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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/15/2026 has been entered.
Response to Amendments
The Amendment filed 4/15/2026 has been entered. Claim 1 was amended, and claims 3 and 5 were canceled. Thus, claims 1-2 and 4 are pending in the application.
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 1-2 and 4 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 1, the limitation “a position” in lines 7-8 is confusing, as it is unclear whether or not this limitation is meant to be the same as “a position” in line 6. For the purposes of examination, they will be interpreted as the same limitation. Moreover, the limitations “is generated” in line 21, “is reflected” in lines 22-23, “dispersed” in line 23, “focalizing” in line 25, “are prevented” in line 25, and “being trapped” in line 26 are confusing, as these are method steps while the claim is directed towards an apparatus. It is suggested to use claim language such as --is configured to be-- or --is adapted for-- in order to avoid such indefiniteness.
Regarding claim 4, the limitation “an inner surface” in line 2 is confusing, as it is unclear whether or not this limitation is meant to be the same as “an inner surface” in claim 1. For the purposes of examination, they will be interpreted as the same limitation.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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.
Claims 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Massardier et al. (US 2006/0137685 A1) in view of Sioutas (US 5,115,803), or alternatively over Massardier in view of Knoch et al. (US 5,309,900) and Sioutas.
Regarding claim 1, as best understood, Massardier discloses an inhalation aid for being mounted on a spout port of an atomization type inhaler (aerosol transfer device mounted on a pneumatic or ultrasonic nebulizer 12 spout) (Figs. 8.1-8.2; abstract; para. [0046]), comprising:
a tubular main body part (tubular main body defining the area ZS) (Figs. 8.1-8.2; para. [0046]);
an introduction port disposed on one end side of the main body part for introducing drugs atomized from the spout port of the inhaler into the main body part (first opening 2a on the bottom end of the tubular main body, where the pneumatic or ultrasonic nebulizer 12 introduces an aerosol from its spout) (Figs. 8.1-8.2; para. [0046]);
a wall surface part disposed in a position opposed to the introduction port on another end side of the main body part, wherein the wall surface part is disposed at a position intersecting with a center line that passes through a center of the introduction port and extends along a longitudinal direction of the main body part (the wall on the top end of the tubular main body opposite the first opening 2a, and which is disposed along a longitudinal centerline of the tubular main body that runs through the center of the of first opening 2a) (Figs. 8.1-8.2; para. [0046]);
a side surface formed from the one end side to the another end side of the main body part, wherein the side surface is formed at least partly in a reverse-tapered shape radially expanding from the one end side to the other end side (tubular main body has a side surface in a reverse tapered shape radially expanding in the direction of the first opening 2a towards the second opening 2b) (Figs. 8.1-8.2; para. [0046]); and
an inhalation port disposed on the side surface for inhaling the drugs introduced into the main body part (second opening 2b is on the side surface of the tubular main body, and a patient uses it to inhale the aerosol from the tubular main body during inspiration) (Figs. 8.1-8.2; para. [0046]), wherein
the inhalation port extends along a tangential direction of the main body part (the second opening 2b extends from the periphery of the tubular main body) (Figs. 8.1-8.2; para. [0046]).
Alternatively, if Massardier is not seen as definitely disclosing the inhalation port extends along a tangential direction of the main body part, Knoch teaches an atomizer (Knoch; abstract) wherein the inhalation port extends along a tangential direction of the main body part (opening 3 for withdrawal of vaporized liquid is tangentially into the side surface of wall 4 of the atomizing space 1) (Knoch; Figs. 1-2; col. 3, lines 10-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Massardier inhalation port such that the inhalation port extends along a tangential direction of the main body part, as taught by Knoch, for the purpose of providing a more specific location for the inhalation port on the main body part periphery which would help to create a spiral vortex of flow for the more homogenous, even distribution and deceleration of the particles (Knoch; col. 3, lines 20-29).
Massardier does not disclose an inner surface of the wall surface part is continuously curved and recessed in a hemispherical shape, a deepest portion of the recessed surface of the wall surface part is positioned on an extended line of the center line of the introduction port, and the inhalation aid is configured such that: a spiral airflow is generated in the main body part, and an airflow including drug particles introduced from the introduction port is reflected by the inner surface of the wall surface part and dispersed toward a center of the main body part, and whereby focalizing a flow of the drug particles, the drug particles are prevented from being trapped on an inner surface of the side surface.
