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 responsive to the amendment filed on June 17, 2022. As directed by the amendment: claims 6, 8, and 16 have been amended, claims 20-23 have been canceled, and no new claims have been added. Thus, claims 1-19 and 24 are presently pending in the application.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-13, 16, 18, 19, and 24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wekell (US 2013/0053719).
As to claim 1, Wekell discloses a system 100 (Fig. 1) comprising:
at least one inhaler 140 (Fig. 1, Figs. 10-12), each of the at least one inhaler 140 comprising a use determination system 400 (Fig. 4) configured to determine at least one value of a usage parameter relating to use of the respective inhaler by a subject, wherein the usage parameter comprises a parameter relating to airflow during an inhalation performed by the subject with the at least one inhaler (Fig. 5, paragraphs [0055]-[0058]: device detects inhalation and stores the time inhalation occurred; paragraph [0060]: rate of airflow during inhalation and exhalation is measured, stored, etc.);
a user interface 350, 360, 365 (Fig. 3, paragraph [0043]) configured to enable user-inputting of an indication of a status of a respiratory disease being experienced by the subject (answers to patient symptom questions, paragraph [0072]); and
a processing module configured to control the user interface 350,360,365 to issue a prompt to input said indication based on said at least one value (trigger message 825,125 sent if patient medication administration rises above a threshold, sensor measurements may trigger automated patient symptom questions, see paragraph [0072]).
As to claim 2, Wekell discloses the system according to claim 1, wherein the usage parameter comprises a use of the at least one inhaler 140 by the subject (Fig. 5, paragraphs [0055]-[0058]: device detects inhalation and stores the time inhalation occurred); paragraphs [0072]: patient’s medication administration level).
As to claim 3, Wekell discloses the system according to claim 2, wherein the use determination system comprises a sensor 425,435 for detecting an inhalation performed by the subject and/or a mechanical switch configured to be actuated prior to, during, or after use of the at least one inhaler (paragraphs [0055]-[0058]).
As to claim 4, Wekell discloses the system according to claim 1, wherein the processing module is configured to record a number of uses of the at least one inhaler, and control the user interface to issue the prompt at least partly based on a difference between said recorded number of uses and a baseline number of uses reaching or exceeding a given threshold (paragraphs [0111]).
As to claim 5, Wekell discloses the system according to claim 1, wherein the at least one inhaler comprises a rescue inhaler 140 configured to deliver a rescue medicament (Figs. 10-12, paragraphs [0009]-[0010]).
As to claim 6, Wekell discloses the system according to claim 5, wherein the processing module is configured to control the user interface to issue the prompt at least partly based on a recorded number of rescue inhaler uses exceeding a predetermined number of rescue inhaler uses (paragraph [0072]: trigger message 825,125 sent if patient medication administration rises above a threshold, sensor measurements may trigger automated patient symptom questions, see also paragraphs [0090],[0111] which disclose tracking patient usage).
As to claim 7, Wekell discloses the system according to claim 1, wherein the at least one inhaler 140 comprises a maintenance inhaler configured to deliver a maintenance medicament (paragraphs [0072],[0111]).
As to claim 8, Wekell discloses the system according to claim 7, wherein the processing module is configured to control the user interface to issue the prompt at least partly based on a recorded number of maintenance inhaler uses being less than a predetermined number of maintenance inhaler uses (paragraph [0111]: compliance can be monitored by the recognition of insufficient usage of a maintenance medication; the system can send medication reminders to patients who miss a dose).
As to claim 9, Wekell discloses system according to claim 1, wherein the use determination system comprises a sensor 425, 435 for sensing the parameter relating to airflow (paragraphs [0055]-[0058]; see also paragraph [0086] describing that the sensors can instead be pressure sensors).
As to claim 10, Wekell discloses the system according to claim 1, wherein the system comprises a memory 430 (Fig. 4) for storing said indication inputted via the user interface (paragraph [0043],[0058]).
As to claim 11, Wekell discloses the system according to claim 1, wherein the processing module is configured to control the user interface to issue the prompt at least partly based on a difference between said parameter relating to airflow and an airflow parameter baseline reaching or exceeding a given threshold (paragraph [0072]: trigger message 825,125 sent if patient medication administration rises above a threshold, sensor measurements may trigger automated patient symptom questions, see also paragraphs [0090],[0111] which disclose tracking patient usage).
