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 .
Election/Restrictions
Applicant's election with traverse of Group II, Claims 10-20 in the reply filed on 2/24/26 is acknowledged. The traversal is on the ground(s) that: i) no additional search would be required, as claim 20 is directed to a CRM “applicable to the method described in Claim 1”, and ii) claims 13 and 20 are allegedly “linking claims”.
This is not found persuasive because:
i) The non-elected group (Claims 1-9, method) and the elected group (Claims 10-20, product) belong in different statutory categories (see 35 USC 101), which in itself is sufficient to show search burden. Furthermore, search burden has already been shown in the restriction requirement, on the basis of different classification (A61B 5/7246, A61B 5/349), as well as different the basis of requiring different search strategies, given the difference in statutory categories, and the mutual differences in scope and potential use (see “the product need not apply an arc-length curve function to an ECG, determine an R-point, an onset point, and a J-point based on the function. The product may use Shannon energy envelope extraction and as claimed, it may be used to report a Q-T segment to a clinician and discard results outside certain margins.”). Claim 20 being a CRM does not change any of the above. Claim 1 clearly does not require all the limitations of Claim 20, or even a CRM, and CRMs belong in the product statutory category.
ii)
a) Claim 20 is not a linking claim as Claim 1 clearly does not require all the limitations of Claim 20. Claim 20 clearly recites a plethora of limitations that are not found in Claim 1 (e.g. inter alia, a CRM tangibly embodying instructions comprising: computing a Q-T segment separately for each beat during the averaging interval using the onset point and J-point of the average beat; sorting the computed Q-T segments of each beat and discarding upper and lower marginal values; computing an each beat averaged measurement comprising an average of undiscarded Q-T segments; computing an average of the interval complex measurement and the each beat averaged measurement; and reporting the computed average of the interval complex measurement and the each beat averaged measurement to a clinician).
b) Claim 13 is not an independent claim, and restrictions are determined on the basis of independent claims. Still, Claim 1 does not require all the limitations of Claim 13, as it does not require all the limitations of Claim 10 or Claim 20.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/30/26.
Claim Objections
Claims 10-20 are objected to because of the following informalities:
1) In Claim 10: the following changes are required for consistency and cohesiveness (e.g. in the distinction between the average beat measurements and the beat-by-beat measurements):
“compute a Q-T segment separately for each beat of the plurality of beats during the averaging interval using the R-point, onset point, and the J-point of the average beat;
sort the computed Q-T segments of each beat of the plurality of beats and discarding upper and lower marginal Q-T segment values;
compute an each-beat-averaged measurement comprising an average of undiscarded Q-T segments of the sorted Q-T segments;
compute an average of the interval complex measurement and the each-beat-averaged measurement; and
report the computed average of the interval complex measurement and the each-beat-averaged measurement to a clinician.”
The respective changes should be applied to Claim 20.
2) In Claim 14, “mSec. w” should be “msec, w”
Appropriate correction is required.
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 10-19 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 10 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 10, which is a system claim, recites in the preamble “a plurality of ECG leads connected to a patient” and then recites in the body “at least one lead for providing an ECG signal from the patient”. Thus, Claim 10 does not preclude that the “at least one lead” is part of the “ECG leads connected to a patient”, and as such does not preclude requiring a human being. None of the dependent claims remedy this. It is suggested that the “connected to a patient” is amended to “configured to be connected to a patient”.
Claims 10-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1)
Claims 10 and 20 recite products, thus they belong in one of the four statutory categories. All dependent Claims meet this step.
Step 2a, prong one)
The claims recite determining (“compute” or “determine”) or performing the following:
-an average beat from a plurality of beats occurring during a predetermined averaging interval
-an R-point, an onset point, and a J-point of the average beat;
-an interval complex measurement reflecting a Q-T segment of the average beat based on the determined onset point and J-point
-a Q-T segment separately for each beat during the averaging interval using the R-point, onset point, and the J-point of the average beat
-sort the computed Q-T segments of each beat and discarding upper and lower marginal values
-an each beat averaged measurement comprising an average of undiscarded Q-T segments
-an average of the interval complex measurement and the each beat averaged measurement”. Each of these and their combination are directed to an ineligible concept, namely an abstract idea. These limitations would cover a mental process performed in the human mind or by mere use of pen and paper, such as observing and evaluating an ECG presented to a clinician or other expert. Note that ECG printout were traditionally evaluated manually. All dependent claims include this ineligible concept. Claims 12-18 only add details to the abstract idea itself (ie. more calculations).
Step 2a, prong two)
This judicial exception is not integrated into a practical application because: the claims do not recite an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. The claims merely add the generic and extra solution “computer readable medium”, “signal processing circuitry”, “lead”, and “report” of the average. These are generally linking the use of the exception to a generic technological environment or field of use, and merely use a computer to perform the ineligible concept. The bare minimums to acquire the input, automate the ineligible concept and provide a signal as an output, do not integrate the ineligible concept to a practical application. None of these limitations add to the claims: a) improvements to the functioning of a computer, or to any other technology or technical field, b) use of the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, c) a particular machine or a transformation, or d) use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the courts have well established that 35 USC 102 and 103 are separate determinations than 35 USC 101 [e.g. Parker v. Flook, 437 U.S. 584 (1978)], and in some instances claims that meet the former, do not meet the latter. MPEP 2106.05: “Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination”.
