DETAILED ACTION
The present Office Action is responsive to the Amendment received on April 21, 2026.
Claim Interpretation
Claim 1 has been interpreted to be drawn to a product that does not actively require the presence of any reagents employed in the UCNP-based assay due to the usage of the phrase, “[a] sample chamber for holding a cuvette with a UCNP-based assay and said sample”. The usage of, “for holding a cuvette with a UCNP-based assay and said sample” simply requires a chamber that is able to hold a cuvette.
Consequently, dependent claims which further recite the reagents which is comprised in an UCNP-based assay and sample (i.e., claims 5-10 and 13-16) are also not necessarily required and do not further limit said dependent claims.
The term, “UCNP” is understood in the art as being directed to an acronym for “UpConversion NanoParticles” as evidenced by Ye et al. (below).
The term, “NIR” is also understood in the art as being directed to an acronym for “Near InfraRed” as evidenced by Ye et al.
The term, “TTL” in context of the claim, that is, in context of a wireless technology (see claim 3) has been construed to be directed to acronym for “Transistor-Transistor Logic”.
Response to Applicants’ Remark:
Applicants state that the Office has interpreted claim 1 to the effect of “not requri[ng] the device to be configured for UCNP-based detection”. (page 7, Response).
This statement is erroneous. The Office clearly stated that claim 1 does not, “actively require the presence of any reagents employed in the UCNP-based assay”. The device’s physical constructs have been examined to the extent they are actively limiting. The reagents of the UCNP, however, such as UCNP modified surface and AuNP modified surface and their respective oligos, etc., are not actively required and the Office maintains that the claimed device comprises a sample chamber “for holding a cuvette with a UCNP-based assay”.
Claim Objections
The objection made to claims 1, 7, 13, 16, and 17 for reasons discussed in the Office Action mailed on November 21, 2026 is withdrawn in view of the Amendment received on April 21, 2026.
New Objection
Claim 7 is objected to for containing a typographical error, “AuNR”. The term should be “AuNP”.
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.
The rejection of claims 1-16 under 35 U.S.C. 103 as being unpatentable over Ye et al. (Small, 2014, vol. 10, no. 12, pages 2390-2397) in view of Silverbrook et al. (US 2011/0312841 A1, published December 22, 2011), made in the Office Action mailed on November 21, 2026 is maintained for the reasons of record.
Applicants’ arguments presented in the Amendment received on April 21, 2026 have been carefully considered but they have not been found persuasive for the reasons discussed in the, “Response to Arguments” section.
The Rejection:
With regard to claim 1, Ye et al. teach a method of detecting a target nucleic acid, wherein the method involves UCNPs (UpConversion NanoParticles) that comprise a capture nucleic acid probe sequence and a AuNP (gold nanoparticles) comprising a target nucleic acid sequence, wherein the presence is determined by FRET which occurs between the UCNPs and the AuNP when bound in proximity (see below representation from Fig. 1 below):
PNG
media_image1.png
240
542
media_image1.png
Greyscale
As seen, UCNP is labeled with a capture (“[c]apture oligonucleotide probe was designed based on the sequence specific for hemaglutin (HA) genes of H7 virus subtypes and conjugated to poly(ethylenimine) (PEI) modified UCNPs”, page 2391, 2nd column); and AuNPs are labeled with a target nucleic acid sequence (“AuNPs were then conjugated to H7 hemaglutinin gene oligonucleotides”, page 2391, 2nd column).
Ye et al. teach that the assay also requires an NIR (Near InfraRed) photons for the upconversion (“[i]t is known that lanthanide-based upconversion nanoparticles (UCNPs) can convert low-energy near-infrared (NIR) photons into visible emission”, page 2391, 1st column, 2nd paragraph) using a CW 980 nm diode laser for excitation and the use of a sensor to detect the fluorescence emission from UCNP-FRET assay (“upconversion LRET spectra were obtained using FLS920P Edinburgh analytical instrument apparatus equipped with CW 980 nm diode laser as an excitation source”, page 2396, 1st column).
