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 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 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 8, 10-13, 17-20 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Burchman; Corey A. et al. (US 8747764 B1) in view of Lowe; Thomas J. (US 20130248459 A1).
Regarding claim 1, Burchman discloses a fluid disinfection system (col. 4, lines 45-55, As shown in FIG. 1, an exemplary arrangement of an intravenous (IV) fluid delivery system 100);
wherein the fluid disinfection system comprises: an input tube configured to receive a flow of input fluid (col. 4, lines 60-65, A proximal tubing section 116 is interconnected to the bag via the fitting 118);
a disinfection unit including a microbicidal light emitting device configured to emit a plurality of light emissions for multiband disinfection treatment (col. 6, lines 40-45, By removing the cassette 230, the central UV light-emitting lamp 310 is revealed; col. 7, lines 30-40, In an illustrative embodiment, the lamp 310 comprises a 13-watt PL-S type lamp available from Phillips of the Netherlands. The lamp emits UV-C at a wavelength of approximately 254 nm. In general, it is desirable that UV-C in the range of approximately 100-290 nm be employed);
a treatment flowpath in fluid communication with the input tube (cols. 7-8, lines 60-5, FIG. 7, which shows the cassette 230 in further detail … The top and bottom caps 232 and 330 act to secure and align (concentrically) the walls 710 and 720 … so as to form therebetween a relatively thin-radius fluid chamber 730);
wherein the treatment flowpath is disposed around the microbicidal light emitting device in radiative communication therewith; and is substantially transparent to the emitted light of the microbicidal light emitting device (col. 8, lines 20-25, The inner cassette wall 720 is constructed from a cylinder of a highly UV-transmissive material. In a reusable version of the cassette, quartz glass can provide an effective material due to its high UV transmissibility; col. 11, lines 5-15, FIG. 13, the cassette fluid chamber assembly 1310 is provided with a fluid chamber 1320 having a pair of inner and outer walls 1330 and 1340 separated by a spiral baffle 1350. Thus, when fluid enters through the top cap, it travels around the spiral pathway (exemplary upward arrows 1360) until it exits the outlet in the bottom cap);
wherein the treatment flowpath is configured to receive at least a portion of the flow of the input fluid therethrough from the input tube (col. 10, lines 35-55, With reference also to FIG. 12, the generalized flow of fluid through the cassette 230 is depicted. Fluid enters the inlet 250 (arrow 1196) … The fluid enters the inlet hole 750 and travels upwardly travels around the fluid chamber (arrows 1192) … Note that the flow pattern through the cassette 230 and fluid chamber 730 described herein is only exemplary);
wherein the microbicidal light emitting device effectuates a dose of the plurality of light emissions to the input fluid flowing through the treatment flowpath to disinfect the fluid (col. 5, lines 25-35, By way of further background, the illustrative embodiment effectively employs ultraviolet (UV) radiation to effectively kill microbiological organisms in a continuous flow of fluid … to a sterility assurance level of up to 10-8); and
an output tube fluidly and physically connected to the treatment flowpath wherein material can flow within the treatment flowpath forming a flowpath for the flow of the input fluid from the disinfection unit towards a patient (col. 6, lines 25-30, The outlet 240 is connected to the distal tubing 134, which terminates at the patient; col. 8, lines 5-10, This allows the fluid chamber to draw fluid by capillary action from the lower inlet 750 through the chamber 730, to an upper outlet 740, where it is directed distally to the patient);
Burchman does not disclose light emissions having a wavelength in a range between about 380 nm and about 800 nm and does not explicitly configure the system to receive a flow of infected blood and to disinfect the blood. Burchman is also silent regarding the system’s EDD.
