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 .
Response to Amendment
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
During interview conducted 12/18/2025, the argument with respect to the rejection(s) of combining Ross with Bach and Py have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lammel. Claim 1 is now rejected under 35 U.S.C 102, as Ross discloses depression of a valve core will expel the pressurized aerosol and does not require movement from the reservoir. Therefore, the reservoir is inherently fixed axially as the valve core needs to be push down, requiring the reservoir to be stationary. Regarding Claim 2, Ross is now modified with Lammel, as Lammel teaches an inhaler housing comprising of a lever actuation mechanism. Lammel teaches the actuation of the lever will depress a valve stem to release aerosol, thus directly analogous to Ross. The housing and lever of Lammel merely open a valve in the reservoir and does not include any pumping mechanism. Therefore, the release of aerosol relies on pressurized fluid within the reservoir and the fluid is therefore inherently held under pressure. It would have been obvious to one of ordinary skilled in the art to modify Ross, and place the insert shown in Ross Fig. 1 into the housing of Lammel shown in Lammel Fig. 2.
Claim Rejections - 35 USC § 102
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 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)(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.
Claim(s) 1, 3-9, 15, 16, 18 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Ross (US20030191180).
Regarding Claim 1, Ross discloses an inhaler (par. 0058, “a spray or aerosol device has a bespoke mouthpiece”) comprising: a reservoir (Fig. 1, canister 2) with a liquid medicament preparation (Fig. 1, composition 25) held under pressure by a propellant in the reservoir or in the liquid medicament preparation (par. 0100, “Since the composition 25 in the metering chamber 6 is pressurised with the propellant”), an inhaler housing in which the reservoir is located (par. 0061, “the mouthpiece for directing the dispensed composition to the sublingual area is part of a housing in which the main body, including the container, of the spray device is held”), a discharge nozzle (Fig. 1, outlet passage 19) for forming an aerosol of the medicament preparation that is connected to receive the medicament preparation from the reservoir (par. 0100, “Since the composition 25 in the metering chamber 6 is pressurised with the propellant, it will be expelled from the metering chamber 6 through the outlet orifice 21 and the outlet passage 19”)
Ross further discloses a chamber connected for receiving the aerosol from the discharge nozzle and for holding and temporarily storing the aerosol (Examiner Notes: See par. 0058-0061, a mouth piece as part of the housing is disclosed, a chamber is formed by the mouth piece and the aerosol from the discharge nozzle is temporarily stored in the mouth piece before entering the user’s body; see Fig. 2-7, examples of mouthpiece 100, 200). the chamber comprising a respiratory orifice adapter (Fig. 5 shows the chamber adapts to a dispensing orifice 300, par. 0106) with a dispensing opening fixed at an outlet end of the chamber (Fig. 4, opening 106), and an aerosol receiving inlet surrounding the discharge nozzle at an inlet end of the chamber (See Fig. 5, the chamber surrounds the discharge nozzle and defines an aerosol receiving inlet), the chamber forming an open path from the discharge nozzle to the dispensing opening (par. 0056, “a mouthpiece and a passage leading from the orifice or outlet of the container to the mouthpiece.”), wherein the reservoir is fixed against axial movement relative to the inhaler housing including during actuation of the inhaler (See par. 0100, “Subsequent depression of the valve core 14, in the direction of arrow A… Since the composition 25 in the metering chamber 6 is pressurised with the propellant, it will be expelled from the metering chamber 6 through the outlet orifice 21 and the outlet passage 19.”; par. 0102, “the mouthpiece 200 is used with a conventional upright valve device 202 and is affixed to the moveable button part 204 of the dispensing device. Thus, when the device is in use, the moveable button 204 is depressed and the mouthpiece will also move relative to the main body of the dispensing device”; See Fig. 6,7, actuation only requires the valve 14/button204 to move down, the reservoir must be fixed axially so force can be applied to the valve).
Regarding Claim 3, Ross discloses the inhaler according claim 1, wherein the inhaler comprises an axially movable activating element (Ross, Fig. 1, valve core 14), the medicament preparation being capable of being dispensed by the movement of the activating element (Ross, par. 100, “Subsequent depression of the valve core 14, in the direction of arrow A… Since the composition 25 in the metering chamber 6 is pressurised with the propellant, it will be expelled from the metering chamber 6 through the outlet orifice 21 and the outlet passage 19.”; Fig. 1).
