DETAILED ACTION
This office action is in response to the preliminary amendment filed 11/28/2023. As directed by the amendment, claim 1 have been amended, claim 12 has been cancelled, and claims 13-17 have been newly added. Thus, claims 1-11 and 13-17 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement filed 5/17/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 7 is objected to because of the following informalities: Lines 1-2 recites, “wherein the electrical energy generator is configured to generate EMS or TENS”; it is suggested to amend the claim to recite --wherein the electrical energy generator is configured to generate electronic muscle stimulation (EMS) or transcutaneous electrical nerve stimulation (TENS)-- so that it is clear what the initials stand for in the claims. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an electrical energy generator configured to generate electrical energy and apply the electrical energy to the user of the handheld treatment device” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 4 is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
The following claims appear positively recite part of the human body in combination with the structure of the claimed invention:
“the heater transfers the heat to the user via the metal plate” in claim 4.
Applicant needs to clearly state using inferential language (e.g. configured to, adapted to, etc.) so that the human anatomy is not claimed.
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 of this title, 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 7-10, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kriksunov et al (2010/0228304) in view of Aguiar (2022/0110821).
Regarding claim 1, Kriksunov discloses a handheld treatment device comprising: a heater (22) (secondary modality or sensory cue means can be a heater) (para [0030]) configured to generate heat and apply the heat to a user of the handheld treatment device (secondary modality or sensory cue means can comprise a heater (such as an electric heating element) and a cooler (such as a Peltier device) (para [0042]); a massager (22) (secondary modality or sensory cue can comprise a vibratory sensory cue means) (para [0032]) configured to vibrate and apply the vibration to the user (para [0048]); an electrical energy generator (11,12) (electric circuit, electrode pads) configured to generate electrical energy and apply the electrical energy to the user of the handheld treatment device (para [0029]); and a control interface (15) (control means can include on/off switches, amplitude and frequency control switches, etc) configured to activate one or more of the heater, the massager, and the electrical energy generator (for programming and customizing the treatment) (para [0029])
Kriksunov discloses the secondary modality device can be a cooling means such as a Peltier device (para [0043]); however, Kriksunov does not disclose fan disposed inside the handheld treatment device that is arranged and configured to draw air into an interior of the handheld treatment device, and expel the air to an exterior environment so as to circulate air through the interior of the handheld treatment device.
However, Aguiar in fig 1 teaches a device to apply vibration, heat, and/or cooling to a patient, including a housing (154, 158) (cap, cover) (para [0069]) and a cooling means including a thermoelectric cooler (150), a heatsink (152), and a fan (154) disposed in the housing (154, 158) (para [0154]), wherein the thermoelectric cooler (150) can be a Peltier device (para [0137]), wherein the fan (154) is arranged and configured to draw air into an interior of the housing (154, 158) (through intake (131), and expel the air to an exterior environment (through vents (155) so as to circulate air through the interior of the handheld treatment device (para [0069]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Kriksunov by configuring the cooling secondary treatment modality to be a thermoelectric electric cooler comprising a Peltier device, a fan, and a heat sink, disposed in a housing of the device, wherein the fan is arranged and configured to draw air into an interior of the handheld treatment device, and expel the air to an exterior environment so as to circulate air through the interior of the handheld treatment device as taught by Aguiar in order to improve air circulation from the thermoelectric cooler (para [0077]).
Regarding claim 2, Kriksunov discloses a thermoelectric cooler (22) configured to generate a cooling effect (secondary modality means can provide cold (para [0030]), and can be a Peltier device, which is a thermoelectric cooler (para [0044]), wherein the control interface (15) is further configured to activate the thermoelectric cooler (control means (15) is configured to program and customize the treatment, and therefore can activate the thermoelectric cooler) (para [0029]).
Regarding claim 3, Kriksunov discloses a battery power source housed inside the handheld treatment device that is configured to power the handheld treatment device (power source can be a battery (para [0079]) which is integrated into the device (para [0080]).
Regarding claim 7, Kriksunov discloses the electrical energy generator (11) is configured to generate EMS or TENS (electrical energy generator (11) is capable of generating high voltage pulses for therapeutic treatment through electrode pads (12) (para [0029]), and therapeutic treatment can correspond to treatment parameters corresponding to TENS or Neuromuscular Electrical Stimulation (which is also known as electrical muscle stimulation (EMS) (para [0028])).
