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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, 8-9, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khan et al. 2017/0274161
Regarding claim 1, Khan discloses a medication delivery system (0002 inhaler) comprising: a chamber housing (Figure 1 flow chamber 103) defining an interior volume (Figure 1 depicts an interior volume within 103) and comprising an inlet adapted to receive a dosage of medicament (Figure 2b depicts an inlet) and an outlet spaced apart from the inlet (Figure 2a depicts an outlet 105 spaced away from the inlet), wherein the inlet and outlet are in fluid communication with the interior volume (Figure 2a depicts an interior volume); a flow channel (Spirometer 101 depicts a flow channel) in fluid communication with the interior volume (0061 states “As shown in FIG. 10, flow path 116 provides a fluid connection between flow chamber 103 and the upper portion of the spirometer 101.”); and a dosage indicator (float 106) translatable in the flow channel from a pre-inhalation position to a complete dosage position (0056 states “This creates a pressure difference within the spirometer chamber, allowing float 106 to rise.” The float starts at the bottom (First position) and makes its way upwards to reach any arbitrary second position based on the flow rate being achieved.), wherein a positioning of the dosage indicator in the complete dosage position indicates a complete administration of the dosage of medicament through the outlet (The second position does indicate a complete administration of dosage through the outlet as the second position is only achieved once product is being supplied, and paragraph 0055 of the specification refers to a complete dosage position as “the position of the dosage indicator after a predetermined, or prescribed, dosage of medicament, aerosolized in the holding chamber, has been administered”. Based on this definition, the predetermined amount can be the amount that flows through based on a pressure applied by the user, as a predetermined amount of aerosol would begin to flow based on the pressure that is being applied by the user), wherein the dosage indicator is visible through the flow channel as the dosage indicator is translated between the pre-inhalation position and the complete dosage position (0064 states “The components of the spacer device are preferably made of transparent plastic so that a user of the device may watch the movement of the fluids inside of the chambers of the spacer device during use”) wherein a rod is disposed in the flow channel (0071 states “The float may be allowed to free float within the spirometer or be tethered within the spirometer, such as by being disposed over an elongated rod or spire 115”), and wherein the dosage indicator comprises a piston slidable along the rod from the pre-inhalation position to the complete dosage position (0055 states “The float 106 may preferably be a piston-type float and not a ball-type float” This piston float slides along spire 115 and achieves a complete dosage position as described above).
Regarding claim 3, Khan teaches the medication delivery system of claim 1 wherein the dosage indicator is translatable along a linear path between the pre-inhalation position and the complete dosage position (Spire 115 allows the piston to translate along a linear path).
Regarding claim 4, Khan teaches the medication delivery system of claim 1 further comprising a user interface coupled to the chamber housing (Figure 10 mouthpiece 105), wherein the dosage indicator is closer to the user interface in the pre-inhalation position than in the complete dosage position (As depicted in figure 10, the float 106 would be closer to the user interface at rest due to the tilt of the spirometer).
Regarding claim 5, Khan teaches the medication delivery system of claim 1 wherein the flow channel comprises a track (The walls of the spirometer act as a track to guide the float as “the float 106 is generally shaped to slidably fit within the fluid chamber of the spirometer 101” as stated in 0065), therein the piston is moveable along the track between the pre- inhalation position and complete dosage position (float 106 moves along spire 115 in between a pre-inhalation position when no inhalation occurs and the spire is at the bottom of the cylinder, and the completed dosage position where an arbitrary amount of dose has been administered and the float is located towards the top.).
Regarding claim 8, Khan teaches the medication delivery system of claim 1 further comprising an auditory indicator adapted to provide an audible signal when the dosage indicator is translated to the complete dosage position (0052 states “a device may include a visual indicator as well as one or more indicators such as an auditory indicator.”).
Regarding claim 9, Khan teaches the medication delivery system of claim 8 wherein the dosage indicator comprises the auditory indicator (0052 states “the device may produce a specific noise once the preferred flow rate is maintained or while the optimal flow rate is not maintained.”).
Regarding claim 14, Khan teaches the medication delivery system of claim 1 wherein the inlet and outlet are spaced apart in a longitudinal direction (the inlet 104 and outlet 105 are spaced in a longitudinal direction as depicted in figure 5a), and wherein the flow channel extends in the longitudinal direction (Figure 8 depicts a part of the flow channel of the spirometer running in a longitudinal direction).
