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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/01/2026 has been entered.
Response to Amendment
The amendment filed 06/01/2026 has been entered. Claims 47-49, 51-54, 56, 58-60, 63, 67, 74-78 and 80-84 remain pending in the application. The amendments to the claims have overcome the objections and 112(a) rejection previously set forth in the Final Rejection mailed 12/01/2025.
Response to Arguments
Applicant's arguments filed 06/01/2026 (“Remarks”) have been fully considered.
The argument on page 9 regarding the 112(f) interpretation of “liquid film forming structure” has been considered, but is not persuasive. “Structure” is considered a nonce term in this case since it does not convey a specific structure such that one of ordinary skill in the art would understand how a “structure” performs the function of forming a liquid film (see MPEP 2181(I)(A)). When referring to the specification to understand what structure the “liquid film forming structure” is required to perform its function, applicant describes a variety of structures (a web, mesh, one or more fibers, or a slot in the liquid supply conduit”, along with figs. 12a-d [0102] and [0146]). “Structure” is a sufficiently broad term that it is not readily clear to one of ordinary skill in the how the function is performed without reading the specification for two of the three claimed alternatives. Applicant argues that the structural limitations connecting the “liquid film forming structure” to the device provide sufficient structure to avoid a 112(f) interpretation; however, only the limitation “includes one or more slots in each supply conduit” provides additional structure describing how a liquid film would be formed by the “structure”. The remaining two limitations “an integral part of the substrate” and “directly bonded to the substrate” only describe the relationship of the structure to the substrate, not how a liquid film is formed by the “structure”. The claims additionally recites that “a liquid film forming structure in fluid communication with the liquid supply conduit and the at least one piezoelectric substrate to control a thickness of a meniscus of liquid”, but this again only describes the structure in relation to the conduit and the substrate and does not describe a structure that would form a liquid film.
The drawings submitted 10/15/2025 have been received but remain objected to. The update to the specification submitted 06/01/2026 has resulted in withdrawal of the reference character objection; however, figure 9 in the drawings remains in poor resolution and is partially illegible. Please see below for the maintained drawing objection of figure 9.
The arguments on pages 10-11 regarding the 112(b) rejections has been considered, and is persuasive. The 112(b) rejections have been withdrawn.
The argument on page 13 that Nagata does not disclose the claimed “one or more slots formed in each of the at least one supply conduit” is not persuasive. The supply conduit and slots of Nagata are shown in the Final Rejection mailed 12/01/2025. Since slots are provided to supply the surface of the IDT with droplets, it is readily understood that these slots act as a control means for controlling the size of the nebulized liquid droplets, since the nozzle size would have been understood by one of ordinary skill in the art to directly affect the amount of liquid supplied to the nebulizer surface see [0072-0073], where Nagata discloses that the nozzles are controlled to supply liquid to meet a target diameter of particles emitted.
The argument that Nagata’s fig. 2 embodiment of the conduit is not contacting the substrate is persuasive. It does appear that the upper end of the conduit is raised above the surface of the substrate and thus is not contacting it. However, in light of further search and consideration, a new rejection has been made. Please refer to the updated rejection below.
The argument that Nagata does not disclose a liquid supply conduit is not persuasive. The droplet discharge device 1 acts as a conduit (using the standard definition of “a natural or artificial channel through which something, such as a fluid, is conveyed” Merriam-Webster) to convey fluid from reservoir 7 to the substrate 2 ([0048]).
The argument that Nagata’s slots differ from the claimed slots has been considered, but is not persuasive. One of ordinary skill in the art would readily understand that Nagata’s slots control the amount of fluid supplied to the substrate, and thus would also control the thickness of a liquid film or meniscus since the amount of fluid is controlled.
The argument on pages 15-16 that Murtazin and Friend in combination do not disclose a control means for controlling a droplet size by using a wick (Friend) has been considered, but is not fully persuasive. However, upon further search and consideration, a new rejection has been made which more clearly discloses the use of a control means for controlling the size of droplets which includes a liquid film forming structure. Please see below.
The argument that Friend does not teach making the wick integral with the substrate is not persuasive, since Friend is not utilized to teach this claimed feature. Making components integral has been held "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice." In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965), MPEP 2144.04(V)(B). Please see below for the updated rejection.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation is: “control means” in claims 47, 59, 60, and 76. These claims include sufficient structure to perform the claimed function via the liquid film forming structure in fluid communication with a liquid supply conduit and at least one piezoelectric substrate.
