DETAILED ACTION
Receipt is acknowledged of the amendment filed on June 3, 2026, which has been fully considered in this action. Claims 30-37, 39-43 and 45-48 have been amended, claims 38, 44 and 49 canceled and claims 50-52 newly added. An action as to the merits follows for claims 30-37, 39-43, 45-48 and 50-52.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claims 30-37, 39-43, 45-48 and 50-52 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification is silent to the recitation of “at least one subset of the plurality of exit openings, respectively, each subset of the at least one subset second apertures including at least two exit openings” as recited in claim 30, lines 8 and 9, “a respective subset of the plurality of exit openings including at least two exit openings” as recited in claim 40, lines 9 and 10, and “a respective subset of a plurality of subsets of the plurality of exit openings, each subset including at least two exit openings” in claim 45, lines 9 and 10. Such subject matter was not disclosed in the specification and is considered new matter. As currently disclosed in the specification the cavity is only positioned above the entire plurality of apertures and is in fluid communication the entire plurality of apertures and does not recite at least one cavity or each cavity of the plurality of cavities in fluid communication with at least one subset of the plurality of exit openings or in fluid communication with a respective subset of the plurality of exit openings or in fluid communication with a respective subset of a plurality of subsets of the plurality of exit openings.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 30(as best understood), 33, 37, 40(as best understood), 41, 50 and 51are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by US 5,565,113 A(Hadimioglu et al).
As to claim 30, Hadimioglu et al ‘113 discloses an aperture plate 262 comprising an inlet portion having a first height including at least one cavity at 310; an outlet portion disposed downstream of the inlet portion, having a second height and including a plurality of exit openings, wherein the at least one cavity at 310 is in fluid communication with at least one subset of the plurality of exit openings 250, respectively, each subset of the at least one subset including at least two exit openings, and wherein the first height thickness is greater than the second height. See marked up Fig. 14 and Figures 5-14 and col. 5, line 65 through col. 6, line 65. With respect to applicant’s statement of intended use in the preamble, i.e. (for use in aerosolizing a liquid in a nebulizer), the device of Hadimioglu et al ‘113 is capable of performing applicant’s intended use, therefore, the claims are fully anticipated and the preamble has not given any patentable weight since it does not breathe life into the claim.
As to claim 33, see marked up Fig. 14 where it shows the first height at least two times greater than the second height.
As to claim 37, see Figs. 6 and 14 and at least 50 exit openings 250.
As to claim 40, Hadimioglu et al ‘113 discloses an aperture plate 262 comprising an inlet portion having a first height including a plurality of cavities at 310; an outlet portion disposed downstream of the inlet portion, having a second height and including a plurality of exit openings, wherein each cavity at 310 of the plurality of cavities is in fluid communication with a respective subset of the plurality of exit openings 250, respectively, including at least two exit openings, and wherein the first height is greater than the second height. See marked up Fig. 14 and Figures 5-14 and col. 5, line 65 through col. 6, line 65. With respect to applicant’s statement of intended use in the preamble, i.e. (for use in aerosolizing a liquid in a nebulizer), the device of Hadimioglu et al ‘113 is capable of performing applicant’s intended use, therefore, the claims are fully anticipated and the preamble has not given any patentable weight since it does not breathe life into the claim.
As to claim 41, see Fig. 14.
As to claims 50 and 51, see Figure 10 showing the outlet portion including a second layer of material 306 and Figures 11 and 12 show the inlet portion including a first layer of material 310 and wherein the second layer of material 306 is positioned downstream of the first layer of material 310.
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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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 31, 32, 34-36, 39, 42, 43, 45(as best understood), 46-48 and 52 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,565,113 A(Hadimioglu et al).
As to claim 31, Hadimioglu et al ‘113 discloses an aperture plate comprising all the featured elements of the instant invention, except wherein the first height is at least 40 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention wherein the first height is at least 40 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art(i.e. a first height greater than the second height), 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). See MPEP 2144.05.II.A. In addition, it has not been disclosed in the specification that there is any criticality to having the first height at least 40 mm.
As to claim 32, Hadimioglu et al ‘113 discloses an aperture plate comprising all the featured elements of the instant invention, except wherein the second height is at least 5 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention wherein the second height is at least 5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art(i.e. a first height greater than the second height), 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). See MPEP 2144.05.II.A. In addition, it has not been disclosed in the specification that there is any criticality to having the second height at least 5 mm.
As to claim 34, Hadimioglu et al ‘113 discloses an aperture plate comprising all the featured elements of the instant invention, except wherein a sum of the first height and the second height is at least 40 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention wherein a sum of the first height and the second height is at least 40 mm, 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). See MPEP 2144.05.II.A. In addition, it has not been disclosed in the specification that there is any criticality wherein a sum of the first height and the second height is at least 40 mm.