However, Sioutas teaches an inhalation therapy device with a deagglomeration chamber (Sioutas; abstract) including wherein an inner surface of the wall surface part is continuously curved and recessed in a hemispherical shape (deagglomeration chamber 32 has the inner wall surface opposite the aerosol canister 12 and adjacent to exit chamber 38 as an arcuate surface 34, which is a curved and recessed hemispherical shape) (Sioutas; Figs. 2-3; col. 3 lines 42-47).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Massardier wall surface such that an inner surface of the wall surface part is continuously curved and recessed in a hemispherical shape, as taught by Sioutas, for the purpose of providing the chamber with a shape that helps aerosol particles to remain suspended in the chamber for a time sufficient for a patient to inhale them without having to carefully coordinate with the actuation of the aerosolization canister (Sioutas; col. 5 lines 6-18) and which also helps to trap the large particles outside of the respirable range in the curved recessed shape, which can later be cleaned out, and thereby help to reduce the amount of drug inadvertently administered (Sioutas; col. 5 lines 19-28).
With this modification, the modified Massardier would thus teach a deepest portion of the recessed surface of the wall surface part is positioned on an extended line of the center line of the introduction port (the Massardier wall on the top end of the tubular main body opposite the first opening 2a was modified by Sioutas to be hemispherical, and so would have its deepest portion of the hemisphere on the extended centerline running through the Massardier first opening 2a) (Massardier, Figs. 8.1-8.2, para. [0046]; Sioutas, Figs. 2-3, col. 3 lines 42-47), and the inhalation aid is configured such that: a spiral airflow is generated in the main body part, and an airflow including drug particles introduced from the introduction port is reflected by the inner surface of the wall surface part and dispersed toward a center of the main body part, and whereby focalizing a flow of the drug particles, the drug particles are prevented from being trapped on an inner surface of the side surface (as the modified Massardier device teaches the structure as claimed, it would thus be able to function as claimed to create the spiral airflow with aerosolized drug particles from the Massardier first opening 2a and pneumatic or ultrasonic nebulizer 12, and reflect the spiral airflow off the inner surface off the Massardier wall on the top end of the tubular main body opposite the first opening 2a modified by Sioutas to be hemispherical to disperse the aerosolized particles towards a center of the Massardier tubular main body, thereby focalizing the flow of aerosolized drug particles and preventing them from being trapped on an inner surface of the sides of the Massardier tubular main body) (Massardier, Figs. 8.1-8.2, para. [0046]; Sioutas, Figs. 2-3, col. 3 lines 42-47).
Regarding claim 2, the modified Massardier teaches wherein the inhalation port is disposed on an extended line of the wall surface part (the second opening 2b is disposed on an extended line of the wall on the top end of the tubular main body opposite the first opening 2a) (Massardier; Figs. 8.1-8.2).
Regarding claim 4, as best understood, the modified Massardier teaches the invention as previously claimed, but does not teach wherein one or a plurality of protrusions or recesses are formed on an inner surface inside the main body part of the wall surface part.
However, Knoch further teaches wherein one protrusion is formed on an inner surface inside the main body part of the wall surface part (cylindrical central part 8 is a protrusion formed on an inner surface of cylindrical atomizing space 1 body at the side wall of end 7) (Knoch; Figs. 1-2; col. 4, lines 45-64; col. 5, lines 18-28).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Massardier device to include one protrusion formed on an inner surface inside the main body part of the wall surface part, as taught by Knoch, for the purpose of supporting the formation of the spiral vortex (Knoch; col. 4, lines 45-64).
Response to Arguments
Applicant's arguments filed 4/15/2026 have been fully considered but they are not persuasive.
On page 5 in the “Claim objections” section of the Applicant’s remarks, the Applicant argues that claims have been amended to overcome the claim objection of the previous office action. The Examiner agrees, and has thus withdrawn that claim objection.
On page 5 in the “Claims 1-4 stands rejected under 35 U.S.C. 112(b) as being indefinite” section of the Applicant’s remarks, the Applicant argues that claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections. However, the newly amended claims have raised new 35 U.S.C. 112(b) rejections as detailed above.
Applicant’s arguments on pages 5-14 of the Applicant’s remarks with respect to the newly amended independent claim 1 have been considered but are moot in view of new grounds of rejection with new additional Massardier and Sioutas references being used in the current 35 U.S.C. 103 rejection as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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