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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation “the inhalation device is configured to open a blister of a blister strip in response to the mouthpiece cover being moved from the closed position to the open position to expose the mouthpiece, wherein each blister of the blister strip comprises a dose of medicament” (claim 10, lines 1-4) and “the inhalation device is configured to open a blister of a blister strip in response to the mouthpiece cover being moved from the closed position to the open position to expose the mouthpiece, wherein each blister of the blister strip comprises a dose of medicament” (claim 14, lines 1-4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because all of the outlines of the figures in figs. 1-5D and the inhaler “302” in fig. 8 are faded. Every line must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well-defined. Additionally, the weight of all lines must be heavy enough to permit adequate reproduction. See 37 C.F.R. 1.84(l).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, (i.e., the term “comprising” in line 3 of the abstract). Correction is required. See MPEP § 608.01(b).
Claim Objections
Claims 1, 5-6, 11 and 15-18 are objected to because of the following informalities:
In claim 1, line 2, the term “computer-readable storage medium” is suggested to be changed to --non-transitory computer-readable storage medium-- in order to clarify the claim that the applicant intends on claiming a non-transitory computer-readable storage medium.
In claim 1, line 11, the term “computer-readable storage medium” is suggested to be changed to --non-transitory computer-readable storage medium-- in order to clarify the claim that the applicant intends on claiming a non-transitory computer-readable storage medium.
In claim 5, lines 4-5, the term “computer-readable storage medium” is suggested to be changed to --non-transitory computer-readable storage medium-- in order to clarify the claim that the applicant intends on claiming a non-transitory computer-readable storage medium.
In claim 6, lines 4-5, the term “computer-readable storage medium” is suggested to be changed to --non-transitory computer-readable storage medium-- in order to clarify the claim that the applicant intends on claiming a non-transitory computer-readable storage medium.
In claim 11, line 12, the term “computer-readable storage medium” is suggested to be changed to --non-transitory computer-readable storage medium-- in order to clarify the claim that the applicant intends on claiming a non-transitory computer-readable storage medium.
In claim 15, line 3, the term “computer-readable storage medium” is suggested to be changed to --non-transitory computer-readable storage medium-- in order to clarify the claim that the applicant intends on claiming a non-transitory computer-readable storage medium.
In claim 16, line 6, the term “computer-readable storage medium” is suggested to be changed to --non-transitory computer-readable storage medium-- in order to clarify the claim that the applicant intends on claiming a non-transitory computer-readable storage medium.
In claim 17, lines 4-5, the term “computer-readable storage medium” is suggested to be changed to --non-transitory computer-readable storage medium-- in order to clarify the claim that the applicant intends on claiming a non-transitory computer-readable storage medium.
In claim 18, lines 2 and 13, the term “computer-readable storage medium” is suggested to be changed to --non-transitory computer-readable storage medium-- in order to clarify the claim that the applicant intends on claiming a non-transitory computer-readable storage medium.
Appropriate correction is required.
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.
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.
Claims 1-3, 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Morrison (WO 2016/033419) in view of Biswas et al (US 2016/0144141 A1) and Samson (2016/0325058).
