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 .
Response to Amendment
This office action is responsive to a preliminary amendment filed on 11/11/2025. As directed by the amendment, claim 1 was amended, no claims were cancelled nor added. Thus, claims 1-6 are presently pending in this application.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geser (2005/0194472).
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Regarding claim 1, Geser discloses a nozzle fixing assembly (entire assembly in fig. 6 minus 65) for an inhalation device (see paragraphs 0002-0003, 0053-0059, inhalation device are connected to the nozzle fixing assembly, and is interpreted as including 65 and piston pump) comprising:
(i) a nozzle (5, fig. 6, paragraphs 0044 and 0049) having an inlet end and an outlet end (see the annotated-Geser fig. 6 above), the outlet end being distal with respect to the inhalation device and the outlet end configured to deliver a liquid for inhalation (see the annotated-Geser fig. 6 above, relatively, the outlet is being distal with respect to the inhalation device and is configured to deliver a liquid, see paragraphs 0049 and 0058), the inlet end being proximal with respect to the inhalation device and the inlet end being configured to receive the liquid for inhalation (see the annotated-Geser fig. 6 above);
(ii) a nozzle holder (1, fig. 6, paragraphs 0043 and 0049) comprising a holder portion that encircles at least a portion of the outlet end of the nozzle and the nozzle holder comprising an end wall, the end wall comprising an aperture, such that the end wall retains the nozzle and the aperture allows delivery of the liquid from the outlet end of the nozzle (see the annotated-Geser fig. 6 above and figs. 1a-1c for reference, as shown, the holder portion encircles at least a portion of the outlet end of the nozzle and the nozzle holder comprising an end wall having an aperture (3), see paragraph 0043), the holder portion comprising a holder abutment surface facing proximally (see the annotated-Geser fig. 6 above);
(iii) a chamber body (9, fig. 6, paragraphs 0045 and 0049) which is proximal with respect to the nozzle holder and defines a chamber (chamber formed by projection 11 comprising the dead space 63, see the annotated-Geser fig. 6 above) communicating with the inlet end of the nozzle to supply the liquid to the nozzle, the chamber body comprising a chamber portion (portion of 11 encircling at least a proximal portion of the chamber, see the annotated-Geser fig. 6 above) encircling at least a proximal portion of the chamber, and the chamber body comprising a first chamber abutment surface that faces distally and abuts at least a portion of the holder abutment surface to define an abutting interface (see the annotated-Geser fig. 6 above, see figs. 1a-1c for reference and paragraphs 0044-0049); and
(iv) a nozzle seal (4, figs. 1a-1c and 6, paragraphs 0044-0049) arranged annularly (see figs. 1a-1c) around at least a portion of the nozzle (5) to make sealing contact with the nozzle (see figs. 1a-8c and paragraphs 0044 and 0051), wherein the nozzle seal has a first end that at least partially abuts the end wall of the nozzle holder (1), and a second end at or towards the inlet end of the nozzle, wherein the nozzle seal extends between the nozzle (5) and the nozzle holder (1) and between the nozzle (5) and the chamber body (9) such that the nozzle seal makes sealing contact with the nozzle holder and chamber body and provides a perimetral line of sealing at the abutting interface (see the annotated-Geser fig. 6 above and figs. 1a-8c, paragraphs 0044-0051); wherein the chamber body (9) comprises a second chamber abutment surface facing distally, and wherein an annularly outer portion of the second end of nozzle seal makes sealing contact with the second chamber abutment surface; and wherein an annularly inner portion (annularly inner portion is portion of 8 that forms the recess, see figs. 1a-1c and paragraph 0048) of the second end of the nozzle seal is recessed such that the chamber extends into the second end of the nozzle seal (see figs. 1a-8c, the annotated-Geser figs. 1a-1c and fig. 6 above and paragraphs 0044-0051), and wherein the chamber surrounds a portion of one or more sides of the nozzle so that in use liquid under pressure in the chamber exerts a force on the annularly inner portion of the second end of the nozzle seal (see the annotated-Geser fig. 6 above and the annotated-Detail fig. 6 of Geser above, as shown, the chamber surrounds a portion of one or more sides of the nozzle ever after the seal has been deformed, see paragraph 0049, Geser discloses that the high pressure in the fluid acts in the channel structure within the fluidic component (5), within the dead volume (63), within the bore (10), in the mating part (9) and within the housing that contains the fluid, therefore, the fluid that enter the chamber, would exerts force on the annularly inner portion of the second end of the nozzle seal).
Regarding claim 2, Geser discloses that the annularly inner portion (annularly inner portion is portion of 8 that forms the recess, see figs. 1a-1c and paragraph 0048) of the nozzle seal (4) is recessed to comprise a nozzle facing surface and a proximal facing inner surface, meeting at a sharp edge, defining a recess which extends circumferentially around at least a portion of the nozzle (5, see the annotated-Geser figs. 1a-1c and fig. 6 above and paragraphs 0044-0051).
Regarding claim 3, Geser discloses that the annularly inner portion (annularly inner portion is portion of 8 that forms the recess, see figs. 1a-1c and paragraph 0048) of the nozzle seal (4) is recessed to comprise a nozzle facing surface and a proximal facing inner surface, meeting at a radiused edge, defining a recess which extends circumferentially around at least a portion of the nozzle (5, see the annotated-Geser figs. 1a-1c and fig. 6 above and paragraphs 0044-0051 and see the annotated-Detail fig. 6 of Geser above, relatively, the sharp edge formed between the chamfered edge 8 and the nozzle facing surface is a radius edge because the edge is circular/annular, alternatively, the bulging/convex portion/surface of the chamfered surface/edge 8 can be considered as a radial edge, the bulge forms a radial edge, alternatively, the chamfered surface would form a chamfered edge that extends in a radial manner, therefore the chamfered edge is a radial edge (under both of the alternative interpretations, the chamfered surface/edge 8 is the edge that is formed between the proximal facing inner surface and the nozzle facing surface).
