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 .
Supplemental Office Action
Please note that this Election/Restriction Requirement serves as a replacement for the previous Election/Restriction Requirement mailed out 11/19/25, which should be disregarded due to errors therein. Examiner issued Election/Restriction Requirement 11/19/25 under U.S. practice. The current applicant has been filed under PCT application and should be viewed as Lack of Unity of Invention.
The Applicant filed a Response to Election/Restriction on 01/15/26. However, due to an error in the previous Election/Restriction Requirement 11/19/25, the application is required to reelect one of the Groups I, II or III in accordance with the current office action. See below.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-8 & 20-26, drawn to a method for monitoring delivery of a drug.
Group II, claim(s) 9-16 & 27-33, drawn to a method for delivering a drug & a drug delivery system.
Group III, claim(s) 17-19, drawn to a method for characterizing a drug.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Group I, claims 1 & 20 requires that: determining, based on the measured capacitance, a volume of a drug in the fluid chamber; comparing the volume of the drug in the fluid chamber to a target volume; and in response to the volume of the drug in the fluid chamber being greater than the target volume, instructing a stopper actuator to expel at least a portion of the drug from the fluid chamber. These features do not include in the Groups II & III.
Group II, claims 9-16 & 27-33 requires that: determining a target capacitance for a drug dose; … comparing the measured capacitance to the target capacitance; and in response to the measured capacitance being greater than the target capacitance, instructing a stopper actuator to expel at least a portion of the drug from the fluid chamber. These features do not include in the Groups I & III.
Group III, claims 17-19 requires that: determining an expected capacitance across the pair of electrodes, the expected capacitance based on an expected volume of the drug in the container and an expected relative permittivity of the drug; comparing the measured capacitance to the expected capacitance; and in response to the measured capacitance being outside a tolerance threshold of the expected capacitance, outputting an alert. These features do not include in the Groups II & II.
Groups I, II & III lack unity of invention because the groups do not share the same or corresponding technical feature.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: none.
During a telephone conversation with attorney Gaspare J. Randazzo on 01/29/26 & 01/30/26, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8 & 20-26. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-19 & 27-33 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 & 20-26 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.
The limitation “comparing the volume of the drug in the fluid chamber to a target volume; and in response to the volume of the drug in the fluid chamber being greater than the target volume…” in claim 1 is vague. It is noted that the claim 20 contains same claimed limitation above, and therefore, the claim 20 is being rejected with the same analysis in claim 1. Let’s break down the analysis:
the recitation “volume of drug in the fluid chamber”, this refers to the actual amount of drug present in the fluid chamber at any given time. Meanwhile, the “target volume” is defined as the volume of drug remaining in the syringe after the dose has been delivered (see para [0096] of the original specification). Having said above, in other words, the “volume of drug in the fluid chamber” should be matched (or same value) with the “target volume”. Therefore, it is unclear to Examiner that how is possible that “the volume of the drug in the fluid chamber” being greater than the “target volume”?
The recitation “target volume” is broadest understood that that the system aims to dispense or a set dosage value. Examiner cannot be determined the meaning of claimed “target volume” whether be the definition in the para [0096] in the original spec (e.g., the volume of drug remaining in the syringe) or the amount of drug being dispensed (or set dosage value).
Claims 2-8 & 21-26 are being rejected due to their dependency.
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.
Claims 1, 4, 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (US 2009/0069756) in view of Fago et al. (US 2007/0250005).
