67Notice 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 Claims
Claims 26-34 and 36-52 are pending. Claims 44-52 are withdrawn as being drawn to the nonelected inventions. Claims 1-25 and 35 are canceled. Claims 26-34 and 36-43 are under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim recites “A1-XVO4(1-y)(PO4)y” should be – A1-xLnxVO4(1-y)(PO4)y – to be consistent with the recited formula II above. Appropriate correction is required.
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 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.
Claims 26-32, 34 and 36-43 are rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. (“Synthesis of carboxyl-capped and bright YVO4:Eu,Bi nanoparticles and their applications in immunochromatographic test strip assay”, Materials Research Bulletin, vol. 48, 2013, pgs. 4454-4459, published 07/29/2013, of record dated 11/15/2024) and Shen et al. (“Biocompatible Bright YVO4:Eu Nanoparticles as Versatile Optical Bioprobes”, Advanced Functional Materials, 2010, vol. 20, pgs.3708-3714, published 09/07/2010, of record dated 11/15/2024).
Luo teaches carboxyl-capped YVI:Eu,Bi nanoparticles with average diameter of ~10 nm were synthesized via a copolymer of phosphono and carboxylic acid mediated hydrothermal method (see abstract). Luo further teaches that based these kind optical and surface properties of the YVO:Eu,Bi nanoparticles, an immunochromatographic test strip assay for quantitative determination of human IgG was achieved (see abstract). Luo teaches immunochromatographic test strip assay (ITSA) is one of the most common methods for the rapid detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring (see pg. 4454, left col. para. 1). Luo teaches the small size of NPs facilitate them flowing on the nitrocellulose membrane under capillary force in ITSA applications (see pg. 4456, left col., middle of para. 2). Fig. 3(b) teaches YVO4:Eu, x%Bi nanoparticles wherein x is 0% which makes the nanoparticle YVO4:Eu and the fig. shows that the excited wavelength is at 300 nm. In other words, Luo teaches YVO4:Eu in Fig. 3(b). Luo teaches YVO4:Eu nanoparticles (see Fig. 3b). Luo teaches YVO4:Eu wherein Y and Eu were estimated to be 77.7% and 9.8%, respectively (see pg. 4456, left col., bottom of para. 2), which would read on the range of 0 < x < 1 and y is 0. Because Luo teaches the structure of YVO4:Eu as claimed, the emission lifetime is shorter than 100 ms. Luo teaches in Fig. 4 the photoluminescent inorganic nanoparticles are coupled to at least one reagent specifically binding the substance to be analyzed. Luo teaches a photo-electricity detecting system using a CCD camera for detection in the presence of UV-light source (see Fig. 5a) to produce sharp peaks (fluorescence spectrophotometer) and visually detected through the test strip (see Fig. 5b and c), which would read on using means for analysing the luminescence emission which are directed naked-eye observation or a photon detector (fluorescence spectrophotometer, caption for Fig. 5c).
Even though Luo teaches a capillary action test and YVO4:Eu, x%Bi nanoparticles wherein x is 0% (i.e., YVO4:Eu nanoparticle), Luo does not explicitly teach that YVO4:Eu is used for detecting and/or quantifying a biological or chemical substance of interest in a liquid sample by a capillary action test.