Regarding claim 1, Morrison discloses a system comprising a computer-readable storage medium residing on an external device (see smart phone in page 12, lines 20-37, page 18, lines 18-25, a smartphone would be an external device and would have a memory (computer-readable storage medium) in order to receive data from the inhalation device); and an inhalation device (inhalers 700, 800, 700, 1100 and 1200 in figs. 7A-13C) comprising: a mouthpiece (770, 870, 970, figs. 7A-9, see page 14, line 32 to page 15, line 37), a mouthpiece cover (780, 880, 980, figs. 7A-9 and page 14, line 32 to page 15, line 37), and medicament (page 1, lines 5-8), wherein the mouthpiece cover is configured to move from a closed position to an open position to expose the mouthpiece (figs. 7A-9 and page 14, line 32 to page 15, line 37); an electronics module (750, 850 and 950, see figs. 7A-9) comprising a processor, sensor (page 14, line 32 to page 15, line 37, see pressure sensor and processor and transmitter) and wireless communication circuit (page 14, line 32 to page 15, line 37, Morrison discloses transmitter and further discloses in page 12, line 20 to page 13, line 2, that the transmitter allows wireless communication), wherein the processor of the electronics module is configured to generate a usage event based on feedback from the sensor (see page 6, line 22 to page 7, line 6 and page 13, line 19 to page 14, line 29 and page 16, lines 4-11 and page 18, line 26 to page 19, line 8, Morrison discloses that pressure sensor can be used to determine compliance including use of the inhalation device and notification can be provided when a particular condition is met or not met, such notification includes that the mouthpiece is opened and a dose has been fully completed) and that the inhaler is configured to send information to the smart phone (page 12, lines 20-37, page 18, lines 18-25 and full disclosure), but fails to specifically disclose sending the usage event to the external device wherein the computer-readable storage medium comprises computer-executable instructions, that when executed by a processor of the external device cause the processor of the external device to: receive the usage event from the inhalation device; determine that a number of usage events exceeds a predetermined number of events for a set time period; and provide a notification to the user of an overuse event based on the determination that the number of usage events exceeded the predetermined number for the set time period.
PNG
media_image1.png
1087
865
media_image1.png
Greyscale
However, Biswas teaches a system (see Figure 3, inhaler 18 and personal mobile device (smart phone), see paragraphs 0070-0071) comprising: a computer-readable storage medium residing on an external device (25, see Figure 10, mobile app and cloud computing system, there would be a computer-readable storage medium); and an inhalation device (inhaler 18 shown in fig. 3) comprising a mouthpiece (see the annotated-Biswas fig. 3 above), medicament (see paragraph 0036, Biswas discloses inhaler medicine), and an electronics module (1, electronic cap) comprising a processor (10, microcontroller), a sensor (8, fig. 5, paragraphs 0059-0073), and wireless communication circuit (11, fig. 5, paragraphs 0070-0071); wherein the inhalation device is configured to prepare a dose of medicament for delivery to a user (see paragraphs 0029 and 0067, Biswas discloses delivering a medication, therefore, the inhalation device is configured to prepare a dose of medicament for delivery to a user), and wherein the electronics module is configured to generate usage events based on usage of the inhalation device by the user and feedback from the sensor (see paragraphs 0027 and 0066, Biswas discloses that the flow sensors can also confirm whether the medication was dumped outside or actually inhaled by a patient), Biswas further teaches that the computer-readable storage medium comprises computer-executable instruction that, when executed by a processor of the external device cause the processor of the external device to receive the usage event from the inhalation device and provide notification to the user (see paragraphs 0066-0075 of Biswas, Biswas discloses that the data and information are sent to the care giver for viewing via the external device, a mobile device would have a storage medium that has instruction, and when executed by a processor of the external device would receive usage event from the inhalation device).
Therefore, 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 inhalation device and the external device of Morrison to have the external device of Morrison configured to receive usage data of Morrison and Biswas and provide notification to the user based on the usage data as taught by Biswas for the purpose of improving compliance by allowing the user or a third party to view the usage data (see paragraphs 0066-0075 of Biswas).
After the modification, usage events are being transmitted to the external device and can be viewed on the external device, this usage events including usage event of Biswas that is based on pressure sensor detecting inhalation of the user (see paragraphs 0027 and 0065-0066 of Biswas, Biswas discloses that the flow sensor (pressure sensor) can also confirm whether the medication was dumped outside or actually inhaled by a patient). The modified Morrison fails to disclose that the processor of the external device configured to determine that a number of usage events exceeds a predetermined number of events for a set time period; and provide a notification to the user of an overuse event based on the determination that the number of usage events exceeded the predetermined number for the set time period.
