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
Applicant’s amendments, filed 17 April 2026, with respect to the claims have been entered. Therefore, the rejections of claims 1-4, 7-11, and 13-16 under 35 U.S.C. 103 have been withdrawn.
Response to Arguments
Applicant’s arguments, see page 8, filed 17 April 2026, that Schleifer in view of Takada fails to disclose determining a position of the liquid capillary relative to the outlet aperture based on the measured flow rate of the gas supplied to the outlet aperture have been fully considered but they are not persuasive.
In this case, Schleifer discloses a “base” method comprising measuring a property of the gas supplied to the outlet aperture (column 12, lines 21-24); and determining a position of the liquid capillary relative to the outlet aperture based on the measured property (column 12, lines 18-21). The only limitation of claim 1 which Schleifer does not disclose is that the “measured property” is a flow rate of the gas.
However, Schleifer does disclose that the capillary position has a predictable relationship with the gas flow rate. For example, Schleifer discloses that “the fluid mechanics-related conditions in the fluid interaction region 170A…[include] the flow rates of the liquid sample and the nebulizing gas” (column 11, lines 38-46, emphasis added), wherein “[t]he fluid mechanics in the fluid interaction region 170A are influenced by the presence of the first conduit [capillary] 108 in the fluid interaction region 170A” (column 11, lines 47-49). Schleifer further specifically discloses that the gas back pressure across the exit orifice (as one example of said fluid mechanics in the fluid interaction region 170A; another example is the flow rate of the nebulizing gas as discussed above) “varies with the position of the first conduit 108…That is, the gas back pressure…varies with the axial distance between the first conduit 108 (and thus the first conduit outlet 134) and the exit orifice 172” (column 11, lines 50-54).
Furthermore, the disclosure of Takada shows a known technique that is applicable to the base method disclosed in Schleifer, wherein one of ordinary skill in the art would have recognized that applying the known technique would have yielded predictable results and resulted in an improved system as discussed below. See MPEP 2143 I (D).
Takada discloses controlling a flow rate of the gas supplied to the outlet aperture, wherein the flow rate of the gas is dependent on the flow rate of the sample solution (page 4, paragraph 3: “A mechanism for measuring the flow rate of the sample solution is provided, and…the flow rate of the spray gas…[is] controlled according to the flow rate [of the sample solution]”), and controlling a position of the liquid capillary relative to the outlet aperture, wherein the position of the liquid capillary is also dependent on the flow rate of the sample solution (page 4, paragraph 3: “A mechanism for measuring the flow rate of the sample solution is provided, and…the position of the spray capillary…[is] controlled according to the flow rate [of the sample solution]”). Controlling the flow rate of the gas and the position of the capillary inherently involves determining the gas flow rate and the capillary position, because the initial flow rate and position affects the magnitude and direction of change required to achieve a desired position.
Therefore, the disclosure of Takada demonstrates that the steps of determining the flow rate of the gas supplied to the outlet aperture of a nebulizer (FIG. 1, outlet aperture at element 13) and determining a position of the liquid capillary (FIG. 1, capillary 11) relative to the outlet aperture are a known technique, applicable to the base method of nebulizer operation disclosed in Schleifer, with predictable results comprising the achievement of desired or optimal operating conditions in the nebulizer (see, e.g., page 4, paragraphs 2-3; page 8, paragraph 4). Furthermore, the application of the known technique of Takada would result in an improved system due to enabling operation at high flow rates (Takada, page 4, paragraph 1).
A person of ordinary skill in the art would recognize from the combined teachings of Schleifer and Takada that there is a known relationship with a known function between the gas flow rate and the position of the capillary, and would have found it obvious, before the effective filing date of the claimed invention, to substitute the flow rate of the gas as the measured property used to determine the position of the liquid capillary in the base method of Schleifer. The combined teachings of Schleifer and Takada show that substituting the flow rate of the gas for another fluid-mechanics related condition yields a predictable result with respect to determining the position of the capillary due to the known dependence between the various fluid-mechanics related conditions (including pressure, gas flow rate, sample flow rate, etc.) and the position of the capillary (Schleifer, column 11, lines 37-67; and Takada, page 4, paragraphs 2-3). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” United States v. Adams, 383 U.S. 39 (1966). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schleifer in view of Takada to include measuring a flow rate of the gas supplied to the outlet aperture; and determining a position of the liquid capillary relative to the outlet aperture based on the measured flow rate, because it is not inventive to substitute one known element for another which yields predictable results to one of ordinary skill in the art. See MPEP 2143 I (B).