Shen teaches lanthanide nanoparticles and a typical red emission material Eu3+-doped YVO4 is investigated in pursuit of an integral methodology for Ln-based bioprobes and assisted with phosphino-polyacrylic acid, YVO4:Eu NPs with a luminescent quantum yield of ca. 54% are synthesized via a one-pot hydrothermal reaction (see abstract). Shen teaches that water-soluble YVO4:Eu NPs were synthesized via a one-pot hydrothermal route and P-PAA also encapsulated the NPs without further aggregation (see pg. 3709, left col., para. 2). Shen teaches that playing the roles as both coordinating ligand and capping agent, the P-PAA had an evident influence on the particle size and colloidal stability of YVO4:Eu NPs (see pg. 3709, left col., para. 3 – right col., para. 1). Fig. 1(d) shows excitation (EX) of the matrix at a wavelength less than or equal to 320 nm (also see pg. 3709, right col., last para.). Fig. 3 shows a sandwich fluoroimmunoassay with YVO4:Eu NPs (also Table 1 and caption) wherein the YVO4:Eu NPs is YVO4:8%Eu NPs and a typical reaction is with 0.2 mmol of Ln (pg. 3709, right col., para. 2). Shen teaches that the water-soluble YVO4:Eu NPs from one-pot synthesis can be applied as versatile luminescent bioprobes and with advantages in performance, the robust luminescent of Ln NPs could be excited either by low-power UV light or by visible laser beam and their ultra-sharp emission peaks ensure superior quality for imaging via spectral mapping (see pg. 3713, left col., Conclusions). Shen also teaches the P-PAA mediated hydrothermal protocol largely saves the cost of bioprobe preparation, and it is easy to be scaled up (see pg. 3713, left col., Conclusions).
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 used the immunochromatographic assay under capillary force as taught by Luo with the comparative YVO4:Eu nanoparticles because Luo teaches that YVO4:Eu nanoparticles are being used as a comparative example against YVO4:Eu,Bi nanoparticles. Thus, the person would recognize using YVO4:Eu in Luo’s immunochromatographic assay under capillary force to further analyze or confirm the results of YVO4:Eu,Bi nanoparticles under capillary action.
Additionally, it would have been obvious to the person to have used the immunochromatographic assay under capillary force as taught by Luo with the phosphino-polyacrylic acid YVO4:Eu nanoparticles of Shen because Luo recognizes producing YVO4:Eu nanoparticles as comparative nanoparticles against YVO4:EuBi nanoparticles and Shen teaches that their robust YVO4:Eu nanoparticles have ultra-sharp emission peaks to ensure superior quality for imaging via spectral mapping and the nanoparticles are synthesized through a one-pot hydrothermal reaction and feasible for biomodification through the surface carboxylic acid groups. Because Luo recognizes and appreciates biomolecule modifications and superior properties for capillary action, it would have been obvious to try the robust YVO4:Eu nanoparticles having superior properties.
Furthermore, the person would have been motivated to use the robust YVO4:Eu nanoparticles in the immunochromatographic assay of Luo because Shen also teaches a protocol to produce the nanoparticles to save cost of bioprobe preparation and easy to be scaled up.
The person would have reasonably expected success in using the YVO4:Eu nanoparticles in the immunochromatographic assay for capillary action because it has been well understood by Luo and Shen to use YVO4:Eu nanoparticles for nanoparticle property performances.
With respect to claim 27, Luo teaches Fig. 3(b) teaches YVO4:Eu, x%Bi nanoparticles wherein x is 0% and the fig. shows that the excited wavelength is at 300 nm.
With respect to claim 28, Luo teaches in Fig. 4 that the liquid sample is a biological sample.
With respect to claim 29, Luo teaches in Fig. 4 the detection of proteins (i.e., human IgG).
With respect to claim 30, Luo does not explicitly teach the photoluminescent nanoparticles have an average size greater than or equal to 5nm and strictly less than 1 µm. Shen teaches the size of the nanoparticles are 20 nm (see abstract).
With respect to claims 31-32, Luo teaches YVO4:Eu nanoparticles (see Fig. 3b).
With respect to claim 34, Luo teaches YVO4:Eu wherein Y and Eu were estimated to be 77.7% and 9.8%, respectively (see pg. 4456, left col., bottom of para. 2), which would read on 0 < x < 1.
With respect to claim 36, Luo teaches in Fig. 4 the photoluminescent inorganic nanoparticles are functionalized on the surface with one or more agent intended to facilitate their migration within the capillary action test device.
With respect to claim 37, Luo teaches in Fig. 4 the claimed capillary action rest device with the zones as claimed.
