DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on February 22nd, 2024 and August 15th, 2025 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Declaration Pursuant to 37 C.F.R. 1.130
It is noted that the Applicant, Jung-Hoon Lee, has provided a Declaration under 37 C.F.R. 1.130, filed March 7th, 2024, with regard to the scientific article “Ultrasensitive Plasmonic Photothermal Immunomagnetic Bioassay Using Real-Time and End-Point Dual-Readout” published in Sensors and Actuators B: Chemical, Volume 377, on February 15, 2023. The Applicant has identified this as a grace period disclosure published less than one year before the EFD of the instant application. The Applicant declares they are the original inventor of the subject matter of the instant application and co-author of the above identified article. The Applicant declares that other listed co-authors of the above identified article did not contribute to the conception or development of the subject matter of the instant application, and only contributed elements from the above identified article that are not claimed or were not involved in the conception or reduction to practice of the claimed subject matter.
This Declaration is acknowledged by the Examiner and the above identified article is not considered available as prior art.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8, in the reply filed on June 3th, 2026 is acknowledged.
Claims 9-11 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 30th, 2026.
Claim Summary
Claims 1-11 are pending. Claims 9-11 are withdrawn from consideration as being drawn to a non-elected invention/species. Claims 1-8 are under examination and discussed in this Office action.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The use of terms such as VENT and DEEPVENT, which are trade names or a marks used in commerce, has been noted in this application. All terms should be accompanied by the generic terminology; furthermore all terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations “a) binding capture antibody and plasmonic immunomagnetic nanoparticles (PIMNs); (b) binding detection antibody and streptavidin-nucleic acid complex; (c) mixing the nanoparticles bound to the capture antibody and the complex bound to the detection antibody; (d) separating the mixed nanoparticles and complex”. It is unclear from this recitation what the capture antibody and detection antibody are intended to interact with as there is no interaction partner, like an antigen or a protein, recited in the claim. With no described interaction partner, it is further unclear how it is possible to separate the mixed nanoparticles and complex together, as it appears to be intended. A mixture of the nanoparticles and complex bound to their respective antibodies without an interaction partner does not appear to result in an association between the antibodies as no such step is recited, and therefore separation will potentially separate the nanoparticles from the complex. Given these issues, it is also unclear what the method is attempting to accomplish through the use of the capture and detection antibodies. The only mentioned nucleic acid is the one in complex with streptavidin, and it appears to be the only nucleic acid that could serve as the target nucleic acid that is claimed. If the intention is to detect this nucleic acid in complex with streptavidin, this could be accomplished without the inclusion of the antibodies at all. Because of these identified issues, the claim is found indefinite. Claims 2-8 are also rejected here for their dependence on claim 1 and not further clarifying the identified issues.
For the purpose of examination, the specification has been reviewed for an indication of the purpose of the antibodies of claims 1. In the detailed description at page 15 and continuing through page 17, there is description related to examining the use of PPT-iqPCR with Human IL-6, a protein in humans. The antibodies in the described method are clearly intended to interact with this protein in a sandwich assay, with the DNA from a streptavidin-DNA complex reasonably serving as a target nucleic acid and also acting as a signaling probe (Page 15, lines 12-19). This method is further shown in more generic terms in Figure 1, where there is a target antigen shown interacting with the detection antibody and capture antibody. For the purpose of compact prosecution, it will be interpreted that the antibodies interact with an antigen, as has been described in the specification and shown in Figure 1, and the target nucleic acid will be interpreted to be the nucleic acid complexed with streptavidin.
Claim 1 also has several instances of insufficient antecedent basis, as listed below:
Regarding step (c), there has been no earlier introduction of “nanoparticles bound to the capture antibody”. The only earlier description is “binding capture antibody and plasmonic immunomagnetic nanoparticles”. Therefore, there is insufficient antecedent basis for this limitation in the claim.
Also regarding step (c), there has been no earlier introduction of “complex bound to the detection antibody”. The only earlier description is “binding detection antibody and streptavidin-nucleic acid complex”. Therefore, there is insufficient antecedent basis for this limitation in the claim.