Because this claim limitation is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation is “liquid film forming structure” in claim 47.
Claim 47 does not contain sufficient structure which indicates how the nonce term “structure” performs the liquid film forming to control the thickness of the meniscus of the liquid supplied to the piezoelectric substrate for two of the three recited alternative structures. A “liquid film forming structure is an integral part of the substrate, (or) directly bonded to the substrate” does not provide sufficient structure for one of ordinary skill in the art to understand how a liquid film is formed without consulting the specification. Original specification [0038] indicates that this structure may be a “web, mesh, one or more fibers, or a slot in the liquid supply conduit”, along with figs. 12a-d [0102] and [0146]. The liquid film forming structure has been interpreted to be one of these structures, or an equivalent. The third alternative, “a respective one or more of slots in each of the at least one supply conduit” does provide sufficient structure to understand how a liquid film is formed.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Examiner notes that “liquid film forming structure” is also recited in claims 80-84. Claims 80-84 recite sufficient structure such that a 112(f) interpretation is not required.
Drawings
Formal drawings require that every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. (37 CFR 1.84(l)). The drawings are of inadequate reproduction quality. Figure 9 remains illegible in the substitute sheet submitted 10/15/2025.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 § 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.
Claims 47, 67, 74, 79-78, and 80-82 are rejected under 35 U.S.C. 103 an unpatentable over Hu et al. (CN 109011043 A), hereafter Hu, in view of Löser (US 5918593), hereafter Löser. A machine translation of Hu is relied upon to address claims.
Regarding Claim 47, Hu discloses a nebuliser for nebulising liquid droplets (page 1 “Background technique” para.), including: at least one piezoelectric substrate (fig. 1, 101, page 4 second para.) and having a transducer surface (fig. 1, the top surface of 101) upon which is located at least one electroacoustic transducer (fig. 1, 103, page 4 second para.) for generating acoustic wave energy within the piezoelectric substrate (page 4, fourth para.); a liquid supply system for supplying a liquid to the piezoelectric substrate (fig. 1, 2, 3, and 4), the liquid supply system including a reservoir for accommodating the liquid (fig. 1, 4, page 4, third para.); at least one supply conduit (fig. 1, 3, page 5, 8th para.) including an end in contact with the at least one piezoelectric substrate (fig. 1, protective sleeve 3 is in indirect contact with substrate 101 via 2; see also page 6, second full para.) for supplying the liquid from the reservoir to the at least one piezoelectric substrate (page 6 last para. to page 7); and a control means for controlling a size of the nebulised liquid droplets, wherein the control means for controlling a size of the nebulised liquid droplets includes a liquid film forming structure in fluid communication with the liquid supply conduit and the at least one piezoelectric substrate (fig. 1, polyester fiber paper 2, page 5, 8th para.) to control a thickness of a meniscus of liquid supplied to the at least one piezoelectric substrate to thereby control the size of the nebulised droplets (page 6 last sentence to first para. page 7).
Hu is silent on accommodating the piezoelectric substrate in a housing, as well as wherein the liquid film forming structure is an integral part of the substrate, directly bonded to the substrate, or includes a respective one or more of slots in each of the at least one supply conduit.
Löser teaches the use of a housing to enclose a piezoelectric atomization unit (fig. 1, housing 50, piezoelectric element 16, col. 6 lines 51-55). The housing is used to separate the piezo unit from the electronics in order to protect electronics from moisture, as well as to provide a support stand for the atomization device (col. 7 lines 3-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a housing to accommodate the piezoelectric substrate in order to provide a support stand to the device, as well as to protect any electronics from moisture emitted by the substrate.
The device remains silent on whether the liquid film forming structure is an integral part of the substrate.
However, it has been held "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice." See MPEP 2144.04(V)(B), In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Thus it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to make Hu's polyester fiber paper an integral part (i.e., as defined by Merriam-Webster, "essential to completeness"). It further would have been obvious to one of ordinary skill in the art to bond the Hu's polyester fiber to the piezoelectric substrate to maintain contact with the substrate, thereby avoiding the fiber from displacing from the substrate due to vibrations of the substrate.
