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 Objections
Claims 1 and 3-4 are objected to because of the following informalities:
In claim 1, line 4, the term “the activation” is suggested to be changed to --an activation-- in order to clarify the claim.
In claim 3, line 3, the term “the electrical signal are” is suggested to be changed to --the electrical signal is-- in order to fix grammatical error.
In claim 4, line 2, the term “to second medicant dispenser” has been changed to --to a second medicant dispenser-- in order to clarify the claim.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the limitation “a storage device in communication with the processor further configured to store data indicating activation of the medicant dispenser” (claim 1, lines 5-6, the term “device” is a generic placeholder and the function is “configured to store data indicating activation of the medicant dispenser”), “a first attachment mechanism for attaching the sensor body to a first medicant dispenser” (claim 1, lines 8-9, the term “mechanism” is a generic placeholder and the function is “for attaching the sensor body to a first medicant dispenser”), “the storage device is further configured to store a plurality of breathing profiles” (claim 2, lines 1-2, the term “device” is a generic placeholder and the function is “configured to store a plurality of breathing profiles”), and “a second attachment mechanism for attaching the sensor body to second medicant dispenser” (claim 4, lines 1-2, the term “mechanism” is a generic placeholder and the function is “for attaching the sensor body to second medicant dispenser”).
It is noted that the limitation “first attachment mechanism” in claims 5 and 6-7 no longer invoke 112(f) because sufficient structure is being provided.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“a storage device”: memory, see paragraphs 0040 and 0052 of the specification filed on 11/09/2023.
“a first attachment mechanism”: first attachment mechanism can include adhesive and removable strip, or the first attachment mechanism can include a strap, see paragraph 0011 of the specification filed on 11/09/2023.
“a second attachment mechanism”: attachment mechanism for first attachment mechanism that can include adhesive and removable strip, or the attachment mechanism can include a strap, see paragraph 0011 of the specification filed on 11/09/2023.
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 1-20 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, the limitation “types” (line 2) is unclear as to how to determine the metes and bounds of the limitation “types”, specifically, what feature makes the medicant dispenser to be considered as different types from another medicant dispensers. The term “types” is too relative.
Regarding claim 1, the limitation “a first medicant dispenser” (line 8-9) is unclear if the first medicant dispenser is the same as or different from “a medicant dispenser…the medicant dispenser” being claimed in claim 1, lines 4 and 6.
Regarding claim 3, 5, 6 and 18, the limitation “the medicant dispenser” (claim 3, line 2, claim 5, lines 2-3, claim 6, line 2, and claim 18, line 2) is unclear if the medicant dispenser is referring to “a medicant dispenser” being claimed in claim 1, line 4 or “a first medicant dispenser” being claimed in claim 1, lines 8-9.
Regarding claim 15, the limitation “the…. and dome contact switch” (line 2) lacks proper antecedent basis. It is noted that claim 15 is not dependent on claim 14.
Any remaining claims are rejected for their dependency on 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 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, 6-9, 11, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118).
Regarding claim 1, Helmlinger discloses an attachable adherence monitor (40, 40a, 40b, 24, 27, 25, 28, 22, 24A-26C and 60, figs. 1-21 and paragraphs 0059-0082), the adherence monitor being attachable to a plurality of different types of medicant dispensers (10, figs. 1-3 and paragraphs 0005, 0067, and 0070-0072), the adherence monitor comprising: a sensor body (40B, 41, 24, 27, 25, 28, 27, 26A-26C, figs. 1-21 and paragraphs 0059-0061 and 0063-0065, specifically see embodiment of fig. 20) including: a processor (28, fig. 1, paragraphs 0059-0061) in communication with sensing electronics (26A-26C, fig. 1, paragraphs 0059-0060) that are triggered to indicate the activation of a medicant dispenser (12 and 18, paragraphs 0012 and 0059-0061), a storage device in communication with the processor further configured to store data indicating activation of the medicant dispenser (Helmlinger discloses in paragraph 0017 a memory and further discloses in paragraphs 0012 and 0059-0061 activation of the medicant dispenser is detected, to detect and communicate to the user when the dispenser has been actuated would involve memory to store data, see paragraphs 0014 and 0060, Helmlinger discloses that the captured data are evaluated either directly by means of the processor 28 or entirely or partially on an external system which is connected to the analysis unit 40 via a wireless interface), and a connector conduit (90b, fig. 20, paragraph 0081); and an attachment module (entire strap 60 and 40A, see figs. 10-14 with reference to fig. 20, paragraphs 0064 and 0070-0076) including a coupling fixture (90A, fig. 20, paragraph 0081) that allows attachment to the sensor body via the connector conduit and a first attachment mechanism (60 or portion of 60 and 40A, figs. 10-13 with reference to figs. 18-20, paragraphs 0073-0075 and 0079-0081) for attaching the sensor body to a first medicant dispenser (dispenser 10 having housing 12 and 18, see figs. 1-2, paragraph 0061), but fails to disclose that the processor assign a timestamp to the activation.
