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 .
Claim Status: Claims 2-14 and 16-21 are pending.
Response to Arguments
Applicant's arguments filed on November 25, 2025 have been fully considered but they are not persuasive.
Re Claims 2 and 20, Applicant made an argument that combining Yang’s flat heat pipe with a wearable garment would render the garment completely unusable, because the combination would result in an extremely fast conduction of heat within the textile, leading to injury.
This argument has been considered but is not persuasive.
Firstly, Applicant mentioned that Kalaoglu-Altan states that thermal conductivities of textile structures in general vary from 0.033 to 0.20 W/(m*K). Applicant also mentioned Thielen regarding heat flux. However, Thielen and Kalaoglu-Altan references have not been provided in IDS; the context of these values cannot be reviewed to make a response.
Applicant made an argument that Yang’s heat pipe “cannot be used with a wearable garment as the mechanism is configured to produce heat far above the acceptable heat for an individual to wear.” This argument is not persuasive, because disclosed heat flux of 10-20 W/cm2 of Yang’s heat pipe is the rate of heat energy transfer per unit area. Therefore, heat pipe moves the heat instead of producing heat. Additionally, the rate of heat transfer will not exceed the amount of heat being produced. Regardless of how high the thermal conductivity of heat pipe is, if a device produces a small amount of heat, Yang’s heat pipe will transfer the small amount of heat within its limit of heat flux and not larger. Therefore, Applicant’s argument that using Yang’s heat pipe would lead to injury is not persuasive.
2) Applicant made an argument that Yang does not show a plurality of heat pipes within a garment extending from a center of the garment to an edge of the garment as claimed.
This argument has been considered but is not persuasive.
Yang teaches flat polymer heat pipe for removing heat from a given heat source, i.e. LED module. Zhang teaches the plurality of light emitters or optical fibers providing an irradiance at a center of the wearable garment and extending from the center of the wearable garment to an edge of the wearable garment (para. [0024], fig. 6, a wearable LLLT treatment device in the form of a bandage or garment, para. [0261], LLLT light guides 615 and 620; para. [0025], fig. 7, a further wearable LLLT treatment device in the form of a bandage or garment; para. [0262], light guide 725a and light guide 725b; para. [0100], [0101], [0342], the light guide or light guide arrangement is configured to emit light substantially non-uniformly along the length thereof, with certain sections to side-emit light while other sections to be non-emitting – This disclosure discloses that the plurality of light emitters provides an irradiance at a center of the wearable garment).
Therefore, Yang’s teaching of flat polymer heat pipe can be used in Zhang extending from the center of the wearable garment to an edge of the wearable garment for the purpose of cooling the thermal transfer region and controlling temperature with advantage of process compatibility, light weight, and good temperature and chemical resistance (page 38).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-14 and 16-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11110295 in view of Solomon et al. (US 2012/0041523), hereinafter “Solomon”, Shapiro et al. (US 2006/0282134), hereinafter “Shapiro”, and Yang et al. (Non-Patent Literature, A novel flat polymer heat pipe with thermal via for cooling electronic devices).
Patented claims read on the instant claims substantially.
Patented claims are silent regarding the two or more temperature sensors being spaced apart within the structure, wherein the controller is configured to modulate the duty cycle in response to signals from the two or more temperature sensors indicating a selected temperature at which to modulate the irradiance.
Solomon discloses skin treatment device using light and temperature (abstract) and discloses a light source secured to the housing and temperature (abstract) and a temperature sensor (para. [0051], temperature sensor 160 is arranged to sense a temperature associated with the temperature of one of skin treatment area 100 and skin treatment area portion 110, figs 2 and 3) and discloses that the controller is configured to modulate the duty cycle in response to signals from the two or more temperature sensors indicating a selected temperature at which to modulate the irradiance (para. [0052], Control and driving circuitry 120 is further preferably operative to adjust one or more of the PWM (pulse width modulation) duty cycle of temperature adjusting element 60, the PWM duty cycle of light source 70, the power per cycle applied to temperature adjusting element 60 and the power per cycle applied to light source 70 responsive to temperature sensor 160, thus ensuring that the temperature of one of skin treatment area 100 and skin treatment area portion 110 remains within predetermined parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claims, by configuring the controller to modulate the duty cycle in response to signals from the two or more temperature sensors indicating a selected temperature at which to modulate the irradiance, as taught by Solomon, for the purpose of ensuring that the temperature of one of skin treatment area 100 and skin treatment area portion 110 remains within predetermined parameters during light therapy (para. [0052]).
Solomon is silent regarding two or more temperature sensors being spaced apart within the structure.