Lowe discloses an extracorporeal blood disinfection system (¶ [0047] FIG. 5 … a method 550 of using a cuvette. At 552, a fluid can be passed from a fluid inlet at a first end of an elongated tube to a fluid outlet at a longitudinally opposing second end of the elongated tube. The fluid can be pumped or can pass under the force of gravity (e.g., gravity fed); ¶ [0055] In an example, the fluid exposed to UV light includes blood, such as animal blood or human blood. In such an example, the blood can be drawn from an animal or human and passed (e.g., circulated) through the apparatus, such as to expose the blood to light, and reintroduced back into the animal or human, such as by a closed-looped system);
wherein the extracorporeal blood disinfection system is configured to receive a flow of infected blood from a mammalian patient (Fig. 1, cuvette 114 includes couplers on both of its ends which are configured to interface with input and output tubes);
a disinfection unit including a microbicidal light emitting device configured to emit a plurality of light emissions for multiband disinfection treatment (¶ [0037] The apparatus 100 can include a light bar 110, which can include one or more light emitting diode (LED) or other light sources 112. The light bar 110 can extend along all or at least a portion of the length of the cuvette 114);
each light emission having a wavelength in a range between about 380 nm and about 800 nm (¶ [0036] The apparatus 100 can include one or more ultraviolet (UV) light sources 108-A, 108-B, and 108-C … One or more of the UV light sources 108-A, 108-B, and 108-C can include one or more of a UVA, UVB, or UVC light source. UVA can include wavelengths in a range of from about 315 nanometers (nm) to about 400 nm …UV light sources 108-A, 108-B, and 108-C can include one or more visual light source; ¶ [0037], The one or more diode light sources 112 can include a semiconductor light source such as a LED that can be configured to be capable of emitting light at a wavelength that is visible to a human eye, such as at a wavelength in a range of from about 400 nm to about 475 nm);
a treatment flowpath, wherein the treatment flowpath is in radiative communication therewith and is substantially transparent to the emitted light of the microbicidal light emitting device; wherein the treatment flowpath is configured to receive at least a portion of the flow of the infected blood (¶ [0035] FIG. 1 … The apparatus 100 can include a cuvette 114. The apparatus 100 can be configured to irradiate a fluid, passing through the cuvette 114, such as water, or a bodily fluid such as blood or spinal fluid);
wherein the microbicidal light emitting device effectuates a dose of the plurality of light emissions to the infected blood flowing through the treatment flowpath to disinfect the blood (¶ [0055], Exposure of the circulated blood to light, such as UV light, can help promote an immune response by inactivating pathogens within the circulated blood); and
an output path, wherein material can flow within the treatment flowpath forming a flowpath for the flow of the disinfected blood from the disinfection unit back to the patient (Fig. 1, cuvette 114 includes couplers on both of its ends which are configured to interface with input and output tubes).
Lowe enables a system to purify blood before transfusing it into a patient (¶ [0005], the cuvette can be used to irradiate blood during a blood transfusion procedure; ¶ [0055], [0058]). One would be motivated to modify Burchman with Lowe’s light emission wavelength range and blood treatment configuration to include blood among the fluids that can be transfused into a patient, since Burchman calls for transfusing fluids into a patient (col. 2, lines 45-50, providing an inline intravenous (IV) fluid sterilization system; col. 5, lines 35-40, The illustrative embodiment utilizes the germicidal properties of ultraviolet radiation to render intravenous fluid sterile). Therefore, it would have been obvious to modify Burchman with Lowe’s light emission wavelength range and blood treatment configuration in order to expand Burchman’s range of transfusable fluids.
Burchman and Lowe do not explicitly disclose an EDD according to the claimed equation. However, Burchman calls for disinfecting fluids with UV-C light (col. 5, lines 25-35, the illustrative embodiment effectively employs ultraviolet (UV) radiation to effectively kill microbiological organisms in a continuous flow of fluid … to a sterility assurance level of up to 10-8).
Lowe also calls for delivering photonic energy to the liquid or blood which flows through the cuvette 114 (¶ [0055], The amount of blood drawn can be about 20 milliliters (mL) per 100 pounds of the animal or human. Exposing the blood to light can help to provide energy, such as photonic energy, of around about 500 joules per square meter to about 1000 joules per square meter, to hemoglobin of the blood).
It is the Office’s position that the testing method for a material or structural property does not impart a patentable weight. The property is attributed to the material and structure, not the testing method. As such, a reference does not need to recite an EDD power disinfection dosage to read on the claim language.
This claim calls for an EDD power disinfection dosage but does not specify any value or range. Therefore, the EDD power disinfection dosage limitation appears to apply to any treatment flowpath having any possible geometry and size.
