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 1-4, 6-12, and 14-16 are pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 15, and 16 have been considered but are moot because the new grounds of rejection have been made necessitated by amendments.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 9, 10, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0083809) in view of Cumbie (US 2003/0153962) and Jarausch (US 2022/0016437).
Re Claim 1, Zhang discloses a treatment apparatus for treatment of an open wound, the treatment apparatus comprising:
a processor and a light source, wherein the light source is arranged to emit light towards the open wound when in use; and wherein the processor is configured to control the light source to emit (para. [0206], PBM control module; para. [0088], PBM control modules suitable for use in the devices and methods of the present invention can comprise at least one light source suitable to generate a therapeutic amount of LLLT to a patient in need of treatment):
during a first period of time, a light comprising a first plurality of wavelength ranges, wherein at least one of the first plurality of wavelength ranges is a first disinfecting wavelength range of light having a first radiant power, the first disinfecting wavelength range of light is from about 250 to about 270 nm and the first radiant power is 1mW/cm2, wherein the first time period is 60 seconds, wherein the first radiant power is a radiant power of the first disinfecting wavelength range of light at the wound (para. [0224], generate LLLT application in the UV-C spectrum at from about 250 to about 270 nm with a dose to 1 mW/cm2, for about 60 seconds; para. [0136], it may be desirable to provide a first light wavelength for a first-time period, followed by a second, third, fourth etc. light wavelength at respective second, third fourth etc. time periods that are each, independently, different from one or more of the other applied wavelengths and/or time periods); and
during a second period of time, a light comprising a second plurality of wavelength ranges, wherein at least one of the second plurality of wavelength ranges is the first disinfecting wavelength range having the first radiant power or a second disinfecting wavelength range of light having a second radiant power, the second disinfecting wavelength range of light is from 320 nm to 370 nm, wherein the second time period is between 30 to 90 seconds and wherein the second radiant power is a radiant power of the second wavelength range of light at the wound (para. [0133], For a disinfection application, direct UV-emitting laser diodes are available to use; para. [0202], the appropriate wavelength to treat psoriasis is from about 300 nm to about 320 nm. Examiner note: It is inherent that the light with the second disinfecting wavelength would have its own radiant power; para. [0224], para. [0164]; para. [0136], it may be desirable to provide a first light wavelength for a first-time period, followed by a second, third, fourth etc. light wavelength at respective second, third fourth etc. time periods that are each, independently, different from one or more of the other applied wavelengths and/or time periods).
Zhang is silent regarding the first radiant power is between 50uW/cm2 to less than 0.5mW/cm2 and the second radiant power is between 10mW/cm2 to less than 20mW/cm2.
However, Cumbie discloses a method for the prevention and treatment of skin and nail infection (abstract) and teaches a first disinfecting wavelength range of light is from 200 nm to less than 250 nm and the first radiant power is between 50 uW/cm2 to less than 0.5 mW/cm2, during a first period of time, wherein the first time period is between 30 to 90 seconds (para. [0067], [0097], The most recognized form of germicidal radiation is UVC radiation in the range of 240 to 280 nm. Radiation in this range is absorbed by the RNA and DNA of a cell and damages the ability of the cell to reproduce. Other forms of radiation have also been found to inactivate organisms including sources at 180 to 1370 nm and sources that emit in a high intensity pulsed manner. Although the author does not wish to be bound by any theory of operation it is believed that germicidal light affects the ability of the cell to reproduce by damaging its genetic material or by damaging the cell so that it cannot survive and reproduce; para. [0068], [0098], For most organisms a dose of 5 to 10,000 mw-sec/cm 2 (5 mJ/cm2 to 10 J/cm2) is sufficient to completely inactivate an organism; para. [0081], Inactivation doses are available in charts for many of the organisms that cause skin infections such as Staphylococcus aureus (6,600 uw-sec/cm2 to inactivate), Streptococcus pyrogenes (4,200 uw-sec/cm2to inactivate), and Psuedomonas aeriginosa (10,500 uw-sec/cm2 to inactivate). Additionally, new organisms are being added all the time as more research is directed to the germicidal effects of UVC light. For example, of the more than 50 types of bacteria listed on one manufacturer's chart, all the inactivation doses ranged from 2,500 to 26,400 uw/cm2; para. [0083], Therefore a G6T5 lamp held 6-inches from an infection will irradiate 132 uw/cm2 (11 uw/cm2 times the conversion factor of 12). Thus, a practitioner would need to irradiate a person for 50 seconds (6,600 uw-sec/cm2 divided by 132 uw/cm2) at a distance of 6-inches from the infection to inactivate an organism.).
