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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 712 from Fig. 27. Applicant is encouraged to change “412” in ¶157 of the specification to recite –712--. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“the analyzing steps” in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
For the limitation of “the analyzing steps” in claim 1, the Examiner is interpreting each of the analyzing limitations performed as an analyzing step.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claim 1 is directed to statutory subject matter as the claims recite a method for arrhythmia analysis.
Step 2A, Prong One
Regarding claim 1, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claim 1, the limitations of “acquiring…an electrocardiogram (ECG) waveform signal of a subject at a set sampling frequency rate; processing…the acquired ECG waveform signal to remove low frequency noise and high frequency noise artifacts and form a denoised ECG waveform signal; processing…the denoised ECG waveform signal to remove low quality segments and form a high quality ECG waveform signal; analyzing…the high quality ECG waveform to detect a presence of a beat-independent ventricular arrhythmia within the high quality ECG signal; processing…the denoised ECG signal to extract beat (R-peak) locations corresponding to QRS complexes from the denoised ECG signal; analyzing…the denoised ECG signal to detect a presence of a beat-dependent ventricular arrhythmia within the denoised ECG signal based on the extracted beat (R-peak) locations of the denoised ECG signal; analyzing…the denoised ECG signal to detect a presence of one or more supraventricular arrhythmias within the denoised ECG signal based on the extracted beat locations of the ECG signal; and outputting…a report containing one or more arrhythmias detected by the analyzing steps” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving a print out of an electrocardiogram (ECG) waveform signal of a subject at a set sampling frequency rate, using pen and paper to remove low frequency noise and high frequency noise artifacts from the ECG signal, removing low quality segments from the previously denoised ECG signal to form a high quality ECG signal, detecting a presence of a beat-independent ventricular arrhythmia within the high quality ECG signal, extracting beat (R-peak) locations corresponding to QRS complexes from the denoised ECG signal, detecting a presence of a beat-dependent ventricular arrhythmia within the denoised ECG signal based on the extracted beat (R-peak) locations of the denoised ECG signal, detecting a presence of one or more supraventricular arrhythmias within the denoised ECG signal based on the extracted beat locations of the ECG signal, and writing down a report containing one or more arrhythmias detected.
Step 2A, Prong Two
For claim 1, the judicial exception is not integrated into a practical application. In particular, claim 1 recites “at least one computing device.” The at least one computing device is recited at a high-level of generality and amounts to nothing more than a part of a generic computer. The Examiner notes that the acquiring step is being performed by the at least one computing device, not ECG electrodes. In addition, the outputting step amounts to nothing more than mere post-solution activity of displaying results. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional element of at least one computing device amounts to nothing more than a part of a generic computer, which does not amount to an inventive concept. Further, simply appending well-understood, routine, conventional activities previously known to 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 to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
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.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Brockway (US 20160256112 filed on 5/17/16) in view of Gregg (US 20180242872 filed on 8/25/16).
Regarding claim 1, Brockway teaches an arrhythmia analysis method (¶9-a process is described for detecting, classifying, and reporting arrhythmia events that provides for efficiency and accuracy) comprising: acquiring, by at least one computing device (¶5-computing circuit; ¶49-a processor (e.g., computer circuit)), an electrocardiogram (ECG) waveform signal of a subject at a set sampling frequency rate (¶6-a patient-worn apparatus for recording an ECG from the patient. The apparatus includes a first circuit that digitizes an ECG signal obtained from the patient via at least two ECG leads, and a computing circuit that is connected to the first circuit to receive the digitized ECG signal; ¶45-sampling each ECG signal at 300 Hz or less; ¶76-the sampling rate is chosen to be 2.5 to 5 times the cut-off frequency of the low-pass anti-aliasing filter implemented in signal conditioning circuits 202); processing, by the at least one computing device, the acquired ECG waveform signal to remove low frequency noise and high frequency noise artifacts and form a denoised ECG waveform signal (¶75-amplifiers in condition and digitize circuitry 202 may have associated filtering that suppresses spectral content outside the bandwidth of the signal of interest. Such filters may incorporate both low pass and high pass filtering functions; ¶7-the computing circuit processes the digitized signals to remove noise therefrom; ¶79-remove noise (e.g., denoising)); analyzing, by the at least one computing device, the ECG waveform to detect a presence of a beat-independent ventricular arrhythmia within the ECG signal (¶95-computing dSNR, the energy level of signal relative to noise, is used in various embodiments for evaluating the validity and accuracy of information derived from a signal or segment of a signal as well for determining if useful information can be extracted from a segment of a signal, events (e.g., onset and offset of ventricular tachycardia) of a cardiac signal; ¶98-a confidence signal is used in determining whether a detected