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.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Khan in view of Tseng et al. 2023/0330484
Regarding claim 10, Khan teaches the medication delivery system of claim 1 further comprising an adaptor coupled to the chamber housing (Figure 7 depicts an adaptor connecting mouthpiece 110 to flow chamber 103), wherein the inlet comprises a first inlet defined by the adapter (Figure 2b depicts a first inlet at the adaptor connection point), but fails to teach wherein the adapter further comprises a second inlet communicating with the interior volume, the second inlet comprising a variable size opening. Tseng discloses an analogous pulmonary device that does teach wherein the adapter (Figure 2 depicts second opening end 102 connected to the mouthpiece of 20) further comprises a second inlet (Figure 1 depicts a first inlet of second opening end 102 a second inlet consisting of aperture 12), the second inlet communicating with the interior volume (Depicted in Figure 1), the second inlet comprising a variable size opening (0056 states “an adjustment gate 11 having an aperture 12 with an adjustable size”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan with the teachings of Tseng and include wherein the adapter further comprises a second inlet communicating with the interior volume, the second inlet comprising a variable size opening as this allows for a method of controlling the amount of airflow (0056).
Regarding claim 11, Khan in view of Tseng teaches the medication delivery system of claim 10 wherein the variable size opening is defined by a one-way inhalation valve disposed over the second inlet (0068 of Tseng depicts check valve 14 disposed over the area containing aperture 12). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to further include wherein the variable size opening is defined by a one-way inhalation valve disposed over the second inlet as this prevents airflow in the opposite direction (0068). Regarding claim 12, Khan in view of Tseng teaches the medication delivery system of claim 10 wherein the variable size opening is defined by a dial moveable relative to the second inlet (Rotation part 113 of Tseng is rotated to adjust blades 112 as stated in 0083). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan with Tseng and include a dial on the variable size opening to provide a method of controlling the airflow to the user.
Regarding claim 13, Khan in view of Tseng teaches the medication delivery system of claim 10 wherein the flow channel is in fluid communication with the interior volume at a third inlet (Figure 10 of Khan, Flow path 116) spaced apart from the first and second inlets (Since the first and second inlet as depicts by Tseng would be provided onto the space where mouthpiece 110 and chamber 103 of Khan intersect, flow path 116 would be spaced apart from the two inlets as they are spaced away from that location as depicted in figure 10 of Khan).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Khan in view of Ginn et al. 2003/0024527
Regarding claim 16, Khan teaches the medication delivery system of claim 1 wherein the flow channel comprises an inlet opening (Entrainment ports 107, Figure 11) and an outlet opening in fluid communication with the interior volume (Flow path 116), but fails to teach further comprising a valve assembly having a valve disposed adjacent the inlet of the flow channel, wherein the valve is moveable from a normally open position to an inhalation position in response to inhalation by a user. Ginn discloses an analogous lung assist apparatus that does teach a valve assembly wherein the valve is moveable from a normally open position to an inhalation position in response to inhalation by a user (0048 states “When the lumen 18 is subjected to a positive pressure, e.g., during inhalation, the flapper valve may be pushed coextensive with the lateral opening 24, i.e., closed”. During inhalation, this flapper valve is pushed closed, which is the same type of valve situation that is being described in the present application based on the depiction of figure 29, wherein a closing of the valve takes place when inhalation occurs.). One of ordinary skill in the art would have the ability to add the described flapper valve the exterior of the entrainments 107 of Khan and it would be prima facie obvious to do so before the effective filing date of the claimed invention as it provides a seal for the opening when inhalation occurs (0048). The combination further discloses a valve disposed adjacent the inlet opening of the flow channel, as this is where the modification is taking place.
