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 Amendments
The Amendment filed 11/13/2025 has been entered. Claims 1 and 4 were amended, and claim 5 was canceled. Thus, claims 1-4 are pending in the application.
Claim Objections
Claim 1 is objected to because of the following informality: claim 1 recites “the other end side” in line 10, and is suggested to read --the another end side-- in order to more clearly reference how the limitation was originally claimed. 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 1-4 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 “can be” in line 14 is confusing, as it is unclear as to whether the following limitations are required for the claimed invention or not. It is suggested to use claim language such as --is configured to be-- or --is adapted to be-- in order to ensure clarity.
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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Berg et al. (US 6,435,176 B1) in view of Knoch et al. (US 5,309,900).
Regarding claim 1, as best understood, Berg discloses an inhalation aid for being mounted on a spout port of an atomization type inhaler (spacer connected to mouth-piece of a meter dose inhaler or MDI) (Berg; abstract), comprising:
a tubular main body part (spacer 1 is tubular) (Figs. 1-3; col. 2, lines 39-46);
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 (central opening 8 on end surface 3 of spacer 1 is adapted for a standard mouth-piece adapter of an MDI, thereby receiving the aerosolized drug from the MDI) (Figs. 1-3; col. 2, lines 63-65);
a wall surface part disposed in a position opposed to the introduction port on another end side of the main body part (a small portion of the hemispherical part 5 immediately adjacent to the flange 7, and which is positioned on the opposite end of spacer 1 from the central opening 8) (Figs. 1-3; col. 2, lines 57-65);
a side surface formed from the one end side to the other 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 (side surfaces of spacer 1 extending between its ends, including conically tapering part 2, central cylindrical part 4, and most of hemispherical part 5; the conically tapering part 2 expands radially in the direction from surface 3 towards hemispherical part 5/flange 7) (Figs. 1-3; col. 2, lines 39-65); and
an inhalation port disposed on the main body part for inhaling the drugs introduced into the main body part (central opening 6 at flange 7 of the spacer 1, which is for the attachment of a mouth-piece or face mask through which the aerosol would be inhaled) (Figs. 1-3; col. 2, lines 57-65; col. 3, lines 8-18).
Berg does not disclose the inhalation port disposed on the side surface of the main body part, wherein the inhalation port extends along a tangential direction of the main body part, and the inhalation aid is configured such that a spiral airflow can be generated in the main body part.
However, Knoch teaches an atomizer (Knoch; abstract) the inhalation port disposed on the side surface of the main body part, wherein the inhalation port extends along a tangential direction of the main body part, and the inhalation aid is configured such that a spiral airflow can be generated in 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, such that a spiral vortex of vaporized liquid can be formed in 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 Berg introduction port and inhalation port to be tangential to the main body part, such that the inhalation port disposed on the side surface of the main body part, wherein the inhalation port extends along a tangential direction of the main body part, and the inhalation aid is configured such that a spiral airflow can be generated in the main body part, as taught by Knoch, for the purpose of helping to create a homogenous, even distribution and deceleration of the particles in the spiral vortex (Knoch; col. 3, lines 20-29).
Regarding claim 4, the modified Berg 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 Berg 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).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Berg in view of Knoch as applied to claim 1 above, and further in view of Volgyesi (US 6,116,239).
Regarding claim 2, the modified Berg teaches the invention as previously claimed, but does not teach wherein the inhalation port is disposed on an extended line of the wall surface part.
However, Volgyesi teaches an inhalation device (Volgyesi; abstract) wherein the inhalation port is disposed on an extended line of the wall surface part (mouthpiece opens immediately adjacent to the ceiling 136 of the hold-up chamber, thereby being disposed on an extended line of the ceiling 136) (Volgyesi; Fig. 7; col. 12, lines 39-43).
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 modified Berg device’s inhalation port to be disposed on an extended line of the wall surface part, as taught by Volgyesi, for the purpose of ensuring the substance has traveled several times around the hold-up chamber for improved deaggregation (Volgyesi; col. 8, lines 64-67; col. 9, lines 1-3).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Berg in view of Knoch as applied to claim 1 above, and further in view of Patton et al. (US 5,458,135).
Regarding claim 3, the modified Berg teaches the invention as previously claimed, but does not teach wherein an inner surface inside the main body part of the wall surface part is formed as a recessed surface.