Regarding claim 4, Geser discloses that the annularly inner portion (annularly inner portion is portion of 8 that forms the recess, see figs. 1a-1c and paragraph 0048) of the nozzle seal (4) is recessed to comprise a nozzle facing surface and a proximal facing inner surface, meeting at a chamfered edge, defining a recess which extends circumferentially around at least a portion of the nozzle (5, see the annotated-Geser figs. 1a-1c and fig. 6 above and paragraphs 0044-0051, as shown, the annularly inner portion is recessed to comprise a nozzle facing surface and a proximal facing inner surface, meeting at a chamfered edge, defining a recess which extends circumferentially around at least a portion of the nozzle 5).
Regarding claim 5, Geser discloses an inhalation device comprising a nozzle fixing assembly according to claim 1 (see paragraphs 0002-0003, Geser discloses that the nozzle fixing assembly shown in fig. 6 and figs. 1a-8c are part of an inhalation device (nebulizers)).
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 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 6 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Geser (2005/0194472) or, in the alternative, under 35 U.S.C. 103 as obvious over Geser (2005/0194472) in view of Karle (2012/0103326).
Regarding claim 6, Geser discloses that the inhalation device of claim 5, being a soft mist inhaler (see paragraphs 0002-0004, Geser discloses the inhaler being a nebulizer, a nebulizer, relatively is a soft mist inhaler, see paragraph 0058, the inhaler is operated by a piston pump that is configured to pump amounts about 15 microliters, therefore, the aerosol that leaves the nozzle would be soft and quick, and would produce a soft mist, see paragraphs 0029, 0053-0059, Geser discloses two outlets are arranged at 90 degrees relative to one another and are configured to intersect, therefore, would product a soft mist). However, if there is any doubt that the nozzle assembly is part of an inhalation device that is a soft mist inhaler.
Karle teaches an inhalation device (1, fig. 1) comprising a piston (9, fig. 1, paragraph 0044), the inhalation device is a soft mist inhaler (see claim 16, paragraphs 0002, 0012-0016, 0036, and 0061, see soft mist inhaler (SMI)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nozzle and the inhalation device of Geser to be a portable soft mist inhaler as taught by Karle for the purpose of providing an alternative inhalation device that is portable inhaler that can deliver low speed aerosols that can be used to treat large animals such as horses (see paragraph 0012 of Karle) and for the purpose of providing a more versatile inhaler that permits improved treatment or the use of different medicament preparations (see paragraph 0016 of Karle).
Claim 6 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Geser (2005/0194472) or, in the alternative, under 35 U.S.C. 103 as obvious over Geser (2005/0194472) in view of Bartels (2021/0008298).
Regarding claim 6, Geser discloses that the inhalation device of claim 5, being a soft mist inhaler (see paragraphs 0002-0004, Geser discloses the inhaler being a nebulizer, a nebulizer, relatively is a soft mist inhaler, see paragraph 0058, the inhaler is operated by a piston pump that is configured to pump amounts about 15 microliters, therefore, the aerosol that leaves the nozzle would be soft and quick, and would produce a soft mist, see paragraphs 0029, 0053-0059, Geser discloses two outlets are arranged at 90 degrees relative to one another and are configured to intersect, therefore, would product a soft mist). However, if there is any doubt that the nozzle assembly is part of an inhalation device that is a soft mist inhaler.
Bartels teaches an inhalation device comprising a nozzle (4, figs. 1-3, paragraphs 0060, 0065 and 0071) and the inhalation is a soft mist inhaler (see paragraph 0014).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inhalation device and the nozzle of Geser to be the nozzle and the inhalation device as taught by Bartels for the purpose of providing an alternative inhalation device that would provide the predictable result of creating a therapeutic mist to be provided to the user (see paragraphs 0014-0015 of Bartels).
Response to Arguments
Applicant's arguments filed on 11/11/2025 have been fully considered but they are not persuasive.
The applicant on pages 6-9 of the remarks argues that that Geser discloses “a dead volume” or “dead space 63”, however, this dead space is specifically characterized as something to be minimized and further cited paragraphs 0039 and 0049, this “dead volume” is reduced to the minimum necessary and effectively collapses once the elastomeric part is compressed during assembly, therefore, Geser does not disclose or suggest a chamber that remains active under pressure to exert a sealing force on the nozzle. Geser provides no teaching or suggestion that liquid under pressure in the dead space would or should exert force on the seal to improve sealing performance. However, the argument is not persuasive because as shown in the annotated-Geser fig. 6 and detailed fig. 6, the chamber surrounds a portion of one or more sides of the nozzle and is over the annularly inner portion of the second end of the nozzle seal, furthermore, Geser discloses in paragraph 0049, that the high pressure in the fluid acts in the channel structure within the fluidic component (5), within the dead volume (63), within the bore (10), in the mating part (9) and within the housing that contains the fluid, therefore, the fluid that enter the chamber, would exerts force on the annularly inner portion of the second end of the nozzle seal. It is noted that the claim does not claim what is the sealing force and how much the sealing force is being exerted or the extent/area of the portion of one or more sides of the nozzle being surrounded by the chamber to distinguish the claimed invention over the prior art reference Geser. Therefore, the rejection still stands.
The arguments to the newly added claim limitations in claims 1-6 has been addressed in the above rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hausmann (12,370,566)(2023/0103823) is cited to show a nozzle assembly.
Boeck (2007/0282276) is cited to show a nozzle assembly.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/TU A VO/Primary Examiner, Art Unit 3785