Regarding claim 8, Kriksunov discloses a data port or wireless communication circuitry configured to communicate with an external electronic device (control means (15) can be positioned as a remote control device, wirelessly communicating with the electronic circuit (11)).
Regarding claim 9, Kriksunov discloses a plurality of patch connectors (14) (conductive lines), and an electrode pad (12) connected to each patch connector (14), the handheld treatment device being configured to apply the electrical energy to the user via the electrode pads (14) (para [0029]).
Regarding claim 10, Kriksunov discloses a medicinal substance is disposed on the electrode pads (14) (chemical agent can be applied to a hydrogel which is added to the electrode pad of the device) (para [0059]).
Regarding claim 13, Kriksunov discloses the electrical energy generator (11) generates the electrical energy so as to be EMS treatment (electrical energy generator is capable of generating high voltage pulses for therapeutic treatment through electrode pads (12) (para [0029]), and therapeutic treatment can correspond to treatment parameters corresponding to Neuromuscular Electrical Stimulation (para [0028]), which is also known as electrical muscle stimulation (EMS)).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kriksunov et al and Aguiar et al as applied to claim 1 above, and further in view of Wersland et al (2022/0192868).
Regarding claim 4, modified Kriksunov discloses a handheld treatment device
Modified Kriksunov does not disclose a metal plate disposed on a side of the handheld treatment device, wherein the heater transfers the heat to the user via the metal plate.
However, Wersland in figs 1-5 in teaches a device to apply vibration, heat, and/or cooling to a patient, including controllable temperature element (38) configured to provide heating or cooling to a user (para [0063]), and including a spreader member (40) which can be metal (para [0035]) shown in figs 4-5 to be a plate and disposed on a bottom side of the device, wherein the controllable temperature element (38) transfers the heat to the user via the spreader member (40) (para [0063]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Kriksunov by providing a metal plate disposed on a side of the handheld treatment device, wherein the heater transfers the heat to the user via the metal plate as taught by Wersland in order to facilitate transfer of thermal energy (hot or cold) to a user’s body part (Wersland, para [0063]).
Regarding claim 5, modified Kriksunov discloses a metal plate.
Modified Kriksunov does not disclose the metal plate is curved.
However, Wersland in figs 1-5 in teaches a device to apply vibration, heat, and/or cooling to a patient, including controllable temperature element (38) configured to provide heating or cooling to a user (para [0063]), and including a spreader member (40) which can be metal (para [0035]) and shown to be a plate and including a lower surface (40a) (para [0063]), wherein the lower surface of the spreader member (40a) is curved (para [0005]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Kriksunov so that the metal plate is curved as taught by Wersland in order to facilitate contacting a user’s body part (Wersland, para [0005]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kriksunov et al and Aguiar et al as applied to claim 1 above, and further in view of Sedic et al (2022/0015987).
Regarding claim 6, modified Kriksunov discloses a control interface.
Modified Kriksunov does not disclose the control interface a first intensity control button and a second intensity control button, wherein activation of the first intensity control button increases a temperature of the heater, a frequency or amplitude of the vibration, or an energy amount of the electrical energy, and activation of the second intensity control button decreases the temperature of the heater, the frequency or amplitude of the vibration, or the energy amount of the electrical energy.
However, Sedic in fig 1 teaches a device configured to provide a plurality of treatments including operation buttons (104a-c) to select a different treatment, and a first intensity control button (104d) and a second intensity control button (104e) (para [0047]), wherein activation of the first intensity control button (104d) increases an intensity of a selected treatment, and activation of the second intensity control button (104e) decreases intensity of a selected treatment (para [0047]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Kriksunov by providing the control interface with operation buttons to select a desired treatment and a first intensity control button and a second intensity control button, wherein activation of the first intensity control button increases a temperature of the heater, a frequency or amplitude of the vibration, or an energy amount of the electrical energy, and activation of the second intensity control button decreases the temperature of the heater, the frequency or amplitude of the vibration, or the energy amount of the electrical energy as taught by Sedic in order to allow a user to increase or decrease an intensity of a desired therapeutic function using the control interface (Sedic, para [0049]).
