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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on December 18, 2025 fail to comply with 37 CFR 1.98(a)(3)(i) because they do not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. They have been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hou et al. (CN 109621110 A, hereinafter "Hou") in view of Chen et al. (CN 104971411 A, hereinafter "Chen"), further in view of Young et al. (WO 2004026380 A2, hereinafter "Young").
Regarding Claim 1, Hou discloses: A counter structure of a dry powder aerosol delivery system (Paragraph 0003, This invention belongs to the field of medical device technology, and specifically relates to a dose counting component for an inhaler), comprising a housing of a dry powder aerosol delivery system (Paragraph 0061, As shown in Figures 1 to 20, the inhaler of this preferred embodiment includes a housing 1, a vial 2, and a dose counting component for displaying the remaining dose in the vial 2. The vial 2 is detachably disposed in the housing 1 and can move up and down relative to the housing 1), wherein:
a knob is arranged at an end of a housing (Paragraph 0078, A knob located on the upper part of the housing 1 is formed at the upper end of the sleeve 64. This knob is the mounting bracket 641);
a counting disc, a counting disc cover (Figure 26, counting disk 7), (Paragraph 0067, The mounting bracket 641 is provided with a second window 651 for partially exposing the counting bar 73 of the counting disk 7, or the part of the mounting bracket 641 corresponding to the counting bar 73 is at least partially made of transparent material),
a transmission gear (Figure 29, primary gear 91), (Paragraph 0064, The counting disk 7 and the linkage device are both located in the accommodating cavity 6412, and the counting disk 7 is located on one side of the drive rod 8 in the radial direction. The linkage device includes a primary gear 91 and a second final gear 91a mounted on the mounting bracket 641. The drive rod 8 and the primary gear 91 are connected by a drive structure to drive the primary gear 91 to rotate. The counting disk 7 is provided with teeth 71 that mesh with the second final gear 91a. The second final gear 91a and the primary gear 91 are indirectly meshed and driven through at least one second intermediate gear 93),
a spring (Figure 6, spring 8a), (Paragraph 0063, The first elastic member 8a is a spring, and its two ends abut against the top wall of the mounting bracket 641 and the drive rod 8, respectively),
and a rotating disc (Figure 29, drive disc 81), (Paragraph 0065, The drive structure includes a drive disc 81, a drive rod 8, and a primary gear 91, which are coaxially mounted and arranged sequentially from the inside to the outside. That is, the drive disc 81 is located between the drive rod 8 and the primary gear 91)
are arranged in the housing (Paragraph 0062, As shown in Figures 3-10, the dosage counting assembly includes a counting disk 7, a driving component, and a linkage device);
the housing, the knob, the spring, and the rotating disc are arranged coaxially (Figure 4, Paragraph 0065, The drive structure includes a drive disc 81, a drive rod 8, and a primary gear 91, which are coaxially mounted and arranged sequentially from the inside to the outside. That is, the drive disc 81 is located between the drive rod 8 and the primary gear 91);
the counting disc, the counting disc cover, and the spring are disposed around a straight rod of the rotating disc (Paragraph 0062, As shown in Figures 3-10, the dosage counting assembly includes a counting disk 7, a driving component, and a linkage device. The driving component is a driving rod 8 that moves axially up and down with the medicine bottle 2. The movement of the medicine bottle 2 triggers the counting disk 7 to operate or reset to its initial state (i.e., zeroing)), (Paragraph 0065, The drive structure includes a drive disc 81, a drive rod 8, and a primary gear 91, which are coaxially mounted and arranged sequentially from the inside to the outside. That is, the drive disc 81 is located between the drive rod 8 and the primary gear 91);
an outer gear (Figure 6, second intermediate gear 93) meshed with the transmission gear is arranged on a periphery of the straight rod (Paragraph 0064, The linkage device includes a primary gear 91 and a second final gear 91a mounted on the mounting bracket 641. The drive rod 8 and the primary gear 91 are connected by a drive structure to drive the primary gear 91 to rotate. The counting disk 7 is provided with teeth 71 that mesh with the second final gear 91a. The second final gear 91a and the primary gear 91 are indirectly meshed and driven through at least one second intermediate gear 93. Of course, the teeth 71 and the primary gear 91 can also be directly meshed and driven);
a counter window is formed on a front surface of the knob to allow a patient to see readings and obtain used inhalation times or available remaining inhalation times (Paragraph 0067, The mounting bracket 641 is provided with a second window 651 for partially exposing the counting bar 73 of the counting disk 7, or the part of the mounting bracket 641 corresponding to the counting bar 73 is at least partially made of transparent material);
