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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/24/2025 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tagaya 1 (Inorganic Chemistry, 2014; document already in record) in view of Mont (High-refractive-index TiO2-nanoparticles -loaded encapsulants for light-emitting dioses, J. Appl. Phys. 103, 083120, 2008). Tagaya 1 teaches a light-emitting nanoparticle comprising silica as a matrix material and Eu(III) (a light-emitting substance; a fluorescein-based dye molecule; a rare earth ion; trivalent Eu) for use in bioimaging and observation of cancer cells (Abstract; Experimental Section). Tagaya 1 teaches a light-emitting nanoparticle comprising silica and Eu(III) (a light-emitting substance; a fluorescein-based dye molecule; a rare earth ion; trivalent Eu) for use in bioimaging and observation of cancer cells (Abstract; Experimental Section). The compound 3-aminopropyltriethoxysilane (a cell bonding molecule) is bonded to the surface (wherein an amino group bonded to the cationic element is formed at a surface) (Experimental Section). The concentration of Europium is 2.5, 5.0 or 10 mol% (Experimental Section). The pore diameter is 2.4 to .7 nm (Results and Discussion). The particle size is 30-1000 nm (Results and Discussion). The photoluminescence of the nanospheres functionalized with folic acid exhibit a characteristic peak due to energy transfer between FA and Eu3+, and further the orange luminescence could be clearly detected by fluorescence microscopy in air and water. Furthermore, the nanospheres highly dispersed in cell culture medium exhibited nontoxicity in the cellular proliferation stages of the Hela cancer cells and NIH3T3 fibroblasts and specifically bind to the Hela cells (Results and Discussion). The nanospheres after the binding and uptake also showed intense luminescence from the outer/inner cell surfaces for the culture time of 4 days. Therefore, the luminescent FA-functionalized Eu:NPS nanospheres can be used for specific targeting and imaging abilities for cancer cells (Results and Discussion). The method “possesses attractive features such as… controllable pore size” (Introduction). A pore diameter given is 2.7 nm (Results and Discussion). The compound 3-aminopropyltriethoxysilane (a cell bonding molecule) is bonded to the surface (wherein an amino group bonded to the cationic element is formed at a surface) (Experimental Section). The concentration of Europium is 2.5, 5.0 or 10 mol% (Experimental Section). The particle size is 30-1000 nm (Results and Discussion). The photoluminescence of the nanospheres functionalized with folic acid exhibit a characteristic peak due to energy transfer between FA and Eu3+, and further the orange luminescence could be clearly detected by fluorescence microscopy in air and water. Furthermore, the nanospheres highly dispersed in cell culture medium exhibited nontoxicity in the cellular proliferation stages of the Hela cancer cells and NIH3T3 fibroblasts and specifically bind to the Hela cells (Results and Discussion). The nanospheres after the binding and uptake also showed intense luminescence from the outer/inner cell surfaces for the culture time of 4 days. Therefore, the luminescent FA-functionalized Eu:NPS nanospheres can be used for specific targeting and imaging abilities for cancer cells (Results and Discussion).
Tagaya 1 fails to teach TiO2 as the nanoparticle matrix material. Tagaya 1 further fails to teach incorporation of a surfactant. Tagaya 1 further fails to teach nanoparticles is 10 nm to 500 nm (claim 9), and further fails to teach applicant’s claimed pore diameter of 0.1 to 10 nm (claim 10).
