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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/03/2026 has been entered.
Claim Objections
Claim 7 is objected to because of the following informalities. Claim 7 recites "the server," which lacks proper antecedent basis because claim 6, from which claim 7 depends, recites "a server system." Claim 7 also recites "the one or more output mechanisms transmits," which should read "the one or more output mechanisms transmit." The Examiner suggests amending claim 7 to read, e.g., "…wherein the one or more output mechanisms transmit the information to the one of the mobile device, the computing device, or the server system, and wherein the mobile device or the server system presents the information." Appropriate correction is required.
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) 1–5 and 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 (As amended, claim 1 requires that the monitoring component and the user interface be co-located in a singular physical device body. The rejection therefore relies on the construction of Eltorai in which circuit 100, FIG. 4, "represents the architecture of components within a clamp system 200," FIG. 5 ([0035]–[0037]). Clamp system 200 is "removably placed on an incentive spirometer as desired" ([0036]); see also [0008] and [0015] (sensor integrated into a removable clamp). Because it is removable and re-placeable, clamp system 200 is a reusable monitoring device.), comprising:
at least one attachment mechanism operatively attaching the reusable monitoring device to a first analog incentive spirometry device (Eltorai discloses clamp system 200 includes a first portion 202 and a second portion 204 pivotally connected to each other at pivot hinge 205 and biased to a closed condition. Gripping surfaces 220, 222, and 224 engage the cylindrical tube defining the chamber of the incentive spirometer, so that clamp system 200 is removably placed on the incentive spirometer ([0036]–[0037]; FIG. 5). The incentive spirometer is a conventional device in which the user's inhalation displaces a piston P within a chamber C bearing volume graduations ([0029]; FIGS. 1–3). It is therefore an analog incentive spirometry device.);
a monitoring component monitoring use of the analog incentive spirometry device by a first patient (Eltorai discloses circuit 100 includes sensor 102, comprising light source 104 and photo resistor 106, connected to microcontroller 130 ([0035]; FIG. 4). In clamp system 200, light source 210 directs optical radiation 211 through the tube of the incentive spirometer, and photo sensor 212 identifies disruption of the radiation when the piston passes between the light source and the detector ([0037]; FIG. 5). The microcontroller takes the sensor inputs indicating piston movement and records the events ([0038]; FIG. 6). The sensor and microcontroller thus monitor the patient's use of the incentive spirometer.); 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 circuit 100 includes control unit 140 having an on/off switch 144 and a control 146 "to enable an authorized user to increase or decrease the interval between sessions" ([0035]; FIG. 4). Control 146 and switch 144 are physically actuated by a user and are therefore user-actuatable input mechanisms. The interval between sessions is the rate at which the particular patient is to perform incentive spirometry, and it is "set by a healthcare professional" for the user ([0030]). The session-interval settings received via control 146 are thus patient-specific incentive spirometry parameters associated with the first patient's use of the incentive spirometer. The claim does not require that the input mechanism be actuated by the patient, as opposed to a healthcare professional or other authorized user.); 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 discloses circuit 100 includes noise maker 150, controlled by microcontroller 130 ([0035]; FIG. 4), which corresponds to the alarm device contained within housing 230 of clamp system 200 ([0037]). The alarm sounds to prompt the user at the preselected session interval and is deactivated only after the sensor detects that the piston has at least reached a preselected threshold ([0025]–[0026], [0038]; FIG. 6, steps 304–310; Abstract). Because the claim recites "at least one of" the listed categories, the alarm's presentation of a session prompt at the patient-specific interval set via control 146 satisfies the limitation, as it presents information regarding the first patient-specific incentive spirometry parameters. In addition, upon detection of sufficient piston movement, the device records the time of activation, and the timer begins counting the next selected period from that point ([0038]; FIG. 6, steps 312–314). Each subsequent prompt therefore reflects processing of the monitored use relative to the selected interval.),
wherein the monitoring component and the user interface are co-located in a singular physical device body (Eltorai discloses that circuit 100 "represents the architecture of components within a clamp system 200" ([0036]). Circuit 100 includes sensor 102, microcontroller 130, control unit 140 with switch 144 and control 146, and noise maker 150. The microcontroller, control unit, and alarm device are contained within housing 230 of the clamp, and light source 210 and photo sensor 212 are carried on the clamp itself ([0037]; FIG. 5). Portions 202 and 204 are pivotally connected to each other at pivot hinge 205, and the clamp system is placed on and removed from the incentive spirometer as a single unit ([0036]). The monitoring component and the user interface are thus co-located in a singular physical device body, namely clamp system 200.).
