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
The amendment filed 01/30/2026 has been entered. Claims 1, 3-6, 8-12, 15-19 remain pending in the application, with claims 7, 13-14, 20-21 remaining withdrawn in response to the election of species, and claims 22-23 newly added. Applicant’s amendments to the claims, specification, and drawings have overcome the objections and 112(b) rejections previously set forth in the Non-Final Office Action mailed 10/31/2025.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that Jewett’s switch contact arrangement is not a contact mechanism disposed between the battery and the PCB assembly, is not persuasive. As cited in the Non-Final Office Action mailed 10/31/2025, the contact mechanism is located in a region between the battery and the PCB as seen in Jewett’s figure 7. Please refer to the annotated figure included in the maintained prior art rejection below.
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 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jewett et al. (WO 0001612), hereafter Jewett.
Regarding Claim 9, Jewett discloses an indicating device (fig. 3, device 30, page 9 line 24) comprising: a mechanical dose counter (fig. 7, page 15 line 26 to page 16 line 3; foam spring 42 and switch contact 62 must be mechanically compressed to record a dispensation, page 17 lines 8-10) adapted to count the number of doses that have been dispensed from or remain in a container (page 17 and fig. 8, lines 12-15), wherein the mechanical dose counter comprises a base (figs. 7 and 8, 92, no text citation) and a cap (figs. 7 and 8, housing 32, page 16 line 5) moveable relative to the base between a first cap position and a second cap position (figs. 6-8, foam spring 42 compresses in response to finger pressure so that the housing 32 will depress in order to force switch contact 62 to connect with switch pad 68, page 17 lines 8-15); a printed circuit board assembly (figs. 6-8, circuit board 60, page 17 lines 17-19) adapted to record when the doses have been dispensed from the container (page 17 lines 28-31); a battery (figs. 6-8, battery 58, page 18 line 12) electrically connectable to the printed circuit board assembly (figs. 7-8, retainer 78 connects the battery to the circuit board, page 18 lines 11-13); and a contact mechanism (figs. 6-8, switch contact 62, page 18 line 27) disposed between the battery and the printed circuit board (figs. 7-8, 62 is disposed in a plane between the battery and the circuit board; see annotated fig. below; in both states of contact or non-contact, the switch contact 62 remains in the space between the battery and the PCB), wherein the contact mechanism is moveable between a first contact position wherein the battery is not electrically coupled to the printed circuit board assembly (fig. 7, page 18 lines 30-33) and a second contact position wherein the battery is electrically coupled to the printed circuit board (fig. 8, page 18 lines 33-34).
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Regarding Claim 10, Jewett discloses an indicating device of claim 9 wherein the contact mechanism comprises a switch (figs. 7 and 8, the switch includes switch contact 68 and contact switch pad 68, page 17 lines 8-10), wherein the switch is moveable between the first contact position (fig. 7) and second contact position (fig. 8) in response to the movement of the cap relative to the base between the first and second positions (page 17 lines 8-10 and page 18 lines 30-34).
Claim Rejections - 35 USC § 103
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.
Claim 11 is rejected under 35 U.S.C. 103 as unpatentable over Jewett in view of Barney (WO 2004/078236 A1), hereafter Barney.
Regarding Claim 11, Jewett discloses an indicating device of claim 10, but is silent on wherein the switch comprises a pair of spring fingers, wherein the cap and/or the base biases one of the spring fingers into contact with the other of the spring fingers as the cap is moved relative to the base between the first and second positions.
However, Barney teaches the use of spring fingers (figs. 18 and 20A, [0092]) as a contact mechanism such that when an inhalation device is pressed downward, the contacting spring fingers make electrical contact ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute the contacting mechanism in Jewett’s disclosure (from figs. 6-7, with switch contact 62 already resembling a spring finger, modifying contact switch pad 68 to be a second spring finger), as both types of electrical contacts perform equally well at making electrical contact when the cap of an inhalation device is depressed in order to dispense and record the dispensation.
Claims 15-16 and 18 are rejected under 35 U.S.C. 103 as unpatentable over Jewett in view of Askem et al. (US 2013/0331823 A1).
Regarding Claim 15, Jewett discloses an indicating device of claim 9, but is silent on wherein the contact mechanism comprises a pull tab.
However, Askem teaches that an opening and a pull tab (fig. 27G, opening 822 and pull tab 820 [0343]) can be used to prevent accidental operation of a battery powered device when on end of the pull tab is inserted between the battery terminals of an electrical circuit and the battery ([0343]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a pull tab in the contact mechanism described in Jewett’s device, including an opening in the exterior of the device, as taught by Askem, in order to prevent accidental usage of the device prior to activation by the user (Askem [0343]).
