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 § 102
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 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 –
(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.
Claim(s) 1-3, 6-8, 12-14, 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2018 196753.
As to claims 1 and 12, JP 2018 196753 discloses a drug injector monitoring method performed by a processor, the drug injector monitoring method comprising: obtaining at least one or more pieces of state information on an operation of a drug injector from the drug injector [0063; 0215; 0335; 0346]; and outputting one of a notification signal on a state of the drug injector and a control signal for stopping a drug injection operation of the drug injector based on a result of comparing the state information with a reference value for each piece of the state information [0063; 0219; 0313], wherein the state information includes a battery remaining amount of the drug injector, a drug remaining amount of the drug injector, temperature of a specific region in the drug injector, and or pressure of the specific region in the drug injector [0215; 0219; 0313; 0335; 0346].
As to claims 2 and 13, JP 2018 196753 discloses the drug injector monitoring method of claim 1, wherein the outputting of one of the notification signal and the control signal includes outputting the notification signal when an hourly change rate of at least one of the battery remaining amount, the drug remaining amount, the temperature, and the pressure is greater than or equal to a reference change rate [0193; 0313].
As to claims 3 and 14, JP 2018 196753 discloses the drug injector monitoring method of claim 1, wherein the outputting of one of the notification signal and the control signal includes outputting the control signal for stopping a drug injection of the drug injector when temperature of the drug injector is higher than or equal to a preset maximum temperature or is lower than or equal to a preset minimum temperature [0063; 0215; 0316].
As to claims 6 and 17, JP 2018 196753 discloses the drug injector monitoring method of claim 1, wherein, in the outputting of one of the notification signal and the control signal, when pressure of the drug injector is higher than a first pressure value, the control signal is output such that a preset flow path blockage preventing operation is performed, and when the pressure of the drug injector is a second pressure value that is higher than the first pressure value, the notification signal and the control signal for stopping the drug injection operation of the drug injector are output [0193; 0313; 0316].
As to claims 7 and 18, JP 2018 196753 discloses the drug injector monitoring method of claim 1, wherein in the obtaining of at least one or more pieces of state information, the battery remaining amount, the drug remaining amount, the temperature, and the pressure are simultaneously received from the drug injector [0335; 0346].
As to claims 8 and 19, JP 2018 196753 discloses the drug injector monitoring method of claim 1, wherein in the obtaining of at least one or more pieces of state information, the battery remaining amount, the drug remaining amount, the temperature, and the pressure are received from the drug injector only during a period in which the drug injection operation of the drug injector is performed [0193; 0335].
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 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) 4, 5, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2018 196753 in view of US 2019/274624 A1 to Mazlish.
As to claims 4, 5, 15-16, JP 2018 196753 discloses the invention substantially as claimed for the drug injector monitoring method of claim 1, wherein in the outputting of one of the notification signal and the control signal, when the battery remaining amount of the drug injector is less than or equal to a first battery remaining amount, the notification signal is output [0219; 0316], however is silent regarding when the battery remaining amount of the drug injector is less than or equal to a second battery remaining amount that is less than the first battery remaining amount, the control signal for stopping the drug injection of the drug injector is output; when the drug remaining amount of the drug injector is less than or equal to the second drug remaining amount value that is less than the first drug remaining amount value, the control signal for stopping the drug injection of the drug injector is output. Mazlish discloses when the battery remaining amount of the drug injector is less than or equal to a second battery remaining amount that is less than the first battery remaining amount, the control signal for stopping the drug injection of the drug injector is output; when the drug remaining amount of the drug injector is less than or equal to the second drug remaining amount value that is less than the first drug remaining amount value, the control signal for stopping the drug injection of the drug injector is output [0008; 0013]. Hence, it would have been obvious to one of ordinary skill in the art at the effective filing to modify the injector to include notifications of battery and drug status as taught by Mazlish to ensure that a user is alerted to safety concerns in a timely manner to take corrective action [0008].
Claim(s) 9, 11, 20, 22 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2018 196753 in view of KR 101 933 062.
As to claims 9 and 20, JP 2018 196753 discloses the invention substantially as claimed for the drug injector monitoring method of claim 1, however is silent wherein the drug injector includes an electroosmotic pump, and the temperature of the specific region is temperature of the electroosmotic pump, and the pressure of the specific region is the pressure of the electroosmotic pump. KR 101 933 062 discloses wherein the drug injector includes an electroosmotic pump, and the temperature of the specific region is temperature of the electroosmotic pump, and the pressure of the specific region is the pressure of the electroosmotic pump [0038]. Hence, it would have been obvious to one of ordinary skill in the art at the effective filing to modify the injector to include an electroosmotic pump known to provide the advantage of being silent and controlling the flow rate in proportion to the voltage applied.
As to claims 11 and 22, JP 2018 196753 discloses the invention substantially as claimed for the drug injector monitoring method of claim 1, however is silent regarding wherein the pressure of the specific region is pressure of a drug discharge portion of the drug injector. KR 101 933 062 discloses wherein the pressure of the specific region is pressure of a drug discharge portion of the drug injector [0038; 0044]. Hence, it would have been obvious to one of ordinary skill in the art at the effective filing to modify the injector to include an electroosmotic pump known to provide the advantage of being silent and controlling the flow rate in proportion to the voltage applied.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. SEE PTO-892.
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/IMANI N HAYMAN/Supervisory Patent Examiner, Art Unit 2841
