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 .
Response to Arguments
Applicant's arguments filed 7/22/25 have been fully considered but they are not persuasive. The Applicant has amended claim 1 and 16 to state that the system divides the ECG into segments of a specified duration. Sitzman teaches dividing the ECG into segments equal to individual beats that are of a specified duration (e.g. ¶¶ 49, 50, 55, 56). It is noted that the claims states that each individual segment has a specified duration and not that the ECG is broken into equal segments. The claim is further silent as to the length of the duration. As written the claim requires each segment to have their own individual duration that is clearly anticipated by the Sitzman reference. Therefore, the rejection stands.
The Applicant further argues that the dependent claims are allowable for depending from an allowable independent claim. As clearly explained above, the independent claims are anticipated by the Sitzman reference and are not allowable. Therefore, the dependent claims are not allowable and their rejections stand.
The Applicant further argues that the dependent claims that rejected under 35 USC 103 are allowable for depending from an allowable independent claim. As clearly explained above, the independent claims are anticipated by the Sitzman reference and are not allowable. Therefore, the dependent claims rejected under 35 USC 103 are not allowable and their rejections stand.
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.
Claim(s) 1-5, 10-11 and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sitzman et al. (U.S. Pub. 2010/0022903 hereinafter “Sitzman” previously cited).
Regarding claim 1, Sitzman discloses a monitoring device (e.g. Abstract), comprising: an electrocardiograph (e.g. ¶¶ 212, 214) structurally configured to derive an electrocardiogram from at least one of ECG lead responsive to a connection of the electrocardiograph to the at least one ECG lead (e.g. ¶¶8-9 and 22); and an ECG quality controller (e.g. 18) structurally configured, in response to the connection of the electrocardiograph to the at least one ECG lead, to segment the electrocardiogram into a plurality of segregated electrocardiogram segments (e.g. ¶¶ 49, 55, 56) each of a specified duration (e.g. ¶¶ 49, 50, 55, 56) and for each electrocardiogram segment of the specified duration (e.g. ¶¶ 49, 50, 55, 56), to control separate evaluations of two noise levels in each segregated electrocardiogram segment including a high-frequency noise level and a low-frequency noise level of an individual ECG lea on an electrocardiogram segmentation basis (e.g. ¶¶ 49, 55, 56).
Regarding claim 2, Sitzman further discloses wherein the high-frequency noise leveI evaluation of the individual ECG lead by the ECG quality controller further includes: the ECG quality controller being structurally configured to ascertain the standard deviation of the individual ECG lead relative to a specified activity level of each electrocardiogram segment (e.g. ¶56).
Regarding claim 3, Sitzman further discloses wherein a high-frequency noise leveI evaluation of the individual ECG lead by the ECG quality controller includes: the ECG quality controller being structurally configured, during each electrocardiogram segment, to derive a high-frequency noise score for the individual ECG lead from a standard deviation of the individual ECG lead (e.g. ¶¶49, 56).
Regarding claim 4, Sitzman further discloses wherein a high-frequency noise level evaluation of the individual ECG lead by the ECG quality controller further includes: the ECG quality controller being structurally configured, during each electrocardiogram segment, to scale the standard deviation of the individual ECG lead by a weighting factor to thereby derive the high-frequency noise score for the individual ECG lead (e.g. ¶¶49, 56).
Regarding claim 5, Sitzman further discloses wherein the high-frequency noise level evaluation of the individual ECG lead by the ECG quality controller further includes: the ECG quality controller being structurally configured, during each electrocardiogram segment, to compare the high-frequency noise score to at least one signal quality threshold differentiating a plurality of distinct signal quality zones (e.g. ¶¶43-49).
Regarding claim 10, Sitzman further discloses wherein, for each electrocardiogram segment, the ECG quality controller is further structurally configured to control a display of the separate evaluations of only the two noise levels including the high-frequency noise level and the low-frequency noise level of the individual ECG lead (e.g. 927; Fig. 2, step 110; ¶48; “less than or more than three preparation components could be employed”).
