DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first
inventor to file provisions of the AIA .
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 49-50, 52, 54-61, and 64 are rejected on the ground of nonstatutory double patenting
as being unpatentable over claims 1-4 and 6-13 of U.S. Patent No. 11103717 in view of Macho et al. (US Patent Application Publication 2008/0306560), hereinafter Macho.
INSTANT APPLICATION 18760311
U.S. PATENT NUMBER: 11103717
Claim 49. A wearable cardioverter defibrillator (WCD) system, comprising: a support structure configured to be worn by an ambulatory patient;
Claim 1. A wearable cardioverter defibrillator (WCD) system, comprising: a support structure configured to be worn by an ambulatory patient;
an energy storage module configured to store an electrical charge;
an energy storage module configured to store an electrical charge;
a discharge circuit coupled to the energy storage module;
a discharge circuit coupled to the energy storage module;
electrodes configured to sense an Electrocardiogram (ECG) signal of the patient;
electrodes configured to sense an Electrocardiogram (ECG) signal of the patient;
and a processor configured to: determine, from the sensed ECG signal, whether or not a first shock criterion is met;
and a processor configured to: determine from a first portion of the sensed ECG signal, whether a first shock criterion is met;
responsive to the first shock criterion being met, determine whether or not the sensed ECG signal meets a High-Frequency (H-F) noise criterion;
determine whether the first portion of the sensed ECG signal meets a High-Frequency (H-F) noise criterion, wherein H-F noise is present in the sensed EGC signal when a peak in the sensed ECG signal has a duration 25 milliseconds or less;
and responsive to the first shock criterion being met and the H-F noise criterion not being met, control the discharge circuit to discharge the stored electrical charge through the patient while the support structure is worn by the patient so as to deliver a shock to the patient, else responsive to the first shock criterion being met and the H-F noise criterion being met;
responsive to the first shock criterion being met and the H-F noise criterion not being met, control the discharge circuit to discharge the stored electrical charge through the patient while the support structure is worn by the patient so as to deliver a shock to the patient, else responsive to the first shock criterion being met and the H-F noise criterion being met;
determine, from the sensed ECG signal whether or not a second shock criterion is met;
determine from a second portion of the sensed ECG signal, whether a second shock criterion is met;
responsive to the second shock criterion being met, control the discharge circuit to discharge the stored electrical charge through the patient while the support structure is worn by the patient.
the second portion sensed subsequently to the first portion and, responsive to the second shock criterion being met, control the discharge circuit to discharge the stored electrical charge through the patient while the support structure is worn by the patient to deliver a shock to the patient.
Claim 50. in which the second shock criterion is the same as the first shock criterion.
Claim 2. in which the second shock criterion is the same as the first shock criterion.
Claim 52. in which the ECG segment includes the potential R peak that it corresponds to.
Claim 3. in which the ECG segment includes the potential R peak that it corresponds to.
Claim 54. in which the ECG segment starts at the potential R peak.
Claim 4. in which the ECG segment starts at the potential R peak that it corresponds to.
Claim 55. in which the ECG segment is filtered, and the H-F noise criterion is met responsive to the filtered ECG segment meeting the segment noise criterion.
Claim 6. a filter to filter the ECG segment, and wherein the processor is further configured to: determine whether the H-F noise criterion is met responsive to the filtered ECG segment meeting the segment noise criterion.
Claim 56. in which the ECG segment is thus filtered with a filter passing frequencies between 8 Hz and 25 Hz.
Claim 7. in which the filter is configured to pass frequencies between 8 Hz and 25 Hz.
Claim 57. in which the ECG segment has a duration between 160 ms and 200 ms.
Claim 8. in which the ECG segment has a duration between 160 ms and 200 ms.
Claim 58. in which the ECG segment includes the potential R peak that it corresponds to.
Claim 9. in which the ECG segment starts at the potential R peak that it corresponds to.
