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 .
Election/Restrictions
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 July 2026.
Claim Objections
Claim 4 is objected to because of the following informalities:
Regarding claim 4, line 1, “wherein expansion chamber” should be changed to --wherein the expansion chamber--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 9 is 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.
The term “high-melting-point” in claim 9 is a relative term which renders the claim indefinite. The term “high-melting-point” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification points towards molten salt as an example of a high-melting-point solution, but fails to specify any specific range of melting points as a “high-melting-point”. As such, the limitation “high-melting-point” solution is rendered indefinite by the usage of the term “high-melting-point”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Riggs et al. (US 5,227,175) (hereinafter Riggs).
Regarding Claim 1, Riggs teaches a dilution apparatus (Col 2, lines 28-43, see Abstract) comprising:
a structural body (see Fig. 3) defining
an introductory chamber having a first chamber cross-sectional area [gas source 44 into chamber having baffles 264, 266] (Col 8, lines 4-15, see Fig. 3),
an expansion chamber extending continuous from the introductory chamber and having a second chamber cross-sectional area that is larger than the first chamber cross-sectional area [conically shaped part 76 having larger cross-sectional areas than chamber having baffles 264, 266] (Col 8, lines 25-44, see Fig. 3),
an inert gas port extending into the introductory chamber [inflow connecting tube 44’ from gas source 44] (Col 7, line 55 - Col 8, line 15, see Fig. 3), and
a solution port extending into the introductory chamber [inserted feedthrough 74 for fluid comprising a drug] (Col 2, lines 44-56, see Fig. 3),
an exhaust passage having a first passage cross-sectional area fluidly coupled to the expansion chamber [inhalation respiratory pathway 26] (Col 6, lines 24-41, see Figs. 3 and 7-9), and
a dilution passage having a second passage cross-sectional arca fluidly coupled to the expansion chamber [aspirator tube 66] (Col 7, lines 31-68, see Fig. 3),
wherein the first passage cross-sectional area is greater than the second passage cross-sectional area (see Fig. 3).
Regarding claim 2, Riggs as applied to claim 1 above teaches the claimed invention, in addition to wherein the introductory chamber [chamber having baffles 264, 266] and the expansion chamber [conically shaped part 76] define a continuous multi-chamber volume (see Fig. 3).
Regarding claim 3, Riggs as applied to claim 2 above teaches the claimed invention, in addition to wherein the expansion chamber extends from an end of the introductory chamber (see Fig. 3).
Regarding claim 4, Riggs as applied to claim 3 above teaches the claimed invention, in addition to wherein the expansion chamber and the introductory chamber are each disposed, concentrically, along a common longitudinal axis of the structural body (see Fig. 3).
Regarding claim 5, Riggs as applied to claim 1 above teaches the claimed invention, in addition to wherein the structural body defines the inert gas port [44’] circumferentially offset from the solution port [74] (see Fig. 3).
Regarding claim 6, Riggs as applied to claim 5 above teaches the claimed invention, in addition to wherein the structural body defines the inert gas port [44’] as longitudinally offset from the solution port [74] (see Fig. 3).
Regarding claim 8, Riggs as applied to claim 1 above teaches the claimed invention, in addition to wherein the structural body defines an exit chamber continuous from the expansion chamber and having a third chamber cross-sectional area that is smaller than the second chamber cross-sectional area, and the exhaust passage and the dilution passage extend from the exit chamber [port 22 or baffle 278] (see Fig. 3).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Riggs as applied to claim 1 above.
Regarding claim 7, Riggs as applied to claim 1 above teaches the claimed invention, in addition to wherein the structural body is configured to withstand a temperature of a solution therein (Col 19, lines 22-62). Riggs fails to teach wherein the temperature is up to 700 degrees C; however, it would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Riggs to choose a temperature tolerance, such as up to 700 degrees C, in order to provide a robust apparatus. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
As best understood regarding claim 9, Riggs as applied to claim 1 above teaches the claimed invention, in addition to wherein the expansion chamber is configured to produce a diluted aerosol from an aerosolized form of a solution using an inert gas received from the inert gas port, and the dilution passage is configured to cause an exit of a port of the diluted form of the aerosolized solution (Col 8, lines 4-44, see Fig. 3). Riggs fails to teach wherein the solution is a high-melting-point solution. Riggs additionally teaches wherein the solution is aerosolized to treat a desired condition (Col 1, lines 14-23). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Riggs to choose an appropriate solution, such as a high-melting-point solution, in order to treat a condition with the solution. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955). It has also been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID Z HUANG whose telephone number is (571)270-5360. The examiner can normally be reached Monday - Friday, 9:00 AM - 5:00 PM EST.
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/DAVID Z HUANG/ Primary Examiner, Art Unit 2855
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