Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment/Arguments
The Amendment filed 7/1/2026 has been entered. Claims 1-17, and 19-66 remain pending on the application. Applicant’s amendments to the Specification and the Claims have overcome each and
every 112(b) rejection to the Claims previously set forth in the Non-Final Office Action mailed 4/1/2026.
Applicant argues with respect to claim 1:
In an effort to advance prosecution of the current application, Applicant has amended independent claim 1 to even more clearly recite the structural and configurational features that distinguish the claimed subject matter from the cited prior art. As a preliminary note, Applicant respectfully submits that a rejection under 35 U.S.C. § 103 requires that the differences between the claimed invention and the prior art be such that the claimed invention as a whole would have been obvious to a person of ordinary skill in the art at the time of the invention. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). Additionally, the Examiner must articulate "some rational underpinning to support the legal conclusion of obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Moreover, the prior art must be considered as a whole, and references cannot be selectively combined through impermissible hindsight reconstruction using the applicant's own disclosure as a roadmap. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992).
The grounds of rejection for claim 1 and its dependent claims have been updated to now rely on Standfest as the primary reference to read on the new claim limitations.
With regard to Laugharn, Applicant submits that Laugharn is directed primarily to a
focused acoustic energy sample treatment system. Throughout Laugharn, the principal teaching is the use of acoustic energy from an acoustic energy source 2 to process sample material within a processing chamber 10. UV radiation, where mentioned, is disclosed as one optional auxiliary modality-not as the core operating principle-typically used in combination with acoustic treatment of laboratory samples. Furthermore, Laugharn's system is described in the context of laboratory benchtop sample preparation, not potentially portable field-deployable medical equipment intended for direct injection of treated biofluid into a human patient at the point of care. Furthermore, it is evident that Laugharn does not teach components at the micro level.
Instead, Laugharn teaches operating at bulk fluid volumes (110 ML yeast experiments [0145] and gallon-scale reservoirs [0168].
By contrast, amended independent claim 1 of the current application clearly recites microcassettes and micro devices.
Since this concerns an apparatus claim, the prior art would read on the claim limitations so long as all claimed structures are found in the prior art and the prior art apparatus is capable of performing the same functions as the instant invention.
Absent a specific recitation of dimensions for the instant invention or a recitation of a function which only a device of certain dimensions can perform, the prior art apparatus would read on the instant invention. The term “microfluidics” is not interpreted to impart any additional structural limitation to the claim, absent evidence that one of ordinary skill in the art would interpret specific dimensions to “microfluidics”.
There is no inclusion of an acoustic energy source. Furthermore, the range of the emitted ultraviolet light has been amended to 266 nm to 380 nm. The Examiner has previously concluded that Laugharn's range is "approximately 185 nm and 265 nm (e.g., 185 nm, 254 nm, 265 nm". Amended claim 1 further recites that the microcassette is "removably insertable into said housing" and "configured to process said biofluid for at least on of analysis, storage, and direct injection into a human. None of these limitations are taught by Laugharn or a combination of Laugharn with any of the cited prior art.
Examiner first notes that Applicant’s Specification does not recite a lower endpoint of 266 nm and thus this new range is subject to a 35 U.S.C. 112(a) rejection for lack of written description.
At the same time, the grounds of rejection for claim 1 have been updated to read on this new range.
Applicant further notes that throughout the Office Action, the Examiner dismisses numerous claim limitations as mere recitations of "intended use," including the limitations directed to (i) processing biofluid for direct injection into a human, (ii) PCR analysis without additional reagents or adjuvants, (iii) direct injection with or without adjuvant chemicals, (iv) battlefield wound-care use, (v) battlefield sturdiness, and (vi) non-terrestrial use.
Applicant respectfully traverses the Examiner's characterization. Applicant respectfully notes that under MPEP § 2111.04, a recitation of intended use must be evaluated to determine whether it results in a structural difference between the claimed invention and the prior art. Where, as here, a claim recites that a component is "configured to" or "capable of' performing a specified function, that recitation imposes a structural requirement on the apparatus. See In re Giannelli, 739 F.3d 1375, 1379 (Fed. Cir. 2014) (holding that the phrase "adapted to" in an apparatus claim required the apparatus to be structurally configured for the specified function, not merely capable of being so used).
For example, amended independent claim 1 of the current application expressly recites a microcassette "configured to process said biofluid for at least one of analysis, storage, and direct injection into a human." Direct injection of biofluid into a human imposes substantive structural and material requirements, such as sterile fluid pathways, biocompatible materials, appropriately sized flow channels for human vascular access, and validated absence of leachables. A bench-top acoustic sample-processing chamber as disclosed in Laugharn, intended for laboratory cell- lysis and sample-preparation purposes, is not structurally configured for this purpose. The Examiner has not identified any teaching in Laugharn or Bernhard that indicates that the disclosed apparatus is structurally suitable for direct human injection of its output.
Examiner notes that the fluid sterilized by the system of Standfest and/or Laugharn can then be placed in something such as a needle and injected into a human. Likewise, the fluid can also be sterilized and then later stored and analyzed. Therefore, the system of Standfest reads on being configured to process a fluid for analysis, storage, and direct injection into a human. The claim wording does not require that the system is capable of directly performing the injection itself, nor directly performing the analysis itself. Moreover, for analysis and storage, Standfest is capable of this as well and the claim only requires that the system is configured for at least one of analysis, storage, and direct injection into a human.
With regard to Bernhard, Applicant notes that Bernhard is directed to UV disinfection or sterilization of the inner surface of a formed article; that is, container sterilization. While Bernhard does disclose substitution of UV LEDs for mercury lamps, Applicant respectfully submits that the Examiner's proposed combination of Bernhard's LED-substitution teaching with Laugharn's acoustic processing system to arrive at the claimed biofluid irradiating device requires more than mere component substitution. Rather, it demands that a person having ordinary skill in the relevant art(s) (PHOSITA) to (i) extract UV teachings from a primarily acoustic system (Laugharn), (ii) recharacterize that system as having micro components, (iii) incorporate UV LED substitution from a container-sterilization context (Bernhard), and (iv) reconfigure the microfluidics architecture to enable at least direct human injection.
Claim 1 now relies on Standfest as the primary reference. Even so, Standfest also teaches a container sterilization context. Furthermore, this modification does not require recharacterizing the system as having micro components nor reconfiguring the microfluidics architecture to enable direct human injection at all (at best, this argument is directed towards the overall obviousness of the combined prior art). It simply concerns the benefits of one UV light source over the other for the purpose of sterilization within a container.
Applicant notes that the Federal Circuit has consistently held that an obviousness
rejection requires a reason, suggestion, or motivation to combine the references in the manner claimed, and that such motivation cannot be supplied solely by the applicant's own disclosure. See In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998); In re NTP, Inc., 654 F.3d 1279, 1299 (Fed. Cir. 2011). In view of these standards, Applicant respectfully submits that the motivation articulated by the Examiner-"to easily adjust the wavelength, decrease warm-up time, and avoid mercury exposure"-is a generic LED-versus-mercury rationale that does not address why a PHOSITA would have selected Laugharn's laboratory acoustic system as a starting point for designing a microfluidics biofluid irradiating device suitable for at least one of analysis, storage, and direct injection of treated biofluid into a human.
Again, this modification does not require selecting Standfest’s or Laugharn’s system as a starting point for designing a microfluidics biofluidic irradiating device, and merely requires Bernhard giving a reason to replace the mercury lamp with LED’s, which Bernhard does.
Applicant further argues with respect to claim 36:
With regard to the rejection of independent claim 36, which is based on Standfest in view of Laugharn and Bernhard, Applicant notes that Standfest is directed to a modular irradiation device with a main module and interchangeable support cassettes, primarily described in the context of laboratory fluid sample irradiation to minimize cross-contamination. Standfest does not teach a UV transmissible microfluidics device including interchangeable microcassettes capable of ice and/or fluid handling techniques, enabling the device to process at least one of said ice and said fluid for analysis to determine presence of pathogens, wherein a first microcassette is configured to actively convert ice slurry into liquid water through a thermal processing element disposed therein and wherein a second microcassette is sequentially operable with said first microcassette and configured to irradiate the liquid water received from said first microcassette with said UV LEDs, as required by amended independent claim 36. Additionally, Applicant notes that Laugharn, as set forth above, is a laboratory acoustic processing system that operates at bulk fluid volumes. Neither reference, either alone or in combination, teaches, discloses, or suggests the limitations discussed above.
