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 .
Response to Amendment
This office action is in response to the amendment filed 5/16/2025. As directed by the amendment, claims 1, 2, 7 and 8 have been amended, and claims 4, 5, 9 and 10 have been cancelled. As such, claims 1-3, 6-8 and 11 are pending in the instant application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 3, 6 and 7 are objected to because of the following informalities:
Claim 3, line 2 should read “above the” for clearer antecedent basis, since it is understood in view of e.g. instant para [0043] to be the same threshold as claim 1, line 11
Claim 6, line 1 should read “the fluid is configured to be delivered” to make it clearer that a method step is not being recited in an apparatus claim
Claim 7, line 1 should read “controlling
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7, 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kern (US 2019/0290879 A1; hereinafter “Kern”) in view of Clancy et al. (EP 2273933 B1; hereinafter “Clancy”) and Crockford et al. (US 2003/0205229 A1; hereinafter “Crockford”).
Regarding claim 7, Kern discloses a method for controlling the delivery of a fluid to a user (inhalation using a nebulizer, para [0002]), the method comprising:
providing a fluid delivery device (nebulizer unit 1) containing a fluid (liquid medication, para [0038]) and a fluid jet ejection head (aerosol generator 101) (para [0004]) for delivering the fluid to the user (Fig. 1; paras [0009] and [0038]);
providing a sensor (a suitable sensor for measuring a pressure and/or a flow through the mouthpiece, para [0012]) in the fluid delivery device for detecting, during use of the fluid delivery device, (i) an inhalation pressure and (ii) an inhalation rate (sensor for measuring a pressure and…a flow through the mouthpiece, para [0012]; inhalation…[through] the mouthpiece, para [0009]);
activating the fluid jet ejection head to deliver the fluid to the user (beginning of aerosol production, para [0024]; starting aerosol production, para [0029]) at a variable rate (ṁ2) (Fig. 2; the aerosol production rate is chosen proportional to the standardized difference of a control parameter and a threshold value, para [0021]; para [0043]) when the pressure sensor senses a threshold pressure (beginning of aerosol production…dynamically during the inhalation…due to the measured actual pressure or flow…the start as well as the stop criteria…the threshold values for pressure and/or flow rate, para [0024]; criterion for starting aerosol production…falling below a threshold value of the pressure, para [0029]);
increasing or decreasing the variable rate of fluid delivery from the fluid jet ejection head based on the sensed inhalation rate (Fig. 2; continuous increase [or decrease] of the emitted aerosol amount can be provided according to the formula…values of the control parameter…flow rate, paras [0017-18]; the rate can also be changed, in which the aerosol generation after a trigger is increased and/or reduced, para [0024]; para [0043]), where Kern paras [0017-18] and [0024] teach control based on pressure and/or flow (emphasis added), and pressure and flow are inversely related according to Bernoulli’s Principle, such that selecting pressure (as dependent on flow) for the activation threshold and flow for varying the aerosol production rate during operation would have been obvious to an artisan before the effective filing date of the claimed invention to choose from the finite possible combinations for control variables, in order to provide the predictable results of a suitable activation threshold and a suitable variable for directing variable aerosol generation, particularly when using a differential pressure sensor as discussed below.
While Kern paras [0012], [0017-18] and [0024] teach a sensor that measures pressure and/or flow and control based on the measured pressure and/or flow, Kern is silent regarding wherein the sensor is a differential pressure sensor, such that the threshold pressure is specifically a threshold inhalation differential pressure. However, where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another," the claim is unpatentable under 35 U.S.C. 103(a), see MPEP 2143.I.B, and Clancy teaches that it was known specifically in the art of flow rate detection for varying aerosol production output therewith before the effective filing date of the claimed invention to utilize a differential pressure sensor ([a]erosolisation may be controlled responsive to the flow of the ventilation gas…gas flow is measured (via…differential pressure sensor), para [0018]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for Kern to include where the sensor is a differential pressure sensor as taught by Clancy, such that the threshold pressure is a threshold inhalation differential pressure, in order to provide the predictable result of utilizing a type of sensor that was well-known to be able to measure both pressure and flow as taught by Kern para [0012].