However, Samson teaches an inhaler (14, fig. 1, paragraph 0037) having an electronics module (sensor 154, 155 and processor 150 and output device 162, fig. 4, paragraph 0106) that is configured to determine that a number of usage events exceeds a predetermine number of events for a set time period, and provide a notification to the user of an overuse event (see paragraph 0145, Samson discloses that the processor 170 may continue to receive actuation information (270), if the number of actuations exceed the predetermined threshold, a processor 170 may generate an alert for display to a user, wherein the alert is considered as an overuse event).
Therefore, 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 electronics module of the modified Morrison to utilize the number of usage events of the modified Morrison such that when the usage events exceeds a predetermined number of events for a set time period, provide a notification to the user of an overuse event as taught by Samson or alternatively for to modify the electronics module of the modified Morrison to utilize the number of actuations as usage events and when the number of actuations exceed a predetermined number of events for a set period of time, provide a notification to the user of an overuse event as taught by Samson for the purpose of preventing overdose, thereby providing safety to the user (see paragraphs 0106 and 0145 of Samson).
After the modification, usage event are being transmitted to the external device and can be viewed on the external device, this usage event including usage event of Biswas that is based on pressure sensor detecting inhalation of the user (see paragraphs 0027 and 0065-0066 of Biswas, Biswas discloses that the flow sensor (pressure sensor) can also confirm whether the medication was dumped outside or actually inhaled by a patient) is being used to determine when the usage event would exceed a predetermined number to determine an overuse event as taught by Samson, or alternatively, the number of actuation of Samson is the usage event that is being used to determine of an overuse event as taught by Samson.
Regarding claim 2, the modified Morrison discloses that the medicament is a rescue medicament (see page 19, line 25 to page 20, line 4 of Morrison, see rescue inhaler, which would have a rescue medicament), but fails to disclose that the set time period is twenty four hours and the predetermined number is eight.
However, the feature of choosing the set time period to be twenty-four-hours and the predetermined number being eight is considered as an obvious treatment design choice since it is based on the manufacturer and doctor’s determination on what set time period and what predetermined number can be used to determine an overuse event for the rescue medicament since it is based on the patient’s needs, severity, and the dosage being used.
Regarding claim 3, the modified Morrison discloses that the medicament is a rescue medicament (see page 19, line 25 to page 20, line 4 of Morrison, see rescue inhaler, which would have a rescue medicament), but fails to disclose that the set time period is twenty four hours and the predetermined number is twelve.
However, the feature of choosing the set time period to be twenty-four-hours and the predetermined number being twelve is considered as an obvious treatment design choice since it is based on the manufacturer and doctor’s determination on what set time period and what predetermined number can be used to determine an overuse event for the rescue medicament since it is based on the patient’s needs, severity, and the dosage being used. Regarding claim 7, the modified Morrison discloses that the sensor comprises a pressure sensor (page 14, line 32 to page 15, line 37 of Morrison, see pressure sensor, after the modification with Biswas and Samson, the pressure sensor can be utilized to determine a usage exceeding a predetermine number to determine an overuse event).
Regarding claim 9, the modified Morrison discloses that the inhalation device is configured to both prepare a dose of medicament for delivery to the user and cause the processor to transition between power states when the mouthpiece cover is moved from a closed position to an open position to expose the mouthpiece (see page 16, lines 4-11 of Morrison, the opening of the mouthpiece cover opens to prime the inhaler for dosing, furthermore, Morrison discloses in page 14, line 32 to page 16, line 3 that the PCB is powered on when the mouthpiece cover is open in order to conserve battery power).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Morrison (WO 2016/033419) in view of Biswas et al (US 2016/0144141 A1) and Samson (2016/0325058) as applied to claim 1 above, and further in view of Levy (2010/0094099).
Regarding claim 4, the modified Morrison discloses that the medicament is a rescue medicament (see page 19, line 25 to page 20, line 4 of Morrison, see rescue inhaler, which would have a rescue medicament), but fails to specifically disclose that the medicament is a maintenance medicament.
However, Levy teaches an inhaler comprising a maintenance medicament (see claim 16 and paragraphs 0009, 0072, 0111, see maintenance medication).
