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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04 August 2025 has been entered. Claims 16 and 23 are currently amended. Claims 33-34 are new. Claims 16-34 are pending in the application. Applicant’s amendments to the claims have overcome the rejections under 35 U.S.C. 112(b) previously set forth in the Final Office Action mailed 02 April 2025.
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.
Claims 16-18, 22-30, and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Go et al. (KR 101722904), hereinafter Go, in view Rogers et al. (US PGPub No. 2017/0135854), hereinafter Rogers, and further in view of Fia et al. (US PGPub No. 2019/0111240), hereinafter Fia.
Regarding claim 16, Go teaches a device for the hyperthermal treatment of itching or herpes diseases (see machine translation par. 0010: “a portable pest bite soothing device that can minimize itching by soothing the area bitten by a pest at a constant temperature”)
comprising at least one treatment surface (Figs. 1-2 and par. 0034: “The heating part 11 provides heat by directly contacting the affected area”)
and a control device (Fig. 5: control unit 120), which is configured to regulate the treatment surface in a heating-up phase to a treatment temperature between 40° – 65° C by heating at least one heating element according to predetermined treatment parameters of a treatment program (Fig. 2: heating element 112; par. 0061: “the control unit 120 operates in response to settings set from the mobile communication terminal 1. For example, when 'infant' is selected in 'age group', the portable insect bite soothing device 10 enters the infant mode and sets the initial temperature to 37° C and controls the maximum temperature not to exceed 45° C;” examiner notes that the disclosed temperature range overlaps with the claimed temperature range and therefore meets the limitation),
characterized in that at least two different treatment programs specifying different treatment parameters are available for selection (par. 0060: “a settings screen where you can set 'age range', 'season', 'set temperature (initial (lowest)/highest)', 'rise temperature', 'rise time', etc. For example, 'age range' is set to 5 levels such as infants, toddlers, children, teenagers and adults, 'season' is set to 2 levels (summer and winter)” and par. 0061: “For example, when 'infant' is selected in 'age group', the portable insect bite soothing device 10 enters the infant mode and sets the initial temperature to 37° C and controls the maximum temperature not to exceed 45° C”),
and wherein the device has at least one interface for a connection to a mobile device (Fig. 1: connection port 13; par. 0058: “a connection port 13 (i.e., USB port) electrically connected to the end of the connection cable 12. It is electrically connected to the mobile communication terminal 1” and par. 0060: “an interface is formed between the mobile communication terminal 1 and the portable insect bite soothing device 10”),
and the device is configured for a selection of one of the at least two treatment programs by said mobile device (par. 0061: “the control unit 120 operates in response to settings set from the mobile communication terminal 1”), so that the selected treatment program is executed after actuation of an operating element which is present on the device or the mobile device (Fig. 2: switch 113; par. 0055: “the heating element 112 heats the heating plate of the metal PCB 111 when the switch 113 is turned on”),
wherein the device is configured in such a way that the mobile device is excluded from changing the treatment parameters, which are specified by the treatment programs (par. 0061: “For example, when 'infant' is selected in 'age group', the portable insect bite soothing device 10 enters the infant mode and sets the initial temperature to 37° C and controls the maximum temperature not to exceed 45° C;” examiner notes that the treatment parameter of maximum temperature is specified by the treatment program and cannot be changed by the mobile device).
Go does not explicitly teach wherein the at least two different treatment programs are stored on the control device, or wherein the device is configured in such a way that the mobile device can be used only to select one of the at least two stored treatment programs, but is excluded from setting or changing the treatment parameters specified by the stored treatment programs, in order to limit the regulatory rights of the mobile device and avoid security risks associated with a possibility of the mobile device setting or changing the treatment parameters according to which the treatment surface is to be heated.
