DETAILED ACTION
The preliminary amendment filed 04/23/2025 has been entered.
Claims 1-7, 11-17, and 19-24 are hereby the present claims under consideration.
Examiner’s Note: All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2025/0000389 A1.
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 .
Claim Objections
Claims 5-6 and 11-17 are objected to because of the following informalities:
Claims 5 and 11-13 it appears that “compute the indicator quantity” should read “generate the indicator quantity” to more clearly show that the limitation being further defined is “generate an indicator quantity” of claim 1
Claims 6 and 14-17 it appears that “the individual middle portion of a corresponding individual diastolic phase of the one or more diastolic phases of the heart” should recite “an individual middle portion of the one or more middle portions of a corresponding individual diastolic phase of the one or more diastolic phases of the heart” or the like to make clear the relationship between the “individual portion” of claims 6 and 14-17 and the “one or more individual middle portions” of claim 1. The language of claim 19 or the like would also be sufficient.
Claims 11-13 it appears that “compute the indicator quantity the formula” is missing a linking phrase such as “based at least in part on using”
Appropriate correction is required.
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:
Signal interface in claim 1
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.
A signal interface of claim 1 is interpreted as a wired or wireless communication interface including a simple wire or a radio transmitter as described in paragraph 0034 and their equivalents.
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(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “receive a signal indicative of cardiac rotations … extract, from the signal, one or more temporal portions … generate an indicator quantity indicative of energy … generate an indication of a presence or absence of a cardiac abnormality” which appears to convey that any signal “indicative of cardiac rotations” may be processed in the claimed manner to produce an indication of any type of cardiac abnormality. The claimed genus of signal types and cardiac abnormalities is not supported by the disclosed species of signal types and cardiac abnormalities. In particular, the specification paragraphs 0033-0034 and 0036 describe that the signal types are three dimensional motion signals generated from an accelerometer and/or gyroscope. Thus it would appear that the specification supports the use of any type of three dimensional motion signal but the claimed “signal indicative of cardiac angular rotation” is not limited to three dimensional motion signals. It would seem that any type of cardiac signal such as ECG signals and PPG signals are “indicative of” cardiac angular rotation since these types of signals are indicative of a cardiac cycle which includes the angular rotation involved in contraction and relaxation. The specification does not appear to contemplate how these other categories of signal types may be processed to produce the recited outcomes. It would appear that the processing of ECG and/or PPG signals would be fundamentally different than the processing of the described three-dimensional motion signals and thus the scope of the claimed genus including the processing of signals such as ECG and PPG which are “indicative of” cardiac angular rotations is not supported by the disclosed species. This rejection is further applied to the similar limitations of claim 7.
Claim 1 recites “generate an indication of a presence or absence of a cardiac abnormality of the heart based on a comparison between indicator quantity and a threshold value” which appears to convey that any type of cardiac abnormality may be detected by the threshold comparison with the generated indicator quantity indicative of energy of the extracted one or more temporal portions. The claimed genus of any cardiac abnormality is not supported by the disclosed species provided in the specification. In particular, paragraphs 0036-0037 describe how the quantitative indicator which is indicative of energy can be used to detect heart failure but it is unclear how this indicator could be applied to cardiac abnormalities that are related to timing of heartbeats rather than the energy contained in the heart beat. In particular, the specification does not seem to contemplate using a threshold energy level to diagnose conditions such as arrythmia which are cardiac abnormalities which are associated with the timing of beats rather than the energy contained therein. The claimed genus of cardiac abnormalities is not supported by the disclosed species of heart failure detection using energy thresholds. This rejection is further applied to the similar limitations of claim 7.
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, 11-17, and 19-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-7, 11-17, and 19-24 are directed to a method of processing angular rotation signals using a computational algorithm, which is an abstract idea. Claims 1-7, 11-17, and 19-24 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] extract, from the signal, one or more temporal portions of the signal, the one or more temporal portions being associated with one or more individual portions of one or more diastolic phases of a heart, each of the one or more diastolic phases of the heart having an individual portion
[B1] generate an indicator quantity indicative of energy of the extracted one or more temporal portions
[C1] generate an indication of a presence or absence of a cardiac abnormality of the heart based on of a comparison between the indicator quantity and a threshold value
These elements [A1]-[C1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] a signal interface configured to receive a signal indicative of cardiac angular rotations
[B2] one or more computer processors coupled to the signal interface
These elements [A2]-[B2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[B2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “receive a signal indicative of cardiac angular rotations” does not qualify as significantly more because this limitation merely describes the nature of the received data and does not incorporate the sensor as part of the claimed invention. Also, in an interpretation where the sensors are included in the system, the recitation “receive a signal indicative of cardiac angular rotations” is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than an accelerometer and/or gyroscope for collecting cardiac motion data. Such sensors are conventional as evidenced by Applicant’s lack of a particular description as to their structure and operation as well as paragraph 0003 of Applicant’s specification which indicates that gyrocardiography “GCG” and seismocardiography “SCG” are known methods of cardiography based on cardiac motion which utilize accelerometers and gyroscopes.