However, Markey teaches that the processor assign a timestamp to the activation (see paragraph 0071).
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 processor of Helmlinger to assign a timestamp to the activation as taught by Markey for the purpose of allowing a client device to further analyze adherence data in relation to use of the inhaler, thereby, improving compliance and adherence (see paragraph 0071 of Markey).
Regarding claim 6, the modified Helmlinger discloses that the first attachment mechanism includes a strap operable to be wrapped around the medicant dispenser (see strap 60 of Helmlinger figs. 10-13 with reference to figs. 18-20, paragraphs 0073-0075 and 0079-0081 of Helmlinger).
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Regarding claim 7, the modified Helmlinger discloses that the first attachment mechanism includes a slot holding one need of a strap (60, see the annotated-Helmlinger figs. 10 and 12 above, paragraphs 0073-0075 and 0079-0081 of Helmlinger).
Regarding claim 8, the modified Helmlinger discloses that the strap (60 of Helmlinger) includes a hook and loop fastener surface (see paragraphs 0036 and 0073 of Helmlinger, the two strap portions can be magnetic or hook-and-loop).
Regarding claim 9, the modified Helmlinger discloses that the sensor body includes a rectangular shape body (see housing 41 of 40b of Helmlinger in figs. 18 and 20 of Helmlinger) and the sensor body comprising a bottom surface defining the connector conduit (see fig. 20, relatively, the bottom surface of 41 is what defines the connector conduit 90B), but fails to disclose that the sensor body includes a cylindrical body.
However, the feature of choosing to have the sensor body comprises a cylindrical shape would be considered as an obvious design choice since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 11, the modified Helmlinger discloses that the sensor body includes a movable cap that is operable to activate the sensing electronics (the housing 41 is the cap, since it is responsible for covering the different components, see fig. 1, paragraphs 0063-0065 of Helmlinger, furthermore, the housing is operable to be moved to trigger the sensors such as sound/vibration/acceleration, see paragraphs 0060-0061 of Helmlinger).
Regarding claim 18, the modified Helmlinger discloses a visual indicator that indicates activation of the medicant dispenser (see paragraph 0013 of Helmlinger, Helmlinger discloses that the output device comprises a display and LED in order to output signals to the user, for example in order to transmit the information that a discharge has been sensed).
Regarding claim 19, the modified Helmlinger discloses that the first medicant dispenser is an inhaler (see paragraphs 0009, 0011 and claim 20 of Helmlinger).
Regarding claim 20, the modified Helmlinger discloses that the first medicant dispenser has a form factor (form of dispenser 12/18 of Helmlinger, figs. 1-6 and paragraphs 0062-0065 of Helmlinger), wherein the first attachment mechanism includes registration features matching the form factor (see 44 and 42 of Helmlinger, which form the registration features that would match the curvature of the dispenser 12/18, see paragraphs 0065-0069 of Helmlinger, alternatively, the registration features is the features of surface of 60 that touches the curvature of 12/18 of Helmlinger).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 1 above, and further in view of Schuster (2016/0129182).
Regarding claim 2, the modified Helmlinger discloses a microphone for detecting noise and sound (see paragraphs 0060-0061 of Helmlinger) and that the medicant dispenser can be an inhaler (see paragraphs 0009, 0011 and claim 20 of Helmlinger), but fails to disclose the storage device is further configured to store a plurality of breathing profiles, wherein each breathing profile comprises a frequency-spectrum representation of a user breathing activity.