Regarding claim 17, Khan in view of Ginn teaches the medication delivery system of claim 16 wherein the valve at least partially closes the inlet opening when moved to the inhalation position (Since the purpose of the flapper valve of Ginn is to close an opening when inhalation occurs, the flapper valve on the exterior of the entrainments of Khan would close the inlet opening when inhalation occurs.).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Khan and Ginn, further in view of Rosenfeld et al. 2017/0087313
Regarding claim 18, Khan in view of Ginn teaches the medication delivery system of claim 16, but fails to teach further comprising a fulcrum member biasing the valve to the normally open position. Rosenfeld teaches an analogous aerosol device that does teach a fulcrum member biasing a valve (Figure 7b depicts upper flange 18 biasing tab 16 in an open position). One of ordinary skill in the art would be able to take this concept and place a similar sort of flange on the exterior of the entrainments of Khan to help bias the flapper valve taught by Ginn and it would have been prima facie obvious to do so before the effective filing date of the claimed invention as it would provide a maximum angular position of the valve (0025). The combination further discloses, biasing the valve when it’s in an open position, as the placement of the biasing member would cause this to take place.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Khan and Ginn, further in view of Poormand et al. 2023/0025941
Regarding claim 19, Khan in view of Ginn teaches the medication delivery system of claim 16, but fails to teach wherein the valve assembly is adjustable between a plurality of settings to vary the flow in the flow channel. Poormand discloses an analogous oxygen flow therapy device that does teach wherein a valve assembly is adjustable between a plurality of settings to vary the flow in the flow channel (Figures 9a and 9b depict a flapper valve 20b with a hinge or pivot mechanism 25b. 0115 states that “The hinge 25b may be adjustable”.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan in view of Ginn with the teachings of Poormand and include wherein the valve assembly is adjustable between a plurality of settings to vary the flow in the flow channel as the inclusion of an adjustable hinge member allows for an adjustment of valve opening pressure or the angular range of the valve (0115).
Response to Arguments
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive. Applicant argues that the float of Khan is not a dosage indicator. Examiner respectfully disagrees with this assertion as simply put, the float does indicate a dosage that is administered through the flow chamber. This indication device does not move unless medicament flows through the flow chamber, therefore its movement would indicate a dosage being administered to the user. Furthermore, an argument is made stating that the position of the float of Khan does not correspond to a complete administration of the dosage when it is in its second position. Examiner also respectfully disagrees with this assertion as the claim language of claim one simply states that the second position is a position wherein complete administration of the dosage has occurred. Based on this language, the complete administration of the dosage could be any point in time wherein an arbitrary amount of dosage as pre-determined by the user (either through timing or flow rate based on a physician’s orders) has been administered. Since movement of the float indicates the dosage being administered, an instantaneous point in time where a certain amount of dosage has passed through the mouthpiece 105 after inhalation by the user, can be a complete dosage position, as dosage is indeed being administered to the user. At that point in time, the float would be at a second position, meeting the requirements of the claim language.
Next, the argument is made that the piston in the present invention is incrementally advancing as opposed to the float of Khan. However, examiner respectfully disagrees as the float is also incrementally advancing upwards as the applicant inhales, a certain amount of dosage comes through as applicant inhales, subsequently reaching a second position when an arbitrary amount of dosage has been provided to the user, which could also be a point in which a complete and sufficient dosage has been provided to the user. Furthermore, there is no language in claim 1 pertaining to the dosage indicator incrementally advancing.
Next, the argument is made that Khan’s float position is a function of instantaneous flow rate and not of a complete dosage position. While true that khan’s float also pertains to flow rate, that does not mean that it also does not pertain to a complete dosage position. As stated above, the complete dosage position can be defined as an instantaneous position where an amount of dosage has been administered. When the float is in a second position towards the top, an amount of dosage has indeed been administered through the mouthpiece, and this position of dosage being provided could be a complete dosage position. There is no language in the claim that defines the complete dosage position as a position that outputs a dosage that has been set by the user through the device features itself, wherein once this predetermined amount based on the dosage setting of the device is reached, the indicator is in a complete dosage position. Based on the current claim language, this predetermined amount can be arbitrary and something that is mentally decided by the user (determined by a medical professional) based on either inhalation time or flow rate.
Lastly, the argument is made that Khan’s float does not meet the requirement of being a piston that is slidable along a rod. Examiner respectfully disagrees as the dictionary definition of a piston is “a sliding piece moved by or moving against fluid pressure which usually consists of a short cylindrical body fitting within a cylindrical chamber or vessel along which it moves back and forth” (Merriam webster). Based on this definition, Khan does in fact teach this as float 106 does slide along a rod in spire 115. This sliding is in conjunction with a pre-inhalation position and a complete dosage position as described above. Furthermore, claim 1 does not contain any language that would suggest that the dosage indicator position is dependent on a dose position across multiple breaths.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S Lee can be reached at (571) 2707410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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