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 an amendment filed on 2/9/2026. As directed by the amendment, claim 12 was canceled, and no claims were amended or added. Thus, claims 1-11 are pending for this application.
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over O’Callaghan (US 2019/0160237) in view of Germinario (US 2017/0319797) and Djupesland (US 2009/0293873).
Regarding claim 1, O’Callaghan discloses (Fig. 1A) a spacer for an inhaler, comprising:
a housing (spacer 120) defining a chamber (chamber 122),
an inhaler port (inlet 121) configured to attach an inhaler (inhaler 110, paragraph [0019])
an outlet (outlet 124).
O’Callaghan does not disclose the housing having an ambient port in fluid communication with ambient air, and a fan for generating a flow of air through the chamber from the ambient port to the outlet.
However, Germinario teaches (Fig. 1A-2B) a spacer comprising a housing (housing 116) having an ambient port (laminar flow element 120) in fluid communication with ambient air (paragraph [0098]) and comprising a fan (“mini fan”, paragraph [0102]) for generating a flow of air through the chamber from the ambient port to the outlet (paragraph [0074]).
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 spacer of O’Callaghan to include a an ambient port in fluid communication with ambient air, and a fan for generating a flow of air through the chamber from the ambient port to the outlet, as taught by Germinario, for the purpose of providing additional airflow and pressure to the output of the airstream (paragraph [0102] Germinario) and ensure that the ejected stream of droplets is pushed through the device into the patient's airway for patients with low pulmonary output (paragraph [0102] Germinario).
Modified O’Callaghan does not disclose a primer operable by a user to provide energy for powering the fan.
However, Djupesland teaches (Fig. 15) an inhalation system comprising a fan (turbine 353) and a primer (resilient element, e.g. spring) for providing energy for powering the fan (paragraph [0320]).
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 spacer of modified O’Callaghan to include a primer, as taught by Djupesland, for the purpose of allowing for user controlled activation of the turbine, thereby preventing misuse of the device.
Regarding claim 2, modified O’Callaghan discloses the fan is powered by way of a spring (paragraph [0320] Djupesland) such that the fan generates the flow of air as stored energy is released from a spring (paragraph [0320]), and further comprising an actuator (mechanism responsible for decompressing spring of turbine 353 of Djupesland) for triggering a release of stored energy from the spring thereby actuating the fan (paragraph [0320]).
Regarding claim 3, modified O’Callaghan discloses the actuator is further configured to actuate the inhaler such that a dose of medicament is released from the inhaler into the flow of air (inhaler is indirectly actuated through use of actuator, as actuator drives the airflow which causes the dose of medicament to enter the flow of air. Paragraph [0320] Djupesland).
Regarding claim 8, modified O’Callaghan discloses an oronasal mask (facemask 130 of O’Callaghan, shown to cover the nose and mouth and those an “oronasal mask”) coupled to the outlet of the housing (coupled to outlet 124 of spacer 120, see Fig. 1A and paragraph [0020] of O’Callaghan).
Regarding claim 10, modified O’Callaghan discloses an oronasal mask couped to the outlet of the housing (as shown in Fig. 1A), and thus does not discloses a mouthpiece coupled to the outlet of the housing. However, an alternative embodiment of O’Callaghan shown in Fig. 1B teaches a mouthpiece (accessory 130 in the form of a mouthpiece as opposed to an oronasal mask, see Fig. 1B and paragraph [0020]) coupled to the outlet of the housing (coupled to outlet 124 of spacer 120, see Fig. 1B O’Callaghan).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the mask of modified O’Callaghan with a mouthpiece, as taught by the second embodiment of O’Callaghan, for the purpose of allowing for medicaments more targeted to the lower respiratory region to be better delivered to a user (since user is only able to inhale through the mouth as opposed to both mouth and nose).
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Callaghan (US 2019/0160237) in view of Germinario (US 2017/0319797) and Djupesland (US 2009/0293873), and further in view of Zidulka (US 2018/0050165).
Regarding claim 4, modified O’Callaghan discloses the fan is located within the spacer (paragraph [0102] Germinario), but does not disclose explicitly disclose that the fan is located between the ambient port and inhaler port.