Regarding claims 2 and 17-20, Burchman discloses a system further comprising a pump configured to at least one of: provide the flow of infected blood from the patient through the input tube; pass the blood from the input tube through the treatment flowpath; and provide the flow of disinfected blood to the patient through the output tube (cols. 4-5, lines 65-5, A fluid pump or metering system (120, not depicted) can also be provided inline with the tubing 116 to direct fluid through the system at a predetermined flow rate);
wherein the dose of light is effective in at least one of: eliminating pathogenic microorganisms from the fluid; partially reducing a number of the pathogenic microorganisms in the fluid; and reducing a rate of proliferation of the pathogenic microorganisms in the fluid; wherein the pathogenic microorganisms include microorganisms associated with at least one of sepsis, severe sepsis, and septic shock; wherein the pathogenic microorganisms include at least one of bacteria, fungi, yeast, and a combination thereof; wherein the pathogenic microorganisms include at least one of gram positive bacteria, gram negative bacteria, bacterial endospores, yeast, filamentous fungi, and a combination thereof (col. 5, lines 25-35, By way of further background, the illustrative embodiment effectively employs ultraviolet (UV) radiation to effectively kill microbiological organisms in a continuous flow of fluid … to a sterility assurance level of up to 10-8).
Burchman does not enumerate the specific pathogenic microorganisms which are killed or inactivated by UV light. However, Burchman quantifies the level of sterilization for microorganisms in general, which includes all of the claimed microorganisms.
Regarding claims 3, 8 and 10, Burchman lacks a thermal management device. Lowe discloses a system wherein the disinfection unit further includes a thermal management device associated with at least one of the microbicidal light emitting device and the treatment flowpath, wherein the thermal management device includes a blood temperature sensor configured to measure a temperature of the blood within the treatment flowpath (¶ [0023], controlling an ambient temperature in or about the tube; ¶ [0038] The apparatus 100 can include one or more switches 116, 118, and 120, which can be configured to … turn on or off a fan that can be included in the apparatus 100 … or control a temperature sensor that can be included in the apparatus 100; ¶ [0043], A fan within the apparatus can also help control the temperature surrounding the cuvette, such as to help inhibit or eliminate overheating; ¶ [0057], The fan … can be automatically controlled without requiring user intervention, such as via a control loop … When a specified threshold temperature value is reached or exceeded, the fan can be activated, such as to circulate air within the apparatus to reduce the ambient temperature within the apparatus); and
wherein the thermal management device is configured to maintain the temperature of the blood within the treatment flowpath below a blood temperature set point (¶ [0047] FIG. 5 … At 552, a fluid can be passed from a fluid inlet at a first end of an elongated tube … The fluid flow rate can be controlled, such as by a pump or flow regulator, such as in the path of fluid flow, for example, outside of the cuvette. The fluid flow rate can effect a residency time of the fluid within the cuvette, so as to help control an amount of time the fluid is potentially exposed to light. For example, the fluid flow rate can be increased, so as to decrease the amount of time the fluid is potentially exposed to light; ¶ [0057], The control loop can include a temperature sensor within the apparatus or at the fluid outlet);
further including a blood temperature sensor configured to measure a blood temperature of the blood; wherein the thermal management device controls a blood flow rate, the blood flowrate being generated by a pump based on the blood temperature (¶ [0047] FIG. 5 … At 552, a fluid can be passed from a fluid inlet at a first end of an elongated tube … The fluid flow rate can be controlled, such as by a pump or flow regulator, such as in the path of fluid flow, for example, outside of the cuvette. The fluid flow rate can effect a residency time of the fluid within the cuvette, so as to help control an amount of time the fluid is potentially exposed to light. For example, the fluid flow rate can be increased, so as to decrease the amount of time the fluid is potentially exposed to light; ¶ [0057], The control loop can include a temperature sensor within the apparatus or at the fluid outlet);
wherein the disinfection unit (14) further includes a thermal management device (800, 910) associated with the microbicidal light emitting device (24) configured to dissipate heat from the microbicidal light emitting device (24) to maintain a temperature of at least a portion thereof below a predefined temperature such that the microbicidal light emitting device (24) is prevented from heating the blood within the treatment flowpath (22) above a blood temperature set point (¶ [0023], controlling an ambient temperature in or about the tube; ¶ [0038], one or more switches 116, 118, and 120 … turn on or off a fan; ¶ [0043], A fan … to help inhibit or eliminate overheating; ¶ [0057], The fan … circulate air within the apparatus to reduce the ambient temperature within the apparatus).