Regarding Claim 67, Hu discloses a method of nebulising a liquid using a nebuliser according to claim 47, wherein the liquid includes functional or therapeutic agents (page 1, first full para., pulmonary drug delivery), or, non-therapeutic agents (page 1, first full para.).
Regarding Claim 74, Hu discloses a nebuliser of claim 47, wherein the at least one piezoelectric substrate further comprises a non-transducer surface opposite the transducer surface (fig. 1, the bottom surface of 101), and wherein the liquid supply system is configured for supplying a liquid to at least one of the transducer surface or the non-transducer surface (fig. 1, the liquid supply system is shown delivering the liquid to the transducer surface).
Regarding Claim 76, Hu as modified discloses a nebuliser according to claim 47, wherein the at least one piezoelectric substrate further comprises a non-transducer surface opposite the transducer surface (Hu, the bottom surface of 103, fig. 1) and wherein the liquid supply system is configured for supplying a liquid to at least one of the transducer surface or the non-transducer surface (Hu fig. 1, the liquid supply system 2, 3, 4 supplies liquid to the transducer surface), but is silent on wherein control means for controlling a size of the nebulized liquid droplets includes at least one baffle located in a generally parallel and adjacent relationship to at least one of the transducer surface and the non-transducer surface.
Löser teaches the use of a baffle in a ultrasonic atomizer (fig. 1, piezo vibrating element 16, baffle plate 18, col. 5 lines 36 and 45). The baffle plate deflects particles and effectively separates larger particles (col. 5 lines 42-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a baffle plate in Murtazin’s device as taught by Löser to prevent particles that are too large from leaving the nebulizer (Löser col. 3 lines 53-57), and only the most appropriately sized droplets for depositing in the lungs would be delivered to the patient (Löser col. 2 lines 9-12).
Regarding Claim 77, Hu discloses a nebuliser according to claim 74, wherein the acoustic wave energy includes one or more of: (i) surface acoustic waves (SAW) propagated in the transducer surface of the at least one piezoelectric substrate (page 1, 6th para. beginning with “The interdigital transducer”); and (ii) surface reflected bulk waves (SRBW) reflected between the transducer and non- transducer surfaces of the at least one piezoelectric substrate.
Regarding Claim 78, Hu discloses a nebuliser according to claim 74, wherein the liquid is nebulised from the transducer surface (fig. 1, the fluid is nebulized from the transducer surface, 6th para. beginning with “The interdigital transducer”), the non-transducer surface, or both the transducer surface and the non-transducer surface.
Regarding Claim 80, Hu as modified discloses a nebuliser of claim 47, wherein the liquid film forming structure includes a web, mesh, or one or more fibers (page 2, line 12, polyester fiber paper is one or more fibers) as an integral part of the substrate or directly bonded to the substrate (as taught above, the polyester fiber paper 2 is made integral with the substrate).
Regarding Claim 81, Hu discloses a nebuliser of claim 47, wherein the liquid film forming structure includes one or more fibers (page 2, line 12, polyester fiber paper is one or more fibers) as an integral part of the substrate or directly bonded to the substrate (as taught above, the polyester fiber paper 2 is made integral with the substrate).
Regarding Claim 82, Hu discloses a nebuliser of claim 80, wherein the liquid film forming structure is integrally formed with an integral part of the at least one piezoelectric electric substrate (as taught in claim 47, the polyester fiber paper is integral with the substrate).
Claim 48 is rejected under 35 U.S.C. 103 as unpatentable over Hu and Löser, further in view of Takahashi et al. (US 5299739), hereafter Takahashi.
Regarding Claim 48, Hu as modified discloses a nebuliser of claim 47, but is silent on including: a compliant material in contact with at least a portion of a perimeter surface of the at least one piezoelectric substrate.