Claim 59. in which the segment noise criterion is met responsive to the ECG segment containing more zero- crossings than a crossings threshold.
Claim 10. in which the segment noise criterion is met responsive to the ECG segment containing more zero-crossings than a crossings threshold.
Claim 60. in which the crossings threshold is five.
Claim 11. in which the crossings threshold is five.
Claim 61. in which the ECG segment has a duration between 160 ms and 200 ms.
Claim 12. in which the ECG segment has a duration between 160 ms and 200 ms.
Claim 64. in which the ECG segment has a duration between 160 ms and 200 ms.
Claim 13. in which the ECG segment has a duration between 160 ms and 200 ms.
However, the patent does not teach “deliver a shock to the patient at least 5 seconds later than
the shock that would have been delivered responsive to the H-F noise criterion not being met.”
Macho, in the same field of endeavor, teaches that when a shockable event is detected and a
noise criterion is not met in the first portion, the shock is delivered at an earlier time (Macho, ¶[0035]), and when the shockable event is detected and the noise criterion is met in the first portion, the shock is delayed to a later time if the shockable event is also detected in the second portion (Macho, ¶0036]).
Macho teaches the claimed invention but does not disclose expressly the “to deliver a shock to the
patient at least 5 seconds later than the shock that would have been delivered responsive to the H-F noise criterion not being met.”
It would have been obvious to one having ordinary skill in the art to modify US Pat. 11103717 with Macho’s teachings in order to provide a shock treatment when a signal is not noisy, and also make provision for providing a shock treatment for a noisy signal that also shows that it contains a shockable rhythm, through further analysis of more of the ECG signal, which may have a different or better signal quality than the segment first analyzed.
US Pat. 11103717 in view of Macho teaches the claimed invention but does not disclose expressly the “to deliver a shock to the patient at least 5 seconds later than the shock that would have been delivered responsive to the H-F noise criterion not being met.” However, Macho teaches that the “processing unit 15 may be configured to delay a delivery of treatment if a high level of background noise is identified because significant background noise may reduce the quality of the data obtained by the electrodes.”
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 delay of delivery of treatment from US Pat. 11103717 in view of Macho to 5 seconds in order to optimize the quality of data by reducing background noise. In re Aller, 105 USPQ 233 (See MPEP §2144.05).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
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 1-16 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The term “H-F noise criterion” is not clearly defined in the claims or the Specification, therefore it is impossible to determine the metes and bounds of the claim and to make and use the invention based on the disclosed subject matter.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without knowing what a H-F noise criterion is. This definition is critical or essential to the practice of the invention but not included in the claim(s) or in the Specification. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). One might gather that the criterion has something to do with high frequency noise, but what it is it? Is it when the signal is above a certain frequency? And if so, what frequency? Or is the criterion met when there is noise above a certain frequency, and if so what frequency? The bounds of the limitation are not clear, thus it is not possible to make and use the invention.
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.
Claims 1-16 are 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.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the definition of a H-F noise criterion, which is not clearly defined in the specification, and without which information it is impossible to make and use the invention.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 49-50 and 97-100 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (US Patent Application Publication 2016/0000349), hereinafter Sullivan, in view of Macho et al. (US Patent Application Publication 2008/0306560), hereinafter Macho.
Regarding claim 49, Sullivan teaches a wearable cardioverter defibrillator (WCD) system (Sullivan, Fig. 1), comprising:
a support structure configured to be worn by an ambulatory patient; an energy storage module configured to store an electrical charge (Sullivan, Fig. 2, power supply 17);
a discharge circuit coupled to the energy storage module (Sullivan ’349, ¶[0047], software controls power supply’s application of defibrillation shocks);
electrodes configured to sense an Electrocardiogram (ECG) signal of the patient (Sullivan, ¶[0017], sensing electrodes).
