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 .
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.
Claims 1-8 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. Claims that depend directly or indirectly from claim 1 is/are also rejected due to said dependency. In regard to claim 1, the claim recites “…an extracorporeal blood circuit mounted on the hemodialysis machine, the extracorporeal blood circuit comprising a blood chamber; and an optical blood monitoring system, the optical monitoring system comprising: an emitter disposed on a first side of a blood chamber of an extracorporeal blood circuit…” It is unclear whether the second appearances of “a blood chamber” and “an extracorporeal blood circuit” refer to the same chamber/ circuit of the first appearances or they are additional elements. Clarification is requested by amendments. If they are the same, it is suggested that “the blood chamber” and “the extracorporeal blood circuit” should be set forth in the second appearances.
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 1-5, 9-13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Barrett et al. (USPGPUB 2010/0110416) and further in view of Anderson et al. (USPN 5,879,294 – applicant cited). In regard to claims 1, 9 and 17, Barrett discloses an hemodialysis system, an optical blood monitoring system and associated method (Figs. 1-6 and associated descriptions), comprising: a hemodialysis machine configured to provide a hemodialysis treatment for a patient (element 12, Fig. 1 and associated descriptions); an extracorporeal blood circuit mounted on the hemodialysis machine (elements 16, 18, 20, 22, 24, 26,28, 30, 32, and/ or 34, Fig. 1 and associated descriptions), the extracorporeal blood circuit comprising a blood chamber (element 32, Figs. 1-4 and 6 and associated descriptions); and an optical blood monitoring system chamber (element 34, Figs. 1-4 and 6 and associated descriptions), the optical monitoring system comprising: an emitter disposed on a first side of a blood chamber of an extracorporeal blood circuit (element 48 disposed on a first side of a blood chamber 32, Figs. 1-4 and 6 and associated descriptions), wherein the emitter is configured to emit light through extracorporeal blood in the blood chamber (Figs. 4 and 6 and associated descriptions [0028]); a sensor disposed on a second side of the blood chamber (element 52 disposed on a second side of the blood chamber, Figs. 4 and 6 and associated descriptions), wherein the sensor is configured to detect light from the emitter that has passed through the extracorporeal blood in the blood chamber (Figs. 4 and 6 and associated descriptions [0028]).
Barrett does not specifically disclose a reference sensor disposed on the first side of the blood chamber, wherein the reference sensor is configured to detect light from the emitter that has not passed through the blood chamber; and a controller configured to adjust an intensity of the light emitted by the emitter based on measurements from the reference sensor.
Anderson teaches an optical detection system (Fig. 15 and associated descriptions) comprises a reference sensor disposed on the same side of emission potion (element 1512, Fig. 15 and associated descriptions; Col 12 line 50 – Col 13 line 14), wherein the reference sensor is configured to detect light from an emitter that has not passed through the measurement area (lamp 1402, Col 12 line 50 – Col 13 line 14 and LEDs, Col 13 lines 25-57); and a controller (elements 1508 and/or 1550, Fig. 15 and associated descriptions; Col 12 line 50 – Col 13 line 14) configured to adjust an intensity of the light emitted by the emitter based on measurements from the reference sensor (Fig. 15 and associated descriptions; adjust the lamp 1402 voltage and/or current, Col 12 line 50 – Col 13 line 14).
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 systems and method (Barrett) to incorporate a reference sensor at the same side of the emission portion of the system and associated functions/steps/configurations as taught by Anderson, since both devices are blood related optical sensing systems and one of ordinary skill in the art would have recognized that the use of a reference sensor for the emitter facilitates minimizing signal drift due to lamp aging/ avoid amplitude drift due to time dependent intensity profile shifts (see at least Col 12 line 50 – Col 13 line 14 of Anderson). The rationale would have been to provide stabilized light output from the emitter.
In regard to claims 2, 10 and 18, Barrett as modified by Anderson discloses the optical blood monitoring system further comprises: a current source configured to drive the emitter; and a current set resistor connected to the current source; wherein adjusting the intensity of the light emitted by the emitter is based on controlling the current source (inherent properties of the modulating controller, Col 12 line 50 – Col 13 line 14 of Anderson).
In regard to claims 3, 11 and 19, Barrett as modified by Anderson discloses adjusting the intensity of the light emitted by the emitter is in response to power fluctuations affecting the emitter (amplitude drift due to time dependent intensity profile shifts, Col 12 line 50 – Col 13 line 14 of Anderson).
