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 Amendment
This office action is responsive to the amendment filed on 4/22/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1, 23 has/have been amended;
Claim(s) 4-6 is/are canceled;
Claim(s) 1-3, 7-23 is/are presently pending.
The amendment(s) to the claim(s) is sufficient to overcome the 35 U.S.C. 101 rejection(s) from the previous office action.
Response to Arguments
Applicant argues mainly starting on p. 14 of remarks that the combination of Barry, Zhang, and De Taboada is not obvious because each art is concerned with treating a different tissue type or different treatment. At p. 18 Applicant further explains that “each device is being used for a different purpose so the power and power density (irradiance) values disclosed in one reference will have no bearing on the power and power density (irradiance) values disclosed in the other references” and at p. 20 Applicant argues that this means the claimed parameter would not be arrived at via routine optimization. For clarity, the claim limitation from claim 1 is “each of the one or more near-infrared light source groupings are configured to generate a radiant flux or power of at least 500 mW and generate an average irradiance or flux density of at least 10 mW/cm2 to at most 400 mW/cm2 on the skin surface of the foot.”
After review, this is not persuasive. Applicant discusses how the different references teach treating different tissues and emphasizes the differences such as Barry using heat while another reference does not and posits that this means the references are not combinable. However, Applicant has not pointed to nor does the Examiner find any citation in the references that would amount to a “teaching away” (MPEP 2144.05 III B) that would prevent a person of ordinary skill in the art from combining.
Primary reference Barry teaches treating a variety of conditions including both soft tissue and hard tissue (e.g. bone) ([0008]) and also “neural stimulation” ([0009]). De Taboada was relied upon to teach these parameters ([0080]; [0082] “300 mW/cm2”; [0087]; Table 1; [0088]). De Taboada teaches treating brain tissue via light application through scalp but also discusses how phototherapy on neuronal cells in vitro show positive effects on neuronal cell cultures ([0134]; [0140]). As would be known to a person of ordinary skill in the art, peripheral nervous system would also have neural cells and so there is no reason why this teaching would not be combinable with Barry and Zhang. Lastly, Zhang teaches using infrared to travel deeper into patient’s body to aid in healing broken bone ([0134]) as well as using phototherapy for a variety of conditions such as neuropathic pain ([0233]) which a person of ordinary skill in the art would understand to involve neural cells. As discussed in the rejection of claim 1, all references teach that the light parameters are results-effective-variable (De Taboada [0087]-[0088]; [0112]; Barry [0037]; [0158] “control the amount of energy being invoked to a specific site”; Zhang [0005]-[0006]; [0114]-[0115]; [0117]). Thus, all references are within the same field of endeavor and there is at least a teaching, suggestion, and/or motivation for a person of ordinary skill in the art to find obvious to combine to obtain the claimed recitation.
The remainder arguments regarding dependent claims rise and fall with the argument that has been addressed above.
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) 1-3, 7-11, 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry (US 20050177093 A1; 8/11/2005; cited in previous office action) in view of Zhang (US 20190083809 A1; 3/21/2019; cited in IDS), and further in view of De Taboada (US 20100010592 A1; 1/14/2010; cited in previous office action).
Regarding claim 1, Barry teaches a garment comprising a photobiomodulation unit and a controller (Fig. 8; Fig. 17).
Barry does not teach the garment being sized and dimensioned to be form fitting to a foot. However, Zhang teaches in the same field of endeavor ([0002]; [0196]) the garment being sized and dimensioned to be form fitting to a foot (Fig. 11A-C; [0260]; [0272]-[0274]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Barry to include this feature as taught by Zhang because this enables providing photobiomodulation to the target area for healing ([0260]; [0273]); MPEP 2144.04 change in shape/size.
In the combination of Barry and Zhang, Barry teaches the photobiomodulation unit comprising a connection terminal (Fig. 16, connection 80), one or more near-infrared light source groupings (Fig. 2; Fig. 11; [0161]-[0162]) arranged in a single layer (Fig. 2, even though this is labeled as prior art with respect to Barry, this still demonstrates that “arranged in a single layer” is/was contemplated in the prior art; Fig. 18A; [0049] “single layer”; [0105] “single layer(s) consisting of depths from contact with the skin”; [0172]), and one or more sensors ([0114]; [0150] “sensors”), the connection terminal in electronic communication with the one or more near-infrared light sources and one or more sensors (Fig. 16),
wherein the one or more near-infrared light source groupings comprise one or more near-infrared light sources ([0161]-[0162]), each of the one or more near-infrared light sources are configured to emit near-infrared light at a wavelength between 750 nm to 1200 nm ([0065] “wavelength of 700-900 nm”; [0150]; [0161] “near-infrared”).
