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 .
Claims 1-28, filed 5/12/23, are currently pending.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 42, line 5 recites “peripheral portion 102 of the injector 126” suggested to be changed to --peripheral portion 126 of the injector 102-- for consistency. 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 18 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 18 recites “the damping,” however it is unclear which damping applicant is referring back to.
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.
Claims 1, 3-5 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collins (2010/0163582).
Regarding claim 1, in fig. 3A-3C Collins discloses a nebulizing device 110, comprising: a hollow housing 116, wherein the hollow housing comprises a cavity (space within 116), and the cavity comprises a liquid channel (from 120 to 152) located inside the cavity and a nebulizing spray nozzle (structure surrounding 152) located at a distal end of the liquid channel; and an injector (120, 176, and 194), wherein the injector is at least partially accommodated in the cavity (Fig. 3A), and coupled to the hollow housing through a bias spring 118, and the injector comprises: a reservoir 170, configured to accommodate liquid [0073][0085]; a liquid conveying pipe (172 and 114), comprising a liquid inlet (end of 172 within 170) and a liquid outlet (end of 114 within 120) arranged opposite to each other, wherein the liquid inlet is located in the reservoir (Fig. 3A), the liquid outlet is located in the liquid channel (Fig. 3A), and the liquid outlet and the nebulizing spray nozzle jointly define a liquid chamber (Fig. 3A); and an injector proximal end (proximal end of 170), coupled to the liquid conveying pipe (Fig. 3A) and configured to operatively receive a pushing force [0152], wherein under an action of the pushing force and the bias spring, the liquid conveying pipe is movable between a proximal position in the cavity (Fig. 3B) and a distal position (Fig. 3C) relatively closer to the distal end [0152]; and when the liquid conveying pipe is at the distal position (Fig. 3C), the bias spring is in a compressed state (Fig. 3C), wherein when the pushing force is removed from the injector proximal end (Fig. 3B), the bias spring is capable to drive the liquid conveying pipe to move from the distal position to the proximal position (Fig. 3B), so as to convey the liquid from the reservoir into the liquid chamber [0158]; and when the injector proximal end receives the pushing force [0152], the pushing force is capable to compress the bias spring to drive the liquid conveying pipe to move from the proximal position to the distal position (Fig. 3C), so as to form a predetermined nebulizing pressure at the nebulizing spray nozzle [0164], so that the liquid in the liquid chamber can flow out of the liquid channel through the nebulizing spray nozzle ([0164] Fig. 16j).
Regarding claim 3, Collins discloses that the bias spring 118 is configured to, when the pushing force pushes the liquid conveying pipe to move from the proximal position to the distal position, generate a resistance in an opposite direction to the pushing force (since the spring biases the device into to configuration in fig. 3B [0102], compression of the spring in fig. 3B generates a resistance), and the resistance is used for substantially offsetting an increased pushing force [0102], so that the predetermined nebulizing pressure is maintained at the nebulizing spray nozzle [0152][0102].
Regarding claim 4, Collins discloses that the bias spring 118 is configured to generate a damping when the pushing force pushes the liquid conveying pipe to move from the proximal position to the distal position [0102], and the damping and a liquid damping in the liquid channel [0102] cause a time for the liquid conveying pipe to move from the proximal position to the distal position to be not less than a predetermined nebulizing time (due to the spring and liquid resistance, a nebulizing time is increased to a time not less than a predetermined nebulizing time [0102]).
Regarding claim 5, Collins discloses that the nebulizing device further comprises a distal stopper 120c, and the distal stopper is arranged in the hollow housing and is configured to, when the liquid conveying pipe is at the distal position, prevent the liquid conveying pipe from moving distally ([0099] Fig. 3C).
Regarding claim 8, Collins discloses that when the liquid conveying pipe is at the proximal position (Fig. 3B), the bias spring is substantially in a relaxation state or in an under-compression state (Fig. 3B [0102]).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Collins, as applied to claim 1 above, in further view of Kladders et al. (2004/0164186).
Regarding claim 2, Collins discloses that the nebulizing spray nozzle comprises a fluid outlet 152, but is silent regarding that the nebulizing spray nozzle comprises a plurality of fluid outlets, wherein at least 50% of droplets in the plume spray have an average particle size ranging from 1 um to 10 um. However, in fig. 4 Kladders teaches a nebulizing spray nozzle comprises a plurality of fluid outlets (each of 82), and wherein at least 50% of droplets in the plume spray have an average particle size ranging from 1 um to 10 um [0073]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Collins’ fluid outlet and droplets with a plurality of fluid outlets and wherein at least 50% of droplets in the plume spray have an average particle size ranging from 1 um to 10 um, respectively, as taught by Kladders, for the purpose of providing inhalable aerosol to the user ([0073] Kladders). The modified Collins discloses that movement of the liquid conveying pipe from the proximal position to the distal position (Fig. 3B Collins) causes the liquid to flow out of the liquid channel through the plurality of fluid outlets (Fig. 4 Kladders) and converge to generate a plume spray (Fig. 4 Kladders) with a predetermined initial speed (there is a predetermined initial speed based on at least the spring, fluid and nebulizer dimensions).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Collins, as applied to claim 1 above, in further view of Hsu et al. (2012/0160873).