However, Takahashi discloses a piezoelectric substrate (first embodiment, fig. 3, piezoelectric vibrator 1, col. 2 lines 60-61; second embodiment fig. 8A, 1 is a piezoelectric vibrator, col. 2 lines 60-21 and col. 5 line 9) and having a transducer surface upon which is located at least one electroacoustic transducer (fig. 3, electrode surface 2A is the operation surface; assembly comprising vibrator 1 and electrodes 2A, 2B provide a vibrator element TD, col. 2 lines 64-68) for generating acoustic wave energy within the substrate (col. 2 last line to col. 3 first line); and a liquid supply system for supplying a liquid to at least one of the transducer and non-transducer surfaces (fig. 3, supply tube 7, col. 3 lines 42-44), and at least one supply conduit in contact with the at least one piezoelectric substrate for supplying the liquid from the reservoir to the at least one piezoelectric substrate (fig. 3, supply tube 7) and a liquid supply system including a reservoir for accommodating the liquid (fig. 8B, container 26, col. 5 lines 28-30), including: a compliant material (examiner’s note: “compliant” is interpreted to mean a material which is able to deform and return to its previous state; both first embodiment of fig. 3 and second embodiment of figs. 8 include a resilient holder 4, col. 3 line 5 and col. 5 line 9) in contact with at least a portion of a perimeter surface of the at least one piezoelectric substrate (figs. 3 and 8A, the resilient holder 4 is in contact with the entire perimeter of the substrate 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a compliant material in contact with at least a portion of a perimeter surface of Hu’s piezoelectric substrate as taught by Takahashi to serve as a flexible holder for the piezoelectric substrate within a housing as it vibrates (Takahashi col. 2 line 17 and col. 5 lines
Claim 49 is rejected under 35 U.S.C. 103 as unpatentable over Hu, Löser, and Takahashi, further in view of Ivri et al. (US 6014970), hereafter Ivri ‘970.
Regarding Claim 49, Murtazin as modified discloses a nebuliser according to claim 48, but is silent on wherein the at least one electroacoustic transducer is configured to provide an output indicative of a volume of liquid on the at least one piezoelectric substrate.
Ivri ‘970 teaches the use of a sensing circuit with the piezoelectric substrate of an aerosolization apparatus which detects the voltage across a piezoelectric element (fig. 1, 26, col. 7 lines 35-54). As the liquid on the substrate decreases, the voltage also decreases.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a sensing circuit in the electroacoustic transducer to provide an output indicative of a volume of liquid on the piezoelectric substrate as taught by Ivri in order to indicate when the aerosolization of the liquid has been completed (Ivri ‘970, col. 7 lines 50-55).
Claims 51-52 are rejected under 35 U.S.C. 103 as unpatentable over Hu and Löser, further in view of Ivri ‘970.
Regarding Claim 51, Hu as modified discloses a nebuliser according to claim 47, but is silent on the device further comprising a sensor for detecting a volume of liquid on the at least one piezoelectric substrate.
Ivri ‘970 teaches the use of a sensing circuit of an aerosolization generator which detects the voltage across a piezoelectric member (fig. 1, 26, col. 7 lines 35-54; see also col. 6 lines 49-51 that the piezoelectric element electronic circuit includes a transducer which vibrates the piezoelectric member). As the liquid on the substrate decreases, the voltage also decreases.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a sensing circuit in the electroacoustic transducer for detecting a volume of liquid on the piezoelectric substrate as taught by Ivri in order to indicate when the aerosolization of the liquid has been completed (Ivri ‘970, col. 7 lines 50-55).
Regarding Claim 52, Hu as modified discloses a nebuliser according to claim 51, wherein the at least one electroacoustic transducer comprises the sensor (Ivri ‘970, col. 7 lines 35-45, the electrical component of the transducer may include a sensing circuit for detecting the amount of fluid on the piezoelectric member).
Claim 53 is rejected under 35 U.S.C. 103 as unpatentable over Hu and Löser, further in view of Ivri et al. (US 2003/0226906), hereafter Ivri ‘906.
Regarding Claim 53, Hu as modified discloses a nebuliser according to claim 47, but only has one electroacoustic transducer per piezoelectric substrate (fig. 1, 103) and is silent on at least one opposing electroacoustic transducer for generating acoustic wave energy in an opposing direction to reduce an extent to which liquid is driven off the at least one piezoelectric substrate prior to nebulization.
Ivri ‘906 teaches the use of two transducers on a piezoelectric substrate (fig. 17, transducers are 102a, 102b on surface 106 [0057] in order to produce a divergent stream of droplets ([0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an opposing electroacoustic transducer to generate acoustic wave energy in an opposing direction as taught by Ivri ‘906 in order to manipulate the direction of droplet ejection and angle of the stream as needed for the application (Ivri ‘906 [0057]).