Shapiro discloses photo-thermal therapeutic device having a plurality of light emitting diodes resiliently mounted in the housing, where the housing of the device can conform to any surface of the body of a user (abstract). Shapiro teaches two or more temperatures operatively connected to the flexible circuit and are positioned in the conformable housing and spaced apart within the housing and teaches a controller that is configured to modulate the energy supplied to the diodes to maintain the desired temperature on the surface being treated, where the desired temperature for the surface that is being treated can be set with the controller (fig. 1, thermistors 59, para. [0022], The thermistors 59 are designed to measure the temperature on the surface that is being treated by the photo-thermal device 10. The thermistors 59 are positioned on the flexible circuit 37 in a manner that allows the thermistors to effectively monitor the temperature on the entire surface that is being treated by the photo-thermal device 10. The thermistors 59 are designed to measure the temperature on the surface that is being treated by the photo-thermal device 10. The thermistors 59 are positioned on the flexible circuit 37 in a manner that allows the thermistors to effectively monitor the temperature on the entire surface that is being treated by the photo-thermal device 10. The flexible circuit 37 contains a feedback loop that reacts to the temperature readings and adjusts the energy supplied to the diodes 43 and resistors 53 to maintain the desired temperature on the surface being treated; para. [0027] also discloses that the photo-thermal device 10 has the ability to provide for adjustment of several parameters such as the duty cycle for the light emitting diodes, the frequencies for the light emitting diodes, the temperature of the surface that is being treated, the treatment time, sequencing patterns for the light emitting diodes and the rate at which each light emitting diode or clusters of light emitting diodes are electrically energized. All of the above parameters can be controlled to provide the most effective light and heat stimulation to treat the user of the photo-thermal device 10.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claims as modified by Solomon, by configuring two or more temperature sensors to be spaced apart within the structure, wherein the two or more temperature sensors are connected to the controller to provide feedback information on skin temperature, as taught by Shapiro, for the purpose of providing a feedback control that reacts to the temperature readings and adjusts the energy to maintain the desired temperature on the surface being treated, where the desired temperature for the surface that is being treated can be set with the controller (para. [0022]).
Patented claim is silent regarding a cooling mechanism configured to be carried by the wearable garment extending from the first portion to a second portion spaced apart from the first portion, the cooling mechanism comprising a flat flexible polymer heat pipe, wherein the cooling mechanism dissipates heat transferred from the first portion to the second portion away from the testes of the individual.
Yang discloses a cooling mechanism configured to be carried by electronic device extending from the first portion to a second portion spaced apart from the first portion, the cooling mechanism comprising a flat flexible polymer heat pipe, wherein the cooling mechanism dissipates heat transferred from the first portion to the second portion away from the LED module (page 38, 1.1. Miniature FR4 flat heat pipe design and fabrication, A polymer heat pipe has the added benefit of being light in weight and compatible with most electronics fabrication. A polymer can also be flexible and good electrical insulation properties make it very suitable for simple incorporation in electronics packaging; fig. 2 shows the FR4 heat pipe and cooling flow and heater that dissipates the heat).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claims as modified by Solomon and Shapiro, by adding a cooling mechanism configured to be carried by the wearable garment extending from the first portion to a second portion spaced apart from the first portion, the cooling mechanism comprising a flat flexible polymer heat pipe, wherein the cooling mechanism dissipates heat transferred from the first portion to the second portion away from the testes of the individual, as taught by Yang, for the purpose of cooling the thermal transfer region and controlling temperature with advantage of process compatibility, light weight, and good temperature and chemical resistance (page 38).
Yang is silent regarding a plurality of flat flexible polymer heat pipes extending from a center of the wearable garment to an edge of the wearable garment, wherein the plurality of flat flexible polymer heat pipes dissipate heat transferred from the first portion to the second portion away from the testes of the individual.
However, Yang further teaches that the flat flexible polymer heat pipe does lateral heat transfer (page 37, Flat plate heat pipes are considered as potential alternatives to the common solid substrates due to the ability of transferring heat laterally with small temperature differences between the concentrated heat source (at the evaporator section) and the cold edges (at the condenser section) of the flat plate heat pipes).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claims as modified by Solomon, Shapiro, and Yang, by adding a plurality of flat flexible polymer heat pipes, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (MPEP 2144.04); and by configuring a plurality of flat flexible polymer heat pipes to extend from a center of the wearable garment to an edge of the wearable garment, wherein the plurality of flat flexible polymer heat pipes dissipate heat transferred from the first portion to the second portion away from the testes of the individual, since it has been held that rearranging parts of an invention involves only routine skill in the art (MPEP 2144.04) using the advantage of lateral heat transfer with flat flexible polymer heat pipes taught by Yang (page 37).
Claims 2-14 and 16-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11660467 in view of Solomon et al. (US 2012/0041523), hereinafter “Solomon”, Shapiro et al. (US 2006/0282134), hereinafter “Shapiro”, and Yang et al. (Non-Patent Literature, A novel flat polymer heat pipe with thermal via for cooling electronic devices).
Patented claims read on the instant claims substantially.
Patented claims are silent regarding the two or more temperature sensors being spaced apart within the structure, wherein the controller is configured to modulate the duty cycle in response to signals from the two or more temperature sensors indicating a selected temperature at which to modulate the irradiance.