Further, the elements [A2]-[B2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in 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 in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-6, 11-17, and 19-24 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claims 2-4: the system including one or more sensors, the one or more sensors including a gyroscope which is a Coriolis vibratory gyroscope;
Claims 22-24: The system including a sensor system in a handheld device which is a smartphone; and
Each of these claim’s limitations does not integrate the exception into a practical application. In particular, the elements of claims 2-4 and 22-24 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the Coriolis vibratory gyroscope is well known in the art as evidenced by:
Overall US Patent Application Publication Number US 2007/0032749 A1 teaches that Coriolis acceleration measurement in a vibratory gyroscope including those in MEMS are commercially available and known in the art (Paragraph 0065).
And smartphones which include accelerometers and/or gyroscopes are conventional as evidenced by:
Deng US Patent Application Publication Number US 2018/0078179 A1 teaches that conventional smartphones include accelerometers and gyroscopes (Paragraph 0028)
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim 7 recites only limitations which have already been addressed in the above rejection of claim 1 and its dependents and is thus rejected on the same grounds as claim 1 and its dependents.
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 1-3, 5-7, 11-12, 14-15, 17, 19-20, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Koivisto US Patent Application Publication Number US 2021/0338108 A1 hereinafter Koivisto
Regarding claim 1, Koivisto discloses a system (Abstract) comprising:
a signal interface configured to receive a signal indicative of cardiac angular rotations (Paragraphs 0011 and 0030-0031: the signal interface for receiving accelerometer and/or gyroscopic signals of cardiac movement and/or the sensors themselves); and
one or more computer processors coupled to the signal interface (Paragraphs 0005 and 0026: the processing system) and configured to:
extract, from the signal, one or more temporal portions of the signal, the one or more temporal portions being associated with one or more individual portions of one or more diastolic phases of a heart, each of the one or more diastolic phases of the heart having an individual portion (Paragraphs 0006, 0027, and 0036: extracting temporal portions of the signal which belong to diastolic phases of the heart, The signals having their respective portions is an intrinsic property of the signals),
generate an indicator quantity indicative of energy of the extracted one or more temporal portions (Paragraph 0028: form an indicator quantity indicative of energy of the temporal portions; Paragraph 0033: the quantification of indicator quantity indicative of energy of diastolic phases), and
generate an indication of a presence or absence of a cardiac abnormality of the heart based on of a comparison between the indicator quantity and a threshold value (Paragraph 0029: output an indication of cardiac abnormality based on a comparison of the indicator quantity to a threshold; Paragraph 0034: the indication of heart failure with reduced ejection fraction).
Koivisto fails to explicitly disclose the temporal portions being middle portions of the diastolic phases. Koivisto instead discloses the analysis of the end portions of the diastolic phases wherein each end phase may cover at most 50% of the diastolic phase. Thus Koivisto explicitly discloses the extraction of the entire signal and/or the end portions of the signal.
An obvious variation of Koivisto would be to extract only the middle portion of the signal and perform the analysis on the middle portion. Such a variation would be obvious because there are a finite number of portion of the signal which can be extracted and analyzed with a reasonable expectation of success. Such portions include the whole signal, the end portions, and the middle portion. Since Koivisto explicitly discloses the extraction and analysis of the whole signal and the end portion of the signal it would be obvious to try the extraction and analysis of the middle portion of the signal. One of ordinary skill in the art would have a reasonable expectation of success since the middle portion is already encompassed by the analysis of the whole signal and thus is relevant to the desired metric being determined.
As such, the extraction and analysis of the middle portion of the signal is considered an obvious variation of Koivisto.
Examiner’s Note: All dependent claims are rejected with the understanding that an obvious variation of Koivisto teaches the extraction and processing of the middle portion of the signals.
Regarding claim 2, Koivisto teaches the system of claim 1. Koivisto further discloses the system wherein the system further comprises one or more sensors configured to generate the signal indicative of the cardiac angular rotations (Paragraphs 0011 and 0030: a gyroscope and/or accelerometer).