As to claim 12, Wekell discloses the system according to claim 1, wherein the parameter is at least one of a peak inhalation flow, an inhalation volume, and an inhalation duration. (paragraph [0055]-[0056]: the sensor monitors airflow activity to determine if it is sustained activity (i.e., the inhalation continues for a certain duration) or not; see also paragraph [0060] disclosing measuring of tidal volume (i.e., inhalation volume)).
As to claim 13, Wekell discloses the system according to claim 12, wherein the processing module is configured to control the user interface to issue the prompt at least partly based on: a change in the peak inhalation flow relative to a baseline peak inhalation flow; a change in the inhalation volume relative to a baseline inhalation volume; and/or a change in the inhalation duration relative to a baseline inhalation duration (detects a change in sensor 425 indicating airflow and determines if the change is sustained; this is essentially detecting a duration of inhalation exceeding a certain baseline duration).
As to claim 16, Wekell discloses the system according to claim 1, wherein the user interface is at least partly defined by a first user interface of a user device 350, 360, 365 in communication with the at least one inhaler (Fig. 3, paragraph [0043],[0101]).
As to claim 18, Wekell discloses a method comprising: receiving at least one value of a usage parameter relating to use of at least one inhaler 140 (Fig. 1, Figs. 10-12) by a subject, the at least one value being determined by a use determination system 400 (Fig. 4) included in the respective inhaler 140, wherein the usage parameter comprises a parameter relating to airflow during an inhalation performed by the subject with the respective inhaler 140 (Fig. 5, paragraphs [0055]-[0058]: device detects inhalation and stores the time inhalation occurred; paragraph [0060]: rate of airflow during inhalation and exhalation is measured, stored, etc.); and controlling a user interface 350, 360, 365 to issue a prompt to input an indication of a status of a respiratory disease being experienced by the subject, the prompt being issued based on said at least one value (trigger message 825,125 sent if patient medication administration rises above a threshold, sensor measurements may trigger automated patient symptom questions, see paragraph [0072]).
As to claim 19, Wekell discloses the method according to claim 18, wherein the usage parameter comprises a use of the at least one inhaler 140 by the subject (Fig. 5, paragraphs [0055]-[0058]: device detects inhalation and stores the time inhalation occurred); paragraphs [0072]: patient’s medication administration level).
As to claim 24, Wekell discloses a non-transitory computer readable medium having stored thereon a computer program comprising computer program code which is adapted, when said computer program is run on a computer, to cause the computer to implement the method of claim 18 (paragraphs [0108]-[0110]).
Claims 1, 14, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Barrett et al. (US 2019/0102522).
As to claim 1, Barrett discloses a system (Fig. 1) comprising: at least one inhaler 160 (paragraph [0059]), each of the at least one inhaler 160 comprising a use determination system 100 (Fig. 2) configured to determine at least one value of a usage parameter relating to use of the respective inhaler by a subject, wherein the usage parameter comprises a parameter relating to airflow during an inhalation performed by the subject with the at least one inhaler 160 (via sensor 120 detecting medication events, see paragraphs [0049],[0064]; sensor 120 can detect inhalation by the user, see paragraph [0066]); a user interface (client device 110, Fig. 1, paragraph [0054]: user can input commands via user interface provided by application 115 on client device 110) configured to enable user-inputting of an indication of a status of a respiratory disease being experienced by the subject (user response to survey/questionnaire, see paragraphs [0104]-[0105]); and a processing module configured to control the user interface to issue a prompt to input said indication based on said at least one value (survey card solicits a user response by presenting yes/no, multiple choice, or open-ended questions for the user to respond to, see paragraphs [0104]-[0105]; patient behavior or sensor-reported event information may trigger the sending of a survey card, paragraph [0106]-[0107]).
As to claim 14, Barrett discloses the system according to claim 1, wherein the user interface is configured to provide a plurality of user-selectable respiratory disease status options, wherein the indication is defined by user-selection of at least one of said status options (Fig. paragraph [0096]: user selects the medication being used to treat their condition from a list 315b, Fig. 3B).
