DETAILED ACTION
This Application has been transferred to Primary Examiner Annette Dixon, AU 3785.
This Office Action is in response to the election/restriction response, filed on March 18, 2026. Primary Examiner acknowledges Claims 1-16 are pending in this application, with Claims 1-15 having been currently amended, Claim 16 having been newly added by preliminary amendment on October 11, 2023, and Claims 13-15 having been withdrawn; thus, leaving Claims 1-12 and 16 to be examined.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-12 and 16, and Species C, interchangeable mouthpiece for a medical inhaler, in the reply filed on March 18, 2026 is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 18, 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “1” has been used to designate “interchangeable mouthpiece” and “mouthpiece”. Appropriate correction is required.
Reference character “10” has been used to designate “memory”, “data memory”, “data storage”, and “data storage device”. Appropriate correction is required.
Reference character “101” has been used to designate “inhaler mouthpiece” and “mouthpiece”. Appropriate correction is required.
Reference character “14” has been used to designate “channel”, “flow channel”, and “mouthpiece”. Appropriate correction is required.
Reference character “31” has been used to designate “carrier” and “inner wall”. Appropriate correction is required.
Reference character “4” has been used to designate “data acquisition device”, “housing”, and “interior”. Appropriate correction is required.
Reference character “8” has been used to designate “adapter” data acquisition device”, and “data acquisition system”. Appropriate correction is required.
Reference characters “6” and “8” have been used to designate “adapter”. Appropriate correction is required.
Reference characters “21”, “31” and “32” have been used to designate “carrier”. Appropriate correction is required.
Reference character “200” and “201” have been used to designate “cartridge”. Appropriate correction is required.
Reference characters “12” and “26” have been used to designate “energy storage device”. Appropriate correction is required.
Reference characters “14”, “24” and “25” have been used to designate “flow channel”. Appropriate correction is required.
Reference characters “3” and “4” have been used to designate “housing”. Appropriate correction is required.
Reference characters “18”, “19”, and “34” have been used to designate “interface”. Appropriate correction is required.
Reference characters “1”, “101”, and “14” have been used to designate “mouthpiece”. Appropriate correction is required.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Reference character “9” is missing from the Figures. Primary Examiner notes Figure 4 appears to show variants of reference character “9” by the recitation of “9a”, “9b”, “9c”, “9d”, “9e” and “9f”; yet, there is no explicit correlation that reference character “9” is the same as reference characters 9a”, “9b”, “9c”, “9d”, “9e” and “9f”. Appropriate correction is required.
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. 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.
Specifically, the abstract filed on October 11, 2023, has a word count over 150 words in length, and includes legal phraseology “means”. Appropriate correction is required.
The disclosure is objected to because of the following informalities:
Reference character “1” has been used to designate “interchangeable mouthpiece” and “mouthpiece”. Appropriate correction is required.
Reference character “10” has been used to designate “memory”, “data memory”, “data storage”, and “data storage device”. Appropriate correction is required.
Reference character “101” has been used to designate “inhaler mouthpiece” and “mouthpiece”. Appropriate correction is required.
Reference character “14” has been used to designate “channel”, “flow channel”, and “mouthpiece”. Appropriate correction is required.
Reference character “31” has been used to designate “carrier” and “inner wall”. Appropriate correction is required.
Reference character “4” has been used to designate “data acquisition device”, “housing”, and “interior”. Appropriate correction is required.
Reference character “8” has been used to designate “adapter” data acquisition device”, and “data acquisition system”. Appropriate correction is required.
Reference characters “6” and “8” have been used to designate “adapter”. Appropriate correction is required.
Reference characters “21”, “31” and “32” have been used to designate “carrier”. Appropriate correction is required.
Reference character “200” and “201” have been used to designate “cartridge”. Appropriate correction is required.
Reference characters “12” and “26” have been used to designate “energy storage device”. Appropriate correction is required.
Reference characters “14”, “24” and “25” have been used to designate “flow channel”. Appropriate correction is required.
Reference characters “3” and “4” have been used to designate “housing”. Appropriate correction is required.
Reference characters “18”, “19”, and “34” have been used to designate “interface”. Appropriate correction is required.
Reference characters “1”, “101”, and “14” have been used to designate “mouthpiece”. Appropriate correction is required.
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 1-12 and 16 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.