Sullivan teaches a processor configured to: determine, from a first portion of the sensed ECG signal, whether or not a first shock criterion is met (Sullivan, ¶[0088], the system detects whether there has been a treatable VT or VF event; treatable means that a shock criterion is met);
responsive to the first shock criterion being met, determine whether or not the sensed ECG signal meets a high frequency (H-F) noise criterion (Sullivan, ¶[0067], power spectrum density may be used to distinguish between noise contamination and arrhythmia; this constitutes a high frequency noise criterion).
Sullivan further teaches, responsive to the first shock criterion being met (Sullivan, ¶[0088], the system detects whether there has been a treatable VT or VF event; treatable means that a shock criterion is met) and the H-F noise criterion being met (Sullivan, the signal has been determined to be noisy, ¶[0088-0090], the signal is analyzed in a series of subsequent segments, including discovering that some signals are noisy), control the discharge circuit to discharge the stored electrical charge through the patient while the support structure is worn by the patient so as to deliver a shock to the patient (Sullivan, ¶[0099], after a VT/VF event signal, meaning a second shock criterion is met, and a noise condition is met, the system may pause, provide an alarm to the user, and then initiate treatment if the user does not respond).
Sullivan further teaches, responsive to the first shock criterion being met (Sullivan, ¶[0088], the system detects whether there has been a treatable VT or VF event; treatable means that a shock criterion is met) and the H-F noise criterion being met (Sullivan, the signal has been determined to be noisy, ¶[0088-0090], the signal is analyzed in a series of subsequent segments, including discovering that some signals are noisy), determine, from the sensed ECG signal whether or not a second shock criterion is met, and, responsive to the second shock criterion being met (Sullivan, ¶[0104], when possible noise is detected, the system continues to evaluate the incoming ECG signal), control the discharge circuit to discharge the stored electrical charge through the patient while the support structure is worn by the patient so as to deliver a shock to the patient (Sullivan, ¶[0099], after a VT/VF event signal, meaning a second shock criterion is met, and a noise condition is met, the system may pause, provide an alarm to the user, and then initiate treatment if the user does not respond).
Sullivan does not necessarily teach all of these features in the same embodiment of the invention, “to deliver a shock to the patient at least 5 seconds later than the shock that would have been delivered responsive to the H-F noise criterion not being met.” Sullivan teaches that a high level of noise may lead to a false detection of an arrhythmia (Sullivan, ¶[0012]). Sullivan teaches that when a shockable event is detected and the H-F noise criterion is not met in the first portion, treatment mode is entered at an earlier time, and when the shockable event is detected and the H-F noise criterion is met in the first portion, the treatment mode is delayed to a later time if the shockable event is also detected in the second portion (Sullivan, ¶[0098]). Sullivan does not explicitly teach that the shock itself is applied earlier or later; reference is only made to entering treatment mode at different times.
Macho, in the same field of endeavor, teaches that when a shockable event is detected and a noise criterion is not met in the first portion, the shock is delivered at an earlier time (Macho, ¶[0035]), and when the shockable event is detected and the noise criterion is met in the first portion, the shock is delayed to a later time if the shockable event is also detected in the second portion (Macho, ¶0036]).
It would have been obvious to one having ordinary skill in the art to modify Sullivan’s invention with Macho’s teachings in order to provide a shock treatment when a signal is not noisy, and also make provision for providing a shock treatment for a noisy signal that also shows that it contains a shockable rhythm, through further analysis of more of the ECG signal, which may have a different or better signal quality than the segment first analyzed.
Sullivan in view of Macho teaches the claimed invention but does not disclose expressly the “to deliver a shock to the patient at least 5 seconds later than the shock that would have been delivered responsive to the H-F noise criterion not being met.” However, Macho teaches that the “processing unit 15 may be configured to delay a delivery of treatment if a high level of background noise is identified because significant background noise may reduce the quality of the data obtained by the electrodes.”