a counter function is realized on the knob of the counter structure, such that doses are be distributed by means of the knob, and the remaining doses are counted and displayed (Paragraph 0091, The actual method for administering the medication once is as shown in Figure 19: 1. First, adjust the airflow of the second air inlet 13b to a suitable level; 2. Then, check the remaining dosage in the medicine bottle 2 from the counter 7. If there is no remaining dosage, replace the medicine bottle 2; 3. If there is remaining dosage, first rotate the knob clockwise (as shown in Figure 11 from above). Stop rotating after hearing two clicks. At this time, the first window 16 will show red, indicating that the energy storage component has completed the energy storage work).
Hou discloses a gear train assembly (Paragraph 0064, The linkage device includes a primary gear 91 and a second final gear 91a mounted on the mounting bracket 641. The drive rod 8 and the primary gear 91 are connected by a drive structure to drive the primary gear 91 to rotate. The counting disk 7 is provided with teeth 71 that mesh with the second final gear 91a. The second final gear 91a and the primary gear 91 are indirectly meshed and driven through at least one second intermediate gear 93. Of course, the teeth 71 and the primary gear 91 can also be directly meshed and driven), but does not explicitly disclose a vibration gear.
Chen, however, does disclose: A counter structure of a dry powder aerosol delivery system (Paragraph 0003, This invention belongs to the field of devices for introducing media into the human body, and particularly relates to an inhalation-type drug delivery device for delivering a specified dose of powder into the lungs of a patient via the mouth through an airflow during respiration), comprising a housing of a dry powder aerosol delivery system (Paragraph 0086, The drug delivery device housing is composed of an upper cover 16, a housing 6, and a lower housing 1 that are coaxially fitted together in sequence, with a screw cap 8 provided at the lower end of the lower housing), wherein:
a knob is arranged at an end of a housing (Paragraph 0028, The aforementioned screw cap is used to drive the drug delivery metering component and the vibrating drug storage unit to work, respectively realizing their drug delivery metering and vibration functions, thereby enabling the entire drug delivery device to have good adaptability to drug types and convenient adjustment of mechanical structure parameters and vibration effects, and improving the metering accuracy of the drug powder supplied by the drug storage unit during each drug delivery process of the entire powder aerosol drug delivery device);
a transmission gear, a spring, a vibration gear and a rotating disc are arranged in the housing (Paragraph 0027, The screw cap, spring, vibrating gear, turntable, and outer cartridge disposed on the lower component of the flow channel constitute the vibrating drug storage unit of the powder aerosol delivery device);
the housing, the knob, the spring, the vibration gear and the rotating disc are arranged coaxially (Paragraph 0023, The drug delivery metering assembly includes at least one turntable, with a vibrating gear and a spring arranged sequentially below the turntable; the turntable, vibrating gear, and spring are coaxially mounted);
the spring and the vibration gear are disposed around a straight rod of the rotating disc (Paragraph 0088, The drug delivery metering assembly includes at least one turntable 3, with a vibrating gear 12 and a spring 13 arranged sequentially below the turntable; the turntable, vibrating gear and spring are coaxially mounted).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the vibration gear, as disclosed by Chen, with the inhaler assembly taught by Hou, so as to improve the measuring and dispensing of the medicament (Paragraph 0019, The technical problem to be solved by this invention is to provide a powder inhaler delivery device, which has a vibrating gear arranged below the drug delivery metering component to provide longitudinal vibration to the drug delivery metering component. By adopting a "single" or "double" vibration mode for the drug powder in the drug powder storage container, the powder inhaler delivery device has good drug powder adaptability and convenient adjustment of the vibration effect in the design of mechanical structure parameters, so as to better ensure the metering accuracy of the drug powder supplied by the drug storage unit during each drug delivery. At the same time, it simplifies the operation steps of the entire powder inhaler delivery device and provides better operation convenience for patients)
Hou in view of Chen does not explicitly disclose the counting disc and counting disc cover being arranged coaxially with the other elements of the device. However, it would have been obvious to one skilled in the art before the effective filing date to modify or rearrange the gear assemblies to be coaxial.
