DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to applicant’s remarks filed December 5, 2025. Claims 16-30 are pending and stand rejected.
Claim Rejections - 35 USC § 103
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.
Claims 16-30 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060213503 A1 (hereinafter BORGSCHULTE). BORGSCHULTE was made of record on applicant’s information disclosure statement filed September 6, 2022.
Regarding claim 16, BORGSCHULTE discloses an inhalation therapy device with a control device connected to an actuating device to cause the membrane of the nebulizing device to oscillate (abstract). BORGSCHULTE discloses a membrane (Figs. 1-2b, membrane 3, ¶54) having an aerosol-generation zone (Fig. 5, ¶51, ¶63) in which the aerosol-generation zone comprises a plurality of nozzles (Fig. 5, holes 38, ¶63), the plurality of nozzles being the only nozzles in the aerosol-generation zone. BORGSCHULTE further discloses an actuator (Fig. 1, actuating device 4, ¶54) coupled to the membrane, wherein the actuator is configured to excite the membrane to induce a vibration of the membrane at one or more predetermined modal frequencies of the membrane such that a liquid aerosol-forming substrate passing through the plurality of nozzles is aerosolized (¶13). BORGSCHULTE discloses that the actuating device causes the membrane to oscillate at different frequencies and that this oscillation excited at different frequencies generates the aerosol in different droplet sizes (¶13). BORGSCHULTE discloses that the different frequencies provide therapy at different droplet spectrums for example, the respiratory system of an adult vs an infant or the upper vs the lower respiratory system (¶14). BORGSCHULTE further discloses wherein more than 50% of the plurality of nozzles are located closer to antinodes than to nodes of the membrane, where the antinodes and the nodes correspond to the membrane being excited at the one or more predetermined modal frequencies of the membrane. BORGSCHULTE discloses that the points of the membrane which experience high deflection, the generation of an aerosol is especially effective if a larger number of holes is present (¶19). BORGSCHULTE discloses in areas of lower deflection or at oscillation nodes which experience no deflection at all it cannot be anticipated that an aerosol will be generated (¶19). BORGSCHULTE discloses that for reasons of efficiency it is desired to dispense with holes at points with no aerosol generation (the nodes). BORGSCHULTE further discloses that dispensing with holes at oscillation nodes or oscillational nodal lines makes it possible to prevent fluid from passing through the membrane at that point by way of holes or to prevent liquid from inadvertently collecting on the structures (¶19). Therefore, since BORGSCHULTE discloses to not have holes at the no aerosol generation nodes, more than 50% of the holes are located closer to the antinodes (¶19, ¶61-¶62)
BORGSCHULTE teaches, in another embodiment, wherein the membrane continuously and progressively changes in thickness in a step-free manner from a centre of the membrane to a peripheral edge of the membrane. BORGSCHULTE teaches that varying the thickness of the membrane can promote or suppress oscillation to generate aerosols with a specific droplet spectrum (Figs. 6-7, ¶22-¶23, ¶64-¶65).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the teachings of BORGSCHULTE to provide wherein the membrane continuously and progressively changes in thickness in a step-free manner from a centre of the membrane to a peripheral edge of the membrane as taught in the embodiment of Figs. 6-7 of BORGSCHULTE. A person of ordinary skill would obviously change the thickness of the membrane because doing so would promote or suppress oscillation to generate aerosols with a specific droplet spectrum (Figs. 6-7, ¶22-¶23, ¶64-¶65). Though Fig. 6 teaches a step change for the thickness, this is a non-limiting drawing. The written description of BORGSCHULTE teaches varying the thickness and with respect to the embodiment of Fig. 7, the change in thickness is not show stepwise but is taught to be a variable to change. The courts have held changes in proportion or shape to be prima facie obvious in the absence of new or unexpected results. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). One of ordinary skill in the art would appreciate that the change in thickness changes oscillation behavior and that the change being done will cause varying resonant frequencies in areas of the membrane (¶65).
Regarding claim 17, BORGSCHULTE discloses the aerosol-generating device according to claim 16. BORGSCHULTE further discloses wherein the plurality of nozzles are non-homogenously distributed over the aerosol-generation zone. As shown in Fig. 5, the holes are spaced apart in varying distances and the holes are different sizes.