Claims 54 and 56 are rejected under 35 U.S.C. 103 as unpatentable over Hu and Löser, further in view of Ivri ‘906 and Ivri ‘970.
Regarding Claim 54, Hu as modified discloses a nebuliser according to claim 53, but is silent on wherein the at least one opposing electroacoustic transducer is configured to provide an output indicative of a volume of liquid on the at least one piezoelectric substrate.
Ivri ‘970 teaches the use of a sensing circuit with the piezoelectric substrate of an aerosolization apparatus which detects the voltage across a piezoelectric element (fig. 1, 26, col. 7 lines 35-54). As the liquid on the substrate decreases, the voltage also decreases.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a sensing circuit in the electroacoustic transducer for detecting a volume of liquid on the piezoelectric substrate as taught by Ivri in order to indicate when the aerosolization of the liquid has been completed (Ivri ‘970, col. 7 lines 50-55).
Regarding Claim 56, Hu as modified discloses a nebuliser according to claim 53, but is silent on wherein the at least one opposing electroacoustic transducer comprises a sensor.
Ivri ‘970 teaches the use of a sensing circuit of an aerosolization generator which detects the voltage across a piezoelectric member (fig. 1, 26, col. 7 lines 35-54; see also col. 6 lines 49-51 that the piezoelectric element electronic circuit includes a transducer which vibrates the piezoelectric member). As the liquid on the substrate decreases, the voltage also decreases.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a sensing circuit in the at least one opposing electroacoustic transducer for detecting a volume of liquid on the piezoelectric substrate as taught by Ivri in order to indicate when the aerosolization of the liquid has been completed (Ivri ‘970, col. 7 lines 50-55).
Claims 58-60 are rejected under 35 U.S.C. 103 as unpatentable over Hu and Löser, further in view of Miyamatsu et al. (JP 2013128569), hereafter Miyamatsu. A machine translation of Miyamatsu is relied upon to address claims.
Regarding Claim 58, Hu as modified discloses a nebuliser according to claim 47, but is silent on including at least two piezoelectric substrates spaced apart and located in a parallel adjacent relationship.
Miyamatsu teaches a nebulizer for distributing water which includes two piezoelectric substrates spaced in a parallel relationship in order (fig. 1, 81a, 81b page 5, third full para. “The refining means”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Murtazin’s arrangement of the piezoelectric substrate to include two piezoelectric substrates as taught by Miyamatsu, as this arrangement was known in the art to be effective for applying aerosolized liquid (Miyamatsu page 5, fifth full para. “The SAW generated”), as well as to produce particles in the nanometer range (page 5, second full para.) for the benefit of producing a very fine spray of liquid.
Regarding Claim 59, Hu as modified discloses a nebuliser according to claim 47, but is silent on including at least two piezoelectric substrates spaced apart and located in a parallel adjacent relationship, and wherein the control means for controlling a size of the nebulized liquid droplets is configured to enable pre-setting of a spacing between the at least two piezoelectric substrates to control a thickness of a meniscus of liquid supplied between adjacent substrate surfaces, to thereby control the size of the nebulised droplets.
Miyamatsu teaches a nebulizer for distributing water which includes two piezoelectric substrates spaced in a parallel relationship in order (fig. 1, 81a, 81b page 5, third full para. “The refining means”). The structure of the device, including the spacing of the piezoelectric substrates (81a, 81b, on either side of water supply means 84), allows the control of the particle size to be between 5-200nm, (page 4, fifth para. and page 5, fifth full para.).
Miyamatsu also teaches the capillary action of the treated water transports water from the water supply means to the piezoelectric substrates (fig. 1, water supply means 84, and page 5, second full para. to fifth para.). One of ordinary skill in the art would understand that the thickness of the meniscus emitted from the water supply means (84) depends on the amount of fluid emitted from the water supply means, which in turn depends on the diameter of the water supply means (i.e., a smaller tube would emit a smaller amount of water and thus have a thinner meniscus). Since the delivery means is in contact with both substrates (page five, fourth full para.), the amount of water and thus the thickness of the meniscus therefore would be dependent on the spacing of the substrates.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hu’s device to include two piezoelectric substrates as taught by Miyamatsu, as this arrangement was known in the art to be effective for applying aerosolized liquid (Miyamatsu page 5, fifth full para. “The SAW generated”). It also would have been obvious to modify the spacing between the piezoelectric substrates by changing the diameter of the water supply tube, which would adjust the amount of liquid supplied for spraying based on Miyamatsu’s teaching to control the particle size (Miyamatsu page 4, fifth para.).