If the Applicant is not convinced, Young explicitly discloses: the housing, the knob, the counting disc, the counting disc cover are arranged coaxially (Page 9, lines 24-34 As shown in Figure 2, unit wheel 30 is rotatably mounted on a central axle 82 substantially aligned with the central axis 46 and extending from the bottom 44 of the cover 36 […] As shown in Figures 4 and 4A, the unit wheel 30 is nested within the tens wheel 34 such that the outwardly facing side surfaces 60 and 84 are coaxial with and adjacent to one another), (Page 7, lines 26-34, As shown in detail in Figure 2, cover 36 of counter 26 has a bottom 44 which supports the tens wheel 34 for rotational motion about a central axis 46. […] Cooperation between the flange 48 and the boss 50 keeps the tens wheel 34 concentric within the cover 36 and allows guided rotation of the tens wheel about the central axis 46. Bottom 44 also has a circular groove 52 positioned concentric with the central axis)
Similar to Hou in view of Chen, Young also discloses an inhaler system for administering specific doses of medicament to a user, and utilizes rotating elements to accomplish this.
Regarding Claim 2, Hou in view of Chen and Young discloses all of the limitations of Claim 1. Hou further discloses: wherein a limiting groove is formed in an outer wall of the housing, unidirectional grooves are formed in an inner wall of the housing, one surface of each said unidirectional groove is a straight surface, and the other surface of each said unidirectional groove is an oblique surface (Paragraph 0078, As shown in Figures 11-17, a fixing frame 5 is fitted on the medicine bottle 2 and connected to the can body 21 by a snap-fit structure. The fixing frame 5 includes an upper fixing frame 54 and a lower fixing frame 55 that are fixedly connected. The upper fixing frame 54 surrounds the can body 21, and the lower fixing frame 55 is located on the outside of the nozzle 12), (Paragraph 0064, The linkage device includes a primary gear 91 and a second final gear 91a mounted on the mounting bracket 641. The drive rod 8 and the primary gear 91 are connected by a drive structure to drive the primary gear 91 to rotate. The counting disk 7 is provided with teeth 71 that mesh with the second final gear 91a. The second final gear 91a and the primary gear 91 are indirectly meshed and driven through at least one second intermediate gear 93. Of course, the teeth 71 and the primary gear 91 can also be directly meshed and driven).
Regarding Claim 3, Hou in view of Chen and Young discloses all of the limitations of Claim 1. Hou further discloses: wherein the counting disc and the transmission gear are arranged in the knob (Paragraph 0064, The counting disk 7 and the linkage device are both located in the accommodating cavity 6412, and the counting disk 7 is located on one side of the drive rod 8 in the radial direction. The linkage device includes a primary gear 91 and a second final gear 91a mounted on the mounting bracket 641. The drive rod 8 and the primary gear 91 are connected by a drive structure to drive the primary gear 91 to rotate).