Mont teaches that TiO2 is known in the art as a matrix material for encapsulation of light-emitting diodes (a light-emitting substance) (Abstract; Introduction). The TiO2 matrix material comprises a surfactant, which drastically enhances particle stability (Experimental and Results).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use TiO2 as the matrix material of Tagaya 1. The motivation for this would have been that TiO2 is known in the art to serve as a matrix material for encapsulating a light-emitting substance. This satisfies a matrix material comprising at least one cationic element wherein the element is Ti, and at least one anionic elements wherein the element is O. It would have been further obvious to incorporate a surfactant into the modified composition, as Mont teaches that the presence of a surfactant drastically enhances particle stability. As “dispersed” means to be distributed or spread over a wide area, and as the TiO2 matrix material of Mont comprises a surfactant and TiO2 is known in the art as a matrix material for encapsulation of light-emitting diodes, both the surfactant and the light-emitting substance would be dispersed in the matrix material, which is “a surfactant dispersed in the matrix material together with the light-emitting substance.” It would have been further obvious to optimize the average particle diameter of the light-emitting nanoparticles of Tagaya 1 to improve their efficacy for bioimaging. In this way, one would the applicant’s range of 10 nm to 500 nm. Tagaya 1 provides sufficient guidance to this end as it teaches the range of 30-1000 nm which overlaps with the instant range of 10 nm to 500 nm. It would have been further obvious to optimize the pore diameter to improve the efficacy of the light-emitting nanoparticles for bioimaging, and in this way, the artisan would find the range of 0.1 to 10 nm through routine experimentation. The prior art provides sufficient guidance to this end, as it teaches that the pore size is a result effective parameter, and further teaches the diameter of 2.7 nm, which nearly touches applicant’s range.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that Tagaya 1 does not teach incorporation of a surfactant, the examiner’s response is that Mont teaches that incorporating a surfactant into the matrix material drastically enhances particle stability (Experimental and Results), and for the reasons stated above, it would have been obvious to incorporate a surfactant into the modified composition to enhances particle stability. Regarding applicant’s argument that in the Experimental Section of Tagaya 1, the method of preparing the composition involves calcination, which would remove the specific surfactant used by Tagaya 1, the examiner’s response is that a reference is not limited to examples and specific embodiments. Although the specific surfactant used in the example would have been reasonably removed during calcination in the method of preparation presented in the example, there is no teaching against incorporating surfactants into the composition, and there would be motivation to incorporate surfactants into the composition for the reasons set forth above. Regarding applicant’s argument that the references fail to teach a surfactant dispersed in the matrix material together with the light-emitting substance, the examiner’s response is that as “dispersed” means to be distributed or spread over a wide area, and as the TiO2 matrix material of Mont comprises a surfactant and TiO2 is known in the art as a matrix material for encapsulation of light-emitting diodes, both the surfactant and the light-emitting substance would be dispersed in the matrix material, which is “a surfactant dispersed in the matrix material together with the light-emitting substance.”
Claims 1-7,9-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tagaya 2 (Journal of Colloid and Interface Science, 2011; document already in record) in view of Mont (High-refractive-index TiO2-nanoparticles -loaded encapsulants for light-emitting dioses, J. Appl. Phys. 103, 083120, 2008). Tagaya 2 teaches a light-emitting nanoparticle comprising silica as a matrix material and Eu(III) (a light-emitting substance; a fluorescein-based dye molecule; a rare earth ion; trivalent Eu), which provides enhanced luminescence for biological applications (Abstract; Introduction Experimental Section). The surface is provided with a micropore in which the pore diameter is 2.3-2.7 nm (Section 3.2.). The average particle diameter is between about 200 to about 1350 (Figure 6). The concentration of Eu3+ is 2.5, 5.0, or 10.0 mol% (Table 1). The light-emitting nanoparticles were prepared by combining and stirring water, cetyltrimethylammonium bromide, and NaOH, to which was added tetraethoxysilane and an aqueous solution of Eu3+ comprising EuCl3-6H2O, and after stirring at elevated temperature for 2 hours, the resulting solution was filtered, the solid were washed, vacuum dried, and calcined (Section 2.2).
Tagaya 2 fails to teach TiO2 as the matrix material. Tagaya 2 further fails to teach incorporation of a surfactant. Tagaya 2 further fails to teach applicant’s claimed pore diameter of 0.1 to 10 nm. Tagoya 2 fails to teach “wherein an average particle diameter of the light-emitting nanoparticles is 10 nm to 500 nm.”
