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
Claims 1-8 are deemed to have an effective filing date of September 3, 2021.
Claim Rejections - 35 USC § 112
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 1-8 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. While the written description provides adequate detail of its determination device w/r/t the existence/nonexistence of a heart abnormality using electrocardiograms, the instant written specification provides an adequate written description for determination devices outside the cardiac art. A broad genus claim is presented, but the instant specification describes a narrow species with no evidence beyond the statements of “Technical Problem” and “Solution to the Problem” on pages 1-2 of the instant specification. The inclusion of the broad genus claim language in the instant specification does not provide an adequate written description for species outside determining the existence/nonexistence of a heart abnormality based on an electrocardiogram as the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. See Enzo Biochem, Inc. v Gen-Probe, Inc, 323 F,3d 956,968, 63 USPQ2d 1609 (Fed Cir. 2002) and MPEP 2163. The originally-filed specification only describes the claimed invention with respect to determination device that determines the existence/nonexistence of a heart abnormality using electrocardiograms in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of that species of the claimed invention. See Moba, B.V. v Diamond Automation, Inc., 325 F.3d 1306, 1329, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The scope of the claim is unclear as the recitation of “inputting a signal into the determination target from an outside of the determination target” in reference to “a time step that serves a reference to a changing state of the determination target” (claim 1) is vague and indefinite. The identify step of claim 3 appears to add a new step (inputting a signal into a determination target) that is not related to claim 1. The instant specification does not appear to shed any light on “inputting a signal into a determination target”.
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.
Claims 2-3 are 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 1 recites “identify a reference time step as a time step serving as a reference to a changing state of the determination target”. Claims 2-3 respectively identify the reference time step as a time step for inputting the data …; or as a time step for inputting a signal into the determination target …” The scope of the claims are unclear as it appears that “identify a reference time step” of claim 1 is changed to a different function. Thus, no longer limiting the subject matter of claim 1. 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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a memory and a processor executing the instructions of the memory. For example, in claim 1 (and claim 8 for the last two steps), the limitations of receiving input data relating to a determination target…for each time step”, “identify a reference time step…determination target” and “perform determination…reference time step” can be interpreted as mental process as they are nothing more than a person receiving medical data (e.g., ECG data), observing changes in ECG time to determine a baseline reference and detecting a cardiovascular condition based on the baseline reference.
This judicial exception is not integrated into a practical application because the additional limitations are memory and processor, which are nothing more than parts of generic computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements do no more than automate the mental process (e.g., the mental computation of identifying/processing a harmonic), using the memory and processor as a tool. There is no change to generic computers and other technology recited in the claims, and thus, the claims do not improve computer functionality or other technology (see MPEP 2106.05 I. A. and 2106.05(a)). Accordingly, the claims, taken as a whole, do not integrate the recited judicial exception into a practical application. Thus, the above-identified claims are directed to the judicial exception.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2018/0368723 to Ibáñez Català et al. (hereinafter referred to as “I.C.”).
Regarding claim 1, I.C. discloses a determination device (e.g., Abstract: arrhythmia detection system), comprising: a memory configured to store instructions and a model for receiving an input of data relating to a determination target for each time step and for changing the state thereof for each time step (e.g., paragraph [0021]: computing device 22 contains the hardware and software necessary to carry out the exemplary methods for classifying arrhythmia-related heartbeats … and provides a user application 40 residing locally in memory 42); and a processor configured to execute the instructions (e.g., paragraphs [0017] and [0021]: computing device 22 is configured to receive and process select data obtained by a beat detector) to: identify a reference time step as a time step serving as a reference to a changing state of the determination target (e.g., paragraphs [0007] and [0025]: each ECG recording comprises a temporal position within a window of pre-determined temporal length (reference time step) and a beat class associated with each represented heartbeat (changing state of the heart) and the segments are identified by a real-time matrix); and perform determination of the determination target based on the state of the model (e.g., real-time matrix) at a derivative time step from the reference time step (e.g., paragraphs [0007]: arrhythmia detection system is based on the state of the real-time matrix shifting from a reference time step where the initially populated heartbeat occurs at the reference time step; [0025] and Fig. 5).