However, in an analogous art, Rogers teaches a thermal therapy device with a patient control device that can be used only to select one of several stored treatment programs stored on a controller (Fig. 7 and par. 0025: “a treatment module screen that enables a user to provide instructions to apply an idealized thermal waveform to the ear canal of a patient by touching the circular selection indicator to the right of the desired waveform;” see also par. 0152: “The treatment module may be configured to retrieve prescriptions from any suitable database, including […] a prescription database residing in the controller”), but is excluded from setting or changing the treatment parameters specified by the stored treatment programs, in order to limit the regulatory rights of the controller and avoid security risks associated with a possibility of the controller setting or changing the treatment parameters according to which the treatment surface is to be heated (par. 0087: “A prescription may comprise any suitable instructions and/or limitations, including, but not limited to, the parameters of the waveform(s) to be delivered to the patient [...] Any conventional security means may be provided to prevent unauthorized modification of the prescription (e.g., the prescription may be password protected, with only the prescribing physician having knowledge of and/or access to the password);” see also par. 0224: “For example, the controller may be configured to operate in a patient mode, wherein the user is allowed to perform patient-oriented tasks, such as starting/stopping a treatment session and/or providing feedback regarding the effectiveness of a treatment session, but is prevented from accessing other modules/databases/functionalities (e.g., the user may be prevented generating, modifying, updating and/or extending prescriptions)”).
To provide the device of Go with a patient mode restricting the ability to modify treatment programs stored on a patient control device, as suggested by Rogers, would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, for the following reasons:
Go teaches a prior art thermal therapy device upon which the claimed invention (having treatment programs stored on the control device and limiting regulatory rights of the mobile device such that the treatment programs cannot be modified) may be seen as an “improvement.” Rogers teaches a prior art thermal therapy device using a known technique that is applicable to the device of Go, namely, the technique of storing treatment programs on a controller and providing conventional security means on a patient control interface to prevent patients from modifying the stored treatment programs.
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Rogers to the thermal therapy device of Go would have yielded predictable results and resulted in an improved system, namely, a system having a patient mode with conventional security means to prevent patient users from modifying prescribed treatment programs.
Go also does not explicitly teach wherein the control device is configured to maintain the treatment temperature for a treatment duration between 1 and 12 seconds. However, in an analogous art, Fia teaches a device for hyperthermal treatment of herpes diseases wherein the device is configured to maintain a treatment temperature for a treatment duration between 1 and 12 seconds (par. 0039: “The heat treatment and/or the antimicrobial treatment may have a treatment time of about 3-15 seconds;” examiner notes that the disclosed duration range overlaps with the claimed duration range and therefore meets the limitation) in order to kill or inactivate a virus such as a herpes virus (par. 0039: “par. 0039: there is provided use of heat and an antimicrobial agent to kill or inactivate a virus. The heat treatment and antimicrobial treatment may be effected by applying a heated source of antimicrobial agents to an environment containing the virus. The virus may comprise the Zika virus, the herpes simplex virus, and/or the West Nile virus”). 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 control device of Go to maintain the treatment temperature for a treatment duration between 1 and 12 seconds, as taught by Fia, in order to kill or inactivate a herpes virus, as taught by Fia.
Regarding claim 17, the combination teaches the device of claim 16 as described previously. Go further teaches wherein the treatment parameters defined by the treatment programs include the treatment temperature (par. 0061: “For example, when 'infant' is selected in 'age group', the portable insect bite soothing device 10 enters the infant mode and sets the initial temperature to 37° C and controls the maximum temperature not to exceed 45° C”).
Go does not explicitly teach wherein the treatment duration is a treatment parameter defined by the treatment programs. However, Fia teaches wherein treatment duration is a treatment parameter defined by treatment programs (par. 0074: “predetermined treatment programs having different treatment times and/or intensities”) as needed in order to inactivate a virus (par. 0044: “The heat treatment and the antimicrobial treatment may be applied for a time and an intensity sufficient to inactivate the virus topically”). 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 treatment parameters defined by the treatment programs of Go to include a treatment duration, as taught by Fia, at an appropriate duration in order to inactivate a virus, as taught by Fia.
Regarding claim 18, the combination teaches the device of claim 16 as described previously. Go further teaches wherein the device exhibits only exactly one operating element for heating the treatment surface in accordance with the selected treatment program (Figs. 2-3: switch 113; par. 0040: “the user can drive the heating unit 11 by pressing the switch 113;” examiner notes that no other operating elements are disclosed) and a manual selection of a treatment program cannot be made manually on the device itself (Fig. 6 and par. 0060: “the screen window of the mobile communication terminal (1) provides a settings screen;” because the settings screen is only available on the mobile communication terminal and not on the device itself, examiner interprets the disclosed configuration as meeting this limitation).