With respect to claim 38, Luo teaches in Fig. 4 and Fig. 5 applying the liquid sample to be analyzed at the level of the deposition zone (1) of the capillary action test device; (ii) incubating the device until the luminescence generated by the photoluminescent nanoparticles is detected in the reaction zone (3) and/or until the luminescence is detected in the migration control zone (4); and (iii) reading and interpreting the results.
With respect to claim 39, Luo teaches in Figs. 4-5 that the results of the capillary action test is affected by detecting the luminescence generated by the probes immobilized, at the end of the assay, at the level of the capillary action test device.
With respect to claim 40, Luo teaches YVO4:Eu nanoparticles (see Fig. 3b). Luo teaches YVO4:Eu wherein Y and Eu were estimated to be 77.7% and 9.8%, respectively (see pg. 4456, left col., bottom of para. 2), which would read on 0 < x < 1. Luo further teaches Fig. 3(b) teaches that the excited wavelength is at 300 nm which would be resulted from YVO4 matrix.
With respect to claim 41, Luo teaches in Fig. 4 and Fig. 5b which is based on the naked eye observation of the capillary action test.
With respect to claim 42, Luo teaches in Fig. 4 and Fig. 5 which is using detection equipment comprising an emission filter and a photon detector.
With respect to claim 43, Luo teaches in Fig. 4 and Fig. 5 which is the determination of the signal corresponding to the detection zone, the control zone and the background signal of the capillary action test device, subtracting the value of luminescence of the background signal and then determining the ratio of the signal from the detection zone to the signal from the control zone.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. and Shen et al., as applied to claim 26 above, and further in view of Iso et al. (“Fabrication and characterization of transparent monolithic nanocomposites between YVO4:Bi3+,Eu3+ nanophosphor and TMAS-derived silica”, Optical Materials, vol. 36, 2014, pgs. 717-722, published 12/11/2013, of record dated 11/15/2024)
Luo and Shen have been discussed in the above rejection. Shen teaches the result confirm that P-PAA-coated Ln NPs possess low adhesion onto the cell membranes, maybe owing to the negative charge of P-PAA (see pg. 3713, left col., bottom of para. 2). The references do not explicitly teach said nanoparticles have tetraalkylammonium cations on their surface in an amount such that said nanoparticles have a zeta potential, designated (, less than or equal to - 28 mV, in an aqueous medium of pH > 5, and with ionic conductivity strictly less than 100 p S.cm-1.
Iso teaches a basic aqueous solution of tetramethylammonium silicate is chosen, YVO4:Bi, Eu nanoparticles can be well-dispersed in solution (see abstract). Iso teaches a basic aqueous solution of tetramethylammonium silicate (CH3)4N(OH) 2(SiO2) (see pg. 717, right col., last para.). Iso teaches that aggregates are observed for VO4:Bi, Eu and TMA (tetramethylammonium) cations stabilize silicate species in water (see pg. 719, right col., para. 2). Iso teaches the nanoparticles are negatively charged because of adsorption of citrate anions and hence are well-dispersed in neutral and basic water (see pg. 717, left col., bottom of para. 1). Iso teaches tetramethylammonium silicate is a promising silica source for fabricating its transparent nanocomposites containing negatively-charged hydrophilic nanoparticles (see pg. 721, right col., Conclusions).
It would have been obvious to the person to have used the negatively charged YVO4:Eu nanoparticles in the modified assay of Luo and Shen with a basic solution of tetramethylammonium as taught by Iso because Iso teaches that the negatively-charged hydrophilic nanoparticles can be well dispersed in basic aqueous solution of tetramethylammonium solution. Therefore, it would have been obvious to have used a basic solution for the P-PAA-coated nanoparticles of Shen because the nanoparticles are colloidally in solution without aggregation. The person would reasonably expected success because it has been well understood in the art to have used a solution that is counter in charge to prevent aggregation of YVO4:Eu nanoparticles.
