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 action is responsive to applicant's amendment and remarks received on 03/10/2026.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Eltorai (US 20180000379 A1 – cited in IDS filed 04/25/2024).
Regarding claim 1, Eltorai discloses a reusable monitoring device (fig. 1, system 10 and fig. 6, apparatus 600; [0025]-[0032], [0042], [0050]-[0051], [0054]-[0055]), comprising:
at least one attachment mechanism operatively attaching the reusable monitoring device to a first analog incentive spirometry device (Eltorai teaches a clamp system 200 that is removably placed on an incentive spirometer over the cylindrical tube defining the chamber, including pivot hinge 205 and gripping surfaces 220, 222, 224, and an apparatus 600 with base 604 that receives and secures an interchangeable incentive spirometer IS ([0036]–[0037], [0051]–[0052]). The incentive spirometer 20/IS is a conventional piston-in-chamber device operated by user inhalation ([0029], [0033], [0051]–[0052]), i.e., an analog incentive spirometry device.);
a monitoring component monitoring use of the analog incentive spirometry device by a first patient (Eltorai teaches sensor(s) 12, 50, 60 that detect piston movement and inspiratory volume, along with processor/microcontroller 14/130/610 and storage that record time-stamped inspiratory events and target achievements over a series of sessions to enhance compliance and monitor lung volumes and function ([0025]–[0027], [0028]–[0034], [0038], [0041]–[0042], [0054]–[0055])); and
a user interface comprising: one or more user-actuatable input mechanisms receiving first patient-specific incentive spirometry parameters associated with the use of the first analog incentive spirometry device by the first patient (Eltorai discloses user-actuatable input mechanisms including mode control button 32, on/off switch 144, and control 146 ([0028], [0035]) — control 146 being a physically actuated control that enables an authorized user to increase or decrease the interval between sessions, a parameter set per patient by a healthcare professional ([0030]) — as well as snooze button 640 ([0053]), each of which is actuated by a user (i.e., is user-actuatable) and is carried on the device itself within housing 230/602 ([0037], [0050]–[0051]); Eltorai further discloses that the device button "enables configuration of certain aspects of the device" ([0041]). Configuration is additionally performed by a healthcare professional operating host laptop/workstation 670 ([0053]–[0054]), which is likewise user-actuated. The claim does not require that the user-actuatable input mechanism be integral to a single housing or be actuated by the patient. These input mechanisms receive patient-specific incentive spirometry parameters associated with use of the incentive spirometer by that patient.); and
one or more output mechanisms transmitting or presenting information regarding at least one of the first patient-specific incentive spirometry parameters, first patient-specific incentive spirometry operating values based on the monitored use of the first analog incentive spirometry device, and results of processing the first patient-specific incentive spirometry operating values based on the monitored use of the first analog incentive spirometry device by the first patient relative to the first patient-specific incentive spirometry parameters (Eltorai teaches multiple output mechanisms: alarm device 16 and status/mode indicator light 34 (LED) that generate perceptible prompts and indicate device state; the alarm is activated at preselected intervals and deactivated only after the sensor detects the piston has reached a preselected inspiratory threshold, i.e., a processed comparison of monitored inspiratory volume to configured parameters ([0025]–[0027], [0028], [0031], [0038], [0042]); prompts and messages presented via mobile devices (smartphone, tablet) to the user ([0031]), and host laptop 670 which displays configured test settings and uploaded, time-stamped inspiratory events and usage history, i.e., operating values and processed results relative to the set thresholds and timing parameters ([0041]–[0042], [0054]–[0055]).).
Regarding claim 2, Eltorai discloses the reusable monitoring device of claim 1, the at least one attachment mechanism operatively attaching the reusable monitoring device to a second analog incentive spirometry device (Eltorai discloses that the monitoring device (system 10 / apparatus 600) is removably mountable and configured to be reused with different incentive spirometers: the clamp system 200 is “removably placed on an incentive spirometer as desired over the cylindrical tube defining the chamber of the incentive spirometer” ([0036]), indicating that it can be removed from one spirometer and placed on another analog incentive spirometer as needed; and apparatus 600 is described as working with an “interchangeable incentive spirometer IS”, and housing 602/base 604 are designed to receive and secure new incentive spirometers, with the electronics and sensor unit reused across clinical studies ([0050]–[0052]). A removable clamp/base specifically designed to work with interchangeable incentive spirometers inherently provides “at least one attachment mechanism operatively attaching the reusable monitoring device to a second analog incentive spirometry device” once it is removed from a first spirometer and attached to another. Additionally, the recitation of attaching to a "second" analog incentive spirometry device is a recitation of intended use and capability in an apparatus claim. An apparatus claim covers what a device is, not what a device does, and is anticipated where the prior-art structure is the same as the claimed structure and is capable of performing the recited function; a recitation directed to the manner in which an apparatus is intended to be employed does not distinguish the apparatus from a prior-art apparatus meeting the claimed structural limitations (MPEP 2114).).
