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 .
Claim Rejections - 35 USC § 112a
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2 and dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim recites “determine a second measurement of the physiological parameter by adjusting said first measurement based at least in part on the motion, movement, and/or position data”. This is interpreted to mean taking a second measurement from the ECG sensor since “determining a first measurement” is interpreted as taking a measurement from the EDG sensor. Then, the second measurement is adjusted using the first measurement and the motion, movement, and/or position data. This is not considered to be sufficiently described in the specification to show the inventor at the time the application was filed, had possession of the claimed invention. The closest description appears to be 0092-0093, which only describes in generalities a process which includes “more aggressively” or “less aggressively” compensating for motion (0092) without further details as to how this is accomplished. Additionally, 0093 describes a database which is used to “detect trends that can be used to perform parameter calculation adjustments based on motion” but does not provide a specific description of this step, i.e. what are the trends that are being detected, what the adjustments are, and how motion affects this analysis. It will be interpreted as provided in the rejection and including but not limited to any modification or adjustment made to a physiological parameter.
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.
Claim 2 and dependent claims 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.
Claim 2 recites “determine a second measurement of the physiological parameter by adjusting said first measurement”. It is unclear if “a second measurement” is actually a measured value read from the sensor or if it is a derived quantity from the first measurement. The claim language appears to be conflicting and is therefore indefinite. It will be interpreted as given in the rejection below.
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.
Claim(s) 2-4, 6-11, 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. US2009/0069642 and further in view of Shin US20070142735.
Gao discloses for claim 2, “A patient-worn monitoring system comprising:
a wearable monitor (100; fig 1A; 0029) configured to be worn by a patient (0025 “wearable patient monitor may be worn by a patient”), the wearable monitor comprising a housing (0046), one or more hardware processors (processor 103, monitor controller 105; fig 1A), at least one battery (0081 and 0083 describes battery checking function of the device), and a transceiver (wireless transmitter/receiver 111; fig 1A), wherein the wearable monitor is configured to secured to an arm of the patient (0046);
an electrocardiograph ("ECG") sensor (0030 ECG sensor connects with patient monitor 100; fig 1A) in communication with the wearable monitor with a single cable (fig 1A showing the connection between the sensor 150 and the monitor 100) and configured to be secured to a chest of the patient (the patient monitor is to be worn by the patient and the ECG as part of the system is therefore also configured to be worn by the patient) and obtain physiological information of the patient (0030 respective ECG data); and
Gao does not disclose:
“a motion measurement device integrated into a housing of the ECG sensor while in communication with the wearable monitor with the single cable and configured to obtain motion, movement, and/or position data of the patient,
wherein the one or more hardware processors are configured to:
determine a first measurement of a physiological parameter of the patient based on the physiological information obtained by the ECG sensor;
determine a second measurement of the physiological parameter by adjusting said first measurement based at least in part on the motion, movement, and/or position data”.
Shin teaches in the same field of endeavor, an electrode motion artifact as a kind of noise generated due to any motion of the subject when measuring a biosignal from the subject, specifically as noise in an ECG signal and the artifact may distort a waveform of measurement results and interfere with the measurement of a heart rate or analysis of a state of a heart 0028. Shin further teaches when measuring an ECG signal, it is necessary to improve the accuracy of measurement results by classifying and removing electrode motion artifact 0029. Along with Gao’s disclosure of motion sensors used in the device (0078), it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Shin into the invention of Gao in order to configure the system e.g. as claimed, specifically measuring an ECG reading and then compensating and adjusting the data based on measurement data as noise because provides a more accurate reading by removing noise artifact (Shin: 0029).
Gao discloses for claim 3, “The patient-worn monitoring system of Claim 2, wherein the motion measurement device includes at least one of: an accelerometer, or a gyroscope (0078 accelerometer)”.
Gao discloses for claim 4, “The patient-worn monitoring system of Claim 2, wherein the motion measurement device is included in the wearable monitor (0078 describes the wearable patient monitors may also include a sensor which is described as a position sensor including an accelerometer)”.
