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, 4, 6, 8-10, and 12 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.
Regarding claim 1, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05. Therefore, the limitations “a medication” and “a semiconductor sensor or a thermopile” are not considered.
Regarding claim 4, the claim is unclear and difficult to adequately understand what is being claimed. The following interpretation is being used: the processing device is configured to predict an amount of time for a predetermined amount of radiation to be absorbed by the substance or object or the container space.
Regarding claim 6, the claim is unclear and difficult to adequately understand what is being claimed. The following interpretation is being used: the processing device has a module that determines whether a temperature or temperature profile has exceeded a predetermined threshold of irradiation or rate of change threshold of the temperature, and the processing device is connected to an alarm module for generating an alarm signal.
Regarding claim 8, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05. Therefore, the limitation “when the container is designed as a bag” is not considered.
Regarding claim 9, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05. Therefore, the limitations “a medication” and “a semiconductor sensor or a thermopile” are not considered.
Regarding claim 10, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05. Therefore, the limitation “a self-learning device which is set up to continuously correlate, as a function of time, the measurement data of the radiation intensity and/or the measured temperature data and to determine therefrom rules for predicting a temperature profile or a period of time after which a determined amount of radiation has been absorbed by the object or substance” is not considered.
Regarding claim 12, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05. Therefore, the limitations “a medication-delivering pump, a syringe or an injector pen” and “with a device for storing a medication for injection” are not considered.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5, 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shavit (US 20170239404 A1) in view of Thacher (US 20190342947 A1).
Regarding claim 1, Shavit discloses a device (10) for storing an object or a substance (para. [0122]), in particular a medication, having a container (1) with a container space for storing the object or the substance (para. [0122-0123]) and having a monitoring device (20) which comprises a first sensor (25) for recording measurement data (para. [0126]) and a processing device (23) for determining an irradiation input and/or heat input and/or the temperature (para. [0126]) and/or a temperature profile of the object or the substance or the container space using the recorded measurement data (para. [0126]), characterized in that the first sensor (25) is a sensor, in particular a semiconductor sensor or a thermopile.
However, Shavit fails to disclose the first sensor is a sensor for detecting electromagnetic radiation (para. [0193, 0200]).
Thacher teaches a similar device the first sensor is a sensor for detecting electromagnetic radiation (para. [0193, 0200]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Shavit and incorporate the electromagnetic radiation sensor of Thacher with predictable results—a sensor capable of measuring temperature of a contained medication (para. [0120, 0193]).
Regarding claim 2, the combination of Shavit and Thacher discloses the device of claim 1. However, Shavit fails to disclose the first sensor is set up to detect electromagnetic radiation in a wavelength-sensitive manner.
Thacher teaches the first sensor is set up to detect electromagnetic radiation (para. [0105, 0200]) in a wavelength-sensitive manner (para. [0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Shavit and incorporate the electromagnetic radiation sensor of Thacher with predictable results—a sensor capable of measuring temperature of a contained medication (para. [0120, 0193]).
Regarding claim 3, the combination of Shavit and Thacher discloses the device of claim 1, and Shavit further discloses that the monitoring device (20) has, in addition to the first sensor (the sensor assembly is not limited to a single sensor, para. [0126, 0132]), one or two temperature sensors for measuring the temperature in the container (para. [0103, 0126]) and/or on the out- side of the container or in the vicinity of the container, and in that the processing device (23) is set up to process, in addition to the measurement data of the first sensor, also the measurement data of the temperature sensor(s) (25) for determining a temperature and/or a temperature profile (para. [0126]).
Regarding claim 5, the combination of Shavit and Thacher discloses the device of claim 1. Shavit further discloses the processing device (23) for determining a temperature (para. [0126]) and/or a temperature profile is arranged to determine and/or predict a rate of change of the temperature of the object or substance.
Regarding claim 8, the combination of Shavit and Thacher discloses the device of claim 1. Shavit further discloses that at least one boundary wall of the container (1) consists of a flexible material (para. [0122]), in particular when the container is designed as a bag.
Regarding claim 9, Shavit discloses a monitoring device (20) for a container (1) having a container space for storing an object or a substance (para. [0122-0123]), in particular a medication (para. [0123]), the monitoring device (20) comprising a first sensor (25) for detecting measurement data (para. [0126]) and a processing device (23) for determining the irradiation input and/or heat input and/or temperature (para/ [0126]) and/or a temperature profile of the object or the substance or of the container space using the detected measurement data, characterized in that the first sensor (25) is a sensor, in particular a semiconductor sensor (para. [0105]) or a thermopile.