Solomon discloses skin treatment device using light and temperature (abstract) and discloses a light source secured to the housing and temperature (abstract) and a temperature sensor (para. [0051], temperature sensor 160 is arranged to sense a temperature associated with the temperature of one of skin treatment area 100 and skin treatment area portion 110, figs 2 and 3) and discloses that the controller is configured to modulate the duty cycle in response to signals from the two or more temperature sensors indicating a selected temperature at which to modulate the irradiance (para. [0052], Control and driving circuitry 120 is further preferably operative to adjust one or more of the PWM (pulse width modulation) duty cycle of temperature adjusting element 60, the PWM duty cycle of light source 70, the power per cycle applied to temperature adjusting element 60 and the power per cycle applied to light source 70 responsive to temperature sensor 160, thus ensuring that the temperature of one of skin treatment area 100 and skin treatment area portion 110 remains within predetermined parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claims, by configuring the controller to modulate the duty cycle in response to signals from the two or more temperature sensors indicating a selected temperature at which to modulate the irradiance, as taught by Solomon, for the purpose of ensuring that the temperature of one of skin treatment area 100 and skin treatment area portion 110 remains within predetermined parameters during light therapy (para. [0052]).
Solomon is silent regarding two or more temperature sensors being spaced apart within the structure.
Shapiro discloses photo-thermal therapeutic device having a plurality of light emitting diodes resiliently mounted in the housing, where the housing of the device can conform to any surface of the body of a user (abstract). Shapiro teaches two or more temperatures operatively connected to the flexible circuit and are positioned in the conformable housing and spaced apart within the housing and teaches a controller that is configured to modulate the energy supplied to the diodes to maintain the desired temperature on the surface being treated, where the desired temperature for the surface that is being treated can be set with the controller (fig. 1, thermistors 59, para. [0022], The thermistors 59 are designed to measure the temperature on the surface that is being treated by the photo-thermal device 10. The thermistors 59 are positioned on the flexible circuit 37 in a manner that allows the thermistors to effectively monitor the temperature on the entire surface that is being treated by the photo-thermal device 10. The thermistors 59 are designed to measure the temperature on the surface that is being treated by the photo-thermal device 10. The thermistors 59 are positioned on the flexible circuit 37 in a manner that allows the thermistors to effectively monitor the temperature on the entire surface that is being treated by the photo-thermal device 10. The flexible circuit 37 contains a feedback loop that reacts to the temperature readings and adjusts the energy supplied to the diodes 43 and resistors 53 to maintain the desired temperature on the surface being treated; para. [0027] also discloses that the photo-thermal device 10 has the ability to provide for adjustment of several parameters such as the duty cycle for the light emitting diodes, the frequencies for the light emitting diodes, the temperature of the surface that is being treated, the treatment time, sequencing patterns for the light emitting diodes and the rate at which each light emitting diode or clusters of light emitting diodes are electrically energized. All of the above parameters can be controlled to provide the most effective light and heat stimulation to treat the user of the photo-thermal device 10.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claims as modified by Solomon, by configuring two or more temperature sensors to be spaced apart within the structure, wherein the two or more temperature sensors are connected to the controller to provide feedback information on skin temperature, as taught by Shapiro, for the purpose of providing a feedback control that reacts to the temperature readings and adjusts the energy to maintain the desired temperature on the surface being treated, where the desired temperature for the surface that is being treated can be set with the controller (para. [0022]).
Patented claim is silent regarding the cooling mechanism comprising a flat flexible polymer heat pipe, wherein the cooling mechanism dissipates heat transferred from the first portion to the second portion away from the testes of the individual.
Yang discloses a cooling mechanism configured to be carried by electronic device extending from the first portion to a second portion spaced apart from the first portion, the cooling mechanism comprising a flat flexible polymer heat pipe, wherein the cooling mechanism dissipates heat transferred from the first portion to the second portion away from the LED module (page 38, 1.1. Miniature FR4 flat heat pipe design and fabrication, A polymer heat pipe has the added benefit of being light in weight and compatible with most electronics fabrication. A polymer can also be flexible and good electrical insulation properties make it very suitable for simple incorporation in electronics packaging; fig. 2 shows the FR4 heat pipe and cooling flow and heater that dissipates the heat).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claims as modified by Solomon and Shapiro, by adding a cooling mechanism configured to be carried by the wearable garment extending from the first portion to a second portion spaced apart from the first portion, the cooling mechanism comprising a flat flexible polymer heat pipe, wherein the cooling mechanism dissipates heat transferred from the first portion to the second portion away from the testes of the individual, as taught by Yang, for the purpose of cooling the thermal transfer region and controlling temperature with advantage of process compatibility, light weight, and good temperature and chemical resistance (page 38).
Yang is silent regarding a plurality of flat flexible polymer heat pipes extending from a center of the wearable garment to an edge of the wearable garment, wherein the plurality of flat flexible polymer heat pipes dissipate heat transferred from the first portion to the second portion away from the testes of the individual.
However, Yang further teaches that the flat flexible polymer heat pipe does lateral heat transfer (page 37, Flat plate heat pipes are considered as potential alternatives to the common solid substrates due to the ability of transferring heat laterally with small temperature differences between the concentrated heat source (at the evaporator section) and the cold edges (at the condenser section) of the flat plate heat pipes).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify patented claims as modified by Solomon, Shapiro, and Yang, by adding a plurality of flat flexible polymer heat pipes, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (MPEP 2144.04); and by configuring a plurality of flat flexible polymer heat pipes to extend from a center of the wearable garment to an edge of the wearable garment, wherein the plurality of flat flexible polymer heat pipes dissipate heat transferred from the first portion to the second portion away from the testes of the individual, since it has been held that rearranging parts of an invention involves only routine skill in the art (MPEP 2144.04) using the advantage of lateral heat transfer with flat flexible polymer heat pipes taught by Yang (page 37).