However, Zidulka teaches (Fig. 8) a spacer comprising a fan (fan 156) located between the ambient port (air inlet 124, which fan 156 is located downstream of) and inhaler port (substance inlet 120).
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 position of the fan of modified O’Callaghan to be between the ambient port and inhaler port, as taught by Zidulka, for the purpose of allowing the fan to optimally drawn air from the environment to mix and aerosolize the medicament for better inhalation by user. Furthermore, it has been held that rearrangement of parts are an obvious design choice, and would thus be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. See in re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Callaghan (US 2019/0160237) in view of Germinario (US 2017/0319797) and Djupesland (US 2009/0293873), and further in view of Blick (US 2019/0230992).
Regarding claim 5, modified O’Callaghan does not disclose the fan is located between the inhaler port and the outlet.
However, Blick teaches (Fig. 1-5) a fan located between inhaler port (atomizer) and outlet (fan located downstream of atomizer 145 but upstream of outlet 118, for the purpose of drawing air through the device as opposed to blowing air through the device).
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 spacer of modified O’Callaghan such that the fan is located between the inhaler port and the outlet, as taught by Blick, for the purpose of drawing air through the device as opposed to blowing air through the device.
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Callaghan (US 2019/0160237) in view of Germinario (US 2017/0319797) and Djupesland (US 2009/0293873), and further in view of Genosar (US 20100059049).
Regarding claim 6, modified O’Callaghan discloses a primer, but does not disclose the primer is a lever. However, Genosar teaches (Fig. 1) a primer for a fan of an inhalation device in the form of a lever (Genosar discloses power means in the form of a lever, gas cylinder, or motor, see paragraph [0040]).
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 primer of modified O’Callaghan to comprise a lever, as taught by Genosar, for the purpose of providing an accessible way for user to control fan operation.
Claim 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Callaghan (US 2019/0160237) in view of Germinario (US 2017/0319797) and Djupesland (US 2009/0293873), and further in view of Hickey (US 2008/0223364).
Regarding claim 7, modified O’Callaghan does not disclose wherein the primer is a rotatable knob. However, Hickey teaches (Fig 1) a primer in the form of a rotatble knob (knob 42, rotatable between a plurality of positions on dial 44) that provides energy to a fan (impeller 30. See Paragraphs [0022] and [0038]).
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 primer of modified O’Callaghan to include a knob, as taught by Hickey, for the purpose of allowing for adjustable energy transmission to the fan (paragraph [0022] Hickey).
Claim 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over O’Callaghan (US 2019/0160237) in view of Germinario (US 2017/0319797) and Djupesland (US 2009/0293873), and further in view of Rao (US 7,418,962).
Regarding claims 9, modified O’Callaghan discloses oronasal mask coupled to the outlet of the housing, but does not disclose wherein the mask is releasably coupled to the outlet.
However, Rao teaches (Fig. 3) an oronasal mask (224) coupled to the outlet (222) of the housing and wherein the mask is releasably coupled to the outlet (col. 5 lines 39-50). 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 spacer of modified O’Callaghan such that the mask is releasably coupled to the outlet, as taught by Rao, for the purpose of reduced contamination by making the mask removable so that each user can use their own facemask on the device.
Regarding claims 11, modified O’Callaghan discloses a mouthpiece coupled to the outlet of the housing, but does not disclose wherein the mouthpiece is releasably coupled to the outlet.
However, Rao teaches (Fig. 1-2) a mouthpiece (124) coupled to the outlet (122) of the housing, wherein the mouthpiece is releasably coupled to the outlet (Col. 3 lines 34-41).
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 spacer of modified O’Callaghan such that the mouthpiece is releasably coupled to the outlet, as taught by Rao, for the purpose of providing a comfortable and conformable interface for user when using device, and to allow for reduced contamination by making the mouthpiece removable so that each user can use their own mouthpiece on the device.
Response to Arguments
Applicant’s arguments filed 2/9/2026 have been fully considered but are not found to be persuasive.
