DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1-2, 4, 7-8, 12, 14-27 are objected to because of the following informalities:
Claim 1 recites the limitation “and at least one magnet,, and at least one magnet” in lines 9-10 which should read “and at least one magnet,” as the limitation is erroneously duplicated.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 23, the claim recites mesh sizes with relatively large openings of width between 0.94 and 1 cm and height between 0.97 and 1.03 cm and spacing between of 0.47 and 0.53 cm. The specification does recite these particular values (Paragraphs 0029-0031), however also recites these same values but at a different order of magnitude (Paragraphs 0051-0053). Thus, the different descriptions of the mesh appear to be contrary or point towards wholly different values/ranges and is thus not described sufficiently so as to reasonably convey that the inventor had possession of the particular dimensions of the mesh.
Similar arguments can be made for claims 24 and 25.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/042,814 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are encompassed or are obvious in view of the prior art.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/042,814 in view of Fato (U.S 2022/0305220 A1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, Application No. 18/042,814 discloses a capsule inhaler for administering a single dose of dry powder from a capsule (Claim 1), said inhaler comprising:
a body (Claim 1),
a mouthpiece having a sieve, a base, and a cover comprising an opening, the mouthpiece being coupled with the body (Claim 1),
a capsule receiver (Claim 1),
at least one press button with a capsule piercing mechanism comprising at least one spring (Claim 1 and 2), at least one piercing element (Claim 1) and at least one magnet (Claim 1),
an electronic board arranged in the body and having a microprocessor, said board comprising at least one magnetic field sensor and at least one light indicator, positioned in proximity to the at least one press button (Claim 1),
a first coupler coupling the electronic board with the base of the mouthpiece (Claim 1).
Application No. 18/042,814 is silent regarding the magnet being positioned in proximity to the piercing element and in proximity to the magnetic field sensor.
However, Fato teaches that the capsule piercing mechanism can be adapted to generate magnetic fields on actuation (Paragraph 0060, 0086) and wherein the magnetic field is generated in proximity to the piercing element and in proximity to the magnetic field sensor (Paragraph 0060, 0086, the sensing unit 44 may include a magnetic switch which detects actuation of the capsule piercing mechanism based on the generated magnetic fields generated by the capsule piercing mechanism).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Application No. 18/042,814 to have included a magnet in the capsule piercing mechanism and in proximity to the piercing element and magnetic field sensor, such as that taught by Fato, in order to detect actuation of the button (Paragraph 0060, 0086).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fato (U.S 2022/0305220 A1).
Regarding claim 1, Fato discloses a capsule inhaler for administering a single dose of dry powder from a capsule (Paragraph 0001, the device is specifically a single-dose dry powder capsule inhaler), said inhaler comprising:
a body (inhaler body 10, see Fig. 1 and Paragraph 0048),
a mouthpiece (Paragraph 0048-0050 and Fig. 5-9, mouthpiece 20) having a sieve (see Figs. 5-6, 8-10, the bottom of the mouthpiece 20 includes a grid/sieve/mesh in the flow path), a base (Figs. 1-2, 5-9; the mouthpiece has a base portion which is connected to the inhaler body 10 at the distal end of the mouthpiece which bounds upper volume 14), and a cover comprising an opening (see Paragraph 0102 and Fig. 3-5; The inhaler includes a cap 50 which protects the mouthpiece and can be opened/has an opening to remove the cap), the mouthpiece being coupled with the body (see Fig. 1-8, the mouthpiece is connected to the body),
a capsule receiver (Figs. 1-2 and Paragraph 0048-0051; Chamber 12 has lower recess/chamber 13 which holds the capsule proximate the capsule piercing mechanism),
at least one press button (Paragraph 0050, Figs. 1-4; Buttons 32 are disposed on opposite sides of the inhaler) with a capsule piercing mechanism (Paragraph 0050, capsule piercing mechanism 30) comprising at least one spring (see Figs. 1-2, the buttons/piecing elements include an internal spring/coil which compresses when the buttons are pressed), at least one piercing element (Paragraph 0050 and Figs. 1-2, 8; needles 31),
an electronic board arranged in the body and having a microprocessor (Paragraph 0062-0070 and Fig. 1; Monitoring system 40 includes a printed circuit board 48 with electronic processing unit 46 soldered onto the board to receive and process signals), said board comprising at least one magnetic field sensor (Paragraph 0086, the monitoring system 40 is adapted to detect magnetic fields or features, which may be a dedicated magnetic sensor; also see Paragraph 0060) and at least one light indicator (Paragraph 0097, the inhaler can include a visual lighting system to be signaled by the electronic processing unit), positioned in proximity to the at least one press button (see Figs. 1-2, the monitoring system 40 is positioned in proximity to at least one button; It is noted that applicant has not defined the bounds of ‘proximity’ and thus the magnetic sensor and light being anywhere on the body 10 may be considered ‘in proximity’).