Even though Iso teaches tetramethylammonium solution for stabilizing negatively-charged hydrophilic YVO4:Eu Bi nanoparticles, the reference does not teach the nanoparticles have a zeta potential, ζ, of less than or equal to −28 mV in an aqueous medium with a pH≥5, and with an ionic conductivity of strictly less than 100 μScm−1. However, it is settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum ratio for a result effective variable of YVO4:Eu nanoparticles not aggregating in solution while the surface retains negative charge for immunoassay functionality. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation" Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In particular, Iso teaches that the negatively charged nanoparticles are well dispersed in tetramethylammonium basic solution and retrain the nanoparticle’s properties (see abstract and Conclusion). Absent of unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable negative zeta potential that is less than or equal to -28 mV for YVO4:Eu nanoparticles, as a colloidally solution containing negatively-charged surface of the YVO4:Eu nanoparticles facilitate immunoassay detection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 26-34 and 36-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11401463B2 (‘463) in view of Luo et al. (“Synthesis of carboxyl-capped and bright YVO4:Eu,Bi nanoparticles and their applications in immunochromatographic test strip assay”, Materials Research Bulletin, vol. 48, 2013, pgs. 4454-4459, published 07/29/2013).
Instant claim 26, Patent No. ‘463 recites in claim 1 a luminescent particle comprising a nanoparticle of formula: A1-xLnxVO 4(1-y)(PO4)y in which: A is selected from yttrium (Y), gadolinium (Gd), lanthanum (La), and mixtures thereof; Ln is selected from europium (Eu), dysprosium (Dy), samarium (Sm), neodymium (Nd), erbium (Er), ytterbium (Yb), and mixtures thereof; 0<x<1; and 0≤y<1; wherein the nanoparticle has, at the surface, tetraalkylammonium cations in an amount such that said nanoparticle has a zeta potential, ζ, of less than or equal to −28 mV in an aqueous medium with a pH≥5, and with an ionic conductivity of strictly less than 100 μScm−1. The Patent’s luminescent nanoparticles read on the instant claimed photoluminescent inorganic nanoparticles of formula (II) which would have a wavelength less than or equal to 320 nm. Patent No. ‘463 further recites in Claim 21 a method comprising coupling the luminescent particles as defined in claim 1 to one or more targeting agents of a substance of biological or chemical interest to obtain a diagnostic probe wherein the diagnostic probe in an in vitro diagnostic technique and detecting and/or quantifying said substance of biological or chemical interest.
However, Patent ‘463 does not explicitly recite a capillary action test. Luo has been discussed in the above rejection.
It would have been obvious to the person of ordinary skill in the art at the time of filing to have used a plurality of the nanoparticle of formula: A1-xLnxVO 4(1-y)(PO4)y as recited in Patent ‘463 with the immunochromatographic assay under capillary action of Luo because Luo teaches YVO4:Eu nanoparticles and that immunochromatographic test strip assay (ITSA) is one of the most common methods for the rapid visual detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring.
The person would have reasonably expected success in using the recited YVO4:Eu nanoparticles of Patent ‘463 in the immunochromatographic assay under capillary action because it has been well understood by Luo and recited by the Patent to use YVO4:Eu nanoparticles for assay diagnostics with targeting agents.
Instant claim 27, Patent ‘463 recites all the limitations of the photoluminescent inorganic nanoparticles. Thus, it would produce the excitation of the matrix at a wavelength less than or equal to 300 nm.
Instant claim 28, Patent ‘463 recites in claim 21 a method comprising coupling the luminescent particles as defined in claim 1 and detecting and/or quantifying said substance of biological or chemical interest.
Instant claim 29, Patent ‘463 recites in claim 21 a method comprising coupling the luminescent particles as defined in claim 1 and detecting and/or quantifying said substances of biological or chemical interest which would read on the instant claim 29 of detecting and/or quantifying molecule in a sample.
Instant claim 30, Patent ‘463 does not recite the photoluminescent nanoparticles have an average size. Luo teaches the nanoparticles having 10nm in diameter (see Fig. 1(a)). Thus, it would have been obvious to the person to have the photoluminescent nanoparticles with the average size between 5nm to 1µm to perform immunochromatographic assay under capillary action of Luo.
