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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to PCT EP2019/083441 filed December 3, 2019 and to Foreign App. EP18210195 filed December 4, 2018.
Status of Claims
This Office Action is responsive to the amendment filed on November 25, 2025. As directed by the amendment: claim 3 has been amended. Thus, claims 1-8 and 10-17 are presently pending in this application.
Applicant’s amendment to claim 3 obviates the previous objection made thereto.
Claim(s) 1-4, 7-8, 10-13, and 15-17 were previously rejected under 35 U.S.C. 103 as being unpatentable over Knoch (U.S. Pub. No. 2017/0368282) in view of Aumiller et al (U.S. Patent No. 3,777,742) in view of Fink et al. (U.S. Pub. No. 2005/0217666). Claims 5-6 were previously rejected under 35 U.S.C. 103 as being unpatentable further in view of Denyer et al. (U.S. 6,116,233). Claim 14 was previously rejected under 35 U.S.C. 103 as being unpatentable further in view of Bordoni et al. (U.S. 4,823,784).
Applicant's arguments necessitated the application of new grounds of rejection in light of prior art, shown below.
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) 1-4, 7-8, 10-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Knoch (U.S. Pub. No. 2017/0368282) in view of Doetz et al. ( WO 2000/12161 A1; hereinafter: “Doetz”) in view of Fink et al. (U.S. Pub. No. 2005/0217666; hereinafter: “Fink”).
Regarding Claim 1, Knoch discloses a nebulizer assembly comprising an aerosol generator (3, 22, 24, 30; Fig. 1; ¶¶ 0136-0144) and a chamber (32; Fig. 1) for temporarily accommodating the aerosol generated by the aerosol generator (¶¶ 0139, 0152, 0154, 0159); and a mouthpiece (14, 16; Fig. 1).
Knoch does not specifically disclose the nebulizer assembly wherein the mouthpiece comprising: a body defining a fluid path from an inlet port connectable to the nebulizer to an inhalation opening to be received in the mouth of a user; and a filter having a filter base in fluid communication with the fluid path, a filter top detachably connected to the filter base and a filter material provided between the filter base and the filter top, wherein the filter top has an exhalation opening cooperating with a one-way valve allowing exhaustion of fluid from the fluid path through the filter material to the outside of the mouthpiece upon exhalation of a patient through the inhalation opening; wherein the body and the filter base are an integrated one-piece unit and wherein the filter base extends from the body between the nebulizer and the inhalation opening of the mouthpiece; and wherein a distance between the filter base and the inhalation opening is less than a distance between the inlet port and the inhalation opening.
Doetz teaches an aerosol delivery device a mouthpiece (4, 5, 22, 23, 24; Fig. 1-2) comprising: a body (4; Fig. 1-2) defining a fluid path (29; Fig. 1-2) from an inlet port (5; Fig. 1-2) connectable to a nebulizer (2, 3; Fig. 1-2) to an inhalation opening (22; Fig. 1-2) to be received in the mouth of a user (Pg. 12, ln 8-18; Pg. 13, ln 12-16); and a filter (21, 24, 25, 26; Fig. 1-2) having a filter base (24; Fig. 1-2) in fluid communication with the fluid path, a filter top (26; Fig. 1-2) detachably connected to the filter base (Pg. 12, ln 17 to Pg. 13 ln 9) and a filter material (25; Fig. 1-2; Pg. 12, ln 17 to Pg. 13 ln 9) provided between the filter base and the filter top (Fig. 1-2; Pg. 12, ln 17 to Pg. 13 ln 9), wherein the filter top has an exhalation opening (A, Fig. A annotated below) cooperating with a one-way valve (21; Fig. 1-2) allowing exhaustion of fluid from the fluid path through the filter material to the outside of the mouthpiece upon exhalation of a patient through the inhalation opening (Pg. 12, ln 17 to Pg. 13 ln 9; Pg. 15, ln 1-12; Fig. 2) and wherein the filter base is connected to the body between the nebulizer and the inhalation opening of the mouthpiece (Fig. 2; Pg. 12, ln 17 to Pg. 13 ln 9); a distance (B, Fig. A annotated below) between the filter base and the inhalation opening; and a distance (C, Fig. A annotated below) between the inlet port and the inhalation opening for the purpose of enabling or blocking an air outlet from the body through the exhalation opening and through the filter accordingly, thereby filtering toxic liquids (Pg. 12, ln 17 to Pg. 13 ln 9).
