DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
Claims 5, 6, 8, 16, and 17 were previously canceled. Claims 2, 3, 7, 9-15, 18-20, and 23-25 have been amended. Claims 1-4, 7, 9-15, and 18-25 are pending and examined herein.
Priority
This application, 18/730,462, filed 07/19/2024, is a 371 of PCT/US2023/060547 filed on 01/12/2023, and claims benefit of provisional application 63/301,784 filed on 01/21/2022. This priority is acknowledged and the claims examined herein are treated as having an effective filing date of 01/21/2022.
Information Disclosure Statement
The Information Disclosure Statements filed on 07/19/2024 are acknowledged and have been considered.
Claim Objections
Claims 2-4 are objected to because of the following informalities:
Claims 2-4 recite a droplet size range of “10 to about 100 mm”. However, the specification only recites droplet sizes in the realm of 1-300 µm.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 7, 9-15, 18-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “…a substantially uniform layer…”. The recitation of “substantially” is relative terminology, and as such the claim is indefinite because it is not readily clear compared to what standard is it being compared to be considered substantial.
Claim 3 recites “…a coefficient of variation (CV) of less than 15%”. The claim is indefinite because there is no defined lower limit of the CV range, and therefore represents an open-ended numerical range. See MPEP 2173.05(c)(II).
Regarding claim 7, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “…for about 1 min to about 10 min…”, and the claim also recites “…or for about to 1 min to less than 5 min.”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 22 recites “The method of claim 20, the method further comprising repeating steps (a) through (e)”. The claim is indefinite because step (e) lacks antecedent basis, because it is not recited or defined previously in the claim or in claim 20 from which it depends. Step (e) is introduced and presented only in claim 21, which claim 22 does not depend on.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7, 11, 14, 18-21, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shannon et al. (US20200385731A1), (herein referred to as Shannon).
Regarding claims 1 and 24, Shannon teaches an apparatus for detecting the presence, absence or level of Clostridium difficile spores in a sample, the apparatus comprising a support, and an aptamer having a specific binding affinity for a surface protein of Clostridium difficile spore, wherein the surface protein is a spore-coat surface protein or an exosporium layer protein ([0013]). Shannon also teaches a method of detecting the presence, absence or amount of Clostridium difficile in a sample, the method comprising interacting the sample with an aptamer, a complex, a composition as described herein, and detecting the presence, absence or amount of Clostridium difficile ([0015]). Shannon teaches that in some embodiments, the method of detecting C. difficile may comprise applying one or more of the aptamers of the invention to a location suspected of comprising C. difficile spores ([0235]). Shannon also teaches a method of visualizing Clostridium difficile spores on a surface, comprising contacting a surface with an aptamer having a specific binding affinity for a surface protein of Clostridium difficile spore, wherein the surface protein is a spore-coat surface protein or an exosporium layer protein, and visualizing the presence or absence of C. difficile spores on the surface ([0016]).
Shannon teaches that in some embodiments, the aptamer is conjugated to a detectable moiety thereby forming an aptamer conjugate and the detectable moiety is a fluorophore that emits at a wavelength of between about 500 nm and 510 nm ([0020]). Shannon teaches that in some embodiments, the aptamer comprises a fluorescent and a quencher compound, and that the detectable label can be a FAM fluorophore ([0187], [0188]). Shannon also teaches that the aptamer may be provided in a variety of forms, including but not limited to being pre-immobilized onto a support (e.g. solid support), freeze-dried, or in a liquid medium ([0217]). Shannon also teaches that in some embodiments, the method further comprises illuminating the surface with a light source that has a predetermined wavelength, and the predetermined wavelength corresponds to a wavelength of light emitted by the detectable moiety of the aptamer conjugate ([0021]). Shannon teaches that in some embodiments, the light source is configured to produce light at a wavelength of between about 485 nm and 515 nm ([0021]). Shannon also teaches that in some embodiments, the method further comprises filtering the light produced by the light source, the method comprising passing the light produced from the light source through a bandpass filter ([0021]). Shannon teaches that in some embodiments, the bandpass filter is a 590 nm bandpass filter ([0028]).
Regarding claim 7, Shannon teaches that in some embodiments, the sample and aptamer may be incubated at temperatures between about 20° C. and about 37° C ([0206]). In some embodiments, the sample and aptamer may be incubated at or about 22° C ([0206]). Shannon also teaches that the sample and aptamer may be incubated for 1 minute to less than 5 minutes, 5 minutes to less than 15 minutes ([0206]).
