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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/23/2026 has been entered.
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(e) with reference to Application Number: FR-1650118 filed on 01/07/2016.
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 36 – 39 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 does not provide written support for the limitation “wherein said piston is characterized by a rest position before actuation of said nasal powder dispenser device and a compressed position after at least partial actuation of said nasal powder dispenser device; further wherein said piston, after actuation of said nasal powder dispenser device is maintained at said compressed position”. Furthermore, the limitation covers embodiments not reasonably envisioned from the instant specification. For example, the limitation may cover a locking mechanism that keeps the piston in a compressed position, or a method of use whereby the user keeps the piston in a compressed position following actuation.
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.
Claims 1, 19, 25, 34, and dependents therefrom are 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 claim recites “wherein said nasal dispenser head and air expeller form a unified structure such that said nasal dispenser head cannot be removed from said device”. It is unclear what exactly constitutes removal from said device. For example, while Fig. 2 clearly illustrates the nasal dispenser head and air chamber as an integrated structure, the specification does not support removal of the dispenser head from the piston. Examiner notes that amending the phrase to recite “wherein said nasal dispenser head and air expeller form a unified structure such that said nasal dispenser head cannot be removed from said air chamber” would overcome the rejection, and examiner will hereby interpret the limitation accordingly.
Claims 19, 25, and dependents therefrom are 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. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970). Applicant defines “proximal” and “distal” relative to the dispenser orifice of said device; the closure element is provided at a proximal rather than distal end, as illustrated in Fig. 2, and otherwise recited in claims 1 and 34. Examiner recommends referring to the closure element as provided in the proximal rather than distal end throughout claims 19 and 25 in order to overcome the rejection.
Claims 12 – 16, 20 – 24, 26 – 33, and dependents therefrom are 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 claims recite optimization of the nasal distribution device with “at least 15% of the dose of powder delivered to the ethmoid sinuses and at least 30% of the dose of powder delivered to the turbinate”, for example. It is unclear from the disclosure how the device is tested to the achieve the claimed distribution. For example, a dispenser head barely inserted a few millimeters in the user’s nostril would achieve a different delivery distribution than the same dispenser head fully inserted an inch inside the user’s nostril. As such, the metes and bounds of the claim are unclear. The claims are additionally unclear because they appear to recite a method of use within the apparatus claim. Examiner recommends reciting said powder is “configured to be delivered” in order to overcome the additional aspect of the rejection, where appropriate.
Claims 36 - 39, and dependents therefrom are 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 limitation “wherein said piston, after actuation of said nasal powder dispenser device is maintained at said compressed position” appears to recite a method of use within the apparatus claim. Examiner recommends reciting said nasal powder dispenser device is “configured to be maintained” in order to overcome the rejection.
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.
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.
Claim(s) 34 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baillet (WO 2015001281, with US 20160296957 hereby referenced for translation) in view of Bruna (US 6398074).
34. Baillet discloses a single use nasal powder dispenser device (see Baillet, Figs. 19 – 24; the device is fully capable of disposal after a single use; in this sense, Baillet is single use insofar as applicant’s device is single use) comprising: at least one reservoir, at least one of which containing at least one dose of powder (30); a nasal dispenser head for inserting into a user's nostril (10), said nasal dispenser head including a dispenser orifice (see Fig. 19) and said at least one reservoir being formed by a hollow tube closed at a proximal end of the hollow tube by a closure element when said closure element is in a closed position (50) and closed at a distal end of the hollow tube by an insert (40); during actuation, said insert slides in said hollow tube so as to expel said closure element out from the closed position of the closure element (see Fig. 19 versus Fig. 21); and an air expeller that, during actuation of said nasal powder dispenser device, generates a flow of compressed air so as to dispense a dose of powder into said nostril through said dispenser orifice (22 and 25), said air expeller comprising (a) an air chamber (22) and (b) a piston that slides in airtight manner in said air chamber so as to compress the air contained in said air chamber (25); wherein said piston, during actuation, compresses the air contained in said air chamber so that a continuation of movement of said piston results in dispensing of said at least one dose of powder in at least two consecutive steps: first (a) said continuation of movement of said piston opens a passage between said air expeller and said at least one reservoir (see Fig. 20, [0062-63], continued actuation causes insert 40 to move “away from its position of closing the reservoir”); and, secondly (b) said continuation of movement of said piston causes said closure element to be expelled (see Fig. 21, [0063], continued actuation causes insert 40 to next expel the closure element from its closed position), wherein, when said passage between said air expeller and said at least one reservoir is opened, said flow of compressed air flows from said air chamber to said at least one reservoir through said passage [0063].