Regarding Claim 4, Ross discloses the inhaler according to claim 1, wherein the inhaler comprises a holder (Ross, Fig. 2, 6, the housing defines an internal space which forms the holder) for an insert (Ross, par. 0056, Fig. 1, 2, 6, the device shown in Fig. 1 is an insert to the holder).
Regarding Claim 5, Ross discloses the inhaler according to claim 4, wherein the insert comprises the reservoir (Ross Fig. 1, 2, par. 0056, see rejection for claim 4 above).
Regarding Claim 6, Ross discloses the inhaler according to claim 4, wherein the insert is axially insertable or inserted into the holder (See Ross Fig. 2, 6, par. 0102 the insert is axially inserted into the holder as shown in the Figures).
Regarding Claim 7, the modified Ross discloses the inhaler according to claim 4, wherein the holder comprises a retaining portion for at least axially retaining the reservoir (Ross Fig. 6, the holder is enclosed at the bottom and therefore forms a retaining portion for axially retaining the reservoir)
Regarding Claim 8, the modified Ross discloses the inhaler according to claim 4, wherein the holder is formed by or in a handle or holding grip (See Ross Fig. 6, when the device is used, the holder is being held in in a user’s hand and therefore is formed by a handle).
Regarding Claim 9, the modified Ross discloses the inhaler according to claim 4, wherein the holder comprises an orientation device for orienting insertion of the insert (Ross Fig. 2, 6, the holder cylindrical shaped to fit the reservoir; the insert must be oriented properly so that the dispensing opening of the insert faces the dispensing opening).
Regarding Claim 15, the modified Ross discloses the inhaler according to claim 1 wherein the inhaler comprises a blocking device which is configured to at least one of: prevent accidental actuation, prevent actuation with the insert not fully inserted, and prevent any further dispensing of the medicament preparation or actuation after a predefined number of actuations has been reached or exceeded (Ross Fig. 1, coil spring 23; the actuation must overcome the action of the spring, therefore preventing accidental actuation).
Regarding Claim 16, the modified Ross discloses the inhaler according to claim 1, but is silent on wherein the discharge nozzle comprises at least three discharge openings (Ross, Fig. 5, par. 0106, “In FIG. 5, the orifices 300 of the dispensing device are shown. There are three orifices”)
Regarding Claim 18,the modified Ross discloses the inhaler according to claim 4, wherein the insert comprises at least one of the features that: a. the insert comprises the reservoir (See Ross, Fig. 1 and 2, the insert comprises reservoir 2), b. the insert is axially insertable or inserted into the holder (See Ross Fig. 1 and 2), c. the holder comprises a retaining portion for at least axially retaining the reservoir, d.the holder is formed by or in a handle or holding grip.
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.
Claim(s) 2, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross in view of Lammel et al. (US6592011), hereafter Lammel.
Regarding Claim 2, the modified Ross discloses the inhaler according to claim 1, but is silent on wherein the inhaler comprises a lever-like actuating element for triggering the aerosol formation, an activating element being mounted to the housing such the activating element opens a valve of the reservoir for forming the aerosol.
However, Lammel teaches an aerosol dispenser, comprising of a reservoir (Fig. 2, aerosol container 10), and a housing (Fig. 1, housing of dispenser 2), wherein the inhaler comprises a lever-like actuating element (Fig. 2, upper section 4, col. 2, line 61-62, “Dispenser 2 has upper section 4 and lower section 6 connected by hinge means 8”; upper section 4 connects to a hinger 8, therefore forming a lever) for triggering the aerosol formation (col. 3, line 11-14, “when downward pressure is applied to top section 4, pressure is exerted on valve stem 12 which opens the aerosol valve, and causes fluid to enter channel 14 through opening 16 and exiting channel 14 through opening 18 into the atmosphere”), an activating element (Fig. 2, bottom part of channel 16) being mounted to the housing such the activating element opens a valve of the reservoir (Fig. 2, col. 3 line 12-14, the prior art discloses a valve in the reservoir) for forming the aerosol (col. 3, line 12-13, “pressure is exerted on valve stem 12 which opens the aerosol valve, and causes fluid to enter channel 14 through opening 16 and exiting channel 14 through opening 18 into the atmosphere”). Therefore, it would have been obvious for one of ordinary skilled in the art to the known inhaler of Ross, with the housing of Lammel, for convenient and quick activation to dispense aerosol as taught by Lammel (Lammel, col. 1 line 24-44).
Regarding Claim 10, the modified Ross discloses the inhaler according to claim 4, but is silent on wherein the holder comprises a release portion for releasing the dispensing of the medicament preparation by insertion of the insert.
