DETAILED ACTION
This action is a response to the filing on 9/19/2025. Examiner acknowledges the amendment to claim 8, the cancellation of claim 7, and the addition of claims 21-23.
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 .
Response to Arguments
Applicant's arguments filed 9/19/2025 have been fully considered but they are not persuasive.
Note that Applicant has not addressed the prior art rejections of claims 10, 13, 14, and 17 in the present arguments.
Applicant argues that Prouza does not teach stimulation of acupoints by magnetic fields and is a required teaching. Applicant also states that stimulation of acupoint is not the same as stimulation of a nerve or muscle fiber. While this is true, Prouza states the application of stimulation to a biological structure (which an acupuncture point is) in paragraph 9 and discloses that acupuncture points have been the target of magnetic stimulation previously in paragraph 4. It is also known that acupuncture points are rich in connective tissues, nerves, blood vessels, and lymph nodes. Due to the presence of nerves around the area of an acupuncture point, they would be susceptible to action potentials. Thus, the suggestion of application of stimulation to an acupuncture point is present. The argued teaching is clearly present in Wang. Both Wang and Prouza disclose the usage of magnetic fields for therapy, with Prouza giving specific parameters known to cause responses.
New claim limitations from claims 21-23 are addressed by US 2013/0184792 (Simon et al., hereinafter Simon) as noted in the rejections below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2022/0054856 (Wang) as evidenced by (Alzheimer’s disease symptoms - https://www.nm.org/conditions-and-care-areas/neurosciences/alzheimers-disease/symptoms July 9, 2019).
In regards to claims 10, Wang discloses therapeutic devices and methods to improve body functions. Wang states the device and methods are used for treating dementia, including Alzheimer’s disease or vascular dementia, improving memory and reasoning, reducing cognitive impairment, and treating depression (other depressive disorders) by stimulating acupuncture points (paragraph 6). Paragraph 76 discloses application of the therapy to Neiguan and Shenmen sites. Paragraph 104 discloses the use of combination stimulation of magnetic field and infrared stimulation to selected regions such as acupuncture points. The device has a magnetic field generating means (magnetic field generator) and a heat generator (near infrared source). Paragraph 54 states that the IR stimulation can be continuous or pulsed. Paragraph 41-45 state the stimulation parameters of the combination stimulation which include stimulation frequency, thus oscillatory stimulation. Paragraph 58 further states that the different stimulation types can be applied either simultaneously (contemporaneously) or sequentially. Note that Alzheimer’s disease causes symptoms such as declines in visuospatial ability, memory, and abstract thinking and reasoning skills (As noted by Alzheimer’s disease symptoms), thus Wang treating Alzheimer’s disease meets the limitations of claim 10.
Claim(s) 14 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2022/0054856 (Wang).
In regards to claims 14 and 17, Wang discloses therapeutic devices and methods to improve body functions. Wang states the device and methods are used for treating dementia, including Alzheimer’s disease or vascular dementia, improving memory and reasoning, reducing cognitive impairment, and treating depression (other depressive disorders) by stimulating acupuncture points (paragraph 6). Paragraph 76 discloses application of the therapy to Neiguan and Shenmen sites. Paragraph 104 discloses the use of combination stimulation of magnetic field and infrared stimulation to selected regions such as acupuncture points. The device has a magnetic field generating means (magnetic field generator) and a heat generator (near infrared source). Paragraph 54 states that the IR stimulation can be continuous or pulsed and that the output of the IR radiation is preferably at the level that heats the skin to 40-50 degrees C because the temperature range does not burn or damage skin tissue, which overlaps the range of claim 17. Paragraph 41-45 state the stimulation parameters of the combination stimulation which include stimulation frequency, thus oscillatory stimulation. Paragraph 58 further states that the different stimulation types can be applied either simultaneously (contemporaneously) or sequentially.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-6, 8, 9, 11, 12, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054856 (Wang) in view of US 2017/0120067 (Prouza).
In regards to claims 3-6, 8, 9, 11, 12, and 20, Wang discloses therapeutic devices and methods to improve body functions. Wang states the device and methods are used for treating dementia, including Alzheimer’s disease or vascular dementia, improving memory and reasoning, reducing cognitive impairment, and treating depression (other depressive disorders) by stimulating acupuncture points (paragraph 6), thus meeting the limitations of claims 11 and 12. Paragraph 76 discloses application of the therapy to Neiguan and Shenmen sites, thus meeting the limitation of claims 5 and 20. Paragraph 104 discloses the use of combination stimulation of magnetic field and infrared stimulation to selected regions such as acupuncture points. The device has a magnetic field generating means (magnetic field generator) and a heat generator (near infrared source). Paragraph 54 states that the IR stimulation can be continuous or pulsed and that the output of the IR radiation is preferably at the level that heats the skin to 40-50 degrees C because the temperature range does not burn or damage skin tissue, which overlaps the range of claims 4, 6, and 8. Paragraph 41-45 state the stimulation parameters of the combination stimulation which include stimulation frequency, thus oscillatory stimulation. Paragraph 58 further states that the different stimulation types can be applied either simultaneously (contemporaneously) or sequentially. Wang also states in paragraph 45 several stimulation parameters that are within the claimed frequency range of stimulation (several of the stimulation parameters are within 0.01 to 20 Hz), thus meeting the frequency limitations of claim 3. However, Wang does not state the strength of the pulsed magnetic field.