Regarding Claim 16, the modified Jewett discloses an indicating device of claim 15 wherein the pull tab comprises a first portion disposed between a pair of contacts (as modified by Askem, a portion of the pull tab is positioned between the electrical contacts to prevent connection of the battery prior to activation, Askem [0343]), and a second portion disposed exteriorly to the mechanical dose counter (Askem figs. 27A-G, the second end of the pull tab 820 is disposed outside the device so that the user can pull the tab to remove it and activate the device [0343]).
Regarding Claim 18, the modified Jewett discloses an indicating device of claim 16 wherein the pair of contacts comprises the battery and a contact on the printed circuit board (Jewett figs. 7 and 8, the battery is secured to the circuit board and the switch pad 68 is located on the circuit board, page 18 lines 11-32).
Claim 19 is rejected under 35 U.S.C. 103 as unpatentable over Jewett in view of Askem, further in view of Barney.
Regarding Claim 19, the modified Jewett discloses an indicating device of claim 16, but is silent on wherein the pair of contacts comprises a pair of spring fingers.
However, Barney teaches the use of spring fingers (figs. 18 and 20A, [0092]) as a contact mechanism such that when an inhalation device is pressed downward, the contacting spring fingers make electrical contact ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute the contacting mechanism in Jewett’s disclosure (from figs. 6-7, with switch contact 62 already resembling a spring finger, modifying contact switch pad 68 to be a second spring finger), as both types of electrical contacts perform equally well at making electrical contact when the cap of an inhalation device is depressed in order to dispense and record the dispensation.
Allowable Subject Matter
Claims 1, 3-6, 8, and 22-23 are allowed.
The following is an examiner’s statement of reasons for allowance.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
The closest prior art includes Wang et al. (US 2017/0361036 A1), hereafter Wang, in view of Morton et al. (US 2005/0087191 A1), hereafter Morton, and further in view of Lieberman et al. (US 2007/0295329 A1), hereafter Lieberman, and Good et al. (US 11590299 B1), hereafter Good.
Regarding Claim 1, Wang discloses an indicating device (fig. 1B, [0007]) comprising: a mechanical dose counter (fig. 2, monitoring module 130 [0031] includes mechanical counting components [0032]) adapted to count the number of doses that have been dispensed from or remain in a container ([0034]); a printed circuit board assembly (fig. 3A, printed circuit board 133 (“PCB”) [0034]) adapted to record when the doses have been dispensed from the container (fig. 3A, communication unit 136 on the PCB 133 transmits information about a scheduled time for replacing the spray bottle with a new one, i.e., when all doses have been dispensed); a battery electrically connectable to the printed circuit board assembly (fig. 3A, battery 138 [0031]); and a retaining member coupled to the mechanical dose counter (fig. 3A, partition wall 112 and external wall 113 [0029]), wherein the retaining member sandwiches the printed circuit board assembly between the retaining member and the mechanical dose counter (fig. 2, the external wall 113 is positioned outside the PCB 133 and the monitoring module 130 inside the device).
Wang is silent on the retaining member comprises a ring portion surrounding the battery and printed circuit board assembly and a plurality of arms extending upwardly from the ring portion and engaging the mechanical dose counter. Wang’s mechanical counter is positioned on the interior of the device and the retaining member, battery and circuit board are located on the external side of the device.
Morton teaches that a mechanical dose counter may be positioned on either the top of the device or inside bottom of a metered dose inhaler (compare the embodiment of figs. 70-93 [0272] where the indicator assembly is located in the bottom of the housing, and the embodiment of figs. 1-69 located in the cap of the metered dose device [0181]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reposition the mechanical dose counter in Wang’s metered dose inhaler from the bottom of the device (as shown in Wang fig. 2) to the cap of the device as taught by Morton, since Morton demonstrates that positioning mechanical dose counters in wither the base of the device or the cap are alternatives known in the art, that are expected to function equally well to count doses dispensed from the metered dose inhaler.
However, the now modified device remains silent as to the details connecting the counter, now positioned at the cap of the device, and how the electronic components are also connected to the counter.
Lieberman teaches a dose counting device positioned on the top cap of an inhaler device (fig. 1, 1, [0037]) that includes a control module (fig. 4, 6 [0046]) which includes a printed circuit board (fig. 6, 22 [0046]) and a battery (fig. 6, not shown, but is positioned between circuit board 22 and pedestal 25 [0047]). The control module is adapted to record a time when the dose indicator is cycled ([0042]). The assembly further includes a retaining member (fig. 4, lower portion of housing 4 [0040]) that comprises a ring portion (fig. 4, 4 is ring-shaped) surrounding the battery and printed circuit board assembly (fig. 4 and figs. 11-12, the control module assembly with the PCB and battery is placed inside the lower housing [0055]), and a plurality of arms extending upwardly from the ring portion (fig. 5, lower housing 4 has a plurality of catches 17 [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Wang to position the circuit board and battery in the cap of the device, as taught by Lieberman, as this is a known alternative configuration in the art and would simplify the construction of the device by co-locating the counting and recording components to a single location.