Therefore, 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 medicament of the modified Morrison to be a maintenance medicament as taught by Levy for the purpose of utilizing a smart inhaler to dispense a well-known drug that is effective for preventing symptoms and asthma attacks to the patient and that would provide relief to a patient in need of such drug.
After the modification with Levy, the modified Morrison fails to disclose that the set time period is twenty four hours and the predetermined number is two.
However, the feature of choosing the set time period to be twenty-four-hours and the predetermined number being two is considered as an obvious treatment design choice since it is based on the manufacturer and doctor’s determination on what set time period and what predetermined number can be used to determine an overuse event for the maintenance medicament since it is based on the patient’s needs, severity, and the dosage being used.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Morrison (WO 2016/033419) in view of Biswas et al (US 2016/0144141 A1) and Samson (2016/0325058) as applied to claim 1 above, and further in view of Burns (5,284,133).
Regarding claim 8, the modified Morrison discloses that the pressure sensor can be used to determine usage event (inhalations) including usage event that indicate an overuse event (see the modification of Biswas with Samson) and in the alternative, the actuation sensor of Samson can be the sensor being used to determine a number of usage event (actuation of Samson) is exceeding a predetermine number (for purpose of the modification in the rejection to claim 8, the alternative modification with Samson is being used), but fails to disclose that the sensor is an acoustic or an optical sensor.
However, Burns teaches an optical sensor used to determine usage event (see sensor 144 and 146, fig. 4B, col 10, lines 20-27 and col 11, line 48 to col 12, line 2).
Therefore, 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 sensor to determine the overuse event of the modified Morrison to use an optical sensor as a means to detect when the user actuate the inhalation device as taught by Burns for the purpose of providing an alternative sensor that can detect when the user actuate the inhalation device.
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (2010/0059052) in view of Biswas et al (US 2016/0144141 A1) and Samson (2016/0325058).
Regarding claim 1, Davies discloses an inhalation device (see entire inhalation device in figs. 1-6C) comprising a mouthpiece (281, figs. 4g-5b, paragraphs 0146-0147), a mouthpiece cover (286, figs. 4i-6c, paragraphs 0144-0145), wherein the mouthpiece cover is configured to move from a closed position to an open position to expose the mouthpiece (see figs. 4j-6c), the inhalation device is configured to open a blister of a blister strip (blister strip 100 in fig. 1, paragraphs 0097-0098, as shown, the strip 100 comprising a blister formed by pocket 102) in response to the mouthpiece cover being moved from the closed position to the open position to expose the mouthpiece, wherein each blister of the blister strip comprises a dose of medicament (see paragraphs 0061-0071 and 0151-0159 and 0161-0166), but fails to disclose a system comprising: a computer-readable storage medium residing on an external device; and an inhalation device comprising: an electronics module comprising a processor, sensor, and wireless communication circuit, wherein the processor of the electronics module is configured to: generate a usage event based on movement of the mouthpiece cover from the closed position to the open position or based on feedback from the sensor; and send the usage event to the external device; wherein the computer-readable storage medium comprises computer-executable instructions that, when executed by a processor of the external device cause the processor of the external device to: receive the usage event from the inhalation device; determine that a number of usage events exceeds a predetermined number of events for a set time period; and provide a notification to the user of an overuse event based on the determination that the number of usage events exceeded the predetermined number for the set time period.