Regarding claim 3, Eltorai discloses the reusable monitoring device of claim 2, the monitoring component monitoring use of the second analog incentive spirometry device by a second patient (Eltorai teaches that the monitoring device is reusable and intended for repeated use in a clinical study, and is configured to work with interchangeable incentive spirometers: apparatus 600 with opaque housing 602 and base 604 is designed to work with an interchangeable incentive spirometer IS, and the component parts are 3D-printed from ABS “appropriate for repeated use in a clinical study” ([0050]–[0052]); and base 604 is configured to receive and secure new incentive spirometers within housing 602 ([0050]–[0052]), while the embedded controller 610 and optical sensor/IR LED unit 620 are reused. Eltorai further explains that the system logs inspiratory events and volumes for clinical monitoring of incentive spirometer frequency of use and inspiratory volume achievements ([0033]–[0034], [0054]–[0055]) in post-operative patients ([0003]–[0004]). Given that (i) the monitoring device is expressly reusable in a clinical study, (ii) it is designed to be attached to interchangeable incentive spirometers and to receive new spirometers in base 604, and (iii) it monitors and records the use (inspiratory events and volumes) whenever attached, the same monitoring component that monitors use of a first analog incentive spirometer by a first patient will inherently monitor use of a second analog incentive spirometry device by a second patient when the reusable device is attached to that second spirometer and used by another patient in the clinical setting described by Eltorai. Additionally, as set forth for claim 2, this recitation is one of intended use and capability and does not structurally distinguish the claimed apparatus from Eltorai (MPEP 2114).).
Regarding claim 4, Eltorai discloses the reusable monitoring device of claim 3, the one or more input mechanisms receiving second patient-specific incentive spirometry parameters associated with the use of the second analog incentive spirometry device by the second patient (Eltorai teaches that the monitoring device is reusable and designed for repeated use in a clinical study with interchangeable incentive spirometers: apparatus 600 (opaque housing 602, base 604, controller 610, sensor unit 620) is expressly designed to work with an interchangeable incentive spirometer IS, and the component parts are 3D-printed in ABS “appropriate for repeated use in a clinical study” ([0050]–[0052]). Base 604 “receives and secures new incentive spirometers” in housing 602 ([0050]–[0052]); and as discussed for claim 1, Eltorai discloses input mechanisms including mode control button 32, on/off switch 144 and control 146, snooze button 640, and a host laptop 670 used by a healthcare professional to configure test settings—including timer alarm frequency, reminder duration, and inspiratory threshold behavior—for the user’s spirometry regimen ([0028], [0030], [0035], [0041]–[0042], [0053]–[0055]). Because the same reusable device (system 10 / apparatus 600) is intended to be used sequentially with new, interchangeable incentive spirometers in a clinical study and is explicitly configurable via these input mechanisms for each user’s sessions, the device’s input mechanisms inherently receive incentive-spirometry parameters specific to each new patient when the device is attached to a second analog incentive spirometer and configured for that second patient’s therapy (e.g., alarm frequency, threshold volume, prompt duration). Thus, in Eltorai, the one or more input mechanisms (buttons and host computer interface) receive second patient-specific incentive spirometry parameters associated with the use of the second analog incentive spirometry device by the second patient, as broadly claimed. Additionally, as set forth for claim 2, this recitation is one of intended use and capability and does not structurally distinguish the claimed apparatus from Eltorai (MPEP 2114).).