Taken together, the method disclosed by Ye et al. employs: i) a chamber in which to perform the LRET assay; ii) an NIR light source (i.e., CW 980 nm diode laser); iii) a sensor for measuring the fluorescence emission from FRET (or LRET) quenching (FLS920P machine); and iv) a microcontroller that determines the emission intensity from the UCNP based assay to produce detection results (as evidenced by Figures 5 and 6).
With regard to claim 2, the sensor of Ye et al. measures the fluorescence at 540 nm (“[o]nce UCNPs-oligo captured AuNPs conjugated with H7 target oligonucleotides, the green UC emission of UCNPs is quenched due to the absorption characteristics of AuNPs at 540 nm”, page 2395, 1st column).
With regard to claim 5, the Office initially notes that the portable device does not actively require the presence of any reagents employed in UCNP-based assay nor sample as discussed above. Notwithstanding this, Ye et al. teaches that the UCNP is modified with a first oligonucleotide probe (i.e., capture probe) that is lanthanide-doped UCNP (see “time-resolved LRET biosensor based on amine-functionalized lanthanide doped NaYF4 UCNPs has been developed …”, page 2391, 1st column, also lanthanide doped UCNP being used in the disclosure as shown in Fig. 1).
With regard to claims 6, 8, 10, 12, 13, and 16, the portable device does not actively require the reagents as recited therein and the excitation and emission elements of Ye et al. would be capable of providing the excitation and emission signals generated from the UCNPs of claims 6, 8, and 10. As well, the assay detection limit (claims 12 and 13) is based on the assay reagents, and because they are not actively required by the claimed device, the portable device of Ye et al. would be capable of achieving the limit should the assay reagents be included.
With regard to claim 7, while the portable device as claimed does not actively require the presence of AuNR, the LRET evidences that the longitudinal absorption overlaps with emission spectra of the UCNP.
With regard to claim 9, while the portable device as claimed does not actively require the presence of AuNP surface modified with a second oligo probe, the AuNP of Ye et al. with a nucleic acid sequence would necessarily have an absorbance overlapping with emission of UCNP surface modified with a first oligo probe (i.e., capture probe) based on the exhibited LRET (see above).
With regard to claims 14 and 15, while the portable device as claimed does not actively require the presence of a target nucleic acid nor any of the UCNPs or AuNPs with probe sequences thereto, the target nucleic acid of Ye et al.’s assay is for an avian influenza virus (or pathogen, see “[a]vian influenza virus (AIV) have become an increased threat … influenza A H7 subtypes are characterized as highly pathogenic avian influenza”, page 2390; “[i]n this work … UCNP-based LRET biosensor has been developed for influenza A H7 subtype detection”, page 2391, 2nd column).
Ye et al. do not explicitly teach that their system of detection employs a portable device configured to contain the analytic sample, with a light source, a sensor, optics with necessary wavelength filters and lens, and a microcontroller that can wireless communicate with a remote controller device (claim 1, in-part), wherein the wireless communication is via Bluetooth, WIFI, or network (claim 3), and that the controlling device is a smartphone, computer, or TTL (claim 4), or that the portable device comprises a housing to prevent external light (claim 11).
Silverbrook et al. teach a well-known practice of providing a portable device which is tailored to assay for any types of assays, routinely involve any combination steps of: i) sample preparation, b) sample extraction; c) sample amplification; and d) detection (sections [0010]-[0014]; also “microfluidic device also has … a probe hybridization section … integrated image sensor obviates the need for an expensive external imaging system and provides … inexpensive integrated solution with low system component that is compact, light and highly portable system … integrated image sensor increases the readout sensitivity …” (section [0325]).
Silverbrook et al. also teach that the wireless network can be employed for communication (section [10356], “cellular radio 21 and wireless network connection 23 are used for communications …”; also “mobile phone reader contains all the test and diagnostic information preloaded. Data can also be loaded or updated via a number of wireless or contact interfaces to enable communication with peripheral devices, computers or online servers …”, section [10361]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ye et al. with the teachings of Silverbrook et al., thereby arriving at the invention as claimed for the following reasons.