Cumbie teaches a second disinfecting wavelength range of light having a second radiant power, the second disinfecting wavelength range of light is from 320 nm to 370 nm and the second radiant power is between 0.132mW/cm2 to less than 20mW/cm2, during a second period of time, wherein the second time period is between 30 to 90 seconds (para. [0108], The electromagnetic radiation in an alternative embodiment may be from UVA radiation (315 to 400 nm); para. [0103], In additional preferred embodiments any electromagnetic radiation can be used which is capable of inactivating the infection causing organisms, is able to penetrate sufficiently, and is safe for exposure to humans and animals in the doses contemplated; para. [0116], the amount of irradiation received during one treatment may be substantially more or less than the 5 to 10,000 mw-sec/cm 2 of the preferred embodiment; para. [0083], Therefore a G6T5 lamp held 6-inches from an infection will irradiate 132 uw/cm2 (11 uw/cm2 times the conversion factor of 12). Thus, a practitioner would need to irradiate a person for 50 seconds (6,600 uw-sec/cm2 divided by 132 uw/cm2) at a distance of 6-inches from the infection to inactivate an organism.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zhang, by configuring a first disinfecting wavelength range of light to be from 200 nm to less than 250 nm and the first radiant power to be between 50 uW/cm2 to less than 0.5 mW/cm2, during a first period of time, wherein the first time period is between 30 to 90 seconds and configuring a second disinfecting wavelength range of light having a second radiant power, the second disinfecting wavelength range of light is from 320 nm to 370 nm and the second radiant power is between 0.132 mW/cm2 to less than 20mW/cm2, during a second period of time, wherein the second time period is between 30 to 90 second, as taught by Cumbie, for the purpose of producing germicidal effect by damaging the ability of the cell to reproduce (para. [0067]).
Cumbie does not explicitly mention the second radiant power to be between 10mW/cm2 to less than 20mW/cm2.
However, Cumbie discloses the amount of irradiation received during one treatment is more or less than 5 to 10,000 mw-sec/cm2. Higher irradiation yields higher dose of disinfection. Irradiation is a function of power and time. Cumbie discloses that the treatment power and the treatment time are result-effective variables by implication due to the amount of irradiation being a result effective variable (para. [0083] describes adjustment of treatment power, treatment time, and distance to yield desired irradiation).
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 Cumbie, by configuring the second radiant power to be between 10mW/cm2 to less than 20mW/cm2 and the second time period to be between 30 to 90 second, 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.
Zhang is silent regarding a distance measurement device, wherein the distance measurement device is configured to measure the distance between the light source and the open wound, wherein the first radiant power is adjusted based on this distance between the light source and the open wound to achieve the first radiant power that is required at the site of the wound.
Jarausch discloses a system for light generation for use in therapeutic and disinfection (abstract) and teaches a distance measurement device, wherein the distance measurement device is configured to measure the distance between the light source and the open wound, wherein the radiant power is adjusted based on this distance between the light source and the treatment site to achieve the radiant power that is required at the site of the wound (para. [0065], a distance or proximity sensor may be used to measure a distance between apparatus 100 and a user to adjust the intensity of light emission to deliver a controlled dose of light to 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 Cumbie, by adding a distance measurement device, wherein the distance measurement device is configured to measure the distance between the light source and the open wound, wherein the first radiant power is adjusted based on this distance between the light source and the open wound to achieve the first radiant power that is required at the site of the wound, as taught by Jarausch, for the purpose of delivering a controlled dose of light to the user's skin (para. [0065]).
Re Claim 14, Claim 14 is rejected under substantially the same basis as claim 1. Zhang discloses a computer software product embodied on a non-transitory storage medium, wherein the computer software product is configured to run in a processor and is configured to cause the processor to control the light source according to claim 1 (para. [0124], software instructions associated with the PBM control module can be configured to perform some or all of the clinically appropriate treatment functions, such as treatment programs, data storage, sensor operation and a dosage meter; para. [0126], Information related to treatment time, time since treatment start, patient input, and the general trend, among other factors, can be used to recommend adjustments to the PBM control module operation, such as by being incorporated into software instructions, to improve pain treatment in one or more subsequent treatments).
Re Claim 9, Zhang discloses that the third time period is between 30 to 90 seconds (para. [0164], [0224], 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).
Re Claim 10, Zhang discloses that different ranges of wavelengths do not overlap with each other and have a wavelength range gap between each neighboring ranges (para. [0133], Blue light in the range of from about 450 to about 495 nm is further known to be effective for disinfection. Since wound disinfection is also relevant to wound healing, light in this nm range is also contemplated with the LLLT treatment devices and methods of the present invention. Wavelengths in the UV spectrum can also be effective in disinfecting a wound when signs of infection is detected or confirmed by the healthcare provider. For a disinfection application, direct UV-emitting laser diodes are available at 375 nm are available to use. A UVC LED can be used for disinfection. For sensor applications, LED at about 365 nm or about 395 nm with up to about 20% input to light efficiency, and power outputs at these longer UV wavelengths are suitable.).