Regarding claim 18, BORGSCHULTE discloses the aerosol-generating device according to claim 16. BORGSCHULTE further discloses wherein at least 60% of the plurality of nozzles are located within a region extending either side of the antinodes, the region being where a magnitude of displacement of the membrane is at least 60% of a magnitude of displacement of the membrane at the antinodes for the corresponding one or more predetermined modal frequencies. BORGSCHULTE discloses that due to the different areas the frequencies are determined depending on the oscillation and supporting the hole geometry and distribution (¶60).BORGSCHULTE discloses the wave crests or wave troughs, antinodes, are there is a strong deflection creating deflection (¶61). BORGSCHULTE discloses that at the nodes there is very slight or absolutely no deflection (¶61). BORGSCHULTE discloses that for reasons of efficiency it is desired to dispense with holes at points with no aerosol generation (the nodes). BORGSCHULTE further discloses that dispensing with holes at oscillation nodes or oscillational nodal lines makes it possible to prevent fluid from passing through the membrane at that point by way of holes or to prevent liquid from inadvertently collecting on the structures (¶19). Therefore, since BORGSCHULTE discloses to not have holes at the no aerosol generation nodes, more than 50% of the holes are located closer to the antinodes (¶19, ¶61-¶62)
Regarding claim 19, BORGSCHULTE discloses the aerosol-generating device according to claim 18. BORGSCHULTE further discloses wherein all of the plurality of nozzles are located within the region extending either side of the antinodes. BORGSCHULTE discloses that at the node 36 there is very slight or no deflection (Fig. 4, ¶61). BORGSCHULTE further discloses dispensing with holes for efficiency at locations where there is slight or no generation of aerosol (¶19). BORGSCHULTE further discloses that dispensing with holes at oscillation nodes or oscillational nodal lines makes it possible to prevent fluid from passing through the membrane at that point by way of holes or to prevent liquid from inadvertently collecting on the structures (¶19).
Regarding claim 20, BORGSCHULTE discloses the aerosol-generating device according to claim 16. BORGSCHULTE further discloses wherein the one or more predetermined modal frequencies comprise a first predetermined modal frequency of the membrane and a second predetermined modal frequency of the membrane. BORGSCHULTE discloses that the actuating device causes the membrane to operate at different working frequencies, at such a varied manner that it is possible to set different droplet spectra (¶13). BORGSCHULTE explicitly discloses two or more working frequencies which lead to different droplet spectra (¶13). BORGSCHULTE further discloses wherein the plurality of nozzles are preferentially located in a first and a second intersection region of the aerosol-generation zone. BORGSCHULTE discloses that the nozzles are located within a first area 32 and a second area 31 (fig. 3a, ¶60). Each of the areas has holes that have a specific hole geometry and distribution size (¶60). BORGSCHULTE further discloses for the first intersection region, antinodes corresponding to the first predetermined modal frequency of the membrane are proximate to nodes corresponding to the second predetermined modal frequency of the membrane, and for the second intersection region, antinodes corresponding to the second predetermined modal frequency of the membrane are proximate to nodes corresponding to the first predetermined modal frequency of the membrane. BORGSCHULTE discloses membranes with frequencies in Figs. 3a and 3b where the frequencies f1 and f2 have nodes and antinodes over the two different areas. The point of the intersection of the areas is proximate to nodes that correspond to modulated frequencies (¶60).
Regarding claim 21, BORGSCHULTE discloses the aerosol-generating device according to claim 20. BORGSCHULTE further discloses wherein all of the plurality of nozzles are located in the first and the second intersection regions. BORGSCHULTE further discloses dispensing with holes for efficiency at locations where there is slight or no generation of aerosol (¶19). Therefore when the first and second intersection regions are located where there is slight or no generation of aerosol, the holes will be dispensed. BORGSCHULTE further discloses that dispensing with holes at oscillation nodes or oscillational nodal lines makes it possible to prevent fluid from passing through the membrane at that point by way of holes or to prevent liquid from inadvertently collecting on the structures (¶19).