Specifically, Claim 1, Lines 9-10 recites “data storage device” and Claim 1, Line 15 recites “data memory”; however, the breadth and scope of these limitations is unclear. Primary Examiner is unsure if these limitations are meant to be interpreted as commensurate in scope or separate and distinct. Dependent claims, Claims 2-12 and 16, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 1, Line 4 recites “an interior” and Claim 1, Line 12 recites “inside”; however, the breadth and scope of these limitations is unclear. Primary Examiner is unsure if these limitations are meant to be interpreted as commensurate in scope or separate and distinct. Dependent claims, Claims 2-12 and 16, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 1, Lines 6-7 recites “a mouth-side end of the inhaler” and Claim 2, Line 3 recites “an inhaler mouthpiece”; however, the breadth and scope of these limitations is unclear. Primary Examiner is unsure if these limitations are meant to be interpreted as commensurate in scope or separate and distinct. Dependent claims, Claims 2-12 and 16, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 5, Line 3 recites “one or more of the following sensors”; however, this recitation appears to be indefinite as the breadth and scope of this limitation is unclear. The former recitation in Claim 1, Line 9 required “at least one sensor”. Thus, the limitation of “following sensors” appears to lack antecedent basis in the claims. It appears the recitation of Claim 5, Line 3 should recite “one or more of the at least one sensor”. Appropriate correction and clarification is required.
Specifically, Claim 9, Line 3 recites “Bluetooth module” contains the trademark/trade name Bluetooth®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name Bluetooth® is used to identify/describe “short-range wireless technology standard” and, accordingly, the identification/description is indefinite. Appropriate correction and clarification is required.
Specifically, Claim 9, Line 4 recites “WiFi module” contains the trademark/trade name WiFi module™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name WiFi module™ is used to identify/describe “a family of wireless network protocols based on the IEEE 802.11 family of standards” and, accordingly, the identification/description is indefinite. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 and 16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Alizoti et al. (2017/0333645).
As to Claim 1, Alizoti discloses an interchangeable mouthpiece (defined by the combination of 2 and 12, best seen in Figures 3 and 65, wherein 2 – “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102; and wherein 12 – “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) for an inhaler (5, via 24, wherein 5 – “In one embodiment, the VHC 3 is configured to correctly identify the MDI being inserted into the VHC, correctly identify when the MDI 5 has been actuated, and monitor and provide feedback to the user regarding proper technique, as shown for example in FIG. 12.” Para 0103, and wherein 24 - “The backpiece 8 is configured with an opening 20, which is shaped to receive a mouthpiece portion 22 of a MDI actuation boot 24. The boot further includes a chimney portion 26 defining a cavity shaped to receive a medicament container 28. The boot further includes a support block defining a well shaped to receive a valve stem of the MDI.” Para 0102), comprising: a housing (2, “a chamber housing 2” Para 0102) which forms an interior (4, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) and comprises an air inlet opening (10, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) and an air outlet opening (14, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102), an adapter (8, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) via which the mouthpiece (defined by the combination of 2 and 12) is connectable to a mouth-side end (22, “The backpiece 8 is configured with an opening 20, which is shaped to receive a mouthpiece portion 22 of a MDI actuation boot 24.” Para 0102) of the inhaler (5, via 24) so that the air inlet opening (10) is fluidically coupled to the inhaler (5, via 24) in a connected state (as seen in Figures 3 and 65), and a data acquisition device (500, “The electronic circuitry in the smart VHC and/or MDI (e.g. the controller arrangement of FIG. 16), the local computing device and/or the remote server discussed above, may include some or all of the capabilities of a computer 500 in communication with a network 526 and/or directly with other computers. As illustrated in FIGS. 65, 6A-C, 67, 76, 77, 83 and 84, the computer 500 may include a processor 502, a storage device 516, a display or other output device 510, an input device 512, and a network interface device 520, all connected via a bus 508. A battery 503 is coupled to and powers the computer. The computer may communicate with the network. … The processor 502 executes instructions and includes that portion of the computer 500 that controls the operation of the entire computer. Although not depicted in FIGS. 83 and 84, the processor 502 typically includes a control unit that organizes data and program storage in memory and transfers data and other information between the various parts of the computer 500.” Para 0110) comprising at least one sensor (one of 34/78/90/92/160, wherein 34 – “The processor 502 then looks for inhalation flow, as communicated by the flow sensor 34, and records flow rate and a timestamp of active inhalation.” Para 0119; wherein 78 – “The pressure