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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/01/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 04/14/2026. As directed by the amendment: claims 1, 15, 22 and 24 have been amended. Claims 12 and 13 have been cancelled.
Thus, claims 1-11 and 14-24 are pending in this application.
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 22 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 22 recites the limitation "the orifice of the nozzle cover" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 7-9, 11, 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (WO 2017011361 A1) in view of Djupesland et al (US 20100282246 A1).
Regarding claim 1, Miller discloses a nozzle (48, see fig 4) for a container (1) for intranasal administration of a liquid formulation (17, abstract), comprising a nozzle body with an upper end and a lower end, a channel traversing the nozzle body and ending with an orifice in the upper end (see annotated figure below), and a nozzle cover (47) covering an area of the outer surface of the nozzle body (fig 4) which is designed to be introduced into a user's nostril (page 7, paragraph 2), wherein the nozzle body is made out of a first material (fig 4), and the nozzle cover (47) is made out of a second material (fig 4), and said second material being an elastic plastic material (page 7, paragraph 2), and wherein the nozzle cover (47) is recessed from the orifice of the nozzle body, such that the nozzle cover (47) is not in contact with the orifice (see annotated figure below and fig 4, cover 47 is not in contact with said nozzle body).
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Miller fails to expressly teach said first material being a rigid plastic material.
However, Djupesland et al teach a nozzle (17, see fig 13) comprising a nozzle body (41) and a cover (43) wherein said nozzle body is made out of a first material and wherein said first material being a rigid plastic material (para 0167).
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 nozzle body of Miller to made out of a rigid plastic material as taught by Djupesland et al. This would provide the benefit of ensuring that said nozzle is stable enough to be introduced to the nasal cavity without bending and to promote expansion of the fleshy tissues at the nasal valve (para 0168).
Regarding claim 7, Miller in view of Djupesland et al disclose the limitations of claim 1,
Miller further discloses wherein the second material is an elastomer, a thermoplastic elastomer or a thermoplastic rubber (page 7, paragraph 2).
Regarding claim 8, Miller in view of Djupesland et al disclose the limitations of claim 7,
Miller further discloses wherein the second material is a thermoplastic elastomer (page 7, paragraph 2, Flexible Polyurethane (TPU) is a specific, high-performance subtype of TPE).
Regarding claim 9, Miller in view of Djupesland et al disclose the limitations of claim 1 but fails to teach wherein the second material has a Shore A hardness of 20-40.
Miller teaches the band material can have a durometer of between about 30A and 70A (page 7, paragraph 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second material from a Shore A hardness of 30A and 70A to a Shore A hardness of 20-40 as applicant appears to have placed no criticality on the claimed range (see pp. [0031] indicating the nozzle cover may have a Shore A hardness of 20-40) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 11, Miller in view of Djupesland et al disclose the limitations of claim 1,
Miller further discloses wherein the nozzle, when introduced into a nostril, seals the nostril (abstract and page 7, paragraph 2).
Regarding claim 14, Miller in view of Djupesland et al disclose the limitations of claim 1,
Miller further discloses wherein a flow channel for the liquid formulation is formed in the nozzle, and wherein the flow channel is lined by the first material only (fig 4 and annotated figure above).
Regarding claim 15, Miller in view of Djupesland et al disclose the limitations of claim 1,
Miller further discloses wherein an orifice of the nozzle cover has a larger diameter than the orifice of the nozzle body (fig 4 and annotated figure above).
Regarding claim 16, Miller in view of Djupesland et al disclose the limitations of claim 1,
Miller further discloses wherein the nozzle is designed such that the liquid formulation is not in contact with the second material when dispensed from the nozzle (see figs 4-6- substance from outlet is not in contact with band 47).
Regarding claim 17, Miller in view of Djupesland et al disclose the limitations of claim 1,
Miller further discloses a packaging for a liquid formulation (17) for intranasal administration (abstract) comprising a container (1) and a nozzle (48) according to claim 1.
Regarding claim 18, Miller in view of Djupesland et al disclose the limitations of claim 17,
Miller further discloses the packaging according to claim 17 wherein the container is a squeeze bottle (abstract).