Re Claim 12, Zhang discloses that the treatment apparatus is configured to control the light source to emit light when the wound type is a diabetes related wound (para. [0082], In a “chronic wound,” normal healing is not occurring, with progress stalled in one or more of the phases of healing. A variety of factors, including age, poor health and nutrition, diabetes, incontinence, immune deficiency problems, poor circulation, and infection can all cause a wound to become chronic).
Claims 3, 4, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0083809), as modified by Cumbie (US 2003/0153962) and Jarausch (US 2022/0016437), and further in view of Yoon (US 2020/0298016), Wagenaar et al. (WO 2008/017975), and Gardiner et al. (US 2012/0226334).
Re Claims 3, 4, and 8, Zhang as modified by Cumbie and Jarausch discloses the claimed invention substantially as set forth in claim 1.
Zhang discloses during a first period of time, a light comprising a first plurality of wavelength ranges, wherein at least one of the first plurality of wavelength ranges is a first disinfecting wavelength range of light having a first radiant power (para. [0224], generate LLLT application in the UV-C spectrum at from about 250 to about 270 nm with a dose to 1 mW/cm2, for about 60 seconds; para. [0136], it may be desirable to provide a first light wavelength for a first-time period, followed by a second, third, fourth etc. light wavelength at respective second, third fourth etc. time periods that are each, independently, different from one or more of the other applied wavelengths and/or time periods); and
during a second period of time, a light comprising a second plurality of wavelength ranges, wherein at least one of the second plurality of wavelength ranges is the first disinfecting wavelength range having the first radiant power or a second disinfecting wavelength range of light having a second radiant power (Wavelengths in the UV spectrum can also be effective in disinfecting a wound when signs of infection is detected or confirmed by the healthcare provider. For a disinfection application, direct UV-emitting laser diodes are available at 375 nm are available to use, para. [0136], it may be desirable to provide a first light wavelength for a first-time period, followed by a second, third, fourth etc. light wavelength at respective second, third fourth etc. time periods that are each, independently, different from one or more of the other applied wavelengths and/or time periods).
Zhang discloses that the fourth disinfecting wavelength range of light is from 610nm to 660nm (para. [0135], during the hemostasis and inflammatory phases, red light near the about 650 nm range provide benefits of reduction in bruising and swelling) and the fourth radiant power is between 0.1-1 J/cm2 (para. [0135], 0.1-1 J/cm2); and the fifth wavelength range of light is from 820nm to 900nm and the fifth radiant power is between 3-5 J/cm2 (para. [0132], The specific wavelengths identified in the '462 patent as being most effective for healing were reported to be about 620, 680, 760, and 820 nm. Laser diodes, SLD, and LED lights are readily available to emit light in these indicated wavelengths, para. [0135], red and near infrared of about 810 nm can provide significant pain relief at a higher dosage, as much as 15 J/cm2 delivered during the inflammatory phase), wherein each respective radiant power is a radiant power of respective wavelength range of light at the wound (para. [0222], if a patient with skin color type II on a Fitzpatrick scale with a wound of about 30 centimeters long on the abdomen, such as after a Cesarean delivery, which has a large occlusive dressing on post-op day and post-op day 1, and on post-op day 2 and 3, exudates and absorbent dressing a LLLT treatment regimen having a combination of about 650 nm and about 810 nm at 5 J/cm2 on post-op day 1, 4 J/cm2 on post-op day 2 and 3 J/cm2 on post-op day 3 can be used during the inflammatory phase. Higher dose may be recommended for the same wound for a patient with skin color type V on a Fitzpatrick scale).
Zhang discloses that the processor is further configured to control the light to emit: during a third period of time, a light comprising a third plurality of wavelength ranges, wherein the third plurality of wavelength ranges comprises a sixth wavelength range from 400 to 430 nm having a sixth radiant power between 2mW/cm2 to 200mW/cm2, wherein respective radiant power is a radiant power at the wound (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, para. [0133], Blue light in the range of from about 450 to about 495 nm is further known to be effective for disinfection; 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).
Zhang is silent regarding the first plurality wavelength ranges comprising the fourth disinfecting wavelength range of light having the fourth radiant power, and the fifth wavelength range of light having the fifth radiant power; the second plurality of wavelength ranges comprising the fourth disinfecting range of wavelength of light of the fourth radiant power and the fifth range of wavelength of light from of the fifth radiant power; and the third plurality of wavelength ranges comprising the fourth disinfecting range of wavelength of lights having the fourth radiant power and the fifth range of wavelength of lights having the fifth radiant power.
However, Yoon discloses a light irradiation device for skin wounds (abstract) and teaches that first and second lights are irradiated substantially simultaneously (para. [0045]), where the first light has blue wavelength band and the second light has the red visible light to near-infrared wavelength band (para. [0052], [0042], The second light may correspond to a light in the wavelength band from about 610 nm to about 940 nm). Yoon teaches that as the pathogens in the wounded site are sterilized by the first light and an immune mechanism is promoted by the second light, the wound may be efficiently healed (para. [0046], [0060]).
