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 .
Amendment
This action is in response to the Amendment filed on 1/21/2026.
Claims 1-15 are pending.
Response to Arguments
Applicant's arguments with respect to claims 1-15 have been considered but are moot in view of the new grounds of rejection as necessitated by the amendments.
Independent claims 1 and 8 have been amended to now recite: "wherein the body of the user includes at least one of a forehead or a neck of the user" and "the brain stimulation by applying the current to the body of the user is the same as stimulation applied to a brain by a smoking behavior of the user".
Claim Rejections under 35 U.S.C. § 112 - Enablement Requirement
Independent claims 1 and 8 have been amended to now recite: "wherein the body of the user includes at least one of a forehead or a neck of the user". In view of the amendments and the arguments, the rejection has now been withdrawn. However, upon further consideration of the amended claims, a new rejection under 35 U.S.C. 112 has been provided as discussed in the current office action.
Claim rejections under 35 U.S.C. 112
Applicant has amended the claims to now functionally recite “the article”. Therefore, the claim just requires
a housing with an accommodation space
a battery.
a processor to detect a type of article and apply current based on the type of article
Dependent claims 3-4, 11-12 etc. recite limitations regarding the “article”. If an element and it’s components are to be positively recited, it is suggested to first claim the element as part of the claimed invention. Furthermore, applicant’s argument that paragraph [0058] of the original specification describes the article is not persuasive. the paragraph simply states that the article has a memory with identification information of the article 10 and may include information indicating whether the article 10 is a first article or a second article different from the first article, but is not limited thereto. The paragraph further states that the that the article 10 has a stick shape, but the shape of the article 10 is not limited to the stick shape. Therefore, it is unclear as to what the article is and what is being claimed. Therefore, the rejections are maintained.
Claim rejections under 35 U.S.C. 101
In view of the amendments, the rejection has been withdrawn.
Claim Rejections under 35 U.S.C. § 102 And § 103- U.S. Patent Application Publication No. 2017/0224990 A1 ("Goldwasser"), Patent No. 4809697 ("Causey").
Independent claims 1 and 8 have been amended to now recite: "the brain stimulation by applying the current to the body of the user is the same as stimulation applied to a brain by a smoking behavior of the user".
Applicant argues that Goldwasser and Causey taken alone or in combination fail to teach "the brain stimulation by applying the current to the body of the user is the same as stimulation applied to a brain by a smoking behavior of the user".
Goldwasser discloses neurostimulators for application of transdermal electrical stimulation (TES) and methods of using them for comfortably inducing a "cognitive effect". they argue that the cognitive effect in Goldwasser does not satisfy that "the brain stimulation by applying the current to the body of the user is the same as stimulation applied to a brain by a smoking behavior of the user" as recited in amended claim 1. Similarly, they argue that Causey’s teachings also do not meet the claimed limitation. Applicant’s arguments are persuasive and therefore the rejection is withdrawn.
However, upon further search and consideration, the claims are now rejected as discussed in the current office action below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1 and 8 recite a brain stimulation device wherein the "the brain stimulation by applying the current to the body of the user is the same as stimulation applied to a brain by a smoking behavior of the user".
The specifications fail to teach the current parameters or how it is determined as to what current parameters may be used to stimulate the brain so that the stimulation applied is same as by a smoking behavior of the user.
The specifications do not provide any specific current stimulation parameters and simply require that the current is applied to a body based on a “type” of detected article. further the article is not even part of the claimed invention as discussed in the section under 35 U.S.C. 112 (b) discussed below.
Smoking behavior of a user is subjective. the type of smoking behavior varies from user to user as does the kind of substances smoked by the user.
Due to the lack of an enabling specification for how or what the smokibg behvior of the user is and how it is determined and the type of detected article, several questions arise as to how to make and/or use the invention, such as: What stimulation parameters such as amplitude, frequency, pulse width, type of stimulation etc. of the stimulation waveform are required to stimulate the brain when the device is placed on a ball or neck so that the stimulation is same as stimulation applied to a brain by a smoking behavior of the user" as claimed.