Regarding claim 11, Shannon also teaches that in some embodiments, the method further comprises illuminating the surface with a light source that has a predetermined wavelength, and the predetermined wavelength corresponds to a wavelength of light emitted by the detectable moiety of the aptamer conjugate ([0021]). Shannon teaches that in some embodiments, the detectable moiety is a fluorophore that emits a wavelength of between about 485 nm to 515 nm, the light source is configured to produce a light having a wavelength of between about 485 nm to 515 nm, and the viewing goggles are orange viewing goggles ([0026]). Shannon teaches that in some embodiments, the light source produces light having a wavelength of about 505 nm ([0027]).
Regarding claim 14, Shannon teaches that the target molecule is a surface protein of Clostridium difficile spore, wherein the surface protein is a spore coat surface protein or an exosporium layer protein, and in some embodiments the surface protein being visualized is CdeC, CdeM, CotA, CotE or CotE Chitinase ([0016]).
Regarding claim 18, Shannon teaches that in some embodiments, the method further comprises imaging (e.g. photographing) the location and detecting the presence or absence of C. difficile spores ([0234]).
Regarding claim 19, Shannon teaches that the inventors identified aptamers which are capable of identifying C. difficile spores, and that in embodiments, the invention provides an aptamer capable of specifically binding to a Clostridium difficile protein ([0042], [0043]).
Regarding claim 20, Shannon teaches that following detection and/or quantification of C. difficile, action may be taken to kill and/or remove the spores. Non-limiting examples of such action may include washing or destruction of bed linen, and/or cleaning of surfaces including but not limited to medical equipment, beds, walls, floors, and the like ([0223]).
Regarding claim 21, Shannon teaches that bright fluorescence was observed within the sample containing CotE H2 aptamer at 10 μM (FIG. 38D; solid arrows). Fluorescence was observed within the sample containing the combination of CotE H2 aptamer 10 μM and C. difficile SH11 spores (FIG. 38E; solid arrows; [0357]).
Regarding claim 23, Shannon teaches that after incubation under conditions permissive for binding of the first aptamer to a target protein as defined herein excess unbound aptamer may be removed, and the amount of label associated with immobilized target protein as defined herein measured ([0181]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Shannon as applied to claim 1 above, in view of Tisone et al. (US6576295B2), (herein referred to as Tisone).
The teachings of Shannon are incorporated herein.
Regarding claims 2 and 4, Shannon teaches all the limitations of claim 1 of the instant application, but does not teach spraying the surface with the liquid composition or atomizing the liquid composition onto the surface, wherein the spraying or the atomizing comprises dispersing droplets onto the surface, wherein the droplets have an average size ranging from about 10 to about 100 mm. Shannon also does not teach that the spraying includes minimizing disturbance of the one or more pathogen on the surface.
Tisone teaches a method and apparatus in accordance with the present invention can dispense desired quantities of chemical reagents or other liquids onto a substrate, such as a receptive membrane, while advantageously providing the ability to independently and precisely adjust droplet size or mist quality, droplet velocity and reagent flow rates, both in terms of per unit time or per unit distance (column 3, lines 29-39). Tisone teaches that many reagents that are used for diagnostic testing are so reactive with the receptive membrane or substrate that large droplets can form impressions on the membrane surface at the point of initial contact before the droplets flow together to form the desired pattern (column 3, lines 2-6). Tisone teaches that as a result, it is sometimes desirable to dispense a fine mist or very small droplets of reagent onto the substrate (column 3, lines 6-9). Tisone teaches that for several years the industry has been developing dispensing methods based on the use of either air brush dispensers or solenoid valve dispensers, with air brushes using pressurized air flowing across a needle valve opening to atomize the reagent into a mist which is then deposited onto the test strip substrate (column 2, lines 39-41). Tisone teaches that the quality of the mist, reagent dispersion pattern and the amount of reagent flow onto the substrate is controlled by adjusting the needle valve opening and/or the pressure of the atomizing air flow (column 2, lines 41-47). Tisone also teaches that the methods and apparatus disclosed in accordance with the present invention can be used to dispense a wide variety of liquids, reagents and other substances and a variety of substrates (column 15, lines 55-59).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the aptamer-based pathogen visualization/detection method recited by Shannon, to spray the surface with the liquid composition wherein the spraying comprises dispersing droplets onto the surface and minimizing disturbance of the target on the surface, as taught by Tisone, as it would be “obvious to try”. Shannon is silent with regards to applicant of the solution to the surface. Tisone teaches the advantages of spraying to dispense desired quantities of chemical reagents or other liquids onto a substrate, such as providing the ability to independently and precisely adjust droplet size or mist quality which can reduce variance and ensure adequate results. A person of ordinary skill would have been motivated to make this modification because Tisone teaches that large droplets can form impressions on the membrane surface that can influence results, and dispensing a fine mist or very small droplets of reagent onto the substrate can avoid such issues. A person of ordinary skill would have had a reasonable expectation of success in making this modification because Tisone teaches that such spraying methods have been implemented for many years, and also that their method can be used to dispense a wide variety of liquids, reagents and other substances and a variety of substrates.
