See MPEP 2106.05(f)).
Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and mere instructions to apply the exception using generic computer components (the processors and computer readable storage media). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly
more than the judicial exception. As discussed above with respect to Step 2A Prong 2, the
additional elements in the claim amount to no more than insignificant extra solution activity
and mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B and does not provide an inventive concept.
The recitation of a processor is not sufficient to amount to significantly more than the judicial
exception because they are recited at a high level of generality, there is no meaningful
limitation, such as a particular or unconventional structure that distinguishes the elements
from well-known, routine, and/or conventional elements. Recitation of a processor as a tool to
perform the abstract idea does not add significantly more than what is well-known, routine,
and/or conventional in view of Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S. 208, 223, 110
USPQ2d 1976, 1983 (2014).
For these reasons, there is no inventive concept. The claim is not patent eligible. Even when viewed as a whole, nothing in the claim adds significantly more to the abstract idea.
Dependent claims
Claim 11 adds the additional element of “machine learning” which as above, a processor in conjunction with an algorithm. Recitation of a generic processor as a tool to perform the
abstract idea does not add significantly more than what is well-known, routine, and/or
conventional in view of Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S. 208, 223, 110 USPQ2d
1976, 1983 (2014). Even when viewed as whole in combination with independent claim 1, the machine learning in claim 11 fails to add significantly more to the abstract idea.
Claim 12 further limits the abstract idea by introducing limitations which are indicative of concepts practically performable in the human mind (verifying sections of an ECG wave).
Claim 10 is rejected under 35 U.S.C. 101 as not falling within one of the four categories of invention. The broadest reasonable interpretation of a claim drawn to a storage medium typically covers forms on non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of storage medium, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. 101 as covering non-statutory subject matter. A claim drawn to such a storage medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. 101 by adding the limitation “non-transitory” to the claim.
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 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Sasano et al. (JP 2021109049A1), hereinafter Sasano.
Regarding Claim 9, Sasano teaches an electrocardiogram evaluation method (Figures 2 and 3) executed by a computer (Fig. 1, element 105, para. 0011 (device communicates with a computer), the electrocardiogram evaluation method comprising (para. 0001 (method of controlling the device)):
acquiring electrocardiogram data regarding an electrocardiogram of a subject (Fig. 2, element S201);
select, from the electrocardiogram data, lead data of one or more leads (Fig. 2, element S202) corresponding to a target disease of examination (para. 0009 (heart disease), 0016 (presence or absence of the target disease for each lead), Fig. 3, elements 301a – 301l); and
evaluating the electrocardiogram regarding the target disease based on the selected lead data (Fig. 2, element S203, Fig. 3).
Regarding Claim 10, Sasano teaches a storage medium (Fig. 1, element 106) storing a program executed by a computer (Fig. 1, element 105, para. 0011 (device communicates with a computer), the program causing the computer to (para. 0012 (storage medium, stores data used for the operation of the device)):
acquire electrocardiogram data regarding an electrocardiogram of a subject (Fig. 2, element S201);
select, from the electrocardiogram data, lead data of one or more leads (Fig. 2, element S202) corresponding to a target disease of examination (para. 0009 (heart disease), 0016 (presence or absence of the target disease for each lead), Fig. 3, elements 301a – 301l); and
evaluate the electrocardiogram regarding the target disease based on the selected lead data (Fig. 2, element S203).
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.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Sasano and in view of Krusor et al. (US 20210096712A1), hereinafter Krusor.
Regarding Claim 1, Sasano teaches an electrocardiogram evaluation device comprising (Fig. 1, element 100):
at least one memory configured to store instructions (Fig. 1, element 102, para. 0010 (stores programs and data)); and
at least one processor configured to execute the instructions (Fig. 1, element 101, para. 0010 (controls the device)) to:
acquire electrocardiogram data regarding an electrocardiogram of a subject (Fig. 2, element S201, para. 0014 (acquires electrocardiograms));
select, from the electrocardiogram data, lead data of one or more leads (Fig. 2, element S202) corresponding to a target disease of examination (para. 0009 (heart disease), 0016 (presence or absence of the target disease for each lead), Fig. 3);
evaluate the electrocardiogram regarding the target disease based on the selected lead data (Fig. 2, element S203, para. 0018 (determination result by the model based on the respective leads)).
Sasano does not teach displaying a waveform based on the lead data on a display device in a manner that a section of interest in the evaluation is indicated on the waveform.
Krusor teaches an electrocardiogram evaluation device comprising (Fig. 2, element 200):
at least one memory configured to store instructions (Fig. 2, element 252, para. 0069 (memory stores instructions of the device)); and
at least one processor configured to execute the instructions (Fig. 2, element 251, para. 0069 (processor executes the instructions)) to:
acquire electrocardiogram data regarding an electrocardiogram of a subject (Fig. 2, element 232, para. 0057 (ECG signal));
display a waveform based on the lead data on a display device (Fig. 3, element 302) in a manner that a section of interest in the evaluation is indicated on the waveform (Fig. 3, element 320 (para. 0071 (individual lead display), Fig. 3, element 330 (para. 0071 (selected lead display))
Sasano and Krusor are considered to be analogous to the clamed invention because they are in the same field of analyzing electrocardiogram data devices. Sasano discloses an output device (Fig. 1, 104, para. 0011 (display)), but displays only the probability that the subject has the target disease (para. 0017). Krusor discloses a display device that includes the waveforms of the lead data. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sasano to incorporate the teachings of Krusor and provide a display device showing the lead data waveforms. Doing so would allow a health professional to properly look at the waveforms from the corresponding lead data, to increase the accuracy of a target disease diagnosis.
Regarding Claim 11, Sasano (in view of Krusor) teaches an electrocardiogram evaluation device comprising the features of claim 1 as discussed above.
Sasano further discloses at least one processor (Fig. 1, element 101) is configured to execute the instructions to evaluate the electrocardiogram using a model (Fig. 5), the model being subjected to machine learning (Fig. 5, element S502, para. 0024 (machine-learning using the waveform datasets of the leads)) to output an evaluation result regarding a presence or absence of the target disease when the lead data is inputted to the model (Fig. 6, element 601a – 601l, para. 0025 (model determines the target disease based on the waveform of the individual lead included in the ECG of the subject)).
Claim 12 is rejected as being unpatentable over Krusor in view of Sasano.
Regarding Claim 12, Krusor (in view of Sasano) teaches an electrocardiogram evaluation device comprising the features of claim 1 as discussed above.
Krusor (in view of Sasano) further discloses wherein the at least one processor (Fig. 2, element 251) is configured to execute the instructions to display the waveform (Fig. 3, element 302, para. 0071 (display)) to assist an examiner's decision making regarding a diagnosis (para. 0073 (a user can select lead signals for the device to display… a particular length of the signal is displayed which is predetermined or selected by the user)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Sato et al. (JP 20120200957) is an example of an electrocardiogram device that classifies cardiac disease, but does so without extracting individual lead data. Kimura et al. (US Patent No. 9386935B2) is another example of a electrocardiogram device that classifies cardiac disease, but does so with mono-leads. Jadidi et al. (US 20220175299A1) is a system that predicts cardiological dysfunction with ECG traces.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 7:30 - 5:00 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, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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