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
Claims 4 and 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/05/2026.
Applicant's election with traverse of Species 1 in the reply filed on 06/05/2026 is acknowledged. The traversal is on the ground(s) that no search burden exists between the species as outlined from the restriction requirement dated 04/09/2026. This is not found persuasive because the species require a different field of search such as employing different search strategies of search queries. For example, the species of Figs. 1 – 3 requires search queries such as “direct”, “piston”, “mechanical”, etc., the species of Figs. 4 – 6 requires search queries such as “indirect”, “separable”, “linkage”, etc., and the species of Figs. 7 – 9 requires search queries such as “electromagnetic”, “coil”, “induction”, etc.. Additionally, prior art to the embodiment of Figs. 1 – 3 may not necessarily constitute an obvious variant to claimed features of the other species.
The requirement is still deemed proper and is therefore made FINAL.
Priority
With respect to claims 1 – 3 and 7, acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(e) with reference to Application Number: 63424950 filed on 11/14/2022.
With respect to claims 6 and 8 – 10, the later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/424950, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claim 6 lacks support for the claimed micro-motor and electromagnetic reciprocating structure, and claim 8 lacks support at least for the claimed circuit board, position sensor, and battery. Claims 9 and 10 depend from claim 8.
Accordingly, claims 6 and 8 – 10 have an effective filing date of 11/02/2023.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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.
Claim 3 is 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. It is unclear how the piston can define both the first and second space, yet the second space define an enclosed space independent of the first space. The second space must necessarily depend upon the first space as claimed, since any loss in space due to piston movement in the first space must be gained in the second space. Accordingly, the claim is unclear as currently written.
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)(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.
Claim(s) 1 – 3 and 6 – 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imai (US 20100206307).
1. Imai discloses a drug delivery device (see [0001], various figures such as Fig. 3, Fig. 18), comprising: a main housing having an internal space (see 17, Fig. 4, Fig. 19, [0059]); and a drug delivery module (1, 2, and 3; examiner notes that element 3 corresponds to elements 45, 49, and 50 in Fig. 18) disposed in the internal space so as to be isolated from an external environment (see Figs. 3 – 4 and 18 – 19, [0059], the module is placed into the housing 17 with cover 18 then locked, thus completely isolating the drug delivery module from the external environment; the device is controlled internally, see [0079]); wherein the drug delivery module includes a drug bottle that contains a liquid drug (1 and 2, [0047]) and a driver that is connected to the drug bottle (3, e.g. 45, 49, 50), and wherein the driver is configured to push the liquid drug to pass through a drug nebulization structure of the drug bottle (1, [0045], [0066]) such that the liquid drug is nebulized into a nebulized drug (nebulized droplets are produced at the ejection head of the inhaler, see general teachings in [0046], [0002]; the driver provides contributing pushing force during ejection/nebulization, see [0051], [0099]).
2. Imai discloses the drug delivery device according to claim 1, wherein the driver is connected to the drug bottle via a piston (53), and the piston is moved along an inner wall of the drug bottle by a thrust provided by the driver ([0118, 0119]).
3. Imai discloses the drug delivery device according to claim 2, wherein the drug bottle and the piston define a first space, and the piston and the driver define a second space, and wherein the second space is an independent enclosed space (see Fig. 18, first space defined by 29, second space defined by 45, where the second space is independent of 29 which can be removed per [0066]).
6. Imai discloses the drug delivery device according to claim 1, wherein the driver is a pneumatic pump, a micro-motor, or an electromagnetic reciprocating structure (see [0068], and [0118], respectively).
7. Imai discloses the drug delivery device according to claim 1, wherein the drug nebulization structure is a micro-nozzle or a filtering screen (see [0064]).
8. Imai discloses the drug delivery device according to claim 1, further comprising a control module including a circuit board (control substrate 25, see [0116], [0086], Fig. 18) a position sensor (92, see [0121 – 0122]), and a battery (unillustrated, see [0064]), wherein the circuit board drives the driver to execute a driving program (see [0079]), the position sensor senses a position of a piston driven by the driver ([0121 – 122]), and the battery stores electrical power for driving the piston (see [0077 – 0079], the battery is determined to have sufficient power for the inhaling action of driving/pressurizing the movable piston wall).
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.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imai in view of van der Linden (US 5950619).
9. Imai discloses the drug delivery device according to claim 8, further comprising a support base (cartridge holder 29), wherein the support base encloses the drug bottle (the cartridge holder encloses the drug bottle upon closing the housing, compare Figs. 3 and 4). However, Imai does not disclose that the support base supports the control module. Nonetheless, van der Linden discloses an inhaler with a removable cartridge and cartridge holder forming a support base that encloses the drug bottle and supports a control module including a circuit board, a position sensor, and battery (see Fig. 2, support base 36 holding circuit board 6, position sensor 92, and battery 6 per c. 15: 42 - 67). Therefore, according to the teachings of van der Linden, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the support base 29 of Imai to support a control module component(s) such as battery and/or position sensor for the benefit of stably anchoring the components in proximity to the cartridge holder. With regard to the supported position sensor, Imai discloses in para [0122] that any method of directly measuring the moving amount of the rubber plug 34 may be employed for the benefit of recognizing that the drug bottle is empty in the various embodiments as disclosed.
10. Imai discloses the drug delivery device according to claim 9, further comprising a waterproof module, wherein the waterproof module is at least disposed on a side of the drug bottle, and the waterproof module surrounds a periphery of the side (see 36, 37, [0065]). However, Imai does not disclose that the waterproof module is disposed on a side of the support base adjacent to the nozzle. Nonetheless, it would have been obvious to provide the side of the support base adjacent the nozzle of Imai with a waterproof module, as taught elsewhere in the device, for the benefit of preventing the ejection of drug onto sensitive internal components within the housing. Examiner notes that “waterproof module” as claimed is a broad term that may include permanent jointing and/or combinations involving other waterproof components surrounding the periphery.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Other inhalers with enclosed drug bottles:
KR 101692941 B1
EP 4295879 A1
US 20090133691 A1
US 11298472 B2
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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