event is ventricular tachycardia; ¶99); processing, by the at least one computing device, the denoised ECG signal to extract beat (R-peak) locations corresponding to QRS complexes from the denoised ECG signal (¶5-the computing circuit processes the digitized ECG signals by one or more of removing noise, detecting an R-R interval, detecting a Q-T interval, and detecting a QRS complex; ¶44-identifying a location of the QRS complex of a cardiac cycle in the ECG signal; ¶62-valid R-wave feature points are identified based upon the signal to noise ratio; ¶166-identify a fiduciary point in the cardiac cycle (e.g., the peak of the R-wave); ¶89; ¶95; ¶99); analyzing, by the at least one computing device, the denoised ECG signal to detect a presence of a beat-dependent ventricular arrhythmia within the denoised ECG signal based on the extracted beat (R-peak) locations of the denoised ECG signal (¶62-arrhythmic events are detected by evaluating characteristics of consecutive ones of the identified valid R-wave feature points; ¶161-in process 1328, arrhythmias are classified as to their type (e.g., VT, bigeminy, supra-ventricular tachycardia, trigeminy, atrial fibrillation, etc.); ¶173-pie chart 1501 displays the breakdown of the % prevalence of each type of event/rhythm present is a specified time period. In this example, the percentage of each of the following classifications for the time period are normal sinus rhythm (NSR), ventricular tachycardia (VT), premature ventricular contraction (PVC), segments in the time period classified as uncertain, and segments in the time period classified as uninterpretable; Fig. 15; ¶153); analyzing, by the at least one computing device, the denoised ECG signal to detect a presence of one or more supraventricular arrhythmias within the denoised ECG signal based on the extracted beat locations of the ECG signal (¶62-arrhythmic events are detected by evaluating characteristics of consecutive ones of the identified valid R-wave feature points; ¶135-event criteria input in process 804 include morphology criteria, such as QRS width and amplitude, to allow process 805 to discriminate between supra-ventricular tachycardia and life-threatening ventricular tachycardia; ¶161-in process 1328, arrhythmias are classified as to their type (e.g., VT, bigeminy, supra-ventricular tachycardia, trigeminy, atrial fibrillation, etc.); ¶156); and outputting, by the at least one computing device, a report containing one or more arrhythmias detected by the analyzing steps (¶9-reporting arrhythmia events that provides for efficiency and accuracy; ¶173-statistical analysis of extracted features, parameters and events are displayed as pie chart 1501. This allows a user to quickly view the types and prevalence of arrhythmias present; ¶161-the report may include the prevalence of various types of arrhythmias as well as denoised waveforms for all or some of the valid arrhythmia events detected; ¶70; ¶153-154).
While Brockway teaches where another circuit removes subcomponents identified as containing noise energy and reconstruct a denoised ECG signal by performing an inverse transform on the subcomponents that are not removed, the denoised ECG signal having SNRA of at least 20 dB and quality of signal reconstruction (QSR)>95% (e.g., as exemplified further below) (¶68), quantifying performance of a physiological signal denoising technique, a Quality of Signal Reconstruction (QSR) and SNR improvement can be computed (¶91), and following removal of background noise in process 1100 , high amplitude noise such as EMG or ECG noise is removed in process 1101 (¶148), Brockway does not explicitly teach processing the denoised ECG waveform signal to remove low quality segments and form a high quality ECG waveform signal.
Gregg relates generally to signal quality of each electrocardiogram (“ECG”) lead in an ECG recording during continuous ECG monitoring of a patient. The present disclosure more particularly relates an evaluation and visually display of high-frequency and low-frequency noise levels within electrocardiogram segments of each ECG lead in an ECG recording during continuous ECG monitoring of a patient (¶1). Gregg further teaches the invention using the following step:
processing the denoised ECG waveform signal to remove low quality segments and form a high quality ECG waveform signal (¶42-the result of high/low-frequency noise evaluations 51a and 51b is a capability of monitoring device 20 and/or an operator thereof to discard any low-quality segments of cardiogram 41 and to maintain good-quality leads among ECG leads 30 while resolving corrupted leads among ECG leads 30 as indicated by the evaluation of the high/low frequency signal quality of each individual ECG lead 30; ¶73-ECG quality controller 50 comparing the LFE score of each individual ECG lead 30 to the signal quality threshold(s) differentiating the signal quality zones).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Brockway to include processing the denoised ECG waveform signal to remove low quality segments and form a high quality ECG waveform signal of Gregg in order for accurate interpretation and diagnosis of electrocardiogram (Gregg, ¶42) and to maintain good-quality leads among ECG leads while resolving corrupted leads among ECG leads (Gregg, ¶42).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12268527. Although the claims at issue are not identical, they are not patentably distinct from each other because US Patent 12268527 anticipates the claim of the present application. See the table below.
Claims of the Present Application (19/173135)
Claims of US Patent 12268527
1
1
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
NPL “Cardiologist-Level Arrhythmia Detection and Classification in Ambulatory Electrocardiograms Using a Deep Neural Network” published Jan. 2019: Table 1b.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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/LAURA HODGE/Examiner, Art Unit 3792
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