Regarding claim 6, Collins is silent regarding that the nebulizing device further comprises a proximal stopper, and the proximal stopper is arranged in the hollow housing and is configured to, when the liquid conveying pipe is at the proximal position, prevent the liquid conveying pipe from moving proximally. However, in fig. 3-4 Hsu teaches a nebulizing device further comprises a proximal stopper 24, and the proximal stopper is arranged in a hollow housing 23 and is configured to, when a liquid conveying pipe 22 is at the proximal position (Fig. 4), prevent the liquid conveying pipe from moving proximally (Fig. 4 [0017]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Collins’ hollow housing and injector with a proximal stopper, as taught by Hsu, for the purpose of preventing detachment ([0017] Hsu).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Collins and Hsu, as applied to claim 6 above, in further view of Kladders et al. (2004/0164186).
Regarding claim 7, Collins is silent regarding that a distance between the proximal position and the distal position ranges from 5 mm to 30 mm. However, in fig. 1a-1b Kladders teaches a device length of less than 90-150 mm [0077] and a distance between the proximal to distal positions is roughly one seventh (1/7) of the total device length, making the distance between the proximal position and the distal position fall in the range from 5 mm to 30 mm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Collins’ distance between the proximal position and the distal position to be in the range from 5 mm to 30 mm, as taught by Kladders, for the purpose of providing an alternate distance having the predictable result of delivering a spray.
Claim 9-10, 13-16, 19-21, 23-24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Collins (2010/0163582) in view of Kladders et al. (2004/0164186).
Regarding claim 9, in fig. 3A-3C Collins discloses a nebulizing device 110, comprising: a hollow housing 116, wherein the hollow housing comprises a cavity (space within 116), and the cavity comprises a liquid channel (from 120 to 152) located inside the cavity and a nebulizing spray nozzle (structure surrounding 152) located at a distal end of the liquid channel; and an injector (120, 176, and 194), wherein the injector is at least partially accommodated in the cavity (Fig. 3A), the injector comprises: : a reservoir 170, configured to accommodate liquid [0073][0085]; a liquid conveying pipe (172 and 114), comprising a liquid inlet (end of 172 within 170) and a liquid outlet (end of 114 within 120) arranged opposite to each other, wherein the liquid inlet is located in the reservoir (Fig. 3A), the liquid outlet is located in the liquid channel (Fig. 3A), and the liquid outlet and the nebulizing spray nozzle jointly define a liquid chamber (Fig. 3A); and the liquid conveying pipe is configured to operatively convey the liquid accommodated in the reservoir into the liquid chamber [0155]; and an injector proximal end (proximal end of 170), wherein the injector proximal end is coupled to the liquid conveying pipe (Fig. 3A) and configured to receive a pushing force (Fig. 3C), and under an action of the pushing force, the liquid conveying pipe is movable in the cavity from a proximal position (Fig. 3B) to a distal position (Fig. 3C) relatively closer to the distal end to form a predetermined nebulizing pressure at the nebulizing spray nozzle [0102], the nebulizing spray nozzle comprises a fluid outlet 152, but is silent regarding that the nebulizing spray nozzle comprises a plurality of fluid outlets, wherein at least 50% of droplets in the plume spray have an average particle size ranging from 1 um to 10 um. However, in fig. 4 Kladders teaches a nebulizing spray nozzle comprises a plurality of fluid outlets (each of 82), and wherein at least 50% of droplets in the plume spray have an average particle size ranging from 1 um to 10 um [0073]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Collins’ fluid outlet and droplets with a plurality of fluid outlets and wherein at least 50% of droplets in the plume spray have an average particle size ranging from 1 um to 10 um, respectively, as taught by Kladders, for the purpose of providing inhalable aerosol to the user ([0073] Kladders). The modified Collins discloses that the liquid in the liquid chamber can flow out of the liquid channel through the plurality of fluid outlets of the nebulizing spray nozzle and converge to generate a plume spray (Fig. 4 Kladders) with a predetermined initial speed (there is a predetermined initial speed based on at least the spring, fluid and nebulizer dimensions).