However, Shavit fails to disclose the first sensor is a sensor for detecting electromagnetic radiation.
Thacher teaches a similar device the first sensor is a sensor for detecting electromagnetic radiation (para. [0193, 0200]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Shavit and incorporate the electromagnetic radiation sensor of Thacher with predictable results—a sensor capable of measuring temperature of a contained medication (para. [0120, 0193]).
Regarding claim 10, the combination of Shavit and Thacher discloses the device of claim 9. Shavit further discloses one or two temperature sensors (25, the sensor assembly is not limited to a single sensor, para. [0126, 0132]) and a processing device (23) connected thereto for determining the temperature (para. [0126]) and/or a temperature profile of the object or the substance or the container space using the detected measurement data, and in particular a self-learning device which is set up to continuously correlate, as a function of time, the measurement data of the radiation intensity and/or the measured temperature data and to determine therefrom rules for predicting a temperature profile or a period of time after which a determined amount of radiation has been absorbed by the object or substance.
However, Shavit fails to disclose a sensor for detecting radiation.
Thacher teaches a sensor for detecting radiation (para. [0193, 0200]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shavit and incorporate a radiation sensor of Thacher with predictable results—having another sensor capable of measuring temperature of a contained medication (para. [0120, 0193]).
Regarding claim 11, the combination of Shavit and Thacher discloses the monitoring device according to claim 9, and Shavit further discloses an energy supply device (battery) comprising an energy storage (para. [0099]) and/or a harvesting device for converting mechanical, thermal or radiation energy into electrical energy.
Regarding claim 12, the combination of Shavit and Thacher discloses the monitoring device according to claim 9, and Shavit further discloses a system with an injection device (para. [0028] describes the medication bags being used for vein transfusion, necessarily requires some form of injection, pump, or syringe), in particular a medication-delivering pump, a syringe or an injector pen, and in particular with a device for storing a medication for injection.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shavit (US 20170239404 A1) in view of Thacher (US 20190342947 A1), and in further view of Puolitaival et al. (US 20190133884 A1, hereafter “Puolitaival”).
The combination of Shavit and Thacher discloses the device of claim 1. However, the combination fails to disclose the processing device for determining a temperature and/or a temperature profile has a module which determines the exceeding of a predetermined threshold of irradiation absorbed by the object or substance or of the temperature or a rate of change of the temperature and/or in that the processing device for determining a temperature and/or a temperature profile is connected to an alarm module for generating an alarm signal.
Puolitaival teaches container for medication with the processing device (206) for determining a temperature (para. [0087, 0090]) and/or a temperature profile has a module which determines the exceeding of a predetermined threshold of irradiation absorbed by the object or substance or of the temperature (para. [0087, 0090])) or a rate of change of the temperature and/or in that the processing device for determining a temperature and/or a temperature profile is connected to an alarm module (208) for generating an alarm signal (para. [0087, 0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shavit and Thacher and incorporate the temperature alarm system of Puolitaival to notify a user that the temperature has exceeded a limit and requires some attention (para. [0072]).
Allowable Subject Matter
Claim 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 4, there is no art alone or in combination that discloses a processing device that determines either the irradiation input and/or temperature and/or a temperature profile and predicts a time period after which a determined amount of radiation as been absorbed by the object or substance and/or a temperature profile of the object or the substance or the container space. Simply put, no prior art that uses either temperature or an irradiation input to predict a time period the material absorbs a predetermined amount of radiation, and without art to rely on it would not have been an obvious modification of the processor in Shavit. Such a modification without support or a motivation to do so would not be obvious.
Regarding claim 7, there is no art alone or in combination that teaches a processing device that relates the measured data of the radiation intensity and the measured temperature data to one another as a function of time. Simply put, no prior art could be found where a processor relates those two parameters as a function of time, and it would not be obvious to have modified the processor to carry out such a function without a teaching to rely on. It is important to note that the use of self-learning in this claim is not what renders the claim allowable. Rather, implementing a self-learning device that forms rules is not a novel idea/implementation. For example, see para. [0029, 0040] of US 20060026210 A1 and para. [0014] of US 20090024408 A1 that use self-learning devices to make rules from various data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 29 January 2026