Applicant further respectfully asserts that the Examiner's reliance on Laugharn's passing reference to "batteries" (paragraph 260) as a generic power source option, combined with Standfest's modular cassette architecture, requires a PHOSITA to reconstruct Applicant's claimed subject matter by selectively extracting features from disparate references. This is the hallmark of impermissible hindsight reconstruction. See In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) ("it is impermissible to use the claimed invention as an instruction manual or template to piece together the teachings of the prior art so that the claimed invention is rendered obvious").
Standfest already teaches using UV radiation for sterilization for fluids. Laugharn also teaches using UV sterilization for fluids and merely provides more structure for accomplishing that same function in a similar context; the two are closely related analogous art. There is no hindsight required to supply a device utilizing UV sterilization with structure for realizing UV sterilization. Laugharn does not need to be a microfluidic device in order to render this combination obvious for separate reasons.
Applicant respectfully asserts that neither Standfest, Laugharn, nor Bernhard, either alone or in combination, teaches, discloses, or suggests the recited active two-stage ice-to-water processing architecture in which a first microcassette includes a thermal processing element for active phase-change conversion and a second microcassette is sequentially operable to irradiate the resulting liquid water. Applicant respectfully submits that the Examiner's assertion that Standfest's cassette "can be used to turn ice slurry into water if simply left alone at room temperature" is not a teaching of any phase-change processing function at all; rather, it is, at most, an acknowledgment that Standfest is silent on phase-change processing. Passive ambient melting is not equivalent to an active thermal processing element configured to convert ice slurry into liquid water, particularly in non-terrestrial environments where ambient conditions cannot be presumed to support spontaneous melting.
In light of the above, Applicant respectfully submits that the claimed two-cassette architecture with active thermal processing and sequential UV irradiation is a distinct and inventive contribution, particularly suited to non-terrestrial environments where ice processing is a recognized critical-resource challenge and where ambient conditions cannot be relied upon for phase change. Standfest's interchangeable-cassette architecture, even when combined with Laugharn's acoustic processing and Bernhard's LED-substitution teachings, does not arrive at Applicant's claimed sequential, active-thermal-processing-plus-UV-irradiation architecture without impermissible hindsight reconstruction using the current application as a roadmap.
Applicant’s Specification does not recite any such active thermal processing element. Thus, this active thermal processing element is interpreted to be the container walls, which provide some form of insulation which can help with melting to some degree, or can serve to transfer heat between the environment and the interior of the device where the ice slurry is.
Applicant argues with respect to claim 22:
Similar to independent claim 1, Applicant respectfully submits that the recited
"disposable biofluid sampling cartridge capable of containing a biofluid sample and facilitating PCR analysis without the need for additional reagents or adjuvants" of dependent claim 22 is a structural capability limitation, not pure intended use. This is because the cartridge must be physically configured to deliver PCR-ready fluid output, thereby imposing a substantive structural constraint that is not taught by Laugharn's general acoustic processing chamber. Applicant respectfully contends that the Examiner's assertion that Laugharn is "capable of being used" in a manner involving such a cartridge does not, without more, demonstrate that Laugharn teaches, discloses, or suggests Applicant's recited structural configuration.
The cassettes of Standfest would be capable of transferring fluid to another place, so they are physically configured to deliver a fluid output. Any liquid can undergo PCR testing, so that fluid output would read on PCR-ready as well. Applicant has not specified any substantive structural constraint that is necessary for delivering PCR-ready fluid output.
Applicant argues with respect to claim 32:
The recitation in Applicant's dependent claim 32 that pathogens are rendered non- biologically harmful through breaking of the phosphodiester bond between the U-C and U-G bonding groups identifies a specific molecular mechanism applicable to RNA-containing pathogens. By contrast, paragraph 224 of Laugharn, cited by the Examiner, broadly discusses treatment of plant tissue, yeast, and bacterial cells but does not teach the U-C and U-G phosphodiester bond cleavage mechanism. Without an actual teaching of this specific mechanism in the cited art, Applicant respectfully asserts that the Examiner's conclusion that the recited feature is inherent or obvious is not supported by substantial evidence.
In order to read on this limitation, the prior art merely has to be capable of breaking those bonds. Ultraviolet radiation is known to be capable of breaking DNA and RNA bonds. Gunderson (US 20040259106 A1) teaches that phosphodiester bonds can be cleaved via UV light (par. 76: A nucleic acid used in the invention can also include native or non-native bases. In this regard a native deoxyribonucleic acid can have one or more bases selected from the group consisting of adenine, thymine, cytosine or guanine and a ribonucleic acid can have one or more bases selected from the group consisting of uracil, adenine, cytosine or guanine; par. 163: Other methods that can be used to produce genome fragments include, for example, treatment with chemical agents that disrupt the phosphodiester backbone of DNA such as those that cleave bonds by a free radical mechanism, UV light, mechanical disruption or the like. These and the methods set forth above can be used to produce genome fragments from a native genome, further cleave genome fragments, or cleave other nucleic acids used in the invention).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 and 19-66 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 1, the limitation “266 nm” as the lower endpoint to a range is not found within Applicant’s Specification.
Claims 2-17, 19-35, and 61-65 are rejected as dependent on claim 1.
In claim 36, the limitation “266 nm” as the lower endpoint to a range is not found within Applicant’s Specification.
Claims 37-60 and 66 are rejected as dependent on claim 36.
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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12, 14-17, 19-29, 31-33, 62-63, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Standfest (WO 2022129219 A1) in view of Laugharn (US 20150079655 A1) Bernhard (WO 2022218988 A1).
Regarding claim 1, Standfest teaches an ultraviolet biofluid irradiating device comprising:
a) for ultraviolet biofluid irradiating (“UBI”), emitting ultraviolet light (pg. 8 par. 2: Ionizing radiation, in particular electrons and/or UV radiation, are particularly advantageous for the irradiation. Correspondingly, the radiation source can be an electron source or a UV radiation source);
d) a UV transmissible microfluidics device including a microcassette removably insertable into said housing (abstract: The invention relates to a modular irradiation device having a main module and at least one support cassette, the support cassette being insertable into a receptacle of the main module; pg. 7 par. 7: Advantageously, a large number of carrier cassettes can be used, which can then be prepared individually and inserted in quick succession into the main module in order to carry out the irradiation) and capable of biofluid handling techniques (pg. 8 par. 2: The method according to the invention is particularly advantageous for irradiating cell suspensions, virus suspensions, medium, serum and/or blood samples), wherein said microcassette is configured to process said biofluid for at least one of analysis, storage, and direct injection into a human (NOTE: this is a recitation of intended use; the chamber 10 would be capable of sterilizing fluid and thus processing biofluid, which can then be analyzed, stored and injected into a human, especially since Standfest is meant for handling biofluids to begin with);
e) said microcassette which is a biofluid conveying conduit in which said biofluid flows through a tube such that said biofluid can be irradiated with ultraviolet light emitted from said UV LEDs as it is flowing through the microcassette (Fig. 7C: irradiation line 13; pg. 8 last par.: The carrier cassette 2 also has at least one pump 5a, 5b, which is connected to the irradiation line 13 via fluid lines);
such that pathogens in the biofluid are rendered non-biologically harmful as they are irradiated with UV light while flowing through the microcassette in the device (pg. 11 par. 5: The invention permits safe and sterile irradiation of fluids),
but does not teach
light in the range of 266 nm to 380 nm
Ultraviolet Light Emitting Diodes (“UV LEDs”).
b) control circuitry for regulating the ultraviolet light emission by said UV LEDs
c) a housing material capable of ultraviolet light transmittance, housing said UV LEDs and said control circuitry
f) a power source comprising at least one of a battery power source and an AC power source
Standfest teaches UV radiation sources (pg. 8 par. 3: Correspondingly, the radiation source can be an electron source or a UV radiation source) but does not teach what kind of light source is used.
Bernhard teaches a system for UV sterilization (abstract: and a method for their UV disinfection and/or sterilization, including disinfection and/or sterilization of the inner surface of the formed article). Bernhard teaches using UV LEDs in order to easily adjust the wavelength, decrease warm-up time, and avoid mercury exposure (pg. 31 lines 9-13: Typically, UV mercury lamps only emit light at 254 nm, so it is preferred to use UV light- emitting diodes (UV-LEDs) which can be configured to emit certain target wavelengths, i.e. desired UV wavelength from 260 to 300 nm, preferably from 260 to 280 nm, more particularly at 265 nm, in the inventive method. Further, UV mercury lamps have additional disadvantages, such as a long warm-up time, and risk of mercury exposure).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Standfest to use UV LEDs as the UV radiation sources emitting light in the range of 260 to 280 nm, as taught by Bernhard and Laugharn, in order to easily adjust the wavelength, decrease warm-up time, and avoid mercury exposure for UV sterilization.