Fato is silent regarding the capsule piercing mechanism comprising at least one magnet, wherein the magnet is positioned in proximity to the piercing element and in proximity to the magnetic field sensor.
However, Fato teaches that the capsule piercing mechanism can be adapted to generate magnetic fields on actuation (Paragraph 0060 and 0086) and wherein the magnetic field is generated in proximity to the piercing element and in proximity to the magnetic field sensor (Paragraph 0060 and 0086, the sensing unit 44 may include a magnetic switch which detects actuation of the capsule piercing mechanism based on the generated magnetic fields generated by the capsule piercing mechanism).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included a magnet in the capsule piercing mechanism and in proximity to the piercing element and magnetic field sensor, such as that taught by Fato, in order to detect actuation of the button (Paragraph 0060 and 0086).
Fato is silent regarding a first coupler coupling the electronic board with the base of the mouthpiece.
However, Fato also discloses that the circuit board is positioned in order to be influenced by the mechanical oscillations during an inhalation and from signals in the inhalation channel of the mouthpiece (Paragraph 0080-0081, 0083-0084). Fato additionally teaches retention of the circuit board and the rest of the inhaler through supports and transmission elements (Paragraphs 0076, 0079-0080, protruding supports 49 can engage the peripheral of the circuit board to dispose it within the inhaler and to stabilize/transfer vibrations to the sensing elements of the PCB).
Thus, it would have been obvious to one having ordinary skill in the prior art to have positioned and coupled the electronic board with the base of the mouthpiece with a coupler, such as that taught by Fato, in order to dispose the sensing elements closer in proximity to the inhalation channel for determination of flow parameters (Paragraph 0080-0081, 0083-0084).
Regarding claim 18, the modified device of Fato discloses the device of claim 1.
Fato further discloses an audio indicator arranged on the electronic board, coupled with a microprocessor (Paragraph 0097; An audible output from a piezoelectric buzzer can be driven by the electronic processing unit 46; see Paragraph 0070, the electronic processing unit is soldered onto the printed circuit board 48).
Claims 1, 22 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Roszczyk (WO 2019043639 A1) in view of Fato (U.S 2022/0305220 A1).
Regarding claim 1, Roszczyk discloses a capsule inhaler for administering a single dose of dry powder from a capsule (Paragraph 0001 and Abstract), said inhaler comprising:
a body (body 1, see Fig. 1-5 and Paragraph 0038),
a mouthpiece (mouthpiece 21, see Paragraph 0035 and Figs. 1-5) having a sieve (mesh 21A, Paragraph 0035), a base (mouthpiece base 21B), and a cover comprising an opening (upper cover 15, Paragraph 0026, see Figs. 1-5 and 13), the mouthpiece being coupled with the body (see Figs. 1-5, the mouthpiece is coupled to the body),
a capsule receiver (chamber element 11 and capsule chamber 14; Paragraph 0039 and Fig. 11),
at least one press button with a capsule piercing mechanism comprising at least one spring (push buttons 7, Paragraph 0027 and Fig. 5; Springs 23 allow depression of the push buttons), at least one piercing element (Paragraph 0026-0027; Spikes 10 are movable to pierce the capsule).
Roszczyk is silent regarding an electronic board arranged in the body and having a microprocessor, said board comprising at least one magnetic field sensor and at least one light indicator, positioned in proximity to the at least one press button and a magnet in the capsule piercing mechanism in proximity to the piercing element and in proximity to the magnetic field sensor.