Lowe prevents the fluid’s temperature from exceeding a safe limit. One would be motivated to modify Burchman with Lowe’s thermal management device regulate the system’s temperature since Burchman acknowledges a need to dissipate heat from the light emitting device (col. 8, lines 50-55, The base unit 210, more particularly, should be composed of a material (such as polycarbonate or sheet metal) exhibiting a high specific heat, or an efficient dissipation of heat, and that maintains rigid structural integrity after long-term UV exposure). Therefore, it would have been obvious to modify Burchman with Lowe’s thermal management device in order to prevent the system from overheating.
Regarding claims 11-13, Burchman further discloses an insulating layer (806) between the microbicidal light emitting device (24) and the treatment flowpath (22); wherein the insulating layer (806) is optically transparent and resistant to conductive heat transfer; wherein the insulating layer (806) includes at least one of: air, a vacuum, a gas, aerogels, a material configured to trap air pockets, glass wool, and a polymeric material (Fig. 11, an air gap extends between lamp 310 and inner wall 720 of the fluid chamber assembly 340; col. 9, lines 1-10, The inner diameter DIW of the inner wall is approximately 34 millimeters in an illustrative embodiment. In this manner, it will fit over the lamp 310 without interference, but still maintain a relatively close proximity to the lamp for effective UV transmission into the effluent chamber 730).
Regarding claim 24, Burchman lacks a 405 nm emission wavelength. Lowe discloses a system that emits multiband irradiation (¶ [0036], UVA can include wavelengths in a range of from about 315 nanometers (nm) to about 400 nm); and
radiation with a wavelength of 405 nm (¶ [0036], In an example, UV light sources 108-A, 108-B, and 108-C can include one or more visual light source; ¶ [0037], The one or more diode light sources 112 can include … a LED that can be configured to be capable of emitting light at a wavelength that is visible to a human eye, such as at a wavelength in a range of from about 400 nm to about 475 nm).
Burchman and Lowe are silent whether the system has an EDD ratio greater than about 1.0, wherein the EDD ratio is calculated by dividing the EDD for multiband irradiation by the EDD for irradiation with an emission at a wavelength of 405 nm.
The EDD ratio is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The EDD ratio describes the mix of wavelengths delivered by the light sources 112 and can be optimized through routine experimentation. For example, Lowe calls for delivering a blend of wavelengths at UVA, UVB, UVC and visible light wavelengths (¶ [0036], [0037]). Lowe also calls for delivering a blend of various wavelengths into fluids passing through the treatment flowpath (¶ [0039], transparent or translucent tube wall 233 or to otherwise permit passage of light of one or more desired wavelengths into the elongated tube 230; ¶ [0040], allowing for varying UV light wavelengths or intensity).
Therefore, it would have been obvious to adjust the EDD ratio in order to deliver a desired light spectrum to fluids in the treatment flowpath. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 25, Burchman and Lowe do not explicitly disclose that the disinfection unit has an effective delivered dosage of greater than about 4 Watts. However, Burchman calls for a UV light source that consumes approximately 13 Watts of power (col. 7, lines 30-35, In an illustrative embodiment, the lamp 310 comprises a 13-watt PL-S type lamp available from Phillips of the Netherlands).
Lowe quantifies an amount of energy delivered to blood per unit area (¶ [0055], Exposing the blood to light can help to provide energy, such as photonic energy, of around about 500 joules per square meter to about 1000 joules per square meter, to hemoglobin of the blood).
The EDD is interpreted as a result-effective variable, subject to experimentation and testing. The EDD can be optimized to deliver a suitable amount of energy to extracorporeal blood through routine experimentation.
Delivering too much energy will damage blood cells, while delivering too little energy will fail to inactivate pathogens in the blood. For example, Lowe warns against overheating the blood (¶ [0043], Overheating can occur if the temperature of the fluid or of the inner surface of the elongated tube reaches a temperature capable of causing an undesirable reaction because of excessive heat).
Too low
Too many pathogens will survive in the blood
Optimized range
Sufficient pathogens will be killed, in order to resolve or prevent an infection
Too high
Excessive light energy will damage blood cells or overheat the blood flowing through the treatment flowpath
Therefore, it would have been obvious to adjust the EDD in order to protect the patient’s blood while killing pathogens. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 26, Burchman discloses that the treatment flowpath is helical and coaxial with the microbicidal light emitting device (col. 11, lines 5-15, FIG. 13, the cassette fluid chamber assembly 1310 is provided with a fluid chamber 1320 having a pair of inner and outer walls 1330 and 1340 separated by a spiral baffle 1350. Thus, when fluid enters through the top cap, it travels around the spiral pathway (exemplary upward arrows 1360) until it exits the outlet in the bottom cap).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Burchman and Lowe in view of Taniguchi; Tomohiro et al. (US 20240181099 A1).