With respect to claim 2, I.C. discloses the determination device according to claim 1, wherein the processor is configured to execute the instructions to identify the reference time step as a time step for inputting the data of the determination target meeting a predetermined condition (as best understood, e.g., paragraphs [0007] and [0025]: data is input to the real-time matrix as a time step).
As to claim 3, I.C. discloses the determination device according to claim 1, wherein the processor is configured to execute the instructions to identify the reference time step as a time step for inputting a signal into the determination target from an outside of the determination target (as best understood, the sampling of data of the ECG signal of I.C. would input a signal into the heart from outside of the heart).
With respect to claim 4, I.C. discloses the determination device according to claim 1, wherein the processor is configured to execute the instructions to perform the determination of the determination target based on the state of the model at a past time step before the reference time step (e.g., paragraphs [0007] and [0025]: the real-time matrix determines its state based on a heartbeat immediately preceding the initially populated heartbeat or based on the state of the model at a past time step; see also Fig. 5, 502) .
As to claim 5, I.C. discloses the determination device according to claim 1, wherein the processor is configured to execute the instructions to perform the determination of the determination target based on the state of the model at a future time step after the reference time step (e.g., paragraphs [0007] and [0025]: the real-time matrix determines its state based on a heartbeat succeeding the initially populated heartbeat or based on the state of the model at a future step; see also Fig. 5, 504) .
With respect to claim 6, I.C. discloses the determination device according to claim 1, wherein the processor is configured to execute the instructions to perform learning about the determination of the determination target at the derivative time step from the reference time step (e.g., paragraph [0022]: system 20 is capable of classifying arrhythmia-related heartbeats 34 based on extracted data from an ECG recording where the classifier is first trained appropriately (learning how to classify the ECG segments).
Referring to claim 7, I.C. discloses a determination method (e.g., Abstract: arrhythmia detection method) for a device that stores a model for receiving an input of data relating to a determination target for each time step and for changing the state thereof for each time step (e.g., paragraph [0021]: computing device 22 provides a user application 40 residing locally in memory 42); and a processor configured to execute the instructions (e.g., paragraphs [0017] and [0021]: computing device 22 is configured to receive and process select data obtained by a beat detector), the method comprising: identifying a reference time step as a time step serving as a reference to a changing state of the determination target (e.g., paragraphs [0007] and [0025]: each ECG recording comprises a temporal position within a window of pre-determined temporal length (reference time step) and a beat class associated with each represented heartbeat (changing state of the heart) and the segments are identified by a real-time matrix); and performing determination of the determination target based on the state of the model (e.g., real-time matrix) at a derivative time step from the reference time step (e.g., paragraphs [0007]: arrhythmia detection system is based on the state of the real-time matrix shifting from a reference time step where the initially populated heartbeat occurs at the reference time step; [0025] and Fig. 5).
Regarding claim 8, I.C. discloses a non-transitory storage medium having a stored program causing a device that stores a model for receiving an input of data relating to a determination target for each time step and for changing the state thereof for each time step (e.g., paragraph [0021]: computing device 22 contains the hardware and software necessary to carry out the exemplary methods for classifying arrhythmia-related heartbeats … and provides a user application 40 residing locally in memory 42) to execute: (e.g., paragraphs [0017] and [0021]: computing device 22 is configured to receive and process select data obtained by a beat detector) identifying a reference time step as a time step serving as a reference to a changing state of the determination target (e.g., paragraphs [0007] and [0025]: each ECG recording comprises a temporal position within a window of pre-determined temporal length (reference time step) and a beat class associated with each represented heartbeat (changing state of the heart) and the segments are identified by a real-time matrix); and performing determination of the determination target based on the state of the model (e.g., real-time matrix) at a derivative time step from the reference time step (e.g., paragraphs [0007]: arrhythmia detection system is based on the state of the real-time matrix shifting from a reference time step where the initially populated heartbeat occurs at the reference time step; [0025] and Fig. 5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent No. 2017/0112401 to Rapin et al. is directed to an automatic method to delineate or categorize an electrocardiogram using a neural network or Hidden Markov Models.
US Patent No. 2015/0190068 to Cole is directed to a system and method for detecting a characteristic in an ECG waveform where the determination device makes its determination based on a Hidden Markov model and preceding time window; and implementation of an algorithm by processor 40 which calculates the classification score and is compared to corresponding classification threshold (e.g., paragraph [0031] of Cole).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792