DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of US Application no. 17/409,465, now US Patent no. 11,963,746, filed 23 August 2021, which is a continuation of US Application no. 16/504,798, now US Patent no. 11,096,596, filed 8 July 2019, which is a continuation of US Application no. 15/717,645, now US Patent no. 10,342,438, filed 27 September 2017, which is a continuation of US Application no. 12/560,104, now US Patent no. 12/560,104, now abandoned, filed 15 September 2009.
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 (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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Banet et al. (US Publication no. 2007/0142715) in view of Mason (US Publication no. 2008/0306354).
In regard to claim 1, Banet et al. disclose a system for measuring a blood pressure value from a patient (para 10, an algorithm that processes the electrical signal in combination with the optical signal to calculate a blood pressure value),
comprising:
(a) a first sensor 31 configured to generate a first time-dependent waveform indicative of one or more contractile properties of the patient's heart (para 19, amplifier circuit 31 is connected to electrodes 1, 2, 3, on a wearable chest strap 10, wherein amplifier 31 obtains electrical signals from electrodes 1, 2, 3 and processes the signals into ECG signal);
(b) a second sensor 22 configured to generate a second time-dependent waveform indicative of one or more contractile properties of the patient's heart (para 19-20, optical component 22 incudes light sources 30 32 that obtain photoplethysmogram signals);
(c) a third sensor 20 configured to generate a third time-dependent waveform indicative of pressure applied to a patient's arm (para 25, a conventional blood pressure cuff is obtained to calibrate measurements taken by the first and second sensors)
(d) a processing component 5 configured to be worn on the patient's body and comprising a microprocessor and a serial transceiver (para 21, external monitor 5 is attached to a user’s arm and includes a transceiver 11, and is considered to necessarily include a processor in order to execute operation of the component), the processing component 12 configured to:
(i) communicate with a microprocessor and serial transceiver comprised by the first sensor 31 to receive a digitized version of the first time-dependent waveform (para 20, the strap 10 includes a processor 4 and transceiver 8 to process and transmit ECG waveform signals to external monitor 5, the processor 4 digitizes the ECG signal before transmission);
(iii) calculate a pulse transit time calculated using a time difference between time-dependent features in digitized versions of the first and second time- dependent waveforms (para 25, the PTT is calculated based on a time different in arrival of signals measured by the optical component relative to features of the ECG signal);
(iv) calculate a calibration from at least one pulse transit time and a pressure value (para 25-26, the measurement is calibrated with a conventional blood pressure cuff; this results in a calibration table which correlates the time difference to systolic and diastolic blood pressures).
(v) calculate the blood pressure value from the pulse transit time and the calibration (para 26, the calibration source is removed, however the calibration table and the PTT are used to determine the user’s blood pressure).
Banet et al. substantially describes the invention as claimed, however does not teach that the third signal is obtained by configuring external monitor 5 to (ii) communicate with a microprocessor and serial transceiver comprised by the third sensor to receive a digitized version of the third time-dependent waveform. While Banet et al. teaches obtaining a pressure signal from a cuff (considered the third sensor) in order to calibrate the PTT to determine blood pressure, Banet et al. is not clear that the signal obtained from the cuff is either digitized or obtained from a microprocessor and transceiver associated with it. Mason et al. describes a wrist worn blood pressure sensor 16 with a cuff (para 34), wherein the blood pressure sensor 16 includes a processor and transceiver 30 for digitizing and transmitting the blood pressure signal to a monitoring device (para 36). The blood pressure sensor 16 of Mason is considered a suitable blood pressure measurement device for obtaining the blood pressure signal for calibration as used and taught in Banet et al. Therefore the modification of Banet et al. to utilize the blood pressure sensor of Mason to obtain the conventional blood pressure signal for use in the calibration step since the modification is considered to comprise the substitution on a known blood pressure sensor for another to yield a predictable result. Additionally, the transceiver 30 of Mason that digitizes the blood pressure signal is considered capable of transmitting said signal to the external monitor 5 of Banet et al.
In regard to claim 2, Banet et al. disclose a method for calculating blood pressure from a patient (para 10, an algorithm that processes the electrical signal in combination with the optical signal to calculate a blood pressure value), comprising the following steps:
(a) generating a first digital waveform indicating an ECG signal with a first remote sensor (para 10; para 19, amplifier circuit 31 is connected to electrodes 1, 2, 3, on a wearable chest strap 10, wherein amplifier 31 obtains electrical signals from electrodes 1, 2, 3 and processes the signals into ECG signal);
(b) generating a second waveform indicating a pressure signal with a second sensor (para 25, a conventional blood pressure cuff is obtained to calibrate measurements taken by the first and second sensors);
(c) generating an analog waveform indicating an optical signal with a third remote sensor (para 10, para 19-20, optical component 22 incudes light sources 30 32 that obtain photoplethysmogram signals; para 23, the photodetector 34 of the optical component 22 senses the waveform initially as an analog signal, which is then digitized by the analog-to-digital converter);
(d) synchronizing the first digital waveform, the second digital waveform, and a digitized version of the analog waveform (para 25-26; the ECG signal, PPG signal, and pressure signal are utilized together in order to derive the blood pressure measurement without use of a cuff);
(e) determining a pulse transit time from the first digital waveform and a digitized version of the analog waveform following (d) (para 25, the PTT is calculated based on a time different in arrival of signals measured by the optical component relative to features of the ECG signal; para 23, the optical waveform is digitized by an analog-to-digital converter);
(f) determining a calibration from the first digital waveform, the second waveform, and a digitized version of the analog waveform following (d) (para 25-26, the measurement is calibrated with a conventional blood pressure cuff; this results in a calibration table which correlates the time difference to systolic and diastolic blood pressures); and
(g) determining a blood pressure value from the calibration and a pulse transit time (para 26, the calibration source is removed, however the calibration table and the PTT are used to determine the user’s blood pressure).