Regarding Claim 4, Hou in view of Chen and Young discloses all of the limitations of Claim 1. Hou further discloses: wherein a gear meshed with the transmission gear is arranged in the counting disc (Paragraph 0064, The counting disk 7 is provided with teeth 71 that mesh with the second final gear 91a. The second final gear 91a and the primary gear 91 are indirectly meshed and driven through at least one second intermediate gear 93. Of course, the teeth 71 and the primary gear 91 can also be directly meshed and driven).
Regarding Claim 5, Hou in view of Chen and Young discloses all of the limitations of Claim 1. Hou further discloses:
wherein a center shaft is arranged on the transmission gear (Paragraph 0064, The linkage device includes a primary gear 91 and a second final gear 91a mounted on the mounting bracket 641. The drive rod 8 and the primary gear 91 are connected by a drive structure to drive the primary gear 91 to rotate. The counting disk 7 is provided with teeth 71 that mesh with the second final gear 91a. The second final gear 91a and the primary gear 91 are indirectly meshed and driven through at least one second intermediate gear 93. Of course, the teeth 71 and the primary gear 91 can also be directly meshed and driven), an upper end of the center shaft is limited on the counting disc cover by means of a hole, and a lower end of the center shaft is limited on the knob by means of a hole (Paragraph 0065, The drive structure includes a drive disc 81, a drive rod 8, and a primary gear 91, which are coaxially mounted and arranged sequentially from the inside to the outside. That is, the drive disc 81 is located between the drive rod 8 and the primary gear 91. The inner wall of the drive disc 81 is provided with a guide bar 811, and the outer peripheral wall of the drive rod 8 is provided with a second guide groove 82 spirally arranged from top to bottom in a clockwise direction (see top view in Figure 8). The guide bar 811 is adapted to the shape of the second guide groove 82 and is slidably embedded in the second guide groove 82);
two gears are arranged in a middle of the center shaft of the transmission gear, an upper gear is meshed with the rotating disc, a lower gear is meshed with the counting disc (Paragraph 0064, The linkage device includes a primary gear 91 and a second final gear 91a mounted on the mounting bracket 641. The drive rod 8 and the primary gear 91 are connected by a drive structure to drive the primary gear 91 to rotate. The counting disk 7 is provided with teeth 71 that mesh with the second final gear 91a. The second final gear 91a and the primary gear 91 are indirectly meshed and driven through at least one second intermediate gear 93. Of course, the teeth 71 and the primary gear 91 can also be directly meshed and driven), and the upper gear and the lower gear are arranged coaxially (Paragraph 0065, The drive structure includes a drive disc 81, a drive rod 8, and a primary gear 91, which are coaxially mounted and arranged sequentially from the inside to the outside. That is, the drive disc 81 is located between the drive rod 8 and the primary gear 91).
Regarding Claim 6, Hou in view of Chen and Young discloses all of the limitations of Claim 1. Hou further discloses: wherein the counting disc cover is clamped on an inner wall of the knob and rotates synchronously with the knob, a center hole of the counting disc cover is used for limiting the rotating disc (Paragraph 0104, In this embodiment, the two ends of the first elastic member 8a abut against the top wall 6413 of the mounting bracket 641 and the drive rod 8, respectively. One end of the third torsion spring 72 is connected to the counting disk 7, and the other end is connected to the fixing member 6415 fixed in the accommodating cavity 6412. The third torsion spring 72 is a torsion spring that can be axially compressed), (Paragraph 0078, The sleeve 64 can move up and down relative to the housing 1 and can rotate circumferentially. A knob located on the upper part of the housing 1 is formed at the upper end of the sleeve 64. This knob is the mounting bracket 641), (Paragraph 0091, If there is remaining dosage, first rotate the knob clockwise (as shown in Figure 11 from above) […] At this time, the airflow entering through the first air inlet 13a will push the stop plate 44 and drive the stop seat 4 to rotate counterclockwise as shown in Figure 15. The stop block 41 will disengage from the locking block 321, causing the actuator component to rotate under the action of the second torsion spring 61 and drive the medicine bottle 2 to move down to start the spray. During the inhalation process, the counter 7 will rotate)
Chen discloses: uniformly-distributed groove structures are formed in an upper surface of the counting disc cover to allow the vibration gear to rotate synchronously with the counting disc cover (Paragraphs 0032-0033, When the cap rotates in the first rotation direction, it drives the vibrating gear to rotate. At this time, the turntable cannot rotate under the limiting action of the pawl set on its circumference, and the vibrating gear and the turntable generate relative motion. When the vibrating gear and the turntable generate coaxial and opposite relative motion, under the action of the spring force, the upper and lower vibrating teeth generate mutual misalignment, causing the vibrating gear to continuously strike the turntable, generating a vibration effect. This vibration effect is transmitted through the turntable to the outer cartridge located on the lower component of the flow channel, generating the first vibration effect. Simultaneously, as the turntable vibrates, the striking vibration of the vibrating gear is transmitted synchronously to the inner medicine cylinder located in the outer medicine cylinder, causing the inner medicine cylinder to vibrate freely inside the outer medicine cylinder; the synchronous vibration of the inner medicine cylinder produces a second vibration effect, allowing the drug powder located in the drug powder storage container to flow more evenly into the metering tank).