Regarding claim 1, Larsen discloses a method for monitoring delivery of a drug, para [0010], the method comprising:
measuring a capacitance across a pair of electrodes (e.g. a first and second electrodes forming a capacitor in combination, the first and second electrodes being arranged on or integrated with the cartridge receiving portion, the handheld medication delivery device further comprising electronic control means adapted to measure a capacitance of the capacitor, and to associate an amount of medicament with a measured capacitance of said capacitor, para [0026]); the pair of electrodes arranged along either side of a container (e.g., the first and second electrodes being arranged on or integrated with the cartridge receiving portion, para [0026]), the container comprising an air chamber (area in back or right side of plunger 45, Fig. 8), a fluid chamber 48 (area in front or on the left side of the plunger 45, Fig. 8) and a stopper 45 separating the air chamber from the fluid chamber;
determining, based on the measured capacitance, a volume of a drug in the fluid chamber (para [0085], In addition, the electronic circuit is capable of determining the response from the capacitor and to convert the determined capacitance to a measure for the amount of medicament contained in the cartridge), also see paras [0068, 0071];
comparing the volume of the drug in the fluid chamber to a target volume (para [0086], determining the amount of medicament in the cartridge… measuring, in real time, the amount of medicament expelled in a given dose and comparing this measured value with the set dose, also see para [0088], a measure for a given dose expelled by the medication delivery device can be obtained by comparing the current amount of medicament contained in the cartridge with a previously stored amount); and
in response to the volume of the drug in the fluid chamber being greater than the target volume, instructing a stopper actuator to expel at least a portion of the drug from the fluid chamber (para [0089], … Such data may be used for dynamically monitoring the position of the piston during an injecting operation, e.g. for alerting the occurrence of a blocked needle).
Larsen fails to explicitly disclose instructing a stopper actuator to expel at least a portion of the drug from the fluid chamber.
Fago discloses an injector device and method comprising a step of an instructing a stopper actuator (plunger drive ram 46, Fig. 2) to expel at least a portion of the drug from the fluid chamber (para [0118] , … After an injection completes and there is 1 ml or less volume remaining in the syringe 28 the powerhead software may disable the injection).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method of Larsen with including a step of instructing a stopper actuator to expel at least a portion of the drug from the fluid chamber, as taught by Fago, in order to provide a safer, less stress disorder for the user, para [0005], improve the ease of its operation and to provide the injector at low cost, para [0016], as well as using the measured volume in the control of automated syringe by providing enable/disable function for a safer injection process and preventing waste of media, para [0007].
Regarding claim 4, Larsen in view of Fago discloses all the claimed subject matter as required. Larsen in view of Fago further discloses that: measuring a baseline volume of the drug in the fluid chamber prior to expelling the drug from the fluid chamber; and calculating the target volume based on the baseline volume (e.g., a measure for a given dose expelled by the medication delivery device can be obtained by comparing the current amount of medicament contained in the cartridge with a previously stored amount, para [0088]).
Regarding claim 20, Larsen discloses a drug delivery system comprising:
a syringe holder to hold a syringe (e.g. the mechanism for holding the cartridge comprises a separate cartridge holder in the form of an adapter partly of fully encompassing the cartridge, e.g., forming a disposable sub-assembly, para [0067]) containing a drug 48 (Fig. 8) for delivery to a patient,
the syringe comprising an air chamber (area in back or right side of plunger 45, Fig. 8), a fluid chamber 48 (area in front or on the left side of the plunger 45, Fig. 8) and a stopper 45 separating the air chamber from the fluid chamber; a stopper actuator (a plunger rod) couplable to the stopper;
a measurement circuit to measure a capacitance (a suitable electronic circuit is incorporated in the medication delivery device. This circuit is capable of providing a signal having an appropriate voltage level and an appropriate frequency to the electrodes via a pair of electrical connections. In addition, the electronic circuit is capable of determining the response from the capacitor and to convert the determined capacitance to a measure for the amount of medicament contained in the cartridge positioned between the arms of the medication delivery device, para [0068], also see para [0026]) across a pair of electrodes arranged along either side of the container (e.g., the arrangement comprising a cartridge receiving portion comprising a first and a second electrode forming a capacitor in combination, the first and second electrodes being arranged on or integrated with the cartridge receiving portion, see para [0026]); and
a processor to:
receive a measured capacitance from the measurement circuit (e.g. a first and second electrodes forming a capacitor in combination, the first and second electrodes being arranged on or integrated with the cartridge receiving portion, the handheld medication delivery device further comprising electronic control means adapted to measure a capacitance of the capacitor, and to associate an amount of medicament with a measured capacitance of said capacitor, para [0026]);
determine, based on the measured capacitance, a volume of the drug in the fluid chamber (para [0085], In addition, the electronic circuit is capable of determining the response from the capacitor and to convert the determined capacitance to a measure for the amount of medicament contained in the cartridge), also see paras [0068, 0071];
compare the volume of the drug in the fluid chamber to a target volume (para [0086], determining the amount of medicament in the cartridge… measuring, in real time, the amount of medicament expelled in a given dose and comparing this measured value with the set dose, also see para [0088], a measure for a given dose expelled by the medication delivery device can be obtained by comparing the current amount of medicament contained in the cartridge with a previously stored amount); and
in response to the volume of the drug in the fluid chamber being greater than the target volume, (e.g. measuring, in real time, the amount of medicament expelled in a given dose and comparing this measured value with the set dose, para [0086]); … Such data may be used for dynamically monitoring the position of the piston during an injecting operation, e.g. for alerting the occurrence of a blocked needle, para [0089]).