Regarding claim 19, Miller in view of Djupesland et al disclose the limitations of claim 17,
Miller further discloses a product comprising a packaging (1) according to claim 17 and a liquid formulation (17) in said packaging (see figs 1-2).
Regarding claim 20, Miller in view of Djupesland et al disclose the limitations of claim 19,
Miller further discloses the product according to claim 19 wherein the liquid formulation is a nasal wash formulation (page 4, line 9).
Regarding claim 21, Miller in view of Djupesland et al disclose the limitations of claim 19,
Miller further discloses the product according to claim 19 wherein the liquid formulation is a nasal spray formulation (page 4, line 9).
Regarding claim 22, Miller in view of Djupesland et al disclose the limitations of claim 1,
Miller further discloses the/an orifice of the nozzle cover (47) has a larger diameter than the orifice of the nozzle body (see annotated figure above and fig 4); the nozzle cover (47) does not project above the upper end of the nozzle body (fig 4); a flow channel for the liquid formulation is formed in the nozzle (see annotated figure above); the flow channel is lined by the first material only (see annotated figure above); and the nozzle is designed such that the liquid formulation is not in contact with the second material when dispensed from the nozzle (fig 4).
Miller fails to teach the first material has a Shore A hardness of 80-100 and the second material has a Shore A hardness of 20-40.
Miller teach said nozzle body is made of first material.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the first material of Miller to have a shore A hardness of 80 – 100 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Miller teaches the band material can have a durometer of between about 30A and 70A (page 7, paragraph 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second material from a Shore A hardness of 30A and 70A to a Shore A hardness of 20-40 as applicant appears to have placed no criticality on the claimed range (see pp. [0031] indicating the nozzle cover may have a Shore A hardness of 20-40) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 2 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (WO 2017011361 A1) in view of Djupesland et al (US 20100282246 A1) and further in view of Jean (FR 2739294 A1).
Regarding claim 2, Miller in view of Djupesland et al disclose the limitations of claim 1 but fails to teach wherein the nozzle is produced by bi-injection moulding.
However, Jean teaches a nozzle (see fig 1) wherein the nozzle is produced by bi- injection moulding (page 3, lines 1-7).
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 nozzle of Miller in view of Djupesland et al and incorporate the teachings of Jean to have said nozzle produced by bi- injection moulding. This technique makes it possible to use a rigid plastic material for said nozzle body, and to use a flexible plastic material for said cover in order to provide a soft contact between said nozzle and the nasal cavity (see page 3).
Regarding claim 23, Miller in view of Djupesland et al disclose the limitations of claim 1 and further disclose wherein the nozzle, when introduced into a nostril, seals the nostril (page 7, paragraph 2), and wherein a flow channel for the liquid formulation is formed in the nozzle (see annotated figure above and fig 4), and wherein the flow channel is lined by the first material only (fig 4) but fails to teach wherein the nozzle is produced by bi-injection moulding, and the second material is a thermoplastic elastomer with a Shore A hardness of 20-40.
However, Jean teaches a nozzle (see fig 1) wherein the nozzle is produced by bi- injection moulding (page 3, lines 1-7).
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 nozzle of Miller in view of Djupesland et al and incorporate the teachings of Jean to have said nozzle produced by bi- injection moulding. This technique makes it possible to use a rigid plastic material for said nozzle body, and to use a flexible plastic material for said cover in order to provide a soft contact between said nozzle and the nasal cavity (see page 3).
Miller teaches the band material is a thermoplastic elastomer and can have a durometer of between about 30A and 70A (page 7, paragraph 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second material from a Shore A hardness of 30A and 70A to a Shore A hardness of 20-40 as applicant appears to have placed no criticality on the claimed range (see pp. [0031] indicating the nozzle cover may have a Shore A hardness of 20-40) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 3-6 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (WO 2017011361 A1) in view of Djupesland et al (US 20100282246 A1) and further in view of Sumiya (WO 2014104066 A1).
Regarding claim 3, Miller in view of Djupesland et al disclose the limitations of claim 1 but fails to teach wherein the first material is a thermoplastic material.
However, Sumiya discloses a nozzle (fig 4) comprising a nozzle body (12) wherein said nozzle body is made out of a first material and wherein the first material is a thermoplastic material (page 4, para 4).