However, Biswas teaches a system comprising: a computer-readable storage medium residing on an external device (25, see Figure 10, mobile app and cloud computing system, there would be a computer-readable storage medium); and an inhalation device (Biswas discloses that the inhaler can be the inhaler in fig. 1 or DPI inhaler in fig. 13, see paragraphs 0036 and 0059), an electronics module (1, electronic cap) comprising a processor (10, microcontroller), a sensor (8 in fig. 5 and paragraphs 0059-0073, however, for diskus DPI type of device, the pressure sensor is 208 in fig. 13 and paragraph 0059), and wireless communication circuit (11, fig. 5, paragraphs 0070-0071); wherein the inhalation device is configured to prepare a dose of medicament for delivery to a user (see paragraphs 0029 and 0067, Biswas discloses delivering a medication, therefore, the inhalation device is configured to prepare a dose of medicament for delivery to a user), and wherein the electronics module is configured to generate usage events based on usage of the inhalation device by the user and feedback from the sensor (see paragraphs 0027 and 0066, Biswas discloses that the flow sensors can also confirm whether the medication was dumped outside or actually inhaled by a patient), Biswas further teaches that the computer-readable storage medium comprises computer-executable instruction that, when executed by a processor of the external device cause the processor of the external device to receive the usage event from the inhalation device and provide notification to the user (see paragraphs 0066-0075 of Biswas, Biswas discloses that data and information are sent to the care giver for viewing via the external device, a mobile device would have a storage medium that has instruction, and when executed by a processor of the external device would receive usage event from the inhalation device).
Therefore, 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 inhalation device of Davies to be part of a system and to comprise the electronics module comprising sensor and processor and the external device as taught by Biswas for the purpose of improving compliance by allowing the user or a third party to view compliance and usage data and events (see paragraphs 0066-0075 of Biswas).
After the modification, usage data/events are being transmitted to the external device and can be viewed on the external device. The modified Davies fails to disclose that the processor of the external device configured to determine that a number of usage events exceeds a predetermined number of events for a set time period; and provide a notification to the user of an overuse event based on the determination that the number of usage events exceeded the predetermined number for the set time period.
However, Samson teaches an inhaler (14, fig. 1, paragraph 0037) having an electronics module (sensor 154, 155 and processor 150 and output device 162, fig. 4, paragraph 0106) that is configured to determine that a number of usage events exceeds a predetermine number of events for a set time period, and provide a notification to the user of an overuse event (see paragraph 0145, Samson discloses that the processor 170 may continue to receive actuation information (270), if the number of actuations exceed the predetermined threshold, a processor 170 may generate an alert for display to a user, wherein the alert is considered as an overuse event).
Therefore, 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 electronics module of the modified Davies to utilize the number of usage events of the modified Davies such that when the usage events exceeds a predetermined number of events for a set time period, provide a notification to the user of an overuse event as taught by Samson for the purpose of preventing overdose, thereby providing safety to the user (see paragraphs 0106 and 0145 of Samson).
Regarding claim 10, the modified Davies discloses the inhalation device is configured to open a blister of a blister strip (blister strip 100 in fig. 1, paragraphs 0097-0098 of Davies, as shown, the strip 100 comprising a blister formed by pocket 102) in response to the mouthpiece cover being moved from the closed position to the open position to expose the mouthpiece, wherein each blister of the blister strip comprises a dose of medicament (see paragraphs 0061-0071 and 0151-0159 and 0161-0166 of Davies).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Morrison (WO 2016/033419) in view of Biswas et al (US 2016/0144141 A1) and Samson (2016/0325058).
