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 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.
Claim(s) 11, 12, 17 – 21, 23, 26, 27, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochrainer (US 7708011) in view of Voges (US 6443146).
11. Hochrainer discloses a dry powder delivery device for delivering a dry powder as a plume of particles to a pulmonary system of a subject (c. 1: 2 – 3, Fig. 1) comprising: a housing (1) including an airflow exit (2); a dry powder supply disposed within or coupled to the housing (7); a powder dispersion mechanism in communication with the supply (compressed air and valve 5, see c. 10: 6 – 25); wherein the powder dispersion mechanism is configured to produce a plume of particles from a volume of powder from the dry powder supply (see plume entering mouthpiece 2 in Fig. 1); the plume of particles including a first plurality of particles having a smaller mass mean aerodynamic diameter than a second plurality of particles (c. 1: 56 – 67, Table 2, c. 6: 11 – 16, where the fine particle fraction refers to smaller mass MMAD particles in comparison to larger aerosolized particles); and the housing being constructed so that inertial filtering results in the first plurality of particles passing through the airflow exit and the second plurality of particles impacting and being retained on an internal surface of the housing due to inertial forces, thereby preventing the second plurality of particles from passing through the airflow exit (per c. 6: 11 – 16, the mouthpiece increases fine particle fraction, or the percentage of the first plurality of particles passing through the mouthpiece; the housing is constructed with both a 90 degree turn through the mouthpiece and a reduction of speed at the generated plume, see Fig. 1, c. 7: 11 – 18, c. 6: 11 – 16; as discussed in applicant’s specification, the two factors create inertial filtering, see [00101, 00102] as well as [0098]; in this regard, Hochrainer is constructed in the same manner as applicant, compare Fig. 1 in Hochrainer to Fig. 1A in the instant application; impaction of larger particles is additionally evidenced in Muellinger (US 10857310), see c. 19: 23 – 28, Table 2 “VMD”, and Fig. 1a; see further remarks in response to arguments below).
While Hochrainer discloses a flow rate sensor that generates an input signal opening the actuator valve and releasing compressed air from the powder dispersion mechanism, see c. 10: 15 – 25, Hochrainer does not explicitly disclose a power source coupled to the powder dispersion mechanism, wherein the powder dispersion mechanism is configured to be energized by the power source. Nonetheless, Voges discloses an aerosol delivery device with a power source coupled to a dispersion mechanism, wherein the dispersion mechanism is configured to be energized by the power source (c. 1: 27 – 58). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the powder dispersion mechanism of Hochrainer to be energized by a power source, as taught in Voges, for the predictable result of battery that provides electrical energy allowing for control via the flow rate sensor and powder dispersion valve, see Voges, c. 1: 27 – 58.
12. Hochrainer discloses the device of claim 11, wherein the second plurality of droplet particles has a mass mean aerodynamic diameter greater than 5 μm (see Hochrainer, c. 1: 56 – 67, Table 2, c. 6: 11 – 16; where Hochrainer generates MMADs greater than 5.8 um, which would fail to pass through the air exit as explained in claim 1 above).
17. Hochrainer discloses the device of claim 12, further comprising a mouthpiece at the airflow exit (the airflow exit forms a mouthpiece, see c. 10: 1).
18. Hochrainer discloses the device of claim 11, further comprising a mouthpiece at the airflow exit (the airflow exit forms a mouthpiece, see c. 10: 1).
19. Hochrainer discloses a dry powder delivery device for delivering a dry powder as a plume of particles to a pulmonary system of a subject comprising: a housing including an airflow exit; an electronic dry powder dispersion mechanism in communication with a dry powder supply; and the housing being constructed so that application of airflow through the housing produces inertial filtering that results in a first plurality of particles generated by the dry powder mechanism to pass through the airflow exit while a second plurality of particles impacts and is retained on an internal surface of the housing due to inertial forces, thereby preventing the second plurality of particles from passing through the airflow exit, wherein the second plurality of particles has a greater mass mean aerodynamic diameter than the first plurality of particles (see claim 11 above; examiner notes that Hochrainer does not explicitly disclose an electronically responsive dispersion mechanism, and Voges has been relied upon for the teaching of electronic control as discussed in claim 1 above).
20. Hochrainer discloses the device of claim 19, further comprising a mouthpiece at the airflow exit (see claim 17 above).
21. Hochrainer discloses the device of claim 20, wherein the second plurality of particles has a mass mean aerodynamic diameter greater than 5 μm (see claim 12 above).
23. Hochrainer discloses the device of claim 19, wherein the second plurality of particles has a mass mean aerodynamic diameter greater than 5 μm (see above).
26. Hochrainer discloses a method for delivering dry powder as a plume of particles comprising: applying inhaled airflow through a housing including an airflow exit; supplying a dry powder to a dry powder dispersion mechanism; energizing the dry powder dispersion mechanism; and using inertial filtering to cause a first plurality of particles generated by the dry powder dispersion mechanism to pass through the airflow exit while a second plurality of particles impacts and is retained on an internal surface of the housing due to inertial forces, thereby preventing the second plurality of particles from passing through the airflow exit, wherein the second plurality of particles has a greater mass mean aerodynamic diameter than the first plurality of particles (see discussion in claims 11 and 19 above, wherein the battery of Voges electronically energizes the powder dispersion mechanism).