The now-modified device remains silent on whether the plurality of arms extending upwardly from the ring portion for engaging with the mechanical dose counter.
While Good depicts a dose counter (mechanical in the sense that a mechanical action of pressing the device activates the counting mechanism, fig. 2, col. 4 lines 39-49) that connects a retaining member containing a battery (fig. 2, secondary housing 116, battery 118, col. 4 lines 24-25) to a main housing (fig. 2, 112, col. 4 line 15) containing a circuit board (fig. 2, 126, col. 5 line 28) using a plurality of arms (fig. 2, 123, col. 4 line 32), this configuration does not fulfill parent claim 1 requirement of the retaining member sandwiches the printed circuit board assembly between the retaining member and the mechanical dose counter, since the mechanical action occurs between the retaining member and the printed circuit board. Further, there does not appear to be any motivation outside of improper hindsight to combine the various components in the configuration claimed such that a ring portion of a retaining member both sandwiches a printed circuit board assembly between itself and a mechanical dose counter, wherein the ring portion surrounds a battery and the printed circuit board, and also has a plurality of arms which extend upwardly to engage the mechanical dose counter.
Additional prior art of record includes Jewett.
Regarding Claim 1, Jewett discloses an indicating device (fig. 3, device 30, page 9 line 24) comprising: a mechanical dose counter (fig. 7, page 15 line 26 to page 16 line 3; foam spring 42 and switch contact 62 must be mechanically compressed to record a dispensation, page 17 lines 8-10) adapted to count the number of doses that have been dispensed from or remain in a container (page 17 and fig. 8, lines 12-15); a printed circuit board assembly (figs. 6-8, circuit board 60, page 17 lines 17-19) adapted to record when the doses have been dispensed from the container (page 17 lines 28-31); a battery (figs. 6-8, battery 58, page 18 line 12) electrically connectable to the printed circuit board assembly (figs. 7-8, retainer 78 connects the battery to the circuit board, page 18 lines 11-13); and a retaining member coupled to the mechanical dose counter (fig. 7, bushing 44 and housing 32, page 12 lines 27-29), wherein the retaining member sandwiches the printed circuit board assembly between the retaining member and the mechanical dose counter (fig. 7, the circuit board 60 is sandwiched between the housing 32 portion of the retaining member and the foam spring 42 and switch 62 comprising the mechanical dose counter), wherein the retaining member (fig. 7, 44 and 32) comprises a ring portion (fig. 6, bushing 44 is shown as a ring shape); however, is silent on the ring portion surrounding the battery and printed circuit board assembly (as seen in fig. 7, the ring portion, bushing 44, partially surrounds the battery 58 but not the circuit board 60) and a plurality of arms extending upwardly from the ring portion and engaging the mechanical dose counter (fig. 6, a plurality of arms exists, but they are located on the portion of the mechanical dose counter, retainer 78 as clips 56, page 18 lines 16-18, and are not part of the ring portion).
However, attempting to modify Jewett to surround both the battery and the printed circuit board with a plurality of arms extending upwardly to engage the mechanical dose counter using any of the above listed prior art would disrupt the mechanical compression action that performs the counting in the device.
Claims 3-6 and 8 are allowed as depending from claim 1.
Regarding Claim 22, the closest prior art of record includes Jewett and Barney (WO 2004/078236 A1), hereafter Barney.
Regarding Claim 22, Jewett discloses an indicating device (fig. 3, device 30, page 9 line 24) comprising: a mechanical dose counter (fig. 7, page 15 line 26 to page 16 line 3; foam spring 42 and switch contact 62 must be mechanically compressed to record a dispensation, page 17 lines 8-10) comprising a base (figs. 7 and 8, 92, no text citation) and a cap (figs. 7 and 8, housing 32, page 16 line 5) moveable relative to the base between a first cap position and a second cap position (figs. 6-8, foam spring 42 compresses in response to finger pressure so that the housing 32 will depress in order to force switch contact 62 to connect with switch pad 68, page 17 lines 8-15); a printed circuit board assembly (figs. 6-8, circuit board 60, page 17 lines 17-19); a battery (figs. 6-8, battery 58, page 18 line 12) electrically connectable to the printed circuit board assembly (figs. 7-8, retainer 78 connects the battery to the circuit board, page 18 lines 11-13); and a contact mechanism (figs. 6-8, switch contact 62, page 18 line 27) disposed between the battery and the printed circuit board (figs. 7-8, 62 is disposed in a plane between the battery and the circuit board), wherein the contact mechanism comprises a switch (figs. 7 and 8, the switch includes switch contact 68 and contact switch pad 68, page 17 lines 8-10).
