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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 30, 2026 has been entered.
Priority
Acknowledgement is made to Applicant’s claim to priority to Non-Provisional U.S. App. No. 17/205,280 filed March 18, 2021 now Pat. No. 11,925,749.
Status of Claims
This Office Action is responsive to the amendment filed on June 30, 2026. As directed by the amendment: claims 1, 9, and 17 have been amended. Thus, claims 1-26 are presently pending in this application.
Claim(s) 1-4, 7, 9-12, 15, 17-19, 22, and 24-26 were previously rejected under 35 U.S.C. 103 as being unpatentable over Sugita et al. (U.S. Pub. No. 2010/0024814) in view of Curtis et al. (U.S. Pub. No. 2013/0213397). Claim(s) 5-6, 8, 13-14, 16, 20-21, and 23 were previously rejected under 35 U.S.C. 103 as being unpatentable further in view of Davidson et al. (U.S. Pub. No. 2017/0203058).
Applicant's amendments 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, 9-12, 15, 17-19, 22, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sugita et al. (U.S. Pub. No. 2010/0024814; hereinafter: “Sugita’814”) in view of Sugita et al. (U.S. Pub. No. 2010/0024812; hereinafter: “Sugita’812”) in view of Curtis et al. (U.S. Pub. No. 2013/0213397; hereinafter: “Curtis”).
Regarding Claim 1, Sugita discloses a pharmaceutical drug delivery device comprising: a drug delivery device body (5; Fig. 1, 2, 8, 9); a fluid outlet nose cone (8; Fig. 1, 2, 8, 9) attached to the drug delivery device body (Fig. 1, 2; ¶¶ 0032, 0033); a fluid jet ejection cartridge (1; Fig. 1-5B, 9) containing a liquid pharmaceutical drug (¶¶ 0032, 0033, 0053-0057) is disposed in the drug delivery device body (Fig. 1, 2, 8, 9; ¶¶ 0032, 0033, 0053-0057, 0068), wherein a fluid jet ejection head (3; Fig. 1-3A, 4A, 10) is attached to the fluid jet ejection cartridge (Fig. 1-3A, 4A, 10; ¶¶ 0032, 0033, 0053-0057, 0068) and the fluid jet ejection head is in fluid flow communication with the fluid outlet nose cone (Fig. 1-3A, 4A, 8-10; ¶¶ 0032, 0033, 0053-0057, 0068), the fluid jet ejection head capable of producing a spray of the liquid pharmaceutical drug on demand under ambient atmospheric pressure (¶¶ 0032, 0033, 0053-0057, 0068), wherein the fluid outlet nose cone comprises a plurality of air flow ports (11; Fig. 1, 2, 8) open to an ambient atmosphere (¶¶ 0032, 0033) and (ii) an insert (37; Fig. 8-10) comprising a chamber (A, Fig. A annotated below) in communication with a surface (B, Fig. A annotated below) of the fluid jet ejection head, the chamber configured to retain a volume of moist air in contact with the surface of the fluid jet ejection head (Fig. 10; ¶ 0068).
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Figure A, Adapted from Figure 10 of Sugita.
Sugita does not specifically disclose the pharmaceutical drug delivery device wherein the plurality of air flow ports of the fluid outlet nose cone are a plurality of air flow channels open to an ambient atmosphere for providing a pressure differential between an inner area of the fluid outlet nose cone adjacent to the fluid ejection head and the ambient atmosphere.
Curtis teaches a substances deliver inhaler (400; Fig. 4-9) comprising a fluid outlet (404; Fig. 4, 8, 9) comprising a plurality of air flow channels (406, 410; Fig. 4, 5, 8, 9) open to an ambient atmosphere for providing a pressure differential between an inner area (408; Fig. 4, 5, 8, 9; ¶¶ 0135, 0141-0146) of the fluid outlet adjacent to a fluid ejection head (402; Fig. 4, 8, 9) and the ambient atmosphere (Fig. 4-9; ¶¶ 0135, 0141-0146) for the purpose of opening or closing the plurality of air flow channels thereby influencing flow rate through the device thus tuning the device to respond "optimally" to the needs of a patient (¶ 0146).