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 Cumbie and Jarausch, by configuring the processor to control the light source to emit: during a third period of time, a light comprising a third plurality of wavelength ranges, wherein the third plurality of wavelength ranges comprises a sixth range of wavelength of lights having a sixth radiant power, the fourth disinfecting range of wavelength of lights having the fourth radiant power and the fifth range of wavelength of lights having the fifth radiant power, as taught by Yoon, for the purpose of sterilizing the pathogens in the wounded site by the sixth range of wavelength of lights and promoting an immune mechanism by the fourth disinfecting range of wavelength of lights having the fourth radiant power and the fifth range of wavelength of lights having the fifth radiant power (para. [0046], [0060]).
Yoon is silent regarding the first plurality wavelength ranges comprising the fourth disinfecting wavelength range of light having the fourth radiant power, and the fifth wavelength range of light having the fifth radiant power; the second plurality of wavelength ranges comprising the fourth disinfecting range of wavelength of light of the fourth radiant power and the fifth range of wavelength of light from of the fifth radiant power.
However, Gardiner discloses light irradiation device (abstract) and teaches ultraviolet radiation of wavelengths in the range of about 200 nanometers (“nm”) to 300 nm (ultraviolet wavelengths) can be used for sterilizing wounds or other physical objects, and infrared radiation of wavelengths longer than 700 nm (or 770 nm, according to some references) may be used to heat tissues (para. [0049]). Gardiner also teaches that Simultaneous application of two or more wavelengths can be used to augment the response that would have been effected by application of a single wavelength (para. [0049]).
Additionally, Wagenaar discloses light irradiation device (abstract) and teaches generation of at least two different radiation spectra. With the at least two types of LEDs emitting at substantially different wavelengths, for example UV-A radiation and red, a combination of different functions, for example disinfection and healing, can be issued simultaneously for the purpose of accelerating healing process without the disadvantage of the target area drying up too much leading to a dry wound where the bacteria multiply more quickly (page 4, lines 15-30).
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 Cumbie, Jarausch, and Yoon, by configuring the first plurality wavelength ranges to comprise the first disinfecting wavelength range of light having the first radiant power, a fourth disinfecting wavelength range of light having a fourth radiant power, and a fifth wavelength range of light having a fifth radiant power; and the second plurality of wavelength ranges to comprise the second disinfecting wavelength range of light having the second radiant power, the fourth disinfecting range of wavelength of light of the fourth radiant power and the fifth range of wavelength of light from of the fifth radiant power, as taught by Gardiner and Wagenaar, for the purpose of using ultraviolet wavelengths for sterilizing wounds and infrared radiation of wavelength to heat tissue and augmenting the responses by simultaneous application of two or more wavelengths (Gardiner, para. [0049]) and for the purpose of using disinfection from UV-A and healing from red wavelength light to accelerate healing process without the disadvantage of the target area drying up too much leading to a dry wound where the bacteria multiply more quickly (page 4, lines 15-30).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0083809), as modified by Cumbie (US 2003/0153962), Jarausch (US 2022/0016437), Yoon (US 2020/0298016), Wagenaar et al. (WO 2008/017975), and Gardiner et al. (US 2012/0226334), and further in view of Rhodes et al. (US 20160346565).
Re Claim 11, Zhang discloses that the fourth radiant power is provided as pulses having a frequency and with a duty ratio (para. [0164], 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; para. [0298], a duty cycle that is provided to from about 8 minutes on and about 30 minutes off for about three cycles per treatment).
Zhang is silent regarding the fourth radiant power is provided as pulses having a frequency of 80Hz to 120Hz and with a duty ratio of ON: from 30:70 to 70:30.
Rhodes discloses a flexible, therapeutic wound dressing assembly comprising at least one EMR source that emits therapeutic EMR having intensity sufficient to activate desired therapeutic properties (abstract) and teaches EMR source providing sterilizing EMR having a wavelength in the range of approximately 380 nm to approximately 900 nm (para. [0010], para. [0011], those wavelengths centered about 633 nm, 808 nm, and 830 nm) and a power density range covering 1 mW/cm2 and 1 W/cm2 (para. [0010]). Rhodes further discloses that the fourth radiant power is provided as pulses having a frequency of 80Hz to 120Hz and with a duty ratio of ON: from 30:70 to 70:30 (para. [0070], fig. 7, The upper middle duty cycle wave 86 represents a 30% duty cycle, i.e., the therapeutic EMR 24 is active for the pulse width 80 of 30% of each period 82 and the interpulse interval 84 is 70% of the period 82; para. [0071], The therapeutic EMR 24 may be pulsed at a rate of between 0 Hz and 5,000 Hz.).