260-280 nm overlaps with the claimed range of 266-380 nm.
According to MPEP 2144.05.I, a prima facie case of obviousness exists where the prior art range or amount overlaps with or is merely close to the claimed range or amount:
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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV light sources of Standfest modified by Bernhard and Laugharn to emit light at 266-380 nm, with the reasonable expectation that this wavelength would provide a similar amount of sterilization effectiveness as 260-280 nm.
Laugharn teaches emitting ultraviolet light (par. 59: In some cases, the germicidal or virucidal nature of ultraviolet irradiation may be quite effective at wavelengths of between approximately 185 nm and 265 nm (e.g., 185 nm, 254 nm, 265 nm));
b) control circuitry for regulating the ultraviolet light emission by said UV LEDs (par. 76: Or, if exposure of the sample material to ultraviolet radiation is too great, then the controller 20 may adjust the intensity of ultraviolet radiation emitted into the internal volume of the chamber; Fig. 3: controller 20 and line connecting controller 20 to radiation source 70; par. 107: Similarly, depending on the desired level of ultraviolet radiation treatment, which may also be based on feedback information gathered from one or more sensors regarding the sample material (e.g., whether the sample has been sterilized, whether the sample has been damaged from radiation overexposure, etc.), the controller may adjust one or more parameters of ultraviolet irradiation from the source 70 (e.g., intensity, wavelength, frequency, power output, etc.), as also described herein; par. 161: Adjustments to the treatment conditions may be made based on any suitable criteria, such as sensed material properties (such as particle size, density, concentration, transmittance, etc.), a time elapsed, user input; par. 65: the sample treatment system 100 may include a controller 20 (e.g., including a suitably programmed general purpose computer or other data processing device) that receives feedback and control information (e.g., from one or more sensors, user input devices, etc.) and correspondingly controls operation of the acoustic energy source 2 and/or other system components; par. 97: In some cases, sample material is exposed to focused acoustic energy and/or radiation treatment for an extended, or indefinite, period of time, until the controller, or operator, alters the treatment plan or criterion that would allow the sample material to exit the chamber via an outlet);
c) a housing material capable of ultraviolet light transmittance, housing said UV LEDs and said control circuitry (Fig. 3: window 71 houses radiation source 70 and necessarily at least some of the circuitry connected to radiation source 70; par. 74: In some embodiments, the window 11 has an acoustic impedance similar to that of water and a relatively low acoustic absorption. One suitable material is low density polyethylene, but other polymers such as polypropylene);
f) a power source comprising at least one of a battery power source and an AC power source (par. 260: such as a plug for mating with an electrical outlet, batteries);
Laugharn also teaches a device for sterilizing fluids and presents a number of useful improvements to Standfest.
Having control circuitry that regulates the intensity and exposure time of the UV light based on feedback from the fluid characteristics is helpful for adjusting the sterilization treatment appropriately for the specific fluid being sterilized.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Standfest modified by Bernhard and Laugharn to have control circuitry comprising of a controller electronically connected to the UV light sources, capable of regulating the intensity and exposure time of the UV light based on feedback concerning the fluid characteristics and/or as determined by user input, as taught by Laugharn, in order to adjust the sterilization treatment according to the specific fluid being sterilized.
Standfest teaches a UV radiation source 18 (Fig. 7C) but does not teach how that UV radiation source is housed and connected to the rest of the device. Laugharn teaches wherein its UV radiation source is housed in a chamber with a polypropylene window capable of transmitting UV light, wherein the UV radiation source is connected to control circuitry which is also at least partially housed behind the window.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV light source of Standfest modified by Bernhard and Laugharn to be supported within a walled structure and housed behind a polypropylene UV-transparent window, wherein the UV light source is connected to control circuitry that is at least partially housed behind the window as well, as taught by Laugharn, in order to position the UV light source such that the sterilization target can be irradiated.
Standfest teaches UV radiation sources but does not teach a means of powering them. Laugharn teaches that batteries can be used to power the controller and the UV lights.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller and UV radiation sources of Standfest modified by Bernhard and Laugharn be powered by batteries, as taught by Laugharn, in order to provide a power source for the device.
Regarding claim 2, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said pathogens are selected from the group consisting of protozoans, bacteria, fungi, viruses and currently unknown pathogens which may be present in ice and soil on non-terrestrial locations (NOTE: the biofluid and the pathogens in the biofluid are not positively recited; the device of Standfest modified by Bernhard and Laugharn can be used to sterilize the biofluid containing the recited pathogens and thus the device would read on this limitation; pg. 2 par. 4: as well as in the inactivation and sterilization of e.g. pathogenic liquids).
Regarding claim 3, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 2, as set forth above, and teaches wherein said protozoans are selected from the group consisting of malaria, African trypanosomiasis, Chagas disease, toxoplasmosis, cryptosporidiosis, amoebic dysentery and giardia (NOTE: the biofluid and the pathogens in the biofluid are not positively recited; the device of Standfest modified by Bernhard and Laugharn can be used to sterilize the biofluid containing the recited pathogens and thus the device would read on this limitation).
Regarding claim 4, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 2, as set forth above, and teaches wherein said bacteria are selected from the group consisting of salmonella, Lyme disease, streptococcus, staphylococcus, methicillin-resistant staphylococcus aureus (MRSA), clostridium tetani, E. coli, campylobacter and pneumonia pneumococcus (NOTE: the biofluid and the pathogens in the biofluid are not positively recited; the device of Standfest modified by Bernhard and Laugharn can be used to sterilize the biofluid containing the recited pathogens and thus the device would read on this limitation).
Regarding claim 5, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 2, as set forth above, and teaches wherein said fungi are selected from the group consisting of candida albicans, fungal meningitis, Cryptococcosis, Aspergillosism, pneumocystis pneumonia and histoplasmosis (NOTE: the biofluid and the pathogens in the biofluid are not positively recited; the device of Standfest modified by Bernhard and Laugharn can be used to sterilize the biofluid containing the recited pathogens and thus the device would read on this limitation).
Regarding claim 6, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 2, as set forth above, and teaches wherein said viruses are selected from the group consisting of West Nile virus, Zika virus, Avian influenza A virus, Dengue virus, human SARS coronavirus (SARS-CoV), human SARS coronavirus 2 (SARS-CoV-2), MERS coronavirus (MERS-CoV), chikungunya virus and rabies virus (NOTE: the biofluid and the pathogens in the biofluid are not positively recited; the device of Standfest modified by Bernhard and Laugharn can be used to sterilize the biofluid containing the recited pathogens and thus the device would read on this limitation).
Regarding claim 7, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said analysis of the biofluid is Polymerase Chain Reaction (“PCR”) analysis (NOTE: this is a recitation of intended use; the fluid exiting the device of Standfest modified by Bernhard and Laugharn can be subjected to PCR analysis and thus the device would read on this limitation).
Regarding claim 8, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said direct injection into said human is selected from the group consisting of direct injection without adjuvant chemicals and direct injection with adjuvant chemicals (NOTE: this is a recitation of intended use; the fluid exiting the device of Standfest modified by Bernhard and Laugharn can be injected into a human using the recited methods and thus the device reads on this limitation).
Regarding claim 9, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said direct injecting said biofluids into said human can be done in non-medical room settings for soldiers in the field for wound care (NOTE: this is a recitation of intended use; the fluid exiting the device of Standfest modified by Bernhard and Laugharn can be injected into a human using the recited method and thus the device reads on this limitation).
Regarding claim 10, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein the type of said flowing through the microcassette is selected from the group consisting of flowing caused by gravity and flowing caused by a pump to regulate the flowing through said device (abstract: The support cassette has at least one pump, and the main module has at least one pump actuator, these being arranged such that the pump is actuatable with the pump actuator when the support cassette is inserted into the receptacle of the main module).
Regarding claim 11, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 10, as set forth above, and teaches wherein said flowing caused by a pump to regulate the flowing through said device can be done in a low-gravity situation such as that on the surface of the moon or the planet Mars (abstract: The support cassette has at least one pump, and the main module has at least one pump actuator, these being arranged such that the pump is actuatable with the pump actuator when the support cassette is inserted into the receptacle of the main module; NOTE: since a pump does not depend on high or low gravity, they would be able to operate in a low-gravity environment).
