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 .
Status of the Claims
Claims 1-11 are pending and are subject to this Office Action. This is the first Office Action on the merits of the claims.
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 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al. (2022/0001122).
Regarding claim 7, Hunter et al. (2022) teaches a method for controlling the delivery of a fluid to a user (A droplet delivery device and methods for delivering droplets to a subject ([Abstract])), comprising:
A fluid delivery device containing a fluid and a fluid jet ejection head for delivering the fluid to the user (A fluid delivery device (100) containing a fluid reservoir and ejection mechanism module (106) to deliver fluid ([0095])).
A differential pressure sensor in the fluid delivery device for detecting an inhalation differential pressure during use of the fluid delivery device (A differential pressure sensor for detecting a pressure drop during inhalation ([0070])).
The fluid jet ejection head configured to deliver the fluid to the user at a predetermined rate when the differential pressure sensor senses a threshold inhalation differential pressure (The ejection mechanism configured to eject fluid at a fixed rate when the differential pressure sensor detects a threshold pressure decline ([Abstract, 0070, 0074])).
Terminating the activation of the fluid jet ejection head when a prescribed dosage of fluid has been delivered to the user (Stopping the ejector mechanism after a period of time so as to achieve a desired administration dosage ([0070])).
Regarding claim 8, Hunter et al. (2022) teaches the fluid delivery device including a dosage counter, further comprising alerting the user when the prescribed dosage of fluid has been delivered to the user (A dosage counter, the droplet delivery device comprising an audio or visual indicator as to when the dose has been delivered ([0076, 0070])).
Regarding claim 9, Hunter et al. (2022) teaches the predetermined rate of fluid delivery as a constant rate of fluid delivery (A fixed rate of fluid delivery, determined by the frequency of vibrations of the aperture plate ([0074])).
Regarding claim 10, Hunter et al. (2022) teaches the predetermined rate of fluid delivery as a rate corresponding to an inhalation rate of the user (The droplet delivery may have no intrinsic velocity, wherein droplet delivery is instead conducted by the patient’s breath ([0067])).
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (U.S. PGPub. 2022/0001122) in view of Hunter et al. (U.S. PGPub. 2014/0187969) and Maharajh et al. (U.S. PGPub. 2006/0047368).
Regarding claim 1, Hunter et al. (2022) teaches a fluid delivery device (A droplet delivery device (100)) comprising:
A cartridge body (A base unit (104) (Fig. 1A-1B; [0095])).
A fluid outlet nozzle attached to the cartridge body (A mouthpiece (108) attached to the delivery device (Fig. 1A-1B; [0095])).
A fluid jet ejection cartridge disposed in the cartridge body, the fluid jet ejection cartridge containing a fluid and an ejection head attached to the fluid jet ejection cartridge (A fluid reservoir and ejection mechanism module (106) (Fig. 1A-1B; [0095])).
The ejection head containing a nozzle plate having a plurality of fluid ejection nozzles therein associated with the fluid ejectors to deliver the fluid to a user at a predetermined rate. (The ejector mechanism comprising an aperture plate, the aperture plate including a plurality of openings, through which aerosol droplets pass to the user at a fixed ejection rate ([0054, 0074])).
A control system disposed in the fluid delivery device comprising a differential pressure sensor for sensing inhalation differential pressure (A microprocessor that is activated by a differential pressure sensor to detect pressure at the mouthpiece ([0070])).
Hunter et al. (2022) does not specifically teach an ejection head containing a plurality of fluid ejectors.
However, Hunter et al. (2014) teaches an ejection mechanism including a substrate structure (100) coupled to a fluid reservoir, the substrate featuring multiple openings (102) wherein fluid droplets are ejected (Fig. 1-2; [0080, 0088]). Hunter et al. (2014) additionally teaches that a fluid ejector with multiple openings for fluid ejection allows for an increased volume of droplet ejection, based on the dimensions of the openings, and the ability to mix ejected fluids by providing flow communication to multiple fluid reservoirs ([0082, 0086]). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to modify the ejection mechanism of Hunter et al. (2022) with the substrate featuring multiple openings for fluid ejection, as taught by Hunter et al. (2014). The incorporation of a fluid ejector with multiple openings for fluid ejection allows for an increased volume of droplet ejection, based on the dimensions of the openings, and the ability to mix ejected fluids by providing flow communication to multiple fluid reservoirs.
The modified Hunter (2022) is silent regarding that the control system is configured to terminate delivery below a threshold inhalation differential pressure. However, Maharajh et al. teaches a pressure sensor configured to stop fluid delivery when pressure falls below a user-specified threshold ([0068]). It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to modify the delivery termination system of Hunter et al. (2022) with Maharajh et al.’s system to terminate fluid delivery below a threshold of inhalation pressure to allow for the user to personally control fluid delivery by controlling the pressure at which they inhale the aerosol.
Regarding claim 2, Hunter et al. (2022) teaches a control system further comprising a dosage counter, the control system further configured to terminate fluid delivery when a prescribed dosage of fluid is reached. (A microprocessor programmed with a dosage counter, the microprocessor further configured to stop the ejector mechanism after a period of time sufficient to achieve a desired administration dosage ([0076, 0070])).
Regarding claim 3, Hunter et al. (2022) teaches the control system further configured to initiate fluid delivery above a threshold inhalation differential pressure (A microprocessor configured to activate an ejector mechanism after a threshold pressure is attained by a pressure sensor ([0070])).
Regarding claim 4, Hunter et al. (2022) teaches the predetermined rate of fluid delivery as a constant rate of fluid delivery (A fixed rate of fluid delivery, determined by the frequency of vibrations of the aperture plate ([0074])).
Regarding claim 5, Hunter et al. (2022) teaches the predetermined rate of fluid delivery as a rate corresponding to an inhalation rate of the user (The droplet delivery may have no intrinsic velocity, wherein droplet delivery is instead conducted by the patient’s breath ([0067])).
Regarding claim 6, Hunter et al. (2022) teaches the fluid delivered to the user as a mist (The fluid delivered in the form of droplets, the droplet delivery device described as a soft mist inhaler device ([0040])).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (U.S. PGPub. 2022/0001122) in view of Maharajh et al. (U.S. PGPub. 2006/0047368).
Regarding claim 11, Hunter et al. (2022) teaches all the claimed limitations as listed above, but does not specifically teach terminating the delivery of fluid when the differential pressure sensor senses an inhalation differential pressure below the threshold inhalation differential pressure.
However, Maharajh et al. teaches actuation of an aerosol delivery device when sufficient negative pressure is generated by patient inhalation, wherein actuation ceases when the pressure generated by the patient decreases below a pressure threshold ([0059, 0060]).
It would have been obvious to one of ordinary skill in art before the effective filing date of the claimed invention to modify the delivery termination system of Hunter et al. (2022) with Maharajh et al.’s system to terminate fluid delivery below a threshold of inhalation pressure to allow for the user to personally control fluid delivery by controlling the pressure at which they inhale the aerosol.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cameron (U.S. PGPub. 2017/0181474) teaches a vapor delivery device and associated systems.
Germinario et al. (U.S. PGPub. 2017/0319797) teaches a droplet delivery device for precise and repeated dosage delivery.
Fahnert et al. (U.S. PGPub. 2019/0054260) teaches a nebulizer device for delivery of dosage to a user’s respiratory system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jack D. Tangstrom whose telephone number is (703)756-5902. The examiner can normally be reached Monday-Friday 7:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on (571) 272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.T./Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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