Regarding claim 27, Burchman and Lowe disclose a blood disinfection system as discussed above for claim 1. Burchman and Lowe lack two lasers that each emit a respective light emission and a beam combiner. Taniguchi discloses an ultraviolet (UV) light irradiation and decontamination system (¶ [0001], [0016], [0017], [0046] FIGS. 1 and 6 are diagrams illustrating an ultraviolet light irradiation system of the present embodiment);
comprising a light emitting device including at least two lasers each emitting a respective light emission (¶ [0074] The light source 11a is a semiconductor light source such as a laser diode (LD) or a light emitting diode (LED); ¶ [0077] As shown in FIG. 4(A), in a case where the ultraviolet light source unit 11 has a configuration including the plurality of light sources 11a);
the light emitting device further including a beam combiner receiving and combining the light emissions of the at least two lasers (¶ [0082] FIG. 5 … The photosynthesis unit 15 has an optical system 15a for each transmission path 50a, a beam combiner 15b for each transmission path 50a, and one optical system 15c).
Taniguchi demonstrates how to generate UV light at selective wavelengths from multiple lasers and then combine the beams into a single beam (¶ [0082], The optical system 15a is, for example, a lens, and collimates the UV ray from the transmission path 50a to output to the beam combiner 15b. The beam combiner 15b has a function of synthesizing the transmitted light and the reflected light, and multiplexes the UV ray from each optical system 15a and outputs it to the optical system 15c). One would be motivated to modify Burchman and Lowe with Taniguchi’s multiple lasers and beam combiner since Burchman suggests to generate a wider range of wavelengths (cols. 11-12, lines 65-5, It is noted that one device of this kind has been described which allows for the adjustment of radiation wavelengths to any range within 120-2600 nm). Therefore, it would have been obvious to modify Burchman and Lowe with Taniguchi’s two lasers and beam combiner in order to selectively generate extra UV wavelengths.
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Burchman and Lowe in view of Lahmann; John et al. (US 20190374701 A1).
Regarding claims 4-7, Burchman and Lowe lack a coolant flowpath. Lahmann discloses a microfluidic photoreactor for treating extracorporeal blood (¶ [0002], [0023], [0025], [0028], [0033]);
comprising a thermal management device (800, 910) that includes a coolant flowpath thermally coupled with a treatment flowpath, the coolant flowpath including one or more channels configured to allow a coolant to flow therethrough (annotated Fig. 5 shows a treatment flowpath for blood surrounded by two coolant flowpaths for water; ¶ [0032], In embodiments, the cassette further comprises the heat exchanger module. In embodiments, the microfluidic photoreactor includes cooling fluid, such as water, ethylene glycol, or other fluid, in the cooling channel; ¶ [0004] FIGS. 1A-1B … The treatment cartridge has two channels, one for the blood to pass through and one for the water (or other coolant));
wherein the coolant flowpath is optically transparent, thermally coupled with the treatment flowpath, and thermally isolated from the microbicidal light emitting device (¶ [0004] FIGS. 1A-1B … The channels is separated by a transparent layer that is impermeable to the fluids);
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wherein the thermal management device controls a temperature of the coolant based on the blood temperature (¶ [0033], the cooling unit is configured to maintain the blood at a physiologic temperature, such as 37° C.; ¶ [0045], Adequate temperature control by running blood through the device and measuring the temperature at the outlet and at the interface between the reactor housing and the LED array);
further including a heat exchanger (540, 810) configured to control the temperature of the coolant based on the blood temperature (¶ [0004], The water is cooled either by radiators or a refrigeration system; ¶ [0033], In embodiments, the cooling unit comprises a radiator and/or a chiller).