Claims 11 and 19 merely add the extra solution activity of typical LF, HF, and baseline noise removal. Claims 12-18 do not add any element, and only adds mental calculations to the abstract idea itself. Placing a time limit on the averaging interval, as recited, does not place a speed requirement for the calculations.
Step 2b)
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of all the reasons explained in Step 2a, prong two, and in addition, all of those additional elements individually or in combination are well-understood, routine and conventional activity in the field. The processing circuitry, the lead, the generic report, and typical noise removal are all well-understood, routine, conventional activity in the field (e.g. see US 9480411 which is incorporated by Applicant in ¶ 74 as prior art). These are recited with a high level of generality, that merely append the exception to the bare minimum of any type of monitoring in the art. Thus, no claim meets the requirements of Step 2b, and no Claims are eligible.
Claim Rejections - 35 USC § 112
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 10-19 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.
1) In Claim 10, line 4, “the at least one selected leads” lacks clear antecedence.
It is suggested that the first four lines are amended as follows to overcome issues regarding antecedence:
A physiological monitoring system for processing electrocardiogram ("ECG") signals from a plurality of ECG leads configured to be connected to a patient, comprising:
at least one lead selected from the plurality of ECG leads for providing an ECG signal from the patient;
signal processing circuitry coupled to each of the at least one selected leads, the“
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 10-14, 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-15 of copending Application No. 18/736224 in view of US 2009/0088655 by Vajdic.
Regarding Claims 10, Claim 8 of 18/736224 teaches a physiological monitoring system for processing electrocardiogram ("ECG") signals from a plurality of ECG leads connected to a patient, comprising:
at least one lead for providing an ECG signal from the patient;
signal processing circuitry coupled to each of the at least one selected leads, the signal processing circuitry programmed to (Claim 8: “A physiological monitoring system for processing electrocardiogram (“ECG”) signals from a plurality of ECG leads connected to a patient, comprising: at least one lead for providing an ECG signal from the patient; signal processing circuitry coupled to each of the at least one selected leads, the signal processing circuitry configured to:”):
compute an average beat from a plurality of beats occurring during a predetermined averaging interval (Claim 8: “compute an average beat from a plurality of beats occurring during a predetermined averaging interval;”);
determine an onset point, and a J-point of the average beat (Claim 8: determine an onset point and a J-point of the average beat);
compute an interval complex measurement reflecting a T-wave based segment of the average beat based on the determined onset point and J-point (Claim 8: compute an interval complex measurement reflecting an S-T segment of the average beat based on the determined isoelectric point and J-point;);
compute a T-wave based segment separately for each beat during the averaging interval using the onset point and the J-point of the average beat (Claim 8: “compute an S-T segment separately for each beat during the averaging interval using the onset point and the J-point of the average beat;”);
sort the computed T-wave based segments of each beat and discarding upper and lower marginal values (Claim 8: “sort the computed S-T segments of each beat and discarding upper and lower marginal values;”);
compute an each beat averaged measurement comprising an average of undiscarded Q-T segments (Claim 8: “compute an each beat averaged measurement comprising an average of undiscarded S-T segments;”);
compute an average of the interval complex measurement and the each beat averaged measurement (Claim 8: “compute an average of the interval complex measurement and the each beat averaged measurement;”); and
report the computed average of the interval complex measurement and the each beat averaged measurement to a clinician (Claim 8: report the computed average of the interval complex measurement and the each beat averaged measurement to a clinician.).
Claim 8 of the co-pending application does not teach determining an R-point, and does not teach that the T-based segments are Q-T segments.
However, Vajdic, in an analogous ECG monitor, teaches that “[a]n accurate and reproducible determination of QRS onset (QRSon) and its termination (J Point) is useful for determining cardiac time intervals such as PR interval, QRS duration, and QT interval” (e.g. ¶ 210). Furthermore, Vajdic teaches that the onset point is identified based on the R-point (e.g. ¶ 218). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate R-peak detection and Q-T interval detection based in part on Q onset, R, and J points, in a device according to the teachings of Claim 8 of the copending application, as taught by Vajdic, in order to predictably determine QT intervals, given that QT intervals “often mark susceptibility to life-threatening arrhythmias” (¶ 20).
Regarding Claim 11, Claim 9 of the co-pending application as modified by Vajdic (Claim 9 depends on Claim 8) teaches the system of claim 10, wherein the signal processing circuitry removes baseline noise from the ECG signals from the at least one selected lead (Claim 9: “wherein the signal processing circuitry removes baseline noise from the ECG signals from the at least one selected lead.”).
Regarding Claim 12, Claim 10 of the co-pending application as modified by Vajdic (Claim 10 depends on Claim 8) further teaches wherein the averaging interval is 15 seconds (Claim 10: “wherein the averaging interval is 15 seconds”).