Regarding claim 22, the combination teaches the device of claim 16 as described previously. Fia further teaches that the treatment programs have different treatment durations (par. 0074: “predetermined treatment programs having different treatment times”) and appropriate treatment duration ranges that overlap with 1-3 seconds and 3-12 seconds (par. 0043: “the treatment time is about 3-15 seconds [or] about 10-15 seconds”), but the combination does not explicitly teach that in a first of the selectable treatment programs a treatment duration of 1 - 3 seconds is specified, while in a second of the selectable treatment programs a treatment duration between 3 - 12 seconds is specified. However, in light of Fia’s teachings, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a treatment duration of 1-3 seconds for a first treatment program and a treatment duration of 3-12 seconds for a second treatment program, since Fia teaches that the treatment programs have different treatment durations, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 23, the combination teaches the device of claim 16 as described previously. Go is silent with respect to the size of the treatment surface and does not teach wherein the size of the treatment surface is less than 1 cm2 or between 1 cm2 and 18 cm2. However, Fia teaches wherein the size of the treatment surface is less than 1 cm2 or between 1 cm2 and 18 cm2 (par. 0071: “the size of the applicator surface 20 can be adapted according to the intended use of the device 10 […] For example, the applicator surface 20 can have a surface area of between about 20-40 mm2, 30-40 mm2, or about 35-40 mm2. In yet other embodiments, the applicator surface 20 has a surface area of about 40-250 mm2, 40-200 mm2, 40-150 mm2, 40-100 mm2, 150-250 mm2, 175-250 mm2, or 200-250 mm2;” examiner notes that 20-40 mm2 corresponds to 0.2-0.4 cm2, which is less than 1 cm2, and 200-250 mm2 corresponds to 2.0-2.5 cm2, which is between 1 cm2 and 18 cm2). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the specific dimensions taught by Fia in the device of the combined reference, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 24, the combination teaches the device of claim 16 as described previously. Go further teaches, in a further embodiment, wherein the device comprises an energy storage device (Fig. 8: rechargeable battery 23). 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 first embodiment of Go with a battery, as taught in the second embodiment of Go, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, namely, one skilled in the art would have recognized that the battery of Go’s second embodiment would allow the device of the combined reference to be used without receiving power from the mobile device.
Regarding claims 25 and 32, the combination teaches the device of claim 16 as described previously. Go further teaches wherein the interface is additionally configured for a power supply by means of a mobile device and for a data exchange with a mobile device (par. 0058: “a connection port 13 (i.e., USB port) electrically connected to the end of the connection cable 12. It is electrically connected to the mobile communication terminal 1 through. Accordingly, the portable pest bite soothing device 10 operates by receiving power from a battery provided in the mobile communication terminal 1;” examiner interprets a cable connected to a mobile communication terminal as configured for data exchange with the mobile device).
Regarding claim 26, the combination teaches the device of claim 16 as described previously. Go further teaches wherein the device comprises at least one first temperature sensor for measuring the temperature of the treatment surface and the control device is configured to set the temperature of the treatment surface based on the measurement data of the temperature sensor, or further comprising a hardware-implemented temperature monitor configured to reversibly limit the maximum temperature of the treatment surface and a fuse configured to switch off the device in the event of a short circuit or uncontrolled continued heating (Fig. 5: internal temperature sensor 117; par. 0047: “It may further include an internal temperature sensor 117 that detects the temperature of the heating element 112” and par. 0048: “The internal temperature sensor 117 detects the temperature of the heating element 112 in real time and transmits a detection signal corresponding to the detected temperature to the control unit 120. The control unit 120 blocks the temperature of the heating element 112 from excessively rising in response to the detection signal of the internal temperature sensor 117”). Examiner notes that because this claim recites limitations in the alternative, the claim is regarded to be met when only one of the limitations (in this case, the control device configured to set the temperature of the treatment surface based on the measurement data of the temperature sensor) is taught by the prior art.