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 pharmaceutical drug delivery device of Sugita to include the plurality of air flow ports of the fluid outlet nose cone to be the plurality of air flow channels open to the ambient atmosphere for providing a pressure differential between an inner area of the fluid outlet nose cone adjacent to the fluid ejection head and the ambient atmosphere as taught by Curtis for the purpose of opening or closing the plurality of air flow channels thereby influencing flow rate through the device thus tuning the device to respond "optimally" to the needs of a patient (See Curtis: ¶ 0146).
Regarding Claims 2, 10, and 18, the modified device of Sugita discloses the pharmaceutical drug delivery device of claim 1, shown above.
The modified device of Sugita discloses altering the plurality of air flow channels results in a change to the air flow rate (See Curtis: ¶¶ 0141-0146).
The modified device of Sugita does not explicitly disclose the pressure differential ranges from about 5 to about 10 kPa at an air flow rate of from about 50 to about 100 L/min.
The modified device of Sugita discloses altering the plurality of air flow channels needs to be optimized to influence the flow rate to tune the device respond to the needs of a patient (See Curtis: ¶ 0146). As such the opening or closing/blocking of the plurality of air flow channels is disclosed to be a result effective variable in that opening or closing/blocking of the plurality of air flow channels effects the air flow rate and pressure differential. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Sugita to have the air flow rate and pressure differential within the claimed range, as it involves only adjusting the dimensions and/or opening or closing/blocking of a component disclosed to require adjustment.
Therefore, 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 modified device of Sugita by making the plurality of air flow channels opened or closed/blocked such that the pressure differential ranges from about 5 to about 10 kPa at an air flow rate of from about 50 to about 100 L/min 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) (See MPEP 2144.05).
Regarding Claims 3, 11, and 19, the modified device of Sugita discloses the pharmaceutical drug delivery device of claim 1, wherein the plurality of air flow channels are adjacent to an exterior surface (A, Fig. B annotated below) of the fluid outlet nose cone (See Curtis: ¶¶ 0141-0146).
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Figure B, Adapted from Figure 5 of Curtis.
Regarding Claims 4 and 12, the modified device of Sugita discloses the pharmaceutical drug delivery device of claim 1, wherein the plurality of air flow channels extend along a long axis (B, Fig. B annotated above) of the fluid outlet nose cone (See Curtis: Fig. 4-9; ¶¶ 0141-0146).
Regarding Claims 7, 15, and 22, the modified device of Sugita discloses the pharmaceutical drug delivery device of claim 1, shown above.
The modified device of Sugita discloses altering the plurality of air flow channels results in a change to the air flow rate (See Curtis: ¶¶ 0141-0146).
The modified device of Sugita does not explicitly disclose wherein the plurality of air flow channels have a combined air flow area ranging from about 8.0 to about 17.5 mm2.
The modified device of Sugita discloses altering the plurality of air flow channels needs to be optimized to influence the flow rate to tune the device respond to the needs of a patient (See Curtis: ¶¶ 0145, 0146). As such the opening or closing/blocking and/or setting of the diameter of the plurality of air flow channels is disclosed to be a result effective variable in that opening or closing/blocking and/or changing the diameter of the plurality of air flow channels effects the air flow rate. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Sugita to have the air flow rate within the claimed range, as it involves only adjusting the dimensions and/or opening or closing/blocking of a component disclosed to require adjustment.
Therefore, 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 modified device of Sugita by making the plurality of air flow channels opened or closed/blocked or altering their diameter such that the plurality of air flow channels have a combined air flow area ranging from about 8.0 to about 17.5 mm2 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) (See MPEP 2144.05).