However, Fato teaches an electronic board arranged in the body and having a microprocessor
(Paragraph 0062-0070 and Fig. 1; Monitoring system 40 includes a printed circuit board 48 with electronic processing unit 46 soldered onto the board to receive and process signals), said board comprising at least one magnetic field sensor (Paragraph 0086, the monitoring system 40 is adapted to detect magnetic fields or features, which may be a dedicated magnetic sensor) and at least one light indicator (Paragraph 0097, the inhaler can include a visual lighting system to be signaled by the electronic processing unit). Fato also teaches that the capsule piercing mechanism can be adapted to generate magnetic fields on actuation (Paragraph 0060 and 0086) and wherein the magnetic field is generated in proximity to the piercing element and in proximity to the magnetic field sensor (Paragraph 0060 and 0086, the sensing unit 44 may include a magnetic switch which detects actuation of the capsule piercing mechanism based on the generated magnetic fields generated by the capsule piercing mechanism).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Roszczyk to have included an electronic board in the body of the inhaler with a magnetic sensor and light indicator, and magnet in the capsule piercing mechanism and in proximity to the piercing element and magnetic field sensor, such as that taught by Fato, in order to monitor usage of the device and to detect actuation of the buttons based on magnetic sensing (Paragraph 0060 and 0086).
The modified device of Roszczyk is silent regarding specifically a first coupler coupling the electronic board with the base of the mouthpiece.
However, Fato also discloses that the circuit board is positioned in order to be influenced by the mechanical oscillations during an inhalation and from signals in the inhalation channel of the mouthpiece (Paragraph 0080-0081, 0083-0084). Fato additionally teaches retention of the circuit board and the rest of the inhaler through supports and transmission elements (Paragraphs 0076, 0079-0080, protruding supports 49 can engage the peripheral of the circuit board to dispose it within the inhaler and to stabilize/transfer vibrations to the sensing elements of the PCB).
Thus, it would have been obvious to one having ordinary skill in the prior art to have positioned and coupled the electronic board with the base of the mouthpiece with a coupler, such as that taught by Fato, in order to dispose the sensing elements closer in proximity to the inhalation channel for determination of flow parameters (Paragraph 0080-0081, 0083-0084).
Regarding claim 22, the modified device of Roszczyk discloses the device of claim 1.
Roszczyk further discloses a housing positioned on the body and the cover that encloses and covers the mouthpiece and the base (Fig. 5 and Paragraph 0051; Cover 22 is placed over the mouthpiece tube and mouthpiece base and covers the two; The cover is positioned on the body).
Regarding claim 26, the modified device of Roszczyk discloses the device of claim 1.
Roszczyk further discloses a protrusion arranged on the base for raising the base (see Fig. 19 and Fig. 4; The base 21B has a protrusion opposite the hinge 24 which allows a ledge/section for which to raise the base).
Regarding claim 27, the modified device of Roszczyk discloses the device of claim 1.
Roszczyk further discloses wherein the base of the mouthpiece is coupled hingedly on the cover (see Figs. 1-4; Mouthpiece base 21B is hingedly connected to the upper cover 15; see hinge 24).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Fato (U.S 2022/0305220 A1) in view of Merrell (U.S 2020/0345588 A1).
Regarding claim 2, the modified device of Fato discloses the device of claim 1.
Fato is silent regarding wherein the magnetic field sensor is a Hall-effect device and the light indicator is a diode.
However, Merrell teaches wherein a magnetic sensor may be a hall-effect sensor (Paragraph 0069-0070) and wherein a light indicator for an inhaler may be a diode (Paragraph 0090).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included using a hall-effect sensor and a diode, such as that taught by Merrell, in order to use known alternatives of sensors and light emitting devices (Paragraph 0069-0070 and 0090).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Roszczyk (WO 2019043639 A1) in view of Fato (U.S 2022/0305220 A1), as applied to claim 1, in further view of Young (U.S 2013/0174842 A1).
Regarding claim 4, the modified device of Fato discloses the device of claim 1.
Fato further teaches wherein the electronic board is arranged in a frame accommodated within the body (Paragraph 0076, 0079-0080 and rejection of claim 1 above; The circuit board may be peripherally supported by rigid protrusions or transmission elements 49 to locate and fix it to the housing; Thus, the circuit board is arranged in a frame of the body and attached with the supports).
Roszczyk is silent regarding a switch being a base opening sensor that via the first coupler is coupled with the base of the mouthpiece.