However, Berg does teach the wall surface part has a hemispherical exterior (hemispherical part 5) (Berg; Figs. 1-3; col. 2, lines 57-65), although Berg is silent as to the inner surface of this structure. Moreover, Patton teaches a device for delivering aerosolized doses of medicament (Patton; abstract) wherein an inner surface inside the main body part of the wall surface part is formed as a recessed surface (the top end portion of chamber 100, 150 is hemispherical on both its exterior and interior wall surfaces, and so the inner surface is recessed) (Patton; Figs. 8, 11A-11C).
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 Berg hemispherical wall surface to have a corresponding hemispherical interior, such that an inner surface inside the main body part of the wall surface part is formed as a recessed surface, as taught by Patton, for the purpose of providing the device with a specific suitable inner surface shape which one of ordinary skill in the art could reasonably assume to perform feasibly well for dispensing aerosolized medicament.
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
On page 6 in the “Abstract” and “Claim objections” sections of the Applicant’s remarks, the Applicant argues that the abstract and claims have been amended to overcome the objections of the previous office action. The Examiner agrees, and has thus withdrawn those objections. However, the newly amended claims have raised a new claim objection as detailed above.
On page 6 in the fourth paragraph of the Applicant’s remarks, the Applicant argues that claim 4 has been amended to overcome the 35 U.S.C. 112(b) rejection of the previous office action. The Examiner agrees, and has thus withdrawn that 35 U.S.C. 112(b) rejection. However, the newly amended claims have raised a new 35 U.S.C. 112(b) rejections as detailed above.
Applicant’s arguments on pages 6-11 of the Applicant’s remarks with respect to the newly amended independent claim 1, particularly with regards to the Patton reference, have been considered but are moot in view of new grounds of rejection with new additional Berg reference being used in the current rejection as discussed above.
On page 9 in the third paragraph of the Applicant’s remarks, the Applicant argues that Knoch’s device is in a fundamentally different product category than the Applicant’s retrofit spacer, and thus cannot be used to teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In response to applicant's argument that Knoch is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both the Applicant’s claimed invention and the Knoch reference are directed to devices used to provide a chamber of space which receives an aerosol before delivering the aerosol to a patient (Applicant’s Fig. 1, claim 1, specification paras. [0018-0019]; Knoch, Figs. 1-2, col. 3, lines 10-14, 50-66). Therefore, the Knoch reference is analogous to the Applicant’s claimed invention, and can thus still be used as a teaching reference.
On page 9 in the fourth paragraph of the Applicant’s remarks, the Applicant argues that Knoch does not teach the claimed reverse-tapered shape, and thus cannot be used to teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. The Knoch reference is not being used to teach the claimed reverse-tapered shape, as this limitation is already taught by the Berg reference as detailed in the 35 U.S.C. 103 rejection of claim 1 above. Thus, this argument is moot, and the current prior art of record can be used to teach the Applicant’s claimed invention.
On page 9 in the fourth paragraph to page 10 in the first paragraph of the Applicant’s remarks, the Applicant argues that the Knoch tangential arrangement serves a different purpose than generating a spiral airflow, and thus cannot be used to teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Knoch specifically recites that this tangential arrangement is to produce a spiral airflow (“…the connecting pieces 2’ and 3’, respectively provided at the opening 2 and 3, enter tangentially into the wall 4…so that a spiral vortex is formed in supplying the vaporized liquid”) (Knoch; Figs. 1-2; col. 3, lines 16-23). Thus, the current prior art of record can be used to teach the Applicant’s claimed invention.
On page 11 in the second and third paragraphs of the Applicant’s remarks, the Applicant argues that the amended claim 1 features operate to achieve the unexpected result of enabling patients to adjust inhalation timing without requiring a valve mechanism and enabling a spiral airflow, and so are allowable. However, the Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., enabling patients to adjust inhalation timing without requiring a valve mechanism) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, the result of enabling a spiral airflow is taught by Knoch (openings 2, 3 are tangentially into the side surface of wall 4 of the atomizing space 1, such that a spiral vortex of vaporized liquid can be formed in the atomizing space 1) (Knoch; Figs. 1-2; col. 3, lines 10-29). Thus, the current prior art of record can be used to teach the Applicant’s claimed invention as currently claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785