However, Jewett is silent on the switch having a pair of spring fingers configured such that (i) in response to a first movement of the cap relative to the base from the first cap position to the second cap position, the pair of spring fingers are brought into electrical contact to couple the battery to the printed circuit board assembly; and (ii) after said first movement, the pair of spring fingers remain in electrical contact during subsequent movements of the cap relative to the base.
However, Barney teaches the use of spring fingers (figs. 18 and 20A, [0092]) as a contact mechanism such that when an inhalation device is pressed downward, the contacting spring fingers make electrical contact ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simply substitute the contacting mechanism in Jewett’s disclosure (from figs. 6-7, with switch contact 62 already resembling a spring finger, modifying contact switch pad 68 to be a second spring finger), as both types of electrical contacts perform equally well at making electrical contact when the cap of an inhalation device is depressed in order to dispense and record the dispensation.
However, there does not appear to be prior art of record in which spring fingers remain in contact after a first movement of the cap relative to the base between the first and second positions.
Thus, claim 22 is allowed over the prior art.
Regarding Claim 23, the closest prior art of record includes Jewett and Askem et al. (US 2013/0331823 A1).
Regarding Claim 23, Jewett discloses an indicating device (fig. 3, device 30, page 9 line 24) comprising: a mechanical dose counter (fig. 7, page 15 line 26 to page 16 line 3; foam spring 42 and switch contact 62 must be mechanically compressed to record a dispensation, page 17 lines 8-10) comprising a base (figs. 7 and 8, 92, no text citation) and a cap (figs. 7 and 8, housing 32, page 16 line 5); a printed circuit board assembly (figs. 6-8, circuit board 60, page 17 lines 17-19); a battery (figs. 6-8, battery 58, page 18 line 12) electrically connectable to the printed circuit board assembly (figs. 7-8, retainer 78 connects the battery to the circuit board, page 18 lines 11-13); and a contact mechanism (figs. 6-8, switch contact 62, page 18 line 27).
Jewett is silent on the contact mechanism comprising a pull tab having (i) a first portion disposed between a pair of contacts comprising the battery and a contact on the printed circuit board assembly to prevent electrical coupling prior to activation, and (ii) a second portion disposed exteriorly to the mechanical dose counter and adhered to the cap to facilitate removal of the pull tab by a user.
However, Askem teaches that an opening and a pull tab (fig. 27G, opening 822 and pull tab 820 [0343]) can be used to prevent accidental operation of a battery powered device when on end of the pull tab is inserted between the battery terminals of an electrical circuit and the battery ([0343]). A first portion of the pull tab is positioned between the electrical contacts to prevent connection of the battery prior to activation ([0343]) and a second portion is disposed exteriorly to the mechanical dose counter (figs. 27A-G, the second end of the pull tab 820 is disposed outside the device so that the user can pull the tab to remove it and activate the device [0343]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a pull tab in the contact mechanism described in Jewett’s device, including an opening in the exterior of the device, as taught by Askem, in order to prevent accidental usage of the device prior to activation by the user (Askem [0343]).
However, there does not appear to be any prior art of record in which the second portion (examiner’s note: the second portion of a pull tab disposed exteriorly to the mechanical dose counter, the pull tab is disposed between an electrical contact mechanism) is adhered to the cap.
Thus, claim 23 is allowed over the prior art.
Claims 12 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 12 does not appear to have been disclosed, alone or in combination, in the prior art, since no prior art of record discloses spring fingers which remain in electrical contact after a first movement of the cap relative to the base between the first cap position and second cap position.
Claim 17 does not appear to have been disclosed alone or in combination in the prior art in which the second portion of a pull tab, disposed exteriorly to a mechanical dose counter, is adhered to the cap of a mechanical dose counter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Genova et al. (US 2006/0254581 A1) teaches that an electronic dose counter may also be positioned both on the side of the device (fig. 6 [0035]) and on the top of the device (fig. 2 [0031]) where the device includes a circuit board ([0031]) and a battery (implicit, since the LCD 7 and circuit board require power to operate) positioned with the electronic dose counter (EDC module 1 [0023], [0026]).
US 2002/0195102 A1 discloses an electromechanical dose counter for a metered dose inhaler (figs. 6-9 [0056]) which includes a mechanical counter mechanism (fig. 6, 43 [0057]), battery (fig. 6, 48 [0057]) and a printed circuit board (fig. 6, 49 [0057]).
US 2021/0170120 is disclosed by the same assignee, less than 1 year before the effective filing date of the instant application.
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 SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785