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 .
Election/Restrictions
Applicant’s election without traverse of “Group I, claims 1-17 and 26, drawn to Figures 1-8 for an inhaler accessory apparatus” in the reply filed on 12/27/2023 is acknowledged.
Claims 18-20 and 21-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/27/2023.
Response to Amendment
This office action is in response to amendment filed on 01/21/2026. As directed by the amendment, claims 6-7 and 18-26 were canceled, claims 1 and 30 were amended, and claims 31-33 were newly added. Thus, claims 1-5, 8-17, and 27-33 are presently pending in this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a projection” of claim 32 line 1-2 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2, 17, and 27 are objected to because of the following informalities:
Regarding claim 2 line 2, the term “each of the signal” should be changed to --each of the at least one signals-- for consistency.
Regarding claim 17 line 2, the term “a user” should be changed to --the user-- to refer back to the user in claim 16.
Regarding claim 27 line 2, the term “a user” should be changed to --the user-- to refer back to the user in claim 17.
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.
Claims 1-5, 8-17, and 27-33 are 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.
Regarding claim 1 line 4, the term “the inhaler mouthpiece” is indefinite because it lacks proper antecedent basis.
Regarding claim 1 line 16 and claim 12 lines 3-4, the term “if necessary” is unclear as to if the language is positively claimed. Examiner suggests using --when-- instead of “if” since it provides clarity for the recitation.
Regarding claim 4 line 2 and claim 12 line 2, the term “the user’s inhalation” is indefinite because it lacks proper antecedent basis.
Regarding claim 14 line 3 and claim 16 line 2, the term “the remote display device” is indefinite because it lacks proper antecedent basis.
Regarding claim 17 line 2 and claim 27 line 1, the term “pass/fail” in claims 17 and 27 and the term “green/red” in claim 17 are unclear as to if the Applicant intends the “/” to mean or, and/or, or and.
Regarding claim 29 line 3, the term “the inhaler flow pathway” is indefinite because it lacks proper antecedent basis.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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.
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 1-5, 8-12, 14-17, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Figs. 10-13 Overfield et al. (US 2009/0314292; hereinafter referred to solely as “Overfield”) in view Figs. 2 and 5 of Overfield and Blatchford et al. (US 2018/0369512; hereinafter referred to solely as “Blatchford”).
Regarding claim 1, Overfield discloses an inhaler accessory apparatus (see Overfield Fig. 12 detachable sensing and monitoring device 1000 for mounting on dry powder inhaler 900) comprising: a body configured for mounting onto or connection with an inhaler (see Overfield body of sensing and monitoring device 1000, with top surface 1210 and bottom surface 1212);
the body including an arm extension extending distally from a distal end of the body (see Overfield side extensions from first and second flanges 1204, 1206 extend backwards from flanges 1204, 1206 and subsequently down the side of the inhaler when attached, see in Fig. 16 for extensions) and configured to engage with a distal end of the inhaler opposite the inhaler mouthpiece (see Overfield attachable device 1000 attaches on the inhaler on an opposite side from the mouthpiece Fig. 10).
Overfield discloses a processing system (see Overfield [0062] Sensor 1202, depicted in Fig. 12, adapted to communicate “with a wireless device or the signals can be transmitted or stored using wire connection 916 to an analog to digital converter.”), but is silent as to explicitly disclosing a microprocessor. However, Fig. 5 of Overfield teaches a microprocessor (see Overfield microprocessor 530 within inhaler training device 502, able to communicate with processing system 504). Therefore, 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 processing system and sensing and monitoring device 1000 of Overfield with the on-board microprocessor and processing system as taught by Fig. 5 of Overfield as this would have been an obvious substitution for one known type of data collection and processing system for another and would yield predictable results, i.e. control the device systems.
Overfield embodiment comprising detachable sensing and monitoring device 1000 discloses a sensor (see Overfield sensor 1202, [0062] “The sensor can be any sensor…”), but is silent as to a differential pressure sensor generating at least one signal. However, Overfield embodiment in Figs. 2, 5 teaches a differential pressure sensor generating at least one signal (see Overfield sensor 118; [0050] “sensor 118, in an analogue form, is placed within housing 104 and detects pressure differential from training device 100 when training device 100 is turned on”). Therefore, 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 sensor of Overfield Fig. 12 sensor 1202 with the sensor 118 as taught by Overfield Fig. 2, 5 as this would have been an obvious substitution for one known type of sensor for another and would yield predictable results, i.e. measure or sense a defined quantity or quality within the inhaler system.