sensor 78 communicates with the computer 500 and processor 502.” Para 0125; wherein 90 – “The humidity sensor 90 communicates with the computer 500 and processor 502.” Para 0130; wherein 92 – “The temperature sensor 92 communicates with the computer 500 and processor 502.” Para 0131; wherein 160 – “The force sensor 160 communicates a signal to the computer 500 and processor 502.” Para 0195), a data storage device (516, “As illustrated in FIGS. 65, 6A-C, 67, 76, 77, 83 and 84, the computer 500 may include a processor 502, a storage device 516, a display or other output device 510, an input device 512, and a network interface device 520, all connected via a bus 508. A battery 503 is coupled to and powers the computer.” Para 0110), a processor (502, “As illustrated in FIGS. 65, 6A-C, 67, 76, 77, 83 and 84, the computer 500 may include a processor 502, a storage device 516, a display or other output device 510, an input device 512, and a network interface device 520, all connected via a bus 508. A battery 503 is coupled to and powers the computer.” Para 0110), and an energy storage device (503, “As illustrated in FIGS. 65, 6A-C, 67, 76, 77, 83 and 84, the computer 500 may include a processor 502, a storage device 516, a display or other output device 510, an input device 512, and a network interface device 520, all connected via a bus 508. A battery 503 is coupled to and powers the computer.” Para 0110), wherein a flow channel (6, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) is formed inside of the housing (2) by a partition (“wall”, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102), fluidically connecting the air inlet opening (10) with the air outlet opening (14), and wherein the data acquisition device (500) is adapted to store a data set (via 524, “The processor 502 receives input data from the input device 512 and the network 526 reads and stores instructions (for example processor executable code) 524 and data in the main memory 504, such as random access memory (RAM), static memory 506, such as read only memory (ROM), and the storage device 516. The processor 502 may present data to a user via the output device 510.” Para 0110; “The storage device 516 may include a controller (not shown) and a computer readable medium 522 having instructions 524 capable of being executed on the processor 502 to carry out the functions described above with reference to processing sensor data, displaying the sensor data or instructions based on the sensor data, controlling aspects of the smart VHC and/or MDI to alter its operation, or contacting third parties or other remotely located resources to provide update information to, or retrieve data from those remotely located resources.” Para 0113) comprising at least one operating parameter (“flow”, “Referring to FIG. 12, the flow rate information may be used in real-time to provide feedback to the user about practice sessions, for example through a feedback device such as an indicator (visual, auditory and/or haptic) or display, and whether they should begin inhalation, and/or whether they need to slow down the flow rate, for example when exceeding a maximum flow rate. MDI actuation may also be used to provide feedback to the user about initiating actuation and/or beginning inhalation. First, the user 66 inserts the MDI into the backpiece as shown in FIG. 19. A contact switch 62, or other MDI insertion detector or sensor, detects the insertion. When the MDI is inserted, the smart VHC actively looks for MDI actuation and/or inhalation flow detection. Depending on the feedback through a feedback device (e.g., indicator or display), the user may actuate the MDI, dispensing an aerosolized medication into the interior space, with an actuation time stamp being recorded. The processor 502 then looks for inhalation flow, as communicated by the flow sensor 34, and records flow rate and a timestamp of active inhalation. The processor 502 also compares the inhalation rate with a stored predetermined rate, e.g., a maximum recommended flow rate, and provides feedback to the user if the inhaled flow rate exceeds the predetermined flow rate. The processor then compares the inhaled volume, as calculated from the flow rate, with the volume of the interior space 4, and notifies the user that the treatment is complete and the dose has been properly administered. Alternatively, the processor may communicate to the user that further inhalation is required to fully empty the interior space. As noted, the user has the option to practice using the device before the treatment begins. In this case, the MDI is not inserted. Rather, only the flow sensor is activated. The processor records the flow rate and provides feedback about the flow rate, and notifies the user that the practice is complete.” Para 0119) on the data memory (504, “The processor 502 receives input data from the input device 512 and the network 526 reads and stores instructions (for example processor executable code) 524 and data in the main memory 504, such as random access memory (RAM), static memory 506, such as read only memory (ROM), and the storage device 516.” Para 0110; “The storage device 516 represents one or more mechanisms for storing data. For example, the storage device 516 may include a computer readable medium 522 such as read-only memory (ROM), RAM, non-volatile storage media, optical storage media, flash memory devices, and/or other machine-readable media.” Para 0112) in dependence of a fluidic condition (“flow rate” Para 0119) inside the flow channel (6).
