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 .
Claims 1, 3, 5, 7-9, 11, 13, 15-21, 23, 26 and 28-30 are pending.
Claims 2, 4, 6, 10, 12, 14, 22, 24-25, 27 are cancelled.
Claims 13, 15-21, 23, 26 and 28-30 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/29/2026 has been entered.
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, 3, 5 7-9 and 11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. US 11248088 B2 in view of HUANG (Synthesis of Fluorescent Carbohydrate-Protected Au Nanodots for Detection of Concanavalin A and Escherichia coli. Analytical chemistry. 2009) and LIU (A facile one-pot synthesis of higher yield porphyrin functionalized Co3O4 nanoparticles. Materials Science and Engineering B. 2015.).
The patent recites a hybrid nanodot made by a process comprising an operation of reacting a mixture of poly(ethylene imine) (PEI) and an amino acid selected from the group consisting of serine, threonine, cysteine, tyrosine, asparagine, glutamine, lysine, aspartic acid, glutamic acid and mixtures thereof under hydrothermal reaction conditions, wherein the weight ratio of amino acid to PEI is about 3:1 to about 1:1, and wherein PEI has an average molecular weight of about 1200 g/mol to about 1800 g/mol determined by light scattering (claim 1), which reads on a nanoparticle wherein the core is an amorphous core formed from a hydrothermal reaction between threonine and polyethylenimine (PEI). The nanodots exhibit excitation-dependent fluorescence emission (claim 6), which reads on photoluminescent core.
The patent does not teach functionalizing the nanoparticle with a carbohydrate using a hydrothermal process.
HUANG teaches nanoparticles that are used for fluorescence detection of Escherichia coli (abstract). Nanoparticles are often used for diagnostic purposes (Page 875, paragraph 2). Mannose is functionalized on the surface of these nanoparticles because it binds well to Escherichia coli allowing for fluorescence detection (figure 7), which allows for targeting of Escherichia coli (E. Coli). The nanoparticle has a dimeter of 1.8 nm (page 877, paragraph 1). The diameter of the particle has an effect on the intensity of the luminescence (Page 879, paragraph 1).
LIU teaches using a hydrothermal reaction to create porphyrin functionalized nanoparticles (abstract). The hydrothermal formation allowed for a high yield (page 57, paragraph2), was inexpensive convenient and quicker (page 58, paragraph 6). Porphyrin was attached using this method (scheme 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate functionalizing the surface with a carbohydrate, such as mannose. The person of ordinary skill in the art would have been motivated to make those modifications, because mannose can act as a targeting moiety because it binds well to Escherichia coli allowing for fluorescence detection, and reasonably would have expected success because both references are in the same field of endeavor, such as nanoparticles for diagnostic use and the composition in LI can be used as a diagnostic agent and can have various targeting moieties attached.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate forming the core and functionalizing the nanoparticle through a hydrothermal reaction. The person of ordinary skill in the art would have been motivated to make those modifications, because a hydrothermal reaction is inexpensive, simple, convenient and quick, and reasonably would have expected success because the references are in the same field of endeavor, such as the formation of nanoparticles.
Note, since the same compost ion and formation is used, it would be inherent that the prior art would have the same properties of “the photoluminescence from the core is emittable within the range of about 400 nm to about 650 nm” and “wherein the emittable photoluminescence is at least 1.5 times a comparator nanoparticle which does not comprise both threonine and PEI”, unless proven otherwise.
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 (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.
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, 3, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over LI (US 7,261,875 B2) in view of HUANG (Synthesis of Fluorescent Carbohydrate-Protected Au Nanodots for Detection of Concanavalin A and Escherichia coli. Analytical chemistry. 2009), YANG (Green, Hydrothermal Synthesis of Fluorescent Carbon Nanodots from Gardenia, Enabling the Detection of Metronidazole in Pharmaceuticals and Rabbit Plasma. Sensors. 2018.) and LIU (A facile one-pot synthesis of higher yield porphyrin functionalized Co3O4 nanoparticles. Materials Science and Engineering B. 2015.).