Banet et al. substantially describes the invention as claimed, however does not teach that the second signal is obtained as a digitized version of the time-dependent waveform represent a pressure signal. While Banet et al. teaches obtaining a pressure signal from a cuff (considered the third sensor) in order to calibrate the PTT to determine blood pressure, Banet et al. is not clear that the signal obtained from the cuff is either digitized or obtained from a microprocessor and transceiver associated with it. Mason et al. describes a wrist worn blood pressure sensor 16 with a cuff (para 34), wherein the blood pressure sensor 16 includes a processor and transceiver 30 for digitizing and transmitting the blood pressure signal to a monitoring device (para 36). The blood pressure sensor 16 of Mason is considered a suitable blood pressure measurement device for obtaining the blood pressure signal for calibration as used and taught in Banet et al. Therefore, the modification of Banet et al. to utilize the blood pressure sensor of Mason to obtain the conventional blood pressure signal in a digitized manner for use in the calibration step in order for the signal to be in a computer readable form and to be compatible with the digital ECG and PPG signals.
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 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 10,342,438. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘438 patent anticipates each and every limitation of the present invention as exemplified below.
Claim 1 of the ‘438 patent:
A system for measuring a blood pressure value from a patient, comprising:
(a) a first sensor configured to generate a first time-dependent waveform indicative of one or more contractile properties of the patient's heart; (b) a second sensor configured to generate a second time-dependent waveform indicative of one or more contractile properties of the patient's heart;
(c) a third sensor configured to generate a third time-dependent waveform indicative of pressure applied to a patient's arm; and
(d) a processing component configured to be worn on the patient's body and comprising a microprocessor and a serial transceiver, the processing component configured to:
(i) communicate with a microprocessor and serial transceiver comprised by the first sensor to receive a digitized version of the first time-dependent waveform;
(ii) communicate with a microprocessor and serial transceiver comprised by the third sensor to receive a digitized version of the third time-dependent waveform;
(iii) calculate a pulse transit time calculated using a time difference between time-dependent features in digitized versions of the first and second time- dependent waveforms;
(iv) calculate a calibration from at least one pulse transit time and a pressure value determined from a digitized version of the third time-dependent waveform; and
(v) calculate the blood pressure value from the pulse transit time and the calibration, wherein the processing component communicates with the first sensor and the third sensor to transmit a timing synchronizing packet that is received and used by the first and third sensors to time-synchronize the digitized version of the first time-dependent waveform and the digitized version of the third time-dependent waveform for processing by the processing component such that there is a maximum 40-microsecond timing error in the synchrony between the digitized version of the first time-dependent waveform and the digitized version of the third time- dependent waveform.
Claim 2 of the ‘438 patent:
A method for calculating blood pressure from a patient, comprising the following steps:
(a) generating a first digital waveform indicating an electrocardiogram (ECG) signal with a first remote sensor;
(b) generating a second digital waveform indicating a pressure signal with a second remote sensor; (c) generating an analog waveform indicating an optical signal with a third remote sensor;
(d) synchronizing the first digital waveform, the second digital waveform, and a digitized version of the analog waveform using a processing component, wherein the processing component communicates with the first sensor and the second sensor to transmit a timing synchronizing packet that is received and used by the first and second sensors to time-synchronize the first digital waveform and the the second digital waveform for processing by the processing component such that there is a maximum 40-microsecond timing error in the synchrony between the first digital waveform and the second digital waveform; (e) determining a pulse transit time from the first digital waveform and a digitized version of the analog waveform following using the processing component (d); (f) determining a calibration from the first digital waveform, the second digital waveform, and a digitized version of the analog waveform following (d) using the processing component; and (g) determining a blood pressure value from the calibration and a pulse transit time using the processing component.
Claim 1 of the present invention:
A system for measuring a blood pressure value from a patient, comprising:
(a) a first sensor configured to generate a first time-dependent waveform indicative of one or more contractile properties of the patient's heart; (b) a second sensor configured to generate a second time-dependent waveform indicative of one or more contractile properties of the patient's heart;
(c) a third sensor configured to generate a third time-dependent waveform indicative of pressure applied to a patient's arm; and
(d) a processing component configured to be worn on the patient's body and comprising a
microprocessor and a serial transceiver, the processing component configured to:
(i) communicate with a microprocessor and serial transceiver comprised by the first sensor to receive a digitized version of the first time-dependent waveform;
(ii) communicate with a microprocessor and serial transceiver comprised by the third sensor to receive a digitized version of the third time-dependent waveform;
(iii) calculate a pulse transit time calculated using a time difference between time-dependent features in digitized versions of the first and second time- dependent waveforms;
(iv) calculate a calibration from at least one pulse transit time and a pressure value determined from a digitized version of the third time-dependent waveform; and
(v) calculate the blood pressure value from the pulse transit time and the calibration.
Claim 2 of the present invention:
A method for calculating blood pressure from a patient, comprising the following steps:
(a) generating a first digital waveform indicating an ECG signal with a first remote sensor;
(b) generating a second digital waveform indicating a pressure signal with a second remote sensor; (c) generating an analog waveform indicating an optical signal with a third remote sensor; (d) synchronizing the first digital waveform, the second digital waveform, and a digitized version of the analog waveform; (e) determining a pulse transit time from the first digital waveform and a digitized version of the analog waveform following (d); (f) determining a calibration from the first digital waveform, the second digital waveform, and a digitized version of the analog waveform following (d); and (g) determining a blood pressure value from the calibration and a pulse transit time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 11 May 2026
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