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.
Claims 2-14 and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0083809) in view of Solomon et al. (US 2012/0041523), hereinafter “Solomon”, Shapiro et al. (US 2006/0282134), hereinafter “Shapiro”, Stephan (US 2013/0116612), and Yang et al. (Non-Patent Literature, A novel flat polymer heat pipe with thermal via for cooling electronic devices).
Re Claim 2, Zhang discloses a light stimulation system for providing irradiance therapy to a testes of an individual to enhance testosterone levels in the individual (abstract, the claim language “for providing irradiance therapy to an individual’s testes to enhance testosterone levels in the individual” is an intended use), the light stimulation system comprising:
a flexible substrate carrying a plurality of light emitters on a front side of the flexible substrate (para. [0262], fig. 7, light sources 760, 765 and 775 disposed in PBM control module 705, which is removably or permanently engageable with LLLT delivery element 710 in the form of a garment, blanket, or bandage; para. [0089], the various components of the PBM control module can be distributed in a band or strip of fabric or plastic envelope or the like to provide a containment structure.),
the plurality of light emitters being configured to emit at least one selected wavelength between 400 nm and 850nm (para. [0260], wearable LLLT device 505 in any suitable format including pants – carrying at least one light source; para. [0261], fig. 6, shows wearable LLLT device 600. LLLT delivery element 605 comprises a garment or bandage configuration. PBM control module 625 comprises at least one light source 630. More than one light source, each capable of delivering different wavelengths, can be used, where such one or more light sources are configurable to allow transmission of a therapeutic amount of LLLT to a patient in need of treatment; fig. 7, para. [0262], PBM control module 705 comprising light sources 760, 765 and 775 removably or permanently engageable with LLLT delivery element 710 in the form of a garment, blanket, or bandage; para. [0279], fig. 14, PBM control module 1415 on wearable device 1405; para. [0344] discloses a plurality of diodes, LEDs, or SLDs; para. [0164] discloses 650 nm, para. [0292], [0317] discloses light at about 650 nm to about 700 nm for red and about 830 nm to about 980 nm in the infrared range; The wavelengths associated with green, from about 521 nm to about 530 nm. The wavelengths associated with blue, from about 410 nm to about 495 nm),
wherein the flexible substrate is configured to be positioned in a wearable garment of the individual to irradiate testes of the individual at a first portion of the flexible substrate (para. [0260], wearable LLLT device 505 in any suitable format including pants; para. [0209], [0316], provide light energy to the groin regions of the patient in use, especially to the area with lymph nodes and blood vessels near the pelvic area, which can function as “healing vital areas”. Discontinuity area 2555c can enhance healing of the area proximal to the vaginal opening – Zhang discloses a wearable structure in suitable format including pants that is configured to irradiate the groin regions of the patient. This structure is capable of irradiating testes of the individual.);
a controller (abstract, para. [0011], [0088], [0118], [0182] discloses controller associated with the PBM control module) configured to activate the plurality of light emitters to provide a selected irradiance in a duty cycle consisting of an ON and OFF sequence, wherein ON intervals total at least 5 minutes over at least a 30 minute period (para. [0298], the LLLT dose provided to a patient in need of treatment can have a duty cycle that is provided to from about 8 minutes on and about 30 minutes off for about three cycles per treatment; para. [0164], a first LLLT treatment protocol whereby light from the at least one light source at a wavelength of 650 nm at 60 mW, in a continuous wave for about 120 seconds and including a pulsing mode of about 15 or about 30 or about 60 or about 90 or about 120 seconds of pulsing at each of 4 Hz, 10 Hz, 60 Hz and 1000 Hz, or variations thereof. The PBM control module can direct the first treatment protocol to be repeated from time to time, for example, every 15, 30 60, 120 or 240 minutes, with an off cycle in between each cycle.) and
where the plurality of light emitters provides an irradiance between 20 mW/cm2 to 200mW/cm2 (para. [0317], For an actually or potentially infected area during wound healing, the wavelengths associated with blue, from about 410 nm to about 495 nm, can be used with at about 10 to about 70 mW/cm2) at a center of the wearable garment (para. [0024], fig. 6, a wearable LLLT treatment device in the form of a bandage or garment, para. [0261], LLLT light guides 615 and 620; para. [0025], fig. 7, a further wearable LLLT treatment device in the form of a bandage or garment; para. [0262], light guide 725a and light guide 725b; para. [0100], [0101], [0342], the light guide or light guide arrangement is configured to emit light substantially non-uniformly along the length thereof, with certain sections to side-emit light while other sections to be non-emitting – This disclosure discloses that the plurality of light emitters provides an irradiance at a center of the wearable garment);
Zhang additionally discloses temperature sensors carried in the flexible structure (para. [0120], sensors associated with a PBM control module includes temperature sensor; para. [0263], fig. 7, sensor cluster 780 comprises temperature sensor), wherein the controller is configured to modulate operating parameters of the plurality of light emitters in response to signals from the temperature sensors (para. [0223], if sensors associated with the PBM control module provide information signaling the presence of a higher than normal amount exudate on post-op day 2, increase the amount of LLLT treatment to about 2.5 J/cm2 on post-op day 3; para. [0224], the PBM control module receives and completes the new prescription via software instructions by incorporating regular monitoring by sensors and/or patient feedback; para. [0259], Such ongoing treatment information can comprise operational information 415 generated from one or more of sensor data, patient compliance data, images, patient activity level, patient weight, provider generated information relevant to the patient or treatment, or the like; para. [0235] discloses that temperature can be measured in real time and the sensor can be in communications engagement with the LLLT treatment devices. In this regard, individual medical monitoring and treatment equipment associated with the patient can be associated with the communications capability of the LLLT treatment devices to enhance the data available for analysis of the progress and effectiveness of LLLT treatment.).