In regard to claims 4 and 12, Barrett as modified by Anderson discloses adjusting the intensity of the light emitted by the emitter is in response to degradation of the emitter over time (minimizing signal drift due to lamp aging, Col 12 line 50 – Col 13 line 14 of Anderson).
In regard to claims 5 and 13, Barrett as modified by Anderson discloses the emitter is a light-emitting diode (LED) (LED, [0028] of Barrett; LEDs, Col 13 lines 25-57 of Anderson).
Claims 6-7, 14-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Barrett and Anderson as applied to claims 1-5, 9-13 and 17-19 above, and further in view of Kunstar (USPGPUB 2011/0122411 – applicant cited). In regard to claims 6-7, 14-15 and 20, Barrett as modified by Anderson discloses an emitter circuit board (element 48, Fig. 4 and associated descriptions; [0028] of Barrett) but does not specifically disclose the reference sensor is mounted on a same circuit board as the emitter and the reference sensor is edge-mounted on the circuit board.
Kunstar teaches an optical measuring device (Figs. 1-2 and associated descriptions) comprises a light emitter (elements 11/21, Fig. 1-2 and associated descriptions) mounted on a circuit board (element 20, Fig. 1-2 and associated descriptions) and a reference sensor is mounted on the same circuit board as the emitter (monitoring sensor 15, Fig. 1-2 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the reference sensor’s configurations (Barrett as modified by Anderson) with the configurations of the emitter(s) and reference sensor at the emission part of the system and associated functions/ steps as taught by Kunstar to yield predictable results, since both devices are optical measuring systems with reference sensors and one of ordinary skill on the art would have recognized that the emission configurations of the emitter and the reference sensor as taught by Kunstar is an alternative equivalent configuration for generating light emission and obtaining reference light emission characteristics of one or more light emitting parameters (e.g. intensity, wave length, spectrum) vary, fluctuate or drift temporarily or on a long term basis (see at least [0029] of Kunstar). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Barrett as modified by Anderson and Kunstar discloses all the claimed limitations except the reference sensor is edge-mounted on the circuit board. However, Barrett as modified by Anderson and Kunstar discloses an emitter circuit board (Fig. 4 and associated descriptions; [0028] of Barrett) and the reference sensor is mounted on the same circuit board near the edge of the emission portion of the circuit board (see Fig. 2 of Kunstar).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try changing the location of the reference sensor to be mounted to the edge/ side portion of the emitter circuit board in order to find the optimal location(s) of the reference sensor for detecting side-emissions, since the teachings of Kunstar suggests the reference sensor should be mounted on the edge/ side portion for receiving side-emissions of the emitter (see at least Fig. 2 of Kunstar) and the emitter circuit board has limited space for mounting the reference sensor (see at least Fig. 4 of Barrett). The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007).
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Barrett and Anderson as applied to claims 1-5, 9-13 and 17-19 above, and further in view of Al-Ali et al. (USPN 7,880,626). In regard to claims 8 and 16, Barrett as modified by Anderson discloses all the claimed limitations except a memory configured to store a log of calibration parameters corresponding to the emitter; wherein the controller is configured to detect diagnostic events based on the log of calibration parameters.
Al-Ali teaches an oximetry device (Figs. 1-6 and associated descriptions) comprises a memory (element 308, Fig. 3 and associated descriptions) configured to store a log of calibration parameters corresponding to the emitter (parameters associated with the use information/ useful light of the sensor, abstract; element 423, Fig. 4 and associated descriptions; Col 2 line 62 – Col 3 line 39; the amount of current supplied to the sensor and/or LEDs/ temperature of each emitter, Col 9 lines 5-63); wherein the controller is configured to detect diagnostic events based on the log of calibration parameters (parameters associated with the use information/ useful light of the sensor, abstract; element 423, Fig. 4 and associated descriptions; Col 2 line 62 – Col 3 line 39; the amount of current supplied to the sensor and/or LEDs/ temperature of each emitter, Col 9 lines 5-63; determination of sensor expiration, Figs. 5-6 and associated descriptions; sensor expired, Col 6 lines 13-27).
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 system and method (Barrett as modified by Anderson) to incorporate the memory and associated functions/ steps/ operations as taught by Al-Ali, since both devices are blood related optical sensors and one of ordinary skill in the art would have recognized that storing calibration parameters associated with the emitter facilitates determining sensor expiration or the need to replace the sensor (see Al-Ali). The rationale would have been to record and save calibration parameters of the emitter and determine the sensor useful life and/or expiration of the sensor.
Conclusion
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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