Additionally, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have the droplets have an average size ranging from about 10 to about 100 mm, as matter of routine optimization. The MPEP 2144.05 (II) (A) states that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
While Tisone does not teach that droplets have an average size ranging from about 10 to about 100 mm, Tisone does teach that their method and apparatus can produce small droplets of varying sizes. Tisone demonstrates that the droplet size is a results-effective variable that can change detection accuracy, and can be controlled by adjusting parameters such as the needle valve opening and/or the pressure of the atomizing air flow. Furthermore, the specification of the instantly claimed invention fails to that this droplet size range recited produces an unexpected results compared to other ranges; see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). Therefore, the selection of such a droplet size range would be a matter of routine optimization within the level of ordinary skill in the art.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shannon in view of Tisone as applied to claims 2 and 4 above, and further in view of Schick et al. (US8170849B2), (herein referred to as Schick).
The teachings of Shannon in view of Tisone are incorporated herein.
Regarding claim 3, Shannon in view of Tisone teaches all of the limitations of claim 2 of the instant application but does not teach wherein the step of spraying includes a spray distribution with a coefficient of variation (CV) of less than 15%.
Schick teaches a spray nozzle configuration and modeling system where the user inputs basic system parameters, including the desired spray fluid characteristics, to obtain suggested system configuration, including spray nozzle types and quantities (abstract). Schick teaches that spray system input parameters comprise: spray fluid type (e.g., oil, water) and/or specific gravity of the fluid, sides of the item to be coated, surface width of each side of the item to be coated (spray width), conveyor speed, desired coating thickness, spraying distance from each side of an item to be coated, nozzle type (e.g., a hydraulic vs. an air atomizing nozzle), as well as desired nozzle properties such as nozzle material and inlet connection type and size (column 2, lines 9-16). Schick teaches that the accuracy of suggested spray nozzle type and configuration is increased via approximating the viscosity and/or surface tension parameters of the desired spray fluid with that of collected performance data (abstract). Schick teaches determining the coefficients of variation (CV), and that an embodiment of the predicted CV for various spray conditions and nozzle spacings using a numerical computed distribution (adjusted for actual cover age) has a good correlation to the CV computed using the raw experimental data for spray tips with nominal 65 and 80 degree spray angles (column 7, lines 32-37). Additionally, Schick teaches modeled coefficients of variation, many of which fall under 15% (column 7, Table).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have a spray distribution with a coefficient of variation (CV) of less than 15%, as matter of routine optimization. The MPEP 2144.05 (II) (A) states that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
While Shannon in view of Tisone and Schick does not teach the experimental data with a spray distribution with a coefficient of variation (CV) of less than 15%, Schick does teach that their method can be used to predict CV based on the various spray, nozzle, and liquid conditions used, and that their predicted CVs had good correlation with experimental data. Therefore, Schick establishes that determination and optimization of CV is a well-understood, routine, and conventional activity in the field of atomizing liquids onto a surface. Schick also establishes that various parameters can be changed to achieve a target CV. Furthermore, the specification of the instantly claimed invention fails to show that this CV range recited produces an unexpected results compared to other ranges; see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). Therefore, the use of a spray distribution with a CV of less than 15% would be a matter of routine optimization within the level of ordinary skill in the art.
Claims 9, 10, 13, 15 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Shannon in view of Youn et al. (2019). “Aptasensor for multiplex detection of antibiotics based on FRET strategy combined with aptamer/graphene oxide complex”. Scientific reports, 9(1), 7659, (herein referred to as Youn).
The teachings of Shannon are incorporated herein.
Regarding claims 9, 10, and 15, Shannon teaches all the limitations of claim 1 of the instant application, and the step of emitting the light at two or more predetermined wavelength ranges at or around the excitation maximum wavelength of a fluorophore, but not for two or more different fluorophores. Additionally, Shannon does not teach wherein the liquid composition comprises two or more conjugated aptamers that bind to different target protein, wherein each of the two or more aptamers is conjugated to a different fluorophore.
