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 Amendment
The amendment filed 10/15/2025 has been entered. Claims 47-49, 51-54, 56, 58-60, 63, 67, 74-78 remain pending in the application and 80-84 are newly added. Applicant’s amendments to the claims have overcome the 112(b) rejections and double patenting rejections previously set forth in the Non-Final Office Action mailed 04/16/2025.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered.
The drawings submitted 10/15/2025 have been received but remain objected to. Please see below for a detailed description.
The specification objection has been withdrawn; examiner notes that three abstracts have been provided on the same date of 04/04/2022, only one of which is in proper format.
The claims have been amended to sufficiently address the previous claim objections; the claim objections have been withdrawn.
The claims have been amended to overcome the previous 112(b) rejections, which have been withdrawn. However, additional 112(b) rejections have been introduced with the newly added claims. Please see below for the new 112(b) rejections.
The arguments regarding the 102 and 103 rejections over prior art have been carefully considered but are moot, since the amended claims have required a new grounds of rejection that does not rely on the references as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The amendments to the claims have rendered the previously set forth double patenting rejection moot, as the claims now are sufficiently distinct from the co-pending application.
The newly added claims have been addressed in the prior art rejection below.
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. 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.
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
The replacement drawings submitted 10/15/2025 have been received but remain objected to. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 49 in figs. 12a and 12c.
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 Objections
Claims 59, 60, and 63 are objected to because of the following informalities:
Claims 59 and 60 contain further limitations for the control means for controlling a size of the nebulized liquid. To improve clarity, the claims should be amended to recite: “…and wherein the control means for controlling a size of the nebulised liquid droplets is further configured to enable pre-setting of a spacing between the at least two piezoelectric substrates…”.
Claim 63 appears to have an error in the fifth line where a second instance of “a second nebulizer” is recited. This is interpreted to be an unintended error.
Appropriate correction is required.
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 63 is 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.
Claim 63 recites a nebulizer system comprising a first nebulizer according to claim 47 and a second nebulizer according to claim 47, where claim 47 has been amended to include a control means including a liquid film forming structure. It does not appear that both of the disclosed nebulizers have the liquid film forming structure in the embodiment of figs. 14 and 15, described in original specification [0150-0154]. It appears that the second “nebulizer” is comprised of a second piezoelectric substrate that re-nebulizes the fluid discharged from the first nebulizer in order to split the nebulized droplets into smaller droplets. It is not clearly described whether both the first and second nebulizers possess the liquid film forming structure. While [0150] states that the second nebulizer 76 may be in the form of any one of the nebulizers described herein, only the circumstance in which one of the nebulizers (the first) has liquid supplied at a liquid administration point is described ([0151]). It is not detailed whether both nebulizers include all the elements as required by claim 47 and how this arrangement operates since the angle of the second nebulizer is angled to direct the nebulized fluid away from the first, but is needed to reduce the droplet size emitted from the first nebulizer.
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 47-49, 51-54, 56, 58-60, 63, 67, 74-78, and 80-84 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.
Claim 47 limitation “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 slots in each of the at least one supply conduit” is unclear. It appears that the options are 1) an integral part of the structure, 2) directly bonded to the substrate, or 3) includes one or more slots. It is not clear how the liquid film forming structure may be integral to the substrate when, as interpreted according to 112(f) above, it is a different material than the substrate, being a “web, mesh, one or more fibers, or a slot in the liquid supply conduit”. “Integral” is interpreted to mean a single piece construction or inseparable without causing damage. “Bonded” is interpreted to mean permanently secured together. Based on the description presented in original specification [0146] in which making the device integral or directly bonded includes electroplating, it is not clear how these two terms differ from each other. In this case, it has been interpreted that both integral and directly bonded are equivalent, as both would cause irreversible damage if the components were separated.
Claims 48-49, 51-54, 56, 58-60, 63, 67, 74-78, and 80-84 are rejected as depending upon a rejected base claim.
Claims 80-81 are indefinite should the second option in the last limitation of parent claim 47 be chosen. It is not clear how the liquid film forming structure may be a web, mesh, or one or more fibers if the liquid film forming structure takes the form of one or more slots in each of the at least one supply conduit(s).
Claim 82 is indefinite since it is not clear how, should the second option be chosen for the liquid film forming structure, i.e., the slot, would be integrally formed with the substrate, since a slot is considered to be a void or lack of material which allows the liquid to pass from the supply conduit.