Baillet discloses that removing the dispenser head from the device is only optional, see [0064]. However, Baillet does not expressly disclose that said nasal dispenser head and air expeller form a unified structure such that said nasal dispenser head cannot be removed from said device. Nonetheless, Bruna discloses a similar nasal powder dispensing device comprising at least one reservoir containing a dose of powder (10) and a nasal dispenser head for inserting into a user’s nostril (body 1 incorporating orifice 40) and an air expeller comprising an air chamber (22), wherein the reservoir, nasal dispenser head, and air expeller form a unified structure (see c. 4: 5 – 6, “it is possible for element 2 to be produced in one piece with body 1” and thus nasal dispenser head 40, and Fig. 1 illustrating element 2 including its reservoir 10 in one piece with the air expeller via its air chamber 22) such that said nasal dispenser head cannot be removed from said device (the one-piece nasal dispenser head 40 cannot be removed from air chamber 22, and therefore cannot be removed from the device). 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 nasal dispenser head and air chamber of Baillet according to the one-piece construction of Bruna for the benefit of a powder product and dispensation device which are simple and inexpensive to manufacture and to assemble.
39. Baillet discloses the device according to claim 34, wherein said piston is characterized by a rest position before actuation of said nasal powder dispenser device and a compressed position after at least partial actuation of said nasal powder dispenser device; further wherein said piston, after actuation of said nasal powder dispenser device is maintained at said compressed position (examiner considers Baillet fully capable of being maintained at said compressed position, by the user maintaining pressure upon the bottom side of the piston for a non-negligible portion of time following actuation).
Claim(s) 1 – 5, 8 – 17, 19 – 33, and 35 - 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baillet (WO 2015001281, with US 20160296957 hereby referenced for translation) in view of Bruna (US 6398074) in view of Shahaf (US 20150258287).
1. Baillet in view of Bruna discloses a single use nasal powder dispenser device comprising: at least one reservoir, at least one of which containing at least one dose of powder; a nasal dispenser head for inserting into a user's nostril, said nasal dispenser head including a dispenser orifice and said at least one reservoir, said at least one reservoir being formed by a hollow tube closed at a proximal end of the hollow tube by a closure element when said closure element is in a closed position and closed at a distal end of the hollow tube by an insert; during actuation, said insert slides in said hollow tube so as to expel said closure element out from the closed position of the closure element; and an air expeller that, during actuation of said nasal powder dispenser device, generates a flow of compressed air so as to dispense a dose of powder into said nostril through said dispenser orifice, said air expeller comprising (a) an air chamber and (b) a piston that slides in airtight manner in said air chamber so as to compress the air contained in said air chamber; wherein said piston, during actuation, compresses the air contained in said air chamber so that a continuation of movement of said piston results in dispensing of said at least one dose of powder in at least two consecutive steps: first (a) said continuation of movement of said piston opens a passage between said air expeller and said at least one reservoir; and, secondly (b) said continuation of movement of said piston causes said closure element to be expelled, wherein, when said passage between said air expeller and said at least one reservoir is opened, aid flow of compressed air flows from said air chamber to said at least one reservoir through said passage; further wherein said nasal dispenser head and air expeller form a unified structure such that said nasal dispenser head cannot be removed from said device (see claim 34 above).
However, Baillet does not disclose wherein said nasal powder dispenser device presents the following properties: a pressure, of said flow of compressed air generated by said air expeller, that is higher than 0.7 bar and lower than 2 bar; and a volume, of said air chamber, that is greater than 1700 mm.sup.3 and smaller than 3000 mm.sup.3. Nonetheless, Shahaf discloses a nasal powder dispenser comprising a reservoir containing a dose of powder, and nasal dispensing head with dispenser orifice ([0047], [0063]); and, an air expeller that generates a flow of compressed air so as to dispense a dose of powder through said dispenser orifice ([0068], 0070]), said air expeller comprising a chamber and a piston that slides in an airtight manner to compressed the chamber air (1400 and 1500, [0072]), wherein said dispenser presents the following properties: a pressure, of said flow of compressed air generated by said air expeller, that is higher than 0.7 bar and lower than 2 bar [0307]; and a volume, of said air chamber, that is greater than 1700 mm.sup.3 and smaller than 3000 mm.sup.3 [0308]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pressure and volume of air expelled in Baillet within the ranges claimed by applicant, and disclosed by Shahaf, for the benefit of optimizing drug deposition to the olfactory epithelium or ethmoid sinuses (see Fig. 2, [0053], [0062], [0311], see also [0327, 0330, 0331], [0337], Figs. 32 and 33). It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
2. The modified Baillet discloses the device according to claim 1, wherein said pressure lies in the range 1 bar to 1.5 bar (see discussion in Shahaf as found in claim 1 above).