Modified Overfield is silent as to at least an absolute pressure sensor for detecting information on environmental conditions around said inhaler, the absolute pressure sensor generating at least one signal. However, Blatchford teaches at least an absolute pressure sensor for detecting information on environmental conditions around said inhaler (see Blatchford Fig. 18 pressure sensor 525; [0158] “the pressure sensor 525 determines the atmospheric pressure”), , the absolute pressure sensor generating at least one signal (see Blatchford [0158-0159] pressure sensor 525 detects and/or measures dynamically changing art pressure and communicates with the controller). Therefore, 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 housing of modified Overfield with the addition of an absolute pressure sensor as taught by Blatchford so as to monitor environmental factors while the inhaler is in use.
Modified Overfield discloses said absolute pressure sensor and said differential pressure sensor, but is silent as to a pressure equalization channel extending between the absolute pressure sensor and the differential pressure sensor. However, Blatchford teaches an absolute pressure sensor (see Blatchford pressure sensor 525) and another pressure sensor (see Blatchford pressure sensor 527), with a pressure equalization channel extending between (see Blatchford air flow path 514; enables measurement of pressure changes [0161]). Therefore, 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 space between the absolute and differential pressure sensors of modified Overfield with the pressure equalization channel of Blatchford to allow for measurement between the two sensors to provide feedback about the device and the surroundings of the device to the controller.
Modified Overfield discloses wherein each of the signals are processed in the microprocessor resulting in customized microprocessor output (see Overfield all signals are sent to microprocessor 530, where the output is sent through a wireless communicator 532, replacing the wire connection 916 from Fig. 10 embodiment described above),
wherein the absolute pressure sensor is used in conjunction with the differential pressure sensor to adjust, if necessary, for atmospheric conditions (see Blatchford absolute pressure sensor 525 able to measure atmospheric conditions, modified to be used with the invention including differential pressure sensor 118 of Overfield; when processed in microprocessor 530 from above, the atmospheric measurement would be adjusting any calculation).
Regarding claim 2, modified Overfield discloses the absolute pressure sensor and the differential pressure sensor are digital sensors and each of the signals from the absolute pressure sensor and the differential pressure sensor is in digital form (see Overfield [0011] “the apparatus can be used with an analog or digital sensor”; digital signal 526. [0062] sensor 1202 can be any sensor, analog or convertible).
Regarding claim 3, modified Overfield discloses the differential pressure sensor is an analog sensor and its output is in analog form (see Overfield sensor 118 in analogue form as described above) and wherein the inhaler accessory apparatus further comprises additional circuitry to condition, filter, amplify and/or convert a sensor signal to digital form (see Overfield [0051] description of Fig. 5 transition of electrical signal 516 from sensor 118 to digital signal 526).
Regarding claim 4, modified Overfield discloses the differential pressure sensor detects a pressure drop during the user’s inhalation (see Overfield sensor 118 measures pressure differential, or pressure drop. [0050] detects when device is on).
Regarding claim 5, modified Overfield discloses the absolute pressure sensor detects atmospheric pressure (see Blatchford [0158] “the pressure sensor 525 determines the atmospheric pressure”).
Regarding claim 8, modified Overfield discloses wherein the differential pressure sensor is infrared sensor (see Overfield [0051] “the sensor 118 can be a… optical… transducer that is either analogue or digital”).
Regarding claim 9, modified Overfield discloses an inhaler (see Overfield dry powder inhaler training device 900) comprising: the inhaler accessory apparatus of claim 1 (see Overfield in view of Blatchford above), and wherein the inhaler comprises a dry powder inhaler (see Overfield above “dry powder inhaler”).
Regarding claim 10, modified Overfield discloses the dry powder inhaler comprises a dry powder formulation (see Overfield [0007] “Dry powder inhalers and cartridge systems… as incorporated… can generate primary drug particles or suitable inhalation plumes during an inspiratory maneuver by deagglomerating a powder formulation within the inhaler and capsule or cartridge.”).
Regarding claim 11, modified Overfield discloses the dry powder formulation comprises a diketopiperazine and at least one active ingredient (see Overfield [0018] “the dry powder can comprise diketopiperazine microparticles and at least one active ingredient”).
Regarding claim 12, modified Overfield discloses all of the claimed structures, see rejection to claims 1 and 4 above.
Regarding claim 14, modified Overfield discloses a wireless transceiver configured to transmit data from the absolute and differential pressure sensors for display on the remote display device (see Overfield Fig. 12 [0062] sensors can communicate or transmit with wireless device… modified by wireless communicator 532 Fig. 5 transmitting signals to processing system 504 for display on display 508).