Regarding Claim 13, Claim 11 of the co-pending application as modified by Vajdic (Claim 11 depends on Claim 8) further teaches wherein the signal processing circuitry determines the onset point and J-point of the average beat by generating an arc-length curve function for the average beats (Claim 11: “wherein the signal processing circuitry determines the onset point and J-point of the average beat by generating an arc-length curve function for the average beats”).
Regarding Claim 14, Claim 12 of the co-pending application as modified by Vajdic (Claim 12 depends on Claim 11) further teaches wherein the arc-length curve function comprises: [equation 1 of ¶ 77 of the instant specification]
where i is a time index, C is a constant related to sample interval in mSec. w is time window approximately equal to the width of the widest QRS complex during the predetermined period of time (Claim 12 discloses the exact same equation and the same limitations).
Regarding Claim 18, Claim 13 of the co-pending application as modified by Vajdic (Claim 13 depends on Claim 8) further teaches wherein the signal processing circuitry computes an average beat from a plurality of beats occurring during a predetermined averaging interval by updating the average beat on each incoming new beat such that each beat contributes a fractional weighting to the average beat (Claim 13: “wherein the signal processing circuitry computes an average beat from a plurality of beats occurring during a predetermined averaging interval by updating the average beat on each incoming new beat such that each beat contributes a fractional weighting to the average beat”).
Regarding Claim 19, Claim 14 of the co-pending application as modified by Vajdic (Claim 14 depends on Claim 8) further teaches wherein the signal processing circuitry performs low-frequency and high-frequency noise measurements of the ECG signal on each selected lead and excludes beats with low or high frequency noise exceeding a predetermined threshold from the computed average beat (Claim 19: “wherein the signal processing circuitry performs low-frequency and high-frequency noise measurements of the ECG signal on each selected lead and excludes beats with low or high frequency noise exceeding a predetermined threshold from the computed average beat.”).
Regarding Claim 20, Claim 15 of the co-pending application discloses a computer-readable medium tangibly embodying instructions that, when executed by a processor, performs a method of processing of electrocardiogram ("ECG") signals from a plurality of ECG leads connected to a patient, comprising (Claim 15: “A computer-readable medium tangibly embodying instructions that, when executed by a processor, performs a method of processing of electrocardiogram (“ECG”) signals from a plurality of ECG leads connected to a patient”):
selecting at least one lead to provide an ECG signal from the patient; and
for each of the at least one selected leads; computing an average beat from a plurality of beats occurring during a predetermined averaging interval (Claim 15: “selecting at least one lead to provide an ECG signal from the patient; for each of the at least one selected leads: computing an average beat from a plurality of beats occurring during a predetermined averaging interval”);
determining an onset point and a J-point of the average beat; computing an interval complex measurement reflecting a T-based segment of the average beat based on the determined onset point and J- point; computing a T-based segment separately for each beat during the averaging interval using the onset point and J-point of the average beat (Claim 15: “determining an onset point and a J-point of the average beat; computing an interval complex measurement reflecting an S-T segment of the average beat based on the determined… J-point; computing an S-T segment separately for each beat during the averaging interval using the onset point and J-point of the average beat”);
sorting the computed T-based segments of each beat and discarding upper and lower marginal values; computing an each beat averaged measurement comprising an average of undiscarded T-based segments; computing an average of the interval complex measurement and the each beat averaged measurement (Claim 15: “sorting the computed S-T segments of each beat and discarding upper and lower marginal values; computing an each beat averaged measurement comprising an average of undiscarded S-T segments; computing an average of the interval complex measurement and the each beat averaged measurement”); and
reporting the computed average of the interval complex measurement and the each beat averaged measurement to a clinician (Claim 15: “reporting the computed average of the interval complex measurement and the each beat averaged measurement to a clinician.”).
Claim 15 of the co-pending application does not teach determining an R-point, and does not teach that the T-based segments are Q-T segments.
However, Vajdic, in an analogous ECG monitor, teaches that “[a]n accurate and reproducible determination of QRS onset (QRSon) and its termination (J Point) is useful for determining cardiac time intervals such as PR interval, QRS duration, and QT interval” (e.g. ¶ 210). Furthermore, Vajdic teaches that the onset point is identified based on the R-point (e.g. ¶ 218). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate R-peak detection and Q-T interval detection instructions based in part on Q onset, R, and J points, in a CRM according to the teachings of Claim 8 of the copending application, as taught by Vajdic, in order to predictably determine QT intervals, given that QT intervals “often mark susceptibility to life-threatening arrhythmias” (¶ 20).
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 10 and 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 USC 101 and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, where applicable, as set forth in this Office action. In short, the closest prior art is NPL by Zong et al., A Real-time ST -segment Monitoring Algorithm Based on a Multi-channel Waveform-Length-Transform Method for Q-onset and J-point Detection, Philips Healthcare, Computing in Cardiology 2014; 41:641-644, fails to teach Claims 10 and 20, each as a whole.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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