Regarding claim 27, the combination teaches the device of claim 16 as described previously. Go further teaches wherein the device comprises a contact sensor which can determine whether or not the treatment surface is in contact with a skin (Figs. 3 and 5: contact sensor 119; par. 0054: “the heating unit 11 may further include a contact sensor 119 […] The contact sensor 119 is installed at the bottom of the lower cover 115 to detect when the heating unit 11 is in contact with the human body”).
Regarding claim 28, the combination teaches the device of claim 16 as described previously. Go further teaches a kit comprising a device according to claim 16 and a software for installation on a mobile device (Fig. 6 and par. 0059: “An application for controlling and setting the operation of the portable pest bite soothing device 10 may be installed in this mobile communication terminal 1”), wherein the software is configured to select one of at least two treatment programs via the interface of the device (par. 0060: “When the user runs the app installed on the mobile communication terminal 1, an interface is formed between the mobile communication terminal 1 and the portable insect bite soothing device 10. In addition, the screen window of the mobile communication terminal (1) provides a settings screen where you can set 'age range', 'season', 'set temperature (initial (lowest)/highest)', 'rise temperature', 'rise time', etc.”).
Regarding claim 29, the combination teaches the device of claim 16 as described previously. Go further teaches a system comprising a device according to claim 16 and a mobile device (Fig. 6: device 10, mobile communication terminal 1), wherein a software is installed on the mobile device, which is configured to select one of at least two treatment programs via the interface of the device (par. 0060: “When the user runs the app installed on the mobile communication terminal 1, an interface is formed between the mobile communication terminal 1 and the portable insect bite soothing device 10. In addition, the screen window of the mobile communication terminal (1) provides a settings screen where you can set 'age range', 'season', 'set temperature (initial (lowest)/highest)', 'rise temperature', 'rise time', etc.”).
Regarding claim 30, the combination teaches the device of claim 16 as described previously. Go further teaches wherein in between 2 and 10 treatment programs are stored on the control device (par. 0060: “For example, 'age range' is set to 5 levels such as infants, toddlers, children, teenagers and adults, 'season' is set to 2 levels (summer and winter)”).
Regarding claims 33-34, the combination teaches the device of claim 16 as described previously. Rogers also teaches that the treatment programs are stored in a firmware of the control device (par. 0073: “the present invention may be embodied in hardware and/or software (including firmware, resident software, micro-code, etc.)”) in a manner that a change of the treatment program via the at least one interface for the connection to the mobile device is excluded, and that within the firmware a parameter for the selection of one of the at least two stored treatment programs can only be changed via the at least one interface for the connection to the mobile device by an appropriate command, but not any one of the treatment parameters defined in the stored treatments programs (Fig. 7 and par. 0025: “a treatment module screen that enables a user to provide instructions to apply an idealized thermal waveform to the ear canal of a patient by touching the circular selection indicator to the right of the desired waveform;” par. 0224: “the controller may be configured to operate in a patient mode, wherein the user is allowed to perform patient-oriented tasks, such as starting/stopping a treatment session and/or providing feedback regarding the effectiveness of a treatment session, but is prevented from accessing other modules/databases/functionalities (e.g., the user may be prevented generating, modifying, updating and/or extending prescriptions)”), for the same reasons set forth previously in the rejection of claim 16.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Go in view of Rogers and Fia and further in view of Bradley et al. (WO 2017/127552), hereinafter Bradley.
Go in view of Rogers and Fia teaches the device of claim 16 as described previously. The combination does not teach wherein the device is configured in such a way that, independently of an existing communication to a mobile device, a last selected treatment program is executed after an actuation. However, in the same field of endeavor, Bradley teaches a handheld skin care appliance with a heat source wherein a last selected treatment program is executed after an actuation (par. 00194: “In some embodiments, at step 604, the user selects the program setting. […] The user may change the level setting by pressing a level-selection button on the device 100 to cycle through the different level options. In some embodiments, upon subsequent use, device 100 will default to its previous selected setting”). To configure the device of the combined reference such that a last selected treatment program is executed after an actuation, as suggested by Bradley, would have been obvious to one skilled in the art for the following reasons:
Go in view of Rogers and Fia teaches a skin treatment device upon which the claimed invention (configured such that a last selected treatment program is executed after an actuation) can be seen as an “improvement.” Bradley teaches a prior art comparable device (skin care appliance) using a known technique that is applicable to the skin treatment device of the combined reference, namely, the technique of configuring the device to default to its previous selected program setting. Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that applying the known technique taught by Bradley to the skin treatment device of the combined reference would have yielded predictable results and resulted in an improved system.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Go in view of Rogers and Fia and further in view of McMahon et al. (WO 2019/046129), hereinafter McMahon.