Mont teaches that TiO2 is known in the art as a matrix material for encapsulation of light-emitting diodes (a light-emitting substance) (Abstract; Introduction). The TiO2 matrix material comprises a surfactant, which drastically enhances particle stability (Experimental and Results).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use TiO2 as the matrix material of Tagaya 2. The motivation for this would have been that TiO2 is known in the art to serve as a matrix material for nanoparticles encapsulating a light-emitting substance. This satisfies a matrix material comprising at least one cationic element wherein the element is Ti, and at least one anionic elements wherein the element is O. As “dispersed” means to be distributed or spread over a wide area, and as the TiO2 matrix material of Mont comprises a surfactant and TiO2 is known in the art as a matrix material for encapsulation of light-emitting diodes, both the surfactant and the light-emitting substance would be dispersed in the matrix material, which is “a surfactant dispersed in the matrix material together with the light-emitting substance.” It would have been further obvious to incorporate a surfactant into the modified composition, as Mont teaches that the presence of a surfactant drastically enhances particle stability. It would have been further to optimize the average particle diameter of the light-emitting nanoparticles of Tagaya 2 to improve their efficacy for biological applications. In this way, one would the applicant’s range of 10 nm to 500 nm. Tagaya 2 provides sufficient guidance to this end as it teaches the range of about 200 to about 1350 (Figure 6) which overlaps with the instant range of 10 nm to 500 nm. It would have been further obvious to optimize the pore diameter to improve the light-emitting particles efficacy for bioimaging, and in this way, the artisan would find the range of 3.7 to 10 nm through routine experimentation. The prior art provides sufficient guidance to this end, as it teaches the pore size is a result effective parameter, and further teaches the diameter of 2.7 nm, which nearly touches applicant’s range. “’[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)” MPEP § 2144.05, II. Regarding the intended use limitations recited in claims 15-16, the recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the present case, as the light-emitting nanoparticle of modified Tagaya 2 is structurally identical to the presently claimed light-emitting particle, it must be capable of performing the claimed intended uses of the light-emitting particle.
Applicant’s arguments have been fully considered but are not found persuasive.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that Tagaya 2 does not teach incorporation of a surfactant, the examiner’s response is that Mont teaches that incorporating a surfactant into the matrix material drastically enhances particle stability (Experimental and Results), and for the reasons stated above, it would have been obvious to incorporate a surfactant into the modified composition to enhances particle stability. Regarding applicant’s argument that in the Experimental Section of Tagaya 2, the method of preparing the composition involves calcination, which would remove the specific surfactant used by Tagaya 2, the examiner’s response is that a reference is not limited to examples and specific embodiments. Although the specific surfactant used in the example would have been reasonably removed during calcination in the method of preparation presented in the example, there is no teaching against incorporating surfactants into the composition, and there would be motivation to incorporate surfactants into the composition for the reasons set forth above. Regarding applicant’s argument that the references fail to teach a surfactant dispersed in the matrix material together with the light-emitting substance, the examiner’s response is that as “dispersed” means to be distributed or spread over a wide area, and as the TiO2 matrix material of Mont comprises a surfactant and TiO2 is known in the art as a matrix material for encapsulation of light-emitting diodes, both the surfactant and the light-emitting substance would be dispersed in the matrix material, which is “a surfactant dispersed in the matrix material together with the light-emitting substance.”
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 1-7, 9-13 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-12, 14-15 and 17-18 of U.S. Patent Application No. 16/089,759. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are directed to a light-emitting nanoparticle comprising a matrix material, and a light- emitting substance included in the matrix material, wherein the matrix material comprises: Si being a cationic element; O being an anionic element; and a surfactant molecule, and the light-emitting nanoparticle has a surface provided with a pore having a pore diameter of 3.7 to 10 nm (copending claim 1), wherein the matrix material comprises Ti02 (copending claim 3). The light-emitting nanoparticle has a surface provided with a pore having a pore diameter of 3.7 to 10 nm, wherein the organic light-emitting dye is a fluorescein-based dye molecule, wherein a contained concentration of the organic light-emitting dye is 1 mmol% to 6 mol% with respect to the cationic element, wherein an average particle diameter of the light-emitting nanoparticles is 10 nm to 500 nm, wherein a hydroxyl group and/or amino group bonded to the cationic element is formed at a surface, wherein a surface is modified by a cell bonding molecule. This anticipates the present claims.
Applicant requests the rejection be held in abeyance. The examiner’s response is that the rejection is proper and is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
October 31, 2025