However, Schuster teaches a sensor for capturing inhalation event (see paragraphs 0154-0155, and 0368), and a storage device is further configured to store a plurality of breathing profiles, wherein each breathing profile comprises a frequency-spectrum representation of a user breathing activity (see paragraphs 0029, 0032, 0038, 0040, 0050, 0061, and 0336, Schuster discloses that when the inhaler is inhaled through, the measured vibration signals’ time waveforms and/or frequency spectra are being compared to pre-loaded reference time waveforms and/or frequency spectra to identify a desired event, such as the loading or triggering of the device, a frequency spectra of inhalation is of a breathing profile of a user’s breathing activity).
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 attachable adherence monitor of the modified Helmlinger to have a sensor and the storage device being configured to store a plurality of breathing profiles, wherein each breathing profile comprises a frequency-spectrum representation of a user breathing activity as taught by Schuster for the purpose of analyzing usage data to improve adherence and compliance (see paragraphs 0029, 0032, 0038, 0040, 0050, 0061, and 0336 of Schuster).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 1 above, and further in view of Andersen (2009/0308387).
Regarding claim 2, the modified Helmlinger discloses a microphone for detecting noise and sound (see paragraphs 0060-0061 of Helmlinger) and that the medicant dispenser can be an inhaler (see paragraphs 0009, 0011 and claim 20 of Helmlinger), but fails to disclose the storage device is further configured to store a plurality of breathing profiles, wherein each breathing profile comprises a frequency-spectrum representation of a user breathing activity.
However, Andersen teaches a microphone for capturing inhalation event (see microphone in paragraphs 0049-0057, see detection of inhalation using noise/vibration/sound), and a storage device is further configured to store a plurality of breathing profiles, wherein each breathing profile comprises a frequency-spectrum representation of a user breathing activity (see paragraphs 0026-0028 and 0053-0068, Andersen discloses that after an inhalation, whether the inhalation was correct, such as if the duration, power consistency and frequency spectrum fulfils certain requirements, Andersen further discloses in paragraphs 0067-0068 that any parameter sensed or determined may be read out to the user using a display, thus, the quality of the inhalation, the number of inhalations, compliance to a determined inhalation scheme, point in time of last or next inhalation, or similar information may be given to a person, and the information may be stored for later reading, see fig. 3, there are a plurality of frequency spectrums/breathing profiles being recorded and compared, see paragraphs 0053-0060).
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 attachable adherence monitor and microphone of the modified Helmlinger to have the storage device being configured to store a plurality of breathing profiles, wherein each breathing profile comprises a frequency-spectrum representation of a user breathing activity as taught by Andersen for the purpose of analyzing usage data to improve adherence and compliance (see paragraphs 0001, 0026-0028, 0040 and 0053-0068 of Andersen).
Regarding claim 3, the modified Helmlinger discloses a microphone being configured to generate electrical signals based on audio signals received during usage of the medicant dispenser (see microphone in paragraphs 0049-0057 of Andersen, see detection of inhalation using noise/vibration/sound), such that the electrical signal are transformed to the frequency spectrum representation for comparison with the plurality of breathing profiles (see paragraphs 0026-0028 and 0053-0068, Andersen discloses that after an inhalation, whether the inhalation was correct, such as if the duration, power consistency and frequency spectrum fulfils certain requirements, Andersen further discloses in fig. 3 and paragraphs 0053-0060 that there are a plurality of frequency spectrums/breathing profiles being recorded and compared to determine inhalation).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 1 above, and further in view of Guthrie (2011/0253139).
Regarding claim 4, the modified Helmlinger fails to disclose a second attachment module includes a second attachment mechanism for attaching the sensor body to second medicant dispenser, wherein the first and second attachment mechanism are different and wherein the first and second medicant dispensers are different.
However, Guthrie teaches a plurality of attachment mechanism that are different to accommodate different medicant dispensers (see figs. 1-3 and paragraphs 0082-0083, Guthrie discloses that inhaler module 330 is mounted to a mounting element 310, and that inhaler modules can interchangeably fit in different mounting elements, other bands that fit other inhalers of different shapes and sizes can be utilized to mount an inhaler module).
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 monitor of the modified Helmlinger to have attachment mechanisms that are different as taught by Guthrie for the purpose of accommodating different medicant dispensers to provide an adherence monitor to different medicant dispensers using the same sensor body (see paragraphs 0082-0083 of Guthrie).
After the modification with Guthrie, there would be a second attachment mechanism for attaching the sensor body to second medicant dispenser, wherein the first and second attachment mechanism are different and wherein the first and second medicant dispensers are different, see the modification with Guthrie above and paragraphs 0082-0083 of Guthrie).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 1 above, and further in view of Schuster (2016/0129182).