Instant claim 31, Patent ‘463 recites in claim 1 Ln is selected from europium (Eu), dysprosium (Dy), samarium (Sm), neodymium (Nd), erbium (Er), ytterbium (Yb), and mixtures thereof; 0<x<1; and 0≤y<1.
Instant claim 32, Patent ‘463 recites in claim 1 variable A is selected from yttrium (Y), gadolinium (Gd), lanthanum (La), and mixtures thereof.
Instant claim 33, Patent ‘463 recites in claim 1 the nanoparticle has, at the surface, tetraalkylammonium cations in an amount such that said nanoparticle has a zeta potential, ζ, of less than or equal to −28 mV in an aqueous medium with a pH≥5, and with an ionic conductivity of strictly less than 100 μScm−1.
Instant claim 34, as stated above, Patent‘463 does not explicitly recite a capillary action test. Luo has been discussed in the above rejection. It would have been obvious to the person to have used a plurality of the nanoparticle of formula: A1-xLnxVO 4(1-y)(PO4)y as recited in Patent ‘463 with the immunochromatographic assay under capillary action of Luo because Luo teaches YVO4:Eu nanoparticles and that immunochromatographic test strip assay (ITSA) is one of the most common methods for the rapid detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring.
Instant claims 36-38, Patent‘463 does not recite the claimed capillary action test device. Luo has been discussed in the above rejection. Luo also teaches the different zones in the immunochromatographic assay under capillary action (see Fig. 4). Thus, it would have been obvious to the person have used a plurality of the nanoparticle of formula: A1-xLnxVO 4(1-y)(PO4)y as recited in Patent ‘463 with the immunochromatographic assay under capillary action of Luo because Luo teaches YVO4:Eu nanoparticles and that immunochromatographic test strip assay (ITSA) is one of the most common methods for the rapid detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring.
Instant claim 39, Patent‘463 does not recite in which reading of the results of the capillary action. Luo has been discussed in the above rejection. Luo also teaches the results of the capillary action test with CCD detector (Fig. 5). Thus, it would have been obvious to the person have used a plurality of the nanoparticle of formula: A1-xLnxVO 4(1-y)(PO4)y as recited in Patent ‘463 with the immunochromatographic assay under capillary action of Luo because Luo teaches YVO4:Eu nanoparticles and that immunochromatographic test strip assay (ITSA) is one of the most common methods for the rapid detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring.
Instant claim 40, the Patent’s luminescent nanoparticles read on the instant claimed YVO4 matrix at a wavelength between 230 and 320 nm as it reads on structure of the claimed photoluminescent inorganic nanoparticles having formula (II).
Instant claim 41, as stated above, Patent ‘463 does not recite capillary action test. Luo has been discussed in the above rejection. Luo also teaches the results of the capillary action test with CCD detector (Fig. 5). However, it would have been obvious that the Patent’s luminescent nanoparticles would provide the result of direct, naked eye observation as it reads on structure of the claimed photoluminescent inorganic nanoparticles having formula (II).
Instant claim 42, Patent ‘463 does not recite the reading of the results of the capillary action test is using detection equipment comprising an emission filter and a photon detector. Luo has been discussed in the above rejection. Luo also teaches the results of the capillary action test with CCD detector (Fig. 5). Thus, it would have been obvious to the person to have read the results as claimed because Luo teaches YVO4:Eu nanoparticles and that immunochromatographic test strip assay (ITSA) under capillary force is one of the most common methods for the rapid detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring.
Instant claim 43, as stated above Patent ‘463 does not recite the claimed interpretation of the results. Luo has been discussed in the above rejection. Luo also teaches analyzing the results of the capillary action test with CCD detector (Fig. 5). Luo teaches subtracting the value of luminescence of the background signal and then determining the ratio of the signal from the detection zone to the signal from the control zone (Fig. 5c-d). Thus, it would have been obvious to the person to interpret the results as claimed because Luo teaches YVO4:Eu nanoparticles and that immunochromatographic test strip assay (ITSA) under capillary force is one of the most common methods for the rapid detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring.