As discussed above, Ye et al. already teach a method which detects the presence of a target pathogen sequence by utilizing an energy transfer which occurs between lanthanide doped UNCP and AuNP, wherein the two are brought in proximity upon binding. While Ye et al. did not teach that their detection method should be engineered to be performed in a portable system, one of ordinary skill in the art before the effective filing date of the claimed invention would have already recognized the well-known advantages provided by fabricating a portable device which is designed to perform the method of Ye et al., allowing for the tests to be done on-site as a point-of-care means, while reducing the costs and time associated with collecting and transporting the collected sample from a site to a clinical laboratory, waiting for the assay result to be completed and communicated back to the site. And given the technological advancement which has occurred as well as the availability of means of such fabrication (as evidenced by Silverbrook et al.), one of ordinary skill in the art would have had a reasonable expectation of success at arriving at a portable device that is designed to perform the assay disclosed by Ye et al., including typical elements, such as a reaction region in which a reaction occurs, an excitation and emission generation/detection means that utilize filters/mirrors (i.e., optics) to allow specific excitation wavelength of light to excite while only allowing a specific emission wavelength of light to flow through for detection while preventing outside interfering light of undesired wavelengths, as well as means of processing the instructions on the device in a wireless manner, all of which would have yielded no more than a predictable outcome of performing the assay on a portable device.
As stated by the Supreme Court in KSR, “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
Therefore, for these reasons, the invention as claimed is deemed prima facie obvious over the cited references.
Response to Arguments:
Applicants traverse the rejection. (page 9, Response).
Applicants contend that the Office’s position relies on an “overextension of Ye and an improper combination with the unrelated imaging-based systems of Silverbrook” (page 9, Response).
Applicants do not dispute the fact that Ye discloses a UCNP-AuNP LRET/FRET assay, but contends that Ye does not teach or suggest a “portable diagnostic device as required by claim 1” (id.)
Applicants also contend that Ye’s methods depend on controlled laboratory optical pathways and external scientific detectors and provide no teachings or indication of integrating NIR excitation, UCNP-specific emission filtering, or detection via a light-to-frequency converter within a compact standalone device and Office invokes Silverbrook which teaches portable diagnostics systems to bridge the gap, where the system of Silverbrook is fundamentally incompatible with the UCNP-based point-optical fluorescence detection system (page 9, Response).
Applicants further discuss the diagnostics technology disclosed by Silverbrook, which centers around a microfluidic device (page 9, Response, bottom paragraph), contending that the, “tightly integrated design allows Silverbrook’s devices to perform in-chip fluorescence assays within microfluidic environments, with excitation and detection occurring entirely within the confines of the chip, rather than free-space optical path” and does not teach/suggest NIR-excited upconversion nanoparticles or optical paths configured to block excitation wavelengths and pass only UCNP emission (page 9, bottom paragraph to page 10, 1st paragraph, Response).
Finally, Applicants conclude while there may be a general desire to make benchtop devices and systems more portable, the proposed combination of Ye and Silverbrook is far removed from a mere scaling down, and instead require a fundamental reworking of those references that is neither taught nor suggested therein, and that the claimed device achieves, “rapid, ultrasensitive UCNP-based detection in a portable format through structural features, such as NIR-optimized optical filtering and light-to-frequency conversion” (page 10, Response).
These statements and contentions have been carefully considered but they have not been found persuasive for the following reasons.
As Applicants acquiesce, there is a motivation in the art to make portable devices for diagnostics tests which have long been performed on bench tops, evidenced by portable diagnostics devices, such as portable PCR device, lateral-flow based diagnostics, microfluidic devices, etc.
The question that is fundamental to the question of obviousness in the present case is whether elements required in the “portability” of the claimed device results in characteristics which is more than the well-known benefit of, portability.
To the end, the Office finds no basis for such additional benefit.
As discussed above, Ye et al. teach a method of detecting a target nucleic acid, wherein the method involves UCNPs (UpConversion NanoParticles) that comprise a capture nucleic acid probe sequence and a AuNP (gold nanoparticles) comprising a target nucleic acid sequence, wherein the presence is determined by FRET which occurs between the UCNPs and the AuNP when bound in proximity (see below representation from Fig. 1 below):
PNG
media_image1.png
240
542
media_image1.png
Greyscale
In the disclosed scheme, the detection is based on a UCNP labeled with a capture oligonucleotide probe that is designed based on HA gene that anneals to another complementary nucleic acid which is immobilized to AuNP, wherein the hybridization results in detectable emission. The initial excitation is from an NIR source having 980 nm (“[i]t is known that lanthanide-based upconversion nanoparticles (UCNPs) can convert low-energy near-infrared (NIR) photons into visible emission”, page 2391, 1st column, 2nd paragraph) and a sensor that detect the fluorescence emission from UCNP-FRET assay (“upconversion LRET spectra were obtained using FLS920P Edinburgh analytical instrument apparatus”, page 2396, 1st column).