Regarding Claim 7, Hou in view of Chen and Young discloses all of the limitations of Claim 1. Chen further discloses: wherein the spring is arranged between the counting disc cover and the vibration gear (Paragraph 0088, The drug delivery metering assembly includes at least one turntable 3, with a vibrating gear 12 and a spring 13 arranged sequentially below the turntable; the turntable, vibrating gear and spring are coaxially mounted);
first bevel vibration teeth are arranged on a top surface of the vibration gear and matched with second bevel vibration teeth arranged on a bottom surface of the rotating disc, potential energy of the spring is stored by means of bevel surfaces of the first and second bevel vibration teeth and is released by means of straight surfaces of the first and second bevel vibration teeth to provide a vibration force (Paragraph 0112, In actual operation, when the cap 8 rotates to the first rotation angle along the first rotation direction (counterclockwise when viewed from the top of the powder atomizer), it will drive the vibrating gear 12 to rotate. At this time, the turntable does not rotate under the limiting action of the pawl 3c set on its circumference. The vibrating gear and the turntable generate relative motion (coaxial rotation). Since the upper and lower vibrating teeth 3b and 12a are respectively set on the joint end face of the vibrating gear and the turntable, when the vibrating gear and the turntable generate relative motion, under the elastic force of the spring 13, the two sets of vibrating teeth 3b and 12a will move against each other, causing the vibrating gear to continuously strike the turntable and generate a vibration effect. This vibration effect is transmitted to the outer cartridge located on the lower component of the flow channel through the turntable, generating the first vibration effect), (Paragraph 0114, In this technical solution, the overall vibration effect of the drug storage unit can be adjusted by changing the number and height of the vibrating teeth and the elasticity of the spring, thereby improving the metering accuracy of the drug powder dosage).