Regarding claim 5, Eltorai discloses the reusable monitoring device of claim 4, the one or more output mechanisms transmitting or presenting information regarding at least one of the second patient-specific incentive spirometry parameters, second patient-specific incentive spirometry operating values based on the monitored use of the second analog incentive spirometry device, and results of processing the second patient-specific incentive spirometry operating values based on the monitored use of the second analog incentive spirometry device by the second patient relative to the second patient-specific incentive spirometry parameters (Eltorai discloses one or more output mechanisms that transmit or present information about patient-specific spirometry parameters, operating values, and processed results. Specifically, Eltorai teaches an alarm device 16 and indicator LED 34 that provide audible/visual prompts and are deactivated only after the sensor detects that the piston has reached a preselected inspiratory threshold, i.e., a processed comparison of measured inspiratory volume to configured parameters (Abstract; [0025]–[0028], [0031], [0038], [0042]). Eltorai further discloses that data (including time-stamped inspiratory events and usage history) is uploaded to and displayed on a host laptop/workstation 670 for clinical monitoring of incentive spirometer frequency of use and inspiratory volume achievements ([0041]–[0042], [0054]–[0055]). As established for claims 2–4, the same reusable device is used with interchangeable incentive spirometers and additional patients ([0050]–[0052]); thus, these output mechanisms are capable of, and are expressly disclosed for, transmitting or presenting information regarding second patient-specific parameters, second patient-specific operating values, and results of processing those values relative to the parameters when the reusable device is used with a second analog incentive spirometry device by a second patient, as recited. Additionally, as set forth for claim 2, this recitation is one of intended use and capability and does not structurally distinguish the claimed apparatus from Eltorai (MPEP 2114).).
Regarding claim 6, Eltorai discloses the reusable monitoring device of claim 1, further comprising a communications interface operatively connecting the reusable monitoring device to one of a mobile device, a computing device, or a server system over one of a wired connection or wireless connection (Eltorai discloses that system 10/apparatus 600 includes communication interfaces to both mobile and computing devices: in FIG. 1, signal 42 represents wireless communication (e.g., Bluetooth Low Energy) between system 10 and a laptop LP ([0029]–[0032]), i.e., a wireless interface to a computing device; a host laptop/workstation 670 is connected to the embedded controller 610 via USB cable 668 to configure test settings and download logged data ([0041]–[0042], [0053]–[0054]), i.e., a wired connection between the reusable monitoring device and a computing device; and alarm device 16 can also communicate with a smartphone or tablet to generate vibratory, auditory, or visual prompts ([0031]), i.e., a wireless interface to a mobile device.).
Regarding claim 7, Eltorai discloses the reusable monitoring device of claim 6, the one or more output mechanisms transmits the information to the one of the mobile device, the computing device, or the server, wherein the one of the mobile device or the server presents the information (Eltorai expressly discloses that: system 10 communicates wirelessly with a laptop LP via signal 42 (e.g., Bluetooth Low Energy) to transmit data for collection and display on the laptop ([0029]–[0032]), the embedded controller 610 is connected to host laptop/workstation 670 via USB cable 668 to upload logged, time-stamped inspiratory events and usage data, which the workstation uses for clinical monitoring of spirometer frequency of use and inspiratory volume achievements ([0041]–[0042], [0054]–[0055]), and alarm device 16 communicates with a smartphone or tablet to produce vibratory, auditory, or visual prompts to the user ([0031]), meaning information output from the device is transmitted to a mobile device, which then presents it. In other words, Eltorai’s output mechanisms (alarm device, communication interface, controller) transmit information (alarms, prompts, logged data) to mobile and computing devices, and those devices (smartphone/tablet, laptop/workstation) present the information to the user/clinician as recited.).
Regarding claim 8, Eltorai discloses the reusable monitoring device of claim 1, wherein the one or more output mechanisms presenting the information operates in real time or non-real time (Eltorai discloses output mechanisms that operate in real time and non-real time: in real time, alarm device 16 and indicator LED 34 provide immediate audible/visual prompts when a session is due and are deactivated only after the sensor detects that the piston has reached a preselected inspiratory threshold (Abstract; [0025]–[0027], [0031], [0038], [0042]), i.e., real-time presentation of information as the patient uses the spirometer; and in non-real time, Eltorai logs time-stamped inspiratory events and usage data to storage and later uploads them via USB/Bluetooth to a host laptop/workstation 670 for subsequent review by a clinician ([0032], [0041]–[0042], [0054]–[0055]), i.e., presenting information after the fact.).
Response to Arguments
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive.
Response regarding Claim 7 objection: Applicant states that claim 7 has been amended in accordance with the Examiner's suggestion, rendering the objection moot. The objection is maintained. The amendment did not adopt the suggested correction in full: amended claim 7 recites "…or the server, whererin the one of the mobile device or the server presents…," which (1) introduces the informality "whererin" (for "wherein"), and (2) recites "the server," which lacks proper antecedent basis because claim 6 recites "a server system." Appropriate correction is again required as set forth above.
Argument A: Applicant argues that, per the specification at [0027]–[0028], the claimed device is a self-contained unit requiring no separate, remote, or other device to receive patient-specific parameters, whereas Eltorai requires a separate host laptop/workstation 670 to configure test settings.