Taken together, the elements of the instantly claimed portable device are taught by Ye et al.
With regard to the presence of optical-paths through which the excitation and emission lights are routed, the use of optical paths using lens and filter combination has been common in the art of molecular diagnostics, especially that which pertains to devices having detection modules in closed settings, such as portable or movable ones.
As well, the use of a microcontroller that communicates with a controlling device for the purposes of illuminating, detecting and converting the received intensity to interpretable results, such components routine in such diagnostic devices.
Therefore, the Office respectfully maintains the elements of the claimed device implement elements which are typically employed in portable devices that have been applied for the assay of Ye et al., yielding no more than the predictable outcome of providing an assay on a portable device utilizing typical portable device elements.
As to Applicants’ arguments pertaining to the teachings of Silverbrook being incompatible with UCNP detection means, the Office respectfully point out that one of ordinary skill in the art is not a robot. With the well-recognized motivation to make known assays portable (as evidenced by Silverbrook), one of ordinary skill in the art would be have had the requisite knowledge of utilizing elements which are utilized the art, such as optical paths, lens, and microcontrollers, etc. that apply the assay of Ye et al.1
Indeed, in KSR International Co v. Teleflex Inc, the Supreme Court stated that, “A person of ordinary skill in the art is also a person of ordinary creativity, not an automation” (82 USPQ2d at 1397) and that “in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle” and take into account, “the inference and creative steps that a person of ordinary skill in the art would employ” (82 USPQ2d at 1396).
And it is respectfully submitted that such “fitting” of the teachings would not have been “beyond [the] ... skill [level]” of one of ordinary skill in the art
In KSR, the supreme court stated:
“When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” (page 13, emphasis added).
For these reasons, Applicants’ arguments are not deemed persuasive and the rejection is maintained.
The rejection of claims 1-20 under 35 U.S.C. 103 as being unpatentable over Tsang et al. (US 2019/0119731 A1, published April 25, 2019) in view of Silverbrook et al. (US 2011/0312841 A1, published December 22, 2011) and Muhr, Verena (URN: NBN:DE: BVB, 2017, vol. 355, pages 75-98), made in the Office Acton mailed on November 21, 2026 is maintained for the reasons of record.
Applicants’ arguments presented in the Amendment received on April 21, 2026 have been carefully considered but they have not been found persuasive for the reasons discussed in the, “Response to Arguments” section.
The Rejection:
The present rejection is based on the prior art teaching which renders obvious the inventive concept of the claimed invention, that is, sandwich-based targeting of a target nucleic acid utilizing a first probe comprising UCNP and a second probe comprising AuNP, wherein the two probe anneal to separate regions on the target nucleic acid, and inducing LRET signal.
With regard to claim 1, Tsang et al. teach a method of detecting a target nucleic acid in a sample which is reflected in Figure 3 reproduced below:
PNG
media_image2.png
329
754
media_image2.png
Greyscale
As seen, the method involves: i) UCNPs which comprise oligonucleotide probes (see left-side, also “nanoprobe having one or more first oligonucleotide probes, each complementary to a first segment of said target nucleic acid sequence”, section [0012]; “[c]onjugating said UCNP with polyacrylic acid followed by conjugation with an oligo sequence to obtain the upconversion nanoprobe”, section [0039]); ii) a AuNP comprising oligonucleotide probes (see left-side, also “invention provides a sandwich assay consisting of an upconversion (UC) and a gold (Au) nanoprobe, in which the target recognition is achieved by two segments of DNA oligonucleotide (oligo) hybridization.”, section [0043]; “the upconversion sandwich assay … to increase the specificity and efficiency of the detection … the csUCNPs and oligo modifications are used to form the first probe (P2) but the acid-assisted approached is used to conjugate another segment of oligo probe (P1) on AuNPs”, section [0053]); iii) NIR source (“[e]xposing said mixture to a near infrared wavelength”, section [0013]; and iv) sensor for measuring said fluorescence emission from UCNP-based assay comprising light-to-frequency converter (“measuring the intensity of said luminescence, wherein when said intensity is lower than intensity fluorescence from a control without said target nucleic acid sequence, said sample is shown to contain said nucleic acid sequence”, section [0013]).