Larsen fails to explicitly disclose instructing a stopper actuator to expel at least a portion of the drug from the fluid chamber.
Fago discloses an injector device comprising a stopper actuator (plunger drive ram 46, Fig. 2) couplable to the stopper and to instruct the stopper actuator to expel at least a portion of the drug from the fluid chamber (the plunger drive ram 46 is driven by a motor to move in a forward or rearward motion along its longitudinal axis of symmetry 76 to deploy the plunger drive ram 46 and thus the syringe plunger 74 in a forward or rearward motion along the axis of symmetry 66 of the syringe 28 to inject fluid into a human or animal subject or fill the syringe 28 with fluid, respectively, para [0056], and a processor (the remote console 44 I includes a microprocessor having internal non-volatitle memory to store the software program and data constant, para [0210].
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Larsen with including the teaching of Fago, in order to provide a safer, less stress disorder for the user, para [0005], improve the ease of its operation and to provide the injector at low cost, para [0016], as well as using the measured volume in the control of automated syringe by providing enable/disable function for a safer injection process and preventing waste of media, para [0007].
Regarding claim 21, Larsen in view of Fago discloses all the claimed subject matter as required. Larsen further discloses that a voltage source generates a voltage applied to the pair of electrodes (e.g., a suitable electronic circuit is incorporated in the medication delivery device. This circuit is capable of providing a signal having an appropriate voltage level and an appropriate frequency. In addition, the electronic circuit is capable of determining the response from the capacitor and to convert the determined capacitance to a measure for the amount of medicament contained in the cartridge, para [00850]) to generate an electric field extending through at least a portion of the syringe (e.g. means for providing an electrical coupling to the medicament contained in the cartridge so that the electrically conducting layer forms a capacitor with the medicament contained in the replaceable cartridge, the medicament forming a virtual capacitor electrode of the capacitor, para [0033]).
Regarding claim 22, Larsen in view of Fago discloses all the claimed subject matter as required. 22. Larsen further discloses that a memory to store data characterizing the drug, the processor further configured to determine the volume of the drug based on the data (e.g., para [0088], The medication delivery device may further comprise electronic circuitry for calculating and storing amounts of the medicament contained in the cartridge along with previously stored amounts, such as to provide a measure of an expelled dose. The storage of such data may also comprise the corresponding time and date, e.g. determined by the end of an injecting operation. Further, a measure for a given dose expelled by the medication delivery device can be obtained by comparing the current amount of medicament contained in the cartridge with a previously stored amount.
Claims 2-3 & 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (US 2009/0069756) in view of Fago et al. (US 2007/0250005) and further in view of Novet (US 2020/0045162).
Regarding claim 2, Larsen in view of Fago discloses all the claimed subject matter as required. Larsen further discloses that: determining the volume of the drug in the fluid chamber based on a measurement (the medicament that is contained within the body of the cartridge functions as a dielectric between these electrodes so that the capacitance of the capacitor varies in accordance with the volume of the medicament between the electrodes, para [0065].
Larsen in view of Fago fails to disclose the limitations that: receiving a temperature measurement from a temperature sensor; determining the volume of the drug in the fluid chamber based on the temperature measurement, wherein a relative permittivity of sensor dielectric depends on temperature.