Regarding Claim 9, Sugita discloses a method for reducing a pressure differential on a fluid jet ejection head for a nasal spray device (5, 8; Fig. 1, 2, 8, 9; ¶¶ 0032, 0033, 0053-0057, 0068), the method comprising: providing a fluid outlet nose cone (8; Fig. 1, 2, 8, 9) attached to a body (5; Fig. 1, 2, 8, 9) for the nasal spray device (Fig. 1-3A, 4A, 8-10; ¶¶ 0032, 0033, 0053-0057, 0068); a fluid jet ejection cartridge (1; Fig. 1-5B, 9) disposed in the body, the fluid jet ejection cartridge containing the fluid jet ejection head in fluid flow communication with the fluid outlet nose cone and a pharmaceutical drug in the fluid jet ejection cartridge (Fig. 1-3A, 4A, 8-10; ¶¶ 0032, 0033, 0053-0057, 0068), the fluid jet ejection head capable of producing a spray of the liquid pharmaceutical drug on demand under ambient atmospheric pressure (¶¶ 0032, 0033, 0053-0057, 0068), providing a plurality of air flow ports (11; Fig. 1, 2, 8) open to an ambient atmosphere (¶¶ 0032, 0033); providing an insert (37; Fig. 8-10) within the fluid outlet nose cone (Fig. 8-10; ¶ 0068), the insert comprising a chamber (A, Fig. A annotated above) in communication with a surface (B, Fig. A annotated above) of the fluid jet ejection head, the chamber configured to retain a volume of moist air in contact with the surface of the fluid jet ejection head (Fig. 10; ¶ 0068); and activating the nasal spray device when the fluid outlet nozzle is inserted into the nasal passage of a user (¶¶ 0032, 0033, 0053-0057, 0068).
Sugita does not specifically discloses the method wherein the plurality of air flow ports open to an ambient atmosphere comprises providing a plurality of air flow channels open to an ambient atmosphere for providing a pressure differential between an inner area of the fluid outlet nose cone adjacent to the fluid jet ejection head and the ambient atmosphere; and activating the nasal spray device while flowing air through the air flow channels when the fluid outlet nozzle is inserted into the nasal passage of a user thereby preventing fluid from drooling from the fluid jet ejection head upon inhalation by a user of the nasal spray device.
Curtis teaches a substances deliver method comprising a substances deliver device (400; Fig. 4-9) comprising a fluid outlet (404; Fig. 4, 8, 9) providing a plurality of air flow channels (406, 410; Fig. 4, 5, 8, 9) open to an ambient atmosphere for providing a pressure differential between an inner area (408; Fig. 4, 5, 8, 9; ¶¶ 0135, 0141-0146) of the fluid outlet adjacent to a fluid ejection head (402; Fig. 4, 8, 9) and the ambient atmosphere (Fig. 4-9; ¶¶ 0135, 0141-0146) and activating the device while flowing air through the air flow channels (¶¶ 0135, 0141-0146) thereby preventing fluid from drooling from the fluid ejection head upon inhalation by a user of the device (¶¶ 0135, 0141-0146) for the purpose of opening or closing the plurality of air flow channels thereby influencing flow rate through the device thus tuning the device to respond "optimally" to the needs of a patient (¶ 0146).
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 method of Sugita to include the plurality of air flow ports open to the ambient atmosphere comprises providing the plurality of air flow channels open to an ambient atmosphere for providing a pressure differential between an inner area of the fluid outlet nose cone adjacent to the fluid jet ejection head and the ambient atmosphere; and activating the nasal spray device while flowing air through the air flow channels when the fluid outlet nozzle is inserted into the nasal passage of a user thereby preventing fluid from drooling from the fluid jet ejection head upon inhalation by a user of the nasal spray device as taught by Curtis for the purpose of opening or closing the plurality of air flow channels thereby influencing flow rate through the device thus tuning the device to respond "optimally" to the needs of a patient (See Curtis: ¶ 0146).
