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 .
Priority
This application filed 03/17/2023 is a National Stage entry of PCT/KR2021/013538, with an International Filing Date of 10/01/2021, and further claims foreign priority to 10-2020-0128484, filed 10/06/2020, and to 10-2020-0128979, filed 10/06/2020. The claims are therefore examined as filed on 10/06/2020, the effective filing date. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further review of the priority application(s).
Claim Status
Claims 1-11 are pending.
Claims 1-11 are examined.
Claims 1-11 are rejected.
Information Disclosure Statement
The Information Disclosure Statements are in compliance with the provisions of 37 CFR 1.97. Accordingly, all references have been considered.
Drawings
The drawings are objected to because the text within the figures is blurry and difficult to read, and because the figure label numbers are not all on the same pages as their corresponding figures, such that it is confusing as to what number goes with what figure (for example, the first figure on page 28 has both a Fig 1 and Fig 2 label, and the two figures on pg 29 are labeled as Fig 3).
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.
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:
The “biosignal collection unit” of claim 6
The “preprocessing unit” of claim 6
The “signal quality estimation unit” of claims 6 and 9
The “signal analysis unit” of claims 6 and 10
The “episode determination unit” of claims 6 and 7
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. The specification indicates that the biosignal collection unit includes a sensor [53] while the remaining units are part of a processor [51] and may further contain either hardware or software components [105].
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 § 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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of mental processes and mathematical concepts, without significantly more.
The MPEP at MPEP 2106 sets forth steps for identifying eligible subject matter:
(1) Are the claims directed to a process, machine, manufacture or composition of matter?
(2A)(1) Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea?
(2A)(2) Do the claims recite additional elements that integrate the judicial exception into a practical application?
(2B) If the claims recite a judicial exception and do not integrate the judicial exception, do the claims recite additional elements that provide an inventive concept and amount to significantly more than the judicial exception?
With regard to step (1) (Are the claims directed to a process, machine, manufacture or composition of matter?): Yes. The claims are directed to one of the statutory classes. Claims 1-5 are directed to a process (a method performed using a device), and claims 6-11 are directed to a product (a device comprising units for performing the method).
With regard to step (2A)(1) (Do the claims recite a judicially recognized exception?): Yes. The claims recite the abstract ideas of processing data using mental steps and mathematical concepts. Claims that recite nothing more than abstract ideas, natural phenomena, or laws of nature are not eligible for patent protection (see MPEP 2106.04).
Abstract ideas include mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (See MPEP 2106.04(a)(2)). In particular, these abstract ideas include but are not limited to:
Removing noise from a biosignal (mental process/mathematical concept; the human mind is capable of removing noise from data using data processing methods, such as removing datapoints exceeding a threshold or subtracting a baseline; removing noise with data processing methods is a mathematical concept; claims 1, 6)
Estimating signal quality (mental process/mathematical concept; the human mind is capable of estimating quality, and determining an estimation is equivalent to performing a calculation; claims 1, 6)
Classifying the biosignal as an abnormal or normal signal (mental process; the human mind is capable of classifying data as normal or abnormal; claims 1, 6)
Determining whether an abnormal condition episode has occurred and a duration time based on signal quality and classification results (mental process/mathematical concept; the human mind is capable of making a determination based on processed data, and doing so is equivalent to performing a calculation; claims 1, 6)
Determining that an abnormal condition episode has occurred when each of biosignals of consecutive unit times of more than a preset minimum number is classified as an abnormal signal and signal quality is determined to be good; and determining, after occurrence of an abnormal condition episode, that the abnormal condition episode has ended when each of biosignals of a preset minimum number of consecutive unit times is determined as a non-abnormal signal (mental process; the human mind is capable of making a determination based on a set of occurrences; claims 2, 7)
Calculating a time from start of the abnormal condition episode to end of the abnormal condition episode as a duration time (mental process/mathematical concept; the human mind is capable of calculating a time from the start to end of a time period, and doing so is a mathematical calculation; claims 2, 7)
Dependent claims 3 and 8 further limit the abstract ideas recited in the independent claims, and do not change their characterization as abstract ideas.