3. The modified Baillet discloses the device according to claim 1, wherein said pressure is about 1.3 bar (see discussion in Shahaf as found in claim 1 above).
4. The modified Baillet discloses the device according to claim 1, wherein said volume lies in the range 2000 mm3 to 2700 mm3 (see discussion in Shahaf as found in claim 1 above).
5. The modified Baillet discloses the device according to claim 1, wherein said volume is about 2600 mm3 (see discussion in Shahaf as found in claim 1 above).
8. Baillet discloses the device according to claim 1, wherein said at least one reservoir contains a single dose of powder for dispensing during a single actuation of said nasal powder dispenser device (see general teaching, [0010]; note additionally Shahaf, [0294]).
9. Baillet discloses the device according to claim 1, wherein said nasal powder dispenser device includes a plurality of reservoirs, each containing a single dose of powder (see general teaching, [0010], claim 1, wherein at least one includes 2 or more and thus plurality of reservoirs; note additionally Shahaf, [0294]).
10. Baillet discloses the device according to claim 1, wherein actuation of the nasal powder dispenser device comprises sliding the piston in the air chamber so as to compress the air contained in the air chamber to generate the flow of compressed air (see Baillet, [0062 – 0063], Figs. 19 – 21).
11. Baillet discloses the device according to claim 1, wherein the closure element is a ball (see Fig. 19).
12. Baillet discloses the device according to claim 1. Baillet, modified within the claimed pressure and volume as taught by Shahaf, would inherently distribute the dose of powder in the nasal cavity with at least 15% of the dose of powder delivered to the ethmoid sinuses and at least 30% of the dose of powder delivered to the turbinate, wherein at least 20% of the dose of powder is delivered to the nasal valve. Baillet discloses essentially the same device as the instant application, compare Fig. 2 in applicant’s specification to Fig. 1 and Fig. 19 in Baillet, nearly identical in construction except Baillet is silent as it relates to the pressure and volume developed by the air chamber. Baillet, when modified with the pressure and volume as taught in Shahaf, is thus identical or substantially identical in structure to that of applicant’s claims and disclosure, thus inherently distributing the dose of powder in the nasal cavity with at least 15% of the dose of powder delivered to the ethmoid sinuses and at least 30% of the dose of powder delivered to the turbinate, wherein at least 20% of the dose of powder is delivered to the nasal valve. See MPEP 2112.01(I).
Without admitting otherwise, if applicant is unconvinced that the discussed modification of Baillet in view of Shahaf would inherently provide the dose distribution, then it would have been obvious to optimize the device to provide the distribution as claimed. Shahaf discloses that increased deposition of delivered powder to the turbinates results in facilitating transfer of the substance to the blood, and furthermore targets increased deposition via the ethmoid bone or sinuses, see [0062]. The drug is driven by pressure deep into the nasal passages for appropriate deposition in the desired or target region, see [03337]. Therefore, it would have been obvious to a person having ordinary skill in the art to optimize Baillet to increase delivery to the ethmoid sinuses and turbinate as such structures are understood to facilitate transfer of the drug and are desired targets for drug delivery. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
13. The modified Baillet discloses the device according to claim 1, wherein at least 18% of the dose of powder is delivered to the ethmoid sinuses (see discussion of Baillet as modified in claim 12 above).
14. The modified Baillet discloses the device according to claim 1, wherein at least 35% of the dose of powder is delivered to the turbinate (see discussion of Baillet as modified in claim 12 above).
15. The modified Baillet discloses the device according to claim 1, wherein at most 40% of the dose of powder is delivered to the nasal valve (see discussion of Baillet as modified in claim 12 above; note also [0336] in Shahaf, powder may impact walls of passage close to exit of device, but it is limited).
16. The modified Baillet discloses the device according to claim 1, wherein at most 45% of the dose of powder is delivered to the turbinate (see discussion of Baillet as modified in claim 12 above; note also [0336] in Shahaf, powder may impact walls of passage close to exit of device, but it is limited).