However, Lammel teaches an aerosol dispenser, comprising of an insert (Fig. 2, aerosol container 10), and a holder (Fig. 1, housing of dispenser 2),, wherein the holder comprises a release portion (Fig. 2, upper section 4) for releasing the dispensing of the medicament preparation by insertion of the insert (col. 3, line 11-14, “when downward pressure is applied to top section 4, pressure is exerted on valve stem 12 which opens the aerosol valve, and causes fluid to enter channel 14 through opening 16 and exiting channel 14 through opening 18 into the atmosphere”; See Fig. 2, releasing the medicament requires the insert to be inserted). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known inhaler of Ross, with the holder of Lammel, for convenient and quick activation to dispense aerosol as taught by Lammel (Lammel, col. 1 line 24-44).
Regarding Claim 11, the modified Ross discloses the inhaler according to claim 10, wherein the holder comprises an orientation portion for orienting insertion of the insert (Lammel Fig. 2, the holder comprises a structure that holds the insert substantially vertically) and wherein the orientation portion comprises the release portion or vice versa (Lammel Fig. 2, the holder comprises the release portion).
Regarding Claim 12, Ross discloses the inhaler according to claim 10, wherein the dispensing of the medicament preparation is releasable after total insertion of the insert in an intended orientation (See Lammel Fig. 2; a total insertion of the insert is required so the notched lever can function properly).
Claim(s) 13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross, in view of Haikarainen et al. (US6769601), hereafter Haikarainen.
Regarding Claim 13, Ross discloses the inhaler according to claim 1, but is silent on wherein the inhaler comprises a replaceable counter.
However, Haikarainen teaches an inhaler (Fig. 1 and 2), including a reservoir (Fig. 1 and 2, medicament container 8), a holder (Fig. 1, hollow cylindrical element 11) and a replaceable counter (Fig. 1 and 5, metering drum 2 and a counter wheel 1) adapted to be inserted in the holder (Fig. 1, the counter is inserted to the holder), the counter is capable of being replaced as set forth by the functional language of the claim. Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known inhaler of Ross, with the counter inserted into the holder of the inhaler of Haikarainen, to help the patient to keep track of the number of doses still available from the inhaler device as taught by Haikarainen (Haikarainen, col. 1 line 24-33).
Regarding Claim 14, the modified Ross discloses the inhaler according to claim 13, wherein the inhaler comprises a holder (Ross, Fig. 2, the housing defines an internal space which forms the holder) for an insert (Ross, par. 0056, Fig. 1, 2, the device shown in Fig. 1 is an insert to the holder), and wherein the replaceable counter is adapted to be inserted in the holder (Haikarainen, Fig. 1 and 5, metering drum 2 and a counter wheel 1, See rejection for claim 13 above).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross, in view of Brunerie et al. (US5368231), hereafter Brunerie.
Regarding Claim 17, Ross discloses the inhaler according to claim 16, but is silent on wherein the discharge openings have a cumulative outlet surface of more than 0.1 mm2.
However, Brunerie teaches an inhaler (Fig. 1), comprising of a discharge opening (Fig. 1, nozzle 39), wherein the discharge openings have a cumulative outlet surface of more than 0.1 mm2 (col. 1 line 24-40, “said nozzle having a diameter lying between 0.7 and 2mm…”). A diameter between 0.7-2 mm equals to an area of 0.38-3.14 mm2, which is greater than the claimed range of more than 0.1 mm2. Therefore, it would have been obvious for one of ordinary skilled in the art to modify the inhaler of Ross, to incorporate a discharge opening surface of more than 0.1 mm2 as taught by Brunerie, to ensure enough aerosol is provided to a user.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross, in view of Karle (US20120103326), hereafter Karle.
Regarding Claim 19, the modified Ross discloses the inhaler according to claim 1, wherein the respiratory orifice adapter has a shape adapted for dispensing the aerosol into a nostril of a horse.
However, Karle teaches an inhaler (Abstract), comprising of a respiratory orifice adapter (Fig. 4, dispensing device 27) has a shape adapted for dispensing the aerosol into a nostril of a horse (See Fig. 4, par. 0085, “The dispensing device 27 is preferably constructed as a nasal adapter for insertion in a nostril 31 of a horse 32 or other animal”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known inhaler of Ross, with the respiratory orifice adapter of Karle, to allow the inhaler to be used on horse and other animals as taught by Karle (Karle, par. 0085).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785