Applicant’s arguments, see pages 8-9, filed 17 April 2026, that Canals fails to disclose determining whether a liquid capillary is in a position that corresponds to flow blurring nebulisation based on a measured flow rate of a gas; and that it would not be obvious based on the teachings of Schleifer, Takada, and Canals to use a measurement of the flow rate of the gas to determine whether the capillary is in a position that corresponds to flow blurring nebulisation, have been fully considered but they are not persuasive.
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the case at hand, determining the position of the capillary based on a measured flow rate of the gas is obvious over the combined teachings of Schleifer in view of Takada as discussed supra. The teachings of Canals demonstrate that there is a predictable relationship between the position of the capillary relative to the outlet aperture and the occurrence of flow blurring nebulisation. Canals discloses that a particular position (FIG. 3D, distance H) of the outlet of the liquid capillary (6) with respect to the outlet aperture of the nebuliser (4) corresponds to flow blurring nebulisation (page 5, paragraph 3, lines 6-9; see also page 8, second paragraph from the last: “[w]hen the relationship between the distance (H), between the outlet orifice (4) and the plane of the outlet assembly (6) of the liquid flow supply ducts (5), and the diameter of the aerosol outlet orifice (D)…is less than 0.6, the fogging occurs through the phenomenon called “flow blurring””). Therefore, Canals discloses either that: the liquid capillary is in a first position relative to the outlet aperture (page 8, second paragraph from the last, H/D less than 0.6); or that the liquid capillary is other than in the first position relative to the outlet aperture (page 8, second paragraph from the last, H/D greater than 0.6), and wherein the first position is a position of the liquid capillary relative to the outlet aperture that corresponds to flow blurring nebulisation (page 8, second paragraph from the last, lines 5-6).
Furthermore, the instant specification discloses that the capillary position corresponding to flow blurring nebulisation is a position wherein the outlet of the liquid capillary is withdrawn within the nebuliser outlet aperture (see, e.g., page 3, lines 25-27: “…arrangements in which the outlet of the liquid capillary is withdrawn from the nebuliser outlet aperture, such as for so-called “flow blurring” nebulisers”; page 13, lines 15-18: “…the outlet (tip) of the liquid capillary 2 does not protrude beyond the outlet aperture 1, but is instead arranged within the nozzle 3 and withdrawn from the outlet aperture 1. This arrangement may be so as to produce so-called “flow blurring” nebulisation”; and page 15, lines 12-13: “…flow blurring nebulisers, i.e. where the liquid capillary 2 is withdrawn inside the nebuliser nozzle 3”). This positional relationship is disclosed in both Schleifer (FIG. 1C: the outlet 134 of the liquid capillary 108 is withdrawn within the nebuliser outlet aperture 172) and Canals (FIG. 3D: the outlet 6 of the liquid capillary 5 (FIG. 1) is withdrawn within the nebuliser outlet aperture 4; see also page 5, paragraph 3: (“the outlets of the liquid flow supply conduits of the nebulizer of the invention are positioned…in a plane retracted with respect to the plane of the orifice Nebulizer outlet”).
Applicant’s arguments, see pages 9-10, filed 17 April 2026, regarding the rejection of claims 17 and 20-22 under 35 U.S.C. 103 have been fully considered but are not persuasive.
Features of an apparatus may be recited either structurally or functionally (In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997)), but “apparatus claims cover what a device is, not what a device does” (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)(emphasis in original)). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), i.e., a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the case at hand, Schleifer in view of Hirabayashi teaches the structural limitations of the nebuliser apparatus (see Claim Rejections - 35 USC § 103 below). Therefore, the limitations of the claim are met.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schleifer et al. (U.S. Patent No. 9,673,032 B1), hereinafter Schleifer, in view of Takada et al. (JP Patent No. 2003203599 A), hereinafter Takada (English machine translation provided in a prior office action), and Canals et al. (WO Patent No. 2016087694 A1), hereinafter Canals (English machine translation provided in a prior office action).
Regarding claim 6, Schleifer discloses a method of operating a nebuliser that comprises an outlet aperture (FIG. 1C, element 172) and a liquid capillary (FIG. 1C, element 108), the method comprising:
supplying a gas to the outlet aperture (column 8, lines 31-32);
measuring a property of the gas supplied to the outlet aperture (column 12, lines 21-24); and
determining a position of the liquid capillary relative to the outlet aperture based on the measured property (column 12, lines 18-21),
wherein determining the position of the liquid capillary relative to the outlet aperture based on the measured flow rate comprises:
determining, based on the measured flow rate, either that:
(i) the liquid capillary is in a first position relative to the outlet aperture; or that
(ii) the liquid capillary is other than in the first position relative to the outlet aperture (column 11, lines 28-31; the first position being the “desired axial position”).