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Figure A, Adapted from Figure 2 of Doetz.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the mouthpiece of Knoch to include the a body defining a fluid path from an inlet port connectable to the nebulizer to an inhalation opening to be received in the mouth of a user; and a filter having a filter base in fluid communication with the fluid path, a filter top detachably connected to the filter base and a filter material provided between the filter base and the filter top, wherein the filter top has an exhalation opening cooperating with a one-way valve allowing exhaustion of fluid from the fluid path through the filter material to the outside of the mouthpiece upon exhalation of a patient through the inhalation opening; wherein the body and the filter base are an integrated one-piece unit and wherein the filter base is connected to the body between the nebulizer and the inhalation opening of the mouthpiece as taught by Doetz for the purpose of enabling or blocking an air outlet from the body through the exhalation opening and through the filter accordingly, thereby filtering toxic liquids (See Doetz: Pg. 12, ln 17 to Pg. 13 ln 9).
The modified device of Knoch does not specifically disclose the mouthpiece wherein the body and the filter base are an integrated one-piece unit; wherein the filter base extends from the body; and wherein the distance between the filter base and the inhalation opening is less than the distance between the inlet port and the inhalation opening.
Fink teaches a mouthpiece (490; Fig. 4D) comprising a body (492; Fig. 4D) being an integrated one-piece unit (¶ 0078) and a filter base (496; Fig. 4D); wherein the filter base extends from the body. As such, Fink contemplates forming the various pieces (“endpiece, T-piece, and wye”; ¶ 0078) of the mouthpiece as a single continuous piece.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the mouthpiece of Knoch to include integrating into a one-piece unit the filter base with the body such that the filter base extends from the body, since it has been held that forming in one piece an article which has formerly been formed in two or more pieces and put together involves only routine skill in the art. See MPEP 2144.04 V. (B).
Finally, though prior art drawings are not interpreted as depicting scale, unless specified, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Doetz clearly depicts the distance (B, Fig. A annotated above) between the filter base and the inhalation opening is less than the distance (C, Fig. A annotated above) between the inlet port and the inhalation opening.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distance between the inlet port and the inhalation opening and the distance between the filter base and the inhalation opening for the purpose of locating the inlet port closer to the inhalation opening thereby reducing the travel distance of the aerosol.
Regarding Claim 2, the modified device of Knoch discloses the nebulizer assembly wherein the integrated one-piece unit is an injection molded part (See Fink: Fig. 4A, 4B, 4D; ¶ 0078; Examiner notes: Fink discloses the integrated one-piece unit, see above. The claimed phrase “the integrated one-piece unit is an injection molded part” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though the modified device of Knoch is silent as to the process used to the integrated one-piece unit, and there being no evidence to show that the claimed process imparts any patentable distinction between the claimed product and that of the prior art, it appears that the product of the modified device of Knoch would be the same or similar as that claimed. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). MPEP 2113.
Regarding Claims 3 and 15, the modified device of Knoch discloses the nebulizer assembly wherein the distance (B, Fig. A annotated above) between the filter base and the inhalation opening (See Doetz: 22; Fig. 2) as seen in a side view (See Doetz: Fig. 2). (Examiner notes: The limitation “side view” is a term of perspective and/or orientation. The claims have not established a specific perspective or orientation. As such, using broadest reasonably interpretation, any distance from a perspective maybe labeled as height in a side view).
The modified device of Knoch does not explicitly disclose the nebulizer assembly wherein the distance between the filter base and the inhalation opening as seen in a side view is at least 35 mm and not more than 40 mm.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to set the distance between the filter base and the inhalation opening as seen in a side view is at least is at least 35 mm and not more than 40 mm in the modified device of Knoch because Applicant has not disclosed that setting the distance to at least 35 mm and not more than 40 mm provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the distance between the filter base and the inhalation opening of the modified device of Knoch, and Applicant’s distance between the filter base and the inhalation opening as seen in a side view being at least 35 mm and not more than 40 mm, to perform equally well because both mechanisms perform the same function of spacing the filter base and the inhalation opening apart from each other.
Therefore, it would have been prima facie obvious to modify the modified device of Knoch to obtain the invention as specified in claims 3 and 15 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired spacing between the filter base and the inhalation opening and thus fails to patentably distinguish over the modified device of Knoch.