Regarding claim 3, Koivisto teaches the system of claim 2. Koivisto further discloses the system wherein the one or more sensors comprise a gyroscope configured to measure the cardiac angular rotations (Paragraphs 0011 and 0030: the gyroscope for measuring angular rotations).
Regarding claims 5, 11, and 12, Koivisto teaches the system of claims 1, 2, and 3 respectively. Koivisto further discloses the system wherein the one or more computer processors are configured to compute the indicator quantity based at least in part on using the formula:
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where i is an index increasing with time, N is a number of samples of the one or more temporal portions associated with the one or more individual middle portions of the one or more diastolic phases, xi is an it sample of cardiac rotation with respect to an x- direction of a cartesian coordinate system, yi is an ith sample of cardiac rotation with respect to a y-direction of the cartesian coordinate system, and zi is an ith sample of cardiac rotation with respect to a z-direction of the cartesian coordinate system (Paragraph 0033 and Equation 1). Koivisto further teaches the system wherein each direction of the cardiac rotation is measured by the gyroscope and/or the one or more sensors (Paragraph 0033: the gyroscope may measure the cardiac rotation in the x, y, and z directions)
Regarding claims 6, 14, 15, and 17 Koivisto teaches the system of claims 1, 2, 3, and 5 respectively. Koivisto further discloses the system wherein the one or more computer processors are configured to extract, from the signal, the one or more temporal portions so that each individual temporal portion of the extracted one or more temporal portions represents the individual middle portion of a corresponding individual diastolic phase of the one or more diastolic phases of the heart (Paragraphs 0036 and 0047: extract the temporal portions so that the extracted temporal portions represent the portion of the corresponding diastolic phase). The signal from which the temporal portions are extracted may be the gyroscope signal (Paragraphs 0030, 0033, and 0047: the signal may be gyroscope and/or accelerometer signal; extracting temporal portions of the signal).
Koivisto fails to explicitly disclose the portion being extracted is a middle one-third portion. As described in the above rejection of claim 1, the middle portion being extracted is considered an obvious variation of Koivisto. Furthermore, the particular percentage or size of the middle portion being extracted is a matter of routine optimization and experimentation with no surprising technical effect. In particular, the exact percentage of the signal being extracted as the “middle portion” is an optimizable variable to configure the system to use a large enough portion of the signal to produce reliable outcome while not needlessly processing excess data which would increase computational efforts. The particular amount of data extracted is a variable subject to routine optimization and experimentation to achieve a desired accuracy and/or precision while minimizing the computational effort for the system.
Regarding claim 19, Koivisto teaches the system of claim 1. Koivisto further discloses the system wherein each of the one or more individual portions of the one or more diastolic phases of the heart corresponds to an individual portion of a corresponding individual diastolic phase of the one or more diastolic phases of the heart (Paragraphs 0036 and 0047: extract the temporal portions so that the extracted temporal portions represent the portion of the corresponding diastolic phase).
Koivisto fails to explicitly disclose the portion being extracted is a middle one-third portion. As described in the above rejection of claim 1, the middle portion being extracted is considered an obvious variation of Koivisto. Furthermore, the particular percentage or size of the middle portion being extracted is a matter of routine optimization and experimentation with no surprising technical effect. In particular, the exact percentage of the signal being extracted as the “middle portion” is an optimizable variable to configure the system to use a large enough portion of the signal to produce reliable outcome while not needlessly processing excess data which would increase computational efforts. The particular amount of data extracted is a variable subject to routine optimization and experimentation to achieve a desired accuracy and/or precision while minimizing the computational effort for the system.
Regarding claim 20, Koivisto teaches the system of claim 1. Koivisto further discloses the system wherein the cardiac abnormality comprises a heart failure (Paragraphs 0034-0035: the detection of heart failure with preserved ejection fraction).
Regarding claim 22, Koivisto teaches the system of claim 2. Koivisto further discloses the system wherein the one or more sensors comprise a sensor system, wherein the sensor system is communicatively coupled to the one or more processors (Paragraphs 0030-0031: the sensor system may be linked to the processors wirelessly or may be part of the processing device).
Regarding claims 23 and 24, Koivisto teaches the system of claim 22. Koivisto further discloses the system wherein the sensor system is comprised in a handheld device, wherein the handheld device is placed on the chest of an individual to measure the cardiac rotation, and wherein the handheld device comprises a smartphone (Paragraphs 0030-0031: the sensor system is placed on the chest, the apparatus with integrated sensor system may be a smartphone or other handheld device).