Lahmann actively removes heat from blood or a treatment fluid while delivering light to the fluid. One would be motivated to modify Burchman and Lowe with Lahmann’s coolant flowpath to more closely regulate the blood temperature since Lowe calls for regulating the blood temperature (¶ [0038] The apparatus 100 can include one or more switches 116, 118, and 120, which can be configured to … control a temperature sensor that can be included in the apparatus 100; ¶ [0043], A fan within the apparatus can also help control the temperature surrounding the cuvette, such as to help inhibit or eliminate overheating). Therefore, it would have been obvious to modify Burchman and Lowe with Lahmann’s coolant flowpath in order to more closely regulate the blood temperature.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Burchman and Lowe in view of Petrie; Thomas R. (US 20170274105 A1).
Regarding claim 9, Burchman and Lowe do not explicitly disclose an alarm. Petrie discloses a method and apparatus to neutralize or destroy pathogens with UV light (¶ [0002], [0010], [0025], [0028] A sterilizing apparatus 100 illustrated in FIGS. 2A-C);
further including a fault detection system configured to generate an alarm in response to at least one of: a blood temperature exceeding a blood temperature set point; a temperature of a microbicidal light emitting device (24) being outside of an allowable range; and detection of an air bubble in a treatment flowpath (¶ [0046], the controller may monitor a temperature and energy output of the lamp 157 by monitoring a sensor or sensors arranged to provide indications of temperature and energy output; ¶ [0049] Additionally, the sterilizing apparatus 100 may be subjected to heat so as to have the chamber portion 130 at a predetermined temperature, such as near human body temperature (97-100 degrees F.); ¶ [0053] During operation, the controller 162 may cause visual and/or audio indications of the operation to be provided for the operator … Such visual representation and/or audio output may provide the operator with real time status of the overall operation, actual measured values of one or more of the parameters (such as an actual temperature of the chamber, actual flow rate, and so forth), and/or a warning of any malfunction).
Petrie informs a caregiver or user when the system has encountered an error or needs the user’s attention. One would be motivated to modify Burchman and Lowe with Petrie’s alarm since Lowe calls for monitoring the system temperature (¶ [0038], a temperature sensor that can be included in the apparatus 100). Therefore, it would have been obvious to modify Burchman and Lowe with Petrie’s alarm in order to inform a user when the system temperature has exceeded a limit, or when other errors appear.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Burchman and Lowe in view of Horton, Isaac B. III (US 20030086817 A1).
Regarding claims 14-16, Burchman and Lowe do not explicitly disclose an optical diffuser. Horton discloses an ultraviolet disinfection (UV) system for blood (¶ [0002], [0009], [0010], [0020], FIG. 1 shows a schematic diagram of a UV blood disinfection system, generally described as 10);
further including an insulating layer (806) between a microbicidal light emitting device (24) and a treatment flowpath (22); wherein the insulating layer (806) includes a surface, the surface configured to provide at least one of reflection or resistance of transmission of infrared thermal energy; wherein the insulating layer (806) includes at least one optically transmissive portion to direct the plurality of light emissions (¶ [0020], UV light generated by the UV lamp contained within the housing is focused and controlled by the means of the source optical components into at least one UV transmission line 18 that connects to the blood purifier 20 at a portal 22; ¶ [0021], a UV light source that is remotely connectable to the blood purifier via at least one fiber optic transmission line … The fiber optic lines may include quartz fibers, side-emitting fibers, glass fibers, acrylic fibers, liquid core fibers, hollow-core fibers, core sheath fibers, dielectric coaxial fibers, or a combination of fibers; ¶ [0027] The light generated by these sources is focused via optics and fibers that are joined by UV-transmissive optical couplers);
wherein the insulating layer (806) includes an optical diffuser (¶ [0021], Additionally, optical component such as gratings, dichroic filters, focalizers, gradient lenses, gradient reflectors, off-axis lenses, and off-axis reflectors may be used).
Horton imposes a distance between a UV light source and a treatment flowpath. One would be motivated to modify Burchman and Lowe with Horton’s optical diffuser to minimize the heat transfer between the UV light source and treated fluid. Therefore, it would have been obvious to modify Burchman and Lowe with Horton’s optical diffuser in order to transfer less heat to the treated fluid.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Burchman and Lowe in view of Hopkins; Andrew et al. (US 20210299257 A1).
Regarding claim 22, Burchman emits light along a range of wavelengths (col. 7, lines 35-40, The lamp emits UV-C at a wavelength of approximately 254 nm. In general, it is desirable that UV-C in the range of approximately 100-290 nm be employed).