Regarding claim 12, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said housing is selected from the group consisting of thermoform/injection-molded material for handling microfluidics and molded polymer material for handling microfluidics (see Laugharn polypropylene housing modification in claim 1 rejection; NOTE: since several shaping techniques can be used to achieve the same structure, as polypropylene is capable of being produced via thermoforming or injection molding, the method of forming the material does not add any additional structure to the claim limitation).
Regarding claim 14, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, but does not teach wherein said control circuitry regulates temperature control.
Laugharn teaches wherein the control circuitry regulates temperature control (par. 204: Control of the acoustic energy source 2 may be performed by the controller 20 using a feedback control mechanism so that any of accuracy, reproducibility, speed of processing, control of temperature; par. 142: The controller 20 is in electrical communication with each of the components of the system (e.g., acoustic energy source, radiation source, temperature control system). Laugharn teaches wherein high temperature gradients or high temperatures can damage a biological fluid (par. 176: However, some of the non-uniform aspects are highly deleterious to samples, such as extreme temperature gradients that damage sample integrity. For example, in some instances, high temperatures generated would irreversibly denature target proteins).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control circuitry of Standfest modified by Bernhard and Laugharn to be capable of regulating temperature, as taught by Laugharn, in order to prevent biological fluids from being damaged.
Regarding claim 15, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said control circuitry regulates the intensity of the ultraviolet light emission (see Laugharn control circuitry modification in claim 1 rejection).
Regarding claim 16, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches a pump (abstract: The support cassette has at least one pump, and the main module has at least one pump actuator, these being arranged such that the pump is actuatable with the pump actuator when the support cassette is inserted into the receptacle of the main module) but does not teach wherein said control circuitry regulates control of said pump (internal or external).
Laugharn teaches wherein its control circuitry controls a pump (par. 182: par. 260: For example, the controller 20 may include… software or other computer-executable instructions (e.g., including instructions for carrying out functions related to controlling the acoustic energy source 2, a pump 33…)) in order to control a processing time of the fluid (par. 255: The material can be controlled by the timing of the transfer mechanism, such as the pump, to allow discrete processing times `in chamber` before discharging the material and bringing in new material. This can provide time for process steps such as processing, mixing, cooling and others to fully develop before introducing new unprocessed sample to the chamber; par. 97: In some cases, sample material is exposed to focused acoustic energy and/or radiation treatment for an extended, or indefinite, period of time, until the controller, or operator, alters the treatment plan or criterion that would allow the sample material to exit the chamber via an outlet).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control circuitry of Standfest modified by Bernhard and Laugharn to regulate the pump and its time of operation, as taught by Laugharn, in order to control a processing time of the fluid to be sterilized.
Regarding claim 17, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, but does not teach wherein said control circuitry selected from the group consisting of wireless and data ports, data storage memory components on the device, a microcontroller, a clock, and input/output functions which regulates the duration of exposure of the fluid to UV radiation from the UV LEDs.
Laugharn teaches wherein said control circuitry selected from the group consisting of wireless and data ports (par. 260: communication buses or other communication devices for wired or wireless communication (e.g., including various wires, switches, connectors, Ethernet communication devices, WLAN communication devices, and so on)), data storage memory components on the device (par. 260: one or more memories for storing data and/or operating instructions (e.g., including volatile and/or non-volatile memories such as optical disks and disk drives), a microcontroller (par. 260: microprocessors), a clock, and input/output functions which regulates the duration of exposure of the biofluid to UV radiation from the UV LEDs (par. 260: user data input devices (such as buttons, dials, knobs, a keyboard, a touch screen or other), information display devices (such as an LCD display, indicator lights, a printer, etc.), and/or other components for providing desired input/output and control functions).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control circuitry of Standfest modified by Bernhard and Laugharn to comprise of wireless and data ports, data storage memory components, a microcontroiller, and iput/output functions that regulate the UV sterilization treatment, as taught by Laugharn, in order to provide a physical apparatus means of fulfilling the function of the control circuitry.
Regarding claim 19, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said control circuitry further comprises a feedback mechanism for adjusting the emission intensity of said UV LEDs based on detected biofluid characteristics (see Laugharn control circuitry modification in claim 1 rejection).
Regarding claim 20, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said device is comprised of ultraviolet transmittance capable thermoform (see Laugharn polypropylene housing modification in claim 1 rejection; NOTE: since several shaping techniques can be used to achieve the same structure, as polypropylene is capable of being produced via thermoforming or injection molding, the method of forming the material does not add any additional structure to the claim limitation)/ injection molded UV-resistant polymer.
Regarding claim 21, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 20, as set forth above, and does not need to teach wherein said UV-resistant polymer is polypropylene (claim recites a thermoform/injection molded UV-resistant polymer, wherein the slash is interpreted to mean that the device comprises a thermoform or a polymer, and the prior art teaches a thermoform, so it does not need to read on a UV-resistant polymer).
Regarding claim 22, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said UV transmittable Microfluidics device is capable biofluid handling techniques that comprise a disposable biofluid sampling cartridge capable of containing a biofluid sample and facilitating PCR analysis without the need for additional reagents or adjuvants (NOTE: the device of Standfest modified by Bernhard and Laugharn is capable of being used in biofluidic handling techniques that could involve a separate disposable biofluid sampling cartridge that is capable of the recited function).
Regarding claim 23, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said device comprises a portable device (see Laugharn battery modification in claim 1 rejection, which is interpreted to make the device portable).
Regarding claim 24, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said device comprises a battery-powered device (see Laugharn battery modification in claim 1 rejection).
Regarding claim 25, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said device comprises a compact device (NOTE: absent any recitation as to what dimensions would be compact, the device of Standfest modified by Bernhard and Laugharn has finite dimensions that are interpreted to be compact).
Regarding claim 26, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said device comprises a lightweight device (NOTE: absent a recitation of a specific weight or weight range that would qualify as lightweight, the device of Standfest modified by Bernhard and Laugharn has a finite weight that is interpreted to be lightweight).
Regarding claim 27, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said device comprises a sturdy device for use on a battlefield (NOTE: absent a recitation of a quantitative physical standard that equates to sturdiness, the device of Standfest modified by Bernhard and Laugharn has a finite sturdiness that is interpreted to be sturdy).
Regarding claim 28, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein the biofluid is selected from the group consisting of whole blood (pg. 8 par. 2: blood samples), plasma and platelets, plasma, platelets, red blood cells and white blood cells.
Regarding claim 29, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said pump is regulated on a timing cycle for effectiveness in rendering pathogens non-biologically harmful (see Laugharn modification in claim 16 rejection).
Regarding claim 31, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, but does not have to teach wherein said AC power source has a DC transformer (Standfest modified by Bernhard and Laugharn teaches wherein the power source comprises at least one of a battery power source and an AC power source; since Laugharn provides a battery power source, the AC power source does not need to be read upon).
Regarding claim 32, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said pathogens are rendered non-biologically harmful by the irradiation as the phosphodiester bond between the pathogens’ bonding group consisting of Uracil and Cytosine (U-C) and Uracil and Guanine (U-G) is broken (NOTE: this is a recitation of intended use, as fluids containing pathogens, DNA, and RNA can be fed into the device of Standfest, wherein the DNA/RNA would have the recited bonding group, and UV radiation would be capable of breaking the phosphodiester bond in this group, rendering the pathogens with this DNA/RNA non-biologically harmful).
Regarding claim 33, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein said power source is selected from the group consisting of a battery power source and AC power source (see Laugharn modification in claim 1 rejection).
Regarding claim 62, Standfest modified by Bernhard, and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, but does not teach wherein the said microcassette comprises a high transmissible plastic film to enable UV radiation transmissibly to the biofluid.
Laugharn teaches a window to protect the UV light source from the biological fluid being sterilized (par. 99: In some embodiments, the radiation source 70 is located behind a window 71. The window 71 may provide protection for the radiation source 70 so that the source does not come into direct contact with the sample material. As the sample material may be biological in nature, with soft tissue and other particles, it may be preferable for the sample material not to collect at the radiation source, and possibly adhering to the source itself, which may diminish the effectiveness of the emitted radiation. The window 71 may further be transparent or translucent so as to transmit radiation emitted from the source 70 through the window and toward the internal volume 12 of the chamber), wherein a window material can be a thin transparent plastic film (par. 100: The window 71 may include any suitable material that is transparent or translucent so as to allow transmission of radiation therethrough, for example, glass, thin film polymers; par. 73: In certain embodiments, the window 11 is glass, sapphire, quartz, a polymer such as a thin film polymer such as a polyimide; NOTE: polyimide is a plastic).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV light source of Standfest modified by Bernhard, Laugharn, and Siegert to have a transparent plastic film, as taught by Laugharn, in order to protect the UV light source from contact with a biological fluid.