Regarding Claim 17, Sugita discloses a nose cone (8; Fig. 1, 2, 8-10) for a nasal spray device (Fig. 1, 2), comprising a fluid inlet (A, Fig. C annotated below) adjacent to a fluid jet ejection head (1; Fig. 1-5B, 9) and a fluid outlet (12; Fig. 1, 2, 8-10) for delivery of a pharmaceutical drug to a nasal cavity of a user (¶¶ 0032, 0033, 0053-0057, 0068), wherein the fluid outlet nose cone comprises a plurality of air flow ports (11; Fig. 1, 2, 8) open to an ambient atmosphere (¶¶ 0032, 0033) and the fluid jet ejection head capable of producing a spray of the liquid pharmaceutical drug on demand under ambient atmospheric pressure (¶¶ 0032, 0033, 0053-0057, 0068) and (ii) an insert (37; Fig. 8-10) comprising a chamber (A, Fig. A annotated above) in communication with a surface (B, Fig. A annotated above) of the fluid jet ejection head, the chamber configured to retain a volume of moist air in contact with the surface of the fluid jet ejection head (Fig. 10; ¶ 0068).
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Figure C, Adapted from Figure 1 of Sugita.
Sugita does not specifically disclose wherein the plurality of air flow ports of the fluid outlet nose cone are a plurality of air flow channels open to an ambient atmosphere for providing a pressure differential between an inner area of the fluid outlet nose cone adjacent to the fluid ejection head and the ambient atmosphere.
Curtis teaches a fluid outlet (404; Fig. 4, 8, 9) comprising a plurality of air flow channels (406, 410; Fig. 4, 5, 8, 9) in an exterior surface (A, Fig. B annotated above) thereof for providing a pressure differential between the fluid inlet and the ambient atmosphere; wherein the plurality of air flow channels are open to an ambient atmosphere for providing a pressure differential between an inner area (408; Fig. 4, 5, 8, 9; ¶¶ 0135, 0141-0146) of the fluid outlet adjacent to a fluid ejection head (402; Fig. 4, 8, 9) and the ambient atmosphere (Fig. 4-9; ¶¶ 0135, 0141-0146) for the purpose of opening or closing the plurality of air flow channels thereby influencing flow rate through the device thus tuning the device to respond "optimally" to the needs of a patient (¶ 0146).
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 nose cone of Sugita to include the plurality of air flow ports of the fluid outlet nose cone are the plurality of air flow channels in the exterior surface thereof for providing the pressure differential between the fluid inlet and the ambient atmosphere as taught by Curtis for the purpose of opening or closing the plurality of air flow channels thereby influencing flow rate through the device thus tuning the device to respond "optimally" to the needs of a patient (See Curtis: ¶ 0146).
Regarding Claims 24-26, the modified device of Sugita discloses wherein the fluid jet ejection head is selected from the group consisting of a thermal jet ejection head, a bubble jet ejection head, and a piezoelectric jet ejection head (See Sugita: ¶¶ 0053, 0054).
Claim(s) 5-6, 8, 13-14, 16, 20-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Sugita in view of Curtis as applied to claims 1, 9, 15, and 17, respectively, above, and further in view of Davidson et al. (U.S. Pub. No. 2017/0203058; hereinafter: “Davidson”).
Regarding Claims 5-6, 13-14, and 20-21, the modified device of Sugita discloses the pharmaceutical drug delivery device of claims 1, 9, and 17, respectively, wherein the plurality of air flow channels comprise apertures (See Curtis: 410; Fig. 4, 5, 8, 9) in an exterior surface (A, Fig. B annotated above) of the fluid outlet nose cone.
The modified device of Sugita does not specifically disclose the pharmaceutical drug delivery device wherein the plurality of air flow channels comprise elongate channels in an exterior surface of the fluid outlet nose cone and wherein the elongate channels are partially covered by an outer nose cone structure.
Davidson teaches a flow regulating inhaler device (1300; Fig. 13A-13D) comprising a plurality of air flow channels (1310, 1312, 1330, 1340; Fig. 13A-13D) having elongate channels (¶¶ 0260-0269) in an exterior surface (A, Fig. D annotated below) of a fluid outlet nose cone (1301; Fig. 13A, 13B) and wherein the elongate channels are partially covered by an outer nose cone structure (1302; Fig. 13B; ¶¶ 0260-0269) for the purpose of allowing control of the flow through the plurality air flow channels (“bypass conduits”; ¶¶ 0263-0265).