Regarding claim 22, BORGSCHULTE discloses the aerosol-generating device according to claim 20. BORGSCHULTE further discloses for the first intersection region, the nodes corresponding to the second predetermined modal frequency are located within a first zone extending either side of the antinodes corresponding to the first predetermined modal frequency, the first zone being where a magnitude of displacement of the membrane is at least 60% of a magnitude of displacement of the membrane at the antinodes for the first predetermined modal frequency, and for the second intersection region, the nodes corresponding to the first predetermined modal frequency are located within a second zone extending either side of the antinodes corresponding to the second predetermined modal frequency, the second zone being where the magnitude of displacement of the membrane is at least 60% of the magnitude of displacement of the membrane at the antinodes for the second predetermined modal frequency. BORGSCHULTE further discloses several embodiments of modulated frequencies as shown in Figs. 3a-3b (¶14). These various embodiments read on the recited language of claim 22. The frequency varies at the dotted lines with a magnitude shift of at least 60% as can be seen in Fig. 3a. Further this is considered to be a rearrangement of parts. Courts have held that rearrangement of parts of the prior art is unpatentable. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and MPEP 2144.04, IV., part C. Here, applicant is merely rearranging the membrane, the applied frequencies, and the holes within the ranges disclosed and contemplated in the prior art of BORGSCHULTE,
Regarding claim 23, BORGSCHULTE discloses the aerosol-generating device according to claim 16. BORGSCHULTE further discloses wherein the aerosol-generating device is configured to selectively apply and release a constraint to the membrane so as to adjust a response of the membrane to the one or more predetermined modal frequencies (¶65). BORGSCHULTE discloses that the first area and second area may oscillate in differing modes depending on a bending or curving that arises due to an external boundary conditions (Fig. 7, ¶65). As shown in Fig. 7, there are different combinations of the bending or curving (shown in dotted lines) that a person with knowledge in the art would apply (¶65).
Regarding claim 24, BORGSCHULTE discloses the aerosol-generating device according to claim 23. BORGSCHULTE further discloses wherein the aerosol-generating device is configured to selectively apply and release the constraint along one or more portions of the periphery of the membrane. As shown in Fig. 7, the constraint is changed on the periphery (second area 32) of the membrane (Fig. 7, ¶65).
Regarding claim 25, BORGSCHULTE discloses the aerosol-generating device according to claim 16. BORGSCHULTE further discloses wherein the actuator is further configured to selectively excite different parts of the membrane (¶12-¶13, ¶20).
Regarding claim 26, BORGSCHULTE discloses the aerosol-generating device according to claim 25. BORGSCHULTE further discloses wherein the actuator comprises a plurality of actuator segments, each actuator segment coupled to a different part of the membrane. As shown in Figs. 4 and 7, there is a top actuator and a bottom actuator (fig. 7). Further, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04, VI, Part B.
Regarding claim 27, BORGSCHULTE discloses the aerosol-generating device according to claim 16. BORGSCHULTE further discloses wherein the actuator is further configured to apply a modulated driving signal to the membrane in order to excite the membrane (¶40-¶43). BORGSCHULTE discloses that several modes may be actuated simultaneously (¶42)
Regarding claim 28, BORGSCHULTE discloses the aerosol-generating device according to claim 16. BORGSCHULTE does not disclose, but nonetheless teaches wherein the membrane progressively reduces in thickness from a centre of the membrane to a peripheral edge of the membrane.
BORGSCHULTE teaches that the generation of aerosol across a droplet spectrum can be done by designing areas of the membrane with varying thickness which are caused to oscillate to a specific extent (¶22). BORGSCHULTE teaches that by appropriately selecting the thickness the basic oscillation behavior of the membrane will alter (¶23). BORGSCHULTE teaches that by designing the different oscillations the droplet spectrum can be specifically supported (¶24).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the teachings of BORGSCHULTE to provide wherein the membrane progressively reduces in thickness from a centre of the membrane to a peripheral edge of the membrane modified. A person of ordinary skill in the art would obviously vary the thickness because doing so would create a customized droplet spectrum for the user (¶24, ¶14). BORGSCHULTE discloses that the membrane thickness needs to be optimized to customize droplet spectrum. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the thickness across the membrane as a matter of routine optimization since it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05.II.A).
Regarding claim 29, BORGSCHULTE discloses the aerosol-generating device according to claim 16. BORGSCHULTE further discloses wherein the membrane progressively increases in thickness from a centre of the membrane to a peripheral edge of the membrane. As shown in Fig. 6, the thickness is the least at the center 31 and increases at the edge 32 (¶64).