As to claim 15, Barrett discloses the system according to claim 14, wherein the user interface is configured to provide said status options in the form of selectable icons, checkboxes, a slider, and/or a dial (scrollable list of selectable medications 315b, see Fig. 3B, paragraph [0096]).
As to claim 17, Barrett discloses the system according to claim 1, wherein the at least one inhaler comprises an inhaler configured to deliver a medicament selected from albuterol, budesonide, beclomethasone, fluticasone, formoterol, salmeterol, indacaterol, vilanterol, tiotropium, aclidinium, umeclidinium, glycopyrronium, salmeterol combined with fluticasone, beclomethasone combined with albuterol, and budesonide combined with formoterol (see Fig. 3B showing “Albuterol” as one of the selectable medications, paragraph [0096], see also paragraph [0059] listing albuterol among a list of example medications used).
Response to Arguments
Applicant's arguments filed July 21, 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 8-10 of the remarks, with respect to the 102 rejection over Wekell, that claim 1 differs from Wekell in two ways:
1) according to claim 1, the “usage parameter comprises a parameter relating to airflow during an inhalation performed by the subject with the at least one inhaler,” not an exhalation as described in Wekell; and
2) claim 1 requires that “an inhalation performed by the subject with the at least one inhaler.” In contrast, the method of Fig. 8 of Wekell is explicitly not based on the airflow sensors in the inhaler (that is, the low and high-resolution sensors 425 and 435). Rather, it is understood that the peak expiratory airflow indication described in Wekell must be obtained using some other sensor — such as the spirometer mentioned in paragraph [0005], for example.
In response, it is noted that Wekell discloses that an inhalation detected via sensors 425, 435 is considered a medication administration event (paragraph []). Wekell then states that the if the patient’s medication administration rises above a specified level, a trigger message can be sent to the patient reporting unusual activity. Finally, Wekell lists possible trigger messages including automated symptom questions. Thus, the sensed inhalation/medication administration events rising above a threshold level can trigger a message (such as the patient symptom questions).
While Wekell does state the method of Fig. 8 is for sensors other than the high/low resolution sensors 425, 435, it is also disclosed that the sensor data can be combined with data from sensor 425, 435 (paragraph [0071]). Further, even if the inhalation event/medication administration event is detected from some other sensor, the parameter indicating a medication administration event is still “related to airflow during an inhalation”, since the medication must be delivered during an inhalation.
Finally, while Wekell discloses peak expiratory flow measurements as one example of a trigger for a message, such as patient symptom questions, it is clear that Wekell did not mean for it to be the only sensor measurements that triggers a message (see paragraph [0072] “By way of yet another example, sensor measurements (e.g. measurements indicating increased difficulty in breathing via peak expiratory flow indication”), but rather any of the sensor measurements indicating a problem could trigger patient symptom questions.
Applicant then argues on page 10 of the remarks, with respect to the rejection of claim 1 that Barrat does not disclose or suggest that "patient behavior or sensor-reported event information" includes any parameter related to airflow during inhalation. Rather, paragraphs [0106] and [0107] refer to patient behavior or sensor-reported event information in terms of the count of asthma events or adherence to a prescribed treatment regimen, neither of which constitutes a parameter associated with airflow. Applicant further argues that the mere detection of an inhalation event does not anticipate the claimed “parameter relating to airflow during an inhalation”.
However, the argument is not well taken. Examiner maintains that the usage count data is a parameter related to airflow during inhalation. Barrett’s system counts medication events by detecting inhalation (paragraph [0061]: sensor 120 monitors usage of the dispenser, paragraph [0066]: implementation of sensor 120 can be by detecting inhalations). Thus, the count of medication events is essentially a count of inhalations. It is unclear why applicant does not consider detecting the number/frequency of inhalation events as a parameter related to airflow during inhalation, but it is pointed out that the claim is broad enough to read on Barrett’s inhalation/usage count as the claimed parameter since inhalation is by definition an airflow during inhalation and the claim does not specify what property or aspect of the inhalation airflow is detected by the sensor.
Thus, the rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785