Regarding claim 7, Koivisto discloses a non-transitory computer readable medium comprising machine-executable instructions where, when executed by one or more processors, the machine-executable instructions cause the one or more processors to perform a method (Abstract; Paragraph 0050: computer readable medium) comprising:
extracting, from a signal associated with cardiac rotation of a heart (Paragraphs 0011 and 0030-0031: the signal interface for receiving accelerometer and/or gyroscopic signals of cardiac movement and/or the sensors themselves), one or more temporal portions of the signal, the one or more temporal portions being associated with one or more individual portions of one or more diastolic phases of the heart, each of the one or more diastolic phases of the heart having an individual middle portion (Paragraphs 0006, 0027, and 0036: extracting temporal portions of the signal which belong to diastolic phases of the heart, The signals having their respective portions is an intrinsic property of the signals);
generating an indicator quantity indicative of energy of the extracted one or more temporal portions of the signal associated with the one or more diastolic phases of the heart (Paragraph 0028: form an indicator quantity indicative of energy of the temporal portions; Paragraph 0033: the quantification of indicator quantity indicative of energy of diastolic phases); and
generating an indication of a presence of or absence of a cardiac abnormality of the heart based on a comparison between the indicator quantity and a threshold value (Paragraph 0029: output an indication of cardiac abnormality based on a comparison of the indicator quantity to a threshold; Paragraph 0034: the indication of heart failure with reduced ejection fraction).
Koivisto fails to explicitly disclose the temporal portions being middle portions of the diastolic phases. Koivisto instead discloses the analysis of the end portions of the diastolic phases wherein each end phase may cover at most 50% of the diastolic phase. Thus Koivisto explicitly discloses the extraction of the entire signal and/or the end portions of the signal.
An obvious variation of Koivisto would be to extract only the middle portion of the signal and perform the analysis on the middle portion. Such a variation would be obvious because there are a finite number of portion of the signal which can be extracted and analyzed with a reasonable expectation of success. Such portions include the whole signal, the end portions, and the middle portion. Since Koivisto explicitly discloses the extraction and analysis of the whole signal and the end portion of the signal it would be obvious to try the extraction and analysis of the middle portion of the signal. One of ordinary skill in the art would have a reasonable expectation of success since the middle portion is already encompassed by the analysis of the whole signal and thus is relevant to the desired metric being determined.
As such, the extraction and analysis of the middle portion of the signal is considered an obvious variation of Koivisto.
Claims 4, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Koivisto US Patent Application Publication Number US 2021/0338108 A1 hereinafter Koivisto as applied to claim 3 above and further in view of Meriheina US Patent Number US 10178964 B2 hereinafter Meriheina.
Regarding claim 4, Koivisto teaches the system of claim 3. Koivisto fails to further disclose the system, wherein the gyroscope is a Coriolis vibratory gyroscope comprising a vibrating structure configured to determine a rate of rotation.
Meriheina teaches a device that includes a sensor of angular motion configured to obtain an angular ballistograph signal indicative of rotational movement of a chest of a subject. Signal processing means are configured to generate from this angular ballistocardiograph signal measured values of an output parameter, which is indicative of cardiac operation of the subject (Abstract). Thus, Meriheina falls within the same field of endeavor as Applicant’s invention.
Meriheina teaches the measurement of rotary motion of the heart (Col 4 lines 10-25). The sensor to measure this motion may be a MEMS gyroscope which utilizes the Coriolis effect and mechanical oscillation to measure angular motion (Col 5 lines 13-58).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the MEMS gyroscope utilizing the Coriolis effect to measure angular movement as taught by Meriheina into the system of Koivisto because using the gyroscope of Meriheina in the system of Koivisto is a simple substitution of one known element (the gyroscope of Koivisto) for another known element (the gyroscope of Meriheina) with no surprising technical effect.
Regarding claim 13, Koivisto in view of Meriheina teaches the system of claim 4. Modified Koivisto further discloses the system wherein the one or more computer processors are configured to compute the indicator quantity based at least in part on using the formula:
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Greyscale
where i is an index increasing with time, N is a number of samples of the one or more temporal portions associated with the one or more individual middle portions of the one or more diastolic phases, xi is an it sample of cardiac rotation with respect to an x- direction of a cartesian coordinate system, yi is an ith sample of cardiac rotation with respect to a y-direction of the cartesian coordinate system, and zi is an ith sample of cardiac rotation with respect to a z-direction of the cartesian coordinate system (Paragraph 0033 and Equation 1). Koivisto further teaches the system wherein each direction of the cardiac rotation is measured by the gyroscope and/or the one or more sensors (Paragraph 0033: the gyroscope may measure the cardiac rotation in the x, y, and z directions). Koivisto in view of Meriheina as presented in claim 4 above teaches that the gyroscope may be the Coriolis vibratory gyroscope.