Zhang is silent regarding the two or more temperature sensors being spaced apart within the structure, wherein the controller is configured to modulate the duty cycle in response to signals from the two or more temperature sensors indicating a selected temperature at which to modulate the irradiance.
Solomon discloses skin treatment device using light and temperature (abstract) and discloses a light source secured to the housing and temperature (abstract) and a temperature sensor (para. [0051], temperature sensor 160 is arranged to sense a temperature associated with the temperature of one of skin treatment area 100 and skin treatment area portion 110, figs 2 and 3) and discloses that the controller is configured to modulate the duty cycle in response to signals from the two or more temperature sensors indicating a selected temperature at which to modulate the irradiance (para. [0052], Control and driving circuitry 120 is further preferably operative to adjust one or more of the PWM (pulse width modulation) duty cycle of temperature adjusting element 60, the PWM duty cycle of light source 70, the power per cycle applied to temperature adjusting element 60 and the power per cycle applied to light source 70 responsive to temperature sensor 160, thus ensuring that the temperature of one of skin treatment area 100 and skin treatment area portion 110 remains within predetermined parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang, by configuring the controller to modulate the duty cycle in response to signals from the two or more temperature sensors indicating a selected temperature at which to modulate the irradiance, as taught by Solomon, for the purpose of ensuring that the temperature of one of skin treatment area 100 and skin treatment area portion 110 remains within predetermined parameters during light therapy (para. [0052]).
Solomon is silent regarding two or more temperature sensors being spaced apart within the structure.
Shapiro discloses photo-thermal therapeutic device having a plurality of light emitting diodes resiliently mounted in the housing, where the housing of the device can conform to any surface of the body of a user (abstract). Shapiro teaches two or more temperatures operatively connected to the flexible circuit and are positioned in the conformable housing and spaced apart within the housing and teaches a controller that is configured to modulate the energy supplied to the diodes to maintain the desired temperature on the surface being treated, where the desired temperature for the surface that is being treated can be set with the controller (fig. 1, thermistors 59, para. [0022], The thermistors 59 are designed to measure the temperature on the surface that is being treated by the photo-thermal device 10. The thermistors 59 are positioned on the flexible circuit 37 in a manner that allows the thermistors to effectively monitor the temperature on the entire surface that is being treated by the photo-thermal device 10. The thermistors 59 are designed to measure the temperature on the surface that is being treated by the photo-thermal device 10. The thermistors 59 are positioned on the flexible circuit 37 in a manner that allows the thermistors to effectively monitor the temperature on the entire surface that is being treated by the photo-thermal device 10. The flexible circuit 37 contains a feedback loop that reacts to the temperature readings and adjusts the energy supplied to the diodes 43 and resistors 53 to maintain the desired temperature on the surface being treated; para. [0027] also discloses that the photo-thermal device 10 has the ability to provide for adjustment of several parameters such as the duty cycle for the light emitting diodes, the frequencies for the light emitting diodes, the temperature of the surface that is being treated, the treatment time, sequencing patterns for the light emitting diodes and the rate at which each light emitting diode or clusters of light emitting diodes are electrically energized. All of the above parameters can be controlled to provide the most effective light and heat stimulation to treat the user of the photo-thermal device 10.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Solomon, by configuring two or more temperature sensors to be spaced apart within the structure, wherein the two or more temperature sensors are connected to the controller to provide feedback information on skin temperature, as taught by Shapiro, for the purpose of providing a feedback control that reacts to the temperature readings and adjusts the energy to maintain the desired temperature on the surface being treated, where the desired temperature for the surface that is being treated can be set with the controller (para. [0022]).