Similarly, claims 83-84 are indefinite when the first option in the last limitation of parent claim 47 is chosen. It is not clear how the liquid film forming structure may be one or more slots (or a plurality of slots) when the liquid film forming structure is an integral part of the substrate or directly bonded to the substrate, since a slot cannot be bonded or considered an integral part.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 47, 83, and 84 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Nagata et al. (JP 11207224 A1). A machine translation 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. 2, 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. 2, interdigital transducer “IDT” 31 [0037], 32 [0039]); 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 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. 6, droplet discharge device 1 [0048], also shown in fig. 2); 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]).
Regarding Claim 83, as best understood based on the 112(b) rejection above, Nagata 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, as best understood based on the 112(b) rejection above, Nagata 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.)).
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, 63, 67, 74-75, 77-78, and 80-81 are rejected under 35 U.S.C. 103 as unpatentable over Murtazin (US 2017/0178884), hereafter Murtazin, in view of Friend et al. (US 2012/0187209), hereafter Friend.
Regarding Claim 47, Murtazin discloses a nebulizer (fig. 2a, 40 [0038]) for nebulising liquid droplets ([0038] line 3), including: a housing (fig. 1, fig. 8a, 50 [0038]); at least one piezoelectric substrate (fig. 2a, 100 [0044]) accommodated within the housing (fig. 8a) and having a transducer surface (top surface of 100, fig. 2a) upon which is located at least one electroacoustic transducer (fig. 2a, interdigital transducer 110 [0044]) for generating acoustic wave energy within the piezoelectric substrate ([0044] lines 3-4); and a liquid supply system (fig. 1, fig. 9, 30 [0038]) for supplying a liquid to the piezoelectric substrate (fig. 2a, fig. 9 [0038]), the liquid supply system including a reservoir for accommodating the liquid (fig. 1 and fig. 9 400 [0038], [0082]), and at least one supply conduit (fig. 2a, liquid feeding line 120 [0044]) including an end in contact with the at least one piezoelectric substrate (fig. 2a, center, the line 120 is in contact with 100 via liquid 130 [0044]) for supplying the liquid from the reservoir to the at least one piezoelectric substrate ([0044]), and a control means for controlling a size of the nebulised liquid droplets ([0100] particle size can be controlled via filtration).
Murtazin is silent on wherein the droplet size control means 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, 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 slots in each of the at least one supply conduit.
Friend teaches the use of a wick at the end of a capillary tube (fig. 1, capillary tube 15 with wick 17 [0037]) in contact with working surface of a piezoelectric substrate (fig. 1, 7 [0035]) that enables a meniscus to form for atomization ([0037]). The wick is a strip or string (i.e., a fiber; see the 112(f) interpretation of the structures included in “liquid film forming structure” [0038]). The meniscus formed by the wick provides a surface to eject atomized droplets ([0038] and controls the droplet size to be less than 5 µm ([0044]).
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 capillary tube to include a wick as taught by Friend in order to provide a meniscus for a controlled particle size atomized from the device (Friend [0044]).
Friend does not explicitly disclose whether the liquid film forming structure is an integral part of the substrate or directly bonded to the substrate ([0038] states that the wick is in contact with the working surface of the working surface 7 of the piezoelectric substrate 5; based on the 12(b) rejection as interpreted by the examiner, “integral” is interpreted to mean that the liquid film forming structure is irreversibly bonded to 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)). Examiner notes that applicant does not appear to place criticality on the integration of the components (see original specification [0146] and Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983)).
Regarding Claim 63, Murtazin discloses a nebuliser system comprising: a first nebulizer according to claim 47 (fig. 12, top nebulizer assembly [0105], as modified by Friend the nebulizer meets the requirements of claim 47) and a second nebulizer according to claim 47 (fig. 12, bottom nebulizer assembly; as best understood based on the 112(a) rejection above), wherein the first nebuliser comprises a first nebuliser water contacting surface (water contacting surface shown face up in fig. 12); and the second nebuliser comprises a second nebuliser water contacting surface (fig. 12 shows the second nebulizer having a water contacting surface face up); however, the embodiment of fig. 12 is silent on wherein the first nebuliser water contacting surface is transverse to the second nebuliser water contacting surface (both nebulizer assemblies are shown having their water contacting surfaces in the same plane).
However, in the embodiment of 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 67, Murtazin as modified discloses a method of nebulising a liquid using a nebuliser according to claim 47, wherein the liquid includes non-therapeutic agents (Murtazin nebulizes non-therapeutic agents for providing a liquid sample for spectrometry analysis [0002]).
Regarding Claim 74, Murtazin discloses a nebuliser of claim 47, wherein the at least one piezoelectric substrate further comprises a non-transducer surface opposite the transducer surface (Murtazin fig. 2a, the bottom surface of 100), 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 (Murtazin fig. 2a, liquid supply system from 120 is applied to the transducer surface, which is the top surface of 100 where transducer 110 is located [0044]).