Regarding Claim 60, Hu as modified discloses a nebuliser according to claim 47, but is silent on including at least two piezoelectric substrates spaced apart and located in a parallel adjacent relationship and wherein the control means for controlling a size of the nebulized liquid droplets is configured to enable pre-setting of a spacing of the at least two piezoelectric substrates from internal walls of the housing to control a thickness of a meniscus of liquid supplied between adjacent substrate surfaces and the inner walls, to thereby control the size of the nebulised droplets.
Miyamatsu teaches a nebulizer for distributing water which includes two piezoelectric substrates spaced in a parallel relationship in order (fig. 1, 81a, 81b page 5, third full para. “The refining means”). The structure of the device, including the spacing of the piezoelectric substrates (81a, 81b, on either side of water supply means 84), allows the control of the particle size to be between 5-200nm, (page 4, fifth para. and page 5, fifth full para.).
Miyamatsu teaches the capillary action of the treated water transports water from the water supply means to the piezoelectric substrates (fig. 1, water supply means 84, and page 5, second full para. to fifth para.). One of ordinary skill in the art would understand that the thickness of the meniscus emitted from the water supply means (84) depends on the amount of fluid emitted from the water supply means, which in turn depends on the diameter of the water supply means (i.e., a smaller tube would emit a smaller amount of water and thus have a thinner meniscus). Since the delivery means is in contact with both substrates (page five, fourth full para.), the amount of water and thus the thickness of the meniscus therefore would be dependent on the spacing of the substrates.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hu’s device to include two piezoelectric substrates as taught by Miyamatsu, as this arrangement was known in the art to be effective for applying aerosolized liquid (Miyamatsu page 5, fifth full para. “The SAW generated”). It also would have been obvious to modify the spacing between the piezoelectric substrates from the internal walls of the housing by modifying the diameter of the water supply tube, which would adjust the amount of liquid supplied for spraying based on Miyamatsu’s teaching to control the particle size (Miyamatsu page 4, fifth para.).
Claims 63 and 67 are rejected under 35 U.S.C. 103 as unpatentable over Hu and Löser, further in view of Murtazin (US 2017/0178884), hereafter Murtazin.
Regarding Claim 63, Hu discloses a nebuliser system comprising: a first nebulizer according to claim 47 (fig. 1, as described in claim 47 above), wherein the first nebuliser comprises a first nebuliser water contacting surface (water contacting surface shown as the upper surface of 103 in fig. 1), but is silent on a second nebulizer, and the second nebuliser comprises a second nebuliser water contacting surface, wherein the first nebuliser water contacting surface is transverse to the second nebuliser water contacting surface.
Murtazin teaches the use of two nebulizers in order to mix aerosols (fig. 12 [0105]). Each of the two nebulizers has a water contacting surface (i.e., the top surface, shown in fig. 12 as emitting aerosols).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a second nebulizer in Hu’s invention in order to mix aerosols as needed, as taught by Murtazin ([0105]).
The now-modified device having two nebulizers remains silent on the first nebulizer water contacting surface being transverse to the second nebulizer water contacting surface (Murtazin fig. 12 shows the two surfaces as being on the same plane).
However, in the embodiment of Murtazin’s figs. 8a-c, the nebulizer assembly is shown in different orientations relative to the housing 50 ([0104]), which demonstrates the ability of the nebulizer to operate regardless of the orientation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orient the second nebulizer such that the water contacting surface is transverse to the water contacting surface of the first nebulizer, as the aerosols of each would still mix ([0105]) and it has been held that the rearrangement of parts is an obvious matter of design choice (see MPEP 2144.04(VI)(C) In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)).
Regarding Claim 75, Hu discloses a nebuliser of claim 47, but is silent on wherein the at least one supply conduit is rigid (page 5, eighth para. down, the tube is silicone, but does not state whether is a hard or soft durometer).