Lowe emits light at about 405 nm (¶ [0036], UVA can include wavelengths in a range of from about 315 nanometers (nm) to about 400 nm).
Burchman and Lowe do not explicitly disclose light within at least two of the claimed ranges. Hopkins discloses a system wherein the plurality of light emissions includes light at about 405 nm (¶ [0061], delivering, to the pathogen tissue having this nanoparticle, light having a wavelength of from about 550 nm to about 750 nm, light having a wavelength of about 300 to 400, light having wavelengths of about 350 nm about 625 nm and about 689 nm, light from about 600 nm to about 800 nm, light from bout 650 nm to about 725 nm, light from about 675 nm to about 725 nm, light at about 689 nm, light at 689 nm, and all wavelength within these ranges, as well as higher and lower wavelengths); and
light within at least two ranges between about 380 nm and about 420 nm; between about 400 nm and about 415 nm; between about 500 nm and about 700 nm; between about 500 nm and about 520 nm; between about 530 nm and about 555 nm; between about 565 nm and about 590 nm; and between about 615 nm and about 645 nm (¶ [0061], delivering, to the pathogen tissue having this nanoparticle, light having a wavelength of from about 550 nm to about 750 nm, light having a wavelength of about 300 to 400, light having wavelengths of about 350 nm about 625 nm and about 689 nm, light from about 600 nm to about 800 nm, light from bout 650 nm to about 725 nm, light from about 675 nm to about 725 nm, light at about 689 nm, light at 689 nm, and all wavelength within these ranges, as well as higher and lower wavelengths).
Hopkins selects a broader range of wavelengths for inactivating pathogens in blood. One would be motivated to modify Burchman and Lowe with Hopkins’s broader light spectrum to more thoroughly irradiate and inactivate pathogens since Burchman acknowledges the advantage of emitting a wide spectrum (col. 11-12, lines 65-5, It is noted that one device of this kind has been described which allows for the adjustment of radiation wavelengths to any range within 120-2600 nm). Therefore, it would have been obvious to modify Burchman and Lowe with Hopkins’s broader light spectrum in order to deliver more light energy for inactivating pathogens.
Response to Arguments
The objection to claim 16 for minor informalities and the rejections of claims 4, 5 and 24 under 35 USC § 112 are withdrawn in view of the amendments filed 20 February 2026.
Applicant’s arguments filed 20 February 2026 regarding the rejection of claims 1-20, 22, 24 and 25 as amended, under 35 USC § 103 over Lowe, Lahmann, Petrie, Horton and Hopkins, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Burchman, Lowe, Taniguchi, Lahmann, Petrie, Horton and Hopkins (see above).
Applicant notes that in Lowe, Lahmann, Petrie, Horton, and Hopkins, the rough equivalent of Applicant's recited treatment flowpath is adjacent or between the respective rough equivalents of Applicant's recited microbicidal light emitting device (remarks p. 10). Applicant has added new claim 26, which recites that "the treatment flowpath is helical and coaxial with the microbicidal light emitting device (remarks p. 11).
Examiner responds that amended claim 1 is rejected on new grounds over Burchman and Lowe. Burchman explicitly discloses a flowpath that surrounds a microbicidal light (Figs. 3, 11, 12) and which forms a helical coaxial path (col. 11, lines 5-15, FIG. 13, the cassette fluid chamber assembly 1310 is provided with a fluid chamber 1320 having a pair of inner and outer walls 1330 and 1340 separated by a spiral baffle 1350. Thus, when fluid enters through the top cap, it travels around the spiral pathway (exemplary upward arrows 1360) until it exits the outlet in the bottom cap).
Applicant has also added new claim 27, which recites that "the light emitting device including at least two lasers … a beam combiner …" (remarks p. 11). Examiner replies that new claim 27 is rejected over Burchman, Lowe and Taniguchi.
Applicant contends that claim 27 depends on amended independent claim 1 and inherits all recitations thereof (remarks p. 11). Examiner finds that new claim 27 is an independent claim which does not depend on amended claim 1 or any other claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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Blum; Dieter Wolfgang US 20080305018 A1
Tribelsky; Zamir et al. US 20090000639 A1
Leonard; Edward F. US 20110021966 A1
Yu; Litao et al. US 20160009570 A1
Deguchi; Kenichiro et al. US 20160046507 A1
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De Best; Anna Wilhelmina Maria et al. US 20230128715 A1
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Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781