Claim(s) 11, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kriksunov et al and Aguiar et al as applied to claims 1 and 2 above, and further in view of Gorham (2007/0282400).
Regarding claim 11, modified Kriksunov discloses a processor (15) (control means for programming and customizing the treatment) disposed within the handheld treatment device and configured to control the handheld treatment device (para [0029]).
Modified Kriksunov does not disclose the processor is configured to control the handheld treatment device to apply, at the same time: heat from the heater; vibration from the massager; and electrical energy from the electrical energy generator.
However, Gorham teaches a combination medical therapy device including a processor (4-6) (power/controller means) configured to control different medical therapy modalities such as vibration (15), heat (16), and electrical stimulation (18) (para [0041]), wherein the process is configured to control simultaneously, heat from a heater (16); vibration from the massager (15); and electrical energy from the electrical energy generator (12) (treatment modalities can be provided simultaneously) (para [0042]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Kriksunov by configuring the processor to control the handheld treatment device to apply, at the same time: heat from the heater; vibration from the massager; and electrical energy from the electrical energy generator as taught by Gorham in order to allow the device to apply multiple healing modalities simultaneously to provide a rapid synergistic healing effect (Gorham, para [0046]).
Regarding claim 14, modified Kriksunov discloses a processor (15) (control means for programming and customizing the treatment) disposed within the handheld treatment device and configured to control the handheld treatment device (para [0029]); wherein the electrical energy applied to the user is EMS treatment (electrical energy generator is capable of generating high voltage pulses for therapeutic treatment through electrode pads (12) (Kriksunov, para [0029]), and therapeutic treatment can correspond to treatment parameters corresponding to Neuromuscular Electrical Stimulation (Kriksunov, para [0028]), which is also known as electrical muscle stimulation (EMS)).
Modified Kriksunov does not disclose the processor is configured to control the handheld treatment device to apply, at the same time: heat from the heater; vibration from the massager; and electrical energy from the electrical energy generator.
However, Gorham teaches a combination medical therapy device including a processor (4-6) (power/controller means) configured to control different medical therapy modalities such as vibration (15), heat (16), and electrical stimulation (18) (para [0041]), wherein the process is configured to control simultaneously, heat from a heater (16); vibration from the massager (15); and electrical energy from the electrical energy generator (12) (treatment modalities can be provided simultaneously) (para [0042]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Kriksunov by configuring the processor to control the handheld treatment device to apply, at the same time: heat from the heater; vibration from the massager; and electrical energy from the electrical energy generator as taught by Gorham in order to allow the device to apply multiple healing modalities simultaneously to provide a rapid synergistic healing effect (Gorham, para [0046]).
Regarding claim 16, modified Kriksunov discloses a processor (15) (control means for programming and customizing the treatment) disposed within the handheld treatment device and configured to control the handheld treatment device (para [0029]); wherein the electrical energy applied to the user is EMS treatment (electrical energy generator is capable of generating high voltage pulses for therapeutic treatment through electrode pads (12) (Kriksunov, para [0029]), and therapeutic treatment can correspond to treatment parameters corresponding to Neuromuscular Electrical Stimulation (Kriksunov, para [0028]), which is also known as electrical muscle stimulation (EMS)).
Modified Kriksunov does not disclose the processor is configured to control the handheld treatment device to apply, at the same time: the cooling effect from the thermoelectric cooler; vibration from the massager; and electrical energy from the electrical energy generator.
However, Gorham teaches a combination medical therapy device including a processor (4-6) (power/controller means) configured to control different medical therapy modalities such as vibration (15), heat (16), and electrical stimulation (18) (para [0041]), wherein the process is configured to control simultaneously, heat from a heater (16); vibration from the massager (15); and electrical energy from the electrical energy generator (12) (treatment modalities can be provided simultaneously) (para [0042]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Kriksunov by configuring the processor to control the handheld treatment device to apply, at the same time: the cooling effect from the thermoelectric cooler; vibration from the massager; and electrical energy from the electrical energy generator as taught by Gorham in order to allow the device to apply multiple healing modalities simultaneously to provide a rapid synergistic healing effect (Gorham, para [0046]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kriksunov et al and Aguiar et al as applied to claim 1 above, and further in view of Mandel (2013/0085552).