17. The modified Baillet discloses the device of claim 1, wherein the device can compress the air in the device to more than 1.5 bar (see discussion in Shahaf as found in claim 1 above).
19. Baillet in view of Bruna in view of Shahaf discloses a single use nasal powder dispenser device for delivering a dose of powder to the nasal cavity of a user, comprising: a nasal dispenser head for inserting into a nostril of the user, the nasal dispenser head including a dispenser orifice; and at least one reservoir, at least one of which containing the dose of powder, wherein the at least one reservoir has a closed position when a closure element is positioned at a distal end of the at least one reservoir and during actuation, the closure element is removed from distal end of the at least one reservoir; and an air expeller that, during actuation of the nasal powder dispenser device, generates a flow of compressed air to dispense the dose of powder into the nostril through the dispenser orifice, wherein the air expeller comprises an air chamber and a piston that slides in airtight manner in the air chamber to compress the air contained in the air chamber, wherein the piston, during actuation, moves while the air contained in the air chamber is being compressed so that a continuation of movement of the piston results in dispensing of said at least one dose of powder in at least two consecutive steps: first (a) said continuation of movement of said piston opens of a passage between the air expeller and the at least one reservoir, and, secondly (b) said continuation of movement of said piston causes the closure element to be expelled from the distal end of the at least one reservoir; wherein, when said passage between said air expeller and said at least one reservoir is opened, said flow of compressed air flows from said air chamber to said at least one reservoir through said passage; further wherein the nasal powder dispenser device has the following properties: a pressure of the compressed air generated by the air expeller is greater than or equals to Pmin and smaller than or equals to Pmax; and a volume of the air chamber is greater than or equals to Vmin and smaller than or equals to than Vmax; wherein Pmin is 0.7 bar, Pmax is 2 bar; Vmin is 1700 mm3 and Vmax is 3000 further wherein said nasal dispenser head and air expeller form a unified structure such that said nasal dispenser head cannot be removed from said device (see claim 1 above).
20. The modified Baillet discloses the device according to claim 19, wherein at least 20% of the dose of powder is delivered to the nasal valve (see discussion of Baillet as modified in claim 12 above).
21. The modified Baillet discloses the device according to claim 19, wherein at least 18% of the dose of powder is delivered to the ethmoid sinuses (see discussion of Baillet as modified in claim 12 above).
22. The modified Baillet discloses the device according to claim 19, wherein at least 35% of the dose of powder is delivered to the turbinate (see discussion of Baillet as modified in claim 12 above).
23. The modified Baillet discloses the device according to claim 19, wherein at most 40% of the dose of powder is delivered to the nasal valve (see discussion of Baillet as modified in claim 12 and 15 above).
24. The modified Baillet discloses the device according to claim 19, wherein at most 45% of the dose of powder is delivered to the turbinate (see discussion of Baillet as modified in claim 12 and 15 above).
25. Baillet in view of Bruna in view of Shahaf discloses a method for intranasal delivery of a dose of powder, the method comprising steps of: a. inserting a nasal dispenser head of a single use nasal powder dispenser device into a nasal cavity of a user, the nasal dispenser head including a dispenser orifice; the device comprises (a) at least one reservoir, at least one of which containing the dose of powder, wherein the at least one reservoir is in a closed position when a closure element is positioned at a distal end of the at least one reservoir; (b) an air expeller comprising an air chamber and a piston that slides in airtight manner in the air chamber; b. actuating the device so that the air expeller generates a flow of compressed air to dispense the dose of powder into the nostril through the dispenser orifice; wherein said step of actuating the device comprises sliding said piston in airtight manner in said air chamber; wherein said piston, during actuation, compresses the air contained in said air chamber so that a continuation of movement of said piston results in dispensing of said at least one dose of powder in at least two consecutive steps: first (a) said continuation of movement of said piston opens a passage between said air expeller and said at least one reservoir; and, secondly (b) said continuation of movement of said piston causes said closure element to be expelled; wherein, when said passage between said air expeller and said at least one reservoir is opened, said flow of compressed air flows from said air chamber to said at least one reservoir through said passage; c. dispensing the dose of powder to the nasal cavity of a user; the nasal powder dispenser device presents the following properties: a pressure of the flow of compressed air generated by the air expeller that is higher than 0.7 bar and lower than 2 bar; and a volume of the air chamber that is greater than 1700 mm3 and smaller than 3000 further wherein said nasal dispenser head and air expeller form a unified structure such that said nasal dispenser head cannot be removed from said device (see claim 1 above).