The combination of Barry and Zhang teaches wherein the one or more near-infrared light source groupings are each configured to cover a region of a skin surface of the foot (Barry Fig. 11; [0161]-[0162]; Zhang Fig. 11A-C; [0260]; [0272]-[0274]).
The combination of Barry and Zhang does not teach each of the one or more near-infrared light source groupings are configured to generate a radiant flux or power of at least 500 mW and generate an average irradiance or flux density of at least 10 mW/cm2 to at most 400 mW/cm2 on the skin surface of the foot.
However, De Taboada teaches in the same field of endeavor (Fig. 1; [0082] “near-infrared”) each of the one or more near-infrared light source groupings are configured to generate a radiant flux or power of at least 500 mW ([0080]; Table 1; [0088]; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.) and generate an average irradiance or flux density of at least 10 mW/cm2 to at most 400 mW/cm2 ([0082] “300 mW/cm2”; [0087]; [0088]; ; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Barry to include this feature as taught by De Taboada because this produces the desired “biostimulative effects on the tissue being treated” with this being a results-effective-variable by tuning the irradiance ([0087]-[0088]; [0112]), because this is a results-effective-variable, the recited term “average” does not distinguish since the prior art teaches tuning this variable to obtain the desired therapeutic effect which would encompass delivering an “average” amount of light as needed. Note that Barry and Zhang also teaches that power of light can be tuned for optimum emission parameter for treatment (Barry [0037]; [0158] “control the amount of energy being invoked to a specific site”; Zhang [0005]-[0006]; [0114]-[0115]; [0117]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the instant claim’s range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
The combination of Barry, Zhang, and De Taboada teaches on the skin surface of the foot (Zhang Fig. 11A-C; [0260]; [0272]-[0274]).
In the combination of Barry, Zhang, and De Taboada, Barry teaches the controller including a processor and a memory (Fig. 8; Fig. 21), the controller configured to operationally engage a terminal rail of the connection terminal in a manner that establishes electronic communication between the controller and the connection terminal (Fig. 16; Fig. 19; Fig. 21), wherein the processor and the memory are configured with executable instructions that control one or more operational parameters of each of the one or more near-infrared light sources, each of the one or more sensors, or a combination thereof (Fig. 8; Fig. 21).
Regarding claim 2, the combination of Barry, Zhang, and De Taboada does not teach wherein the one or more near-infrared light source groupings each comprise a plurality of near-infrared light sources are arranged in a 2 x 2 array, a 2 x 3 array, a 3 x 2 array, a 3 x 3 array, a 3 x 4 array, a 4 x 3 array, a 4 x 4 array, a 2 x 5 array, a 5 x 2 array, a 3 x 5 array, a 5 x 3 array, a 4 x 5 array, a 5 x 4 array, or a 5 x 5 array. However, the combination of Barry, Zhang, and De Taboada teaches that this is a result-effective variable since the light sources are arranged and grouped to target the tissue for treatment as needed (Barry [0080]; [0103]; [0106]; [0108]; [0111]; [0162]; Zhang [0273]; [0350]; De Taboada [0089] “grid or array”) and thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to use the instant claim’s array arrangement(s); MPEP 2144.04 change in shape/size; MPEP 2144.05 result-effective variable.
Regarding claim 3, the combination of Barry, Zhang, and De Taboada teaches wherein the one or more near-infrared light source groupings each comprise one near-infrared light source grouping, two near-infrared light source groupings, three near-infrared light source groupings, four near-infrared light source groupings, or five near-infrared light source groupings (Barry [0080]; [0103]; [0106]; [0108]; [0111]; [0162]; Zhang [0273]; [0350]; De Taboada [0089] “grid or array”; it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.).
Regarding claim 7, in the combination of Barry, Zhang, and De Taboada, Zhang teaches wherein the garment is a sock (Fig. 11A-C; [0260]; [0272]-[0274]).
Regarding claim 8, in the combination of Barry, Zhang, and De Taboada, Barry teaches wherein each of the one or more near-infrared light sources is a near-infrared light emitting laser ([0049] “Laser”), near-infrared light emitting diode ([0150]; [0161]), or a combination thereof ([0063]).
Regarding claim 9, in the combination of Barry, Zhang, and De Taboada, Barry teaches wherein the wavelength emitted by each of the one or more near-infrared light sources is between 800 nm to 1100 nm ([0065] “wavelength of 700-900 nm”; [0150]; [0161] “near-infrared”).