As to Claim 2, Alizoti discloses the adapter (8) is adapted to be connected to an inhaler mouthpiece (22, “The backpiece 8 is configured with an opening 20, which is shaped to receive a mouthpiece portion 22 of a MDI actuation boot 24.” Para 0102).
As to Claim 3, Alizoti discloses the data acquisition device (500) is adapted to detect an inhalation puff (“inhalation” as sensed by 34, “Providing feedback to users regarding their inhalation technique is one feature of the VHC that will help optimize drug delivery. In one embodiment, shown in FIGS. 3 and 9, a flow detector, configured as a flow sensor 34, is used to collect data and provide feedback about technique. The flow sensor measures the flow rate at which the user is inhaling. Inhaling too fast may deposit most of the drug in the throat rather than in the lungs. Effective drug deposition into the lungs may be achieved with controlled inhalation. In addition, the flow rate may be integrated over time to determine the volume of air inhaled, which may be used to provide the user with an indication of when they have emptied the interior space of the chamber housing and received a complete dose. As shown in FIGS. 3 and 9, the flow sensor 34 includes a 58 bypass channel with input and output ports 36, 38 communicating with the interior space. The pressure differential between the proximal and distal openings defined by the input and output ports creates a small flow rate through the bypass channel. A thermal mass air flow sensor 60 is used to measure the flow through the bypass channel, which is correlated to inhalation flow rates, as shown in FIG. 9.” Para 0118; and “Referring to FIG. 12, the flow rate information may be used in real-time to provide feedback to the user about practice sessions, for example through a feedback device such as an indicator (visual, auditory and/or haptic) or display, and whether they should begin inhalation, and/or whether they need to slow down the flow rate, for example when exceeding a maximum flow rate. MDI actuation may also be used to provide feedback to the user about initiating actuation and/or beginning inhalation. First, the user 66 inserts the MDI into the backpiece as shown in FIG. 19. A contact switch 62, or other MDI insertion detector or sensor, detects the insertion. When the MDI is inserted, the smart VHC actively looks for MDI actuation and/or inhalation flow detection. Depending on the feedback through a feedback device (e.g., indicator or display), the user may actuate the MDI, dispensing an aerosolized medication into the interior space, with an actuation time stamp being recorded. The processor 502 then looks for inhalation flow, as communicated by the flow sensor 34, and records flow rate and a timestamp of active inhalation. The processor 502 also compares the inhalation rate with a stored predetermined rate, e.g., a maximum recommended flow rate, and provides feedback to the user if the inhaled flow rate exceeds the predetermined flow rate. The processor then compares the inhaled volume, as calculated from the flow rate, with the volume of the interior space 4, and notifies the user that the treatment is complete and the dose has been properly administered. Alternatively, the processor may communicate to the user that further inhalation is required to fully empty the interior space. As noted, the user has the option to practice using the device before the treatment begins. In this case, the MDI is not inserted. Rather, only the flow sensor is activated. The processor records the flow rate and provides feedback about the flow rate, and notifies the user that the practice is complete.” Para 0119) based on the fluidic condition (“flow rate” Para 0119) inside the flow channel (6).
As to Claim 4, Alizoti discloses the storing of the data set (via 524) takes place in dependence on the detection of the inhalation puff (“inhalation” as sensed by 34, such that “The processor 502 then looks for inhalation flow, as communicated by the flow sensor 34, and records flow rate and a timestamp of active inhalation.” Para 0119).