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 delay of delivery of treatment from Sullivan in view of Macho to 5 seconds if it would optimize the quality of data by reducing background noise.
Regarding claim 50, the modified Sullivan invention does not explicitly teach that that the second shock criterion is the same as the first shock criterion. However, it would have been obvious to one having ordinary skill in the art that they would be the same, because Sullivan teaches use of a noise detector module (Sullivan, ¶[0104]), without specifying use of different noise detector modules depending on whether noise was detected or not in the signal.
Regarding claim 97, Sullivan teaches a wearable cardioverter defibrillator (WCD) system (Sullivan, Fig. 1), comprising:
a support structure configured to be worn by an ambulatory patient; an energy storage module configured to store an electrical charge (Sullivan, Fig. 2, power supply 17);
a discharge circuit coupled to the energy storage module (Sullivan ’349, ¶[0047], software controls power supply’s application of defibrillation shocks);
electrodes configured to sense an Electrocardiogram (ECG) signal of the patient (Sullivan, ¶[0017], sensing electrodes).
Sullivan teaches a processor configured to: in a first operation, determine, from a first portion of the sensed ECG signal, whether or not a first shock criterion is met and whether the first portion of the sensed ECG signal meets a noise criterion (Sullivan, ¶[0088], the system detects whether there has been a treatable VT or VF event; treatable means that a shock criterion is met);
responsive to the first shock criterion being met (Sullivan, ¶[0088], the system detects whether there has been a treatable VT or VF event; treatable means that a shock criterion is met) and noise criterion not being met (Sullivan, the signal has been determined to be noisy, ¶[0088-0090], the signal is analyzed in a series of subsequent segments, including discovering that some signals are noisy), control the discharge circuit to discharge the stored electrical charge through the patient while the support structure is worn by the patient so as to deliver a shock to the patient (Sullivan, ¶[0099], after a VT/VF event signal, meaning a second shock criterion is met, and a noise condition is met, the system may pause, provide an alarm to the user, and then initiate treatment if the user does not respond).
Sullivan further teaches, otherwise: in a second operation, determine from a second portion of the sensed ECG signal whether a second shock criterion is met (Sullivan, ¶[0104], when possible noise is detected, the system continues to evaluate the incoming ECG signal); and
responsive to the first shock criterion being met (Sullivan, ¶[0088], the system detects whether there has been a treatable VT or VF event; treatable means that a shock criterion is met), control the discharge circuit to discharge the stored electrical charge through the patient while the support structure is worn by the patient so as to deliver a shock to the patient (Sullivan, ¶[0099], after a VT/VF event signal, meaning a second shock criterion is met, and a noise condition is met, the system may pause, provide an alarm to the user, and then initiate treatment if the user does not respond).
Sullivan does not necessarily teach all of these features in the same embodiment of the invention, “wherein the shock delivered to the patient in the second operation is delivered at least 5 seconds later than the shock that would have been delivered responsive to the H-F noise criterion not being met.” Sullivan teaches that a high level of noise may lead to a false detection of an arrhythmia (Sullivan, ¶[0012]). Sullivan teaches that when a shockable event is detected and the H-F noise criterion is not met in the first portion, treatment mode is entered at an earlier time, and when the shockable event is detected and the H-F noise criterion is met in the first portion, the treatment mode is delayed to a later time if the shockable event is also detected in the second portion (Sullivan, ¶[0098]). Sullivan does not explicitly teach that the shock itself is applied earlier or later; reference is only made to entering treatment mode at different times.
Macho, in the same field of endeavor, teaches that when a shockable event is detected and a noise criterion is not met in the first portion, the shock is delivered at an earlier time (Macho, ¶[0035]), and when the shockable event is detected and the noise criterion is met in the first portion, the shock is delayed to a later time if the shockable event is also detected in the second portion (Macho, ¶0036]).