Regarding claim 63, Standfest modified by Bernhard, and Laugharn teaches the ultraviolet biofluid irradiating device of claim 62, as set applied to claim 62 above, and teaches wherein variable UV LEDs exposure is determined by the high transmissible plastic film (see Laugharn modification in claim 62 rejection; NOTE: the film, even if transparent, would reflect, absorb, and refract some finite amount of UV light, such that it changes the amount of UV light exposure to the biofluid).
Regarding claim 65, Standfest modified by Bernhard, and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and teaches wherein the housing is sized and configured for portable field deployment (NOTE: the housing of Standfest has a finite size that, absent a recitation of specific dimensions required for portability, reads on sized for portability; see Laugharn modification in claim 1 for a battery power source such that the housing is configured for portable field deployment) but does not teach and wherein the power source is integrated within the housing to enable operation independent of fixed electrical infrastructure.
The battery already must necessarily be electrically integrated with the device in order to serve as a power source.
In addition, in the absence of any teaching to the contrary, the location of the battery does not affect operation in an unexpected way so long as it is in electrical communication with the rest of the device. Absent a showing of significance or unexpected results, the claimed locations of the components are prima facie obvious and do not modify the operation of the invention and further, do not add patentable significance. The Manual of Patent Examining Procedures discloses that in In re Japikse, 181 F.2d 1019, 86 USPQ 70(CCPA 1950), a mere rearrangement of parts for a design change has no patentable significance unless a new and unexpected result is produced. In this case, integrating the battery within the housing has the expected effect of preventing the power source from being disconnected, damaged, or electrically interfered with. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Standfest modified by Bernhard and Laugharn to house its battery within its housing with a reasonable expectation that this would prevent the power source from being disconnected, damaged, or electrically interfered with.
Claims 13, 34-35, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Standfest modified by Bernhard and Laugharn in view of Siegert (US 11857692 B1).
Regarding claim 13, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, but does not teach wherein said control circuitry is controlled by pulse width modulation (“PWM”).
Laugharn already provides motivation to have control circuitry that can adjust the intensity output of UV radiation sources for sterilizing a fluid.
Siegert teaches a UV disinfection device for air (abstract: A system including groups of illuminators configured to provide adaptive irradiance within the ultraviolet spectrum to remove pathogens, particles, and anthropogenic activity from an air mass of a physical environment based on a detection of a presence of and amount of pathogens, particles, and anthropogenic activity in the air mass). Siegert teaches wherein pulse width modulation can be used to adjust the output of its UV light sources in order to adjust the operating mode of the UV light sources according to the status of the sterilization target (C6L11-23: In the current example, the controller 102 may be configured to modulate the output of each individual illuminator or light source in accordance with a dosage protocol for various operating modes either established prior to use or on-the-fly by the controller 102. The modulation may be controlled by the controller 102 by generating or switching the signals that controls the power stage circuitry or the output of the drivers 106 that power the illuminators or light sources. For example, the controller 102 may utilize a pulse width modulation technique which include some sort of feedback to the controller 102. For example, the feedback may include monitoring luminous output, junction temperature, metalclad board temperature, or the like).
In addition, Siegert teaches modifying the output of each UV light source individually in order to tailor the sterilization treatment to different sterilization targets, including fluid environments where different UV light sources can be used (C6L11-36: In the current example, the controller 102 may be configured to modulate the output of each individual illuminator or light source in accordance with a dosage protocol for various operating modes either established prior to use or on-the-fly by the controller 102… The dosage delivered by the system 100 is also a function of the time at which the irradiance regime is sustained and the distance between the illuminator and the target being irradiated, say a region within certain physical constraints, a target body, a volume of air within a filtration system or the like. Hence, the close relationship between the location/distribution of the illuminators or light sources on the support structure 104 with respect to the target. It follows that this relationship is strongly influenced by the type of application or use of the system 100; C14L31-44: As one illustrative example, a water based environmental quality system may be tuned based on environmental sensing (e.g., one or more water quality sensors, such as temperature sensors, color sensors, particle sensors, pH sensors, conductivity sensors, and the like) as well as know variables, such as pH level, electrical conductivity in water, total dissolved solids level, turbidity, dissolved gases, color sensing, and the like. The water based system may include distinctive UV illuminators or light sources, a volume defined by a chamber geometry, in which maximum irradiance levels are attained).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control circuitry of Standfest modified by Bernhard and Laugharn to be capable of pulse width modulation, as taught by Siegert, in order to control the output of its UV light sources in accordance with the status of the sterilization target. This modification overlaps with the control circuitry modification of Laugharn in the claim 36 rejection, as there is independent motivation to have control circuitry with pulse width modification to tailor a UV sterilization treatment, provided by Siegert.
Regarding claim 64, Standfest modified by Bernhard, Laugharn, and Siegert teaches the ultraviolet biofluid irradiating device of claim 13, as set forth above, and teaches wherein at least one of UV radiation intensity (see Siegert modification in claim 13 rejection; changing the pulse width would change the UV radiation intensity) and range of the UV LEDs is adjusted with the pulse width modulation by the control circuitry.
Regarding claim 34, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, but does not teach wherein the control circuitry modifies individual UV LEDs to manage radiation intensity.
Laugharn teaches multiple radiation sources (par. 61: As such, for some embodiments, a sample treatment system is provided with one or more irradiation sources (e.g., ultraviolet irradiation at 185 nm, 254 nm, 265 nm wavelengths, etc.)) that may be at different wavelengths and teaches controlling the UV intensity (par. 76: Or, if exposure of the sample material to ultraviolet radiation is too great, then the controller 20 may adjust the intensity of ultraviolet radiation emitted into the internal volume of the chamber. Conversely, if the intensity of ultraviolet radiation emitted from a radiation source is too small, then the controller may send a signal to make the appropriate adjustment).
Siegert teaches modifying the output of each UV light source individually in order to tailor the sterilization treatment to different sterilization targets, including fluid environments where different UV light sources can be used (C6L11-36: In the current example, the controller 102 may be configured to modulate the output of each individual illuminator or light source in accordance with a dosage protocol for various operating modes either established prior to use or on-the-fly by the controller 102… The dosage delivered by the system 100 is also a function of the time at which the irradiance regime is sustained and the distance between the illuminator and the target being irradiated, say a region within certain physical constraints, a target body, a volume of air within a filtration system or the like. Hence, the close relationship between the location/distribution of the illuminators or light sources on the support structure 104 with respect to the target. It follows that this relationship is strongly influenced by the type of application or use of the system 100; C14L31-44: As one illustrative example, a water based environmental quality system may be tuned based on environmental sensing (e.g., one or more water quality sensors, such as temperature sensors, color sensors, particle sensors, pH sensors, conductivity sensors, and the like) as well as know variables, such as pH level, electrical conductivity in water, total dissolved solids level, turbidity, dissolved gases, color sensing, and the like. The water based system may include distinctive UV illuminators or light sources, a volume defined by a chamber geometry, in which maximum irradiance levels are attained).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Standfest modified by Bernhard and Laugharn to be capable of controlling the intensity of UV light sources separately, as taught by Laugharn and Siegert, in order to better tailor the UV sterilization treatment to different sterilization targets. This modification overlaps with the Bernhard UV LEDs modification in the claim 36 rejection, as there is independent motivation to have control circuitry control the intensity of a plurality of separate UV LED’s, which is provided by Siegert.
Regarding claim 35, Standfest modified by Bernhard, Laugharn, and Siegert teaches the ultraviolet biofluid irradiating device of claim 34, as set forth above, and teaches wherein the control circuitry is managed by a database accessible through a wired or wireless network (see Laugharn modification in claim 17 rejection).
Claims 30 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Standfest modified by Bernhard and Laugharn in view of Hei (US 6544727 B1).
Regarding claim 30, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, and in view of Hei, teaches wherein said control circuitry in the device affects coagulation factors in the biofluid such that Partial Thromboplastin Time (PTT) is effective for said direct injection into said human.
Hei teaches wherein blood can be treated with irradiation without a significant adverse effect on platelets, which are responsible for clotting/coagulation (abstract: The methods include contacting a psoralen- and irradiation-treated blood product with a resin capable of adsorbing psoralens and psoralen photoproducts. The removal process is particularly suitable for use with platelet concentrates and plasma because the process does not have a significant adverse effect on clotting factor function. The methods and devices can be incorporated with apheresis systems and other devices and procedures currently used to process blood products for transfusion). At the same time, irradiation does have a finite affect on platelets (C2L5-22: Several methods have been reported for the inactivation or elimination of viral agents in erythrocyte-free blood products. However, most of these techniques are completely incompatible with maintenance of the function of platelets, an important blood product. Examples of these techniques are… UV alone).