Regarding claim 1, LI teaches a composition that has a core made from branched polyethyleneimine (PEI) (column 3, paragraph 2 and column 8, paragraph 5) and threonine (column 10, paragraph 3). The composition is designed to be a carrier for drugs or diagnostic agents and can have various targeting moieties attached (abstract).
LI does not teach functionalizing the surface with a carbohydrate, such as mannose or forming the core and functionalizing via a hydrothermal reaction.
HUANG teaches nanoparticles that are used for fluorescence detection of Escherichia coli (abstract). Nanoparticles are often used for diagnostic purposes (Page 875, paragraph 2). Mannose is functionalized on the surface of these nanoparticles because it binds well to Escherichia coli allowing for fluorescence detection (figure 7), which allows for targeting of Escherichia coli (E. Coli). The nanoparticle has a dimeter of 1.8 nm (page 877, paragraph 1). The diameter of the particle has an effect on the intensity of the luminescence (Page 879, paragraph 1).
YANG teaches a method of forming fluorescent carbon nanoparticles (abstract). A hydrothermal reaction is used to form the core and functionalization (page 2, paragraph 3). This method allowed for simplicity, cost-effectiveness, and convenience (page 2, paragraph 3).
LIU teaches using a hydrothermal reaction to create porphyrin functionalized nanoparticles (abstract). The hydrothermal formation allowed for a high yield (page 57, paragraph2), was inexpensive convenient and quicker (page 58, paragraph 6). Porphyrin was attached using this method (scheme 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate functionalizing the surface with a carbohydrate, such as mannose. The person of ordinary skill in the art would have been motivated to make those modifications, because mannose can act as a targeting moiety because it binds well to Escherichia coli allowing for fluorescence detection, and reasonably would have expected success because both references are in the same field of endeavor, such as nanoparticles for diagnostic use and the composition in LI can be used as a diagnostic agent and can have various targeting moieties attached.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a diameter of 1.8 nm. The person of ordinary skill in the art would have been motivated to make those modifications, because the diameter has an effect on the luminescence of the nanoparticle, and reasonably would have expected success because both references are in the same field of endeavor, such as nanoparticles for diagnostic use.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate forming the core and functionalizing the nanoparticle through a hydrothermal reaction. The person of ordinary skill in the art would have been motivated to make those modifications, because a hydrothermal reaction is inexpensive, simple, convenient and quick, and reasonably would have expected success because the references are in the same field of endeavor, such as the formation of nanoparticles. Note, since the core would be formed in the same way, hydrothermal, and from the same components, PEI and threonine, it would inherently be an amorphous core, unless proven otherwise.
Regarding claim 3, the prior art’s composition would have the same chemical/physical properties of “wherein the emittable photoluminescence is at least 1.5 times a comparator nanoparticle which does not comprise both threonine and PEI” and “a zeta potential of more than about +5 mV” as claimed by Applicant, because the prior art has the same components as claimed by Applicant, unless proven otherwise.
Regarding claim 5, LI teaches a composition that has a core made from branched polyethyleneimine (PEI) (column 3, paragraph 2 and column 8, paragraph 5).
Regarding claim 7, HUANG teaches nanoparticles that are functionalized with Mannose (figure 7). Furthermore, the prior art’s composition would have the same chemical/physical properties of “wherein the emittable photoluminescence e is at least 4 times a comparator nanoparticle which does not comprise mannose” as claimed by Applicant, because the prior art has the same components as claimed by Applicant, unless proven otherwise.
Regarding claim 8, HUANG teaches the nanoparticle has a dimeter of 1.8 nm (page 877, paragraph 1).
Regarding claim 9, Applicant’s specification states that the photoluminescent stability is effected by the component used as the shell (Page 12, paragraph 5) and the components of the core (page 7, paragraph 3), therefor since the art has the same shell, mannose, it would have the same physical/chemical property of photoluminescence stability of at least 95% after 30 minutes of irradiation, wherein the photoluminescence is fluorescence.