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 clamp system 200 is "removably placed on an incentive spirometer as desired." Projections 207 and 209 may be squeezed to open the clamp "to assist initial placement or removal" ([0036]; FIG. 5); see also [0008] and [0015]. The attachment mechanism is therefore capable of being removed from the first incentive spirometer and operatively attached to a second analog incentive spirometer. Further, the recitation of attachment to a "second" analog incentive spirometry device is directed to the manner in which the claimed apparatus is intended to be used. An apparatus claim covers what a device is, not what a device does. Where the prior art structure is the same as the claimed structure and is capable of performing the recited function, the recitation does not distinguish the claimed apparatus from the prior art (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 discloses the monitoring component of clamp system 200 detects piston movement in whichever incentive spirometer the clamp is placed on. Light source 210 directs radiation through the tube, photo sensor 212 detects its disruption by the piston, and microcontroller 130 records the events ([0035]–[0038]; FIGS. 4–6). When clamp system 200 is moved to a second analog incentive spirometer used by a second patient, as permitted by its removable construction ([0036]), the same monitoring component is capable of monitoring that use. This recitation is directed to intended use 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 discloses control 146 enables an authorized user to increase or decrease the interval between sessions ([0035]). The session interval is set for the user by a healthcare professional ([0030]), and operation continues at that interval "until it is altered by a healthcare professional" ([0038]). The input mechanisms are therefore capable of receiving a second patient's session-interval setting when clamp system 200 is moved to a second incentive spirometer for use by a second patient. This recitation is directed to intended use 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 noise maker 150 sounds at whatever session interval has been set via control 146 and is silenced upon detection of sufficient piston movement ([0035], [0037]–[0038]; FIG. 6). When clamp system 200 is used with a second incentive spirometer by a second patient whose interval has been set via control 146, as set forth for claims 2–4, the same output mechanism presents information regarding the second patient-specific parameters and the results of processing that patient's monitored use, in the same manner as set forth for claim 1. This recitation is directed to intended use and does not structurally distinguish the claimed apparatus from Eltorai (MPEP 2114).).
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 noise maker 150 sounds when a session is due and is silenced upon detection of sufficient piston movement ([0035], [0038]; FIG. 6, steps 304–310). It thus presents information in real time as the patient uses the incentive spirometer. Because the claim recites operation "in real time or non-real time," the limitation is met.).
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.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eltorai (US 20180000379 A1).
Regarding claim 6, Eltorai discloses the reusable monitoring device of claim 1, as set forth above. The clamp system 200 / circuit 100 construction of Eltorai is not expressly described as 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.
However, Eltorai teaches such a communications interface for another construction of the same system. System 10 communicates with a laptop LP via wireless signal 42, such as Bluetooth Low Energy transmission ([0029]; FIG. 1), and alarm device 16 communicates with a smart phone, tablet, or other mobile device of the user ([0031]). Eltorai further teaches that data gathered to local storage is uploaded "via USB linkage to a host computer" ([0041]), and identifies a "network interface for logging data transfer" among the hardware components of a typical system according to the invention ([0040]). Eltorai further states that features shown in some drawings and not in others are so shown "for convenience only, as each feature may be combined with any or all of the other features," and that "[s]ubstitutions of elements from one described embodiment to another are also fully intended and contemplated" ([0056]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the clamp system 200 construction of Eltorai with the wired (USB) or wireless (Bluetooth Low Energy) communications interface that Eltorai teaches for system 10, so that the device is operatively connected to a computing device (laptop LP / host computer) or a mobile device (smart phone or tablet). One of ordinary skill would have been motivated to do so because Eltorai teaches that time-stamped data is stored on the device until required for upload ([0032]) and that recorded data is uploaded to a host computer ([0041]), that time-stamping and tracking of usage is useful for clinical monitoring of incentive spirometer frequency of use and inspiratory volume achievements ([0054]), and that prompts delivered to the patient's mobile device encourage the user to begin a session ([0031]). The modification merely applies a known communications interface, taught by the same reference for the same system, to another construction of that system according to known methods, and would have yielded the predictable result of permitting data and prompts to be exchanged with an external device. See MPEP 2143(I)(A). Moreover, Eltorai expressly suggests combining features and substituting elements between its described constructions ([0056]).
Regarding claim 7, Eltorai, as modified, 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 mobile device or server system presents the information (For purposes of examination, "the server" is construed as referring to the "server system" recited in claim 6. Eltorai teaches that the alarm device communicates with a smart phone, tablet, or other mobile device of the user to produce a sound, a visible message, or a visual cue to induce the user to begin the session ([0031]). The output mechanism thereby transmits information regarding the patient-specific session interval to the mobile device, and the mobile device presents the information. Eltorai further teaches transmission of time-stamped inspiratory event data to laptop LP / a host computer for data collection and clinical monitoring ([0029], [0032], [0041], [0054]).). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the output mechanism of the modified clamp system 200 to transmit such information over the communications interface to the user's mobile device for presentation, as Eltorai teaches, for the same reasons set forth for claim 6. Doing so would encourage the patient to begin each session ([0031]) and support clinical monitoring of compliance ([0054]).
Response to Arguments
Applicant's arguments have been fully considered but are not persuasive. Applicant's amendment to claim 1 adds the limitation that "the monitoring component and the user interface are co-located in a singular physical device body," and it necessitated the revised grounds of rejection set forth above. The rejection of claim 1 now relies on the construction of Eltorai in which circuit 100 "represents the architecture of components within a clamp system 200" (Eltorai [0035]–[0037]; FIGS. 4–5). It no longer relies on host laptop/workstation 670 or on apparatus 600.