Therefore, the claims recite elements that constitute one or more judicial exceptions.
With regard to step (2A)(2) (Do the claims recite additional elements that integrate the judicial exception into a practical application?): No. Claim 1 and its dependents recite the additional element wherein the method is performed using a device for analyzing the biosignals, and wherein the biosignal is generated by a sensor. Claim 6 and its dependents also recite the additional element of a device for analyzing biosignals comprising units, and where the biosignal is generated by a sensor. The device in the specification is described as including at least a processor [51]. Claims 4-5 and 9-10 also recite the additional element of quality estimation and classification steps being performed based on machine learning algorithms. Claim 11 further defines the additional element of the sensor as a PPG sensor.
While the claims recite the additional element of collecting data generated from a sensor, a necessary data gathering step without any further active steps detailing how the data is obtained, in a way that is impacted by the judicial exception, is an insignificant extrasolution activity that does not add a meaningful limitation to the claims (see MPEP 2106.05(g)). Similarly, the additional element of a sensor for gathering/generating data, without further detail on the structure and function of the sensor, merely indicates a field of use or technological environment in which to apply a judicial exception (see MPEP 2106.05(h)). As a result, the judicial exception is not integrated into a practical application. In addition, while the claims recite additional elements related to the use of computers (the analysis device), they do not provide any specific details by which the device or units performs or carries out the judicial exception listed in step (2A)(1), nor do they provide any details of how specific structures of the computer/device are used to implement these functions. The judicial exception is therefore not integrated into a practical application because the generically recited elements do not add a meaningful limitation to the abstract idea, as they amount to simply implementing the abstract idea on a computer (see MPEP 2106.05(f)). This also applies to the use of machine learning algorithms to process data, as a machine learning algorithms, without recited physical structure outside of general computer components, is also analogous to implementing an abstract idea of data analysis on a computer. Because the claims do not recite any additional elements that integrate the judicial exception into a practical application, the claims as a whole are directed to an abstract idea.
With regard to step (2B) (Do the claims recite additional elements that provide an inventive concept and amount to significantly more than the judicial exception?): No. The claims recite an abstract idea with additional elements; however, these additional elements are general computer elements added to abstract ideas, and non-particular instructions to apply the abstract idea by linking it to a field of use or extrasolution activity (see MPEP 2106.05(f-h)). General computer elements used to perform an abstract idea do not provide an inventive concept, and similarly, non-particular instructions to gather or produce data do not provide an inventive concept. Non-particular instructions to gather or output data using general computer elements are also considered well-understood, routine and conventional activities (see MPEP 2106.05(d), which indicates that limitations such as “Receiving or transmitting data over a network” from Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362, and “Storing and retrieving information in memory” from Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, are recognized as conventional activities). Receiving biosignals from sensors, including PPGs, for analysis are also well understood, routine and conventional (see BISWAS 2019, cited on the 892 form). The claims therefore do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As a result, the claims as a whole do not provide an inventive concept.
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.
(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.
Claim Rejection
Claims 1, 5-6, and 10-11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by NEMATI 2019 “Methods And Systems For Determining Abnormal Cardiac Activity” (US 20190328243 A1).
Claim Interpretation and Scope and Contents of Prior Art
Claims 1 and 6 recite a method and device for analyzing biosignals, comprising a step of removing noise from a biosignal generated by a sensor; a step of estimating signal quality of the biosignal of a preset unit time; a step of classifying the biosignal of a preset unit time as an abnormal signal or a normal signal; and a step of determining whether an abnormal condition episode has occurred and a duration time based on signal quality and classification results for biosignals of a plurality of unit times.
With respect to these limitations, NEMATI teaches methods and systems of analyzing biosignals from sensors such as ECG and/or PPG [0025, 38] that include the steps of pre-processing data to remove noise [0063], determining signal quality of the signal in a preset window of time [0007, 61, 66], classifying the signal within each window as normal or abnormal cardiac activity [13, 82-83], and determining whether an abnormal condition episode has occurred and the total time of the episode based on the signal quality and classification [Abstract, 0084, 93, claim 1].
