CTNF 18/794,938 CTNF 77702 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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 (i.e., changing from AIA to pre-AIA) 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-4, and 12-20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Huiku (US 2005/0272984 A1) . With respect to claim 1, Huiku discloses a method for monitoring arterial pressure of a patient and detecting nociception of the patient, the method comprising: receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient from a hemodynamic sensor (see paragraphs 0020, and 0054); performing, by a hardware processor of the hemodynamic monitor, waveform analysis of the sensed hemodynamic data to calculate a plurality of signal measures of the sensed hemodynamic data; organizing, by the hardware processor of the hemodynamic monitor, the plurality of signal measures into pairs of signal measures (see microprocessor #103 according to paragraph 0088-0089); measuring, by the hardware processor of the hemodynamic monitor, a cross-correlational association of each of the pairs of signal measures; outputting to a display a measured cross-correlational association of each of the pairs of signal measures; monitoring the measured cross-correlational association of each of the pairs of signal measures for an increase above a predetermined threshold in the measured cross-correlational association of at least one of the pairs of signal measures (see paragraphs 0031, see also paragraph 0090 discussing the display of the results in monitor #104); and sending, by the hemodynamic monitor, an alert to medical personnel of a nociception event of the patient when the measured cross-correlational association of at least one of the pairs of signal measures increases above the predetermined threshold (see paragraphs 0069-0071, 0075 discussing the nociception event is registered in order to provide analgesics hence it is considered as alerting in order to provide said analgesics to treat the pain causing the event). With respect to claim 2, Huiku discloses the predetermined threshold is at least 50% greater than a moving average of the measured cross-correlational association of the at least one of the pairs of signal measures (see paragraphs 0065-0067 as seen on Figures 4A and 4B). With respect to claim 3, T Huiku discloses normalizing the measured cross-correlational association of each of the pairs of signal measures before outputting the measured cross-correlational association of each of the pairs of signal measures to the display (see paragraphs 0058-0060, 0065 and 0071-0074). With respect to claim 4, 13 and 14, Huiku discloses the signal measures comprise hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles (see paragraph 0054), wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle, and/or wherein the signal measures comprise a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles, and/or the signal measures comprise heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles (see paragraphs 0054-0058). With respect to claim 12, Huiku discloses a method for monitoring arterial pressure of a patient and detecting nociception of the patient, the method comprising: receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient (see paragraphs 0020, and 0054); performing, by a hardware processor of the hemodynamic monitor, waveform analysis of the sensed hemodynamic data to calculate a plurality of signal measures of the sensed hemodynamic data (see microprocessor #103 according to paragraph 0088-0089); calculating, by the hardware processor of the hemodynamic monitor, cross-correlational association measurements between each of the signal measures; outputting to a user interface the cross-correlational association measurements; monitoring the cross-correlational association measurements for bursts in the cross-correlational association measurements (see paragraphs 0031, see also paragraph 0090 discussing the display of the results in monitor #104); and detecting a nociception event of the patient when a burst in one or more of the cross-correlational association measurements is outputted to the user interface (see paragraphs 0069-0071, 0075 discussing the nociception event is registered in order to provide analgesics). With respect to claim 15, Huiku discloses the user interface comprises at least one of a display screen and a speaker (see Figure 10showing a monitor screen #104 for displaying data). With respect to claim 16, Huiku discloses a system for monitoring arterial pressure of a patient and providing a warning to medical personnel of nociception of the patient, the system comprising: a hemodynamic sensor that produces hemodynamic data representative of an arterial pressure waveform of the patient (see paragraphs 0020, and 0054); a system memory that stores nociception detection software code (see paragraph 0054 discussing a memory); a user interface that includes a sensory alarm that provides a sensory signal to warn the medical personnel of a nociception event of the patient (see paragraphs 0089-0090 discussing an indicator); and a hardware processor that is configured to execute the nociception detection software code to: perform waveform analysis of the hemodynamic data to determine a plurality of signal measures; organize the plurality of signal measures into pairs of signal measures; measure a cross-correlational association of each of the pairs of signal measures; output to the user interface measurements of cross-correlational association of the pairs of signal measures; monitor the measurements of cross-correlational association of the pairs of signal measures for bursts in the measurements of cross-correlational association of the pairs of signal measures (see paragraphs 0031, see also paragraph 0090 discussing the display of the results in monitor #104); and invoke a sensory alarm of the user interface indicating a nociception event in response to a burst in one or more of the measurements of cross-correlational association of the pairs of signal measures (see paragraphs 0069-0071, 0075 discussing the nociception event is registered in order to provide analgesics hence it is considered as an alarm for alerting in order to provide said analgesics to treat the pain causing the event). With respect to claim 17, Huiku discloses the hemodynamic sensor is a noninvasive hemodynamic sensor that is attachable to an extremity of the patient (see paragraph 0088). With respect to claim 18, Huiku discloses the hemodynamic sensor is a minimally invasive arterial catheter based hemodynamic sensor (see paragraph 0014). With respect to claim 19, Huiku discloses the hemodynamic sensor produces the hemodynamic data as an analog hemodynamic sensor signal representative of the arterial pressure waveform of the patient (see paragraph 0014). With respect to claim 20, Huiku discloses an analog-to-digital converter that converts the analog hemodynamic sensor signal to digital hemodynamic data representative of the arterial pressure waveform of the patient (see A/D converter #102 in Figure 10 according to paragraph 0088) . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim s 5-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIXOMARA VARGAS whose telephone number is (571)272-2252. The examiner can normally be reached Monday-Friday 8am-5pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Raymond Keith can be reached at 571-270-1790. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DIXOMARA VARGAS/Primary Examiner, Art Unit 3798 Application/Control Number: 18/794,938 Page 2 Art Unit: 3798 Application/Control Number: 18/794,938 Page 3 Art Unit: 3798 Application/Control Number: 18/794,938 Page 4 Art Unit: 3798 Application/Control Number: 18/794,938 Page 5 Art Unit: 3798 Application/Control Number: 18/794,938 Page 6 Art Unit: 3798
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