Response to Argument A: Claim 1 contains no recitation that the device is "self-contained," that it operates without a "separate" or "remote" device, or that the input mechanisms are integral to a single housing. The argued features appear only in the Remarks and the specification, not in the claims, and limitations that do not appear in the claims cannot be relied upon to establish patentability. See MPEP 2145(VI). Moreover, the argued construction is contradicted by Applicant's own dependent claim 6, which depends from claim 1 and expressly recites a communications interface "operatively connecting the reusable monitoring device to one of a mobile device, a computing device, or a server system." A construction of claim 1 that excludes cooperation with any separate device is therefore inconsistent with the claim set as a whole. During examination, claims are given their broadest reasonable interpretation consistent with the specification (MPEP 2111), and so construed, claim 1 does not exclude a device that is configured with the assistance of a separate computing device.
Argument B: Applicant argues that system 10 of Eltorai does not allow a user to enter test settings; that "mode" is undefined except for a sleep-mode reference at [0032] and is not analogous to a patient-specific parameter; that the Arduino processor 101 is not a user-actuatable input mechanism; and that, at best, a user can actuate only mode control buttons.
Response to Argument B: As set forth in the rejection of claim 1, the input mechanisms identified in Eltorai are "mode control button 32, on/off switch 144 and control 146 for adjusting the interval between sessions, snooze button 640 on apparatus 600, and a host laptop 670." Eltorai [0035] expressly discloses that "Control unit 140 includes an on/off switch 144 and a control 146 to enable an authorized user to increase or decrease the interval between sessions." Control 146 is a user-actuatable control — it is actuated by an authorized user (a healthcare professional) — and it is located on the monitoring device itself: Eltorai [0036]–[0037] disclose that the components of circuit 100, including control unit 140 (and thus control 146), are "contained within a housing 230" of clamp system 200. The interval between sessions set via control 146 is a parameter governing the frequency with which the particular patient is to perform incentive spirometry and is set on a per-patient basis by a healthcare professional (Eltorai [0030]: "Sessions for a user to utilize the incentive spirometer 20 and the timing...typically are set by a healthcare professional at a selected rate such as once an hour"). Under its broadest reasonable interpretation, this is a "patient-specific incentive spirometry parameter associated with the use of the...incentive spirometry device by the first patient," as recited. Eltorai [0041] further confirms that the device's button "enables configuration of certain aspects of the device." Accordingly, Eltorai discloses one or more user-actuatable input mechanisms that receive patient-specific incentive spirometry parameters, independent of the mode control button 32 and the Arduino processor that Applicant addresses. The Examiner agrees that the Arduino microcontroller is not, itself, an "input mechanism"; the rejection does not rely on the Arduino as the input mechanism, but on the buttons, switches, and control identified above.
Argument C: Applicant argues that the Office Action's citation of the host laptop/workstation 670 reflects the Examiner's agreement that the on-device controls do not receive the test settings.
Response to Argument C: Claim 1 requires "one or more user-actuatable input mechanisms," and the rejection identified several input mechanisms in the alternative — on/off switch 144, control 146, mode control button 32, snooze button 640, and host laptop 670 — any one of which satisfies the limitation. Identifying the host laptop among the alternatives is not a concession that the on-device controls fail to read on the claim; control 146 alone satisfies the limitation, as explained above. In any event, the host laptop 670 itself is user-actuatable: it is operated by a healthcare professional to configure the device (Eltorai [0053]–[0054]). Claim 1 does not require that the user-actuatable input mechanism be actuated by the patient, nor that it be integral to the device housing; the term "user-actuatable" distinguishes only human-actuated input from input that is automatically derived. Applicant's own specification is consistent with this construction, as it describes medical personnel inputting the desired air volume (e.g., application PGPUB [0029]). Thus, even crediting Applicant's contention that the relevant settings are configured via the workstation, that configuration is performed by a user actuating an input mechanism, and the limitation is met.
For the foregoing reasons, Eltorai discloses each and every limitation of independent claim 1, including the "user-actuatable input mechanisms" added by amendment, and the rejection of claim 1 under 35 U.S.C. 102(a)(1)/(a)(2) is maintained.
Applicant argues that claims 2–8 are allowable by virtue of their dependence from claim 1 and presents no separate arguments directed to the limitations of these claims. Because claim 1 is not allowable for the reasons above, claims 2–8 fall with claim 1, and the rejection of claims 2–8 is 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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/RAJSHEED O BLACK-CHILDRESS/Examiner, Art Unit 2685
/QUAN ZHEN WANG/Supervisory Patent Examiner, Art Unit 2685
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