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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 30, 2026 has been entered.
Response to Amendment
The response filed on March 30, 2026 is acknowledged. Four pages of drawings (two pages with corrections and two pages marked “Replacement Sheet”) and fourteen pages of Specification (one page of specification marked “AMENDMENTS TO THE SPECIFICATION” and thirteen pages marked “SUBSTITUTE SPECIFICATION”) were received on March 30, 2026. The drawings and the specification are acceptable to correct the obvious scrivener’s errors in the original disclosure. However, new issue arises with the newly amended limitation in claim 26. See detailed objection and rejection below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the outer diameter of the outlet being equal or larger than the diameter of the swirl chamber as amended in claim 26 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Figs. 1 and 2 fail to show that the outer diameter of the outlet 130 being equal or larger than the diameter of the swirl chamber 120. Clarification is requested.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 26, 29 and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The disclosure, as originally filed, does not disclose that the outer diameter of the outlet being equal or larger than the diameter of the swirl chamber as amended in claim 26. Figs. 1 and 2 fail to show that the outer diameter of the outlet 130 being equal or larger than the diameter of the swirl chamber 120. Clarification is requested.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 6, 8-10, 12, 20-23, 25, 26, 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fech et al., (US20140107620. Fech hereinafter) in view of Banyasz et al. (WO2022008673. See attached English translation by Google Patent. Banyasz hereinafter).
With respect to claim 1, Fech discloses a method for forming a swirl nozzle (1. Embodiment in Figs. 8a-9b) that is monolithic and configured to (capable of) aerosolize a liquid with a pharmaceutical drug, the swirl nozzle comprising: an inlet (40, 50, 64) for receiving the pharmaceutical drug to be aerosolized; a swirl chamber (11, 45, 55, 65) connected to the inlet and configured to aerosolize the pharmaceutical drug provided by the inlet; and an outlet (23) connected to the swirl chamber and configured to discharge the aerosolized pharmaceutical drug; the method comprising: providing a photoactivatable material; and forming the swirl nozzle by selectively activating voxels in the photoactivatable material (method steps are considered as being implied in the method mentioned in paragraph [0095], i.e. laser sintering).
Fech fails to disclose wherein the photoactivatable material comprises a polymer and wherein the voxels are selectively activated using two-photon polymerization; and removing non-activated photoactivatable material.
However, Banyasz teaches a method and an associated two-photon 3D printing device using two-photon polymerization (Abstract), wherein the photoactivatable material comprises a polymer (radically polymerisable resin) and wherein the voxels (Page 2, third paragraph under “State of the art”) are selectively activated using two-photon polymerization; and removing non-activated photoactivatable material (by final rinsing step of the monomer residues without undergoing significant distortion. Page 6, eight paragraph).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the two-photon polymerization method, as taught by Banyasz, to make Fech’s swirl nozzle, in order to allow the creation of complex miniaturized structure (Page 2, first paragraph under “State of the art;” page 2, last paragraph but one; page 3, eleventh paragraph).
With respect to claim 6, Fech’s sintering method modified by Banyasz’s method, Fech further discloses wherein the swirl nozzle comprises a plurality of inlets (40, 50, 64).
With respect to claim 8, Fech’s sintering method modified by Banyasz’s method, Fech fails to disclose wherein the swirl nozzle comprises a plurality of outlets.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to add a plurality of outlets in order to increase the flow output or rate, since such a modification would amount to a mere duplication of parts. It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. and In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) where the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See MPEP 2144.04, Subtitle VI, Section C.
With respect to claim 9, Fech’s sintering method modified by Banyasz’s method, Fech further discloses wherein the outlet comprises an outlet structure with a gradually increasing hydraulic diameter (Fig. 8b).
With respect to claim 10, Fech’s sintering method modified by Banyasz’s method, Fech further discloses wherein the swirl chamber comprises inlet channels (11, 45, 55, 65. Figs. 8a and 8b), wherein the inlet channels are configured to (capable of) create a swirling motion in a stream of the pharmaceutical drug from the inlet to the outlet, such that the pharmaceutical drug is aerosolized.
With respect to claim 12, Fech’s sintering method modified by Banyasz’s method, Banyasz further teaches wherein a plurality of voxels (Page 2, third paragraph under “State of the art”) are activated simultaneously.
With respect to claim 20, Fech’s sintering method modified by Banyasz’s method, Fech and Banyasz discloses the method according to claim 1 except for wherein selectively activating a voxel in the photoactivatable material comprises exposing the voxel to photons in an ultraviolet range of 100-400 nm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to selectively activating a voxel in the photoactivatable material comprises exposing the voxel to photons in an ultraviolet range of 100-400 nm, since the claimed values are merely an optimum or workable range. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claims 21-23 and 25, Fech’s sintering method modified by Banyasz’s method, Fech discloses the monolithic swirl nozzle configured to aerosolize a pharmaceutical drug, wherein the swirl nozzle is formed by the method according to claim 1. Fech fail to disclose the outlet has a diameter in a range of 10-500 µm (Claim 21), wherein the swirl nozzle comprises a width of 4 mm or less (Claim 22), wherein the swirl nozzle comprises a height in a range of 0.1-1 mm (Claim 23) and wherein the inlet comprises a channel with a height in a range of 20-500 µm (Claim 25).