Zhang, Solomon, and Shapiro are silent regarding a thin film reflective layer on a back side of the flexible substrate, wherein the thin film reflective layer is configured to emit light from the plurality of light emitters to the individual; and
However, Stephan discloses wearable light therapy apparatus (abstract) and discloses side scattering optical light guide (para. [0094], light tubes 602, 612, 622, and 632 in the body support in figs.10-15 as well as on the belt shown in figs. 5 and 8). Stephan teaches a thin film reflective layer on a back side of the flexible substrate, wherein the thin film reflective layer is configured to emit light from the plurality of light emitters to the individual (para. [0097], a reflective layer 601 on one side of the light tube 602 as in fig. 14A or along one edge of the foam layer 603 to reflect light generated in one direction by the light tube 602 back through the foam layer 603 onto the user’s skin).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Solomon and Lee, by adding a thin film reflective layer on a back side of the flexible substrate, wherein the thin film reflective layer is configured to emit light from the plurality of light emitters to the individual, as taught by Stephan, for the purpose of reflecting light generated in one direction by the plurality of light emitters back onto the user’s skin (para. [0097]).
Zang, Solomon, Shapiro, and Stephan are silent regarding a cooling mechanism configured to be carried by the wearable garment extending from the first portion to a second portion spaced apart from the first portion, the cooling mechanism comprising a flat flexible polymer heat pipe, wherein the cooling mechanism dissipates heat transferred from the first portion to the second portion away from the testes of the individual.
Yang discloses a cooling mechanism configured to be carried by electronic device extending from the first portion to a second portion spaced apart from the first portion, the cooling mechanism comprising a flat flexible polymer heat pipe, wherein the cooling mechanism dissipates heat transferred from the first portion to the second portion away from the LED module (page 38, 1.1. Miniature FR4 flat heat pipe design and fabrication, A polymer heat pipe has the added benefit of being light in weight and compatible with most electronics fabrication. A polymer can also be flexible and good electrical insulation properties make it very suitable for simple incorporation in electronics packaging; fig. 2 shows the FR4 heat pipe and cooling flow and heater that dissipates the heat).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Solomon, Lee, and Stephan, by adding a cooling mechanism configured to be carried by the wearable garment extending from the first portion to a second portion spaced apart from the first portion, the cooling mechanism comprising a flat flexible polymer heat pipe, wherein the cooling mechanism dissipates heat transferred from the first portion to the second portion away from the testes of the individual, as taught by Yang, for the purpose of cooling the thermal transfer region and controlling temperature with advantage of process compatibility, light weight, and good temperature and chemical resistance (page 38).
Yang is silent regarding a plurality of flat flexible polymer heat pipes extending from the center of the wearable garment to an edge of the wearable garment, wherein the plurality of flat flexible polymer heat pipes dissipate heat transferred from the first portion to the second portion away from the testes of the individual.
However, Yang further teaches that the flat flexible polymer heat pipe does lateral heat transfer (page 37, Flat plate heat pipes are considered as potential alternatives to the common solid substrates due to the ability of transferring heat laterally with small temperature differences between the concentrated heat source (at the evaporator section) and the cold edges (at the condenser section) of the flat plate heat pipes).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Solomon, Lee, Stephan, and Yang, by adding a plurality of flat flexible polymer heat pipes, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (MPEP 2144.04); and by configuring a plurality of flat flexible polymer heat pipes to extend from the center of the wearable garment to an edge of the wearable garment, wherein the plurality of flat flexible polymer heat pipes dissipate heat transferred from the first portion to the second portion away from the testes of the individual, since it has been held that rearranging parts of an invention involves only routine skill in the art (MPEP 2144.04) using the advantage of lateral heat transfer with flat flexible polymer heat pipes taught by Yang (page 37).
Re Claim 3, Zhang discloses that the ON intervals total at least 5 minutes per hour over at least a 2 hour period (para. [0298], the LLLT dose provided to a patient in need of treatment can have a duty cycle that is provided to from about 8 minutes on and about 30 minutes off for about three cycles per treatment; para. [0164], a first LLLT treatment protocol whereby light from the at least one light source at a wavelength of 650 nm at 60 mW, in a continuous wave for about 120 seconds and including a pulsing mode of about 15 or about 30 or about 60 or about 90 or about 120 seconds of pulsing at each of 4 Hz, 10 Hz, 60 Hz and 1000 Hz, or variations thereof. The PBM control module can direct the first treatment protocol to be repeated from time to time, for example, every 15, 30 60, 120 or 240 minutes, with an off cycle in between each cycle.).
Re Claim 4, Zhang discloses that the ON intervals total 10 minutes per hour over at least a 1 hour period (para. [0298], the LLLT dose provided to a patient in need of treatment can have a duty cycle that is provided to from about 8 minutes on and about 30 minutes off for about three cycles per treatment; para. [0164], a first LLLT treatment protocol whereby light from the at least one light source at a wavelength of 650 nm at 60 mW, in a continuous wave for about 120 seconds and including a pulsing mode of about 15 or about 30 or about 60 or about 90 or about 120 seconds of pulsing at each of 4 Hz, 10 Hz, 60 Hz and 1000 Hz, or variations thereof. The PBM control module can direct the first treatment protocol to be repeated from time to time, for example, every 15, 30 60, 120 or 240 minutes, with an off cycle in between each cycle.).
Re Claim 5, Zhang discloses that the irradiance is from 50 mW/cm2 to 150 mW/cm2 (para. [0317], For an actually or potentially infected area during wound healing, the wavelengths associated with blue, from about 410 nm to about 495 nm, can be used with at about 10 to about 70 mW/cm2).