However, Young teaches wherein a positional sensor can detect when the device is opened based on the positions of first and second housing portions and wherein the sensor can be postioned adjacent the latch wherein the device opens up about a hinge (Paragraph 0099).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Roszczyk to have included switch that is a base opening sensor coupled to the base of the mouthpiece which hingedly opens, such as that taught by Young, in order to detect when the device is opened and to prime the device for use (Paragraph 0099).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fato (U.S 2022/0305220 A1), as applied to claim 1, in view of Wachter (U.S 5,794,612 A).
Regarding claim 7, the modified device of Fato teaches the device of claim 1.
Fato further discloses wherein the capsule receiver comprises a capsule chamber (see Fig. 1 and 4-5; The capsule chamber 12 includes an upper volume 14 which may contain the capsule during rattling/inhalation and a lower recess 13 which holds the capsule for puncturing and thus acts as a capsule chamber).
Fato is silent regarding a pressure drop chamber adjoining the capsule chamber at a lower part of the capsule receiver which includes a pressure sensor arranged on the board.
However, Wachter teaches that flow rate of the air through the device may be measured by a differential pressure sensor through a dedicated channel (Col. 3 lines 40-47; A differential pressure sensor 14 can measure the pressure drop through a channel 15 to determine flow rate of the inhalation/medicament dispensation).
Fato additionally teaches that the electronic processing unit 46 which is soldered to the PCB is adapted to process signals from the sensors to determine inhalation flow rate and presence of the capsule in the chamber (Paragraph 0070 and 0083).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included a pressure drop chamber at the lower part of the capsule receiver leading/connected to a pressure sensor arranged on the board, such as that taught by Wachter, in order to provide a known sensing mechanism to detect flow rate (Col. 3 lines 40-47 of Wachter) and to allow for determination of inhalation parameters based on the signals from the capsule chamber (Paragraph 0070 and 0080-0081, 0083-0084 of Fato).
Claims 8, 12, 14- 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fato (U.S 2022/0305220 A1), as applied to claim 1, in view of Farina (U.S 2019/0224426 A1).
Regarding claim 8, the modified device of Fato discloses the device of claim 1.
Fato is silent regarding an inhaler position sensor and an antenna, the inhaler position sensor and the antenna being arranged on the electronic board and coupled with a microprocessor.
However, Farina teaches an inhaler wherein supporting electronics can include a position sensor (Paragraph 0062) and an antennae (Paragraph 0109). It is noted that the sensors of Fato are connected to the PCB, as described above.
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included a position sensor and an antenna on the electronic board and coupled to the microprocessor as supporting electronics, such as that taught by Farina, in order to allow for monitoring positioning usage of the inhaler (Paragraph 0062) and to provide support in wireless signaling (Paragraph 0109).
Regarding claim 12, the modified device of Fato discloses the device of claim 1.
Fato is silent regarding a connector arranged on the electronic board, coupled with a microprocessor.
However, Farina teaches connectors as supporting electronics which can be connected or arranged on the electronic board, coupled with a microprocessor (Paragraph 0109; Connectors can be provided to connect different electronic components; also see Paragraph 0043). It is noted that connector is recited with a high degree of generality and without any specific function and is thus highly broad.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included a connector arranged on the electronic board and coupled with a microprocessor, such as that taught by Farina, in order to attach or couple electronic components together for communication and support of the sensing functions of the device (Paragraphs 0043, 0109; also see Paragraph 0070 regarding processor receiving parameters from a detected signal and for communication of firmware logic and data processing).
Regarding claim 14, the modified device of Fato discloses the device of claim 1.
Fato is silent regarding an on/off switch arranged on the electronic board, coupled with a microprocessor.
However, Farina teaches a button switch to turn the device on/off, which can be located anywhere on the device (Paragraph 0070) and further that the circuit board may enable the electronic components to couple together and communicate (Paragraph 0073) and further wherein the battery supplying power to the device is disposed on the circuit board (Fig. 3A, battery 312 is disposed on the board 310).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included an on/off switch arranged on the circuit board and connected to the microprocessor, such as that taught by Farina, in order to allow for turning off of the device (Paragraph 0070) and to allow the circuit board to cut power to the communicating electronic components (Paragraph 0073).
Regarding claim 15, the modified device of Fato discloses the device of claim 1.