Youn teaches a novel multiplex aptasensor for antibiotics by fluorescence resonance energy transfer (FRET) strategy using DNase I-assisted cyclic enzymatic signal amplification (CESA) method combined with aptamer/graphene oxide complex (abstract). Youn teaches that the aptamers specific for sulfadimethoxine, kanamycin, and ampicillin were conjugated with Cyanine 3 (Cy3), 6-Carboxyfluorescein (FAM), and Cyanine 5 (Cy5), respectively, and graphene oxide (GO) was adopted to quench the fluorescence of the three different fluorophores with the efficiencies of 94.36%, 93.94%, and 96.97% for Cy3, FAM, and Cy5, respectively (abstract). Youn teaches that CESA method was used for sensitive detection, resulting in a 2.1-fold increased signal compared to those of unamplified method, and that the aptasensor rapidly detected antibiotics in solution with limit of detection of 1.997, 2.664, and 2.337 ng/ mL for sulfadimethoxine, kanamycin, and ampicillin, respectively (abstract). Youn teaches that the multiplexed detection test proved that the fluorescently modified aptamers could work separately from each other, and that the results indicate that the aptasensor offers high specificity for each antibiotic and enables simultaneous and multicolor sensing for rapid screening of multiple antibiotics at the same time (abstract). Youn teaches that after incubation with GO in DNase I-treated buffer containing blocking agent, fluorescence intensity was measured using different wavelength channels at or around the excitation maximum wavelength (Supplementary Fig. S3). Youn teaches that for multiplexed detection, dye-to-dye energy transfer was inhibited by using Cy3, FAM, and Cy5, which were excited at 520, 480, and 650 nm, emitting different colors at 565, 520, and 670 nm, respectively (page 5, 2nd paragraph). Youn teaches that Graphene oxide (GO), which has multiple oxygen-containing groups on its surface, is widely used in the field of sensing because of its unique characteristics, such as facile surface modification, large surface area, strong photoluminescence, and good water dispersibility, and because of its non-radioactive electronic excitation energy transfer and large absorption cross-sections, GO can be used to develop fluorescence resonance energy transfer (FRET) sensors (page 2, 2nd paragraph).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the aptamer-based pathogen visualization/detection method recited by Shannon, to use a composition comprising two or more conjugated aptamers that bind to different target proteins, wherein each of the two or more aptamers is conjugated to a different fluorophore and illuminating these fluorophores, as taught by Youn, as a matter of using a known technique to improve similar methods in the same way. The aptamer-based pathogen visualization/detection method recited by Shannon represents a base device upon which the instant invention can be seen as an improvement, and the teachings of Youn represent a comparable method as it also uses aptamers conjugated to fluorophores, and a quencher, to detect an analyte. The method of Youn has been improved in the same way as the instantly claimed invention by using multiple aptamers and fluorophores simultaneously to perform multiplex analysis. One of ordinary skill in the art would have recognized that the results of the combination would have been predictable because it merely requires performing the same steps but with more aptamers/fluorophores present, and the selection of aptamers and fluorophores to use that will not interact and disrupt the results. A person of ordinary skill would have been motivated to make this modification because it would allow for multiplex analysis of pathogens, saving time and resources by avoiding running multiple tests. Furthermore, a person of ordinary skill would have had a reasonable expectation of success in making this modification because Youn demonstrates good signal and detection limits even while using multiple aptamers/ fluorophores.
Regarding claim 13, Youn teaches the use of graphene oxide as the quencher (abstract). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the aptamer-based pathogen visualization/detection method recited by Shannon, to use graphene oxide as the quencher, as taught by Youn, as it would be “obvious to try”. Shannon teaches the use of a generic quencher and that “Fluorescent and quencher compounds are known in the art” ([0187]). Youn teaches that graphene oxide is widely used as a quencher in the field of sensing because of its unique and characteristics, such as facile surface modification, large surface area, strong photoluminescence, and good water dispersibility, and because of its non-radioactive electronic excitation energy transfer and large absorption cross-sections, and therefore using graphene oxide as the quencher in the method of Shannon would be obvious to try due to these possessed advantages. Furthermore, a person of ordinary skill would have had a reasonable expectation of success in making this modification because Youn teaches that the graphene oxide is commercially available, and teaches how to prepare the graphene oxide solution that is added to the aptamer complex solution to detect the analyte.