Regarding claim 10, in the combination of Barry, Zhang, and De Taboada, De Taboada teaches wherein the one or more near-infrared light sources are each configured to generate an average irradiance or flux density of at least 10 mW/cm2 to at most 300 mW/cm2 ([0082] “300 mW/cm2”; [0087]; [0088]; ; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.; the recited term “average” does not distinguish since the prior art teaches tuning this variable to obtain the desired therapeutic effect which would encompass delivering an “average” amount of light as needed. Note that Barry and Zhang also teaches that power of light can be tuned for optimum emission parameter for treatment (Barry [0037]; [0158] “control the amount of energy being invoked to a specific site”; Zhang [0005]-[0006]; [0114]-[0115]; [0117])).
Regarding claim 11, in the combination of Barry, Zhang, and De Taboada, De Taboada teaches wherein the one or more near-infrared light source groupings are each configured to generate a radiant flux or power of at least 900 mW ([0080]; Table 1; [0088]; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.).
Regarding claim 14, in the combination of Barry, Zhang, and De Taboada, Barry teaches wherein each of the one or more sensors is configured to detect, measure, collect, record, and/or analyze information on one or more parameters of the garment, the photobiomodulation unit and components therein, the controller and components therein, the user, or any combination thereof, and thereafter transmit the information to the controller (Fig. 19-21; [0114]; [0120]-[0121]; [0150] “sensors”).
Regarding claim 15, in the combination of Barry, Zhang, and De Taboada, Barry teaches wherein each of the one or more sensors comprise a neuro-conductivity sensor, a galvanometric sensor, an oxygen level sensor ([0114] “oxygenated”), a carbon dioxide level sensor, a brain oxygen level sensor, a heart rate sensor, a cortical blood flow sensor, a temperature sensor ([0183]; [0204]), an electroencephalogram sensor, or any combination thereof.
Regarding claim 16, in the combination of Barry, Zhang, and De Taboada, Barry teaches wherein the executable instructions independently and/or dynamically control the one or more operational parameters of each of the one or more near-infrared light sources, each of the one or more sensors, or a combination thereof (Fig. 19-20B; [0065] “independent control”; [0122]).
Regarding claim 17, in the combination of Barry, Zhang, and De Taboada, Barry teaches wherein the one or more operational parameters of each of the one or more near-infrared light sources comprise activation of each of the one or more near-infrared light sources, duration of activation of each of the one or more near-infrared light sources, deactivation of each of the one or more near-infrared light sources, duration of deactivation of each of the one or more near-infrared light sources, a pattern and timing of activation of each of the one or more near-infrared light sources, a pattern and timing of deactivation of each of the one or more near-infrared light sources, a fluence level of each of the one or more near-infrared light sources, an irradiance level of each of the one or more near-infrared light sources, a dosimetry level of each of the one or more near-infrared light sources, a pulsed operation of each of the one or more near-infrared light sources, a continuous operation of each of the one or more near-infrared light sources, an operation time of each of the one or more near-infrared light sources, a cycle duration of each of the one or more near-infrared light sources, or any combination thereof (Fig. 19-20B; [0065] “independent control”; [0122]).
Regarding claim 18, in the combination of Barry, Zhang, and De Taboada, Barry teaches wherein the one or more operational parameters of each of the one or more sensors comprise monitoring heart rate variability of the user, monitoring skin temperature of the user ([0183]; [0204]), monitoring skin opacity of the user, monitoring skin density of the user, monitoring mitochondrial functionality of the user, monitoring input into the controller by the user ([0208]), monitoring input into the controller by a third-party (Fig. 21), or any combination thereof.
Regarding claim 19, in the combination of Barry, Zhang, and De Taboada, Barry teaches wherein the processor and the memory are further configured with executable instructions that independently and/or dynamically control detection, measurement, collection, recordation, and/or analysis of information obtained from each of the one or more sensors (Fig. 19-20B; [0065] “independent control”; [0114]; [0122]; [0183]).
Claim(s) 12-13, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry, Zhang, and De Taboada as applied to claim 1 above, and further in view of Bornstein (US 20110295343 A1; 12/1/2011; cited in previous office action).