Regarding rejection of claim 1 under 35 USC 103, applicant argued (page 4 point #1 of Remarks) that O’Callaghan’s delivery device utilizes a p-MDI paradigm, whereas Germinario, the teaching reference, expressly criticizes inhaler systems such as MDI and p-MDI due to them producing droplets with high velocities and wide size distributions, which result in mouth/through and associated condensation and deposition problems. Therefore, a person of ordinary skill would not have been motivated to modify O’Callaghan’s pMDI spacer/adapter to incorporate teachings of Germinario.
Examiner respectfully disagrees for the following reasons.
First, Applicant appears to be arguing that Germinario teaches away from combination with a pMDI device, however applicant is reminded that the device of O’Callaghan is not just a pMDI device. Rather, it is an assembly that utilizes a pMDI device as well as a spacer and mask that attaches to a user. The fact that the invention of O’Callaghan is more than just a pMDI device (and in a way may actually overcome some of the deficiencies stated by Germanio due to the spacer) makes applicant’s arguments less persuasive.
It should also be noted that in the rejection Germinario is a teaching reference, not the primary reference in the combination. Germinario criticizes p-MDI devices as a way to discuss how the improvements of Germinario’s invention are beneficial, but this does not mean that the teachings of Germinario are incompatible with a p-MDI device. Rather, one could argue this makes the combination even more obvious to one of ordinary skill, as Germinario provides not only an improvement in the older design (i.e. incorporation of a fan) but additionally a motivation for doing so (for the purpose of providing additional airflow and pressure to the output of the airstream (paragraph [0102] Germinario) and ensure that the ejected stream of droplets is pushed through the device into the patient's airway for patients with low pulmonary output (paragraph [0102] Germinario). Therefore, examiner contends that Germinario is a strong teaching reference for addressing the deficiencies of O’Callaghan, and thus the rejection of claim 1 is maintained.
Applicant further argued (page 4 point #2 of Remarks) that even if one were to combine the references, there is insufficient motivation to combine, as Germinario criticizes MDI and p-MDI devices for producing droplets with high velocities, high momentum and kinetic energy, so one of ordinary skill would not be motivated to teach a fan into the O’Callaghan reference because this would result in a further increase in velocity, momentum and kinetic energy, which runs counter to Germinario’s stated objectives and concerns.
The examiner respectfully disagrees.
It is noted that a teaching away requires a reference to actually criticize, discredit, or otherwise discourage investigation into the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). It has been further instructed that the Examiner will not read into a reference a teaching away from a process where no such language exists. See DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).
In this case, O’Callaghan, the primary reference for which this teaching of Germinario is combined with, provides no language that would discredit the combination. And as stated above, the device of O’Callaghan is not just a pMDI device, rather an assembly that utilizes a pMDI device as well as a spacer and mask that attaches to a user. And as stated above, Germinario criticizes p-MDI devices as a way to discuss how the improvements of Germinario’s invention are beneficial, but this does not mean that the teachings of Germinario are incompatible with a p-MDI device. Rather, one could argue this makes the combination even more obvious to one of ordinary skill, as Germinario provides not only an improvement in the older design (i.e. incorporation of a fan) but additionally a motivation for doing so (for the purpose of providing additional airflow and pressure to the output of the airstream (paragraph [0102] Germinario) and ensure that the ejected stream of droplets is pushed through the device into the patient's airway for patients with low pulmonary output (paragraph [0102] Germinario).
Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, one of ordinary skill would find it obvious to incorporate the teaching of a fan taught by Germinario into the device of O’Callaghan for the purpose of providing additional airflow and pressure to the output of the airstream (paragraph [0102] Germinario) and ensure that the ejected stream of droplets is pushed through the device into the patient's airway for patients with low pulmonary output (paragraph [0102] Germinario).
Therefore, rejection of claim 1 is maintained.
Applicant stated (page 5 paragraph 1) that the rejection is similar to that of the previous rejection involving Karle which taught the benefit of low velocity particles and Zidulka which taught the use of the fan. The examiner respectfully disagrees, as Karle was the primary reference which explicitly taught against high velocity particle flow, whereas there is no mention in O’Callaghan, the current primary reference, that criticizes high velocity particle flow. Thus applicant’s argument is not persuasive.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785