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 Cumbie, Jarausch, Yoon, Wagenaar, and Gardiner, by configuring the fourth radiant power to be provided as pulses having a frequency of 80Hz to 120Hz and with a duty ratio of ON: from 30:70 to 70:30, as taught by Rhodes, for the purpose of providing a sterilizing EMR and providing the intensity and power required to inactivate infectious agents (para. [0010]) as an appropriate dose of therapeutic EMR for any given patient's needs (para. [0070]).
Claims 2, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0083809), as modified by Cumbie (US 2003/0153962) and Jarausch (US 2022/0016437), and further in view of Rhodes et al. (US 2016/0346565), Wagenaar et al. (WO 2008/017975), and Gardiner et al. (US 2012/0226334).
Re Claims 2, 6, and 7, Zhang discloses the claimed invention substantially as set forth in claim 1.
Zhang discloses that a third disinfecting wavelength range of light is from 400nm to 430nm and a third radiant power is between 3mW/cm2 to 200mW/cm2, wherein respective radiant power is a radiant power at the wound (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, para. [0133], Blue light in the range of from about 450 to about 495 nm is further known to be effective for disinfection; 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).
Zhang discloses that the fourth disinfecting wavelength range of light is from 610nm to 660nm (para. [0135], during the hemostasis and inflammatory phases, red light near the about 650 nm range provide benefits of reduction in bruising and swelling) and the fourth radiant power is between 0.1-1 J/cm2 (para. [0135], 0.1-1 J/cm2); and the fifth wavelength range of light is from 820nm to 900nm and the fifth radiant power is between 3-5 J/cm2 (para. [0132], The specific wavelengths identified in the '462 patent as being most effective for healing were reported to be about 620, 680, 760, and 820 nm. Laser diodes, SLD, and LED lights are readily available to emit light in these indicated wavelengths, para. [0135], red and near infrared of about 810 nm can provide significant pain relief at a higher dosage, as much as 15 J/cm2 delivered during the inflammatory phase), wherein each respective radiant power is a radiant power of respective wavelength range of light at the wound (para. [0222], if a patient with skin color type II on a Fitzpatrick scale with a wound of about 30 centimeters long on the abdomen, such as after a Cesarean delivery, which has a large occlusive dressing on post-op day and post-op day 1, and on post-op day 2 and 3, exudates and absorbent dressing a LLLT treatment regimen having a combination of about 650 nm and about 810 nm at 5 J/cm2 on post-op day 1, 4 J/cm2 on post-op day 2 and 3 J/cm2 on post-op day 3 can be used during the inflammatory phase. Higher dose may be recommended for the same wound for a patient with skin color type V on a Fitzpatrick scale).
Zhang is silent regarding the fourth radiant power is between 0.5mW/cm2 to 200mW/cm2 and the fifth radiant power is between 2mW/cm2 to 200mW/cm2.
However, Rhodes discloses a flexible, therapeutic wound dressing assembly comprising at least one EMR source that emits therapeutic EMR having intensity sufficient to activate desired therapeutic properties (abstract) and teaches EMR source providing sterilizing EMR having a wavelength in the range of approximately 380 nm to approximately 900 nm (para. [0010], para. [0011], those wavelengths centered about 633 nm, 808 nm, and 830 nm) and a power density range covering 1 mW/cm2 and 1 W/cm2 (para. [0010]).
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 Bellini and Jarausch, by configuring the fourth radiant power is between 0.5mW/cm2 to 200mW/cm2 and the fifth radiant power is between 2mW/cm2 to 200mW/cm2, as taught by Rhodes, for the purpose of providing a sterilizing EMR and providing the intensity and power required to inactivate infectious agents (para. [0010]) and since it has been held that 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.
Zhang is silent regarding the first plurality of wavelength ranges comprises the second disinfecting wavelength range of light having the second radiant power, and the third disinfecting wavelength range of light having the third radiant power; and the second plurality of wavelength ranges comprises the fourth disinfecting range of wavelengths of light of the fourth radiant power and the fifth range of wavelengths of light from of the fifth radiant power.
However, Gardiner discloses light irradiation device (abstract) and teaches ultraviolet radiation of wavelengths in the range of about 200 nanometers (“nm”) to 300 nm (ultraviolet wavelengths) can be used for sterilizing wounds or other physical objects, and infrared radiation of wavelengths longer than 700 nm (or 770 nm, according to some references) may be used to heat tissues (para. [0049]). Gardiner also teaches that Simultaneous application of two or more wavelengths can be used to augment the response that would have been effected by application of a single wavelength (para. [0049]).
Additionally, Wagenaar discloses light irradiation device (abstract) and teaches generation of at least two different radiation spectra. With the at least two types of LEDs emitting at substantially different wavelengths, for example UV-A radiation and red, a combination of different functions, for example disinfection and healing, can be issued simultaneously for the purpose of accelerating healing process without the disadvantage of the target area drying up too much leading to a dry wound where the bacteria multiply more quickly (page 4, lines 15-30).