Regarding claim 25, Shannon teaches that the light source may be capable of switching between different wavelengths, each wavelength being suited to a specific interchangeable filter, and that the forensic light source may be in the form of a LED, laser, Polilight® or the like ([0236]). Shannon teaches that each Polilight Flare “torch” may produce light within a specified wavelength range ([0237]). Shannon teaches that, in some embodiments, the light source may produce light at a wavelength of between about 360 nm-385 nm (UV light), and in others, the light source may produce light at a wavelength of between about 405 nm-420 nm ([0237]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Shannon in view of Seville et al. (US6914250B2), (herein referred to as Seville).
The teachings of Shannon are incorporated herein.
Regarding claim 12, Shannon teaches all the limitations of claim 1 of the instant application and teaches blocking the light using a bandpass filter in combination with the light source. Shannon also teaches that in some embodiments, the light source may be capable of switching between different wavelengths, each wavelength being suited to a specific interchangeable filter ([0236]).
However, Shannon does not teach that the filter comprises a long pass filter.
Seville teaches systems, devices and methods for viewing a pattern of fluorophors capable of fluorescing when exposed to visible light, e.g., fluorescently stained DNA, protein or other biological material (abstract). Seville teaches that the system includes a light source emitting light in the visible spectrum, such as a fluorescent lamp used in domestic lighting, a first optical filter capable of transmitting light from the source at wavelengths capable of exciting the fluorophors and of absorbing light of other wavelengths, and a second optical filter capable of blocking substantially all the light from the source not blocked by the first filter, so that the only light reaching the viewer is light produced by fluorescence of the fluorophors (abstract). Seville teaches that spectra were recorded using a S2000 spectrometer (Ocean Optics, Dunedin, Fla.) equipped with a #2 grating (200-850 nm), 200 micrometer width entrance slit, variable long-pass (200-850 nm) longpass detector filter, UV2 upgrade and L2 detector collection lens (column 43, lines 5-9).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the aptamer-based pathogen visualization/detection method recited by Shannon, to use a long pass filter, as taught by Seville, as a matter of simple substitution. Seville demonstrates that the function of long pass filters and their use in methods of viewing a pattern of fluorophors capable of fluorescing when exposed to visible light in order to detect biological material were known in the art. Furthermore, Shannon teaches, in some embodiments, the use of an interchangeable filter. A person of ordinary skill would have been motivated to make this modification because it would allow broader wavelength transmission, which can be advantageous when capturing the full emission spectrum. Furthermore, a person of ordinary skill would have had a reasonable expectation of success in making this modification because both Shannon and Seville are both in the same field of endeavor of methods of viewing fluorophore emission in the context of detecting biological material, and Seville demonstrates that the use of long pass filters is a well-understood, routine, and conventional activity in the field.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Shannon, as applied to claims 1, 20, and 21 above.
The teachings of Shannon are incorporated herein.
Regarding claim 22, Shannon teaches all the limitations of claim 1, 20, and 21 of the instant application, and also that given the rise in antibiotic resistance and the potential mortality associated with C. difficile infection, control measures are of the highest importance ([0079]), and that C. difficile remains a significant healthcare issue and therefore there is a need for rapid identification of the presence of C. difficile in an environment in order to minimize its spread ([0089]).
However, Shannon does not explicitly teach repeating steps (a) through (e).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the aptamer-based pathogen visualization/detection method recited by Shannon, to repeat steps (a) through (e), as it would be “obvious to try”. Shannon teaches the importance of pathogen control and how identification is important to minimizing spread of the pathogen. Therefore, it would have been obvious to a person of ordinary skill in the art to repeat steps (a) through (e) to determine if the decontamination of the surface was effective and ensure the surface is free of pathogen. A person of ordinary skill would have been motivated to make this modification because Shannon teaches that due to potential mortality associated with infection, and therefore one would want to make sure the surfaces were free of the presence of pathogen to reduce patients’ health risks. A person of ordinary skill would have had a reasonable expectation of success in making this modification because it is merely repeating the steps already taught by Shannon, and there are no limitations in the method of Shannon that would prevent the repetition.
Conclusion
For all the reasons discussed above, claims 1-4, 7, 9-15, and 18-25 are rejected and therefore no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER JOSEPH HOFFMAN whose telephone number is (571)272-9080. The examiner can normally be reached 10:00-6:30 M-F.
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/ALEXANDER J. HOFFMAN/ Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 September 15, 2026
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