Regarding claim 30, BORGSCHULTE discloses the aerosol-generating device according to claim 16. BORGSCHULTE further discloses an aerosol-delivery system (fig. 1, inhalation therapy device 1, ¶54) and a liquid feed configured to supply a liquid aerosol-forming substrate to the membrane.
Response to Arguments
Applicant's arguments and amendments filed December 5, 2025 have been fully considered but they are not persuasive.
Applicant argues, “Borgschulte fails to teach or suggest at least the claim feature of "wherein the membrane continuously and progressively changes in thickness in a step free manner from a centre of the membrane to a peripheral edge of the membrane," as recited in claim 16. A continual, progressive change in membrane thickness in a step-free manner from a centre of the membrane to a peripheral edge of the membrane would enhance the volume of aerosol able to be dispersed over the surface area of the membrane by reducing the creation of zero displacement locations over the area of the membrane, while still allowing for varying the aerosol dispersal pattern over the area of the membrane.” Applicant argues that continual is a step-free manner from a center. However, this definition is not disclosed in the specification as filed. For the amendment to recite “wherein the membrane continuously and progressively changes in thickness in a step free manner from a centre of the membrane to a peripheral edge of the membrane” applicant relies on the specification that discloses “progressively reduces in thickness” (PG Pub ¶54). Progressively includes any type of changes. BORGSCHULTE teaches, “An oscillation behavior such as this may arise due to external boundary conditions which are provided, for example, by a varying thickness or a varying geometric design of the membrane areas.” (¶65, emphasis added). Thus the application of the prior art, BORGSCHULTE, that teaches that varying the thickness of the membrane can promote or suppress oscillation to generate aerosols with a specific droplet spectrum (Figs. 6-7, ¶22-¶23, ¶64-¶65) reads on continual changing as disclosed in the instant application. As explained above, the step changes of BORGSCHULTE are not limiting. A preferred embodiment or alternate embodiment does not constitute a teaching away where the specification teaches more broadly. See MPEP 2123, II. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Applicant argues, “Borgschulte's Fig. 6 clearly shows the change in thickness between areas 31 and 32 as being an abrupt step change-contrary the recitation in claim 16 for the membrane to continuously and progressively changing in thickness in a step-free manner from a center of the membrane to a peripheral edge of the membrane.” One of ordinary skill in the art would appreciate that though the depiction in Fig. 6 is an ”abrupt” change, a progressive change would accomplish the desired result of promoting or suppressing oscillation to generate aerosols with a specific droplet spectrum. See reasoning above regarding preferred embodiments. Additionally, the drawing in Fig. 6 is not limiting where the written description discloses more broadly. The variation of the thickness could be done as shown in Fig. 6 or as broadly as taught in BORGSCHULTE ¶65 to read upon the limitation of amended claim 16 with predictable results.
Applicant argues, “In the embodiment of Borgschulte's Fig. 7, the deflection behavior of membrane 3 is shown. A central first area 31 of the membrane 3 is described as oscillating in a bending or curving mode 35, whereas the outer second area 34 is described as oscillating in a deflection mode. See id., ¶ [0065]. Borgschulte's Fig. 7 shows the different deflection behaviors adopted by the first and second areas 31, 34, with an abrupt change in deflection behavior at the interface between the two areas. Borgschulte's¶ [0065] describes the oscillation behavior of Fig. 7 arising from external boundary conditions, for example from a varying thickness of the membrane areas. So, Borgschulte's ¶ [0065] suggests that the different deflection behaviors of areas 31, 34 arise from the two areas having distinct thicknesses. So, in common with the embodiment of Borgschulte's Fig. 6, the embodiment of Borgschulte's Fig. 7 fails to contain any teaching of a continuous and progressive change in membrane thickness in a step-free manner from a center of the membrane to the periphery of the membrane.” There is nothing to preclude thinning of the membrane shown in Fig. 7 in a continual manner. Especially since BORGSCHULTE expressly teaches advantages in varying the thickness to promote or suppress oscillation to generate aerosols with a specific droplet spectrum (Figs. 6-7, ¶22-¶23, ¶64-¶65).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/STEPHANIE LYNN MOORE/Examiner, Art Unit 1747
/PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755