Claims 1, 3, 5, 7-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over LI (US 7,261,875 B2), HUANG (Synthesis of Fluorescent Carbohydrate-Protected Au Nanodots for Detection of Concanavalin A and Escherichia coli. Analytical chemistry. 2009), YANG (Green, Hydrothermal Synthesis of Fluorescent Carbon Nanodots from Gardenia, Enabling the Detection of Metronidazole in Pharmaceuticals and Rabbit Plasma. Sensors. 2018.) and LIU (A facile one-pot synthesis of higher yield porphyrin functionalized Co3O4 nanoparticles. Materials Science and Engineering B. 2015.) in view of DONG (Antibacterial effects of carbon dots in combination with other antimicrobial reagents. PLOS One. 2017.).
LI, HUANG, YANG, and LIU teach Applicant’s invention as discussed above. As discussed above, HUANG teaches targeting E. Coli.
LI, HUANG, YANG, and LIU do not teach a minimum inhibitory concentration (MIC) of 64
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µg/mL.
Regarding claim 11, DONG teaches a carbon nanodot with a MIC of 64
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µg/mL (abstract). This value allowed for complete inhibition of growth for E. coli which equates to good antibacterial properties (page 5, paragraph 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a MIC of 64
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µg/mL. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows for complete inhibition of growth of E. coli, which gives the composition increased antibacterial properties, and reasonably would have expected success because the references are in the same field of endeavor, such as nanoparticles.
Response to Arguments
Applicant argues, the instantly claimed nanoparticles are particularly advantageous for use in a rapid detection method for pathogenic bacteria with high sensitivity for detecting very low bacteria concentrations. The photoluminescence of the claimed nanoparticles is at least 1. 5 times that of a comparator nanoparticle which does not comprise both threonine and PEI. The combination of threonine and PEI under hydrothermal conditions allows for (after polymerization or crosslinking) a further rearrangement and aromatization into a conjugated pi system. This is particularly advantageous for providing the high and/or stable photoluminescent property of the nanoparticle, in contrast to other amorphous core nanoparticles, which can have numerous electron-hole defects which act to reduce the photoluminescent property. Specification, page 7, lines 17-27.
This argument is not persuasive. Unexpected results must be supported by factual evidence, and attorney argument is not evidence. See In re Pearson, 494 F.2d 1399,1405 (CCPA 1974). The cited paragraphs of the Specification detail benefits of the claimed method but do not state that unexpected results were obtained. Thus, Applicant has not provided evidence that unexpectedly superior results were obtained with the claimed method. "Mere improvement in properties does not always suffice to show unexpected results." In re Soni, 54 F.3d 746,751 (Fed. Cir. 1995). In the instant case, as discussed above, LI teaches a core made from PEI and threonine and YANG and/or LIU teach the advantageous of a hydrothermal reaction formation. Since the properties arise from the specific components and formation method, it can be understood to have the same properties, unless proven otherwise.
For a complete discussion of unexpected results, Applicants are referred to MPEP 716.02 et seq.
Applicant argues, the claimed nanoparticles as recited in amended claim 1 comprise carbohydrates that are functionalized on the surface of the nanoparticle through a hydrothermal process. Functionalization with a carbohydrate through a hydrothermal process is particularly advantageous as specific bacterial cells can be targeted when used in an assay. Compared to unfunctionalized nanoparticles, carbohydrate functionalized nanoparticles are able to be endocytosed to a larger extent without causing the bacterial cells to undergo apoptosis. Additionally, unspecific binding is largely reduced. This allows for the bacteria assay to be more accurate and/or precise. Id, page 7, line 34 to page 8, line 3.
The argument is not persuasive because as discussed above, HUANG teaches that Mannose is functionalized on the surface of nanoparticles because it binds well to Escherichia coli allowing for fluorescence detection (figure 7), which allows for targeting of Escherichia coli (E. Coli). It is also well known in the art that a targeted nanoparticle, such as the one described in HUANG, will target and bind better than a non-targeted nanoparticle.
Applicant argues, the presently claimed nanoparticles bind to bacteria more efficiently and are subsequently taken up by the bacteria cells. The nanoparticles provide a brighter photoluminescence, with an at least 8-fold higher intensity compared to serine-PEI nanoparticles (about 90,000 a.u.) Id, page 7, line 29-32 and Figure 1.
The argument is not persuasive because as discussed above, HUAG teaches using mannose to make the nanoparticles targeting, which would lead to higher binding and LI teaches using a threonine/PEI core, which Applicant states is giving the higher intensity.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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