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 Cumbie, Jarausch, and Rhodes, by configuring the second plurality of wavelength ranges to comprise the first disinfecting range of wavelengths of light having the first radiant power, a fourth disinfecting range of wavelengths of light of a fourth radiant power and a fifth range of wavelengths of light from of a fifth radiant power, as taught by Gardiner and Wagenaar, for the purpose of using ultraviolet wavelengths for sterilizing wounds and infrared radiation of wavelength to heat tissue and augmenting the responses by simultaneous application of two or more wavelengths (Gardiner, para. [0049]) and for the purpose of using disinfection from UV-A and healing from red wavelength light to accelerate healing process without the disadvantage of the target area drying up too much leading to a dry wound where the bacteria multiply more quickly (page 4, lines 15-30).
Gardiner and Wagenaar are silent regarding the first plurality of wavelength ranges comprises the second disinfecting wavelength range of light having the second radiant power, and the third disinfecting wavelength range of light having the third radiant power.
However, Cumbie discloses treatment of microbial infections on or below the skin (abstract) and teaches simultaneous application of any combination of UVA at 315 to 400 nm, UVB at 280 to 315 nm, UVC at 100 to 280 nm, visible light, infrared light (claim 3; para. [0107], The light may be of multiple wavelengths and may be coherent or incoherent, and may be pulsed). Cumbi discloses radiation in the UVC range (100 to 280 nm and more specifically in the range of 240 to 280 nm) that is capable of rapidly inactivating an organism (para. [0101]).
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 Cumbie, Jarausch, Rhodes, Gardiner and Wagenaar, by configuring the first plurality of wavelength ranges to comprise the first disinfecting wavelength range of light having the first radiant power, the second disinfecting wavelength range of light having the second radiant power, and a third disinfecting wavelength range of light having a third radiant power, as taught by Cumbie, for the purpose of utilizing the effectiveness of multi-spectrum germicidal light for inactivation of organisms at lower overall doses than UVC alone since other parts of the spectrum have germicidal properties (para. [0093], The effectiveness of multi-spectrum germicidal light for inactivation of organisms at lower overall doses than UVC alone indicates that other parts of the spectrum have germicidal properties. The exact inactivation mechanism is not known, however, it probably is a combination of several mechanisms that act together to render the cell inactivated or incapable of reproducing. The multi-spectrum light could damage other components of the organism necessary to its vital functions. It may also provide instantaneous heating of small areas in the cell which would not kill the organism by high heat but which are nonetheless effective in damaging the cell wall and inactivating the organism).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0083809) in view of Rhodes et al. (US 2016/0346565), Cumbie (US 2003/0153962), Wagenaar et al. (WO 2008/017975), and Gardiner et al. (US 2012/0226334).
Re Claim 15, Zhang discloses during a first period of time of 60 seconds (para. [0164]), a light comprising a first plurality of wavelength ranges, wherein at least one of the first plurality of wavelength ranges is a first disinfecting wavelength range of light from about 250 to about 270 nm having a first radiant power of 1mW/cm2 (para. [0224], generate LLLT application in the UV-C spectrum at from about 250 to about 270 nm with a dose to 1 mW/cm2, for about 60 seconds; para. [0136], it may be desirable to provide a first light wavelength for a first-time period, followed by a second, third, fourth etc. light wavelength at respective second, third fourth etc. time periods that are each, independently, different from one or more of the other applied wavelengths and/or time periods); and
during a second period of time of 60 to 180 seconds (para. [0164]), a light comprising a second plurality of wavelength ranges, wherein at least one of the second plurality of wavelength ranges is the first disinfecting wavelength range of light from 200 nm to 280 nm having the first radiant power between 50 uW/cm2 to 1mW/cm2 (para. [0224], generate LLLT application in the UV-C spectrum at from about 250 to about 270 nm with a dose to 1 mW/cm2, for about 60 seconds; para. [0136], it may be desirable to provide a first light wavelength for a first-time period, followed by a second, third, fourth etc. light wavelength at respective second, third fourth etc. time periods that are each, independently, different from one or more of the other applied wavelengths and/or time periods).
Zhang discloses a second disinfecting wavelength range of light from 320 nm to 370 nm having a second radiant power (Wavelengths in the UV spectrum can also be effective in disinfecting a wound when signs of infection is detected or confirmed by the healthcare provider. para. [0133], For a disinfection application, direct UV-emitting laser diodes are available to use; para. [0202], the appropriate wavelength to treat psoriasis is from about 300 nm to about 320 nm. Examiner note: It is inherent that the light with the second disinfecting wavelength would have its own radiant power; para. [0224], para. [0164]; para. [0136], it may be desirable to provide a first light wavelength for a first-time period, followed by a second, third, fourth etc. light wavelength at respective second, third fourth etc. time periods that are each, independently, different from one or more of the other applied wavelengths and/or time periods)
Zhang discloses that the third disinfecting wavelength range of light is from 400nm to 430nm and the third radiant power is between 3mW/cm2 to 200mW/cm2, wherein respective radiant power is a radiant power at the wound (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, para. [0133], Blue light in the range of from about 450 to about 495 nm is further known to be effective for disinfection; 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).