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 nozzle body of Miller in view of Djupesland et al and incorporate the teachings of Sumiya to have the first material being a thermoplastic material. This would provide the benefit of having a rigid and a high enough modulus of elasticity material that can be formed by injection molding so it can be stable enough when introducing it to the nasal cavity (page 4, para 4).
Regarding claim 4, Miller in view of Djupesland et al disclose the limitations of claim 1 but fails to teach wherein the first material is a polyolefin.
However, Sumiya discloses a nozzle (fig 4) comprising a nozzle body (12) wherein said nozzle body is made out of a first material and wherein the first material is a polyolefin (page 4, para 4).
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 nozzle body of Miller in view of Djupesland et al and incorporate the teachings of Sumiya to have the first material being a polyolefin. This would provide the benefit of having a rigid and a high enough modulus of elasticity material that can be formed by injection molding so it can be stable enough when introducing it to the nasal cavity (page 4, para 4).
Regarding claim 5, Miller in view of Djupesland et al disclose the limitations of claim 1 but fails to teach wherein the first material is a low-density polyethylene.
However, Sumiya discloses a nozzle (fig 4) comprising a nozzle body (12) wherein said nozzle body is made out of a first material and wherein the first material is a low-density polyethylene (page 4, para 4).
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 nozzle body of Miller in view of Djupesland et al and incorporate the teachings of Sumiya to have the first material being a low-density polyethylene. This would provide the benefit of having a rigid and a high enough modulus of elasticity material that can be formed by injection molding so it can be stable enough when introducing it to the nasal cavity (page 4, para 4).
Regarding claim 6, Miller in view of Djupesland et al disclose the limitations of claim 1 but fails to teach wherein the first material has a Shore A hardness of 80-100.
However, Sumiya discloses a nozzle (fig 4) comprising a nozzle body (12) wherein said nozzle body is made out of a first material and wherein the first material is a rigid plastic material (page 4, para 4).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the rigid plastic of Sumiya to have a shore A hardness of 80 – 100 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 24, Miller in view of Djupesland et al disclose the limitations of claim 1 but fails to teach wherein the nozzle body ends at its lower end in a cylindrical press fit plug; and the nozzle cover has a Shore A hardness of 28-32.
However, Sumiya discloses a nozzle (fig 4) comprising a nozzle body (12) wherein the nozzle body ends at its lower end in a cylindrical press fit plug (see fig 4).
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 nozzle body of Miller in view of Djupesland et al and incorporate the teachings of Sumiya to have the nozzle body ends at its lower end in a cylindrical press fit plug. This would provide the benefit of having a tight sealing between said nozzle and container (page 6, para 8).
Miller teaches the band material is a thermoplastic elastomer and can have a durometer of between about 30A and 70A (page 7, paragraph 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second material from a Shore A hardness of 30A and 70A to a Shore A hardness of 28-32 as applicant appears to have placed no criticality on the claimed range (see pp. [0031] indicating the nozzle cover may have a Shore A hardness of 28-32) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (WO 2017011361 A1) in view of Djupesland et al (US 20100282246 A1) and further in view of Garcia et al (ES 2362843 A1).
Regarding claim 10, Miller in view of Djupesland et al disclose the limitations of claim 1 but fails to teach wherein the outer surface of the nozzle body and the nozzle cover have an approximately semi-spherical shape.
However, Garcia et al disclose a nasal applicator (fig 1) which has a semispherical shape (see fig 1).
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 nozzle of Miller in view of Djupesland et al and incorporate the teachings of Kris to have the outer surface of the nozzle body and the nozzle cover have an approximately semi- spherical shape. This semi-spherical shape avoids lesions of the nostril skin and provide a good seal without bumping (see page 4- bump 2 will be introduced slightly into the nostril that will seal the device without bumping on the outside of it any contact with the nasal mucosa, avoiding possible lesions in the same).
Response to Arguments
Applicant’s arguments, see Remarks, filed on 04/14/2026, with respect to the rejection(s) of claim(s) 1-11 and 14-24 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Miller (WO 2017011361 A1) in view of Djupesland et al (US 20100282246 A1).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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