Gao discloses for claim 6, “The patient-worn monitoring system of Claim 2, wherein the motion measurement device is included in another sensor that is in communication with the wearable monitor (0043-0044 describes multiple sensors and 0089-0090 describes those sensors as either being contained with the patient monitor or separate and not included with the patient monitor)”.
Gao discloses for claim 7, “The patient-worn monitoring system of Claim 2, wherein the ECG sensor is in wired communication with the wearable monitor (0030 describes the sensors connected physically via a plug/wired communication)”.
Gao discloses for claim 8, “The patient-worn monitoring system of Claim 2, wherein the wearable monitor is further configured to wirelessly communicate the physiological parameter to a bedside monitor (0027 describes the patient monitor used to track a patient including bedside patient treatment devices, while 0040 describes wireless communications to an external device)”.
Gao discloses for claim 9, “The patient-worn monitoring system of Claim 2 further comprising: an optical sensor (0030 describes a pulse ox sensor which is an optical sensor) in communication with the wearable monitor and configured to be worn by the patient and obtain additional physiological information of the patient, wherein the one or more hardware processors are further configured to: determine, based at least in part on a combination of the additional physiological information and the motion, movement, and/or position data, an additional physiological parameter of the patient (0030 describes determining pulse ox of a patient)”.
Gao discloses for claim 10, “The patient-worn monitoring system of Claim 9, wherein the motion measurement device includes at least one of: an accelerometer, or a gyroscope (0078 accelerometer)”.
Gao discloses for claim 11, “The patient-worn monitoring system of Claim 9, wherein the motion measurement device is included in the wearable monitor (0078 describes the wearable patient monitors may also include a sensor which is described as a position sensor including an accelerometer)”.
Gao discloses for claim 14, “The patient-worn monitoring system of Claim 9, wherein the motion measurement device is included in another sensor that is in communication with the wearable monitor (0043-0044 describes multiple sensors and 0089-0090 describes those sensors as either being contained with the patient monitor or separate and not included with the patient monitor)”.
Gao discloses for claim 15, “The patient-worn monitoring system of Claim 9, wherein the ECG sensor is in wired communication with the wearable monitor (0030 describes the sensors connected physically via a plug/wired communication)”.
Gao discloses for claim 16, “The patient-worn monitoring system of Claim 9, wherein the optical sensor is in wired communication with the wearable monitor (0030 describes the sensors connected physically via a plug/wired communication)”.
Gao discloses for claim 17, “The patient-worn monitoring system of Claim 9, wherein the wearable monitor is further configured to wirelessly communicate the physiological parameter and the additional physiological parameter to a bedside monitor (0027 describes the patient monitor used to track a patient including bedside patient treatment devices, while 0040 describes wireless communications to an external device)”.
Claim(s) 5, 12, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gao and Shin as applied to claim 2 above, and further in view of Goris et al US2008/0281234.
Gao does not disclose for claim 5, “The patient-worn monitoring system of Claim 2, wherein the motion measurement device is included in the ECG sensor”. Goris teaches in the same field of endeavor, providing a single multi-sensor with an ECG sensor and a position detecting accelerometer (fig 1A; 0061). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Goris into the invention of Gao in order to configure the monitoring system e.g. as claimed because it allows a single sensor to have multiple functionalities.
Gao does not disclose for claim 12, “The patient-worn monitoring system of Claim 9, wherein the motion measurement device is included in the ECG sensor”. Goris teaches in the same field of endeavor, providing a single multi-sensor with an ECG sensor and a position detecting accelerometer (fig 1A; 0061). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Goris into the invention of Gao in order to configure the monitoring system e.g. as claimed because it allows a single sensor to have multiple functionalities.
Gao does not disclose for claim 13, “The patient-worn monitoring system of Claim 9, wherein the motion measurement device is included in the optical sensor”. Goris teaches in the same field of endeavor, providing a single multi-sensor with an ECG sensor and a position detecting accelerometer or any other type of sensor, which includes an optical sensor (fig 1A; 0061). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Goris into the invention of Gao in order to configure the monitoring system e.g. as claimed because it allows a single sensor to have multiple functionalities.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
3/30/26
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