Regarding claim 5, the modified Helmlinger discloses that the first attachment mechanism comprises a band (60 of Helmlinger), but fails to disclose that the first attachment mechanism includes an adhesive surface and a removable strip placed over the adhesive surface for adherence to the medicant dispenser.
However, Schuster teaches an attachment mechanism includes an adhesive surface and a removable strip placed over the adhesive surface of adherence to the medicant dispenser (see paragraphs 0053 and 0351-0356, Schuster discloses any means of attachment can be used, such as an adhesive strip or pad, which is supplied with the adhesive covered by a removable release liner).
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 monitor of the modified Helmlinger to have an attachment mechanism including an adhesive surface comprising a removable strip as taught by Schuster for the purpose of providing an alternative means of mounting the sensor body to the medicant dispenser (see paragraph 0053 of Schuster).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 1 above, and further in view of Andersen (2009/0308387).
Regarding claim 9, the modified Helmlinger discloses that the sensor body includes a rectangular shape body (see housing 41 of 40b of Helmlinger in figs. 18 and 20 of Helmlinger) and the sensor body comprising a bottom surface defining the connector conduit (see fig. 20, relatively, the bottom surface of 41 is what defines the connector conduit 90B), but fails to disclose that the sensor body includes a cylindrical body.
However, Andersen teaches a sensor body (12, figs. 1-2) includes a cylindrical body (18, see figs. 1-2 and 4-5).
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 rectangular shape body of the modified Helmlinger to have a cylindrical shape as taught by Andersen for the purpose of providing an alternative shape that would work equally well.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 1 above, and further in view of Mezhinsky (2007/0278786).
Regarding claim 10, the modified Helmlinger discloses that the coupling fixture comprises a tab configured to engage the connector conduit (see fig. 20 and tabs 90A (coupling fixture) that configured to engage conduit 90B of Helmlinger, see paragraph 0081 of Helmlinger), but fails to disclose that the connector conduit comprising at least one semi-circular slot.
However, Mezhinsky teaches a connector conduit comprising a semi-circular slot (see slot 27 which matches 29, see figs. 1-3, paragraph 0019, an arcuate slots 27 that matches 29 would be semi-circular in the same manner as the applicant’s instant disclosure).
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 connector conduit of the modified Helmlinger to be semi-circular slot as taught by Mezhinsky for the purpose of providing an alternative slot/tab connector mechanism that would provide the predictable result of allowing the sensor body to be fastened to the attachment module (see paragraph 0019 of Mezhinsky).
The modified Helmlinger discloses semi-circular slots (90B of Helmlinger modified to be arcuate slots as taught by Mezhinsky, the slots is semi-circular in the same manner as the applicant, since the applicant discloses in paragraph 0047 of the instant invention that there are “three semi-circular slots 222”), however, if there is any doubt that the slot 27 of Mezhinsky is semi-circular. The feature of choosing to have the arcuate slots of Mezhinsky as semi-circular would be considered as an obvious design choice since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 11 above, and further in view of Markey (WO 2021/022118).
Regarding claim 12, the modified Helmlinger fails to disclose an auxiliary button that is operable to activate the sensing electronics.
However, Markey teaches an auxiliary button that is operable to activate the sensing electronics (see paragraphs 0118 and 0126, Markey discloses an auxiliary button 988 for waking the monitor 950 from the inventory state, once the monitor is awake, the monitor proceed to the detection state 1202).
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 sensing electronics and monitor of the modified Helmlinger to have an auxiliary button as taught by Markey for the purpose of providing a button to allow the user to manually transition from a storage/inventory state to a detection state, thereby, preserving the battery life (see paragraphs 0083, 0118 and 0126 of Markey).
Regarding claim 13, the modified Helmlinger discloses a battery (25 of Helmlinger, see fig. 1 and paragraph 0059 of Helmlinger), wherein the sensing electronics have a lower power inventory mode, and wherein the sensing electronics exit the inventory mode when the auxiliary button is pushed (see the modification with Markey above, see paragraphs 0083, 0118 and 0126 of Markey).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 11 above, and further in view of Markey (WO 2021/022118) and Ronger (CN 108452409).
Regarding claim 14, the modified Helmlinger fails to disclose a dome contact switch attached to the cap to trigger the sensing electronics.