Re Claim 6, Zhang discloses that the irradiance is from 10 to about 70 mW/cm2 (para. [0317], For an actually or potentially infected area during wound healing, the wavelengths associated with blue, from about 410 nm to about 495 nm, can be used with at about 10 to about 70 mW/cm2) and from 210 to about 900 mW/cm2 (para. [0292], The wavelengths associated with blue, from about 410 nm to about 495 nm, can be used at about 210 to about 900 mW/cm2 to an actually or potentially infected area during wound healing) for claimed range of wavelengths and claimed range of duty cycle.
Zhang is silent regarding the irradiance being from 80 mW/cm2 to 120 mW/cm2.
However, Zhang discloses that the determining factors for optimal dosages are power level, wavelength, duty cycle, and pulsing frequencies (para. [0291]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Solomon and Shapiro, by configuring the irradiance to be from 80 mW/cm2 to 120 mW/cm2, 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. MPEP 2144.05 II.
Re Claim 7, Zhang discloses that the plurality of light emitters comprise an array of 2 to 200 LEDs (para. [0262], fig. 7, light sources 760, 765 and 775; para. [0344] discloses a plurality of diodes, LEDs, or SLDs).
Re Claim 8, Zhang discloses that the array is carried by a flexible substrate (para. [0262], fig. 7, light sources 760, 765 and 775 disposed in PBM control module 705, which is removably or permanently engageable with LLLT delivery element 710 in the form of a garment, blanket, or bandage; para. [0089], the various components of the PBM control module can be distributed in a band or strip of fabric or plastic envelope or the like to provide a containment structure.).
Re Claim 9, Zhang discloses that the plurality of light emitters comprise side-emitting optical fibers (fig. 6, para. [0261], LLLT light guides 615 and 620, para. [0101], [0342], side emitting fiber optics).
Re Claim 10, Zhang discloses that the side-emitting optical fibers are carried in a fabric (fig. 6, para. [0261], LLLT delivery element 605 comprises a garment or bandage).
Re Claim 11, Zhang as modified by Solomon, Shapiro, and Stephan discloses the claimed invention substantially as set forth in claims 2, 9, and 10.
Zhang is silent regarding the fabric being separate from the wearable garment.
However, Stephan discloses a light stimulation system for providing irradiance therapy comprising a structure carrying a plurality of light emitters, where the structure is wearable (figs. 10-13, para. [0089]-[0094], para. [0089], light source and power supply 604 may be mounted in a small housing on the front of the knee pad 600), and teaches that optical media or light tubes may be detachable or removably plugged so that the pad or bandage in which the light tubes are mounted can be cleaned, disposed of and replaced with a new light tube and bandage (para. [0149]). Such replaceable structure increases the reliability of the laser means and the controls since the laser means and controls are not subject to exposure to water (para. [0149]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Solomon and Shapiro, by configuring the fabric to be separate from the wearable garment, as taught by Stephan, for the purpose of the wearable garment to be cleaned, disposed of, and replaced with new optical fibers carried in a fabric and/or a new wearable garment, thereby increasing the reliability of the laser means and the controls since the laser means and controls are not subject to exposure to water (para. [0149]).
Re Claim 12, Zhang discloses that the fabric is integrated in the wearable garment (para. [0260], fig. 5, wearable LLLT device 505 as garment that can comprise any suitable format such as pants; fig. 6, para. [0261], LLLT delivery element 605 comprises a garment or bandage).
Re Claim 13, Zhang discloses that the controller is configured to activate the ON and OFF sequence with an ON interval ranging from 1 millisecond to 30 minutes and an OFF interval being 15 mins (para. [0298], the LLLT dose provided to a patient in need of treatment can have a duty cycle that is provided to from about 8 minutes on and about 30 minutes off for about three cycles per treatment; para. [0164], a first LLLT treatment protocol whereby light from the at least one light source at a wavelength of 650 nm at 60 mW, in a continuous wave for about 120 seconds and including a pulsing mode of about 15 or about 30 or about 60 or about 90 or about 120 seconds of pulsing at each of 4 Hz, 10 Hz, 60 Hz and 1000 Hz, or variations thereof. The PBM control module can direct the first treatment protocol to be repeated from time to time, for example, every 15, 30 60, 120 or 240 minutes, with an off cycle in between each cycle.) for claimed range of irradiance and claimed range of wavelengths.
Zhang is silent regarding the OFF interval ranging from 1 millisecond to 10 minutes.
However, Zhang discloses that the determining factors for optimal dosages are power level, wavelength, duty cycle, and pulsing frequencies (para. [0291]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Solomon, Shapiro, and Stephan, by configuring the controller to activate the ON and OFF sequence with an ON interval ranging from 1 millisecond to 30 minutes and the OFF interval ranging from 1 millisecond to 10 minutes, 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. MPEP 2144.05 II.
Re Claim 14, Zhang discloses a portable module carrying the controller and a power source, wherein the plurality of light emitters are operatively connected to the portable module (para. [0012], a power source configured to provide power to the control module, the control module comprising: microprocessor, at least one light source; para. [0088], at least one battery power source, PBM control module; para. [0118], PMB control module comprising a battery power source; para. [0261], fig. 6, PBM control module 625).