Zhang discloses that the fourth disinfecting wavelength range of light is from 610nm to 660nm (para. [0135], during the hemostasis and inflammatory phases, red light near the about 650 nm range provide benefits of reduction in bruising and swelling) and the fourth radiant power is between 0.1-1 J/cm2 (para. [0135], 0.1-1 J/cm2); and the fifth wavelength range of light is from 820nm to 900nm and the fifth radiant power is between 3-5 J/cm2 (para. [0132], The specific wavelengths identified in the '462 patent as being most effective for healing were reported to be about 620, 680, 760, and 820 nm. Laser diodes, SLD, and LED lights are readily available to emit light in these indicated wavelengths, para. [0135], red and near infrared of about 810 nm can provide significant pain relief at a higher dosage, as much as 15 J/cm2 delivered during the inflammatory phase), wherein each respective radiant power is a radiant power of respective wavelength range of light at the wound (para. [0222], if a patient with skin color type II on a Fitzpatrick scale with a wound of about 30 centimeters long on the abdomen, such as after a Cesarean delivery, which has a large occlusive dressing on post-op day and post-op day 1, and on post-op day 2 and 3, exudates and absorbent dressing a LLLT treatment regimen having a combination of about 650 nm and about 810 nm at 5 J/cm2 on post-op day 1, 4 J/cm2 on post-op day 2 and 3 J/cm2 on post-op day 3 can be used during the inflammatory phase. Higher dose may be recommended for the same wound for a patient with skin color type V on a Fitzpatrick scale).
Zhang is silent regarding the first radiant power is between 50uW/cm2 to less than 0.5mW/cm2 and the second radiant power is between 10mW/cm2 to less than 20mW/cm2.
Zhang is silent regarding the fourth radiant power is between 0.5mW/cm2 to 200mW/cm2 and the fifth radiant power is between 2mW/cm2 to 200mW/cm2.
However, Rhodes discloses a flexible, therapeutic wound dressing assembly comprising at least one EMR source that emits therapeutic EMR having intensity sufficient to activate desired therapeutic properties (abstract) and teaches EMR source providing sterilizing EMR having a wavelength in the range of approximately 380 nm to approximately 900 nm (para. [0010], para. [0011], those wavelengths centered about 633 nm, 808 nm, and 830 nm) and a power density range covering 1 mW/cm2 and 1 W/cm2 (para. [0010]).
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 fourth radiant power is between 0.5mW/cm2 to 200mW/cm2 and the fifth radiant power is between 2mW/cm2 to 200mW/cm2, as taught by Rhodes, for the purpose of providing a sterilizing EMR and providing the intensity and power required to inactivate infectious agents (para. [0010]) and since it has been held that 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.
Zhang is silent regarding the first radiant power is between 50uW/cm2 to less than 0.5mW/cm2 and the second radiant power is between 10mW/cm2 to less than 20mW/cm2.
However, Cumbie discloses a method for the prevention and treatment of skin and nail infection (abstract) and teaches a first disinfecting wavelength range of light is from 200 nm to less than 250 nm and the first radiant power is between 50 uW/cm2 to less than 0.5 mW/cm2, during a first period of time, wherein the first time period is between 30 to 90 seconds (para. [0067], [0097], The most recognized form of germicidal radiation is UVC radiation in the range of 240 to 280 nm. Radiation in this range is absorbed by the RNA and DNA of a cell and damages the ability of the cell to reproduce. Other forms of radiation have also been found to inactivate organisms including sources at 180 to 1370 nm and sources that emit in a high intensity pulsed manner. Although the author does not wish to be bound by any theory of operation it is believed that germicidal light affects the ability of the cell to reproduce by damaging its genetic material or by damaging the cell so that it cannot survive and reproduce; para. [0068], [0098], For most organisms a dose of 5 to 10,000 mw-sec/cm 2 (5 mJ/cm2 to 10 J/cm2) is sufficient to completely inactivate an organism; para. [0081], Inactivation doses are available in charts for many of the organisms that cause skin infections such as Staphylococcus aureus (6,600 uw-sec/cm2 to inactivate), Streptococcus pyrogenes (4,200 uw-sec/cm2to inactivate), and Psuedomonas aeriginosa (10,500 uw-sec/cm2 to inactivate). Additionally, new organisms are being added all the time as more research is directed to the germicidal effects of UVC light. For example, of the more than 50 types of bacteria listed on one manufacturer's chart, all the inactivation doses ranged from 2,500 to 26,400 uw/cm2; para. [0083], Therefore a G6T5 lamp held 6-inches from an infection will irradiate 132 uw/cm2 (11 uw/cm2 times the conversion factor of 12). Thus, a practitioner would need to irradiate a person for 50 seconds (6,600 uw-sec/cm2 divided by 132 uw/cm2) at a distance of 6-inches from the infection to inactivate an organism.).