Regarding Claim 8, Hou in view of Chen and Young discloses all of the limitations of Claim 1. Young further discloses: wherein unidirectional pawls are arranged on a periphery of the rotating disc, one surface of each said unidirectional pawl is a straight surface, and the other surface of each said unidirectional pawl is an oblique surface, such that the rotating disc is only allowed to rotate along the oblique surfaces in one direction and is not allowed to rotate along the straight surfaces in an opposite direction (Page 11, lines 15-23, Mounted on the coupling 28 opposite to the legs 94 is a ratchet 96 which engages pawls 98 on the unit wheel 30 (see also Figure 5). Thus motion of the air channel assembly 14 relative to the barrel 18 as the inhaler is actuated is transmitted from the mandrel 24 (not shown) to the unit wheel 30 by means of the legs 94, the ratchet 96 and the pawls 98 on the unit wheel 30. The ratchet and pawl are used to move the unit wheel only in one direction to decrement (or increment) the counter for each actuation. As described in detail below, actuation of the inhaler 10 requires a reciprocal motion of the air channel assembly 14 relative to the barrel 18), (Pages 11-12, lines 31-7, As shown in Figure 3, a second ratchet 100 is positioned on the end of barrel 18. As shown in Figure 5, the ratchet 100 faces radially inwardly to engage pawls 102 which are mounted on the unit wheel 30 and face outwardly to engage the ratchet 100. Ratchet 100 and pawls 102 work in cooperation with ratchet 96 and pawls 98 to prevent retrograde motion of the unit wheel when it is actuated by the reciprocal motion of the air channel assembly 14 relative to the barrel 18. The cooperation of the ratchets and pawls is described in detail below in the description of counter operation. Uni-directional motion of the unit wheel is ensured by proper design of the ratchet angles and relative panel lengths of the ratchets 96 and 100 and pawls 98);
Hou discloses: the straight rod is arranged at a center of the rotating disc, and the straight rod downward extends to the transmission gear and is meshed with the transmission gear by means of the outer gear arranged on the straight rod (Paragraph 0064, The second final gear 91a and the primary gear 91 are indirectly meshed and driven through at least one second intermediate gear 93), (Paragraph 0065, The drive structure includes a drive disc 81, a drive rod 8, and a primary gear 91, which are coaxially mounted and arranged sequentially from the inside to the outside. That is, the drive disc 81 is located between the drive rod 8 and the primary gear 91).
Regarding Claim 9, Hou in view of Chen and Young discloses all of the limitations of Claim 1. The combination further discloses: the counter structure is operated and used as follows:
process 1: a patient rotates the knob to drive the counting disc cover and the vibration gear to rotate (Chen, Paragraph 0112, In actual operation, when the cap 8 rotates to the first rotation angle along the first rotation direction (counterclockwise when viewed from the top of the powder atomizer), it will drive the vibrating gear 12 to rotate. At this time, the turntable does not rotate under the limiting action of the pawl 3c set on its circumference. The vibrating gear and the turntable generate relative motion (coaxial rotation)),
the rotating disc keeps static under the action of the unidirectional pawls (Chen, Paragraph 012, At this time, the turntable does not rotate under the limiting action of the pawl 3c set on its circumference),
the vibration gear moves downwards under the action of bevel teeth, and the spring is compressed (Chen, Paragraph 0112, Since the upper and lower vibrating teeth 3b and 12a are respectively set on the joint end face of the vibrating gear and the turntable, when the vibrating gear and the turntable generate relative motion, under the elastic force of the spring 13, the two sets of vibrating teeth 3b and 12a will move against each other, causing the vibrating gear to continuously strike the turntable and generate a vibration effect. This vibration effect is transmitted to the outer cartridge located on the lower component of the flow channel through the turntable, generating the first vibration effect);
when the knob is limited by a lower housing after rotating to an angle, vibration teeth turn from bevel teeth into straight teeth, the vibration gear returns to an original position under the action of the spring (Chen, Paragraphs 0107-0108, When the cap rotates to the first rotation angle along the first rotation direction, i.e., counterclockwise (in this technical solution, the rotation direction of the cap is described or judged as counterclockwise or clockwise when viewed from the top of the powder atomizer dispensing device, the same below), the cap drives the vibrating teeth. At this time, the turntable is not driven by the vibrating teeth, and the vibrating teeth and the turntable generate relative motion. At the same time, the vibrating teeth move up and down under the action of the spring, providing a vibration source for the turntable and the inner and outer cartridges, realizing the function of vibrating or double vibration with the drug storage unit. When the cap rotates to the second rotation angle along the second rotation direction, i.e. clockwise, the cap drives the vibrating teeth, which in turn drive the turntable to rotate along the second rotation direction. At this time, a medicine trough filled with powder rotates from below the medicine cylinder to the ready position, realizing a "quantitative" medicine supply)