Re Claim 16, Zhang discloses a sensing mechanism configured to be carried by the wearable garment, wherein the sensing mechanism is selected from the group of: pulse oximeters, impedance sensors and capacitance sensors (para. [0263], fig. 7, sensor cluster 780 comprises a skin conductivity sensor, a temperature sensor, an oxygen saturation sensor, or a photo sensor).
Re Claim 17, Zhang discloses that the plurality of light emitters are disposed on the flexible structure (para. [0260], wearable LLLT device 505 in any suitable format including pants – carrying at least one light source; para. [0261], fig. 6, shows wearable LLLT device 600. LLLT delivery element 605 comprises a garment or bandage configuration. PBM control module 625 comprises at least one light source 630. More than one light source, each capable of delivering different wavelengths, can be used, where such one or more light sources are configurable to allow transmission of a therapeutic amount of LLLT to a patient in need of treatment; fig. 7, para. [0262], PBM control module 705 comprising light sources 760, 765 and 775 removably or permanently engageable with LLLT delivery element 710 in the form of a garment, blanket, or bandage; para. [0279], fig. 14, PBM control module 1415 on wearable device 1405).
Zhang is silent regarding the plurality of light emitters are spaced apart from a perimeter of the structure by at least 5 mm.
However, Zhang discloses that the PBM control carrying the light source can be attached to the flexible brace material in the configuration that can distribute light in an area proximate to the incision in need to treatment with LLLT (para. [0107]). In broader constructs, the LLLT delivery element (brace/garment/cast, bandage, insertable device) can be provided for selection in range of shapes (e.g., small, medium, large etc.) to accommodate a range of wound sizes, wound types, patient sizes, and the like (para. [0107]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang, by configuring the plurality of light emitters to be spaced apart from a perimeter of the structure, as taught by Zhang, for the purpose of providing a support to the light source to be placed proximate to the treatment target (para. [0107]).
Zhang is silent regarding the plurality of light emitters are spaced apart from a perimeter of the structure by at least 5 mm.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Solomon and Shapiro, by configuring the spacing from a perimeter to be at least 5 mm, 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. MPEP 2144.05 II.
Re Claim 18, Zhang discloses that the plurality of light emitters each comprise different wavelengths (para. [0260], wearable LLLT device 505 in any suitable format including pants – carrying at least one light source; para. [0261], fig. 6, shows wearable LLLT device 600. LLLT delivery element 605 comprises a garment or bandage configuration. PBM control module 625 comprises at least one light source 630. More than one light source, each capable of delivering different wavelengths, can be used, where such one or more light sources are configurable to allow transmission of a therapeutic amount of LLLT to a patient in need of treatment; fig. 7, para. [0262], PBM control module 705 comprising light sources 760, 765 and 775 removably or permanently engageable with LLLT delivery element 710 in the form of a garment, blanket, or bandage; para. [0279], fig. 14, PBM control module 1415 on wearable device 1405; para. [0344] discloses a plurality of diodes, LEDs, or SLDs; para. [0164] discloses 650 nm, para. [0292], [0317] discloses light at about 650 nm to about 700 nm for red and about 830 nm to about 980 nm in the infrared range; The wavelengths associated with green, from about 521 nm to about 530 nm. The wavelengths associated with blue, from about 410 nm to about 495 nm).
Re Claim 19, Zhang discloses that the different wavelengths are selectively modulated over a treatment interval to provide a polychromatic photobiomodulation therapy (para. [0116], at least one aspect of the invention herein comprises selection of at light having a wavelength or wavelength range appropriate for treating of a patient wound or medical condition in need of treatment, para. [0117], [0118], the light generating components can generate light in at least three wavelengths: for example, 590 nm, 650 nm, and 808 nm, individually or simultaneously. The PBM control module is configurable to provide signaling and control to each of the components and functions associated with generation and monitoring of a LLLT treatment regimen; consider para. [0132]-[0135] and the reference in its entirety for the disclosure of advantages of each wavelength or combination of wavelengths).
Re Claim 20, Claim 20 is rejected under substantially the same basis as claims 2, 9, and 10. Para. [0100] of Zhang further discloses details about side-emitting optical fiber.
Re Claim 21, Zhang as modified by Solomon, Shapiro, and Stephan discloses the claimed invention substantially as set forth in claim 20.
Zhang further discloses that each of the plurality of optical fibers comprises a diameter of 1 mm by 3 mm (para. [0099]).
Zhang is silent regarding each of the plurality of optical fibers comprising a diameter between 100 pm to 500 pm.
Zhang discloses that the inventor has found that larger dimensions may increase the risk of pressure wound to the skin of a treated patient and the specific diameter appropriate for each indication can be readily determined by one of ordinary skill in the art without undue experimentation (para. [0099]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang as modified by Solomon, Shapiro, and Stephan, by configuring the diameter to be in the claimed 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. MPEP 2144.05 II.
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 VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, March 10, 2026Examiner, Art Unit 3792