In a related area, Prouza discloses time varying magnetic field therapy. Paragraph 4 states that pulsed magnetic fields have been used and applied to acupuncture points. Paragraph 9 states that the method is used to evoke action potentials in a biological structure. Paragraphs 10 and 40 disclose the various flux densities that can be applied, several which overlap the claimed range (at least 0.2, 0.4, 1.5 or 2 Tesla). Paragraph 47 states that stimulation signals vary depending on the thresholds of the target. Paragraph 64 states that a person skilled in the art is able to repeat, apply, and adjust the magnetic flux density or repetition rate based on the patient’s needs. Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the method of Wang to apply a flux density in the range of 0.2 to 2.0 Tesla to acupuncture points as taught by Prouza in order to provide the optimal stimulation intensity based on the threshold of the target tissue to evoke action potentials in the biological structure.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054856 (Wang) in view of WO 2021/026218 (Van de Ven et al., hereinafter Van de Ven).
In regards to claims 13, Wang discloses therapeutic devices and methods to improve body functions. Wang states the device and methods are used for treating dementia, including Alzheimer’s disease or vascular dementia, improving memory and reasoning, reducing cognitive impairment, and treating depression (other depressive disorders) by stimulating acupuncture points (paragraph 6). Paragraph 76 discloses application of the therapy to Neiguan and Shenmen sites, thus meeting the limitation of claim 20. Paragraph 104 discloses the use of combination stimulation of magnetic field and infrared stimulation to selected regions such as acupuncture points. The device has a magnetic field generating means (magnetic field generator) and a heat generator (near infrared source). Paragraph 54 states that the IR stimulation can be continuous or pulsed and that the output of the IR radiation is preferably at the level that heats the skin to 40-50 degrees C because the temperature range does not burn or damage skin tissue, which overlaps the range of claim 4. Paragraph 41-45 state the stimulation parameters of the combination stimulation which include stimulation frequency, thus oscillatory stimulation. Paragraph 58 further states that the different stimulation types can be applied either simultaneously (contemporaneously) or sequentially. However, Wang does not state that the conditions are post-COVID/ICU/chemotherapy-induced cognitive impairment.
In a related area, Van de Ven discloses treatment for the central nervous system (title and abstract). Of note are the neurocognitive disorders mentioned (which include Alzheimer’s Disease and post-chemotherapy cognitive impairment) as well as the treatment method of the disorders which include magnetic stimulation and acupuncture in combination with light therapy (see pages 73-74 and 78; Note that the IR to produce heat in Wang is still a light therapy). Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to use the method of Wang to treat post-chemotherapy induced cognitive impairment because it is one of several neurocognitive disorders that can be treated by combination of acupuncture, heat, and magnetic fields as taught by Van de Ven.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054856 (Wang), as applied to claim 14 above, and further in view of US 2017/0120067 (Prouza).
In regards to claims 18 and 19, Wang discloses the limitations of claim 14. Wang states in paragraph 54 states that the IR stimulation can be continuous or pulsed and that the output of the IR radiation is preferably at the level that heats the skin to 40-50 degrees C because the temperature range does not burn or damage skin tissue, which overlaps the range of claims 8 and 19. Wang also states in paragraph 45 several stimulation parameters that are within the claimed frequency range of stimulation (several of the stimulation parameters are within 0.01 to 20 Hz). However, Wang does not state the strength of the pulsed magnetic field.
In a related area, Prouza discloses time varying magnetic field therapy. Paragraph 4 states that pulsed magnetic fields have been used and applied to acupuncture points. Paragraph 9 states that the method is used to evoke action potentials in a biological structure. Paragraphs 10 and 40 disclose the various flux densities that can be applied, several which overlap the claimed range (at least 0.2, 0.4, 1.5 or 2 Tesla). Paragraph 47 states that stimulation signals vary depending on the thresholds of the target. Paragraph 64 states that a person skilled in the art is able to repeat, apply, and adjust the magnetic flux density or repetition rate based on the patient’s needs. Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the method of Wang to apply a flux density in the range of 0.2 to 2.0 Tesla to acupuncture points as taught by Prouza in order to provide the optimal stimulation intensity based on the threshold of the target tissue to evoke action potentials in the biological structure.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054856 (Wang) as applied to claim 14 above, and further in view of US 2022/0323784 (Cassano et al., hereinafter Cassano).