With regard to claims 2 and 20, the sensor measures the fluorescence emission around 520-550 nm (see section [0027]).
With regard to claim 5, the UCNP surface modified with a first oligo probe is a lanthanide-doped UCNP (“0.4 mmol of lanthanide acetates (LnAC3) of gadolinium (Gd3+), ytterbium (Yb3+) and erbium (Er3+) were added to a two-necked flask followed by 4 ml of oleic acid (OA) and 6 ml of 1-octadecene (1-ODE) … cyclohexane and ethanol were used to purify and precipitate the oleate UCNPs”, section [0046]).
With regard to claim 6, ligand free UCNP is not actively required (see above rejection and claim interpretation).
With regard to claim 7, the AuNR comprises a longitudinal absorption that overlaps with emission spectra of UCNP as the two result in LRET.
With regard to claim 8, said UCNP surface modified with a first oligo probe is NaGdF4:Yb/Er@ NaGdF4 (see section [0033]).
With regard to claim 9, the AuNP surface modified with a second oligo probe has an absorbance maxima overlapping with emission of said UCNP surface modified with a first oligo probe as the two result in LRET.
With regard to claims 14 and 15, the target is from a pathogen, such as influenza virus (“said nucleic acid sequence is derived from a group consisting of viruses … influenza viruses …”, section [0038]).
Tsang et al. do not explicitly teach that their system of detection employs a portable device configured to contain the analytic sample, with a light source, a sensor, optics with necessary wavelength filters and lens, and a microcontroller that can wireless communicate with a remote controller device (claim 1, in-part), wherein the wireless communication is via Bluetooth, WIFI, or network (claim 3), and that the controlling device is a smartphone, computer, or TTL (claim 4), or that the portable device comprises a housing to prevent external light (claim 11), or a method of using said portable device to detect the target nucleic acid (claim 17), wherein the sample is from nasal swabs, saliva, sputum, etc. (claim 18).
Tsang et al. do not explicitly disclose that the AuNP surface modified with a second probe and the UCNP surface modified probe are spaced less than 10 nm apart after binding to the target nucleic acid sequence (claim 10).
Tsang et al. do not explicitly teach the limit of detection as being about 1 fg/mL (claim 12), or 11 fM (claim 13), or targeting a viral gene from nucleocapsid ORF1a or ORF1b (claim 16) or that the detection is achieved after 5 to 20 minutes after placing the sample into the device (claim 19)
Silverbrook et al. teach a well-known practice of providing a portable device which is tailored to assay for any types of assays, routinely involve any combination steps of: i) sample preparation, b) sample extraction; c) sample amplification; and d) detection (sections [0010]-[0014]; also “microfluidic device also has … a probe hybridization section … integrated image sensor obviates the need for an expensive external imaging system and provides … inexpensive integrated solution with low system component that is compact, light and highly portable system … integrated image sensor increases the readout sensitivity …” (section [0325]).
Silverbrook et al. also teach that the wireless network can be employed for communication (section [10356], “cellular radio 21 and wireless network connection 23 are used for communications …”; also “mobile phone reader contains all the test and diagnostic information preloaded. Data can also be loaded or updated via a number of wireless or contact interfaces to enable communication with peripheral devices, computers or online servers …”, section [10361]).
Muhr teaches a well-known fact that for energy transfer to occur between donor and acceptor, their separation distance should be within 10 nm:
“Due to its strong dependence on the distance between donor and acceptor, which has to be below 10 nm” (page 77)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tsang et al. with the teachings of Silverbrook et al. and Muhr, thereby arriving at the invention as claimed for the following reasons.