As to Claim 5, Alizoti discloses the data acquisition device (500) comprises one or more of the at least one sensor (one of 34/78/90/92/160, wherein 34 – “The processor 502 then looks for inhalation flow, as communicated by the flow sensor 34, and records flow rate and a timestamp of active inhalation.” Para 0119; wherein 78 – “The pressure sensor 78 communicates with the computer 500 and processor 502.” Para 0125; wherein 90 – “The humidity sensor 90 communicates with the computer 500 and processor 502.” Para 0130; wherein 92 – “The temperature sensor 92 communicates with the computer 500 and processor 502.” Para 0131; wherein 160 – “The force sensor 160 communicates a signal to the computer 500 and processor 502.” Para 0195), including: a pressure sensor (78, “The pressure sensor 78 communicates with the computer 500 and processor 502.” Para 0125) for detecting air pressure in the flow channel (6); a temperature sensor (92, “The temperature sensor 92 communicates with the computer 500 and processor 502.” Para 0131) for capturing a temperature inside the flow channel (6); an ambient temperature sensor (140, “the sensor 140 may be located outside the interior space of the holding chamber, for example on the MDI. This would allow for a non-invasive method of MDI actuation using temperature.” Para 0193, whereby “The temperature data may then be input to the microcontroller or other processor 502 (not shown) to indicate and record MDI actuation.” Paras 0192, 0194) for capturing the temperature in the environment of the mouthpiece (defined by the combination of 2 and 12, best seen in Figures 3 and 65); an acceleration sensor (“Hall Effect sensor” and “Pinwheel Anemometer”, wherein “Hall Effect sensor” - “The Hall Effect sensor detects changes in the magnetic field as the magnet moves from one position to another, and this can be analyzed using various algorithms to determine flow.” Para 0166; “Within the MDI adapter is a Hall affect sensor or reed switch 172. When the MDI canister is depressed to its actuation position, the reed switch closes and this is detected by software.” Para 0198; and wherein “Pinwheel Anemometer” – “A pinwheel is placed within the chamber such that its rotational speed changes with changing flow rate. The rotational speed of the pinwheel can be monitored by a rotating contact switch, periodic breaking of a light curtain or magnet and Hall Effect sensor combination and this speed can be used to approximate the flow rate through the chamber.” Para 0170); and/or a sensor (160, “The force sensor 160 communicates a signal to the computer 500 and processor 502.” Para 0195) for capturing the flow resistance in the flow channel (6).
As to Claim 6, Alizoti discloses the data acquisition device (500) is adapted to provide the data set (via 524) with a time stamp (“time stamp”, “Depending on the feedback through a feedback device (e.g., indicator or display), the user may actuate the MDI, dispensing an aerosolized medication into the interior space, with an actuation time stamp being recorded. The processor 502 then looks for inhalation flow, as communicated by the flow sensor 34, and records flow rate and a timestamp of active inhalation.” Para 0119; “In more rudimentary controller arrangements, the data may simply be date/time stamped and stored locally or remotely for later processing. In one embodiment, the data may further be locally or remotely stamped with a unique device or patient identifier.” Para 0122; “Based on these parameters, the smart VHC may accurately determine the MDI actuation. This event may further be used to record a timestamp, which information may be useful for adherence tracking and monitoring.” Para 0178).
As to Claim 7, Alizoti discloses the stored data set (via 524) comprises at least one of the following operating parameters: a mouthpiece ID (“For example, and referring to FIG. 13, a photodiode 222 and color detector sensor 224, or MDI identifier, may be disposed on the exterior surface of the chamber housing wall, or on the backpiece, and be directed toward the MDI, including the actuator boot and container. A unique tag may 226 be attached to each MDI, or a unique rescue tag may be attached to a rescue MDI and a unique controller tag attached to a controller MDI. The sensor 224, e.g., color detector sensor, detects the presence of the tag to identify each specific MDI or to identify each MDI by category, e.g., rescue or controller. The tag may be configured with different colors, barcodes, magnetic properties, surface properties such as reflection/absorption etc.” Para 0231), an inhalation puff duration (“Once the MDI is actuated, the system detects and records the actuation, and the duration between actuation and the first inhalation flow. This information is used to provide coordination feedback following the current treatment and/or at the beginning of subsequent treatments. At the end of an inhalation, a second timer may start that measures the breath-hold duration of the user. This information may be used to provide further feedback before the next breath-hold or before the next treatment.” Para 0006), a temperature (via 92, “The temperature sensor 92 communicates with the computer 500 and processor 502.” Para 0131) within the flow channel (6) a temperature (via 140, “the sensor 140 may be located outside the interior space of the holding chamber, for example on the MDI. This would allow for a non-invasive method of MDI actuation using temperature.” Para 0193, whereby “The temperature data may then be input to the microcontroller or other processor 502 (not shown) to indicate and record MDI actuation.” Paras 0192, 0194) in the environment of the mouthpiece (defined by the combination of 2 and 12, best seen in Figures 3 and 65), orientation data (via “Hall Effect sensor” - “The Hall Effect sensor detects changes in the magnetic field as the magnet moves from one position to another, and this can be analyzed using various algorithms to determine flow.” Para 0166; “Within the MDI adapter is a Hall affect sensor or reed switch 172. When the MDI canister is depressed to its actuation position, the reed switch closes and this is detected by software.” Para 0198) which allow a conclusion of the orientation of the mouthpiece (defined by the combination of 2 and 12, best seen in Figures 3 and 65) in space, and flow resistance data (via 160, “The force sensor 160 communicates a signal to the computer 500 and processor 502.” Para 0195), which allow a conclusion to be drawn about the flow resistance in the flow channel (6).