Regarding claim 15, modified Kriksunov discloses a thermoelectric cooler (22) configured to generate a cooling effect (secondary modality means can provide cold (Kriksunov, para [0030]), and can be a Peltier device, which is a thermoelectric cooler (Kriksunov, para [0044]), and a processor (15) (control means for programming and customizing the treatment) disposed within the handheld treatment device and configured to control the handheld treatment device (Kriksunov, para [0029])
Modified Kriksunov does not disclose the processor is configured to control the handheld treatment device to alternately apply, at different times, heat from the heater and the cooling effect from the thermoelectric cooler.
However, Mandel teaches a therapeutic treatment device including a Peltier therapy assembly (11) (para [0033]) configured to provide heat and a cooling effect to a user (para [0051]), a massager (42) (vibrator mechanism) configured to apply vibration to a user (para [0042]), and a circuit board (18) including a microprocessor configured to control the treatment device to alternately apply, at different times, heat and the cooling effect (circuit board includes a DC motor driver (U14) that allows a microprocessor to turn on any one of the Peltier devices described herein into either a positive or negative voltage thereby allowing alternating between hot and cold temperature treatment to be administered to the patient) (para [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Kriksunov by configuring the controller to control the handheld treatment device to alternately apply, at different times, heat from the heater and the cooling effect from the thermoelectric cooler as taught by Mandel in order to allow alternating temperature patterns to be provided to promote blood flow in the treatment area (Mandel, para [0017]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kriksunov et al and Aguiar et al as applied to claim 1 above, and further in view of Mandel and Gorham.
Regarding claim 17, modified Kriksunov discloses a thermoelectric cooler (22) configured to generate a cooling effect (secondary modality means can provide cold (Kriksunov, para [0030]), and can be a Peltier device, which is a thermoelectric cooler (Kriksunov, para [0044]), and a processor (15) (control means for programming and customizing the treatment) disposed within the handheld treatment device and configured to control the handheld treatment device (Kriksunov, para [0029])
Modified Kriksunov does not disclose the processor is configured to control the handheld treatment device to alternately apply, at different times, heat from the heater and the cooling effect from the thermoelectric cooler.
However, Mandel teaches a therapeutic treatment device including a Peltier therapy assembly (11) (para [0033]) configured to provide heat and a cooling effect to a user (para [0051]), a massager (42) (vibrator mechanism) configured to apply vibration to a user (para [0042]), and a circuit board (18) including a microprocessor configured to control the treatment device to alternately apply, at different times, heat and the cooling effect (circuit board includes a DC motor driver (U14) that allows a microprocessor to turn on any one of the Peltier devices described herein into either a positive or negative voltage thereby allowing alternating between hot and cold temperature treatment to be administered to the patient) (para [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Kriksunov by configuring the controller to control the handheld treatment device to alternately apply, at different times, heat from the heater and the cooling effect from the thermoelectric cooler as taught by Mandel in order to allow alternating temperature patterns to be provided to promote blood flow in the treatment area (Mandel, para [0017]).
The now-modified Kriksunov’s device does not disclose the processor is configured to apply the vibration to the user or apply the electrical energy to the user while applying the heat or the cooling effect.
However, Gorham teaches a combination medical therapy device including a processor (4-6) (power/controller means) configured to control different medical therapy modalities such as vibration (15), heat (16), and electrical stimulation (18) (para [0041]), wherein the process is configured to a vibration to the user or apply an electrical energy to the user while applying the thermal effect (treatment modalities can be provided simultaneously) (para [0042]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Kriksunov by configuring the processor to apply the vibration to the user or apply the electrical energy to the user while applying the heat or the cooling effect as taught by Gorham in order to allow the device to apply multiple healing modalities simultaneously to provide a rapid synergistic healing effect (Gorham, para [0046]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Christiansen et al (2020/0360691), Kerth et al (2022/0347010), Phillips (2017/0312456), and Church et al (2022/0241117) discloses therapeutic treatment devices configured to provide multiple treatment modalities including heating, cooling, vibration, and/or electrical stimulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on 571-272-48354835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785