However, Murtazin teaches the use of a rigid tube (fig. 2a, supply line 120 may be a capillary, which is a rigid tube that uses capillary action to transport fluid [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make Hu’s supply conduit rigid as taught by Murtazin, since both devices work on the principle of capillary action and a rigid tube would perform the same function to supply fluid to the substrate.
Claims 47, 83, and 84 are rejected under 35 U.S.C. 103 as unpatentable over Nagata et al. (JP 11207224 A1) in view of Babington (US 4228795), hereafter Babington. A machine translation of Nagata is relied upon to address claims.
Regarding Claim 47, Nagata discloses a nebuliser for nebulising liquid droplets ([0001]), including: a housing (fig. 6, housing is shown surrounding inhaler 52 [0048]); at least one piezoelectric substrate (fig. 21, propagation surface 21 [0027]) accommodated within the housing (fig. 6, droplet discharge device 2 is contained within the housing [0048]) and having a transducer surface upon which is located at least one electroacoustic transducer for generating acoustic wave energy within the piezoelectric substrate (fig. 21, interdigital transducer “IDT” 31a 32b [0075]); and a liquid supply system for supplying a liquid to the piezoelectric substrate (fig. 6, liquid storage means 7, end of page 19), the liquid supply system including a reservoir for accommodating the liquid (fig. 6, 7 includes reservoirs 721, 722, fig. 21, end of page 19), at least one supply conduit (fig. 21, droplet discharge device 1 [0048]) including an end in contact with the at least one piezoelectric substrate for supplying the liquid from the reservoir to the at least one piezoelectric substrate (fig. 21, 1 is shown as positioned in contact with 21); and a control means for controlling a size of the nebulised liquid droplets, wherein the control means for controlling a size of the nebulised liquid droplets includes a liquid film forming structure in fluid communication with the liquid supply conduit and the at least one piezoelectric substrate to control a thickness of a meniscus of liquid supplied to the at least one piezoelectric substrate to thereby control the size of the nebulised droplets (fig. 2, 1 includes nozzles 110, 111 [0044]), wherein the liquid film forming structure includes a respective one or more of slots in each of the at least one supply conduit (fig. 2, a plurality of nozzles 110, 111 are in the form of slots [0044]).
In the event that it is not clear that Nagata discloses the supply conduit in contact with the substrate, Babington teaches that the distance between a conduit (see fig. 3, 51, col. 6 lines 36-37) relative to an atomizer surface (fig. 3, 43, col. 6 lines 39-42) can be adjusted in order to control the liquid film thickness to be atomized, which in turn affects the emitted particle size (col. 6 lines 48-51).
It has been held that where the general conditions of the claims are disclosed in the prior art, finding the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05.II.A). Optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over prior art (MPEP 2144.05). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the distance between Nagata’s supply conduit and the piezoelectric surface, up to and including contacting the surface, in order to adjust the liquid film thickness and thus the particle size emitted, as taught by Babington. Modifying the distance between the by making the supply conduit and the substrate, including a distance of zero, i.e., the two structures are contacting, would be a matter of routine optimization since it has been held that “where 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).
Regarding Claim 83, Nagata as modified discloses a nebuliser of claim 47, wherein the liquid film forming structure includes a respective one or more of slots in each of the at least one liquid supply conduit (fig. 2, nozzles 110, 11 are slots in the liquid supply conduit 1 [0044]).
Regarding Claim 84, Nagata as modified discloses a nebuliser of claim 47, wherein the liquid film forming structure includes a plurality of slots in each of the at least one liquid supply conduit, wherein the plurality of slots are located proximate to the end of the at least one liquid supply conduit (fig. 2, nozzles 110, 11 are slots in the liquid supply conduit 1 [0044]), the plurality of slots are micron-sized ([0033] the centers of the nozzles are 500 µm apart and are thus smaller than 500 µm [0033]) with high-aspect ratio (fig. 2, the nozzles are shaped as a high aspect ratio rectangles that are wider than they are high; though prior art drawings are not interpreted as depicting scale, unless specified, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125.)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2014/0190496 A [0166] fig. 10A-B, capillary tube is flattened at the end to aid in vaporization.
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/SARA K TOICH/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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