27. Hochrainer discloses the method of claim 26, wherein the second plurality of droplet has a mass mean aerodynamic diameter greater than 5 μm (see above).
30. Hochrainer discloses the method of claim 26, further comprising providing a jet of gas to disperse the dry powder in the housing (see c. 10: 38 – 56; note also jet of gas emanating from valve 5, as illustrated in Fig. 1).
Claim(s) 13-16, 22, 24, 25, 28, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochrainer (US 7708011) in view of Voges (US 6443146) in view of Gamard (US 20050121025).
13. The modified Hochrainer discloses the device of claim 12. However, Hochrainer does not disclose a laminar flow element within or in communication with the housing. Gamard discloses further comprising a laminar flow element within or in communication with the housing (see Fig. 1, unillustrated laminar flow shelf in mouthpiece 96, see [0220]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the mouthpiece of Hochrainer to include the laminar flow shelf of Gamard for the benefit of introducing laminar flow out of the mouthpiece to increase laminar flow of the gas stream in larger air passages of the patient, see [0220, 0040].
14. The modified Hochrainer device of claim 11, further comprising a laminar flow element within or in communication with the housing (see Gamard, claim 13 above).
15. Hochrainer discloses the device of claim 14, further comprising a mouthpiece at the airflow exit (see claim 17 above).
16. Hochrainer discloses the device of claim 13, further comprising a mouthpiece at the airflow exit (see claim 17 above).
22. The modified Hochrainer discloses the device of claim 21, further comprising a laminar flow element within or in communication with the housing (see Gamard, claim 13 above).
24. The modified Hochrainer discloses device of claim 23, further comprising a laminar flow element within or in communication with the housing (see Gamard, claim 13 above).
25. The modified Hochrainer discloses the device of claim 24, wherein the laminar flow element is between the airflow exit and the electronic dry powder dispersion mechanism (see above, Gerard places the laminar flow shelf between the airflow exit and dispersion mechanism, see Fig. 1, [0220]).
28. The modified Hochrainer discloses the method of claim 27, wherein the housing includes a laminar flow element (see Gamard, claim 13 above).
29. The modified Hochrainer discloses the method of claim 26, wherein the housing includes a laminar flow element (see Gamard, claim 13 above).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
On page 7, Applicant argues that Hochrainer in view of Voges fails to disclose that the second plurality of particles impact and are retained on an internal surface of the housing due to inertial forces, thereby preventing the second plurality from passing through the airflow exit. Applicant points to c. 9 : 20 – 24 in Hochrainer, which states that “the powder residues in the device are minimal because of the design, since the deagglomeration of the powder is achieved through the action of the flowing gases in a nozzle, and not through impaction on collision surfaces”. The cited passage of Hochrainer, however, refers to impaction of agglomerated powder on collision surfaces in order to effect deagglomeration of the powder. Instead, the dry powder is deagglomerated in the nozzle of Hochrainer. Thus, the powder residues present in the device are minimal and less than they would be if the powder provided to the mouthpiece had not been previously deagglomerated in the nozzle. While powder residues in the mouthpiece are less than otherwise, the powder residues are nonetheless present.
Hochrainer has designed the housing so its mouthpiece increases fine particle fraction within the previously deagglomerated powder, see c. 6: 11 – 16. Fine particle fraction is the percent of particles possessing an aerodynamic diameter less than 5.8 um, see c. 1: 64 – 67, and the increase in the relative quantity of fine particles is caused by a decrease in aerosolized particles greater than 5.8 um within the set dosage.
As explained in the action above, the housing in Hochrainer is constructed with both a 90 degree turn through the mouthpiece and a reduction of speed at the generated plume, see Fig. 1, c. 7: 11 – 18, c. 6: 11 – 16. As discussed in applicant’s specification, the two factors create inertial filtering, see [00101, 00102] as well as [0098]. In this regard, Hochrainer is constructed in the same manner as applicant, compare Fig. 1 in Hochrainer to Fig. 1A in the instant application. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established, see MPEP 2112.01(I). Hochrainer’s loss of larger aerosolized particles and presence of powder residues within the substantially identical mouthpiece is the result of the second plurality of particles impacting and being retained on an internal surface of the housing due to inertial forces.
The examiner lastly notes Muellinger, provided as an evidencing reference in the above rejection. Muellinger discloses a similarly constructed mouthpiece, albeit for liquid nebulization rather than dry aerosolization, see for example Figs. 11a – 11b. A relatively small fraction of droplets—probably those having the relatively largest diameter—are impacted within the device, thus causing an increase in fine particle fraction, see c. 19: 23 – 27, Table 2 “VMD”. Meullinger further evidences that the residues and loss of larger aerosolized particles within the mouthpiece of Hochrainer is caused by inertial impaction of the second plurality of aerosolized particles.
As such, examiner hereby maintains rejection of claims 11, 19, 26, and dependents therein, as set forth in the rejection above.
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 BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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/BRADLEY H PHILIPS/ Primary Examiner, Art Unit 3799