Regarding claim 12, the combination of Barry, Zhang, and De Taboada does not teach wherein the one or more near-infrared light source groupings are each configured to generate a radiant exposure or fluence of at least 20 J/cm2 to at most 200 J/cm2. Note that De Taboada teaches that the exposure or fluence is a results effective variable and is related to the power settings ([0112]) as does Barry ([0037]; [0158] “control the amount of energy being invoked to a specific site”) and Zhang ([0114]-[0115]; [0117]). However, Bornstein teaches in the same field of endeavor (Abstract; [0570]) wherein the one or more near-infrared light sources are configured to generate a radiant exposure or fluence of at least 20 J/cm2 to at most 200 J/cm2 ([0033] “200 J/cm2”; [0336]). In addition, Bornstein teaches that this is a results effective variable ([0324]-[0326]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the instant claim’s range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
The combination of Barry, Zhang, De Taboada, and Bornstein teaches on a skin surface of the foot (Zhang Fig. 11A-C; [0260]; [0272]-[0274]).
Regarding claim 13, in the combination of Barry, Zhang, De Taboada, and Bornstein, Bornstein teaches wherein the radiant exposure or fluence generated is at least 30 J/cm2 to at most 200 J/cm2 ([0033] “200 J/cm2”; [0336]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
Regarding claim 22, the combination of Barry, Zhang, and De Taboada teaches wherein the wavelength emitted by each of the one or more near-infrared light sources between 800 nm to 1100 nm (Barry [0065] “wavelength of 700-900 nm”; [0150]; [0161] “near-infrared”; Zhang [0135] “near infrared of about 810 nm”) wherein the average irradiance or flux density generated by the one or more near-infrared light sources is at least 10 mW/cm2 to at most 300 mW/cm2 (De Taboada [0082] “300 mW/cm2”; [0087]; [0088]), and wherein the one or more near-infrared light sources are configured to generate a radiant flux or power of at least 900 mW (De Taboada [0080]; Table 1; [0088]; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.)
The combination of Barry, Zhang, and De Taboada does not teach generate a radiant exposure or fluence in a range of at least 20 J/cm2 to at most 200 J/cm2. Note that De Taboada teaches that the exposure or fluence is a results effective variable and is related to the power settings ([0112]) as does Barry ([0037]; [0158] “control the amount of energy being invoked to a specific site”) and Zhang ([0114]-[0115]; [0117]). However, Bornstein teaches in the same field of endeavor (Abstract; [0570]) generate a radiant exposure or fluence in a range of at least 20 J/cm2 to at most 200 J/cm2 ([0033] “200 J/cm2”; [0336]). In addition, Bornstein teaches that this is a results effective variable ([0324]-[0326]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the instant claim’s range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry, Zhang, and De Taboada as applied to claim 1 above, and further in view Berman (US 20160235983 A1; 8/18/2016; cited in previous office action).
Regarding claim 20, the combination of Barry, Zhang, and De Taboada does not teach further comprising one or more stimulators. Note that Zhang teaches auxiliary devices for stimulators ([0238]). However, Berman teaches in the same field of endeavor (Abstract; Fig. 1; [0055] “near infrared”) further comprising one or more stimulators ([0015] “external stimulation…magnetic stimulation”; [0044]; [0053]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Barry, Zhang, and De Taboada to include this feature as taught by Berman because this enables feedback for the therapy ([0015]-[0016]) and improved therapeutic results by specific targeting ([0053]).
Regarding claim 21, in the combination of Barry, Zhang, De Taboada, and Berman, Berman teaches wherein the one or more stimulators include a component that can generate a magnetic field ([0015] “external stimulation…magnetic stimulation”; [0044]; [0053]).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry, Zhang, and De Taboada as applied to claim 1 above, and further in view of Li (CN 108310634 A; 7/24/2018; Espacenet English Translation relied upon; cited in previous office action).
Regarding claim 23, the combination of Barry, Zhang, and De Taboada does not explicitly teach wherein the one or more near-infrared light source groupings are each configured to partially overlay or are substantially centered on a primary acupuncture meridian, a major extraordinary vessel, a minor extraordinary vessel, or any combination thereof. For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The combination of Barry, Zhang, and De Taboada is structurally capable of meeting the instant claim limitations (Zhang Fig. 11A-C; [0260]; [0272]-[0274]).
However, for the sake of clarity of the record and to avoid doubt, Li teaches in the same field of endeavor (Fig. 1) wherein the one or more near-infrared light source groupings are each configured to partially overlay or are substantially centered on a primary acupuncture meridian, a major extraordinary vessel, a minor extraordinary vessel, or any combination thereof (Note that this is interpreted in light of instant specification [0092]; Li p. 2 paragraph 2, paragraph 8, paragraph 14; claim 1). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Barry, Zhang, and De Taboada to include this feature as taught by Li because this enables therapeutic benefit by targeting these areas on foot (p.1 last paragraph; claim 1).
Conclusion
THIS ACTION IS MADE FINAL. 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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792
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