However, Markey teaches an auxiliary button that is operable to activate the sensing electronics (see paragraphs 0118 and 0126, Markey discloses an auxiliary button 988 for waking the monitor 950 from the inventory state, once the monitor is awake, the monitor proceed to the detection state 1202).
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 sensing electronics of the modified Helmlinger to have an auxiliary button as taught by Markey for the purpose of providing a button to allow the user to transition from a storage/inventory state to a detection state, thereby, preserving the battery life (see paragraphs 0083, 0118 and 0126 of Markey).
After the modification, the contact switch that 988 of Markey pushes will be a contact switch that is attached to the cap indirectly to trigger the sensing components (see paragraphs 0118 and 0126 of Markey), but fails to disclose that the contact switch is a dome contact switch.
However, Ronger teaches a contact switch that is a dome contact switch (see switch 19 and paragraphs 0026, 0050 and 0056 of the English translation).
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 contact switch of the modified Helmlinger to be a dome contact switch as taught by Ronger for the purpose of providing a contact switch that can reliably sense the triggering action of the auxiliary button (see paragraph 0026 of Ronger).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 11 above, and further in view of Markey (WO 2021/022118) and Deaton (2005/0028815).
Regarding claim 14, the modified Helmlinger fails to disclose a dome contact switch attached to the cap to trigger the sensing electronics.
However, Markey teaches an auxiliary button that is operable to activate the sensing electronics (see paragraphs 0118 and 0126, Markey discloses an auxiliary button 988 for waking the monitor 950 from the inventory state, once the monitor is awake, the monitor proceed to the detection state 1202).
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 sensing electronics of the modified Helmlinger to have an auxiliary button as taught by Markey for the purpose of providing a button to allow the user to transition from a storage/inventory state to a detection state, thereby, preserving the battery life (see paragraphs 0083, 0118 and 0126 of Markey).
After the modification, the contact switch that 988 of Markey pushes will be a contact switch that is attached to the cap indirectly to trigger the sensing components (see paragraphs 0118 and 0126 of Markey), but fails to disclose that the contact switch is a dome contact switch.
However, Deaton teaches a contact switch that is a dome contact switch (see dome contact switch 44 in paragraphs 0066-0068 and figs. 12-13).
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 contact switch of the modified Helmlinger to be a dome contact switch as taught by Deaton for the purpose of providing an alternative contact switch that would perform equally well (see paragraphs 0066-0068 of Deaton).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 11 above, and further in view of Markey (WO 2021/022118) and Ronger (CN 108452409).
Regarding claim 15, the modified Helmlinger discloses a circuit board holding sensing electronics (see paragraph 0059 of Helmlinger, Helmlinger discloses that a circuit board with a processor 28, operating elements 27 and various sensors 26A-26C), wherein the circuit board is attached to the movable cap (41 of Helmlinger, see fig. 1 of Helmlinger, the circuit board is housed within the movable cap 41, therefore, is attached to the movable cap 41), but fails to disclose the circuit board holding the dome contact switch.
However, Markey teaches an auxiliary button that is operable to activate the sensing electronics (see paragraphs 0118 and 0126, Markey discloses an auxiliary button 988 for waking the monitor 950 from the inventory state, once the monitor is awake, the monitor proceed to the detection state 1202).
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 sensing electronics and the circuit board of the modified Helmlinger to have an auxiliary button as taught by Markey for the purpose of providing a button to allow the user to transition from a storage/inventory state to a detection state, thereby, preserving the battery life (see paragraphs 0083, 0118 and 0126 of Markey).
After the modification, the contact switch that 988 of Markey pushes will be a contact switch that is attached to the cap indirectly to trigger the sensing components (see paragraphs 0118 and 0126 of Markey), but fails to disclose that the contact switch is a dome contact switch.
However, Ronger teaches a contact switch that is a dome contact switch (see switch 19 and paragraphs 0026, 0050 and 0056 of the English translation).
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 contact switch of the modified Helmlinger to be a dome contact switch as taught by Ronger for the purpose of providing a contact switch that can reliably sense the triggering action of the auxiliary button (see paragraph 0026 of Ronger).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 11 above, and further in view of Markey (WO 2021/022118) and Deaton (2005/0028815).