Thus, whether or not the control circuitry affects coagulation such that the PTT is effective for direct injection into a human depends on the intensity and exposure time of the administered UV radiation. Since Laugharn was used to modify Standest so that these parameters can be controlled, (see Laugharn control circuitry modification in claim 1) then the device of Laugharn would be capable of affecting coagulation of the blood such that it is still suitable for injection into a human.
Regarding claim 61, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 1, as set forth above, as set forth above, but does not teach further comprising a plurality of UV filters, wherein the UV filters are compatible with the microcassette and the UV LEDs.
Hei teaches wherein filters can be applied to the radiation source in order to narrow the wavelength range of the emitted light (C21L31-35: When a radiation source, by virtue of filters or other means, does not allow radiation below a particular wavelength (e.g., 320 nm), it is said to have a low end "cutoff" at that wavelength (e.g., "a wavelength cutoff at 300 nanometers")).
Laugharn already teaches the criticality of having certain wavelengths of UV light (par. 59: In some cases, the germicidal or virucidal nature of ultraviolet irradiation may be quite effective at wavelengths of between approximately 185 nm and 265 nm (e.g., 185 nm, 254 nm, 265 nm), particularly for inactivating viruses).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV radiation sources of Standfest modified by Bernhard and Laugharn to have UV filters, as taught by Hei, in order to help limit the wavelength of the emitted light to a desired range, which would be helpful for tailoring the sterilization treatment for specific fluids.
Claims 36-38, 40-56, 59-60 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Standfest in view of Laugharn and Bernhard.
Regarding claim 36, Standfest teaches an ultraviolet ice slurry/fluid irradiating device for use in non-terrestrial environments, comprising:
d) a UV transmissible microfluidics device including interchangeable microcassettes (abstract: The invention relates to a modular irradiation device having a main module and at least one support cassette, the support cassette being insertable into a receptacle of the main module; pg. 7 par. 7: Advantageously, a large number of carrier cassettes can be used, which can then be prepared individually and inserted in quick succession into the main module in order to carry out the irradiation) capable of ice and or fluid handling techniques (pg. 2 par. 8: The object of the present invention is to specify an irradiation device and an irradiation method which enable efficient irradiation of fluid samples while at the same time minimizing the risk of cross-contamination), enabling the device to process at least one of said ice and said fluid for analysis to determine presence of pathogens (NOTE: this is a recitation of intended use, as the fluid exiting the device can be analyzed for the presence of pathogens and thus the prior art structure would read on this claim limitation), wherein a first microcassette is configured to actively convert said ice slurry into liquid water through a thermal processing element disposed therein (NOTE: this active thermal processing element is interpreted to be the container walls, which provide some form of insulation which can help with melting to some degree, or can serve to transfer heat between the environment and the interior of the device where the ice slurry is; the cassette walls thus read on the thermal processing element) and wherein a second microcassette is sequentially operable with said first microcassette and configured to irradiate the liquid water receivedfrom said first microcassette with said UV LEDs (pg. 2 par. 8: The object of the present invention is to specify an irradiation device and an irradiation method which enable efficient irradiation of fluid samples while at the same time minimizing the risk of cross-contamination; pg. 7 par. 7: Advantageously, a large number of carrier cassettes can be used, which can then be prepared individually and inserted in quick succession into the main module in order to carry out the irradiation; NOTE: the second microcassette would be capable of receiving water from the first microcassette and subjecting it to irradiation once inserted),
e) said microcassettes which are fluid conveying conduits in which said fluid water flows through tubes such that said fluid can be irradiated with ultraviolet light emitted from said UV LEDs as it is flowing through the microcassettes (Fig. 7C: irradiation line 13; pg. 8 last par.: The carrier cassette 2 also has at least one pump 5a, 5b, which is connected to the irradiation line 13 via fluid lines);
such that any pathogens in the at least one of ice slurry and water are rendered non-biologically harmful as they are irradiated with UV light while flowing through the microcassettes in the device (pg. 11 par. 5: The invention permits safe and sterile irradiation of fluids) but does not teach
a) Ultraviolet Light Emitting Diodes (“UV LEDs”) for ultraviolet fluid irradiating (“UBI”), emitting ultraviolet light in the range of 266 nm to 380 nm;
b) control circuitry for regulating the ultraviolet light emission by said UV LEDs;
c) a housing material capable of ultraviolet light transmittance, housing said UV LEDs and said control circuitry;
f) a DC power source;
Standfest teaches UV radiation sources (pg. 8 par. 3: Correspondingly, the radiation source can be an electron source or a UV radiation source) but does not teach what kind of light source is used.
Bernhard teaches a system for UV sterilization (abstract: and a method for their UV disinfection and/or sterilization, including disinfection and/or sterilization of the inner surface of the formed article). Bernhard teaches using UV LEDs in order to easily adjust the wavelength, decrease warm-up time, and avoid mercury exposure (pg. 31 lines 9-13: Typically, UV mercury lamps only emit light at 254 nm, so it is preferred to use UV light- emitting diodes (UV-LEDs) which can be configured to emit certain target wavelengths, i.e. desired UV wavelength from 260 to 300 nm, preferably from 260 to 280 nm, more particularly at 265 nm, in the inventive method. Further, UV mercury lamps have additional disadvantages, such as a long warm-up time, and risk of mercury exposure).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Standfest to use UV LEDs as the UV radiation sources emitting light in the range of 260 to 280 nm, as taught by Bernhard and Laugharn, in order to easily adjust the wavelength, decrease warm-up time, and avoid mercury exposure for UV sterilization.
260-280 nm overlaps with the claimed range of 266-380 nm.
According to MPEP 2144.05.I, a prima facie case of obviousness exists where the prior art range or amount overlaps with or is merely close to the claimed range or amount:
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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV light sources of Standfest modified by Bernhard and Laugharn to emit light at 266-380 nm, with the reasonable expectation that this wavelength would provide a similar amount of sterilization effectiveness as 260-280 nm.
Laugharn teaches emitting ultraviolet light (par. 59: In some cases, the germicidal or virucidal nature of ultraviolet irradiation may be quite effective at wavelengths of between approximately 185 nm and 265 nm (e.g., 185 nm, 254 nm, 265 nm));
b) control circuitry for regulating the ultraviolet light emission by said UV LEDs (par. 76: Or, if exposure of the sample material to ultraviolet radiation is too great, then the controller 20 may adjust the intensity of ultraviolet radiation emitted into the internal volume of the chamber; Fig. 3: controller 20 and line connecting controller 20 to radiation source 70; par. 107: Similarly, depending on the desired level of ultraviolet radiation treatment, which may also be based on feedback information gathered from one or more sensors regarding the sample material (e.g., whether the sample has been sterilized, whether the sample has been damaged from radiation overexposure, etc.), the controller may adjust one or more parameters of ultraviolet irradiation from the source 70 (e.g., intensity, wavelength, frequency, power output, etc.), as also described herein);
c) a housing material capable of ultraviolet light transmittance, housing said UV LEDs and said control circuitry (Fig. 3: window 71 houses radiation source 70 and necessarily at least some of the circuitry connected to radiation source 70; par. 74: In some embodiments, the window 11 has an acoustic impedance similar to that of water and a relatively low acoustic absorption. One suitable material is low density polyethylene, but other polymers such as polypropylene);
g) a DC power source (par. 260: a power supply or other power source (such as a plug for mating with an electrical outlet, batteries; NOTE: batteries supply DC power);
Laugharn also teaches a device for sterilizing fluids and presents a number of useful improvements to Standfest.
Having control circuitry that regulates the intensity of the UV light based on feedback from the fluid characteristics is helpful for adjusting the sterilization treatment appropriately for the specific fluid being sterilized.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Standfest modified by Bernhard and Laugharn to have control circuitry comprising of a controller electronically connected to the UV light sources, capable of regulating the intensity of the UV light based on feedback concerning the fluid characteristics, as taught by Laugharn, in order to adjust the sterilization treatment according to the specific fluid being sterilized.