It would have been obvious to one having ordinary skill in the art to modify Sullivan’s invention with Macho’s teachings in order to provide a shock treatment when a signal is not noisy, and also make provision for providing a shock treatment for a noisy signal that also shows that it contains a shockable rhythm, through further analysis of more of the ECG signal, which may have a different or better signal quality than the segment first analyzed.
Sullivan in view of Macho teaches the claimed invention but does not disclose expressly the “to deliver a shock to the patient at least 5 seconds later than the shock that would have been delivered responsive to the H-F noise criterion not being met.” It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the shock delay as taught by Macho with the 5 second parameter, because Applicant has not disclosed that “the specific 5 second delay” provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the shockable event detection control system as taught by Macho, because it provides the benefit of allowing therapy to be applied more delayed in situations where there is high suspicion of noise and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Sullivan in view of Macho.
Therefore, it would have been an obvious matter of design choice to modify [Reference A] to obtain the invention as specified in the claim(s).
Regarding claim 98, in the modified Sullivan invention, Sullivan teaches wherein: the noise criterion comprises a high-frequency (H-F) noise criterion (Sullivan, the signal has been determined to be noisy, ¶[0070, 0088-0090], the signal is analyzed and may identify either low or high frequency content.
Regarding claim 99, in the modified Sullivan invention, Sullivan teaches wherein: the first portion of the sensed ECG segment is classified as noise when the noise criterion is met (Sullivan, the signal has been determined to be noisy, ¶[0088-0090], the signal is analyzed in a series of subsequent segments, including discovering that some signals are noisy).
Regarding claim 100, in the modified Sullivan invention, Sullivan teaches wherein the noise comprises high-frequency (H-F) noise or high-amplitude (H-A) noise (Sullivan, the signal has been determined to be noisy, ¶[0070, 0088-0090], the signal is analyzed and may identify either low or high frequency content.
Claims 51-53 and 55-57 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Macho, further in view of Greenhut et al. (US Patent Application Publication 2018/0028083), hereinafter Greenhut.
Regarding claim 51, Sullivan does not teach that a potential R peak of a QRS complex is identified in the first portion of the sensed ECG signal. Sullivan does not particularly teach R-wave analysis for segmenting a signal. Greenhut teaches a system of sensing noise in R-waves in an arrhythmia detection device (Greenhut, Abstract), in which a potential R peak of a QRS complex is identified in the first portion of the sensed ECG signal (Greenhut, ¶[0005]), an ECG segment becomes defined as a segment of the first ECG signal portion that corresponds to the potential R peak (Greenhut, ¶[0086], ECG portions are centered around R-wave)., and a noise criterion is met responsive to the ECG segment meeting a segment noise criterion (Greenhut, ¶[0160-0161]). It would have been obvious to one having ordinary skill in the art that in the modified Sullivan invention, the R-peaks would be segmented into their own segments and evaluated according to the H-F noise criterion, in order to compare this basic and well-known cardiac waveform with its well-known attributes, to determine whether it conforms or not, and thus whether it is likely noise or arrhythmia.
Regarding claim 52, in the modified Sullivan invention, Greenhut teaches that the ECG segment includes the potential R peak that it corresponds to (Greenhut, ¶[0086]).
Regarding claim 53, in the modified Sullivan invention as modified by Greenhut, .the ECG segment has a duration between 160 ms and 200 ms (Greenhut, ¶[0086]).
Regarding claim 55, in the modified Sullivan invention, Greenhut teaches that the ECG segment is filtered, and the H-F noise criterion is met responsive to the filtered ECG segment meeting the segment noise criterion (Greenhut, ¶[0074]).
Regarding claim 56, in the modified Sullivan invention as modified by Greenhut, Greenhut teaches that the ECG segment is thus filtered with a filter passing frequencies between 10-30 Hz (Greenhut, ¶[0074]). It would have been obvious to one having ordinary skill in the art to use a filter passing frequencies between 8 Hz and 25 Hz because the precise most effective values for the filter frequencies are a result of routine and ordinary experimentation.