Regarding claim 16 Koivisto in view of Meriheina teaches the system of claim 4. Modified Koivisto further discloses the system wherein the one or more computer processors are configured to extract, from the signal generated by the gyroscope, the one or more temporal portions so that each individual temporal portion of the extracted one or more temporal portions represents an individual middle portion of a corresponding individual diastolic phase of the one or more diastolic phases of the heart (Paragraph 0036: extract the temporal portions so that the extracted temporal portions represent the portion of the corresponding diastolic phase). The signal from which the temporal portions are extracted may be the gyroscope signal (Paragraphs 0030 and 0033: the signal may be gyroscope and/or accelerometer signal; extracting temporal portions of the signal). Koivisto in view of Meriheina as presented in claim 4 above teaches that the gyroscope may be the Coriolis vibratory gyroscope.
Koivisto fails to explicitly disclose the portion being extracted is a middle one-third portion. As described in the above rejection of claim 1, the middle portion being extracted is considered an obvious variation of Koivisto. Furthermore, the particular percentage or size of the middle portion being extracted is a matter of routine optimization and experimentation with no surprising technical effect. In particular, the exact percentage of the signal being extracted as the “middle portion” is an optimizable variable to configure the system to use a large enough portion of the signal to produce reliable outcome while not needlessly processing excess data which would increase computational efforts. The particular amount of data extracted is a variable subject to routine optimization and experimentation to achieve a desired accuracy and/or precision while minimizing the computational effort for the system.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Koivisto US Patent Application Publication Number US 2021/0338108 A1 hereinafter Koivisto as applied to claim 1 above and further in view of Kale US Patent Application Publication Number US 2020/0170527 A1 hereinafter Kale
Regarding claim 21, Koivisto teaches the system of claim 1. Koivisto fails to further disclose the system, wherein the cardiac abnormality comprises a heart failure with reduced ejection fraction.
Koivisto teaches the detection of heart failure with preserved ejection fraction (Paragraphs 0034-0035), contemplates the detection of other cardiac abnormalities (Paragraph 0042), and contemplates that heart failure with reduced ejection fraction can be relatively straightforwardly detected with ultrasound based echocardiography (Paragraph 0003) but fails to explicitly disclose that the determined cardiac abnormality is heart failure with reduced ejection fraction.
Kale teaches a system for marking cardiac time intervals from heart valve signals includes a non-invasive sensor unit for capturing electrical signals and composite vibration objects, a memory containing computer instructions, and one or more processors coupled to the memory. The one or more processors causes the one or more processors to perform operations including separating a plurality of individual heart vibration events into heart valve signals from the composite vibration objects, and marking cardiac time interval from the heart valve signals by detecting individual heartbeats using at least one or more of a PCA algorithm or deep learning (Abstract). Thus, Kale falls within the same field of endeavor as Applicant’s invention.
Kale teaches a system which captures vibration signals (Paragraph 0028-0029) and may use these signals to detect various different heart failure conditions including heart failure with reduced ejection fraction (Paragraph 0099).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the system of Koivisto to determine heart failure with reduced ejection fraction (HFrEF) as taught by Kale because such a configuration would allow modified Koivisto to detect a wider range of cardiac abnormalities and be applicable to a wider field of patients and Koivisto already contemplates determining additional cardiac abnormalities (Koivisto: paragraph 0042).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-7, 11-12, 14-15, 17, 19-20, and 22 are rejected on the ground of no statutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US 12207918 B2 (hereinafter the reference Patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent include all the required limitations of the present claims except for the analysis being of the middle portion of the temporal portions. The middle portion of the temporal portions being extracted and used for analysis is considered an obvious variation with a reasonable expectation of success as described in the above rejection of claim 1. Thus the claims of the reference patent are not considered patentably distinct from the present claims.
Claims 4, 13, 16, and 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. US 12207918 B2 in view of US Patent Number US 10178964 B2 hereinafter Meriheina which teaches the measurement of rotary motion of the heart (Col 4 lines 10-25). The sensor to measure this motion may be a MEMS gyroscope which utilizes the Coriolis effect and mechanical oscillation to measure angular motion (Col 5 lines 13-58). The system may be a smartphone placed against the user’s chest to perform measurements (Col 7 lines 17-39; Fig. 4).
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. US 12207918 B2 in view of US Patent Application Publication Number US 2020/0170527 A1 hereinafter Kale which teaches a system which captures vibration signals (Paragraph 0028-0029) and may use these signals to detect various different heart failure conditions including heart failure with reduced ejection fraction (Paragraph 0099).
Conclusion
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/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791