Schleifer fails to disclose that the measured property is a flow rate of the gas, and wherein the first position is a position of the liquid capillary relative to the outlet aperture that corresponds to flow blurring nebulisation.
However, Takada discloses determining a flow rate of the gas, the flow rate of the gas being dependent on the flow rate of the sample solution (page 4, paragraph 3: “A mechanism for measuring the flow rate of the sample solution is provided, and…the flow rate of the spray gas…[is] controlled according to the flow rate [of the sample solution]”); and
determining a position of the liquid capillary, wherein the position of the liquid capillary is also dependent on the flow rate of the sample solution (page 4, paragraph 3: “A mechanism for measuring the flow rate of the sample solution is provided, and…the position of the spray capillary…[is] controlled according to the flow rate [of the sample solution]”).
Controlling the flow rate of the gas and the position of the capillary inherently involves determining the gas flow rate and the capillary position, because the initial flow rate and position affects the magnitude and direction of change required to achieve a desired position.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schleifer to include measuring a flow rate of the gas; and determining a position of the liquid capillary based on the measured flow rate, based on the teachings of Takada that this enables the apparatus to operate at high flow rates (Takada, page 4, paragraph 1).
Schleifer in view of Takada fails to disclose that the first position is a position of the liquid capillary relative to the outlet aperture that corresponds to flow blurring nebulisation.
However, Canals discloses that the first position is a position of the liquid capillary relative to the outlet aperture that corresponds to flow blurring nebulisation (page 5, paragraph 3, lines 6-9).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schleifer in view of Takada to include that the first position is a position of the liquid capillary relative to the outlet aperture that corresponds to flow blurring nebulisation, based on the teachings of Canals that flow blurring nebulisation is beneficial for pneumatic nebulizer applications (Canals, page 5, paragraph 3).
Claims 17 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Schleifer in view of Hirabayashi et al. (JP Patent No. 2001291487 A), hereinafter Hirabayashi (English machine translation provided in a prior office action).
Regarding claim 17, Schleifer discloses a nebuliser apparatus comprising:
a nebuliser comprising an outlet aperture (FIG. 1C, element 172) and a liquid capillary (FIG. 1C, element 108), wherein the nebuliser is configured such that an outlet of the liquid capillary is withdrawn within the nebuliser (FIG. 1C: the outlet at the rightmost end of the capillary is internal to sprayer tip 116 of the nebuliser), and wherein the apparatus is configured such that the position of the liquid capillary relative to the outlet aperture can be altered (FIG. 1C, axial direction 186; column 11, lines 17-19);
a gas supply configured to supply gas to the outlet aperture (column 8, lines 31-32); and
a sensor configured to measure a property of the gas supplied to the outlet aperture (column 12, lines 18-26);
wherein the apparatus is configured such that the position of the liquid capillary relative to the outlet aperture can be determined based on the property measured by the sensor (column 12, lines 18-21).
Schleifer fails to disclose that the sensor is a flow meter; and that the measured property is a flow rate of the gas.
However, Hirabayashi discloses a flow meter configured to measure a flow rate of the gas supplied to the outlet aperture (page 6, paragraph 0025).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schleifer to include a flow meter configured to measure a flow rate of the gas supplied to the outlet aperture, based on the teachings of Hirabayashi that maintaining a particular flow rate is important to avoid fragmentation of the sample at the capillary tip (Hirabayashi, page 4, paragraph beginning “when the characteristic value F / S…”).
The limitations “wherein the apparatus is configured such that it can be determined, based on the flow rate measured by the flow meter, whether: (i) the position of the liquid capillary relative to the outlet aperture is stable; or (ii) the position of the liquid capillary relative to the outlet aperture is a position that corresponds to flow blurring nebulisation” are functional limitations. Features of an apparatus may be recited either structurally or functionally (In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997)), but “apparatus claims cover what a device is, not what a device does” (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)(emphasis in original)). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), i.e., a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the case at hand, the combined teachings of Schleifer in view of Hirabayashi disclose a nebuliser apparatus which meets the structural limitations of the claim and is capable of determining the position of the liquid capillary relative to the outlet aperture. Therefore, the claim limitations are met.
Regarding claim 20, Schleifer in view of Hirabayashi as applied to claim 17 discloses the apparatus of claim 17.