Claims 26-34 and 36-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-14 of U.S. Patent No. 12399124 (‘124) in view of Luo et al. (“Synthesis of carboxyl-capped and bright YVO4:Eu,Bi nanoparticles and their applications in immunochromatographic test strip assay”, Materials Research Bulletin, vol. 48, 2013, pgs. 4454-4459, published 07/29/2013).
Patent No. ‘124 recites in claim 10 a process for ultrasensitive in vitro detection and/or quantification of a target substance of biological or chemical interest by detecting luminescence emission by photoluminescent inorganic nanoparticles wherein the nanoparticles being the formula: A1-xLnxVO 4(1-y)(PO4)y in which: A is selected from yttrium (Y), gadolinium (Gd), lanthanum (La), and mixtures thereof; Ln is selected from europium (Eu), dysprosium (Dy), samarium (Sm), neodymium (Nd), erbium (Er), ytterbium (Yb), and mixtures thereof; 0<x<1; and 0≤y<1. Claim 11 recites wherein said nanoparticles of formula (II) have on their surface tetraalkylammonium cations. Claim 12 recites formula (II’). Claim 13 recites nanoparticles are of formula Y1-xEuxVO4 wherein 0 < x < 1.
However, Patent No. ‘124 does not explicitly recite a capillary action test. Luo has been discussed in the above rejection.
It would have been obvious to the person of ordinary skill in the art at the time of filing to have used the nanoparticles of formula: A1-xLnxVO 4(1-y)(PO4)y as recited by Patent No. ‘124 with the immunochromatographic assay using capillary action as taught by Luo because Luo teaches immunochromatographic test strip assay (ITSA) is one of the most common methods for the rapid visual detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring. The person would have reasonably expected success in using the YVO4:Eu nanoparticles recited by the Patent in the immunochromatographic assay because it has been well understood by Luo to use YVO4:Eu nanoparticles for a sharp immunoassay detection.
Instant claim 27, Patent No. ‘124 recites all the limitations of the photoluminescent inorganic nanoparticles. Thus, it would produce the excitation of the matrix at a wavelength less than or equal to 300 nm.
Instant claim 28, Patent No. ‘124 recites above a process for ultrasensitive in vitro detection and/or quantification of a target substance of biological or chemical interest by detecting luminescence emission by photoluminescent inorganic nanoparticles.
Instant claim 29, Patent No. ‘124 recites above a process for ultrasensitive in vitro detection and/or quantification of a target substance of biological or chemical interest by detecting luminescence emission by photoluminescent inorganic nanoparticles which would read on the instant claim 29 of detecting and/or quantifying molecule in a sample.
Instant claim 30, Patent No. ‘124 does not recite the photoluminescent nanoparticles have an average size. Luo teaches the nanoparticles having 10nm in diameter (see Fig. 1(a)). Thus, it would have been obvious to the person to have the photoluminescent nanoparticles with the average size between 5nm to 1µm to perform immunochromatographic assay under capillary action of Luo.
Instant claim 31, Patent No. ‘124 recites in claim 10 Ln is selected from europium (Eu), dysprosium (Dy), samarium (Sm), neodymium (Nd), erbium (Er), ytterbium (Yb), and mixtures thereof; 0<x<1; and 0≤y<1.
Instant claim 32, Patent No. ‘124 recites in claim 10 variable A is selected from yttrium (Y), gadolinium (Gd), lanthanum (La), and mixtures thereof.
Instant claim 33, Patent No. ‘124 recites in claim 14 the nanoparticle has, at the surface, tetraalkylammonium cations in an amount such that said nanoparticle has a zeta potential, ζ, of less than or equal to −28 mV in an aqueous medium with a pH≥5, and with an ionic conductivity of strictly less than 100 μScm−1.
Instant claims 34 and 36-39, as stated above, Patent No. ‘124 does not recite the claimed capillary action test device. Luo has been discussed in the above rejection. Luo also teaches the different zones in the immunochromatographic assay under capillary action (see Figs. 4-5). Thus, it would have been obvious to the person have used a plurality of the nanoparticles with the immunochromatographic assay under capillary action because Luo teaches YVO4:Eu nanoparticles and that immunochromatographic test strip assay (ITSA) is one of the most common methods for the rapid detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring.