One example of many showing the necessary detail needed to enable someone skilled in the art how to make and/or use system and method is Charlesworth et al (U.S. Patent Number: US 10293161 B2, hereinafter “Charlesworth”) that teaches electrodes that are placed on the subject’s neck and mastoid and are used to modify or induce a cognitive state by providing brain stimulation using specific stimulation parameters (e.g. abstract, col. 13, lines 9-25)
Since there are numerous questions as to how the invention is used, since no amount of direction or guidance was presented, since other systems and methods describe in detail how to provide brain stimulation when the device is place anywhere on the body and/or since one skilled in the art cannot practice the invention without undue experimentation (as seen by the above questions) because of the number of operational parameters in the process/apparatus that are needed to provide brain stimulation when the device is placed anywhere on the body other than the forehead, one skilled in the art to which it pertains is not enabled to use the invention of the subject matter presented in the claims.
The dependent claims inherit the deficiencies.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1 and 8, as amended, the “article” is functionally recited. Dependent claims 3-5 and 9-12 recite additional limitations regarding the “article” such as the memory of the article is connected to an electrical connection unit in the accommodation space. This recitation of the article in the independent claims 1 and 8 and the elements of the article in the dependent claims raises questions such as is the article is actually part of the claimed invention or not.
If the element is being positively recited, it is suggested to first state the system includes the element before it is used in a connection in the claim. The dependent claims inherit the deficiencies.
In claims 1 and 8, it is unclear as to what is the claimed “article”. A review of the specification does not provide any specific structure since just states that the article 10 has a stick shape but the shape of the article 10 is not limited to the stick shape and that the article just comprises identification information in a memory. The specification is broadly reciting an article that does not have any specific shape and is not limited.
[0058] In the disclosure, the article 10 may be a component having the memory 11 embedded therein, and the memory 11 may store identification information of the article 10. In the disclosure, the identification information of the article 10 may refer to information indicating a type of the article 10. For example, the identification information of the article 10 may include information indicating whether the article 10 is a first article or a second article different from the first article, but is not limited thereto. In addition, FIG. 3 illustrates only the embodiment in which the article 10 has a stick shape, but the shape of the article 10 is not limited to the stick shape.
Therefore it is unclear as to what the “article” is and whether it is part of the claimed invention or not. if the “article” is part of the claimed invention it is suggested to positively recite the article as a positively recited limitation in the independent claims and to claim specific structure for the article.
The dependent claims inherit the deficiencies.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Goldwasser et al (U.S. Patent Application Publication Number: US 2017/0224990 A1, hereinafter “Goldwasser”) in view of Jung (Patent Number: KR 20210153329, hereinafter “Jung”- Translation and Original document attached).
Regarding claim 1, Goldwasser teaches a brain stimulation device (e.g. Fig.3A,B, Figs.33, 34, [0102]: transcranial electrical stimulator, [0125],[0126],[0130]) comprising:
a housing having at least one area adapted to be attached to a body of a user, a battery arranged inside the housing (e.g. [0817]: lightweight, self-contained neurostimulator enclosing the circuitry, power supply, and wireless communication components such as a rechargeable battery and charging circuit, Bluetooth chip and antenna, microcontroller, and current source configured to deliver waveforms with a duration of between 10 seconds and tens of minutes, may also include safety circuitry, include circuits to determine that the electrode is attached and what “kind” of electrode it is (i.e., for the calm or the energy mode; or indicating the batch and/or source of manufacture, etc.), and including an accommodation space adapted for accommodating an article (e.g. [0183]: the neurostimulator comprises snap receivers that are configured to receive a male snap post), wherein the body of the user includes at least one of a forehead or a neck of the user (e.g. [0143]);
an output unit (i.e. electrodes) configured to apply a current to the body of the user based on power supplied from the battery; and
a processor electrically (i.e. microcontroller) connected to the battery and the output unit, and configured to:
detect a type of the article (e.g. [0817]: circuits to determine that the electrode is attached and what “kind” of electrode it is (i.e., for the calm or the energy mode; or indicating the batch and/or source of manufacture, etc., [0967]: controller includes an RFID reader, and the electrode assembly includes an RFID tag) accommodated in the accommodation space; and
based on the detected type of the article (e.g. [0404], [0405] : Figs 43H-K “calm” electrode assembly, Figs 43 L-o “energy” electrode assembly, [0827]-[0829]” the calm and energy electrode assemblies are ), apply a current to the body of the user via the output unit so that brain stimulation is applied to the user (i.e. waveforms applied are calm versus energy waveforms e.g. [0834], Fig. 78C, [0478], [0959] -[0961]: the neurostimulator detects the type of electrodes i.e. low capacitor type or high capacitor type and automatically selects waveforms based on the type of electrode attached via the snap connectors).
Goldwasser does not specifically teach that the brain stimulation is provided by applying current to the body of the user is the same as stimulation applied to a brain by a smoking behavior of the user.
Jung teaches a fragrance providing module 200 that may provide a virtual fragrance by transmitting an electrical signal to the user's body (e.g. page 5 of attached translated document). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the processor in the teachings of Goldwasser to be configured to provide an electrical stimulation that provides a virtual fragrance by transmitting an electrical signal as taught by Jung in order to provide the predictable results of providing an improved smoking experience to the user without the deleterious effects of chemical substances.
Regarding claim 2, Goldwasser in view of Jung teaches the claimed invention as discussed above and Goldwasser further teaches at least one button unit configured to receive an input of the user, wherein the processor is configured to control power of the brain stimulation device or an intensity of a current applied to the body of the user, based on a user input to the at least one button unit (e.g. [0113] : a one or more controls on the device to allow selection of the driving stimulation (e.g., selection based on the desired cognitive effect(s), power levels, power on/off, etc.), manually selecting the stimulation parameters (e.g., by the user directly), [0121]).
Regarding claims 3 and 4, Goldwasser in view of Jung teaches the claimed invention as discussed above and Goldwasser further teaches at least one electrical connection unit (e.g. [0183]: the neurostimulator comprises snap receivers that are configured to receive a male snap post) arranged in the accommodation space, wherein the at least one electrical connection unit is electrically connected to a memory of the article when the article is accommodated in the accommodation space and the processor is configured to: receive identification information from the memory of the article via the at least one electrical connection unit when the article is accommodated in the accommodation space; and based on the received identification information, detect the type of the article accommodated in the accommodation space (e.g. [0966]-[0971]: identification or RFID tag or a programmable chip (i.e. memory) on electrode that is read by the controller and compared to stored information to identify the type of electrode that is connected).
Regarding claim 5, Goldwasser in view of Jung teaches the claimed invention as discussed above and Goldwasser further teaches that the processor is configured to:
when detecting that a first article is accommodated in the accommodation space, apply a current corresponding to a first current profile (i.e. waveforms applied are calm versus energy waveforms e.g. [0834], Fig. 78C, [0478], [0959] -[0961]: the neurostimulator detects the type of electrodes i.e. low capacitor type or high capacitor type and automatically selects waveforms based on the type of electrode attached via the snap connectors) to the body of the user via the output unit so that brain stimulation corresponding to a first brain stimulation profile is applied to the user; and when detecting that a second article different from the first article is accommodated in the accommodation space, apply a current corresponding to a second current profile to the body of the user via the output unit so that brain stimulation corresponding to a second brain stimulation profile is applied the user (i.e. calm waveforms for inducing a calm or relaxed mental state, energy waveforms for enhancing attention, alertness, or mental focus) .
Regarding claim 6, Goldwasser in view of Jung teaches the claimed invention as discussed above and Goldwasser further teaches the processor is configured to: count a number of times a current is applied to the body of the user via the output unit; and stop an operation of the output unit when the counted number of times is greater than a predefined value (e.g. [00624], [0625] : the system may be configured so that the electrodes or the entire system itself may be disposable and a machine readable memory is used to count the number of uses or length of time a disposable device or system component has been used, then a microcontroller or other electrical component compares the value in memory to a maximum number of uses or length of time to determine whether stimulation is triggered by the system).
Regarding claim 7, Goldwasser in view of Jung teaches the claimed invention as discussed above and Goldwasser further teaches a communicator configured to transmit a signal to or receive a signal from an external device, wherein the processor is configured to control an operation of the brain stimulation device, based on a signal received from the external device via the communicator (e.g. [0026]: Some or all of the control functions for the apparatus may be remotely controlled, e.g., using non-transient control logic executable on a remote processing device (e.g., smartphone, pad, computer, etc.), [0294]: The wearable neurostimulator may be configured to monitor and/or receive transmissions. For example, when wireless transmission is used, the wearable neurostimulator may be adapted to receive and process the transmitted information, and may therefore include wireless transmission circuitry and/or memory for storing this information).
Claims 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Goldwasser et al (U.S. Patent Application Publication Number: US 2017/0224990 A1, hereinafter “Goldwasser”) in view of Causey III et al (U.S. Patent Number: 4809697, hereinafter “Causey”) and further in view of Jung (Patent Number: KR 20210153329, hereinafter “Jung” ”- Translation and Original document attached).
Regarding claim 8, Goldwasser teaches a brain stimulation system (e.g. Fig. 27C, [0690]) comprising:
a brain stimulation device (i.e. wearable TES unit e.g. 400 Fig. 27C, [0690]) having at least one area adapted to be attached to a body of a user wherein the body of the user includes at least one of a forehead or a neck of the user (e.g. [0143]); and
a control device (e.g. 409 Fig.27C, [0294], [0690]: microprocessor-controlled control unit 409 (e.g. a smartphone running an Android or iOS operating system such as an iPhone or Samsung Galaxy, a tablet such as an iPad, a personal computer including, but not limited to, laptops and desktop computers, or any other suitable computing device) operatively connected to the brain stimulation device,
wherein the brain stimulation device (e.g. 400 Figs.3A,B, 27C, 34, 36A, e.g. [0817]: lightweight, self-contained neurostimulator enclosing the circuitry, power supply, and wireless communication components such as a rechargeable battery and charging circuit, Bluetooth chip and antenna, microcontroller, and current source configured to deliver waveforms with a duration of between 10 seconds and tens of minutes, may also include safety circuitry, include circuits to determine that the electrode is attached and what “kind” of electrode it is (i.e., for the calm or the energy mode; or indicating the batch and/or source of manufacture, etc) includes: a first housing having the at least one area attached to the body of the user; a battery arranged inside the first housing; an output unit configured to apply a current to the body of the user, based on power supplied from the battery; and a first processor electrically connected to the battery and the output unit, and
the control device (e.g. 409 Fig. 27C) includes: a second housing; and a second processor (e.g. 415 Fig. 27C), wherein the first processor is configured to: receive, from the second processor, a signal including data corresponding to the detected type of the article; and based on the received signal, apply a current to the body of the user via the output unit so that brain stimulation is applied to the user (e.g. [0861]-[0863] : Goldwasser teaches that the control device includes a user software that automatically detects the type of electrodes (e.g. [0863]) and controls the wearable device).
Goldwasser does not specifically teach that the control device comprises an accommodation space adapted to accommodate an article that is identified by the control device which is then configured to send a signal to the processor of the wearable device.
Since it is unclear as to what the article is as discussed above and the article comprises a memory, the examiner considers the article to be a removable memory cartridge as best understood.
Causey teaches a system comprising a control device comprising a removable program memory cartridge 40 comprising instructions to be sent to the stimulating pacemaker (e.g. col. 6 lines 3-14: Removable program cartridge 40 allows the operating characteristics of the device to be easily upgraded to include new features and to properly interface with new pacemakers, as new features and new pacemakers are developed. Such upgrading can occur at minimal cost because all that is required is a new program cartridge 40, rather than a whole new analyzer-programming). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the control device in the teachings of Goldwasser to have a removable program cartridge and a slot for the removable program cartridge as taught by Causey in order to provide the predictable results of easy upgrade and switching to new or different programs that include new features and to properly interface with the brain stimulation device.
Goldwasser also does not specifically teach that the brain stimulation is provided by applying current to the body of the user is the same as stimulation applied to a brain by a smoking behavior of the user.
Jung teaches a fragrance providing module 200 that may provide a virtual fragrance by transmitting an electrical signal to the user's body (e.g. page 5 of attached translated document). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the processor in the teachings of Goldwasser in view of Causey to be configured to provide an electrical stimulation that provides a virtual fragrance by transmitting an electrical signal as taught by Jung in order to provide the predictable results of providing an improved smoking experience to the user without the deleterious effects of chemical substances.
Regarding claim 9, Goldwasser in view of Causey and Jung teaches the claimed invention as discussed above and Goldwasser further teaches that the control device may be connected to the brain stimulation device via connected by one or more transmission lines, e.g., electrical traces, wires, etc. (e.g. [0295]) and therefore they teach a connector having one end connected to the brain stimulation device and another end connected to the control device, wherein the first processor is configured to receive, from the second processor via the connector, a signal including data corresponding to the detected type of the article via the connected transmission lines.
Regarding claim 10, Goldwasser in view of Causey and Jung teaches the claimed invention as discussed above and Goldwasser further teaches wireless communication between the control device and the brain stimulation device (e.g. [0295]: the controller is remotely located and wirelessly communicates with the neurostimulator apparatus, the communication between the remotely located controller and the processor of the neurostimulator may be one way (e.g., from the remotely located controller to the neurostimulator) or two-way) and that the control device sends instructions to the brain stimulation device based on the detected type of article therefore they teach that the brain stimulation device further includes a first communicator, the control device further includes a second communicator for communication with the first communicator, and the first processor is configured to receive, from the second processor via the first communicator and the second communicator, a signal including data corresponding to the detected type of the article.
Regarding claim 11, Goldwasser in view of Causey and Jung teaches the claimed invention as discussed above and since Goldwasser in view of Causey teaches a removable program cartridge and a slot for the removable program cartridge as discussed above, the control device further includes at least one electrical connection unit arranged in the accommodation space, wherein the at least one electrical connection unit is electrically connected to a memory of the article when the article is accommodated in the accommodation space.
Regarding claim 12, Goldwasser in view of Causey and Jung teaches the claimed invention as discussed above and while they do teach receiving programming instructions from the removable program cartridge, they do not teach that the second processor is configured to: receive identification information from the memory of the article via the at least one electrical connection unit when the article is accommodated in the accommodation space; and based on the received identification information, detect the type of the article accommodated in the accommodation space. Goldwasser teaches that they detect the identification information regarding the type of article (i.e. electrodes) by the first processor as discussed above in claim 1. It would have been obvious to a person having ordinary skill in the art to modify the program cartridge of Goldwasser in view of Causey and Jung to include identification information in the program cartridge so that the second processor can identify the article (i.e. cartridge) in the identification space similar to the first processor in order to provide the predictable results of ensuring that the correct article is being used.
Regarding claim 13, Goldwasser in view of Causey and Jung teaches the claimed invention as discussed above and Goldwasser further teaches that the control device further includes at least one button unit (e.g. 413 Fig. 27C [0690]: user control elements), wherein the second processor is configured to transmit, to the first processor, a signal for controlling power of the brain stimulation device or an intensity of a current applied from the output unit to the body of the user, based on a user input to the at least one button unit (e.g. 2703 Fig. 27 D, [0694][0695] : control steps 2703, 2705 may be performed via a user interface).
Regarding claims 14 and 15, Goldwasser in view of Causey and Jung teaches the claimed invention as discussed above and since Goldwasser in view of Causey and Jung teaches a removable program cartridge comprising different programs and a slot for the removable program cartridge as discussed above, they teach the second processor (in the control device) is configured to transmit, to the first processor (in the brain stimulation device), a first signal/ second signal including data indicating that a first article/ second article is accommodated, when detecting that the first article/second article is accommodated in the accommodation space, and the first processor is configured to apply a current corresponding to a first current profile/ second current profile to the body of the user via the output unit so that brain stimulation corresponding to a first/ second brain stimulation profile is applied to the user, based on the first/second signal received from the second processor as claimed.
Conclusion
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792