Novet discloses an apparatus and method related to capacitive sensing (see abstract) and receiving a temperature measurement from a temperature sensor (in an embodiment, the mobile device 120 can include one or more sensor configured to detect changes temperature and/or humidity, and can perform a housing calibration upon detection of the changes, para [0221); and determining a quantity (the interpretation of changes in capacitance, e.g., mapping of the changes in capacitance to one or more characteristic/context/action/inputs maybe done in various ways, para [0011], based on the temperature measurement. One such method includes receiving a first capacitive sensor measurement with a first capacitive sensor of the mobile device, see abstract. The calibration engine 730 serves to automatically adjust one or more aspects of the environment sense controller 250, to environmental conditions that have an effect on the ambient levels of the sensor 255 (Figs. 2-4). In various embodiment, the output levels of the capacitance sensor 255 can be sensitive to temperature, humidity, para [0142].
For example, user interaction can create moisture on the sensor 255, causing the new sensor ambient value to be different from the expected value. In an embodiment, the calibration engine 730 can automatically force a recalibration internally, para [0162];
wherein the relative permittivity of sensor dielectric depends on temperature (e.g., para [0221], In an embodiment, the mobile device 120 can be housed in a material (such as plastic) having a dielectric constant that can vary due to changes in, for example, temperature and humidity. In an embodiment, the mobile device 120 can include one or more sensors configured to detect changes in temperature and/or humidity and can perform a housing calibration upon detection of the changes).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method and device of Larsen in view of Fago with the teaching of Novet, for purpose of calibrating a capacitive sensor for temperature and humidity to make the capacitive sensor more accurate over a wider range of environmental condition, para [0222] in Novet.
Regarding claim 3, Larsen in view of Fago discloses all the claimed subject matter as required. Larsen further discloses that: determining the volume of the drug in the fluid chamber based on a measurement (the medicament that is contained within the body of the cartridge functions as a dielectric between these electrodes so that the capacitance of the capacitor varies in accordance with the volume of the medicament between the electrodes, para [0065].
Larsen in view of Fago fails to explicitly disclose the limitations that: receiving a humidity measurement from a humidity sensor; and determining the volume of the drug in the fluid chamber based on the humidity measurement, wherein a relative permittivity of sensor dielectric depends on humidity.
Novet discloses an apparatus and method related to capacitive sensing (see abstract) and receiving a humidity measurement from a humidity sensor (in an embodiment, the mobile device 120 can include one or more sensor configured to detect changes temperature and/or humidity, and can perform a housing calibration upon detection of the changes, para [0021); and determining based on the humidity measurement (One such method includes receiving a first capacitive sensor measurement with a first capacitive sensor of the mobile device, see abstract. For example, user interaction can create moisture on the sensor 255, causing the new sensor ambient value to be different from the expected value. In an embodiment, the calibration engine 730 can automatically force a recalibration internally, para [0162];
wherein the relative permittivity of sensor dielectric depends on temperature (e.g., para [0221], In an embodiment, the mobile device 120 can be housed in a material (such as plastic) having a dielectric constant that can vary due to changes in, for example, temperature and humidity. In an embodiment, the mobile device 120 can include one or more sensors configured to detect changes in temperature and/or humidity and can perform a housing calibration upon detection of the changes).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method and device of Larsen in view of Fago with the teaching of Novet, for purpose of calibrating a capacitive sensor for temperature and humidity to make the capacitive sensor more accurate over a wider range of environmental condition, para [0222] in Novet.
Regarding claim 23, Larsen in view of Fago discloses all the claimed subject matter as required. Larsen further discloses that: determining the volume of the drug (e.g., para [0026], … a first and a second electrode forming a capacitor in combination, the first and second electrodes being arranged on or integrated with the cartridge receiving portion, the handheld medication delivery device further comprising electronic control means adapted to measure a capacitance of said capacitor, and to associate an amount of medicament with a measured capacitance of said capacitor) in the fluid chamber 48 based on a measurement (e.g., para [0065], the medicament that is contained within he body of the cartridge functions as a dielectric between these electrodes so that the capacitance of the capacitor varies in accordance with the volume of medicament between the electrodes).
Larsen in view of Fago fails to disclose that a temperature sensor to measure a temperature, the processor further configured to determine the volume of the drug in the fluid chamber based on a temperature measurement received from the temperature sensor, wherein a relative permittivity of sensor dielectric depends on temperature.