Modified Kern is silent regarding terminating the activation of the fluid jet ejection head when a prescribed dosage of fluid has been delivered to the user. However, Crockford teaches that it was known in the aerosol delivery art before the effective filing date of the claimed invention to include terminating the activation of the aerosol delivery when a prescribed dosage of fluid has been delivered to the user ([o]nce the processor has calculated that the predetermined dose has been given…treatment is stopped such that the patient can only inhale ambient air through the mouthpiece, and not medication-laden air, para [0041]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the method of modified Kern to include terminating the activation of the fluid jet ejection head when a prescribed dosage of fluid has been delivered to the user as taught by Crockford, in order to predictably stop aerosol delivery once a desired dose has been delivered to avoid waste and/or overdose (Crockford paras [0019], [0035], [0041], [0059], [0070]).
Regarding claim 8, Kern in view of Clancy and Crockford teaches the method of claim 7, wherein Crockford further educates modified Kern to include wherein the fluid delivery device includes a dosage counter (dose counter for calculating the dose delivered, Crockford para [0057]) that totals an amount of fluid ejected (Crockford Fig. 5; paras [0035], [0040-41], [0057], [0059]), further comprising alerting the user when the prescribed dosage of fluid has been delivered to the user (indicator 17) (Crockford Fig. 1; dose calculator causes…indicator 17 to indicate that treatment has ended, para [0035]; indicator 17 indicates when a patient has received the full dose, para [0039]; see also paras [0040-41] and [0059]), in order to provide the predictable result of utilizing known means to provide the termination discussed above regarding claim 7, as well as to predictably indicate to the user once a full dose has been delivered.
Regarding claim 11, Kern in view of Clancy and Crockford teaches the method of claim 7, wherein modified Kern further discloses/teaches terminating the delivery of fluid when the differential pressure sensor senses an inhalation differential pressure below the threshold inhalation differential pressure (criterion for starting aerosol production…falling below a threshold value of the pressure…stop criteria…exceeding a second threshold value for the pressure…the used first and second threshold values can…be identical, Kern para [0029]; para [0019]), and Kern further teaches using control values in combination (para [0031]), such that including both the termination criteria of claim 7 as well as those of Kern discussed above would have been obvious to an artisan before the effective filing date of the claimed invention in order to predictably provide termination when either a) a full dose has been delivered (to prevent waste and/or overdose) (claim 7), OR 2) the user has stopped inhaling and/or inhaling with sufficient strength (claim 11), so as not to waste medicament when there is insufficient flow/pressure (as indicated by a differential pressure sensor) for the medicament to reach the desired region(s) of the user.
Claim(s) 1, 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Brammer et al. (US 2015/0114409 A1; hereinafter “Brammer”) in view of Kern and Clancy.
Regarding claim 1, Brammer discloses a fluid delivery device (aerosol delivery device 1200) (Figs. 2-6) comprising:
a cartridge body (outer body 1216) (Figs. 2-3);
a fluid outlet nozzle (mouthpiece 1226) attached to the cartridge body 9Figs. 2-3);
a fluid jet ejection cartridge (cartridge 1204, comprising atomizer assembly 1220 and reservoir 1222) disposed in the cartridge body (Figs. 2-3; paras [0082-83] and [0086]), the fluid jet ejection cartridge containing a fluid (aerosol precursor composition 1246) (an aerosol precursor…a liquid, para [0064]; see also para [0097]) and an ejection head (bubble jet head 1234) attached to the fluid jet ejection cartridge (Figs. 2-3; paras [0087-91]); wherein the ejection head contains a plurality of fluid ejectors (ejection heating elements 1240) thereon and a nozzle plate having a plurality of fluid ejection nozzles (nozzles 1242) therein associated with the plurality of fluid ejectors (Fig. 4; paras [0087-91]) configured to deliver the fluid to a user (Fig. 6; para [0086]); and
a control system (within control body 1202) disposed in the fluid delivery device (paras [0064], [0082], [0085], [0096-99]), comprising a sensor (flow sensor 1212) (flow sensor 1212 detects the puff, para [0086]; a puff sensor for controlling…in response to pressure drop, para [0080]) for sensing an inhalation of the user (para [0085]),