As to Claim 8, Alizoti discloses the mouthpiece (defined by the combination of 2 and 12, best seen in Figures 3 and 65) comprises a data interface (“a smart phone, local computing device and/or remote computing device”, “In order to provide faster and more accurate processing of the data, for example from one or more various sensors, generated within the smart VHC and/or MDI, data may be wirelessly communicated to a smart phone, local computing device and/or remote computing device to interpret and act on the raw sensor data.” Para 0106) for transmitting the at least one stored data set (via 524).
As to Claim 9, Alizoti discloses the data interface (“a smart phone, local computing device and/or remote computing device”) comprises a wireless interface (“wirelessly communicated” Para 0106) comprising a Bluetooth® module (“Bluetooth” Paras 0184, 0205, 0229, 0258, 0259), a mobile radio module (“radio” Paras 0115, 0116, 0206, 0222, 0254), and/or a WiFi™ module (“Wi-Fi” Paras 0184, 0222, 0258, 0259).
As to Claim 10, Alizoti discloses the adapter (8) is formed by a part of the housing (2), as best seen in Figure 65.
As to Claim 11, Alizoti discloses the air inlet opening (10) is arranged on a first end face (proximate the inhaler 5, via 24) of the mouthpiece (defined by the combination of 2 and 12, best seen in Figures 3 and 65) associated with the adapter (8), and the air outlet opening (14) is arranged on a second mouth-side end face (proximate end-user mouthpiece 2) of the mouthpiece (defined by the combination of 2 and 12, best seen in Figures 3 and 65) away from the adapter (8).
As to Claim 12, Alizoti discloses the flow channel (6) connects the air inlet opening (10) in a direct path to the air outlet opening (14).
As to Claim 16, Alizoti discloses a medical inhaler (5, “In one embodiment, the VHC 3 is configured to correctly identify the MDI being inserted into the VHC, correctly identify when the MDI 5 has been actuated, and monitor and provide feedback to the user regarding proper technique, as shown for example in FIG. 12.” Para 0103) comprising an interchangeable mouthpiece (defined by the combination of 2 and 12, best seen in Figures 3 and 65, wherein 2 – “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102; and wherein 12 – “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) for an inhaler (5, via 24, wherein 5 – “In one embodiment, the VHC 3 is configured to correctly identify the MDI being inserted into the VHC, correctly identify when the MDI 5 has been actuated, and monitor and provide feedback to the user regarding proper technique, as shown for example in FIG. 12.” Para 0103, and wherein 24 - “The backpiece 8 is configured with an opening 20, which is shaped to receive a mouthpiece portion 22 of a MDI actuation boot 24. The boot further includes a chimney portion 26 defining a cavity shaped to receive a medicament container 28. The boot further includes a support block defining a well shaped to receive a valve stem of the MDI.” Para 0102), comprising: a housing (2, “a chamber housing 2” Para 0102) which forms an interior (4, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) and comprises an air inlet opening (10, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) and an air outlet opening (14, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102), an adapter (8, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) via which the mouthpiece (defined by the combination of 2 and 12) is connectable to a mouth-side end (22, “The backpiece 8 is configured with an opening 20, which is shaped to receive a mouthpiece portion 22 of a MDI actuation boot 24.” Para 0102) of the inhaler (5, via 24) so that the air inlet opening (10) is fluidically coupled to the inhaler (5, via 24) in a connected state (as seen in Figures 3 and 65), and a data acquisition device (500, “The electronic circuitry in the smart VHC and/or MDI (e.g. the controller arrangement of FIG. 16), the local computing device and/or the remote server discussed above, may include some or all of the capabilities of a computer 500 in communication with a network 526 and/or directly with other computers. As illustrated in FIGS. 65, 6A-C, 67, 76, 77, 83 and 84, the computer 500 may include a processor 502, a storage device 516, a display or other output device 510, an input device 512, and a network interface device 520, all connected via a bus 508. A battery 503 is coupled to and powers the computer. The computer may communicate with the network. … The processor 502 executes instructions and includes that portion of the computer 500 that controls the operation of the entire computer. Although not depicted in FIGS. 83 and 84, the processor 502 typically includes a control unit that organizes data and program storage in memory and transfers data and other information between the various parts of the computer 500.” Para 0110) comprising at least one sensor (one of 34/78/90/92/160, wherein 34 – “The processor 502 then looks for inhalation flow, as communicated by the flow sensor 34, and records flow rate and a timestamp of active inhalation.” Para 0119; wherein 78 – “The pressure sensor 78 communicates with the computer 