Regarding claim 57, in the modified Sullivan invention as modified by Greenhut, .the ECG segment has a duration between 160 ms and 200 ms (Greenhut, ¶[0086]).
Claims 54 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan, in view of Macho and Greenhut, further in view of Grunwald et al. (US Patent Application Publication 2012/0059270), hereinafter Grunwald.
Regarding claims 54 and 58, the modified Sullivan invention does not expressly teach that the ECG segment starts at the potential R peak that it corresponds to. However, Grunwald teaches that identification of an R-peak can trigger analysis of an ECG waveform (Grunwald, ¶[0085]). It would therefore have been obvious to one having ordinary skill in the art to start the ECG segment at the potential R peak that it corresponds to, in order to analyze a peak-to-peak interval, which is a common analysis interval in the field of ECG analysis.
Claims 59-61 is rejected under 35 U.S.C. 103 as being unpatentable over Sullivan, in view of Greenhut, further in view of Sarkar et al. (US Patent Application Publication 2016/0235320), hereinafter Sarkar.
Regarding claims 59-60, the modified Sullivan invention teaches that zero-crossings in a signal segment can indicate noise (Greenhut, ¶[0160]). Greenhut does not teach a crossings threshold. Sarkar teaches using a zero crossings threshold as one of the citeria for declaring a noise event to be present (Sarkar, ¶[0054-0055]). Sarkar does not teach a particular threshold. It would have been obvious to one having ordinary skill in the art to design the device so that the segment noise criterion is met responsive to the ECG segment containing more zero-crossings than a crossings threshold, and wherein the zero-crossings threshold is five. This is because many zero-crossings mean that noise might be present, since the number of zero-crossings in a usual QRS wave is predictable. It would have been obvious to one having ordinary skill in the art to set the zero-crossings threshold to five because a standard QRS complex has four, a slightly divergent QRS complex may have five, and a QRS complex with noise may have more, since many zero-crossings indicate that the heart is not moving smoothly throughout the cardiac cycle.
Regarding claim 61, in the modified Sullivan invention as modified by Greenhut, .the ECG segment has a duration between 160 ms and 200 ms (Greenhut, ¶[0086]).
Claims 62 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan, in view of Macho and Greenhut, further in view of Dascoli et al. (US Patent Application Publication 2017/0252571), hereinafter Dascoli.
Regarding claim 62, the modified Sullivan invention does not teach measurement of a peak duration. Dascoli teaches that for the purpose of identifying noise in a signal, the narrowness of a peak may be used (Dascoli, ¶[0036], used to determine shockable rhythm, ¶[0112], ¶[0114-0115]), because a narrow spike is more likely to be noise than to be a signal containing part of the cardiac complex. It would have been obvious to one having ordinary skill in the art that the segment noise criterion would met responsive to the ECG segment containing at least one peak briefer than a threshold duration, in order to prevent tall but narrow noise spikes from being mistaken for real signals.
Regarding claim 64, in the modified Sullivan invention as modified by Greenhut, .the ECG segment has a duration between 160 ms and 200 ms (Greenhut, ¶[0086]).
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Sullivan, in view of Macho, Greenhut, and Dascoli, further in view of Herleikson (US Patent No. 5,381,803), hereinafter Herleikson.
Regarding claim 63, the modified Sullivan invention does not teach the width of the pike. Herleikson teaches that a certain EG activity detector has maximum sensitivity to triangles having widths from 40-50 ms (Herleikson. Col. 4 lines 32-42). It would have been obvious to one having ordinary skill in the art that when searching a signal for noise spikes, the spike would have a much smaller width, such as a threshold duration of 25 ms. It would have been obvious to one having ordinary skill in the art to make the threshold duration 25 ms, because this is a value easily arrived at by a process of routine experimentation and optimization.
Conclusion
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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