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 .
Claim Objections
The claims are objected to because of the following informalities:
The application has been amended as follows:
Claim 7, line 2, “across concentrator” should read --across the concentrator--
Claim 9, line 3, “across concentrator” should read --across the concentrator--
Appropriate correction is required.
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.
Claim(s) 1-6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeates et al. (US 2018/0099106 A1).
Regarding claim 1, Yeates discloses an aerosol concentrator (figures 5a-d) dividing an input aerosol of an input particle concentration into a concentrated respirable aerosol of an increased particle concentration that is higher than the input particle concentration and an exhaust aerosol of a lower particle concentration that is lower than the input particle concentration [0085], said concentrator comprising:
an input tube (19) having a lumen [0085] (see figures 5a-5d) and comprising:
an input tube entrance port (left end of figure 5d) having an input tube entrance port cross-sectional shape differing from a cross-slit shape (circular as shown in figure 5a);
an input tube exit port (right end of 19 ending near 40 as shown in figure 5d) having a slit shape (linear slit as per [0085]), wherein the input tube entrance port cross-sectional shape transitions between the input tube entrance port and the input tube exit port to the cross-slit-shaped exit port cross-sectional shape (as shown in figure 5D);
an output tube (22) having a lumen (figures 5a-d and [0085]) and comprising:
an output tube entrance port (left end of 22 near 40 as shown in figure 5D) having a slit-shaped cross-section (linear slit as per [0085]), said output tube entrance port being aligned with and spaced apart from the input tube exit port by a gap (40) between the input tube exit port and the output tube entrance port (figure 5d and [0085]);
an output tube exit port (right end of 22 as shown in figure 5d) wherein the output tube entrance port cross-sectional shape transitions between the output tube entrance port and the output tube exit port to an output tube exit port cross-sectional shape (figure 5d, [0085]); and
a housing (78) encompassing a plenum (43), said plenum encompassing the gap (40) between the input tube and the output tube (see figure 5d), wherein the plenum is connected to an exhaust port (44) through which an exhaust aerosol exits the plenum [0085].
Yeates does not explicitly disclose wherein the slit shape of the input tube exit port and the output tube entrance port is a cross-slit shape.
However, changing the linear slit of the input tube exit port and the output tube entrance port as disclosed in [0085] of Yeates to be a cross-slit shape is a simple change in shape. The disclosure of the instant invention fails to provide criticality to having the cross-slit shape and it would have been an obvious matter of design choice to modify the invention of Yeates to have the cross-slit shape, since applicant has not disclosed that having the cross-slit shape solves any stated problem or is for any particular purpose and it appears that the cross-slit shape would perform equally well as the linear slit shape. Further the courts have held that a change in shape supports a prima facia case of obviousness. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)
Regarding claim 2, Yeates further discloses wherein the input tube (19) converges from its input tube entrance port to its input tube exit port from an input tube entrance port cross-sectional area that is larger than an input tube exit port cross-sectional area (see figure 5d).
Regarding claim 3, Yeates further discloses wherein the output tube (22) diverges from its output tube entrance port to its output tube exit port from an output tube entrance port cross-sectional area that is smaller than an output tube exit port cross-sectional area (see figure 5d).
Regarding claim 4, Yeates further discloses wherein the input tube (19) and the output tube (22) have a joint longitudinal axis and have radial sizes transverse to the longitudinal axis that are less than a third of a radial size of the plenum transverse to said longitudinal axis (see figure 5d).
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Regarding claim 5, Yeates further discloses wherein the housing (78) compromises an input housing part holding the input tube (see annotated figure below), and output housing part holding the output tube and an exhaust tube (44) (see annotated figure below).
Yeates does not explicitly disclose a seal is provided between the input housing part and the output housing part.
However, Yeates teaches it is known to provide a seal between two components (seal 73 as shown in figure 5b and described in [0085]).
It would have been obvious to have modified Yeates such that a seal is provided between the input housing part and the output housing part for the benefit of ensuring the components being connected are gas-tight [0085].
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Regarding claim 6, Yeates further discloses wherein the housing shares the same joint longitudinal axis with the input tube and the output tube (see figure 5d) and the plenum is encompassed at least for the most part by either one of the input housing part or the output housing part (plenum 43 is encompassed by output housing part), while the other part of the output or input housing, respectively, is essentially disc-shaped (input housing as shown above is essentially disk shaped), with the housing part encompassing at least for the most part the plenum also having the exhaust tube which extends essentially radially in a transverse direction with respect to said longitudinal axis (output housing part as shown above in annotated figure 5b has exhaust tube 44).
Regarding claim 9, Yeates further discloses wherein the concentrator is designed to concentrate an aerosol using virtual impaction [0024] at a small positive pressure within and across concentrator all the way to the output tube exit port such that the concentrated respirable aerosol can be delivered to the patient at the small positive pressure without the use of pumps to remove the exhausted gas [0027]. "[A]pparatus 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). It is the examiner’s position that Yeates as modified discloses all the claimed structural limitations.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeates et al. (US 2018/0099106 A1) in view of Lindsey at al. (US 4,012,473)
Regarding claim 7, Yeates does not explicitly disclose wherein a pressure relief valve is connected to the exhaust tube keeping the pressure within and across concentrator and consequently at the output tube exit port essentially constant.
However, Lindsey teaches it is known to put a pressure relief valve (190 203) within an exhaust port (189).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Yeates to include a pressure relief valve connected to the exhaust port as taught by Lindsey for the benefit of releasing excess pressure to ensure safe operation but allowing some pressure to build. As modified Yeates reads on the function of keeping the pressure within and across concentrator and consequently at the output tube exit port essentially constant. "[A]pparatus 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). It is the examiner’s position that Yeates as modified discloses all the claimed structural limitations.
Regarding claim 8, Yeates further discloses wherein the concentrator is designed to concentrate an input aerosol having fine particles of a particle size distribution of 1 - 6 pm MMAD suspended in gas [0129]. Further, the examiner notes: "[A]pparatus 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). It is the examiner’s position that Yeates as modified discloses all the claimed structural limitations.
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785