Regarding claim 15, modified Overfield discloses an electronic board, wherein the microprocessor, the absolute pressure sensor, the differential pressure sensor and the wireless transceiver are connected to the electronic board (see Overfield Fig. 5 signal processing/interface board 116).
Regarding claim 16, modified Overfield discloses visual indicators or the remote display for showing differences between an idealized or predetermined inhalation parameters and an attained/performed inhalation maneuver of a user (see Overfield Fig. 6 curve 608 plotted results of treatment; with unacceptable region 602, warning region 604, and preferred region 606).
Regarding claim 17, modified Overfield discloses the visual indicators are green/red indicators to indicate to a user that a proper dose was delivered (see Overfield [0054] preferred region 606 depicted in green , unacceptable region 602 depicted in red; shows whether the inhalation maneuver met the baseline requirement; [0019] “Data obtained from the detection recordations can be analyzed and correlated to the amount of dose emitted or delivered out of the inhalation system, the time that elapsed for dose delivery, and the performance of the inhalation system”).
Regarding claim 27, modified Overfield discloses all of the claimed structures, see rejection to claim 17 above.
Regarding claim 28, modified Overfield discloses the pressure equalization channel is an open channel (see Blatchford air flow path 514) including a side extending along a length of the pressure equalization channel that is open to the atmosphere (see Blatchford air flow path 514 extending from air inlet 515, modified onto Overfield, which has the same air inlet port 112 structure).
Regarding claim 29, modified Overfield discloses the absolute pressure sensor is proximate a distal end of the inhaler accessory apparatus (see Modified Overfield pressure sensor 525 would be nearest to air inlet port 112, on a distal end of housing 104) and positioned outside of the inhaler flow pathway (see Overfield flow pathway to user is through air outlet port 114; pressure sensor 525 measures atmospheric conditions and could be placed nearest air inlet port 112).
Regarding claim 30, modified Overfield discloses the customized microprocessor output generates a pressure differential versus time curve on a remote display device concurrently with or immediately after a user's inhalation (see Overfield Fig. 5 display 508; and Fig. 6 [0054] after an inhalation maneuver),
wherein the pressure differential versus time curve is displayed as a positive inhalation effort versus time curve (see Overfield Fig. 6 shows results of inhalation plotted as curve 608, which falls in either the unacceptable 602, warning 604, or preferred 606 regions. Pressure during inhalation becomes more negative, so positive here is interpreted as getting curve 608 into preferred region 606 being a positive result).
Regarding claim 31, modified Overfield discloses the arm extension is distally offset from the body such that a first portion extends distally from the body (see Overfield Fig. 12 first, second flanges 1204, 1206 portions that extend vertically downwards relative traversing portion 1208) and a second portion of the arm extension extends downwardly in a direction perpendicular to the first portion (see Overfield Fig. 12 first, second flanges 1204, 1206 portions that extend horizontally, creating the gap in the saddle shape in attachment 1000).
Regarding claim 32, modified Overfield discloses the arm extension includes a projection configured to clip onto an outer surface of the inhaler when the inhaler accessory apparatus is mounted onto the inhaler (see Overfield front portion of flanges 1204, 1206 shaped as hooks to engage the outer surface of the inhaler when device 1000 is clipped on).
Regarding claim 33, modified Overfield discloses the projection is L-shaped such that the projection engages with two sides of the inhaler when coupled to the inhaler (see Overfield Fig. 12, 16 front portion of flanges 1204, 1206 is L shaped).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Overfield in view of Blatchford as applied to claim 1 above, and further in view of Day et al. (US 2013/0221097; hereinafter referred to solely as “Day”), as best understood.
Regarding claim 13, modified Overfield is silent as to comprising: a color detection sensor to detect color provided on parts of the inhaler. However, Day teaches a color detection sensor to detect color provided on parts of the inhaler (see Day [0132] sensor 204… optical sensor such as a photosensor (e.g. photodiode, phototransistor), bar code scanner… detects coding features such as protrusions, indentations, color, or marks with different translucency/texture). ). Therefore, 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 housing of modified Overfield with the addition of a color detection sensor as taught by Day so as to identify the medication in the inhaler for the user’s safety.
Response to Arguments
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 1, on pages 7-8 of the remarks, have been considered but are moot because the new ground of rejection does not rely on solely the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, since the argument is regarding the newly added amended language.
Conclusion
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 GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached on (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785