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 .
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.
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Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,478,171 in view of Borgos et al. (USPN 10,244,978). In regard to claim 20, claim 1 of ‘171 recites all the claim limitations except “concurrently displaying at least two of: a first value representative of the tissue oxygenation parameter based on the first signals, or a second value representative of the blood pressure level of the subject based on the second signals, or a third value representative of the subject's autoregulation state based on the peak coherence value”. Borgos teaches a system device and method are presented for determining if cerebral blood flow autoregulation functionality has been compromised in a patient. The system includes sensors for detecting and measuring at least two physiological parameters such as oxygenation and blood pressure (abstract; NIRS oximetry element 14 and pressure sensing device 16, Fig. 3) and concurrently displaying at least two of: a first value representative of the tissue oxygenation parameter based on the first signals, or a second value representative of the blood pressure level of the subject based on the second signals (rSO2 and pressure, Figs. 6-7 and 11). 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 method (claim 1 of ‘171) to incorporate the concurrently displaying step as taught by Borgos in order to present both of the measured parameters to the user/ caregiver.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,121,352 in view of Borgos. In regard to claim 20, claim 1 of ‘352 recites all the claim limitations except “concurrently displaying at least two of: a first value representative of the tissue oxygenation parameter based on the first signals, or a second value representative of the blood pressure level of the subject based on the second signals, or a third value representative of the subject's autoregulation state based on the peak coherence value”. Borgos teaches a system device and method are presented for determining if cerebral blood flow autoregulation functionality has been compromised in a patient. The system includes sensors for detecting and measuring at least two physiological parameters such as oxygenation and blood pressure (abstract; NIRS oximetry element 14 and pressure sensing device 16, Fig. 3) and concurrently displaying at least two of: a first value representative of the tissue oxygenation parameter based on the first signals, or a second value representative of the blood pressure level of the subject based on the second signals (rSO2 and pressure, Figs. 6-7 and 11). 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 method (claim 1 of ‘352) to incorporate the concurrently displaying step as taught by Borgos in order to present both of the measured parameters to the user/ caregiver.
Allowable Subject Matter
Claims 1-19 are allowed.
The following is an examiner’s statement of reasons for allowance: Brady (USPUPUB 2010/0010322 – applicant cited) teaches a method and a system for determining cerebrovascular autoregulation in a patient (Figs. 1-4) comprises a cerebral oximeter / near-infrared spectrometer (NIRS) (element 102, Fig. 1) obtains venous oxygen content measurements of blood within the patient's brain in a plurality of times ([0026]); a blood pressure monitoring device (element 106, Fig. 1) obtains arterial blood pressure measurements of the patient at a plurality of times substantially synchronously with the oxygen content measurements ([0027]); a signal processing unit (element 108, Fig. 1) calculates a linear correlation coefficient, cerebral oximeter index (COx), based on the oxygen content signal and the arterial blood pressure signal in a time domain fora plurality of times ([(0027])/ correlates the blood pressure and the venous oxygen content measurements in a time domain (Fig. 2), wherein the correlation coefficient(s) indicative of a cerebrovascular autoregulation state ([0014]); and low frequencies should be chosen for analysis of COX based on at least the findings of a frequency-domain analysis of coherence between NIRS and ABP ([0054-0055]). Sethi et al. (USPGPUB 2014/0073888 – applicant cited) teaches a method and a system for monitoring cerebrovascular autoregulation (Figs. 1-3) comprises an oximeter generates regional oxygen saturation (RSO2) or hemoglobin (SpO2) signals (element 110, Fig. 1); a blood pressure sensor generates blood pressure signals (element 105, Fig. 1); a controller (element 115, Fig. 1) determines the cerebral autoregulation status of the patient is to derive a cerebral oximetry index (Cox) measurement for the patient based on a linear correlation, a regression line between oxygen saturation and blood pressure, and the slope of the regression line may indicate the autoregulation status (Fig. 2). Addison et al. (USPGPUB 2017/0000423 – applicant cited) teaches a method and a system for monitoring cerebrovascular autoregulation (Figs. 1-9) comprises a regional oxygen saturation sensor (element 14, Fig. 1); a blood pressure sensor (element 12, Fig. 1);a controller (element 16, Fig. 1) derives a cerebral oximetry index (COx) by determining a linear correlation between blood pressure measurements and oxygen saturation measurements (Fig. 2 and [0024]); the controller determines a phase difference between the blood pressure signal and the oxygen saturation signal and utilizes the phase difference to determine whether the COx value is reliable or unreliable (Figs. 3- 6); and the phase difference may be determined based on a cross-wavelet transform of the blood pressure signal and the oxygen saturation signal (Figs. 7-8). Borgos teaches a method and a system for detecting and diagnosing potential dysfunction of cerebral autoregulation (CAR) (Figs. 1-11; claim 1) comprises receiving tissue oxygenation parameter from a tissue oximeter (NIRS oximetry elements 14, Figs. 1-3); receiving blood pressure parameter from a blood pressure sensor (element 16, Fig. 1-3) and determining a maximum, minimum, or optimum coherence and phase delay between the two parameters (Col 9 lines 22-29). However, the prior art of record does not teach or suggest “determining/ determine a coherence value indicative of the subject’s autoregulation state as a function of frequency in each of a plurality of different frequency bands using the frequency domain tissue oxygen parameter values and the frequency domain blood pressure values; determining/determine a temporal phase value for the determined coherence value from each of the plurality of different frequency bands, wherein the temporal phase value is based on an occurrence of a change in the tissue oxygenation parameter during the period of time, and an occurrence of a change in the blood pressure level of the subject during the period of time; identifying/ identify each determined coherence value as an acceptable coherence value or an unacceptable coherence value based on the temporal phase value for the respective determined coherence value; and determining/ determine a peak coherence value indicative of the subject's autoregulation state based on the acceptable coherence values”, in combination with the other claimed elements/ steps.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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