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Figure D, Adapted from Figure 13A of Davidson.
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 Sugita to include the plurality of air flow channels comprise elongate channels in the exterior surface of the fluid outlet nose cone and wherein the elongate channels are partially covered by the outer nose cone structure as taught by Davidson for the purpose of allowing control of the flow through the plurality air flow channels (See Davidson: ¶¶ 0263-0265).
Regarding Claims 8 and 23, the modified device of Sugita discloses the pharmaceutical drug delivery device of claims 1 and 17, respectively, shown above.
The modified device of Sugita does not specifically disclose the pharmaceutical drug delivery device wherein the nose cone further comprises a twistable closure configured to provide a variable air flow rate ranging from about 50 to about 100 L/min.
Davidson teaches a flow regulating inhaler device (1300; Fig. 13A-13D) comprising a fluid outlet nose cone (1301; Fig. 13A, 13B) having a plurality of air flow channels (1310, 1312, 1330, 1340; Fig. 13A-13D), wherein the nose cone further comprises a twistable closure (1302; Fig. 13B) configured to provide a variable air flow rate (¶¶ 0260-0269) for the purpose of allowing control of the flow through the plurality air flow channels (“bypass conduits”; ¶¶ 0263-0265).
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 Sugita to include the nose cone further comprises the twistable closure configured to provide the variable air flow rate as taught by Davidson for the purpose of allowing control of the flow through the plurality air flow channels (See Davidson: ¶¶ 0263-0265).
The modified device of Sugita does not explicitly disclose the pharmaceutical drug delivery device wherein the variable air flow rate ranges from about 50 to about 100 L/min.
The modified device of Sugita discloses altering the plurality of air flow channels needs to be optimized to influence the flow rate to tune the device respond to the needs of a patient (See Curtis: ¶ 0146). As such the opening or closing/blocking of the plurality of air flow channels is disclosed to be a result effective variable in that opening or closing/blocking of the plurality of air flow channels effects the air flow rate. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Sugita to have the air flow rate within the claimed range, as it involves only adjusting the dimensions and/or opening or closing/blocking of a component disclosed to require adjustment.
Therefore, 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 modified device of Sugita by making the plurality of air flow channels opened or closed/blocked such that the variable air flow rate ranges from about 50 to about 100 L/min 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) (See MPEP 2144.05).
Regarding Claim 16, the modified method of Sugita discloses the method of claim 15, shown above.
The modified method of Sugita does not specifically disclose wherein the nose cone comprises a twistable closure, further comprising twisting the twistable closure to increase or decrease the combined are flow area.
Davidson teaches a flow regulating inhaler device (1300; Fig. 13A-13D) comprising a fluid outlet nose cone (1301; Fig. 13A, 13B) having a plurality of air flow channels (1310, 1312, 1330, 1340; Fig. 13A-13D), wherein the nose cone further comprises a twistable closure (1302; Fig. 13B), further comprising twisting the twistable closure to increase or decrease the combined are flow area (¶¶ 0260-0269) for the purpose of allowing control of the flow through the plurality air flow channels (“bypass conduits”; ¶¶ 0263-0265).
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 method of Sugita to include the nose cone comprises the twistable closure, further comprising twisting the twistable closure to increase or decrease the combined are flow area as taught by Davidson for the purpose of allowing control of the flow through the plurality air flow channels (See Davidson: ¶¶ 0263-0265).
Response to Arguments
Applicant’s arguments regarding the new limitations with respect to “(ii) an insert comprising a chamber in communication with a surface of the fluid jet ejection head, the chamber configured to retain a volume of moist air in contact with the surface of the fluid jet ejection head.” as recited in independent claim 1 and 9 and similarly in independent claim 17 have been considered but are moot because the arguments do not apply to the rejection in the previous office action (e.g., do not apply to claim limitations previously rejected). All arguments directed to new limitations in the amended claims are addressed in the 35 U.S.C. 103 rejection Sugita in view of Curtis, shown above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
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