26. The modified Baillet discloses the method according to claim 25, wherein at least 20% of the dose of powder is delivered to the nasal valve (see discussion of Baillet as modified in claim 12 above).
27. The modified Baillet discloses the method according to claim 25, wherein at least 18% of the dose of powder is delivered to the ethmoid sinuses (see discussion of Baillet as modified in claim 12 above).
28. The modified Baillet discloses the method according to claim 25, wherein at least 35% of the dose of powder is delivered to the turbinate (see discussion of Baillet as modified in claim 12 above).
29. The modified Baillet discloses the method according to claim 25, wherein at most 40% of the dose of powder is delivered to the nasal valve (see discussion of Baillet as modified in claims 12 and 15 above).
30. The modified Baillet discloses the method according to claim 25, wherein at most 45% of the dose of powder is delivered to the turbinate (see discussion of Baillet as modified in claims 12 and 15 above).
31. The modified Baillet discloses the device according to claim 1, wherein the properties are optimized so the dose of powder is distributed in the nasal cavity with at least 15% of the dose of powder delivered to the ethmoid sinuses and at least 30% of the dose of powder delivered to the turbinate (see discussion of Baillet as modified in claim 12 above).
32. The modified Baillet discloses the device according to claim 19, wherein the properties are optimized so the dose of powder is distributed in the nasal cavity with at least 15% of the dose of powder delivered to the ethmoid sinuses and at least 30% of the dose of powder delivered to the turbinate (see discussion of Baillet as modified in claim 12 above).
33. The modified Baillet discloses the method according to claim 25, wherein the dose of powder is distributed in the nasal cavity so that at least 15% of the dose of powder is delivered to the ethmoid sinuses and at least 30% of the dose of powder is delivered to the turbinate (see discussion of Baillet as modified in claim 12 above).
35. The modified Baillet discloses the device according to claim 19, further wherein said nasal powder dispenser device presents the following properties: a pressure, of said flow of compressed air generated by said air expeller, that is higher than 0.7 bar and lower than 2 bar; and a volume, of said air chamber, that is greater than 1700 mm3 and smaller than 3000 mm3 (see discussion in Shahaf as found in claim 1 above).
36. Baillet discloses the device according to claim 1, wherein said piston is characterized by a rest position before actuation of said nasal powder dispenser device and a compressed position after at least partial actuation of said nasal powder dispenser device; further wherein said piston, after actuation of said nasal powder dispenser device is maintained at said compressed position (examiner considers Baillet fully capable of being maintained at said compressed position, by the user maintaining pressure upon the bottom side of the piston for a non-negligible portion of time).
37. Baillet discloses the device according to claim 19, wherein said piston is characterized by a rest position before actuation of said nasal powder dispenser device and a compressed position after at least partial actuation of said nasal powder dispenser device; further wherein said piston, after actuation of said nasal powder dispenser device is maintained at said compressed position (examiner considers Baillet fully capable of being maintained at said compressed position, by the user maintaining pressure upon the bottom side of the piston for a non-negligible portion of time).
38. Baillet discloses the method according to claim 25, wherein said piston is characterized by a rest position before actuation of said nasal powder dispenser device and a compressed position after at least partial actuation of said nasal powder dispenser device; further wherein said piston, after actuation of said nasal powder dispenser device is maintained at said compressed position (examiner considers Baillet fully capable of being maintained at said compressed position, by the user maintaining pressure upon the bottom side of the piston for a non-negligible portion of time).
Claim(s) 6 – 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baillet in view of Bruna in view of Shahaf in view of Shahaf (WO 2016071914; hereinafter “Shahaf2”).
Regarding claim 6, Baillet discloses the device according to claim 1, but does not disclose wherein said dose of powder is 10 mg. Shahaf2 discloses wherein said dose of powder is 10 mg (p. 93, claim 8, limitation (c )). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify Baillet according to the dosage of Shahaf2 for the benefit of appropriate dosage.
Regarding claim 7, Baillet discloses the device according to claim 1, but does not disclose wherein the average size of particles of the dose of powder is greater than 5 um. Shahaf2 discloses wherein the average size of particles of the dose of powder is greater than 5 μm (see various examples on pp. 69-71). 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 of Baillet according to the particle size of Shahaf2 for the benefit of appropriate drug delivery/targeting.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 19, 25, 34, and dependents therefrom have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/ Primary Examiner, Art Unit 3799
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