Instant claim 40, Patent’s luminescent nanoparticles read on the instant claimed YVO4 matrix at a wavelength between 230 and 320 nm as it reads on structure of the claimed photoluminescent inorganic nanoparticles having formula (II).
Instant claim 41, as stated above, Patent No. ‘124 does not recite capillary action test. Luo has been discussed in the above rejection. Luo also teaches the results of the capillary action test with visually detected test strip (Fig. 5). However, it would have been obvious that the Patent’s luminescent nanoparticles would provide the result of direct, naked eye observation as it reads on structure of the claimed photoluminescent inorganic nanoparticles having formula (II).
Instant claim 42, Patent No. ‘124 does not recite the reading of the results of the capillary action test is using detection equipment comprising an emission filter and a photon detector. Luo has been discussed in the above rejection. Thus, it would have been obvious to the person to have read the results as claimed because Luo teaches YVO4:Eu nanoparticles and that immunochromatographic test strip assay (ITSA) under capillary force is one of the most common methods for the rapid detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring.
Instant claim 43, as stated above, Patent No. ‘124 does not recite the claimed interpretation of the results. Luo has been discussed in the above rejection. Luo teaches subtracting the value of luminescence of the background signal and then determining the ratio of the signal from the detection zone to the signal from the control zone (Fig. 5c-d). Thus, it would have been obvious to the person to interpret the results as claimed because Luo teaches YVO4:Eu nanoparticles and that immunochromatographic test strip assay (ITSA) under capillary force is one of the most common methods for the rapid detection of a number of analytes, and has been applied in various fields, such as clinical diagnostic, food analysis, and environmental monitoring.
Response to Arguments
Applicant's arguments filed 01/08/2026 have been fully considered but they are not persuasive.
Obviousness Rejections
Applicant argues on page 10 that the office interprets the teaching of Luo beyond its contents; this is beyond the reasonable scope of interpretation. Although Luo teaches YVO4:Eu nanoparticles have good water solubility indicating their biological applications, the ITSA applications using rare-earth nanoparticles as probes need further promotion. Applicant argues on page 11 that Luo describes preliminary evaluations in order to identify which particles containing bismuth (i.e., YVO4:Eu, Bi) are good candidate as biomarker in ITSA applications. Applicant argues on page 12 that Luo teaches how to shift the YVO4:Eu absorption peak to the red because 280/300nm excitation is considered less optimal than 350 nm excitation. Thus, it is not reasonable to consider that it can be considered to use the bismuth-free particles (YVI4:Eu) in the ITSA to complete the comparative study. Applicant further argues bottom of page 12 that there is no indication in Shen to consider that the described particles could be used in ITSA applications.