Regarding claims 4 and 16, the modified device of Knoch discloses the nebulizer assembly as having a maximum height (D, Fig. A annotated above) as seen in a side view (See Doetz: Fig. 2) (Examiner notes: The limitation “side view” is a term of perspective and/or orientation. The claims have not established a specific perspective or orientation. As such, using broadest reasonably interpretation, any distance from a perspective maybe labeled as height in a side view).
The modified device of Knoch does not explicitly disclose the mouthpiece wherein a maximum height of the mouthpiece as seen in the side view is not more than 85 mm.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to set the maximum height of the mouthpiece as seen in the side view is not more than 85 mm in the modified device of Knoch because Applicant has not disclosed that setting the maximum height of the mouthpiece as seen in the side view to not more than 85 mm provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the maximum height of the mouthpiece of the modified device of Knoch, and Applicant’s the maximum height of the mouthpiece, to perform equally well because both mechanisms perform the same function of ensuring the user can handle the mouthpiece.
Therefore, it would have been prima facie obvious to modify the modified device of Knoch to obtain the invention as specified in claims 4 and 16 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired capable handling of the mouthpiece by the user and thus fails to patentably distinguish over the prior art of the modified device of Knoch.[Examiner suggest amending the claims to make clear that the maximum height limitation is to allow the user to see past the mouthpiece unobstructed (Instant Spec. Pg. 21 para. 4).]
Regarding Claim 7, the modified device of Knoch discloses the nebulizer assembly wherein the inlet port is conical to be force-fittingly connectable to a boss (See Doetz: 5; Fig. 1-2) of the nebulizer (See Doetz: Pg. 12, ln 1-4; Pg. 12, ln 8-9).
Regarding claim 8, the modified device of Knoch discloses the nebulizer assembly of claim 1 having a minor axis (E, Fig. A annotated above), wherein the filter base extends from the body in a direction along the minor axis.
The modified device of Knoch does not specifically disclose the nebulizer assembly wherein the inhalation opening is oval-shaped in a front view, the oval shape having a minor axis and a major axis.
Fink teaches an inhalation opening being oval-shaped (A, Fig. B annotated below) in a front view, the oval shape having a minor axis (B, Fig. B annotated below) and a major axis (C, Fig. B annotated below), wherein the filter base extends from the body in a direction (D, Fig. B annotated below) along the minor axis (Examiner notes: Fink discloses the filter base at least extending the direction along the minor axis. Examiner suggest amending the claim to recite “the filter base extends from the body only in a direction along the minor axis” to better capture the instant invention.) for the purpose of conduiting the aerosolized medicament and gases (¶ 0074).
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Figure B, Adapted from Figure 4A of Fink.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Knoch to include the inhalation opening being oval-shaped in the front view, the oval shape having the minor axis and the major axis as taught by Fink for the purpose of conduiting the aerosolized medicament and gases (See Fink: ¶ 0074).
Regarding Claim 10, the modified device of Knoch discloses the nebulizer assembly wherein the aerosol generator, the chamber and the mouthpiece are arranged in that order along a longitudinal direction (See Knoch: A, Fig. 1) of the nebulizer.
Regarding Claim 11, the modified device of Knoch discloses the nebulizer assembly further comprising a fluid reservoir (See Fink: 408; Fig. 4A, See Knoch: 24, 22; Fig. 1; ¶¶ 0136, 0137), wherein the aerosol generator comprises a vibratable membrane (See Fink: 70; Fig. 7-8, See Knoch: 30; Fig. 1) having a plurality of apertures (See Fink: 74; Fig. 8; ¶¶ 0087, 0088, See Knoch: ¶¶ 0136-0139) and separating the fluid reservoir and the chamber (See Knoch: Fig. 1) .
Regarding Claim 12, the modified device of Knoch discloses the nebulizer assembly the fluid reservoir and the membrane are arranged in that order along a longitudinal direction (See Knoch: A, Fig. 1) of the nebulizer.
Regarding Claims 13 and 17, the modified device of Knoch discloses the nebulizer assembly wherein the chamber has a length (A, Fig. C annotated below) along the longitudinal direction of the nebulizer.
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Figure C, Adapted from Figure 1 of Knoch.
The modified device of Knoch does not explicitly disclose the nebulizer wherein the chamber has the length along the longitudinal direction of the nebulizer between 50 mm and 100 mm.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to set the length along the longitudinal direction of the nebulizer between 50 mm and 100 mm the modified device of Knoch device because Applicant has not disclosed that setting the length along the longitudinal direction of the nebulizer between 50 mm and 100 mm provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the nebulizer of the modified device of Knoch, and Applicant’s length along the longitudinal direction of the nebulizer set between 50 mm and 100 mm, to perform equally well because both mechanisms perform the same function of providing a transient area for produced aerosol.