Regarding claim 11, Sitzman further discloses wherein a display of the high- frequency noise level evaluation and the low-frequency noise level evaluation of the individual ECG lead by the ECG quality controller includes: the ECG quality controller being structurally configured to display one of the individual ECG lead or a representative beat of the ECG lead concurrently with a signal quality indication of the separate evaluations of only the two noise levels including the high-frequency noise level and the low- frequency noise level of the individual ECG lead wherein each signal quality indication is at least one of a textual signal quality indication and a graphical signal quality indication (e.g. 427; Fig. 2, step 110; ¶48; “less than or more than three preparation components could be employed”).
Regarding claim 16, Sitzman discloses a monitoring method, comprising an electrocardiograph deriving an electrocardiogram from at least one ECG lead responsive to a connection of the electrocardiograph to the at least one ECG lead; an ECG quality controller segmenting the electrocardiogram into a plurality of segregated electrocardiogram segments each of a specified duration (e.g. ¶¶ 49, 50, 55, 56), and for each electrocardiogram segment (e.g. ¶¶ 49, 55, 56) of the specified duration (e.g. ¶¶ 49, 50, 55, 56), the ECG quality controller controlling separate evaluations two noise levels in each segregated electrocardiogram segment including of a high-frequency noise level and a low-frequency noise level of an individual ECG lead to output a result of the evaluations of the two noise levels (e.g. ¶¶8-9, 22, 49, 55-56; Fig. 3).
Regarding claim 17, Sitzman further wherein the high-frequency noise level evaluation of the individual ECG lead by the ECG quality controller includes: during each electrocardiogram segment, the ECG quality controller deriving a high- frequency noise score for the individual ECG lead from a standard deviation of the individual ECG lead; and the ECG quality controller comparing each high-frequency noise score to at least one signal quality threshold differentiating a plurality of distinct signal quality zones (e.g. ¶¶43-49).
Regarding claim 18, Sitzman further wherein the low-frequency noise level evaluation of the individual ECG lead by the ECG quality controller includes: during each electrocardiogram segment, the ECG quality controller deriving a low- frequency noise score for the individual ECG lead from any change in a baseline level of the individual ECG lead; and the ECG quality controller comparing each low-frequency noise score to at least one signal quality threshold differentiating a plurality of distinct signal quality zones (e.g. ¶¶43-49).
Regarding claim 19, Sitzman further the ECG quality controller controlling, for each electrocardiogram segment, a display of the separate evaluations of the high- frequency noise level and the low-frequency noise level of the individual ECG lead (e.g. 27; Fig. 2, step 110; ¶48; “less than or more than three preparation components could be employed”)..
Regarding claim 20, Sitzman further wherein the display of the high- frequency noise level evaluation and the low-frequency noise level evaluation of the individual ECG lead by the ECG quality controller includes: the ECG quality controller displaying the individual one of the individual ECG lead or a representative beat of the ECG lead concurrently with a signal quality indication of the separate evaluations of the high- frequency noise level and the low-frequency noise level of the individual ECG lead, wherein each signal quality indication is at least one of a textual signal quality indication and a graphical signal quality indication (e.g. (27; Fig. 2, step 110; ¶48; “less than or more than three preparation components could be employed”).
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.
Claims 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sitzman as applied to claims 1-5, 9-11 and 16-20 above, and further in view of Brodnick (U.S. Pub. 2004/0024327 previously cited).
Regarding claims 6-9, Sitzman discloses the claimed invention except for the deriving low-frequency noise from baseline level measurements. However, Brodnick teaches that it is known to use baseline measurements as set forth in Paragraphs 27 and 33 to provide a means for accurately deriving low-frequency noise. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Sitzman, with analysis through baseline measurements as taught by Brodnick, since such a modification would provide the predictable results of analyzing the ECG data based on baseline measurements for providing a means for accurately deriving low-frequency noise.
Claims 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sitzman as applied to claims 1-5, 9-11 and 16-20 above, and further in view of Yeo et al. (U.S. Pat. 5,827,196 hereinafter “Yeo” previously cited).
Regarding claims 12-15, Sitzman discloses the claimed invention except for the deriving the noise based on a noise scorer to provide a quality indication. However, Yeo teaches that it is known to use baseline measurements as set forth in Column 10, line 17 to Column 12, line 58 to provide a means for accurately deriving noise based on the signal quality. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Sitzman, with analysis noise based on a noise scorer to provide a quality indication as taught by Yeo, since such a modification would provide the predictable results of analyzing the ECG for providing a means for accurately deriving noise based on the signal quality.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached on Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3792