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
The amendment filed 04/13/2026 has been entered. Claims 1-7 have been amended. Claims 13-19 have been canceled. Accordingly, claims 1-12 remain pending and are the claims addressed and examined below.
Election/Restrictions
Claim 1 is allowable. Claims 7-12, previously withdrawn from consideration as a result of a restriction requirement, requires all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions I and II, as set forth in the Office action mailed on 02/13/2026, is hereby withdrawn and claims 7-12 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Objections
Claim 10 is objected to because of the following informalities: the recitation “the pressure of the gas” in line 2 should read “the pressure of the pressurized gas jet” as introduced in lines 11-12 of claim 1 - one of ordinary skill in the art would reasonably deduce the pressure of the gas was intended to reference the pressure of the pressurized gas jet and therefore does not result in ambiguous claim language; however, the Examiner recommends using consistent language throughout. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: the recitation “wherein the gas is” in line 2 should read “wherein the pressurized gas jet comprises/includes” as introduced in lines 11-12 of claim 1 - one of ordinary skill in the art would reasonably deduce the gas was intended to reference the pressurized gas jet and therefore does not result in ambiguous claim language; however, the Examiner recommends using consistent language throughout. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3: the phrase “such as” in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 5: the phrase “such as” in line 3 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Allowable Subject Matter
Claims 3 and 5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 1-2, 4 and 6-12 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the primary reason for indicating claim 1 as allowable is that the prior art fails to provide any teaching, suggestion, motivation or other rationales to arrive at the system comprising a primary nebulizer for producing an aerosol flow comprising droplets comprising the active pharmaceutical (API), a secondary nebulizer for exposing the aerosol flow to gas jet, and connecting means therebetween.
Inagaki et al. (US 2020/0391235) discloses: a nebulizer capable of ejecting a sample liquid in the form of fine droplets (Inagaki at [0027], FIG. 1, FIG. 2A) and the nozzle 40 is composed of the tip ends of the liquid supply tube 22 and the gas supply tube 24 of the nebulizer 25 and the tip end of the torch injector 28. The nozzle 40 includes an outlet 22a of the liquid supply tube 22, an outlet 24a of the gas supply tube 24, and an outlet 28a of the torch injector 28 (Inagaki at [0036], FIG. 2A)
Lisa et al. (US 2006/0115535) discloses: an atomizer comprising an inlet, an outlet, and a first coaxial passage and a second coaxial passage configured to terminate adjacent to each other at the outlet, wherein the second coaxial passage is configured to position a nozzle (Lisa at [0023], Figure 3 – see the annotated version provided below).
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Skeath et al. (US 6,352,209) discloses: a gas-assisted atomizing device comprising a substantially planar first layer, and a substantially planar second layer having a plurality of liquid orifices and a plurality of gas orifices formed therein. The first and second layers form a liquid supply network including a plurality of liquid channels that supply liquid to the plurality of liquid orifices and force liquid through the liquid orifices to form streams of liquid, and a gas supply network including a plurality of gas channels that supply gas to the plurality of gas orifices and force gas through the gas orifices to atomize the streams of liquid (Skeath at column 3, lines 21-32; FIG. 1; FIG. 3).
Though, Inagaki, Lisa and Skeath fail to disclose, viewed either alone or in combination, system comprising a primary nebulizer for producing an aerosol flow comprising droplets comprising the active pharmaceutical (API), a secondary nebulizer for exposing the aerosol flow to gas jet, and connecting means therebetween.
Consequently, give the discussion above, it is the Examiner’s assessment that no reference viewed either alone or in combination teaches or reasonably suggests the claimed system meeting every limitation of independent claim 1. Claims 2, 4 and 6-12 are indicated as allowable due to their dependency on claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEIGH K. DARNELL whose telephone number is (469)295-9287. The examiner can normally be reached M-F, 9am-5pm, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Galen H. Hauth can be reached at (571)270-5516. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BAILEIGH KATE DARNELL/Examiner, Art Unit 1743
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