Go in view of Rogers and Fia teaches the device of claim 16 as described previously. The combined reference does not teach wherein the interface and the control device are configured in such a way that a selection of one of the at least two treatment programs by means of a mobile device is only allowed if an authentication has been successful. However, in the same field of endeavor, McMahon teaches a handheld thermal therapy device and separate computer that are configured in such a way that a selection of a treatment program is only allowed if an authentication has been successful (par. 0063: “the device is normally in an inactive state when powered on, waiting for an external communication. The user may then request or purchase a therapy session or sessions, this request being made using the communication methods aforementioned or through any other communication method. In this case, the separate computer may act as a host computer. The host computer may then determine if the request or purchase is authorized, and may potentially process the purchase transaction. The host computer may also be commanded to make the authorization by a third party. If authorized, then the host computer may send a communication to the device which allows it to be operated per the request or purchase”). McMahon further teaches that controlling the number and duration of device operations enables a second party to charge a fee based on the number of operating sessions, the durations of sessions, the combination of the sessions or duration of sessions or some other parameters (par. 0062).
It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the interface and control device of the combined reference so that selection of one of the at least two treatment programs by means of a mobile device is only allowed if an authentication has been successful, as taught by McMahon, in order to enable a second party to charge a fee based on the number of operating sessions, the durations of sessions, the combination of the sessions or duration of sessions or some other parameters, as taught by McMahon.
Claims 21 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Go in view of Rogers and Fia and further in view of Li et al. (US PGPub No. 2007/0265688), hereinafter Li.
Regarding claim 21, Go in view of Rogers and Fia teaches the device of claim 16 as described previously. Go further teaches that the treatment temperature specified in at least one treatment program is between 40° C and 60° C (par. 0061: “when 'infant' is selected in 'age group', the portable insect bite soothing device 10 enters the infant mode and sets the initial temperature to 37° C and controls the maximum temperature not to exceed 45° C;” examiner notes that the disclosed temperature range overlaps with the claimed temperature range and therefore meets the limitation) but does not teach wherein the treatment temperatures of at least two programs are between 40° C and 60° C. However, Li teaches optimal treatment temperatures for at least two age ranges that are between 40° C and 60° C (par. 0008: “Temperatures around 49+/-0.5° C. have been found optimum for most children, as have temperatures of 51.5+/-0.8° C. for adults, and of 47+/-0.5° C. for toddlers and some temperature sensitive women, in the case of itch”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select treatment temperatures for at least two of the treatment programs of the combined reference that are between 40° C and 60° C, as taught by Li, in order to use treatment temperatures that have been found optimal for different age ranges, as taught by Li.
Regarding claim 31, Go in view of Rogers and Fia teaches the device of claim 16 as described previously. Go does not explicitly teach that in a first of the selectable treatment programs a treatment temperature between 48° C and 53° C is specified, while in a second of the selectable treatment programs a treatment temperature between 45° C and 48° C is specified. However, Li teaches optimal treatment temperatures that vary according to age range, wherein one of the optimal treatment temperatures for an age range is between 48° C and 53° C (par. 0008: “Temperatures around 49+/-0.5° C. have been found optimum for most children”) and another optimal treatment temperature for an age range is between 45° C and 48° C (par. 0008: “[…] 47+/-0.5° C. for toddlers and some temperature sensitive women”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a treatment temperature for a first of the combined reference’s selectable treatment programs that is between 48° C and 53° C, and a treatment temperature for a second treatment program that is between 45° C and 48° C, as taught by Li, in order to use treatment temperatures that have been found optimal for different age ranges, as taught by Li.
Response to Arguments
Applicant’s arguments, filed 04 August 2025, with respect to the rejection(s) of claim(s) 16 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claim, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rogers. As described previously, Rogers teaches excluding a patient user from modifying stored treatment programs as a security measure in a patient mode of a thermal therapy device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794