Standfest teaches a UV radiation source 18 (Fig. 7C) but does not teach how that UV radiation source is housed and connected to the rest of the device. Laugharn teaches wherein its UV radiation source is housed in a chamber with a polypropylene window capable of transmitting UV light, wherein the UV radiation source is connected to control circuitry which is also at least partially housed behind the window.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV light source of Standfest modified by Bernhard and Laugharn to be supported within a walled structure and housed behind a polypropylene UV-transparent window, wherein the UV light source is connected to control circuitry that is at least partially housed behind the window as well, as taught by Laugharn, in order to position the UV light source such that the sterilization target can be irradiated.
Standfest teaches UV radiation sources but does not teach a means of powering them. Laugharn teaches that batteries can be used to power the controller and the UV lights.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller and UV radiation sources of Standfest modified by Bernhard and Laugharn be powered by batteries, as taught by Laugharn, in order to provide a power source for the device.
Regarding claim 37, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, as set forth above, and teaches wherein said ice/fluid irradiating device is compactly sized for efficiency and ease of integration in non-terrestrial environments (NOTE: absent a quantitative physical standard for compactness, the device of Standfest modified by Bernhard and Laugharn has finite dimensions, which are interpreted to be compact and therefore optimal for use in non-terrestrial environments).
Regarding claim 38, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, as set forth above, and teaches wherein said housing is selected from the group consisting of thermoform/injection-molded material (see Laugharn polypropylene housing modification in claim 36 rejection; NOTE: since several shaping techniques can be used to achieve the same structure, as polypropylene is capable of being produced via thermoforming or injection molding, the method of forming the material does not add any additional structure to the claim limitation) for handling microfluidics and molded polymer material for handling microfluidics.
Regarding claim 40, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, as set forth above, but does not teach wherein said control circuitry regulates temperature control.
Laugharn teaches wherein the control circuitry regulates temperature control (par. 204: Control of the acoustic energy source 2 may be performed by the controller 20 using a feedback control mechanism so that any of accuracy, reproducibility, speed of processing, control of temperature; par. 142: The controller 20 is in electrical communication with each of the components of the system (e.g., acoustic energy source, radiation source, temperature control system). Laugharn teaches wherein high temperature gradients or high temperatures can damage a biological fluid (par. 176: However, some of the non-uniform aspects are highly deleterious to samples, such as extreme temperature gradients that damage sample integrity. For example, in some instances, high temperatures generated would irreversibly denature target proteins).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control circuitry of Standfest modified by Bernhard and Laugharn to be capable of regulating temperature, as taught by Laugharn, in order to prevent biological fluids from being damaged.
Regarding claim 41, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein said control circuitry regulates the intensity of the ultraviolet light emission (see Laugharn control circuitry modification in claim 36 rejection).
Regarding claim 42, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches a pump (abstract: The support cassette has at least one pump, and the main module has at least one pump actuator, these being arranged such that the pump is actuatable with the pump actuator when the support cassette is inserted into the receptacle of the main module) but does not teach wherein said control circuitry regulates control of said pump (internal or external).
Laugharn teaches wherein its control circuitry controls a pump (par. 182: par. 260: For example, the controller 20 may include… software or other computer-executable instructions (e.g., including instructions for carrying out functions related to controlling the acoustic energy source 2, a pump 33…)) in order to control a processing time of the fluid (par. 255: The material can be controlled by the timing of the transfer mechanism, such as the pump, to allow discrete processing times `in chamber` before discharging the material and bringing in new material. This can provide time for process steps such as processing, mixing, cooling and others to fully develop before introducing new unprocessed sample to the chamber; par. 97: In some cases, sample material is exposed to focused acoustic energy and/or radiation treatment for an extended, or indefinite, period of time, until the controller, or operator, alters the treatment plan or criterion that would allow the sample material to exit the chamber via an outlet).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control circuitry of Standfest modified by Bernhard and Laugharn to regulate the pump and its time of operation, as taught by Laugharn, in order to control a processing time of the fluid to be sterilized.
Regarding claim 43, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, but does not teach wherein said control circuitry selected from the group consisting of wireless and data ports, data storage memory components on the device, a microcontroller, a clock, and input/output functions which regulates the duration of exposure of the fluid to UV radiation from the UV LEDs.
Laugharn teaches wherein said control circuitry selected from the group consisting of wireless and data ports (par. 260: communication buses or other communication devices for wired or wireless communication (e.g., including various wires, switches, connectors, Ethernet communication devices, WLAN communication devices, and so on)), data storage memory components on the device (par. 260: one or more memories for storing data and/or operating instructions (e.g., including volatile and/or non-volatile memories such as optical disks and disk drives), a microcontroller (par. 260: microprocessors), a clock, and input/output functions which regulates the duration of exposure of the biofluid to UV radiation from the UV LEDs (par. 260: user data input devices (such as buttons, dials, knobs, a keyboard, a touch screen or other), information display devices (such as an LCD display, indicator lights, a printer, etc.), and/or other components for providing desired input/output and control functions).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control circuitry of Standfest modified by Bernhard and Laugharn to comprise of wireless and data ports, data storage memory components, a microcontroiller, and iput/output functions that regulate the UV sterilization treatment, as taught by Laugharn, in order to provide a physical apparatus means of fulfilling the function of the control circuitry.
Regarding claim 44, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, but does not teach wherein said UV LEDs emit ultraviolet light in the range of 260 nm to 320 nm.
Bernhard teaches a wavelength of 265 nm which falls within the claimed range of 260-320 nm (pg. 31 lines 9-13: Typically, UV mercury lamps only emit light at 254 nm, so it is preferred to use UV light- emitting diodes (UV-LEDs) which can be configured to emit certain target wavelengths, i.e. desired UV wavelength from 260 to 300 nm, preferably from 260 to 280 nm, more particularly at 265 nm, in the inventive method. Further, UV mercury lamps have additional disadvantages, such as a long warm-up time, and risk of mercury exposure).
Furthermore, a mere change in proportion, even if it leads to better results, holds no patentable significance:
MPEP 2144.05.II.A: Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
especially if it can be shown that the change in proportions can be done by one of ordinary skill in the art through routine optimization of a known result-effective variable (MPEP 2144.05.II.B: the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV light sources of Standfest modified by Bernhard and Laugharn to emit light at 265 nm, with the reasonable expectation that this wavelength would be optimized for sterilization of biofluids as a whole and/or particular biofluids.
Regarding claim 45, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein said control circuitry further comprises a feedback mechanism for adjusting the emission intensity of said UV LEDs based on detected fluid characteristics (see Laugharn control circuitry modification in claim 36 rejection).
Regarding claim 46, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein said device is comprised of ultraviolet transmittance capable thermoform (see Laugharn polypropylene housing modification in claim 36 rejection; NOTE: since several shaping techniques can be used to achieve the same structure, as polypropylene is capable of being produced via thermoforming or injection molding, the method of forming the material does not add any additional structure to the claim limitation)/ injection molded UV-resistant polymer.
Regarding claim 47, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 46, and does not need to teach wherein said UV-resistant polymer is polypropylene (claim 46 recites a thermoform/injection molded UV-resistant polymer, wherein the slash is interpreted to mean that the device comprises a thermoform or a polymer, and the prior art teaches a thermoform, so it does not need to read on a UV-resistant polymer).
Regarding claim 48, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein said device comprises a portable device (see Laugharn battery modification in claim 36 rejection, which is interpreted to make the device portable).
Regarding claim 49, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein said device comprises a battery-powered device (see Laugharn battery modification in claim 36 rejection).
Regarding claim 50, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein said device comprises a compact device (NOTE: absent a quantitative physical standard for compactness, the device of Standfest modified by Bernhard and Laugharn has finite dimensions, which are interpreted to be compact).
Regarding claim 51, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein said device comprises a lightweight device (NOTE: absent a recitation of a specific weight or weight range that would qualify as lightweight, the device of Standfest modified by Bernhard and Laugharn has a finite weight that is interpreted to be lightweight).
Regarding claim 52, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches (NOTE: absent a recitation of a quantitative physical standard that equates to sturdiness, the device of Standfest modified by Bernhard and Laugharn has a finite sturdiness that is interpreted to be sturdy).
Regarding claim 53, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein the type of said flowing through the microcassette is selected from the group consisting of flowing caused by gravity and flowing caused by a pump to regulate the flowing through said device (abstract: The support cassette has at least one pump, and the main module has at least one pump actuator, these being arranged such that the pump is actuatable with the pump actuator when the support cassette is inserted into the receptacle of the main module).