Fato is silent regarding a resetting element arranged on the electronic board, coupled with a microprocessor.
However, Farina teaches a button switch to turn the device on/off which thus restarts/resets the device, which can be located anywhere on the device (Paragraph 0070) and further that the circuit board may enable the electronic components to couple together and communicate (Paragraph 0073) and further wherein the battery supplying power to the device is disposed on the circuit board (Fig. 3A, battery 312 is disposed on the board 310). It is noted that applicant has not defined a function of the resetting element and thus is broader than applicant may intend. Applicant may wish to define data or other functionalities that are acted upon by the resetting element.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included a resetting on/off switch arranged on the circuit board and connected to the microprocessor, such as that taught by Farina, in order to allow for turning off of the device (Paragraph 0070) and to allow the circuit board to cut power to the communicating electronic components (Paragraph 0073).
Regarding claim 16, the modified device of Fato discloses the device of claim 15.
Farina further teaches wherein the resetting element is a resetting switch (see Paragraph 0070, 0073; The on/off button is a button switch; also see element 308 switch).
Regarding claim 17, the modified device of Fato discloses the device of claim 1.
Fato is silent regarding a real time clock arranged on the electronic board, coupled with a microprocessor.
However, Farina teaches wherein a sensor device for an inhaler may include a real-time clock to provide time stamping of usage history (Paragraph 0070). It is noted that the sensing components of Fato are disposed on the PCB, as described above.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included a real-time clock on the electronic board and coupled to the microprocessor, such as that taught by Farina, in order to provide accurate date and time-stamping of usage history entries (Paragraph 0070) and to control time bases for sensor and data acquisition functions (Paragraph 0070).
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Fato (U.S 2022/0305220 A1), as applied to claim 1, in view of Buchberger (U.S 2011/0226236 A1).
Regarding claim 19, the modified device of Fato discloses the device of claim 1.
Fato is silent regarding a battery arranged in a frame.
However, Buchberger teaches an inhaler device which has a battery arranged in a frame (see Fig. 1, 10 and Paragraph 0112; A battery 12 which powers the device is arranged in a frame/pocketed housing; It includes a battery cover 6 which forms a backing frame/support to hold the battery in place).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Fato to have included a battery arranged in a frame couplable to the body of the inhaler, such as that taught by Buchberger, in order to allow detachable covering of the battery for ease of removal and replacement (Paragraph 0112).
Regarding claim 20, the modified device of Fato discloses the device of claim 19.
Buchberger further teaches wherein the body is releasably coupled with the frame by means of at least one second coupler (Paragraph 0112 and Figs. 1, 10; The frame of battery cover 6 is releasably coupled to the body of the rest of the inhaler via screw connection).
Regarding claim 21, the modified device of Fato discloses the device of claim 20.
Buchberger further teaches wherein the at least one second coupler is a screw or a bolt (Paragraph 0112, the cover is attached via screw connection).
Allowable Subject Matter
Claims 23-25 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The closest prior art is Roszczyk (WO 2019043639 A1) and Schmidt (U.S 6,293,279 B1) and Kafer (U.S 6,367,473 B1) and Hoekman (U.S 2014/0083424 A1) and Von Hollen (U.S 2011/0232636 A1) and Walz (U.S 2010/0189780 A1) and Hannon (U.S 2018/0369513 A1) and Beyleveld (U.S 2021/0085564 A1).
Regarding claim 23, none of the prior art teaches or suggest the sieve having the specific dimensions of rectangular openings with width between 0.94 and 1 cm and a height between 0.97 and 1.03 cm and spacings between the openings of 0.47 to 0.53 cm. It is noted that the prior art has drastically smaller mesh sizes and a plurality of openings that are typically an order of magnitude smaller. While the prior art does include some baffles or outlets which have only a small number of openings, it would not have been obvious to arbitrarily make said openings rectangular and with the particularly large dimensions. Furthermore, the previously cited prior art Roszczyk reference which has similar structure and mesh structure nested in the mouthpiece has openings on a scale of 1mm and not an order of magnitude larger to 1cm. Thus, it would not have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the limitations of claim 23 unless through impermissible hindsight reasoning or through arbitrary reconstruction of the mesh to scale it to such a larger size than is taught by the prior art.
Similar arguments can be made for claims 24 and 25.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785