The arguments are not found persuasive for the following reasons. The obviousness rejection above is not based on whether Luo would perform the reaction but rather the person of ordinary skill in the art would use YVO4:Eu without doping Bi3+ nanoparticles for immunochromatographic assay. In particular, Luo’s YVO4:Eu nanoparticles read on the claimed structure of photoluminescent inorganic nanoparticle of formula (II) A1-xLnxVO4(1-0). Meanwhile, the claims only use naked-eye observation or a photon detector but do not require the photoluminescent nanoparticles (as claimed) to produce any specific luminescence emission. The naked-eye observation or photon detector could be detecting zero or low luminescence emission. The difference between YVO4:Eu and YVO4:Eu,%Bi is an additional doping of Bi3+ into the YVO4:Eu nanoparticles. Although Luo did not use the conventional photoluminescent nanoparticle (i.e., YVO4:Eu) in their immunochromatographic assay through capillary action (as stated above in the rejection), Luo teaches using photoluminescent inorganic nanoparticles comprising YVO4:Eu for immunochromatographic assay. Thus, the nanoparticles comprising YVO4:Eu is recognized and established in the art as nanoparticles for immunochromatographic assay. Also, Luo recognizes that YVO4:Eu nanoparticle without Bi3+ is used as a comparison against the modified photoluminescent inorganic nanoparticles (i.e., YVO4:Eu,%Bi, see Fig. 3b) for comparing functional abilities. Thus, the person of ordinary skill in the art would recognize that to establish direct quality or whether the modified YVO4:Eu,%Bi has also improved in immunochromatographic detection, the person would produce a functionalized YVO4:Eu nanoparticle without Bi3+ to directly compare the quality of YVO4:Eu,%Bi in immunochromatographic detection, as YVO4:Eu and YVO4:Eu,%Bi have been known to be comparable. As stated above, the difference between YVO4:Eu and YVO4:Eu,%Bi nanoparticles is the additional doping of Bi3+ into the YVO4:Eu nanoparticles. Thus, the artisan would have excited at 300 nm for YVO4:Eu nanoparticle (as established in Fig. 3 (b) of Luo) to produce a direct comparison to YVO4:Eu,%Bi nanoparticles in immunochromatographic detections.
In addition, the purpose of combining Luo and Shen (secondary reference) is to establish (1) YVO4:Eu without Bi3+ nanoparticles are recognized to be surface modified for immunoassays via polymer and (2) the quality of sharp emissions and high quantum yields of 54% for YVO4:Eu without Bi3+ as taught by Shen. In particular, Luo establishes in Figs 3(a)-(c) the importance of sharp peaks and quantum yields in its photoluminescent nanoparticles for immunochromatographic assay. Importantly, Shen establishes that luminescent quantum yield of YVO4:Eu is 54% and the inorganic core has 20nm. Meanwhile, Luo’s YVO4:Eu,%Bi nanoparticles only have a highest quantum yield of ~ 43%. Luo recognizes in performing its immunochromatographic detection through the quality of photoluminescent nanoparticles (i.e., based on sharp peaks and quantum yields, see abstract). It would have been obvious to try a superior YVO4:Eu nanoparticle that contains a higher quantum yield with nanoparticle size and surface is modifiable for immunoassays. Therefore, it is not hindsight to use YVO4:Eu without Bi3+ for capillary action as recited.
Applicant further argues on page 13 that Iso reference teaches tetramethylammonium silicate (TMAS) and such a composite does not correspond to particles having tetraalkylammonium ions in surface since the particles are included in the silica matrix. Applicant argues that the examiner as taken in account only a part of Iso’s teaching and as not taken in account the addition of methyl lactate which is mandatory for obtaining the final composite.
The arguments are not found persuasive. In particular, claim 33 recites the element of tetraalkylammonium cations that has not been previously disclosed in claim 26 as part of either the claimed formula II of nanoparticles nor part of the reaction. In other words, these limitations are not required for the claimed reaction but rather prior to the claimed reaction that the nanoparticles have tetraalkylammonium cations. Because (1) the claims do not specify the presence of tetraalkylammonium cations are during the claimed reaction and (2) it has been recognized in the art that negatively-charged hydrophilic nanoparticles containing YVO4:Eu can be well dispersed in tetraalkylammonium cationic aqueous solution which means the nanoparticles are colloidally in solution without aggregation.
Nonstatutory double patenting rejections
Applicant argues on page 14 that it is not obvious how Luo would be combined with the cited Patents because of the Luo is deficient for the same reasons as recited above and thereby the combination could only be made with impermissible hindsight.
The arguments are not found persuasive because Luo recognizes using the claimed photoluminescent inorganic nanoparticles for detection and teaches capillary action for photoluminescent inorganic nanoparticles. Also, for the reasons stated above, it would have been obvious to use the Patent’s photoluminescent inorganic nanoparticles for capillary action. Thus, the rejections are not hindsight. Additionally, the instant claims do not require the photoluminescent nanoparticles to produce any specific luminescence emission. The naked-eye observation or photon detector could be detecting no luminescence emission.
Conclusion
No claim is 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.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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