Therefore, it would have been prima facie obvious to modify the modified device of Knoch to obtain the invention as specified in claims 13 and 17 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired transient area for produced aerosol and thus fails to patentably distinguish over the prior art of the modified device of Knoch.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Knoch in view of Doetz in view Fink as applied to claim 1 above, and further in view of Denyer et al. (U.S. 6,116,233; hereinafter: “Denyer”).
Regarding claim 5, the modified device of Knoch discloses the nebulizer assembly, shown above.
The modified device of Knoch does not specifically disclose the nebulizer assembly wherein a retaining rib for being engaged behind the teeth of a user is provided on an upper side of the body and/or on a lower side of the body adjacent to the inhalation opening.
Denyer teaches an aerosol apparatus comprising a mouthpiece (A, Fig. D annotated below) having a retaining rib (B and C, Fig. D annotated below) for being engaged behind the teeth of a user is provided on an upper side of the body (D, Fig. D annotated below) and on a lower side of the body (E, Fig. D annotated below) adjacent to an inhalation opening (F, Fig. D annotated below) for the providing an out turned portion of the mouthpiece to ensure the mouthpiece does not slide out of the users mouth.
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Figure D, Adapted from Figure 1 of Denyer.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Knoch to include the retaining rib for being engaged behind the teeth of a user provided on the upper side of the body and on the lower side of the body adjacent to the inhalation opening as taught by Denyer for the purpose of providing an out turned portion of the mouthpiece to ensure the mouthpiece does not slide out of the users mouth.
Regarding claim 6, the modified device of Knoch discloses the nebulizer assembly comprises a front edge (See Doetz: at 22, Fig. 2) of the body surrounding the inhalation opening.
The modified device of Knoch does not specifically disclose the mouthpiece wherein a front edge of the body surrounding the inhalation opening is curved in a plan view and/or side view.
Denyer teaches a mouthpiece comprising a body (101; Fig. 5) having a front edge (A, Fig. E annotated below) surrounding a inhalation opening (E, Fig. F annotated below) that is curved in a plan view and/or side view (Fig. 5) for the purpose of forming the inhalation opening to better match the anatomy of the user.
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Figure E, Adapted from Figure 5 of Denyer.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Fink to include the front edge of the body surrounding the inhalation opening being curved in the plan view and/or side view as taught by Denyer for the purpose of forming the inhalation opening to better match the anatomy of the user.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Knoch in view of Doetz in view of Fink as applied to claim 1 above, and further in view of Bordoni et al. (U.S. 4,823,784; hereinafter: “Bordoni”).
Regarding Claim 14, the modified device of Fink discloses the nebulizer, shown above.
The modified device of Fink discloses the nebulizer wherein the chamber cooperates with an ambient opening having a one-way valve allowing ambient air to enter the chamber from outside of the nebulizer upon inhalation of a patient through the inhalation opening of the mouthpiece.
Bordoni teaches an aerosol inhalation apparatus comprising an ambient opening (at 23 of Fig. 1, 3) having a one-way valve (23; Fig. 1, 3) allowing ambient air to enter a chamber (interior of 20; Fig. 1, 3) from outside of a nebulizer (16; Fig. 1-3) upon inhalation of a patient through the inhalation opening of a mouthpiece (26; Fig. 1, 3; col 5, ln 26-61) for the purpose of preventing material exhaled by a patient from entering the nebulizer (col 7, ln 23-24).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Fink to include the chamber cooperating with the ambient opening having the one-way valve allowing ambient air to enter the chamber from outside of the nebulizer upon inhalation of a patient through the inhalation opening of the mouthpiece as taught by Bordoni for the purpose of preventing material exhaled by a patient from entering the nebulizer (See Bordoni: col 7, ln 23-24).
Response to Arguments
Applicant’s arguments, see Pg. 5-7, filed November 25. 2025, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Specifically, where prior art Aumiller fails to disclose “and wherein a distance between the filter base and the inhalation opening is less than a distance between the inlet port and the inhalation opening” as recited in independent claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Knoch in view of Doetz in view of Fink. Examiner notes, though not relied upon herein, “a distance between the filter base and the inhalation opening is less than a distance between the inlet port and the inhalation opening” lacks criticality (See Instant Specification: Pg. 25, ln 3-9).
Conclusion
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785