Regarding claim 18, Morrison discloses a system comprising a computer-readable storage medium residing on an external device (see smart phone in page 12, lines 20-37, page 18, lines 18-25, a smartphone would be an external device and would have a memory (computer-readable storage medium) in order to receive data from the inhalation device); and an inhalation device (inhalers 700, 800, 700, 1100 and 1200 in figs. 7A-13C) comprising: a mouthpiece (770, 870, 970, figs. 7A-9, see page 14, line 32 to page 15, line 37), a mouthpiece cover (780, 880, 980, figs. 7A-9 and page 14, line 32 to page 15, line 37), and medicament, wherein the medicament is configured to treat asthma (page 1, lines 5-8, see page 19, line 25 to page 20, line 4, Morrison discloses a rescue inhaler for used during an asthma attack, which would have a rescue medicament), wherein the mouthpiece cover is configured to move from a closed position to an open position to expose the mouthpiece (figs. 7A-9 and page 14, line 32 to page 15, line 37); an electronics module (750, 850 and 950, see figs. 7A-9) comprising a processor, sensor (page 14, line 32 to page 15, line 37, see pressure sensor and processor and transmitter) and wireless communication circuit (page 14, line 32 to page 15, line 37, Morrison discloses transmitter and further discloses in page 12, line 20 to page 13, line 2, that the transmitter allows wireless communication), wherein the processor of the electronics module is configured to generate a usage event based on feedback from the sensor (see page 6, line 22 to page 7, line 6 and page 13, line 19 to page 14, line 29 and page 16, lines 4-11 and page 18, line 26 to page 19, line 8, Morrison discloses that pressure sensor can be used to determine compliance including use of the inhalation device and notification can be provided when a particular condition is met or not met, such notification includes that the mouthpiece is opened and a dose has been fully completed) and that the inhaler is configured to send information to the smart phone (page 12, lines 20-37, page 18, lines 18-25 and full disclosure), but fails to specifically disclose sending the usage event to the external device wherein the computer-readable storage medium comprises computer-executable instructions, that when executed by a processor of the external device cause the processor of the external device to: receive the usage event from the inhalation device; determine that a number of usage events exceeds a predetermined number of events for a set time period; and provide a notification to the user of an overuse event based on the determination that the number of usage events exceeded the predetermined number for the set time period.
However, Biswas teaches a system (see Figure 3, inhaler 18 and personal mobile device, see paragraphs 0070-0071) comprising: a computer-readable storage medium residing on an external device (25, see Figure 10, mobile app and cloud computing system, there would be a computer-readable storage medium); and an inhalation device (inhaler 18 shown in fig. 3) comprising a mouthpiece (see the annotated-Biswas fig. 3 above), medicament (see paragraph 0036, Biswas discloses inhaler medicine), and an electronics module (1, electronic cap) comprising a processor (10, microcontroller), a sensor (8, fig. 5, paragraphs 0059-0073), and wireless communication circuit (11, fig. 5, paragraphs 0070-0071); wherein the inhalation device is configured to prepare a dose of medicament for delivery to a user (see paragraphs 0029 and 0067, Biswas discloses delivering a medication, therefore, the inhalation device is configured to prepare a dose of medicament for delivery to a user), and wherein the electronics module is configured to generate usage events based on usage of the inhalation device by the user and feedback from the sensor (see paragraphs 0027 and 0066, Biswas discloses that the flow sensors can also confirm whether the medication was dumped outside or actually inhaled by a patient), Biswas further teaches that the computer-readable storage medium comprises computer-executable instruction that, when executed by a processor of the external device cause the processor of the external device to receive the usage event from the inhalation device and provide notification to the user (see paragraphs 0066-0075 of Biswas, Biswas discloses that the data and information are sent to the care giver for viewing via the external device, a mobile device would have a storage medium that has instruction, and when executed by a processor of the external device would receive usage event from the inhalation device).
Therefore, 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 inhalation device and the external device of Morrison to have the external device of Morrison configured to receive usage data of Morrison and Biswas and provide notification to the user based on the usage data as taught by Biswas for the purpose of improving compliance by allowing the user or a third party to view the usage data (see paragraphs 0066-0075 of Biswas).
After the modification, usage events are being transmitted to the external device and can be viewed on the external device, this usage events including usage event of Biswas that is based on pressure sensor detecting inhalation of the user (see paragraphs 0027 and 0065-0066 of Biswas, Biswas discloses that the flow sensor (pressure sensor) can also confirm whether the medication was dumped outside or actually inhaled by a patient). The modified Morrison fails to disclose that the processor of the external device configured to determine that a number of usage events exceeds a predetermined number of events for a set time period; and provide a notification to the user of an overuse event based on the determination that the number of usage events exceeded the predetermined number for the set time period.