Regarding claim 10, the modified Collins discloses that at least 50% of the droplets in the plume spray have an average particle size ranging from 1 um to 10 um ([0073] Kladders), but does not explicitly recite that at least 50% of the droplets in the plume spray have an average particle size ranging from 2 um to 5 um. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the modified Collin’s particle sizes wherein at least 50% of the droplets in the plume spray have an average particle size ranging from 2 um to 5 um, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and it appears that wherein at least 50% of the droplets in the plume spray have an average particle size ranging from 2 um to 5 um would perform equally as well at providing inhalable particles to a user. In re Aller, 105 USPQ 233.
Regarding claim 13, the modified Collins discloses that during generation of the plume spray, the pushing force is non-monotonically attenuated (due to the spring increasing resistance as compressed [0102] Collins).
Regarding claim 14, the modified Collins discloses that the nebulizing device further comprises a bias spring (118 Collins); the injector is coupled to the hollow housing through the bias spring (Fig. 3A Collins); and when the liquid conveying pipe is at the distal position (Fig. 3C Collins), the bias spring is in a compressed state (Fig. 3C Collins), and when the pushing force is removed from the injector proximal end, the bias spring is capable to drive the liquid conveying pipe to move from the distal position back to the proximal position (Fig. 3B [0155] Collins), so as to convey the liquid from the reservoir into the liquid chamber ([0155] Collins).
Regarding claim 15, the modified Collins discloses that the bias spring is configured to, when the pushing force pushes the liquid conveying pipe to move from the proximal position to the distal position, generate a resistance in an opposite direction to the pushing force ([0102] Collins), and the resistance is used for substantially offsetting an increased pushing force ([0102] Collins), so that the predetermined nebulizing pressure is maintained at the nebulizing spray nozzle ([0102] Collins).
Regarding claim 16, the modified Collins discloses that the bias spring is configured to generate a damping when the pushing force pushes the liquid conveying pipe to move from the proximal position to the distal position ([0102] Collins), and the damping and a liquid damping in the liquid channel cause a time for the liquid conveying pipe to move from the proximal position to the distal position to be not less than a predetermined nebulizing time (due to the spring and liquid resistance, a nebulizing time is increased to a time not less than a predetermined nebulizing time [0102] Collins).
Regarding claim 19, the modified Collins discloses that the pushing force is manually applied ([0152] Collins).
Regarding claim 20, the modified Collins discloses that a magnitude of the pushing force ranges from 5 N to 8.5 N ([0102] Collins), but is silent regarding that the magnitude of the pushing force ranges from 10 N to 70 N. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the modified Collin’s pushing force with a pushing force that ranges from 10 N to 70 N, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and it appears that a pushing force in the range of 10 N to 70 N would perform equally as well at providing a spray of medicament to a user during inhalation. In re Aller, 105 USPQ 233.
Regarding claim 21, Collins discloses that the nebulizing device further comprises a distal stopper 120c, and the distal stopper is arranged in the hollow housing and is configured to, when the liquid conveying pipe is at the distal position, prevent the liquid conveying pipe from moving distally ([0099] Fig. 3C).
Regarding claim 23, the modified Collins is silent regarding that a cross-sectional area of the plurality of fluid outlets of the nebulizing spray nozzle ranges from 20 um2 to 1000 um2. However, Kladders teaches a cross-sectional area of the plurality of fluid outlets of the nebulizing spray nozzle ranges from 20 um2 to 1000 um2 [0061]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Collins’ fluid outlet cross-sectional areas with cross-sectional areas from 20 um2 to 1000 um2, as taught by Kladders, for the purpose of providing an alternate cross-sectional area having the predictable results of delivering inhalable mist to a user.
Regarding claim 24, the modified Collins is silent regarding that the predetermined nebulizing pressure ranges from 80 MPa to 1000 MPa. However, Kladders teaches a predetermined nebulizing pressure ranges from 5 MPa to 60 MPa [0053]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the modified Collins’ predetermined nebulizing pressure ranges with predetermined nebulizing pressure ranges from 80 MPa to 1000 MPa, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and it appears that predetermined nebulizing pressure ranges from 80 MPa to 1000 MPa would perform equally as well at providing inhalable spray to a user. In re Aller, 105 USPQ 233.
Regarding claim 28, the modified Collins discloses that when the liquid conveying pipe is at the proximal position (Fig. 3B Collins), the bias spring is substantially in a relaxation state or in an under-compression state (Fig. 3B [0102]).
Claims 11-12 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Collins and Kladders, as applied to claim 9 above, in further view of Wuttke et al, (2005/0183718).
Regarding claim 11, the modified Collins is silent regarding that the predetermined initial speed is less than 10 m/s. However, Wuttke teaches a nebulizing device in which the predetermined initial speed is less than 10 m/s [0109]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Collins’ predetermined initial speed with a predetermined initial speed less than 10 m/s, as taught by Wuttke, for the purpose of providing an alternate predetermined initial speed having the predictable results of delivering inhalable mist to a user.