Novet discloses an apparatus related to capacitive sensing (see abstract) and teaches further the comprising: a temperature sensor to measure a temperature (in an embodiment, the mobile device 120 can include one or more sensor configured to detect changes temperature and/or humidity, and can perform a housing calibration upon detection of the changes, para [0221]); the processor 215 (Fig. 2) can configure the environment sense controller 250 to perform one or more environmental measurements using at least one sensor 255, para [0169]) further configured to determine a quantity based on a temperature measurement received from the temperature sensor (e.g., one such method includes receiving a first capacitive sensor measurement with a first capacitive sensor of the mobile device, see Abstract; the calibration engine 730 serves to automatically adjust one or more aspects of the environment sense controller 250, to environmental conditions that have an effect on the ambient levels of the sensors 255 (Figs. 2-4). In various embodiment, the outplet levels of the capacitance sensors 255 can be sensitive to temperature, humidity, para [0142]; For example: user interaction can create moisture on the sensor 255, causing the new sensor ambient value to be different from the expected value. In an embodiment, the calibration engine 730 can automatically force a recalibration internally, para [0162]; wherein a relative permittivity of sensor dielectric depends on temperature. In an embodiment, the mobile device 120 can be housed in a material such as plastic, having a dielectric constant that can vary due to changes in, for example, temperature and humidity. In an embodiment, the mobile device 120 can include one or more sensors configured to detect changes in temperature and/or humidity and can perform a housing calibration upon detection of the changes, para [0221]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Larsen in view of Fago with the teaching of Novet, for purpose of calibrating a capacitive sensor for temperature and humidity (para [0222] in Novet) and using a processor to allow efficient data gathering and coordination of multiple sensors, para [0119] in Novet.
Regarding claim 24, Larsen in view of Fago discloses all the claimed subject matter as required. Larsen further discloses that: determining the volume of the drug (a first and second electrode forming a capacitor in combination, the first and second electrodes being arranged on or integrated with the cartridge receiving portion, the handheld medication delivery device further comprising electronic control means adapted to measure a capacitance of said capacitor, and to associated an amount of medicament with measured capacitance of said capacitor, para [0026]) in the fluid chamber 48 (in the cartridge 46, Fig. 8) based on a measurement (the medicament that is contained within the body of the cartridge functions as a dielectric between these electrodes so that the capacitance of the capacitor varies in accordance with the volume of the medicament between the electrodes, para [0065]).
Larsen in view of Fago fails to disclose the limitation that: a humidity sensor to measure a humidity, the processor further configured to determine the volume of the drug in the fluid chamber based on a humidity measurement received from the humidity sensor, wherein a relative permittivity of sensor dielectric depends on humidity.
Novet discloses an apparatus and method related to capacitive sensing (see abstract) and receiving a humidity measurement from a humidity sensor (in an embodiment, the mobile device 120 can include one or more sensor configured to detect changes temperature and/or humidity, and can perform a housing calibration upon detection of the changes, para [0021);
A processor 215 (can configured the environment sense controller 250 (Fig. 2) to perform one or more environmental measurement suing at least one sensor 255, para [0169]) further configured to determine the volume of the drug in the fluid chamber based on a humidity measurement received from the humidity sensor (One such method includes receiving a first capacitive sensor measurement with a first capacitive sensor of the mobile device, see abstract. For example, user interaction can create moisture on the sensor 255, causing the new sensor ambient value to be different from the expected value. In an embodiment, the calibration engine 730 can automatically force a recalibration internally, para [0162]);
wherein the relative permittivity of sensor dielectric depends on humidity (e.g., para [0221], In an embodiment, the mobile device 120 can be housed in a material (such as plastic) having a dielectric constant that can vary due to changes in, for example, temperature and humidity. In an embodiment, the mobile device 120 can include one or more sensors configured to detect changes in temperature and/or humidity and can perform a housing calibration upon detection of the changes).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Larsen in view of Fago with the teaching of Novet, for purpose of calibrating a capacitive sensor for temperature and humidity (para [0222] in Novet) and using a processor to allow efficient data gathering and coordination of multiple sensors, para [0119] in Novet.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783