DETAILED ACTION
This Office Action is in response to the filing of amendments to the claims filed 4/15/2026. As per the amendments, claims 1 and 8 have been amended, claim 4 and 6-7 have been cancelled, and no claims have been added. Thus, claims 1-3, 5, and 8-9 are pending in the application.
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
Claim 5 is objected to because of the following informalities: the term “the external surface” should be changed to read --an external surface-- in order to have proper antecedent basis. 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.
Claim 9 makes reference to “claim 1 to 8.” In line 2. However, as there is no claim 4, or claims 6-7, and there are also now less than 8 claims previous to claim 9, it would appear that claim 9 is claiming possible dependence on cancelled claims, making the full claimed scope of claim 9 unclear.
Any remaining claims are rejected for being dependent on a rejected claim.
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.
Claims 1 and 3, 5, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Säll et al. (US Pub. 2022/0001402) in view of Sivigny et al. (US Pub. 2010/0300437) in view of Hoffman (US Pub. 2011/0208238).
Regarding claim 1, Säll discloses a nozzle holder for securing a nozzle in an inhalation device (see Figs. 2-4 where aerosol unit 10 fits over and is secured onto the distal end of chamber 110 that is a nozzle), the nozzle holder comprising: a body having first and second ends (see Figs. 3-4 where aerosol unit 10 is defined by a body that forms it, with a first end at the bottom, and a second end at the top (specifically anything below nozzle 35 being the first end, and anything above nozzle 35 being the second end)), the first end comprising a first recess for receiving at least a portion of a nozzle (see Figs. 2-4 where the cylindrical barrel (substantially around the numeral ‘35’ in Fig. 4) comprises a recess that receives a nozzle (see Fig. 2 where this bottom recess interfaces with a nozzle member that is above chamber 110 and defines a nozzle portion out of the chamber)), the body further comprising an aperture through which a liquid spray is delivered from the nozzle through the nozzle holder from the first end to the second end (see Figs. 3-4 where micro nozzle 35 defines an aperture through which liquid spray from the device travels through, with the first end below it and the second end above it), the second end comprising a second recess for directing delivery of the liquid spray from the nozzle through the nozzle holder (see Fig. 3 the recess formed about nozzle carrier 30, which is a recess on the second end of the body of aerosol unit 10, which at least partially directs fluid flow out of the micro nozzle 35 by limiting the spray pattern in the horizontal direction).
Säll lacks a detailed description of the nozzle holder being formed of metal.
However, Sivigny teaches an inhalation device and its components, where parts of the device can be made by metal injection moulding (see [0008] and [0022]-[0023], resulting in being made of metal such as steel (see [0032])).
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 material by which the nozzle holder of Säll is made to be made by metal (such as through metal injection molding) as taught by Sivigny, as it would be a simple substitution of one material for a nozzle holder for another material, to yield the predictable result of providing a rigid body for the device. Additionally, the use of metal such as stainless steel provides high corrosion resistance (Sivigny; see [0032]). Further, it is understood that the modified Säll device, in light of the teachings of Sivigny has wherein the exterior surface of the nozzle holder has a non-periodic surface texture (Sivigny; see [0033]-[0034] where it is understood that the surface texture of the moulding component has a roughness, which is random, at least in the microscopic scale. Further, as the modified Säll device is made from the same process as the invention of the specification, it stands that the resultant surface texture is the same).
In the alternative that the modified Säll device does not have the exterior surface of the nozzle holder comprising a non-periodic surface texture, then it is taught by Hoffman.
Hoffman teaches a handheld medical device for expelling a medical fluid to a patient, where a section of the nozzle of the device can have random texture (see [0035]).
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 surface of the nozzle holder of the modified Säll device to have random surface texture as taught by Hoffman, as it would provide a textured surface to aid in gripping (Hoffman; see [0035]), and it would be a matter of design choice for a person of ordinary skill in the art to choose the pattern of the textured gripping surface to be random.
Regarding claim 3, the modified Säll device has an exterior surface having a surface roughness average (Ra) of 0.56 microns or more (Sivigny; see [0033] where the surface texture creates from the particles in the MIM have a roughness of around 1 micron).
Regarding claim 5, the modified Säll device has wherein 40% or more of an external surface of the nozzle holder is pocketed (Säll; see Fig. 3 where the open space in the middle of aerosol unit 10, circumferentially bound by axially oriented body 20, is a pocket of the nozzle holder that is clearly at least 40% of the external surface).
Regarding claim 8, the modified Säll device has wherein the metal comprises stainless steel (Sivigny; [0032]).
Regarding claim 9, the modified Säll device has an inhalation device comprising a nozzle holder according to claim 1 (Säll; see Fig. 2 where aerosol dispenser 1000 has the aerosol unit 10).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Säll in view of Sivigny in view of Hoffman as applied to claim 1 above, and further in view of Johansson et al (US Pub 2016/0184484).
Regarding claim 2, the modified Säll device has an exterior surface having a water contact angle (some material property of the material). It is understood that the water contact angle is a material property of the nozzle holder due to the material it is made of. The modified Säll device is made of steel (Sivigny; [0012], [0032]), which is understood to have a water contact angle of about 60 degrees as an inherent material property.
The modified Säll device lacks a detailed description of an exterior surface having a water contact angle equal to or less than 60°.
However, Johansson teaches a nozzle and tube for liquid delivery in a medical application, where a surface is hydrophilic so as to have a water contact angle of about 60 degrees (see [0029] where the surface has a substrate surface that can be made of steel, and designed to be hydrophilic such that the water contact angle is 60 degrees or less).
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 water contact angle of the modified Säll device to have a water contact angle of about 60 degrees as taught by Johansson, as it would provide hydrophilic surface for the aqueous solution at a known water contact angle. Further, it is a specified material property of steel, and thus the steel surface of the modified Säll device is understood to be hydrophilic.
Response to Arguments
Applicant’s arguments with respect to claim 1 has been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record. In particular, the newly applied Hoffman reference is relied upon to show that random surface texture on the external surface in medical fluid devices is known for helping with grip. The other amendments with regards to the structure of the nozzle holder are understood to be disclosed by Säll, as outlined in the above rejections.
Thus, the rejections hold.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