Argument A: Applicant argues that the claimed device is a self-contained unit or singular physical device body requiring no separate, remote, or other device to receive the first patient-specific incentive spirometry parameters, as described at [0027]–[0028] and FIGS. 2A–2B of the specification. Applicant further argues that claim 1 has been amended to recite this feature (Remarks, pp. 4–5).
Response to Argument A: Eltorai discloses the co-location now recited. Circuit 100 "represents the architecture of components within a clamp system 200." It includes sensor 102, microcontroller 130, control unit 140 with on/off switch 144 and control 146, and noise maker 150. The microcontroller, control unit, and alarm device are contained within housing 230, and light source 210 and photo sensor 212 are carried on the clamp itself (Eltorai [0035]–[0037]; FIGS. 4–5). The monitoring component and the user interface are therefore co-located in a singular physical device body, namely clamp system 200. To the extent Applicant relies on the device "requiring no separate, remote, or other device," that feature is not recited in the claims. Amended claim 1 requires that the monitoring component and the user interface be co-located. It does not exclude a device that can also communicate with an external device. Claim 1 uses the open-ended transitional term "comprising," and dependent claim 6 expressly recites a communications interface connecting the device to a mobile device, a computing device, or a server system. Limitations from the specification are not read into the claims (MPEP 2111.01(II), 2145(VI)). Applicant's argument is not persuasive.
Argument B: Applicant argues that Eltorai requires a separate host laptop or workstation 670 to configure test settings through an Arduino microcontroller (Eltorai [0053]–[0054]), that the prior Office action's reliance on [0053]–[0054] reflects an appreciation of this distinction, and that Arduino processor 101 is not a user-actuatable input mechanism (Remarks, p. 5).
Response to Argument B: The cited passages of Eltorai describe apparatus 600 (FIGS. 10A–11), in which Arduino 101 controller 610 is configured using workstation 670 (Eltorai [0051], [0053]–[0054]). The rejection of amended claim 1 does not rely on apparatus 600, workstation 670, or Arduino 101, so Applicant's arguments directed to those elements are moot. The rejection relies instead on clamp system 200. In that construction, 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" (Eltorai [0035]), and the control unit is contained within housing 230 of the clamp (Eltorai [0037]). Control 146 is a user-actuatable input mechanism located on the device itself. The session interval it receives is a parameter set for the particular user by a healthcare professional (Eltorai [0030]). This mapping was set forth in the prior Office action (Response to Argument B), and Applicant's remarks do not address it. Identifying workstation 670 as one of several alternatives in the prior action was not a concession that the on-device controls fail to meet the limitation. Applicant's argument is not persuasive.
Argument C: Applicant argues that system 10 of Eltorai, which includes sensor 12, mode control button 32, and indicator light 34, does not allow a user to enter test settings; that Eltorai does not define "mode" except for a sleep mode at [0032], which is not analogous to "patient-specific incentive spirometry parameters"; and that, at best, a user may only actuate mode control buttons (Remarks, p. 5).
Response to Argument C: The rejection does not rely on mode control button 32 as the claimed input mechanism. The argument concerning the meaning of "mode" therefore does not address the rejection. Moreover, Applicant's contention that a user "may only actuate mode control buttons" is contradicted by Eltorai's express disclosure of control 146, which enables an authorized user to increase or decrease the interval between sessions (Eltorai [0035]). Even as to system 10, Eltorai does not limit configuration to an external computer. It describes "adjustment of parameters in system 10 and/or laptop LP" by a healthcare professional or other authorized person (Eltorai [0030]), and it explains that the device button "enables configuration of certain aspects of the device" (Eltorai [0041]). Applicant's argument is not persuasive.
Applicant argues that claims 2–8 are allowable by virtue of their dependence from claim 1 and "in addition to other patentable features when those claims are considered as a whole" (Remarks, p. 5). No separate argument is presented for the limitations of any dependent claim. A general allegation of patentability that does not specifically point out how the claim language distinguishes over the reference does not comply with 37 CFR 1.111(b). Claims 2–5 and 8 stand rejected under 35 U.S.C. 102 as set forth above. Claims 6 and 7 are rejected under 35 U.S.C. 103 over Eltorai on a new ground of rejection necessitated by Applicant's amendment to claim 1. The co-location limitation added to claim 1 precludes reliance on host workstation 670 as the claimed input mechanism and on the apparatus 600 construction previously relied upon, and requires reliance on the clamp system 200 construction, which is not expressly described as including a communications interface.
Applicant's remarks do not address the objection to claim 7. Although the amendment corrects "whererin," amended claim 7 continues to recite "the server," which lacks proper antecedent basis because claim 6 recites "a server system," and further recites "the one or more output mechanisms transmits." The objection is therefore maintained, as set forth above.
For the foregoing reasons, Applicant's arguments are not persuasive, and claims 1–8 stand rejected as set forth above.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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