Brammer is silent regarding wherein the delivery of fluid is at a variable rate, wherein the sensor is a differential pressure sensor for sensing an inhalation differential pressure and an inhalation rate of the user, and wherein the control system is configured to (i) terminate fluid delivery below a threshold inhalation differential pressure and (ii) increase or decrease the variable rate based on the inhalation rate of the user. However, Kern combined with Clancy teaches that it was known in the aerosol delivery art before the effective filing date of the claimed invention for delivery of aerosolized fluid to be at a variable rate, for a sensor to be a differential pressure sensor for sensing an inhalation differential pressure and an inhalation rate of the user, and for a control system to be configured to (i) terminate fluid delivery below a threshold inhalation differential pressure and (ii) increase or decrease the variable rate based on the inhalation rate of the user as discussed above regarding claims 7 and 11. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Brammer to include wherein the delivery of fluid is at a variable rate, wherein the sensor is a differential pressure sensor for sensing an inhalation differential pressure and an inhalation rate of the user, and wherein the control system is configured to (i) terminate fluid delivery below a threshold inhalation differential pressure and (ii) increase or decrease the variable rate based on the inhalation rate of the user as taught by Kern and Clancy, in order to utilize a known sensor type to control the aerosol output in a known fashion to provide predictable results, i.e. to discontinue aerosol production when the user is not inhaling and/or an insufficient differential pressure/flow is detected for delivering the aerosol to the desired region(s) of the user in order to reduce waste, and to vary the aerosol generator output either 1) directly with the flow strength of the user in order to provide a substantially stable aerosol concentration across different flow levels for maximized delivery and/or to avoid condensation of the aerosol at lower flows OR 2) inversely with the flow strength so that each inhalation provides the same amount of fluid regardless of how hard the user draws, depending on the given application.
Regarding claim 3, Brammer in view of Kern and Clancy teaches the fluid delivery device of claim 1, wherein Kern further educates modified Brammer to include wherein the control system is further configured to initiate fluid delivery above [the] threshold inhalation differential pressure, as discussed above regarding claim 7 and in conjunction with the modification discussed above regarding claim 1, in order to predictably provide activation/aerosol generation only when the user is inhaling and/or inhaling with sufficient strength, so as not to waste medicament when there is insufficient flow (as indicated by the differential pressure sensor) for the medicament to reach the desired region(s) of the user.
Regarding claim 6, Brammer in view of Kern and Clancy teaches the fluid delivery device of claim 1, wherein Brammer further discloses/teaches wherein the fluid is delivered to the user as a mist (paras [0005-6] and [0063-65]), and see also Kern para [0004], where providing the aerosol as a mist would have been obvious to an artisan before the effective filing date of the claimed invention in order to predictably provide a desired/known form of aerosol for a given application.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Brammer in view of Kern and Clancy as applied to claim 1 above, and further in view of Crockford.
Regarding claim 2, Brammer in view of Kern and Clancy teaches the fluid delivery device of claim 1, but modified Brammer is silent regarding wherein the control system further comprises a dosage counter that totals an amount of fluid ejected and the control system is further configured to terminate fluid delivery when a prescribed dosage of fluid is reached. However, Crockford teaches that it was known in the aerosol delivery art before the effective filing date of the claimed invention to provide these features as discussed above regarding claims 7 and 8. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Brammer to include wherein the control system further comprises a dosage counter that totals an amount of fluid ejected and the control system is further configured to terminate fluid delivery when a prescribed dosage of fluid is reached as taught by Crockford, in order to utilize known means to provide the predictable results of stopping aerosol delivery once a desired dose has been delivered to avoid waste and/or overdose, as well as to predictably indicate to the user once a full dose has been delivered (Crockford paras [0019], [0035], [0041], [0059], [0070]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references teaching varying atomizer output with inhalation flow rate: Alarcon (US 2020/0022416 A1; para [0120]); Batista et al. (US 2020/0367570 A1; para [0143]); Bessant et al. (US 2018/0146710 A1; abstract); Bilat (US 2019/0008209; abstract); Denyer et al. (US 2009/0025718 A1; abstract); Kilmowitz et al. (US 6,427,682 B1; col. 8, line 65-col. 9, line 3); Nobutani et al. (US 2007/0062520 A1); Pilkington (US 2024/0423285 A1; para [0039]); Voges (US 6,196,218 B1). Additional reference teaching termination of aerosol generation upon reaching a maximum dose: Gallem et al. (US 2012/0037154 A1; para [0020]). Additional reference regarding a fluid jet ejection head with a plurality of fluid ejectors: Katase (US 2005/0016550 A1).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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