Claims 5 and 10 recite the limitations wherein the biosignal is classified based on a machine learning-based algorithm generated based on a correlation between characteristics of an abnormal signal and a normal signal and characteristics of the biosignal.
With respect to these limitations, NEMATI teaches classifying the signal as normal or abnormal using a convolutional neural network based on correlations between characteristics/features associated with abnormal and normal cardiac activity [084-85].
Claim 11 recites the limitation wherein the sensor is a photoplethysmography (PPG) sensor. With respect to this limitation, NEMATI teaches that the sensor can be a PPG [0038, 41].
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.
Claim Rejection
Claims 2-4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over NEMATI as applied to claims 1, 5-6, and 10-11 above, and further in view of ALIAMIRI 2021 “Method And Apparatus For High Accuracy Photoplethysmogram Based Atrial Fibrillation Detection Using Wearable Device” (filed 2018, US 11147463 B2).
Claim Interpretation and Scope and Contents of Prior Art
NEMATI teaches the limitations of claims 1, 5-6, and 10-11 above.
Claims 2 and 7 recite the limitations of determining that an abnormal condition episode has occurred when each of biosignals of consecutive unit times of more than a preset minimum number is classified as an abnormal signal and signal quality is determined to be good; a step of determining, after occurrence of an abnormal condition episode, that the abnormal condition episode has ended when each of biosignals of a preset minimum number of consecutive unit times is determined as a non-abnormal signal; and a step of calculating a time from start of the abnormal condition episode to end of the abnormal condition episode as a duration time.
With respect to these limitations NEMATI teaches determining the total time of abnormal cardiac activity based on the activity determined from the windows, which would inherently include when the abnormal episode has ended based on at least one normal signal following the episode [0082-84, 87-88]. While NEMATI also teaches determining abnormal cardiac activity using the determined signal quality indices for each window [019, 89], it does not teach determining the abnormal condition episode has occurred when signal quality is determined to be good, as it does not classify the quality indices as such. However, ALIMIRI teaches classifying a biosignal as an abnormal signal or a normal signal only when signal quality is determined to be good [13].
Claims 3 and 8 recite the limitations wherein the non-abnormal signal comprises a case in which signal quality of a unit signal is good but a normal signal and a case in which signal quality is poor. With respect to this limitation, ALIMIRI also teaches that a non-abnormal signal can be a signal with good quality determined to be normal (no Afib) or a signal with poor quality, where the AFib status is undetermined [13-14, 31].
Claims 4 and 9 recite the limitations wherein signal quality of the biosignal is estimated to be good or poor based on a preset machine learning algorithm based on correlation between characteristics of the biosignal and signal quality to be estimated. With respect to this limitation, ALIMIRI teaches estimating signal quality using a deep learning model based on a correlation between characteristics of the signal and signal quality [13-14].
Resolving Ordinary Skill in the Art and Obviousness Rationale
A teaching, suggestion, or motivation in the prior art would have led one of ordinary skill in the art to modify or combine the prior art to arrive at the claimed invention. Specifically, a person of ordinary skill in biosignal analysis would have been motivated to combine the teachings of NEMATI with the teachings of ALIMIRI, in order to achieve the claimed invention, because identifying a biosignal as good vs poor allows for selection of only high quality signals for analysis, leading to better prediction results for abnormal cardiac conditions [13, 31]. A person of ordinary skill would reasonably expect success from combining these teachings, as both NEMATI and ALIMIRI teach methods for evaluating signal quality and classifying PPG data using the quality estimation. Therefore, the claims at issue would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention as there is both a reason to modify or combine the prior art, and a reasonable expectation of success (see MPEP 2143.02 (I)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY C LEVERETT whose telephone number is (571)272-5494. The examiner can normally be reached 8:00am - 5:00pm M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz R. Skowronek can be reached at (571) 272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY C LEVERETT/Examiner, Art Unit 1687
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