As discussed above, Tsang et al. already teach a method which detects the presence of a target pathogen sequence by utilizing an energy transfer which occurs between lanthanide doped UNCP and AuNP, wherein the two probes are brought in proximity upon binding of the same pathogenic target nucleic acid sequence. While Tsang et al. did not teach that their detection method should be engineered to be performed in a portable system, one of ordinary skill in the art before the effective filing date of the claimed invention would have already recognized the well-known advantages provided by fabricating a portable device which is designed to perform the method of Tsang et al., allowing for the tests to be done on-site as a point-of-care means, while reducing the costs and time associated with collecting and transporting the collected sample from a site to a clinical laboratory, waiting for the assay result to be completed and communicated back to the site. And given the technological advancement which has occurred as well as the availability of means of such fabrication (as evidenced by Silverbrook et al.), one of ordinary skill in the art would have had a reasonable expectation of success at arriving at a portable device that is designed to perform the assay disclosed by Tsang et al., including typical elements, such as a reaction region in which a reaction occurs, an excitation and emission generation/detection means that utilize filters/mirrors (i.e., optics) to allow specific excitation wavelength of light to excite while only allowing a specific emission wavelength of light to flow through for detection while preventing outside interfering light of undesired wavelengths, as well as means of processing the instructions on the device in a wireless manner, all of which would have yielded no more than a predictable outcome of performing the assay on a portable device.
With regard to the sample being nasal swab, sputum, etc., assaying for sample from which influenza is detected as well as the targeting genes which specifically identify their presence, such as their nucleocapsid encoding genes, ORF1a/1b genees, etc., would have been an obvious conclusion held by the ordinarily skilled artisan assaying types of samples which are known and routinely examined and targeting conventionally targeted gene regions for the pathogens.
As stated by the Supreme Court in KSR, “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
As to the time it takes for the assay to complete, while Tsang et al. explicitly disclosed a range of 0.5-2 hrs (“influenza subtype virus oligos are added to the hybridization medium with the probes for 0.5-2 h followed by the readout process”, section [0052]) which is roughly 30 minutes to 2 hours, the Office contends that the reduction in assay time would have been achievable by routine optimization of assay conditions involving the probe sequences, incubation time, and detection parameters.
Lastly, with regard to the sensitivity achieved, Tsang et al. state that assays such as ELISA having a limit of detection in the nanomolar range (10-9) are considered relatively low (“procedures of ELISA are laborious and the limit of detection is relatively low (nanomolar range)”, section [0003]) and state alludes that their method fulfills the need for “sensitive and quick diagnostic assays”, section [0003]).
Given that the assay disclosed by Tsang et al. employs the same types of assay configuration, one of ordinary skill in the art would have been capable of achieving the requisite sensitivity of detection in the ranges of femtomolar in target in a portable device based on optimization based on the teachings of Tsang et al., absent evidence to the contrary.
Therefore, for these reasons, the invention as claimed is deemed prima facie obvious over the cited references.
Response to Arguments:
Applicants traverse the rejection (page 10, Response).
Applicants’ arguments directed to the integration of onboard NIR source, optical paths and filters, and lens have been discussed above and therefore, are not reiterated herein.
With regard to Applicants’ argument directed to the rapid (5-20 minutes) of detection time with femtamolar sensitivity, this argument has been considered but has not been found persuasive because the detection time and femtamolar sensitivity has not been associated with the strict portability of the device. This is because, as presently claimed, there is no evidence to conclude that the configuration of optical paths, lens and NIR element are what produces the observed characteristics, which may be more based on the actual assay conditions, not the fact that the assay was performed on a portable device.
In addition, regardless of the above issues, none of the claims recite such a limitation and therefore, the argument is moot.
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For these reasons, Applicants’ arguments are not deemed persuasive and the rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YOUNG J KIM/Primary Examiner
Art Unit 1637 September 16, 2026
/YJK/
1 Also see Fig. 5(a) in Lee et al., (Nanomaterials, 2017, vol. 7, pages 1-14) which exhibits the knowledge of an artisan for employing optical paths, NIR, and light directionality, also “NIR LED is commercially available … the UCNP-based assay can give high sensitivity to the portable diagnostic device”, page 10, 2nd paragraph.
Prosecution Insights