Regarding claim 15, the modified Helmlinger discloses a circuit board holding sensing electronics (see paragraph 0059 of Helmlinger, Helmlinger discloses that a circuit board with a processor 28, operating elements 27 and various sensors 26A-26C), wherein the circuit board is attached to the movable cap (41 of Helmlinger, see fig. 1 of Helmlinger, the circuit board is housed within the movable cap 41, therefore, is attached to the movable cap 41), but fails to disclose the circuit board holding the dome contact switch.
However, Markey teaches an auxiliary button that is operable to activate the sensing electronics (see paragraphs 0118 and 0126, Markey discloses an auxiliary button 988 for waking the monitor 950 from the inventory state, once the monitor is awake, the monitor proceed to the detection state 1202).
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 sensing electronics and the circuit board of the modified Helmlinger to have an auxiliary button as taught by Markey for the purpose of providing a button to allow the user to transition from a storage/inventory state to a detection state, thereby, preserving the battery life (see paragraphs 0083, 0118 and 0126 of Markey).
After the modification, the contact switch that 988 of Markey pushes will be a contact switch that is attached to the cap indirectly to trigger the sensing components (see paragraphs 0118 and 0126 of Markey), but fails to disclose that the contact switch is a dome contact switch.
However, Deaton teaches a contact switch that is a dome contact switch (see dome contact switch 44 in paragraphs 0066-0068 figs. 12-13).
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 contact switch of the modified Helmlinger to be a dome contact switch as taught by Deaton for the purpose of providing an alternative contact switch that would perform equally well (see paragraphs 0066-0068 of Deaton).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 1 above, and further in view of Schuster (2016/0129182).
Regarding claim 16, the modified Helmlinger discloses that the sensors 26A-26C sense acceleration (see paragraph 0060 of Helmlinger), but fails to disclose that the structure for sensing acceleration is an accelerometer.
However, Schuster teaches an accelerometer for detecting acceleration (paragraphs 0026 and 0314).
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 that senses acceleration of the modified Helmlinger to be an accelerometer as taught by Schuster for the purpose of providing a well-known acceleration sensor that would provide the predictable result of allowing acceleration and motion to be detected (see paragraphs 0026 and 0314 of Schuster).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Helmlinger (2025/0269122) in view of Markey (WO 2021/022118) as applied to claim 1 above, and further in view of Markey (WO 2021/022118).
Regarding claim 17, the modified Helmlinger discloses a receiver and transmitter that allows communication of the stored activation data to an external device (see paragraph 0014 of Helmlinger, Helmlinger discloses that the analysis comprises Bluetooth or WiFi for communication with an external device (smartphone) and paragraph 0060 that the captured data are evaluated entirely or partially on an external system that is connected to the analysis unit via a wireless interface, see captured data in paragraphs 0012 and 0059-0061), but fails to disclose a transceiver that allows communication of the stored activation data to the external device.
However, Markey teaches a transceiver for sending actuation event to an external client device (see paragraph 0010).
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 monitor of the modified Helmlinger to have the transceiver for sending actuation event to the external device as taught by Markey for the purpose of providing a well-known form of wireless communication means that would allow an external device to receive the actuation event of the monitor, thereby keeping the viewer of the external device informed on the adherence or compliance data (see paragraph 0010 of Markey).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schlebusch (WO 2021/099313) is cited to show a sensor module for a medicament dispensing device.
Liebler (WO 2021/099311) is cited to show a sensor and monitor module.
Allen (GB 2405801) is cited to show a counting module that is adhesively attached to an inhaler.
Engelhard (2018/0247517) is cited to show an adherence monitor.
Shukla (2020/0405579) is cited to show a compliance device and monitoring system.
Farina (2019/0224426) is cited to show a monitoring module for an inhaler.
Merrell (2020/0345588) is cited to show an adherence monitor.
Von Hollen (2011/0226242) is cited to show an adhesive strip for an inhaler.
Biswas (2016/0144141) is cited to show a method for monitoring the user of inhalers.
Mikosz (2024/0050665) is cited to show a device for monitoring use of an inhaler.
Sutherland (2017/0325734) is cited to show a monitor for a medicament inhaler.
Van Sickle (2016/0256639) is cited to show a usage monitoring attachment comprising a band.
Sutherland (2021/0204870) is cited to show an adherence monitor.
Sutherland (2019/0105450) is cited to show an adherence monitor.
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/TU A VO/Primary Examiner, Art Unit 3785
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