Regarding claim 12, the modified Collins discloses that the predetermined initial speed is less than 10 m/s, but is silent regarding that the predetermined initial speed ranges from 1 m/s to 5 m/s. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the modified Collins’ predetermined initial speed with a predetermined initial speed from 1 m/s to 5 m/s, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and it appears that a predetermined initial speed ranges from 1 m/s to 5 m/s would perform equally as well at providing inhalable spray to a user. In re Aller, 105 USPQ 233.
Regarding claim 25, the modified Collins is silent regarding that the initial speed of the plume spray generated during movement of the liquid conveying pipe from the proximal position to the distal position is substantially maintained between 1 m/s to 5m/s for a continuous time period of at least 40% to 80% of a plume spray duration. However, Wuttke teaches a nebulizing device in which the predetermined initial speed is less than 10 m/s [0109] for a continuous time period of a plume spray duration [0109] and Collins’ discloses a compression spring 118 that delivers spray in the same way. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the modified Collins’ initial speed with an initial speed from 1 m/s to 5 m/s for a continuous time period of at least 40% to 80% of a plume spray duration, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and it appears that an initial speed with an initial speed from 1 m/s to 5 m/s for a continuous time period of at least 40% to 80% of a plume spray duration would perform equally as well at providing inhalable spray to a user. In re Aller, 105 USPQ 233.
Regarding claim 26, the modified Collins is silent regarding that the initial speed of the plume spray generated during movement of the liquid conveying pipe from the proximal position remains substantially constant for a continuous time period of 40% to 80% of a plume spray duration. However, Wuttke teaches a nebulizing device in which there is an initial speed is less than 10 m/s [0109] for a continuous time period of a plume spray duration [0109] and Collins’ discloses a compression spring 118 that delivers spray in the same way. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the modified Collins’ initial speed that remains substantially constant for a continuous time period of 40% to 80% of a plume spray duration, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and it appears that an initial speed with an initial remains substantially constant for a continuous time period of 40% to 80% of a plume spray duration would perform equally as well at providing inhalable spray to a user. In re Aller, 105 USPQ 233.
Regarding claim 27, the modified Collins’ discloses that wherein in the continuous time period of the substantially constant initial speed of the plume spray, at least 50% of the droplets in the plume spray have an average particle size ranging from 1 um to 10 um ([0073] Kladders).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Collins and Kladders, as applied to claim 16 above, in further view of Kiesewetter (2012/0132199).
Regarding claim 17, the modified Collins is silent regarding that the predetermined nebulizing time ranges from 0.5 seconds to 5 seconds. However, Kiesewetter teaches that a predetermined nebulizing time ranges from 0.5 seconds to 5 seconds [0070]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Collins’ predetermined nebulizing time with a predetermined nebulizing time from 0.5 to 5 seconds, as taught by Kiesewetter, for the purpose of providing an alternate predetermined nebulizing time having the predictable results of delivering inhalable mist to a user.
Regarding claim 18, the modified Collins does not explicitly recite that the damping causes the time for the liquid conveying pipe to move from the proximal position to the distal position to be substantially equal to a single inhalation time of a normal breathing rhythm of a human. However, Kiesewetter teaches that the damping causes the time for the liquid conveying pipe to move from the proximal position to the distal position to be substantially equal to a single inhalation time of a normal breathing rhythm of a human [0070]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Collins’ time for the liquid conveying pipe to move from the proximal position to the distal position to be substantially equal to a single inhalation time of a normal breathing rhythm of a human, as taught by Kiesewetter, for the purpose of providing an alternate time for the liquid conveying pipe to move from the proximal position to the distal position having the predictable results of delivering inhalable mist to a user.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Collins and Kladders, as applied to claim 21 above, in further view of Hsu et al. (2012/0160873).
Regarding claim 21, the modified Collins is silent regarding that the nebulizing device further comprises a proximal stopper, and the proximal stopper is arranged in the hollow housing and is configured to, when the liquid conveying pipe is at the proximal position, prevent the liquid conveying pipe from moving proximally. However, in fig. 3-4 Hsu teaches a nebulizing device further comprises a proximal stopper 24, and the proximal stopper is arranged in a hollow housing 23 and is configured to, when a liquid conveying pipe 22 is at the proximal position (Fig. 4), prevent the liquid conveying pipe from moving proximally (Fig. 4 [0017]). 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 modified Collins’ hollow housing and injector with a proximal stopper, as taught by Hsu, for the purpose of preventing detachment ([0017] Hsu).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. ALT (2020/0353183) and Shahaf et al. (2018/0344951) directed to fluid dispensers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785