500 and processor 502.” Para 0125; wherein 90 – “The humidity sensor 90 communicates with the computer 500 and processor 502.” Para 0130; wherein 92 – “The temperature sensor 92 communicates with the computer 500 and processor 502.” Para 0131; wherein 160 – “The force sensor 160 communicates a signal to the computer 500 and processor 502.” Para 0195), a data storage device (516, “As illustrated in FIGS. 65, 6A-C, 67, 76, 77, 83 and 84, the computer 500 may include a processor 502, a storage device 516, a display or other output device 510, an input device 512, and a network interface device 520, all connected via a bus 508. A battery 503 is coupled to and powers the computer.” Para 0110), a processor (502, “As illustrated in FIGS. 65, 6A-C, 67, 76, 77, 83 and 84, the computer 500 may include a processor 502, a storage device 516, a display or other output device 510, an input device 512, and a network interface device 520, all connected via a bus 508. A battery 503 is coupled to and powers the computer.” Para 0110), and an energy storage device (503, “As illustrated in FIGS. 65, 6A-C, 67, 76, 77, 83 and 84, the computer 500 may include a processor 502, a storage device 516, a display or other output device 510, an input device 512, and a network interface device 520, all connected via a bus 508. A battery 503 is coupled to and powers the computer.” Para 0110), wherein a flow channel (6, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102) is formed inside of the housing (2) by a partition (“wall”, “Referring to FIG. 3, one exemplary embodiment of a smart VHC includes a chamber housing 2 having a wall defining an interior space 4 extending along a longitudinal axis/inhalation flow path 6, a back piece 8 coupled to an input end 10 of the chamber housing and a mouthpiece and/or valve assembly 12 coupled to an output end 14 of the chamber housing.” Para 0102), fluidically connecting the air inlet opening (10) with the air outlet opening (14), and wherein the data acquisition device (500) is adapted to store a data set (via 524, “The processor 502 receives input data from the input device 512 and the network 526 reads and stores instructions (for example processor executable code) 524 and data in the main memory 504, such as random access memory (RAM), static memory 506, such as read only memory (ROM), and the storage device 516. The processor 502 may present data to a user via the output device 510.” Para 0110; “The storage device 516 may include a controller (not shown) and a computer readable medium 522 having instructions 524 capable of being executed on the processor 502 to carry out the functions described above with reference to processing sensor data, displaying the sensor data or instructions based on the sensor data, controlling aspects of the smart VHC and/or MDI to alter its operation, or contacting third parties or other remotely located resources to provide update information to, or retrieve data from those remotely located resources.” Para 0113) comprising at least one operating parameter (“flow”, “Referring to FIG. 12, the flow rate information may be used in real-time to provide feedback to the user about practice sessions, for example through a feedback device such as an indicator (visual, auditory and/or haptic) or display, and whether they should begin inhalation, and/or whether they need to slow down the flow rate, for example when exceeding a maximum flow rate. MDI actuation may also be used to provide feedback to the user about initiating actuation and/or beginning inhalation. First, the user 66 inserts the MDI into the backpiece as shown in FIG. 19. A contact switch 62, or other MDI insertion detector or sensor, detects the insertion. When the MDI is inserted, the smart VHC actively looks for MDI actuation and/or inhalation flow detection. Depending on the feedback through a feedback device (e.g., indicator or display), the user may actuate the MDI, dispensing an aerosolized medication into the interior space, with an actuation time stamp being recorded. The processor 502 then looks for inhalation flow, as communicated by the flow sensor 34, and records flow rate and a timestamp of active inhalation. The processor 502 also compares the inhalation rate with a stored predetermined rate, e.g., a maximum recommended flow rate, and provides feedback to the user if the inhaled flow rate exceeds the predetermined flow rate. The processor then compares the inhaled volume, as calculated from the flow rate, with the volume of the interior space 4, and notifies the user that the treatment is complete and the dose has been properly administered. Alternatively, the processor may communicate to the user that further inhalation is required to fully empty the interior space. As noted, the user has the option to practice using the device before the treatment begins. In this case, the MDI is not inserted. Rather, only the flow sensor is activated. The processor records the flow rate and provides feedback about the flow rate, and notifies the user that the practice is complete.” Para 0119) on the data memory (504, “The processor 502 receives input data from the input device 512 and the