In addition, Hirabayashi discloses a gas flow controller (FIG. 1, element 4) that comprises the flow meter (page 6, paragraph 0025), wherein the gas flow controller is configured for adjusting the flow rate of gas to the outlet aperture based on a gas flow rate measured by the flow meter (page 5, paragraph beginning “FIG. 1 is a block diagram…” through paragraph ending “200 m / s or more”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schleifer in view of Hirabayashi to include a gas flow controller that comprises the flow meter, wherein the gas flow controller is configured for adjusting the flow rate of gas to the outlet aperture based on a gas flow rate measured by the flow meter, based on the additional teachings of Hirabayashi that maintaining a particular flow rate is important to avoid fragmentation of the sample at the capillary tip (Hirabayashi, page 4, paragraph beginning “when the characteristic value F / S…”).
Regarding claim 21, Schleifer in view of Hirabayashi as applied to claim 17 discloses the nebuliser apparatus of claim 17.
In addition, Schleifer discloses an ion source comprising the nebulizer apparatus (column 2, lines 25-31).
Regarding claim 22, Schleifer in view of Hirabayashi as applied to claim 21 discloses the ion source of claim 21.
In addition, Schleifer discloses an analytical instrument comprising the ion source (column 2, lines 32-37), wherein the analytical instrument comprises a mass and/or ion mobility spectrometer (column 16, lines 13-15).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Schleifer in view of Hirabayashi as applied to claim 17 above, and further in view of Hasegawa et al. (U.S. Patent Application Publication No. 2023/0141083 A1), hereinafter Hasegawa.
Regarding claim 18, Schleifer in view of Hirabayashi as applied to claim 17 discloses the apparatus of claim 17, including determining the position of the liquid capillary relative to the outlet aperture based on the measured flow rate.
Schleifer in view of Hirabayashi fails to disclose information indicative of a first flow rate, wherein the first flow rate is a flow rate that is indicative of the liquid capillary being in a first position relative to the outlet aperture; wherein the apparatus is configured such that the position of the liquid capillary relative to the outlet aperture can be determined by comparing the measured flow rate to the first flow rate.
However, Hasegawa discloses information indicative of a first measured property, wherein the first measured property is a measured property that is indicative of the liquid capillary being in a first position relative to the outlet aperture (paragraph 0066, the first measured property being the value of the current when the capillary is at the “normal position”);
wherein the apparatus is configured such that the position of the liquid capillary relative to the outlet aperture can be determined by comparing the measured property to the first measured property (paragraph 0066).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Schleifer in view of Hirabayashi to include information indicative of a first flow rate, wherein the first flow rate is a flow rate that is indicative of the liquid capillary being in a first position relative to the outlet aperture; wherein the apparatus is configured such that the position of the liquid capillary relative to the outlet aperture can be determined by comparing the measured flow rate to the first flow rate, based on the teachings of Hasegawa that this determination prevents analysis from being performed in a state in which the apparatus is contaminated due to improper positioning of the capillary (Hasegawa, paragraph 0048).
Allowable Subject Matter
Claims 1-4, 7-11, and 13-16 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 1 is allowable because the prior art of record fails to teach “determining, based on the measured flow rate, whether the position of the liquid capillary relative to the outlet aperture is stable” in combination with the additional limitations of claim 1.
The closest prior art of record, Schleifer, teaches determining the position of the liquid capillary relative to the outlet aperture. However, Schleifer fails to teach the position of the capillary being stable or unstable. Therefore, the prior art of record fails to teach “determining, based on the measured flow rate, whether the position of the liquid capillary relative to the outlet aperture is stable” as currently claimed.
Claims 2-4, 7-11, and 13-16 are allowed because of their dependence on claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hirabayashi et al. (U.S. Patent Application Publication No. 2002/0125426 A1), hereinafter Hirabayashi (2002), teaches an ion source comprising an outlet aperture and a liquid capillary, wherein the position of the liquid capillary relative to the outlet aperture can be altered.
Inagaki et al. (U.S. Patent Application Publication No. 2015/0206729 A1), hereinafter Inagaki, teaches an apparatus configured to nebulize a sample by mixing gas and liquid in a highly turbulent manner.
Hirabayashi et al. (U.S. Patent No. 6,147,347 A), hereinafter Hirabayashi (2000), teaches a flow meter configured to measure a flow rate of the gas supplied to the outlet aperture of a nebuliser.
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/A.K./Examiner, Art Unit 2881
/ROBERT H KIM/Supervisory Patent Examiner, Art Unit 2881
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