As to claim 35, Hadimioglu et al ‘113 discloses an aperture plate comprising all the featured elements of the instant invention, except wherein at least one cavity is substantially cylindrical. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention wherein at least one cavity is substantially cylindrical, since the court held that it was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). See MPEP 2144.04.IV.B. In addition, it has not been disclosed in the specification that there is any criticality to having the cavity substantially cylindrical.
As to claim 36, see Figs. 5 and 6, where it shows the exit opening 250 of the plurality of exit openings being substantially cylindrical.
As to claim 39, Hadimioglu et al ‘113 discloses an aperture plate comprising all the featured elements of the instant invention, except wherein a distance between any two exit openings of the plurality of exit openings is at least 1 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention wherein a distance between any two exit openings of the plurality of exit openings is at least 1 mm, 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). See MPEP 2144.05.II.A. In addition, it has not been disclosed in the specification that there is any criticality to having a distance between any two exit openings of the plurality of exit openings being at least 1 mm.
As to claim 42, Hadimioglu et al ‘113 discloses an aperture plate comprising all the featured elements of the instant invention, except wherein the area circumscribed by any cavity of the plurality of cavities is circular. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention the area circumscribed by any cavity of the plurality of cavities is circular, since the court held that it was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). See MPEP 2144.04.IV.B. In addition, it has not been disclosed in the specification that there is any criticality to having the area circumscribed by any cavity of the plurality of cavities being circular.
As to claim 43, see Figs. 6 and 14 and at least 50 exit openings 250.
As to claim 45, Hadimioglu et al ‘113 discloses an aperture plate 262 comprising an inlet portion having a first height including a plurality of cavities at 310; an outlet portion disposed downstream of the inlet portion, having a second height and including a plurality of exit openings, wherein each cavity at 310 of the plurality of cavities is in fluid communication with a respective subset of the of a plurality of subsets of the plurality of exit openings 250, respectively, including at least two exit openings 250, and wherein the first height is greater than the second height, except for wherein each cavity of the plurality of cavities includes a width that is at least ten times greater than a width of any exit opening of the plurality of exit openings. See marked up Fig. 14 and Figures 5-14 and col. 5, line 65 through col. 6, line 65. With respect to applicant’s statement of intended use in the preamble, i.e. (for use in aerosolizing a liquid in a nebulizer), the device of Hadimioglu et al ‘113 is capable of performing applicant’s intended use, and the preamble has not given any patentable weight since it does not breathe life into the claim. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention wherein each cavity of the plurality of cavities includes a width that is at least ten times greater than a width of any exit opening of the plurality of exit openings, since Hadimioglu et al ‘113 shows the cavity including a width of at least 9 times greater than a width of the exit opening 250 as shown in Fig. 14 and it has been held that where the general conditions of a claim are disclosed in the prior art(i.e. cavity including a width of at least 9 times greater than a width of the exit opening 250), 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, 35CPA 1955). See MPEP 2144.05.II.A.
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As to claim 46, Hadimioglu et al ‘113 discloses an aperture plate comprising all the featured elements of the instant invention, except wherein the width of any exit opening of the plurality of exit openings is less than or equal to substantially 5 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention wherein the width of any exit opening of the plurality of exit openings is less than or equal to substantially 5 mm, 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). See MPEP 2144.05.II.A. In addition, it has not been disclosed in the specification that there is any criticality to having the width of any exit opening of the plurality of exit openings being less than or equal to substantially 5 mm.
As to claim 47, Hadimioglu et al ‘113 discloses an aperture plate comprising all the featured elements of the instant invention, except wherein the width of any cavity of the plurality of cavities is greater than or equal to substantially 5 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention wherein the width of any cavity of the plurality of cavities is greater than or equal to substantially 5 mm, 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). See MPEP 2144.05.II.A. In addition, it has not been disclosed in the specification that there is any criticality to having the width of any cavity of the plurality of cavities being greater than or equal to substantially 5 mm.
As to claim 48, Hadimioglu et al ‘113 discloses an aperture plate comprising all the featured elements of the instant invention, except wherein a distance between any two exit openings is greater than or equal to substantially 1 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention wherein a distance between any two exit openings is greater than or equal to substantially 1 mm, 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). See MPEP 2144.05.II.A. In addition, it has not been disclosed in the specification that there is any criticality to having a distance between any two exit openings being greater than or equal to substantially 1 mm.
As to claim 52, see Figure 10 showing the outlet portion including a second layer of material 306 and Figures 11 and 12 show the inlet portion including a first layer of material 310 and wherein the second layer of material 306 is positioned downstream of the first layer of material 310.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J GANEY whose telephone number is (571)272-4899. The examiner can normally be reached M-F 9am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arthur Hall can be reached at (571)270-1814. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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STEVEN J. GANEY
Primary Examiner
Art Unit 3752
/STEVEN J GANEY/ Primary Examiner, Art Unit 3752
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