However, Samson teaches an inhaler (14, fig. 1, paragraph 0037) having an electronics module (sensor 154, 155 and processor 150 and output device 162, fig. 4, paragraph 0106) that is configured to determine that a number of usage events exceeds a predetermine number of events for a set time period, and provide a notification to the user of an overuse event (see paragraph 0145, Samson discloses that the processor 170 may continue to receive actuation information (270), if the number of actuations exceed the predetermined threshold, a processor 170 may generate an alert for display to a user, wherein the alert is considered as an overuse event).
Therefore, 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 electronics module of the modified Morrison to utilize the number of usage events of the modified Morrison such that when the usage events exceeds a predetermined number of events for a set time period, provide a notification to the user of an overuse event as taught by Samson or alternatively for to modify the electronics module of the modified Morrison to utilize the number of actuations as usage events and when the number of actuations exceed a predetermined number of events for a set period of time, provide a notification to the user of an overuse event as taught by Samson for the purpose of preventing overdose, thereby providing safety to the user (see paragraphs 0106 and 0145 of Samson).
After the modification, usage event are being transmitted to the external device and can be viewed on the external device, this usage event including usage event of Biswas that is based on pressure sensor detecting inhalation of the user (see paragraphs 0027 and 0065-0066 of Biswas, Biswas discloses that the flow sensor (pressure sensor) can also confirm whether the medication was dumped outside or actually inhaled by a patient) is being used to determine when the usage event would exceed a predetermined number to determine an overuse event as taught by Samson, or alternatively, the number of actuation of Samson is the usage event that is being used to determine of an overuse event as taught by Samson.
Regarding claim 19, the modified Morrison discloses that the medicament is a rescue medicament (see page 19, line 25 to page 20, line 4 of Morrison, see rescue inhaler, which would have a rescue medicament), but fails to disclose that the set time period is twenty four hours and the predetermined number is eight or twelve.
However, the feature of choosing the set time period to be twenty-four-hours and the predetermined number being eight or twelve is considered as an obvious treatment design choice since it is based on the manufacturer and doctor’s determination on what set time period and what predetermined number can be used to determine an overuse event for the rescue medicament since it is based on the patient’s needs, severity, and the dosage being used.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Morrison (WO 2016/033419) in view of Biswas et al (US 2016/0144141 A1) and Samson (2016/0325058) as applied to claim 18 above, and further in view of Levy (2010/0094099).
Regarding claim 20, the modified Morrison discloses that the medicament is a rescue medicament (see page 19, line 25 to page 20, line 4 of Morrison, see rescue inhaler, which would have a rescue medicament), but fails to specifically disclose that the medicament is a maintenance medicament.
However, Levy teaches an inhaler comprising a maintenance medicament (see claim 16 and paragraphs 0009, 0072, 0111, see maintenance medication).
Therefore, 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 medicament of the modified Morrison to be a maintenance medicament as taught by Levy for the purpose of utilizing a smart inhaler to dispense a well-known drug that is effective for preventing symptoms and asthma attacks to the patient and that would provide relief to a patient in need of such drug.
After the modification with Levy, the modified Morrison fails to disclose that the set time period is twenty four hours and the predetermined number is two.
However, the feature of choosing the set time period to be twenty-four-hours and the predetermined number being two is considered as an obvious treatment design choice since it is based on the manufacturer and doctor’s determination on what set time period and what predetermined number can be used to determine an overuse event for the maintenance medicament since it is based on the patient’s needs, severity, and the dosage being used.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,357,935.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claim and the patented claim are minor and obvious from each other. For example, the instant claim 1 is a broader version of the patented claim 4 (i.e., the instant claim 1 does not include the electronics module or the external device is configured to generate a multiple error event notification in response to a determination that a number of good inhalation events over a predetermined period of time is less than a predetermined number of good inhalation events as in the patented claim 4). In the instant claim 1, the system is included in the patented claim 4. Any infringement over the patented claim would also infringe over the instant claim. Therefore, the instant claim 1 does not differ in scope from the patented claim 4.
Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 2-3 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,357,935 in view of Levy (2010/0094099).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the patented claim are minor and obvious from each other. For example, the instant claims 2-3 are a broader version of the patented claim 4 (i.e., the instant claims 2-3 do not include the electronics module or the external device is configured to generate a multiple error event notification in response to a determination that a number of good inhalation events over a predetermined period of time is less than a predetermined number of good inhalation events as in the patented claim 4). In the instant claims 2-3, the system is included in the patented claim 4. Any infringement over the patented claim would also infringe over the instant claim. Therefore, the instant claims 2-3 do not differ in scope from the patented claim 4.
Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
With respect to the additional features recited in claims 2-3, patented claim 4 fails to recite the inclusion of the medicament is a rescue medicament and the set time period is twenty-four-hours, and the predetermined number is eight and twelve.
However, Levy teaches an inhaler comprising a rescue medicament (see claim 16 and paragraphs 0009, 0072, 0111, see rescue medication and rescue inhaler).
Therefore, 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 medicament of the patented claim 4 to be a rescue medicament as taught by Levy for the purpose of utilizing a smart inhaler to dispense a well-known drug that is effective for treating asthma and that would provide relief to a patient in need of such drug.
After the modification with Levy, the modified patented claims 2-3 fail to disclose that the set time period is twenty four hours and the predetermined number is eight or twelve.
However, the feature of choosing the set time period to be twenty-four-hours and the predetermined number being eight or twelve is considered as an obvious treatment design choice since it is based on the manufacturer and doctor’s determination on what set time period and what predetermined number can be used to determine an overuse event for the rescue medicament since it is based on the patient’s needs, severity, and the dosage being used.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,357,935.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claim and the patented claim are minor and obvious from each other. For example, the instant claim 4 is a broader version of the patented claim 4 (i.e., the instant claim 4 does not include the electronics module or the external device is configured to generate a multiple error event notification in response to a determination that a number of good inhalation events over a predetermined period of time is less than a predetermined number of good inhalation events as in the patented claim 4). In the instant claim 4, the system is included in the patented claim 4. Any infringement over the patented claim would also infringe over the instant claim. Therefore, the instant claim 4 does not differ in scope from the patented claim 4.
Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
With respect to the additional features recited in claim 4, patented claim 4 fails to recite the inclusion of the medicament is a maintenance medicament and the set time period is twenty-four-hours, and the predetermined number two.
However, Levy teaches an inhaler comprising a maintenance medicament (see claim 16 and paragraphs 0009, 0072, 0111, see maintenance medication).
Therefore, 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 medicament of the patented claim 4 to be a maintenance medicament as taught by Levy for the purpose of utilizing a smart inhaler to dispense a well-known drug that is effective for preventing symptoms and asthma attacks to the patient and that would provide relief to a patient in need of such drug.
After the modification with Levy, the modified patented claim 4 fails to disclose that the set time period is twenty four hours and the predetermined number is two.
However, the feature of choosing the set time period to be twenty-four-hours and the predetermined number being two is considered as an obvious treatment design choice since it is based on the manufacturer and doctor’s determination on what set time period and what predetermined number can be used to determine an overuse event for the maintenance medicament since it is based on the patient’s needs, severity, and the dosage being used.
Claim 7 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,357,935 in view of Biswas et al (US 2016/0144141 A1).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claim and the patented claim are minor and obvious from each other. For example, the instant claim 7 is a broader version of the patented claim 4 (i.e., the instant claim 7 does not include the electronics module or the external device is configured to generate a multiple error event notification in response to a determination that a number of good inhalation events over a predetermined period of time is less than a predetermined number of good inhalation events as in the patented claim 4). In the instant claim 7, the system is included in the patented claim 4. Any infringement over the patented claim would also infringe over the instant claim. Therefore, the instant claim 7 does not differ in scope from the patented claim 4.
Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
With respect to the additional features recited in claim 7, patented claim 4 fails to recite the inclusion of the sensor being a pressure sensor.
Biswas teaches a usage sensor is a pressure sensor (8, fig. 5, paragraphs 0059-0073 of Biswas).
Therefore, 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 sensor of the patented claim 4 to be the pressure sensor as taught by Biswas for the pu