and in the process, the counting disc rotates synchronously with the knob, so a reading is not changed (Hou, Paragraph 0020, The first meshing form between the final stage gear and the counting disk is as follows: the teeth are provided on the outer peripheral wall of the counting disk and the counting disk is located on one side of the drive rod in the radial direction), (Paragraph 0091, If there is remaining dosage, first rotate the knob clockwise (as shown in Figure 11 from above) […] At this time, the airflow entering through the first air inlet 13a will push the stop plate 44 and drive the stop seat 4 to rotate counterclockwise as shown in Figure 15. The stop block 41 will disengage from the locking block 321, causing the actuator component to rotate under the action of the second torsion spring 61 and drive the medicine bottle 2 to move down to start the spray. During the inhalation process, the counter 7 will rotate);
process 2: the patient rotates the knob to the initial position, the knob drives the counting disc cover and the vibration gear to rotate (Chen, Paragraphs 0118-0121, A1. Remove the outer cover; B1. Manually rotate the cap to the first rotation angle position along the first rotation direction; C1. During the first rotation of the cap, the vibrating teeth and the turntable move relative to each other, causing vibration to the turntable and the outer medicine cartridge, thereby realizing the vibration function of the medicine storage unit. D1. Manually rotate the cap to the second rotation angle position along the second rotation direction;
the vibration gear drives the rotating disc to rotate by means of the straight teeth (Paragraph 0024, On the lower end face of the turntable, there is a ring of upper vibrating teeth; on the upper end face of the vibrating gear, there is a ring of lower vibrating teeth; and at least one pawl is provided on the circumference of the turntable), (Paragraphs 0101-0102, As shown in Figures 3 and 4, the tips of the upper and lower vibrating teeth are arranged facing each other, forming a one-way ratchet rotation kinematic pair. Furthermore, the upper vibrating teeth are evenly distributed in a ring on the lower end surface of the turntable, with the rotation center of the turntable as the center; the lower vibrating teeth are evenly distributed in a ring on the upper end surface of the vibrating gear, with the rotation center of the vibrating gear as the center)
and during the rotation process of the rotating disc, the transmission gear drives the counting disc to rotate by means of the gear at a bottom (Hou, Paragraph 0064, The linkage device includes a primary gear 91 and a second final gear 91a mounted on the mounting bracket 641. The drive rod 8 and the primary gear 91 are connected by a drive structure to drive the primary gear 91 to rotate. The counting disk 7 is provided with teeth 71 that mesh with the second final gear 91a. The second final gear 91a and the primary gear 91 are indirectly meshed and driven through at least one second intermediate gear 93. Of course, the teeth 71 and the primary gear 91 can also be directly meshed and driven),
and the rotation of the counting disc leads to a change of the reading displayed by the counter window (Hou, Paragraph 0099, As can be seen from the above, during the process of the drive rod 8 moving downward to the first position, the drive arm 83 moves along the first inclined surface 9211; during the process of the drive rod 8 moving upward to the second position, the drive arm 83 moves along the second inclined surface 9221. That is, through one spraying and resetting of the medicine bottle 2, one counting of the counting disk 7 is completed).
Regarding Claim 10, Hou in view of Chen and Young discloses all of the limitations of Claim 9. Hou further discloses: wherein every time the patient completes one time of drug application, the counter structure counts backward once until the reading of the counter structure becomes zero, that is, a service life of the dry powder aerosol delivery system ends (Paragraph 0027, 1. The counting disc of the present invention for displaying the remaining dose in the medicine bottle is triggered by the up and down movement of the medicine bottle to count, which is convenient and accurate without additional operation. Moreover, when the dose counting component is detached from the medicine bottle, the counting disc can automatically return to zero and reset to the initial state, so that the dose counting component can be reused; 2. The dose counting component of the present invention only requires a drive rod, a gear system (linkage device) and a counting disc, involving fewer parts. Compared with the dose counting component with a large number of parts, the dose counting component of the present invention is less prone to failure and has high counting accuracy).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Bruna (US 5988496 A) also discloses a dose counter for inhalers
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights