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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "41" and "A1" and “A2” have both been used to designate Baihui and Sishencong acupoints. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because of reference to:
-“relaxaion-assisted” in line 5 should possibly read –relaxation-assisted—
-“the nighttime difference frequency tone” in lines 10-11. Examiner recommends amending to match corresponding structure in the claim language
-“The nighttime difference frequency tone have a” in line 11. Examiner recommends amending to match corresponding structure in the claim language and should possibly read –The second loading frequency tone has a –
-“second difference frequency rate” in line 13. Examiner recommends amending to match corresponding structure in the claim language.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
-Pg. 4, line 7 recites “nightime.” Examiner recommends amending to –nighttime—
-Pg. 6, line 22 recites “a audio-visual.” Examiner recommends amending to –an audio-visual—
-Pg. 11, line 1 recites “a evaluation.” Examiner recommends amending to –an evaluation—
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 5, 6, 7, 9 are objected to because of the following informalities:
-Claim 1 recites “worn by the head” in line 2. Examiner recommends amending to –worn on the head—
-Claim 1 recites “virtual reality device” in line 3. Examiner recommends amending to –virtual reality unit—
-Claims 1, 5, 7, and 9 recite “the earphones.” Examiner recommends amending to –the two earphones—
-Claim 1 recites “a daytime binaural beats” and “a nighttime binaural beats” in lines 9 and 10. Examiner recommends amending to –daytime binaural beats—and –nighttime binaural beats—
-Claim 1 recites “the control unit can be used” in lines 12 and 14. Examiner recommends amending to –the control unit configured to—
-Claim 1 recites “the earphone” in line 16. Examiner recommends amending to –the two earphones—
-Claim 1 recites “wherein the daytime” in line 18. Examiner recommends amending to –and wherein the daytime—
-Claims 5 and 7 recite “the side regions”. Examiner recommends amending to –the two side regions—
-Claim 5 recites “the connection regions” in line 23. Examiner recommends amending to –the two connection regions—
-Claim 5 recites “the electrical stimulation agents” in lines 1 and 4. Examiner recommends amending to –the plurality of electrical stimulation agents—
-Claim 6 recites “mA-2 mA” in line 9. Examiner recommends amending to –mA—or –mA/cm2—
-Claim 6 recites “mA/cm2-0.09 mA/cm2” in line 10. Examiner recommends amending to --mA/cm2-0.09 mA/cm2—
-Claim 6 recites “electrical stimulation agents is” in lines 8 and 11-12. Examiner recommends amending to –electrical stimulation agents are—
-Claim 9 recites “a audio-visual” in line 13. Examiner recommends amending to –an audio-visual—
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
-Claim 1 recites “control unit” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to be electrically connected to the virtual reality unit. According to the specification the control unit includes a microprocessor [Pg. 6, line 21] and equivalents thereof.
-Claim 5 recites “electrical stimulation agents” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is for outputting physical stimulation. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
-Claim 5 recites “electrical stimulation unit” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to electrically connect to the control unit. According to the specification the electrical stimulation unit includes a plurality of electrical stimulation agents [Pg. 5, lines 7-8] and equivalents thereof.
-Claim 7 recites “acupoint agents” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is for outputting physical stimulation. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
-Claim 7 recites “acupoint stimulation unit” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to electrically connect to the control unit. According to the specification the acupoint stimulation unit includes a plurality of acupoint agents [Pg. 5, line20] and equivalents thereof.
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 § 112
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 1-10 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.
-Claim 1 recites “clock capable of indicating a current time built in” in lines 8-9. It is unclear whether the limitation requiring being built in is referring to the clock, the time, or a separate embodiment.
-Claim 1 recites “frequency following response” in lines 10 and 11. It is unclear what is meant by this limitation. Further clarification should be provided to identify whether this is referring to aspects of the beats, the digital information, the user or a separate embodiment.
-Claim 1 recites “current time is from 8:00 a.m. to 5:00 p.m. …from 7:00 p.m. to 12:00 p.m.” in lines 11-14. It is unclear whether the applicant intended to require these overlapping times. It is possible the recitation should read “current time is from 8:00 a.m. to 5:00 p.m. …from 7:00 p.m. to 12:00 a.m.”
-Claim 1 recites “the first binaural frequency difference” in lines 23-1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 1 recites “the first low frequency” in line 14. There is insufficient antecedent basis for this limitation in the claim. Should possibly read –the first low binaural frequency difference—
-Claim 1 recites “a first loading frequency tone” in line 20. It is unclear what is required by this limitation. Further clarification should be provided to identify whether this is referring to an aspect of the tone of the binaural beats, the frequency of the binaural beats or a separate embodiment.
-Claim 1 recites “a first main carrier frequency tone” in lines 19-20. It is unclear what is required by this limitation. Further clarification should be provided to identify whether this is referring to an aspect of the tone of the binaural beats, the frequency of the binaural beats or a separate embodiment.
-Claim 1 recites “a second main carrier frequency tone” in lines 7-8. It is unclear what is required by this limitation. Further clarification should be provided to identify whether this is referring to an aspect of the tone of the binaural beats, the frequency of the binaural beats or a separate embodiment.
-Claim 1 recites “a second loading frequency tone” in line 8. It is unclear what is required by this limitation. Further clarification should be provided to identify whether this is referring to an aspect of the tone of the binaural beats, the frequency of the binaural beats or a separate embodiment.
-Claim 2 recites “the second low binaural frequency difference” in line 19. There is insufficient antecedent basis for this limitation in the claim.
-Claim 4 recites “if the control unit is requested to perform…image” in lines 6-14. Due to this phrasing listed in the alternative, it is unclear whether the limitations referenced in this recitation are required by the claim. Further clarification should be provided.
-Claim 4 recites “than 8:00 a.m. to 5:00 p.m. …than 7:00 p.m. to 12:00 p.m.” in lines 7-10. It is unclear whether the applicant intended to require these overlapping times. It is possible the recitation should read “than 8:00 a.m. to 5:00 p.m. …than 7:00 p.m. to 12:00 a.m.”
-Claim 5 recites “the top of the user’s head” in line 18. There is insufficient antecedent basis for this limitation in the claim.
-Claim 5 recites “the center” in line 19. There is insufficient antecedent basis for this limitation in the claim.
-Claim 6 recites “the form of outputting direct current” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
-Claim 6 recites “the form of outputting electromagnetic pulse” in line 11. There is insufficient antecedent basis for this limitation in the claim.
-Claim 6 recites “the electromagnetic frequency” in lines 11-12. There is insufficient antecedent basis for this limitation in the claim.
-Claim 7 recites “the top of the user’s head” in line 16. There is insufficient antecedent basis for this limitation in the claim.
-Claim 7 recites “the center” in line 17. There is insufficient antecedent basis for this limitation in the claim.
-Claim 7 recites “the center of the top region in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 7 recites “substantially two to three centimeters” in lines 6-7. It is unclear what is required by this limitation due to the relative language. Further clarification should be provided.
-Claim 7 recites “the Baihui acupoint” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 10 recites “the selected self-assessment items” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 10 recites “the direction of the eye cover” in line 4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 10 recites “the selected self-assessment item” in lines 5-6. It is unclear which self-assessment item is referenced due to the recitation of multiple items in claim 10, lines 2-3. Further clarification should be provided.
-Claim 10 recites “the insomnia and sleep quality self-assessment items” in line 7. There is insufficient antecedent basis for this limitation in the claim. It is possible this should read –the plurality of insomnia and sleep quality self-assessment questions—
-Claim 10 recites “all the insomnia and sleep quality self-assessment scores” in line 8. There is insufficient antecedent basis for this limitation in the claim. Only one score was previously mentioned in lines 4-5, therefore it is unclear what multiple scores are referenced by this limitation.
Claim limitation “electrical stimulation agents” and “acupoint agents” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no corresponding structure listed in the specification or claim language that provides insight into what these limitations include. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 5 and 7 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).
-Claims 5 and 7 recite “earphones and upwardly across the top of the user’s head” in lines 18 and 16, respectively, which is directed towards human subject matter. Examiner recommend amending to –configured to connect between the earphones and upwardly across the top of the user’s head—
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.
Claim(s) 1, 2, 9, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samec (U.S. 20170365101) in view of Zhan (CN 108451742).
Regarding Claim 1, Samec teaches a training device for improving insomnia [0522]—reference to treatment of insomnia and [0790]—reference to training for improved functioning, comprising: a virtual reality unit configured for being worn by the head of a user [Fig. 9D, element 80 (virtual reality display system)], wherein the virtual reality device comprises two earphones [0473]—describes Fig. 9D, element 100 (speaker) with this element also located on the other ear canal of the user, and an eye cover connected to front sides of the earphones and used for displaying a virtual image [Fig. 9D, element 90 (viewer)]; and a control unit configured for being electrically connected to the virtual reality unit [Fig. 9D, element 140 (local data processing module)]—describes the processor controlling the overall operation of the device, with an electronic clock capable of indicating a current time built in [0484]—reference to timing devices and clocks incorporated into the device, interpreted as “built in to the device”, and pre-storing digital information of a daytime binaural beats with frequency following response and a nighttime binaural beats with frequency following response [0410; “Because the display device may be worn daily, for extended durations each day, the frequency of tracking of various conditions and/or the ability to provide feedback to the user is increased, which may increase the efficacy of the treatment plan.”]-extended durations each day is interpreted to include nighttime, wherein when the current time is from 8: 00 a. m. to 5: 00 p. m. the control unit can be used for executing a daytime relaxation-assisted program [0410] and [0842]—reference to the system used for relaxation techniques; when the current time is from 7: 00 p.m. to 12: 00 p.m. the control unit can be used for executing a nighttime anti-insomnia-assisted program [0522]; when the control unit executes the daytime relaxation-assisted program, the control unit controls the earphone to play the daytime binaural beats with frequency following response [0473]—describes the speaker controlling sound, and stop playing after continuing for a first predetermined time [0411]-references varying durations of applying stimulus and collecting data with corresponding time stamps to increase accuracy of analysis, wherein the daytime binaural beats with frequency following response has a first main carrier frequency tone and a first loading frequency tone which differs from the first main carrier frequency tone by a first difference frequency rate [0819]—reference to binaural beats applied in combination of frequencies; the first main carrier frequency tone and the first loading frequency tone are respectively played via the earphones simultaneously [0816]—describes the stimuli applied simultaneously;
when the control unit executes the nighttime anti-insomnia-assisted program, the control unit controls the earphones to play the nighttime binaural beats with frequency following response [0410] and [0842]—reference to the system used for relaxation techniques, and stops playing after continuing for a second predetermined time [0411]-references varying durations of applying stimulus and collecting data with corresponding time stamps to increase accuracy of analysis; the nighttime binaural beats with frequency following response has a second main carrier frequency tone and a second loading frequency tone which differs from the second main carrier frequency tone by a second binaural frequency difference [0819]—reference to binaural beats applied in combination of frequencies; the second main carrier frequency tone and the second loading frequency tone are respectively played via the earphones simultaneously [0816]—describes the stimuli applied simultaneously;
Samec is silent on the first binaural frequency difference gradually decreases from a first high binaural frequency difference to a first low binaural frequency difference within the first predetermined time; and the second binaural frequency difference gradually decreases from a second high binaural frequency difference which is not higher than the first low frequency to a second low frequency within the second predetermined time.
Zhan teaches the first binaural frequency difference gradually decreases from a first high binaural frequency difference to a first low binaural frequency difference within the first predetermined time [Fig. 5]—depicting decrease in frequency; and the second binaural frequency difference gradually decreases from a second high binaural frequency difference which is not higher than the first low frequency to a second low frequency within the second predetermined time [Fig. 6]—depicting a second decrease in frequency in which the slope is not greater than that of the decrease shown in Fig. 5.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to describe the changes in the frequency rates of the binaural beats as taught by Zhan to adjustment of device output as suggested by Samec as Samec discusses varying the stimuli to ensure data accuracy [0411] with Zhan because Zhan teaches the use of gradual frequency reductions to adjust user brainwaves [0077].
Regarding Claim 2, Samec is silent on wherein the first high binaural frequency difference is 20 Hz; the first low binaural frequency difference is 10 Hz; the second high binaural frequency difference is 10 Hz; and the second low binaural frequency difference is 2 Hz. Zhan teaches wherein the first high binaural frequency difference is 20 Hz; the first low binaural frequency difference is 10 Hz; the second high binaural frequency difference is 10 Hz; and the second low binaural frequency difference is 2 Hz [0016]—describes the frequency differences being in the range of 1-20 Hz which encompasses the limitations requiring 2, 10 and 20 Hz differences.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify frequency differences within this range as taught by Zhan to apply to the user to effect change as suggested by Samec as Samec discusses these particular frequency ranges causing brain reactions [0685] with Zhan because Zhan teaches the use of this particular frequency range to relieve tension and increase concentration [0074].
Regarding Claim 9, Samec teaches wherein the control unit is further configured for executing a audio-visual education program [0567]—reference to memory training through kinesthetic learning; and when the control unit executes the audio-visual education program, the control unit controls the virtual image to display a teaching course [0567]—describes memory and learning tests , and generates a teaching image and sound for teaching insomnia improvement in cooperation with the virtual reality unit and earphones [0567]—includes guided imagery and/or audio presented to the user.
Regarding Claim 10, Samec teaches wherein the virtual reality unit further comprises an operation button electrically connected to the control unit [0503]—reference to one or more buttons; the control unit is further configured for executing an evaluation program [0546]—reference to guided imagery program within detection of stimulus and registering and identifying that stimulus; when the control unit executes the evaluation program [0404]—discusses neurological evaluations and treatments, the control unit controls the virtual image to sequentially display a plurality of insomnia and sleep quality self-assessment questions for assessing insomnia conditions [0833]—describes self-exploration and [0542]—includes reference to the system prompting questions, each insomnia and sleep quality self-assessment question having a plurality of self-assessment items [0543]—reference to plurality of questions, and the selected self-assessment items can be changed by changing the direction of the eye cover [0611]—user differentiating between left and right directions; an insomnia and sleep quality self-assessment score corresponding to the selected self-assessment item is generated after confirmation via the operation button for storage [0870]—includes a score of stimulus presence and compares with a threshold score; and after all the insomnia and sleep quality self-assessment items have been answered, all the insomnia and sleep quality self-assessment scores are summed up to generate an insomnia and sleep quality result score for storage [0474]—refers to processing, caching and storage of data and [0543]—describes aggregate score determined.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samec (U.S. 20170365101) in view of Zhan (CN 108451742) and in further view of Pal (U.S. 10485972).
Regarding Claim 4, Samec and Zhan are silent on wherein, if the control unit is requested to perform the daytime relaxation-assisted program when the current time is a time other than 8: 00 a. m. to 5: 00 p. in., the control unit does not perform the daytime relaxation-assisted program and displays an unusable warning message on the virtual image; and when the current time is a time other than 7: 00 p. in. to 12: 00 p. m. and if the control unit is requested to perform the nighttime anti-insomnia-assisted program, the control unit does not perform the nighttime anti-insomnia-assisted program and displays the unusable warning message on the virtual image.
Pal teaches wherein, if the control unit is requested to perform the daytime relaxation-assisted program when the current time is a time other than 8: 00 a. m. to 5: 00 p. in., the control unit does not perform the daytime relaxation-assisted program and displays an unusable warning message on the virtual image [Col 35, lines 14-16]—includes reference to user interface operation and [Col 35, lines 27-31]—describes warning messages shown; and when the current time is a time other than 7: 00 p. in. to 12: 00 p. m. and if the control unit is requested to perform the nighttime anti-insomnia-assisted program, the control unit does not perform the nighttime anti-insomnia-assisted program and displays the unusable warning message on the virtual image [Col 35, lines 24-25]—references locking the user out until a certain operation has occurred.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a warning message as taught by Pal to prevent incorrect user operations as suggested by Samec and Zhan, as Samec discusses the use of the apparatus to present warning messages to teach the user [0577] and Zhan which teaches user control of the device to achieve overall ease of use [0097] with Pal because Pal teaches instructing the user of function of the device user interface [Col 37, lines 49-54].
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samec (U.S. 20170365101) in view of Zhan (CN 108451742) and in further view of Coleman (U.S. 10816939).
Regarding Claim 3, Samec teaches wherein, when the daytime relaxation-assisted program is executed, the control unit controls the eye cover to project light with a wavelength of 465-495 nm [0745]—reference to exposure to blue light, and when the nighttime anti-insomnia-assisted program is executed, the control unit controls the eye cover to project light with a wavelength of 630-670 nm [0470]—reference to red light emitted, also citing the description provided in [0456] that points to blue light encompassing the range of 435-493 nm and red light encompassing the range of 620-780 nm.
Samec and Zhan are silent on and an illumination of 2500-3000 lux via the virtual image; and an illumination of less than 30 lux via the virtual image.
Coleman teaches and an illumination of 2500-3000 lux via the virtual image [Col 92, lines 48-50]; and an illumination of less than 30 lux via the virtual image [Col 97, lines [63-64].
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 specified illuminance parameters as taught by Coleman to provide illumination via the virtual image as suggested by Samec and Zhan, as Samec discusses the user observing illuminance levels of the virtual images [0769] and Zhan which discusses considerations for the weight of emitted light [0012] with Coleman because Coleman teaches the use of the illuminance parameters to treat certain disorders [Col 97, lines 56-65].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samec (U.S. 20170365101) in view of Zhan (CN 108451742) and in further view of Hagedorn (U.S. 8958882).
Regarding Claim 5, Samec teaches further comprising an electronic stimulation unit [0596]—reference to multiple types of stimulation provided, the electronic stimulation unit comprises a plurality of electrical stimulation agents provided at the connection regions and electrically connected to the control unit [Fig. 10, element 30 (magnetic field generator), connected to element 2010 (display system)]; the electrical stimulation agents are used for physical stimulation of one of outputting a current to perform transcranial direct current stimulation and outputting an electromagnetic pulse to perform transcranial magnetic stimulation on the head of the user [0847]—references to providing tDCS and [0849]—providing pulsed magnetic field to the head;
Samec and Zhan are silent on wherein the virtual reality unit further comprises a top-side frame connected between the earphones and upwardly across the top of the user's head, the top-side frame having a top region located at the center between the earphones, two side regions respectively connected between the earphones and the top region, and two connection regions respectively extending forwardly from the side regions; and the electrical stimulation agents respectively correspond to an F3 position and an F4 position in international 10-20 system brain wave electrode positions.
Hagedorn teaches wherein the virtual reality unit further comprises a top-side frame connected between the earphones and upwardly across the top of the user's head [Fig. 1, element 100 (helmet)], the top-side frame having a top region located at the center between the earphones [Fig. 4 element 400 (helmet)]]-depicts the helmet centered between the earphones, two side regions respectively connected between the earphones and the top region [Fig. 4, elements 420 and 440 (clusters)], and two connection regions respectively extending forwardly from the side regions [Fig. 4, elements 444, 442, 446 (anodes and cathodes)]; and the electrical stimulation agents respectively correspond to an F3 position and an F4 position in international 10-20 system brain wave electrode positions [Col 19, lines 28-29].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include design the orientation of the frame to connect the stimulation agents to the original virtual reality and speaker hardware as suggested by Hagedorn to apply stimulation therapies to the user’s head as suggested by Samec and Zhan, as Samec discusses the use of the apparatus to affect the brain by stimulating nerve cells [0849] and Zhan which teaches adjustment of brainwaves [0002] with Hagedorn because Hagedorn teaches the F3 and F4 locations identified as associated with insomnia [Col 19, lines 28-32].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samec (U.S. 20170365101) in view of Zhan (CN 108451742) and in further view of Hagedorn (U.S. 8958882) and in even further view of Taylor (CN 107427663) as evidenced by Chhatbar et al. Transcranial Direct Current Stimulation Post-Stroke Upper Extremity Motor Recovery Studies Exhibit a Dose-Response Relationship, Brain Stimulation, 9, 16-26, 2016.
Regarding Claim 6, Samec, Zhan, and Hagedorn are silent on wherein when the electrical stimulation agents is in the form of outputting direct current, the current magnitude is 0.5 mA, and the current density is 0.03 mA/cm2-0.09 mA/cm2; and when the electrical stimulation agents is in the form of outputting electromagnetic pulse, the electromagnetic frequency is 1-20 Hz. Taylor teaches wherein when the electrical stimulation agents is in the form of outputting direct current [0219]—reference to use of direct current, the current magnitude is 0.5 mA [0172]—reference to current amplitude greater than 0.5 mA, and when the electrical stimulation agents is in the form of outputting electromagnetic pulse, the electromagnetic frequency is 1-20 Hz [0172]—reference to range 3-30, 5-12 and 7-10 kHz ranges.
Samec, Zhan, Hagedorn and Taylor are silent on and the current density is 0.03 mA/cm2-0.09 mA/cm2; As evidenced by Chhatbar et al. 0.03-0.09 mA/cm2 is a commonly used range in human tDCS studies with healthy individuals [Pg. 21, paragraph 3].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include these tDCS and TMS parameters as suggested by Taylor to apply stimulation therapies to the user’s head as suggested by Samec, Zhan and Taylor, as Samec discusses the use of the apparatus to apply a pulsed electromagnetic field to the user’s head [0849] and Zhan which teaches controlling the delivery of frequencies and other stimulation parameters to the user [0012-0013] and Hagedorn which discloses optimizing cortical current density for the brain [Col 18, lines 23-24] with Taylor because Taylor teaches the use of these parameters to induce cognitive effects [0172].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samec (U.S. 20170365101) in view of Zhan (CN 108451742) and in further view of Hagedorn (U.S. 8958882) and in even further view of Greiner (U.S. 20140214124).
Regarding Claim 7, Samec and Zhan are silent on further comprising an acupoint stimulation unit, wherein the virtual reality unit further comprises a top side frame connected between the earphones and upwardly across the top of the user's head, the top side frame having a top region located at the center between the earphones, two side regions respectively connected between the earphones and the top region, a front extension region extending forwardly from the top region, and a rear extension region extending rearwardly from the top region; the acupoint stimulation unit comprises a plurality of acupoint agents electrically connected to the control unit, the acupoint agents being used for outputting physical stimulation of laser light to the user, one of the acupoint agents is adjustably disposed at the center of the top region to correspond to the Baihui acupoint of the user; and four of the acupoint agents are adjustably disposed at the side regions, the front extension region, the rear extension region, and a position at a distance from the center of the top region by a finger distance to correspond to four Sishencong acupoints of the user, respectively, the finger distance being substantially two to three centimeters.
Hagedorn teaches wherein the virtual reality unit further comprises a top side frame connected between the earphones and upwardly across the top of the user's head [Fig. 1, element 10 (helmet)], the top side frame having a top region located at the center between the earphones [Fig. element 400 (helmet)], two side regions respectively connected between the earphones and the top region [Fig. 4, elements 420 and 440 (clusters)], a front extension region extending forwardly from the top region [Fig. 4, element 460 (visor)], and a rear extension region extending rearwardly from the top region [Fig. 4, element 450 (cable)];
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include design the orientation of the frame to connect the stimulation agents to the original virtual reality and speaker hardware as suggested by Hagedorn to apply stimulation therapies to the user’s head as suggested by Samec and Zhan, as Samec discusses the use of the apparatus to affect the brain by stimulating nerve cells [0849] and Zhan which teaches adjustment of brainwaves [0002] with Hagedorn because Hagedorn teaches the use of the system to treat insomnia [Col 19, lines 28-32].
Samec, Zhan and Hagedorn are silent on further comprising an acupoint stimulation unit, the acupoint stimulation unit comprises a plurality of acupoint agents electrically connected to the control unit, the acupoint agents being used for outputting physical stimulation of laser light to the user, one of the acupoint agents is adjustably disposed at the center of the top region to correspond to the Baihui acupoint of the user; and four of the acupoint agents are adjustably disposed at the side regions, the front extension region, the rear extension region, and a position at a distance from the center of the top region by a finger distance to correspond to four Sishencong acupoints of the user, respectively, the finger distance being substantially two to three centimeters.
Greiner teaches further comprising an acupoint stimulation unit [Fig. 17, element 30 (IEAD)], the acupoint stimulation unit comprises a plurality of acupoint agents electrically connected to the control unit [0036]—describes the plurality of electrodes connected to the EA, the acupoint agents being used for outputting physical stimulation of laser light to the user [0048]—reference to light emissions, one of the acupoint agents is adjustably disposed at the center of the top region to correspond to the Baihui acupoint of the user [0145]; and four of the acupoint agents are adjustably disposed at the side regions [0142-150]-reference to remaining acupoints, the front extension region, the rear extension region [0142-150], and a position at a distance from the center of the top region by a finger distance to correspond to four Sishencong acupoints of the user [0145]—references Sishencong specifically, respectively, the finger distance being substantially two to three centimeters [0113]—describes an incision 2-3 cm from an acupuncture site.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include incorporate acupuncture hardware as suggested by Greiner to apply stimulation therapies to the user’s head as suggested by Samec, Zhan, and Hagedorn as Samec discusses the use of the apparatus to affect the brain by stimulating nerve cells [0849] and Zhan which teaches adjustment of brainwaves [0002] and Hagedorn because Hagedorn teaches the use of the system to treat insomnia [Col 19, lines 28-32] with Greiner because Greiner teaches the placement of this system in close proximity of the acupoints to improve cardiovascular health [0157].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samec (U.S. 20170365101) in view of Zhan (CN 108451742) and in further view of Northern (U.S. 20230008214).
Regarding Claim 8, Samec and Zhan are silent on further comprising a vibration bed electrically connected to the control unit and controllable to generate vibration, the vibration bed having an adjustable vibration frequency of 6-53 Hz.
Northern teaches further comprising a vibration bed electrically connected to the control unit and controllable to generate vibration [0057]—refers to device fitting into a bed, mattress, chair or cushion, the vibration bed having an adjustable vibration frequency of 6-53 Hz [0103]—reference to frequency of 30 Hz.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vibratory bed as suggested by Northern to apply stimulation therapies to the user as suggested by Samec, and Zhan, as Samec discusses incorporating a vibratory component [0473] and Zhan which teaches attachment of the device to a massage chair [0076] with Northern because Northern teaches the incorporation of vibratory and stimulation devices in a mattress to promote sleep [0277].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Kwak (WO 2020153584)-references a virtual reality and light therapy system
-Simons (U.S. 20210236806)-includes a sleep induction headband
-Wagner et al. Noninvasive Human Brain Stimulation, Annu. Rev. Biomed. Eng. 9, 527-565, 2007-reference to 0.5 mA commonly used as a current magnitude for TMS and tDCS.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791