network 526 reads and stores instructions (for example processor executable code) 524 and data in the main memory 504, such as random access memory (RAM), static memory 506, such as read only memory (ROM), and the storage device 516.” Para 0110; “The storage device 516 represents one or more mechanisms for storing data. For example, the storage device 516 may include a computer readable medium 522 such as read-only memory (ROM), RAM, non-volatile storage media, optical storage media, flash memory devices, and/or other machine-readable media.” Para 0112) in dependence of a fluidic condition (“flow rate” Para 0119) inside the flow channel (6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Star et al. (2010/0282245) discloses an interchangeable mouthpiece (700, best seen Figure 12, “Inhaler system 650 can, for example, include a mouthpiece or spacer system 700 attachable to, for example, a metered-dose inhaler 800.” Paras 0091-0094) for an inhaler (800, “Inhaler system 650 can, for example, include a mouthpiece or spacer system 700 attachable to, for example, a metered-dose inhaler 800.”Paras 0091-0093), comprising a housing (perimeter of 700) that forms an interior (lumen of 700) and comprises an air inlet opening (via 700 as connected to 800) and an air outlet opening (via 700 as inserted into the end user’s mouth as seen Figure 12), an adapter (defined by the intermediary structure between 700 and 800) via which the interchangeable mouthpiece (700) is connectable to a mouth-side end of the inhaler (800) so that the air inlet opening (via 700 as connected to 800) is fluidically coupled to the inhaler (800) in a connected state (best seen Figure 12), and a data acquisition device (720, “Mouthpiece 700 can also include a controller 720 (for example, including a microprocessor 722 and an associated memory 724) in communicative connection with sensor system 710.” Para 0092) comprising at least one sensor (710, “Mouthpiece system 700 includes a sensor system 710 (for example, similar to sensor system 10 or sensor system 100) as described above to detect NO directly or via conversion to NO.sub.2.” Para 0091), a data storage device (724, “Mouthpiece 700 can also include a controller 720 (for example, including a microprocessor 722 and an associated memory 724) in communicative connection with sensor system 710.” Para 0092), a processor (722, “Mouthpiece 700 can also include a controller 720 (for example, including a microprocessor 722 and an associated memory 724) in communicative connection with sensor system 710.” Para 0092), and an energy storage device (“battery (not shown) powered”, “Each of controllers 720 and 820 can be battery (not shown) powered as known in the art.” Para 0092), wherein a flow channel (via 700, defined by the flow of fluid from 800 into the end user’s mouth as seen Figure 12) is formed inside the housing (perimeter of 700) by a partition (defined as the flow of fluid flow in lumen 700), fluidically connecting the air inlet opening (via 700 as connected to 800) with the air outlet opening (via 700 as inserted into the end user’s mouth as seen Figure 12), yet, Star does not expressly disclose the configuration “wherein the data acquisition device is adapted to store a data set comprising at least one operating parameter on the data memory in dependence of a fluidic condition inside the flow channel”. Although Star appears to hint at the concept of at least one operating parameter (“A signal from controller 720 related to a determined level of NO in the user's breath can be transmitted to controller 820 so that controller 820 can effect a proper dose from inhaler 800 upon user actuation of actuator 830. Alternatively, controller 720 can directly control the dose delivered by inhaler 800.” Para 0092; “Mouthpiece 700 can also be used periodically (for example, daily) as a standalone unit as described above to determine if there is an elevated level of NO in the user's breath to determine whether (and/or in what amount) a dose of controller medicine is required. … Mouthpiece 700 can, for example, be used to determine whether controller medicines should be taken and/or to determine an appropriate dose therefor. The devices, systems and methods of the present invention can thus be used to effect appropriate dosing of controller medications and rescue medications for asthma sufferers.” Para 0094) associated with a fluidic condition inside the flow channel (via 700, defined by the flow of fluid from 800 into the end user’s mouth as seen Figure 12), Star does not expressly correlate the usage of “store[d] data set” associated with “data memory” is looked up and/or compared to real-time data to meet and/or achieve the “determined” features of the “operating parameter”. Thus, the disclosure of Star does not anticipate Claim 1, BUT may be obvious in combination with another prior art reference to meet the limitations of Claim 1. Applicant is strongly advised to review the Star reference prior to the filing of a response to this Office Action to streamline the examination process.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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