Cumbie teaches a second disinfecting wavelength range of light having a second radiant power, the second disinfecting wavelength range of light is from 320 nm to 370 nm and the second radiant power is between 0.132mW/cm2 to less than 20mW/cm2, during a second period of time, wherein the second time period is between 30 to 90 seconds (para. [0108], The electromagnetic radiation in an alternative embodiment may be from UVA radiation (315 to 400 nm); para. [0103], In additional preferred embodiments any electromagnetic radiation can be used which is capable of inactivating the infection causing organisms, is able to penetrate sufficiently, and is safe for exposure to humans and animals in the doses contemplated; para. [0116], the amount of irradiation received during one treatment may be substantially more or less than the 5 to 10,000 mw-sec/cm 2 of the preferred embodiment; para. [0083], Therefore a G6T5 lamp held 6-inches from an infection will irradiate 132 uw/cm2 (11 uw/cm2 times the conversion factor of 12). Thus, a practitioner would need to irradiate a person for 50 seconds (6,600 uw-sec/cm2 divided by 132 uw/cm2) at a distance of 6-inches from the infection to inactivate an organism.).
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 Rhodes, by configuring a first disinfecting wavelength range of light to be from 200 nm to less than 250 nm and the first radiant power to be between 50 uW/cm2 to less than 0.5 mW/cm2, during a first period of time, wherein the first time period is between 30 to 90 seconds and configuring a second disinfecting wavelength range of light having a second radiant power, the second disinfecting wavelength range of light is from 320 nm to 370 nm and the second radiant power is between 0.132 mW/cm2 to less than 20mW/cm2, during a second period of time, wherein the second time period is between 30 to 90 second, as taught by Cumbie, for the purpose of producing germicidal effect by damaging the ability of the cell to reproduce (para. [0067]).
Cumbie does not explicitly mention the second radiant power to be between 10mW/cm2 to less than 20mW/cm2.
However, Cumbie discloses the amount of irradiation received during one treatment is more or less than 5 to 10,000 mw-sec/cm2. Higher irradiation yields higher dose of disinfection. Irradiation is a function of power and time. Cumbie discloses that the treatment power and the treatment time are result-effective variables by implication due to the amount of irradiation being a result effective variable (para. [0083] describes adjustment of treatment power, treatment time, and distance to yield desired irradiation).
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 Rhodes and Cumbie, by configuring the second radiant power to be between 10mW/cm2 to less than 20mW/cm2 and the second time period to be between 30 to 90 second, 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.
Zhang is silent regarding the first plurality of wavelength ranges comprises the second disinfecting wavelength range of light having the second radiant power, and the third disinfecting wavelength range of light having the third radiant power; and the second plurality of wavelength ranges comprises the fourth disinfecting range of wavelengths of light of the fourth radiant power and the fifth range of wavelengths of light from of the fifth radiant power.
However, Gardiner discloses light irradiation device (abstract) and teaches ultraviolet radiation of wavelengths in the range of about 200 nanometers (“nm”) to 300 nm (ultraviolet wavelengths) can be used for sterilizing wounds or other physical objects, and infrared radiation of wavelengths longer than 700 nm (or 770 nm, according to some references) may be used to heat tissues (para. [0049]). Gardiner also teaches that Simultaneous application of two or more wavelengths can be used to augment the response that would have been effected by application of a single wavelength (para. [0049]).
Additionally, Wagenaar discloses light irradiation device (abstract) and teaches generation of at least two different radiation spectra. With the at least two types of LEDs emitting at substantially different wavelengths, for example UV-A radiation and red, a combination of different functions, for example disinfection and healing, can be issued simultaneously for the purpose of accelerating healing process without the disadvantage of the target area drying up too much leading to a dry wound where the bacteria multiply more quickly (page 4, lines 15-30).
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 Rhodes and Cumbie, by configuring the second plurality of wavelength ranges to comprise the first disinfecting range of wavelengths of light having the first radiant power, a fourth disinfecting range of wavelengths of light of a fourth radiant power and a fifth range of wavelengths of light from of a fifth radiant power, as taught by Gardiner and Wagenaar, for the purpose of using ultraviolet wavelengths for sterilizing wounds and infrared radiation of wavelength to heat tissue and augmenting the responses by simultaneous application of two or more wavelengths (Gardiner, para. [0049]) and for the purpose of using disinfection from UV-A and healing from red wave