In regards to claims 15, Wang discloses the limitations of claim 14. While Wang does disclose the device having the embodiment of a band (paragraphs 4, 74, 92, 94, 95, and 99), Wang does not show the presence of a band and that the magnetic field generator and heat generator are mounted with the band and that the heat sources of the heat generator are near the acupuncture points.
In a related area, Cassano discloses a photomodulation garment (see title and abstract) where the device is used to stimulate acupuncture meridians using infrared light (paragraph 92). Paragraph 93 and figures 2, 3, 4, 9, 11, 12, 15 and 16 that the infrared light sources (170 – light source; 171, 172, 173, 174, 175, 176 – light source groupings) are concentrated on one area of a band. Figures 1-16 show that the infrared sources are disposed with the band (element 22; paragraphs 30-38, 61, 90, and 93) in a density (infrared light sources are concentrated in one section divided into subsections of the band). Cassano states that the band allows for correct positioning of the sources of stimuli over the targeted area of interest (paragraphs 93-96). Thus, it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device of Wang to include a band and incorporate the magnetic field generator and infrared LEDs with the band, as taught by Cassano, in order to allow for correct positioning of the sources of stimuli over the targeted area of interest.
In regards to claim 16, Wang discloses the limitations of claim 14. Wang does not show that the heat generator comprises an infrared heating knee wrap. In a related area, Cassano discloses a photomodulation garment (see title and abstract) where the device is used to stimulate acupuncture meridians using infrared light (paragraph 92). Paragraph 93 and figures 2, 3, 4, 9, 11, 12, 15 and 16 that the infrared light sources (170 – light source; 171, 172, 173, 174, 175, 176 – light source groupings) are concentrated on one area of a band. Cassano states that the band allows for correct positioning of the sources of stimuli over the targeted area of interest (paragraphs 93-96). Paragraph 31 states that the garment is configured to wrap about or conform to a wide variety of body parts with several of the examples being wraps, thus the band of Cassano can also be considered as an infrared heating knee wrap. Thus, it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device of Wang to have the heat generator include an infrared heating knee wrap, as taught by Cassano, in order to allow for correct positioning of the sources of stimuli over the targeted area of interest.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054856 (Wang) in view of US 2017/0120067 (Prouza) as applied to claims 5 above, and further in view of US 2013/0184792 (Simon et al., hereinafter Simon).
In regards to claim 21, Wang and Prouza discloses the limitations of claim 5, but does not state that the infrared stimulation is performed on the ST36 acupuncture point. In a related area, Simon discloses magnetic stimulation in treatment of autism or other disorders of psychological development. Simon states in paragraph 28 that ST36 is one of the acupuncture points used in treatment of autistic individuals. Cognitive impairments are common to autistic individuals, though the severity varies per individual. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Wang and Prouza to stimulate the ST36 acupuncture point, as taught by Simon because it is one of the points stimulated for the treatment of autism.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054856 (Wang) as evidenced by (Alzheimer’s disease symptoms - https://www.nm.org/conditions-and-care-areas/neurosciences/alzheimers-disease/symptoms July 9, 2019) as applied to claim 10 above, and further in view of US 2013/0184792 (Simon et al., hereinafter Simon).
In regards to claim 22, Wang and Alzheimer’s disease symptoms disclose the limitations of claim 10 but do not state that stimulation of the ST36 acupuncture point. In a related area, Simon discloses magnetic stimulation in treatment of autism or other disorders of psychological development. Simon states in paragraph 28 that ST36 is one of the acupuncture points used in treatment of autistic individuals. Cognitive impairments are common to autistic individuals, though the severity varies per individual. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Wang and Alzheimer’s disease symptoms to stimulate the ST36 acupuncture point as taught by Simon because it is one of the points stimulated for the treatment of autism.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054856 (Wang) in view of WO 2021/026218 (Van de Ven et al., hereinafter Van de Ven) as applied to claims 13 above, and further in view of US 2013/0184792 (Simon et al., hereinafter Simon).
In regards to claim 23 Wang and Van de Ven disclose the limitations of claim 13, but do not explicitly state the stimulation of the ST36 acupuncture point. In a related area, Simon discloses magnetic stimulation in treatment of autism or other disorders of psychological development. Simon states in paragraph 28 that ST36 is one of the acupuncture points used in treatment of autistic individuals. Cognitive impairments are common to autistic individuals, though the severity varies per individual. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Wang and Van de Ven to stimulate the ST36 acupuncture point as taught by Simon because it is one of the points stimulated for the treatment of autism.
Conclusion
Applicant's amendment necessitated the new ground(s) 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 JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791