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to design the outlet having a diameter in a range of 10-500 µm (Claim 21), the swirl nozzle comprises a width of 4 mm or less (Claim 22), wherein the swirl nozzle comprises a height in a range of 0.1-1 mm (Claim 23) and wherein the inlet comprises a channel with a height in a range of 20-500 µm since the claimed values are merely an optimum or workable range. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 26, Fech discloses a swirl nozzle (1. Embodiment in Figs. 8a-9b) that is monolithic and configured to (capable of) aerosolize a pharmaceutical drug, the swirl nozzle comprising: an inlet (40, 50, 64) for receiving the pharmaceutical drug to be aerosolized; a swirl chamber (11, 45, 55, 65) having a diameter connected to the inlet and configured to (capable of) aerosolize the pharmaceutical drug provided by the inlet; and an outlet (23) connected to the swirl chamber and configured to (capable of) discharge the aerosolized pharmaceutical drug, the outlet having an inner diameter and an outer diameter, the outer diameter of the outlet being equal or larger than the diameter of the swirl chamber.
Fech fails to disclose wherein the swirl nozzle comprises a polymer.
However, Banyasz teaches a method and an associated two-photon 3D printing device using two-photon polymerization (Abstract), wherein the photoactivatable material comprises a polymer (radically polymerisable resin) and wherein the voxels (Page 2, third paragraph under “State of the art”) are selectively activated using two-photon polymerization; and removing non-activated photoactivatable material (by final rinsing step of the monomer residues without undergoing significant distortion. Page 6, eight paragraph).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the two-photon polymerization method, as taught by Banyasz, to make Fech’s swirl nozzle, in order to allow the creation of complex miniaturized structure (Page 2, first paragraph under “State of the art;” page 2, last paragraph but one; page 3, eleventh paragraph).
As for the outlet having an inner diameter and an outer diameter, the outer diameter of the outlet being equal or larger than the diameter of the swirl chamber, it would have been an obvious matter of design choice to make the outlet having an inner diameter and an outer diameter, the outer diameter of the outlet being equal or larger than the diameter of the swirl chamber, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
With respect to claims 29 and 30, Fech discloses the monolithic swirl nozzle as in claim 26 except for wherein a volume of a material forming the swirl nozzle is less than 25 mm3 (Claim 29) and wherein a maximum outer width of the swirl nozzle is less than 4 mm (Claim 30).
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to design the volume of a material forming the swirl nozzle is less than 25 mm3 (Claim 29) and wherein a maximum outer width of the swirl nozzle is less than 4 mm since the claimed values are merely an optimum or workable range. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fech in view of Banyasz and further in view of Melton (US 20150285504).
With respect to claim 14, Fech’s sintering method modified by Banyasz’s method, Fech and Banyasz fail to disclose wherein the forming comprises a first forming stage and a second forming stage, and wherein the first forming stage comprises forming at least part of the swirl nozzle by selectively activating voxels in the photoactivatable material, and the second forming stage comprises an additional curing of the swirl nozzle.
Melton teaches a method (200. Fig. 9) of forming a swirl nozzle (trapped vortex fuel injector 100) that is monolithic, the method comprising: providing a photoactivatable material; and forming the swirl nozzle by selectively activating voxels in the photoactivatable material (206). Melton further teaches wherein the forming comprises a first forming stage (step 204) and a second forming stage (step 206), and wherein the first forming stage comprises forming at least part of the swirl nozzle by selectively activating voxels (using the Direct Metal Laser Sintering (DMLS) process to create the three-dimensional computer model of the component. [0058]) in the photoactivatable material, and the second forming stage comprises an additional curing (time by successively formed 206 by fusing a metallic powder using laser energy. [0059]) of the swirl nozzle.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of the forming method, as taught by Melton, to Fech’s swirl nozzle, in order to reduce costs and weight of the nozzle ([0056]- [0057]).
With respect to claim 16, Fech’s sintering method modified by Banyasz and Melton’s method, Melton further teaches the method further comprises at least one of forming the swirl nozzle on the holder and fixating the swirl nozzle on a holder (laser sintering machine. [0060]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 26 have been considered but are moot because the new ground of rejection does not rely on the reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEE-CHONG LEE whose telephone number is (571)270-1916. The examiner can normally be reached Monday-Friday 8am -5pm.
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/CHEE-CHONG LEE/Primary Examiner, Art Unit 3752 June 13, 2026
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