Regarding claim 54, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein said flowing caused by a pump to regulate the flowing through said device can be done in a low-gravity or no-gravity situation such as that on a non-terrestrial environment (pg. 5 par. 3: In principle, the invention can be implemented with any type of pump. However, an embodiment is preferred in which the at least one pump has a fluid chamber and a piston, the piston closing off the fluid chamber in a fluid-tight manner and being displaceable in the fluid chamber. In particular, the fluid chamber can advantageously be cylindrical and the piston can have an end face with which it delimits the fluid chamber and the shape of which is essentially identical to the base area of the fluid chamber. The respective pump actuator can act on the piston of the pump when the at least one carrier cassette is inserted in the corresponding receptacle. In this way, a force can be brought about in a displacement direction of the piston with the pump actuator. NOTE: since this pump does not depend on gravity, they would be able to operate in a low-gravity environment).
Regarding claim 55, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and as applied to claim 42 above, and teaches wherein said pump is regulated on a timing cycle for effectiveness in rendering pathogens non-biologically harmful (see Laugharn modification in claim 42 rejection).
Regarding claim 56, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and teaches wherein said power source is selected from the group consisting of a battery power source (see Laugharn battery modification in claim 36 rejection) and AC power source.
Regarding claim 59, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and as applied to claim 43 above, and teaches wherein the control circuitry is managed by a database accessible through a wired or wireless network (see Laugharn modification in claim 43 rejection).
Regarding claim 60, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, and as applied to claim 43 above, and teaches wherein said pathogens are rendered non-biologically harmful by the irradiation as the phosphodiester bond between the pathogens’ bonding group consisting of Uracil and Cytosine (U-C) and Uracil and Guanine (U-G) is broken (NOTE: this is a recitation of intended use, as fluids containing pathogens with DNA can be fed into the device of Standfest, wherein the DNA would have the recited bonding group, and UV radiation would be capable of breaking the phosphodiester bond in this group, rendering the pathogens with this DNA non-biologically harmful).
Regarding claim 66, Standfest modified by Bernhard and Laugharn teaches the ultraviolet biofluid irradiating device of claim 36, as set forth above, and teaches wherein said housing is ruggedized for operation in a non-terrestrial environment (NOTE: absent a recitation of a specific structure or function that requires a specific structure, the structure of Standfest is interpreted to be ruggedized for operation in a non-terrestrial environment since this function does not require a specific structure).
Claims 39 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Standfest modified by Bernhard and Laugharn in view of Siegert.
Regarding claim 39, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, as set forth above, but does not teach wherein said control circuitry is controlled by pulse width modulation (“PWM”).
Laugharn already provides motivation to have control circuitry that can adjust the intensity output of UV radiation sources for sterilizing a fluid.
Siegert teaches a UV disinfection device for air (abstract: A system including groups of illuminators configured to provide adaptive irradiance within the ultraviolet spectrum to remove pathogens, particles, and anthropogenic activity from an air mass of a physical environment based on a detection of a presence of and amount of pathogens, particles, and anthropogenic activity in the air mass). Siegert teaches wherein pulse width modulation can be used to adjust the output of its UV light sources in order to adjust the operating mode of the UV light sources according to the status of the sterilization target (C6L11-23: In the current example, the controller 102 may be configured to modulate the output of each individual illuminator or light source in accordance with a dosage protocol for various operating modes either established prior to use or on-the-fly by the controller 102. The modulation may be controlled by the controller 102 by generating or switching the signals that controls the power stage circuitry or the output of the drivers 106 that power the illuminators or light sources. For example, the controller 102 may utilize a pulse width modulation technique which include some sort of feedback to the controller 102. For example, the feedback may include monitoring luminous output, junction temperature, metalclad board temperature, or the like).
In addition, Siegert teaches modifying the output of each UV light source individually in order to tailor the sterilization treatment to different sterilization targets, including fluid environments where different UV light sources can be used (C6L11-36: In the current example, the controller 102 may be configured to modulate the output of each individual illuminator or light source in accordance with a dosage protocol for various operating modes either established prior to use or on-the-fly by the controller 102… The dosage delivered by the system 100 is also a function of the time at which the irradiance regime is sustained and the distance between the illuminator and the target being irradiated, say a region within certain physical constraints, a target body, a volume of air within a filtration system or the like. Hence, the close relationship between the location/distribution of the illuminators or light sources on the support structure 104 with respect to the target. It follows that this relationship is strongly influenced by the type of application or use of the system 100; C14L31-44: As one illustrative example, a water based environmental quality system may be tuned based on environmental sensing (e.g., one or more water quality sensors, such as temperature sensors, color sensors, particle sensors, pH sensors, conductivity sensors, and the like) as well as know variables, such as pH level, electrical conductivity in water, total dissolved solids level, turbidity, dissolved gases, color sensing, and the like. The water based system may include distinctive UV illuminators or light sources, a volume defined by a chamber geometry, in which maximum irradiance levels are attained).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control circuitry of Standfest modified by Bernhard and Laugharn to be capable of pulse width modulation, as taught by Siegert, in order to control the output of its UV light sources in accordance with the status of the sterilization target. This modification overlaps with the control circuitry modification of Laugharn in the claim 36 rejection, as there is independent motivation to have control circuitry with pulse width modification to tailor a UV sterilization treatment, provided by Siegert.
Regarding claim 58, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, as set forth above, but does not teach wherein the control circuitry modifies individual UV LEDs to manage radiation intensity.
Laugharn teaches multiple radiation sources (par. 61: As such, for some embodiments, a sample treatment system is provided with one or more irradiation sources (e.g., ultraviolet irradiation at 185 nm, 254 nm, 265 nm wavelengths, etc.)) that may be at different wavelengths and teaches controlling the UV intensity (par. 76: Or, if exposure of the sample material to ultraviolet radiation is too great, then the controller 20 may adjust the intensity of ultraviolet radiation emitted into the internal volume of the chamber. Conversely, if the intensity of ultraviolet radiation emitted from a radiation source is too small, then the controller may send a signal to make the appropriate adjustment).
Siegert teaches modifying the output of each UV light source individually in order to tailor the sterilization treatment to different sterilization targets, including fluid environments where different UV light sources can be used (C6L11-36: In the current example, the controller 102 may be configured to modulate the output of each individual illuminator or light source in accordance with a dosage protocol for various operating modes either established prior to use or on-the-fly by the controller 102… The dosage delivered by the system 100 is also a function of the time at which the irradiance regime is sustained and the distance between the illuminator and the target being irradiated, say a region within certain physical constraints, a target body, a volume of air within a filtration system or the like. Hence, the close relationship between the location/distribution of the illuminators or light sources on the support structure 104 with respect to the target. It follows that this relationship is strongly influenced by the type of application or use of the system 100; C14L31-44: As one illustrative example, a water based environmental quality system may be tuned based on environmental sensing (e.g., one or more water quality sensors, such as temperature sensors, color sensors, particle sensors, pH sensors, conductivity sensors, and the like) as well as know variables, such as pH level, electrical conductivity in water, total dissolved solids level, turbidity, dissolved gases, color sensing, and the like. The water based system may include distinctive UV illuminators or light sources, a volume defined by a chamber geometry, in which maximum irradiance levels are attained).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Standfest modified by Bernhard and Laugharn to be capable of controlling the intensity of UV light sources separately, as taught by Laugharn and Siegert, in order to better tailor the UV sterilization treatment to different sterilization targets. This modification overlaps with the Bernhard UV LEDs modification in the claim 36 rejection, as there is independent motivation to have control circuitry control the intensity of a plurality of separate UV LED’s, which is provided by Siegert.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Standfest modified by Bernhard and Laugharn in view of Hei.
Regarding claim 57, Standfest modified by Bernhard and Laugharn teaches the ultraviolet ice slurry/fluid irradiating device of claim 36, as set forth above, as set forth above, but does not teach further comprising a plurality of UV filters, wherein the UV filters are compatible with the microcassette and the UV LEDs.
Hei teaches wherein filters can be applied to the radiation source in order to narrow the wavelength range of the emitted light (C21L31-35: When a radiation source, by virtue of filters or other means, does not allow radiation below a particular wavelength (e.g., 320 nm), it is said to have a low end "cutoff" at that wavelength (e.g., "a wavelength cutoff at 300 nanometers")).
Laugharn already teaches the criticality of having certain wavelengths of UV light (par. 59: In some cases, the germicidal or virucidal nature of ultraviolet irradiation may be quite effective at wavelengths of between approximately 185 nm and 265 nm (e.g., 185 nm, 254 nm, 265 nm), particularly for inactivating viruses).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV radiation sources of Standfest modified by Bernhard and Laugharn to have UV filters, as taught by Hei, in order to help limit the wavelength of the emitted light to a desired range, which would be helpful for tailoring the sterilization treatment for specific fluids.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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