Regarding Claim 75, Murtazin discloses a nebuliser of claim 47, wherein the at least one supply conduit is rigid (fig. 2a, supply line 120 may be a capillary, which is a rigid tube that uses capillary action to transport fluid [0044]).
Regarding Claim 77, Murtazin as modified 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 ([0019]).
Regarding Claim 78, Murtazin as modified discloses a nebuliser according to claim 74, wherein the liquid is nebulised from the transducer surface (fig. 2c, the liquid is nebulized from the transducer surface).
Regarding Claim 80, Murtazin as modified discloses a nebuliser of claim 47, wherein the liquid film forming structure includes a web, mesh, or one or more fibers (as modified by Friend, the liquid film forming structure is a wick, fig. 1, which may be cloth fabric or a string, which are both comprised of one or more fibers, Friend [0023]) .
Regarding Claim 81, the modified Murtazin discloses a nebuliser of claim 47, wherein the liquid film forming structure includes one or more fibers (as modified by Friend, the liquid film forming structure is a wick, fig. 1, which may be cloth fabric or a string, which are both comprised of one or more fibers, Friend [0023]).
Regarding Claim 82, Murtazin as modified discloses a nebuliser of claim 80, wherein the liquid film forming structure is integrally formed with the at least one piezoelectric electric substrate (as modified in claim 47, Friend’s wick would have been obvious to make integral as a matter of design choice).
Claim 48 is rejected under 35 U.S.C. 103 as unpatentable over Murtazin and Friend, further in view of Takahashi et al. (US 5299739), hereafter Takahashi.
Regarding Claim 48, Murtazin 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 Murtazin’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 9-11).
Claim 49 is rejected under 35 U.S.C. 103 as unpatentable over Murtazin, Friend, 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 Murtazin and Friend, further in view of Ivri ‘970.
Regarding Claim 51, Murtazin 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, Murtazin 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 Murtazin and Friend, further in view of Ivri et al. (US 2003/0226906), hereafter Ivri ‘906.
Regarding Claim 53, Murtazin as modified discloses a nebuliser according to claim 47, but only has one electroacoustic transducer per piezoelectric substrate (fig. 2a, 110 [0044]), 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 Murtazin and Friend, further in view of Ivri ‘906 and Ivri ‘970.
Regarding Claim 54, Murtazin 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, Murtazin 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 Murtazin and Friend, 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, Murtazin as modified discloses a nebuliser according to claim 47, including at least two piezoelectric substrates spaced apart (fig. 12 shows a pair of nebulizers each having piezoelectric substrates spaced apart [0105]). However, Murtazin is silent on the piezoelectric substrates being 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”).
Regarding Claim 59, Murtazin as modified discloses a nebuliser according to claim 47, including at least two piezoelectric substrates spaced apart (fig. 12 shows a pair of nebulizers each having piezoelectric substrates spaced apart [0105]). However, Murtazin is silent on the piezoelectric substrates being 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 teaches that the capillary action of the treated water from the water supply means to the piezoelectric substrates (page 5, second full para. to fifth para.).
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”). It also would have been obvious to modify the size of the supply tube as needed for the correct capillary action flow, and thus the spacing between the piezoelectric substrates, in order to 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, Murtazin as modified discloses a nebuliser according to claim 47, including at least two piezoelectric substrates spaced apart (fig. 12 shows a pair of nebulizers each having piezoelectric substrates spaced apart [0105]). However, Murtazin is silent on the piezoelectric substrates being 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 that the capillary action of the treated water from the water supply means to the piezoelectric substrates (page 5, second full para. to fifth para.).
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”). It also would have been obvious to modify the size of the supply tube as needed for the correct capillary action flow, and thus the spacing between the piezoelectric substrates, in order to adjust the amount of liquid supplied for spraying based on Miyamatsu’s teaching to control the particle size (Miyamatsu page 4, fifth para.).
Claim 76 is rejected under 35 U.S.C. 103 as unpatentable over Murtazin and Friend, further in view of Löser (US 591893), hereafter Löser.
Regarding Claim 76, Murtazin 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 (Murtazin fig. 2a, the bottom surface of 100 [0044]), and wherein the liquid supply system (Murtazin figs. 1 and 9, 30) is configured for supplying a liquid to at least one of the transducer surface or the non-transducer surface (Murtazin fig. 2a, liquid feeding line 120 [0044]), and wherein the control means for controlling a size of the nebulised liquid droplets (as modified by Friend in claim 47 above), but is silent on the 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).
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.
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785