Regarding step (d), there has been no earlier introduction of “mixed nanoparticles and complex”. The only earlier description is “mixing the nanoparticles bound to the capture antibody and the complex bound to the detection antibody”. Therefore, there is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the surface of the nanoparticle". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 3 depends, introduces “plasmonic immunomagnetic nanoparticles” and other references to “nanoparticles”, not a single nanoparticle. It is further noted that recitations from claim 1 regarding nanoparticles have already been identified as having their own antecedent basis issues and any amendments to recitations in claim 1 and claim 3 should align with each other.
Claim 5 recites the limitation "the nanoparticles and the complex are mixed in a sandwich structure". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 5 depends, introduces “mixing the nanoparticles bound to the capture antibody and the complex bound to the detection antibody”, not “the nanoparticles and the complex”. It is further noted that the recitation from claim 1 identified here has already been identified as having its own antecedent basis issue and any amendments to recitations in claim 1 and claim 5 should align with each other.
Claim 6 contains the trademarks/trade names VENT and DEEPVENT. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademarks/trade names are used to identify/describe DNA polymerases and, accordingly, the identification/description is indefinite.
Claim 6 also recites the limitation “the polymerase”. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 6 depends, introduces “nucleic acid polymerase”, not “polymerase”.
Claim 7 recites the limitation “the amplification”. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 7 depends, introduces “amplifying”, not “amplification”.
Claim 8 recites the limitation “the detection”. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 7 depends, introduces “detecting”, not “detection”.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Barletta (Immunomagnetic quantitative immuno-PCR for detection of less than one HIV-1 virion, Journal of Virological Methods, May 2009, 157, 122-132), in view of Qiu (Fast and sensitive immuno-PCR assisted by plasmonic magnetic nanoparticles, Applied Materials Today, June 2021, 23, 1-8; cited on the IDS filed August 15th, 2025) and Zhang (Gold-Coated Magnetic Particles for Solid-Phase Immunoassays: Enhancing Immobilized Antibody Binding Efficiency and Analytical Performance, Analytical Chemistry, January 2006, 78, 609-616). Claim 3 is further evidenced by ThermoFisher (Dynabeads™ M-280 Tosylactivated [online]. ThermoFisher, [2026] [retrieved on August 13th, 2026]. Retrieved from: https://www.thermofisher.com/order/catalog/product/14203).
Regarding instant claim 1, Barletta teaches a method for detecting target nucleic acids, comprising: (a) binding capture antibody and magnetic nanoparticles (Page 123, column 2, paragraph 3; Figure 1); (b) binding detection antibody and streptavidin-nucleic acid complex (Page 124, column 2, paragraph 3 to Page 125, column 1, paragraph 3; Figure 1); (c) mixing the nanoparticles bound to the capture antibody and the complex bound to the detection antibody Page 124, column 2, paragraph 3 to Page 125, column 1, paragraph 3; Figure 1); (d) separating the mixed nanoparticles and complex (Page 124, column 2, paragraph 3 to Page 125, column 1, paragraph 3; Figure 1); (e) amplifying target nucleic acids using the complex, primer, and nucleic acid polymerase (Page 125, column 1, paragraph 4 to column 2, paragraph 2; Figure 1); and (f) detecting target nucleic acids (Page 125, column 2, paragraph 2; Figure 1). Barletta teaches this method is an immunoPCR method (whole document).
The presented order of steps in Barletta is not the same as what is claimed. However, with respect to the order of steps, it is noted that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Thus, the claimed order of steps is an obvious variant of the steps of the cited prior art.
Barletta does not teach using plasmonic immunomagnetic nanoparticles bound to an antibody.
Qiu, in the same field of endeavor, teaches on using plasmonic magnetic nanoparticles as a part of immunoPCR reactions (Page 2, column 1, paragraph 2). These plasmonic magnetic nanoparticles are iron oxide nanoparticles coated with gold (Page 2, column 1, paragraph 2). Furthermore, Zhang, in a reasonably pertinent field, teaches on gold-coated magnetic nanoparticles functionalized with antibodies for use in immunoassays (Page 610, column 2, paragraph 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Barletta with the plasmonic magnetic nanoparticles of Qiu. Since Barletta and Qiu are in the same field of endeavor (e.g. immunoPCR), one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because plasmonic shells are used to generate photothermal heating for PCR thermocycles and magnetic cores allow separation of nanoparticles from solution using magnets (Qiu, Page 2, column 1, paragraph 2).
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Barletta with the gold-coated magnetic nanoparticles of Zhang. Since Zhang teaches on the use of these nanoparticles in immunoassays, which is reasonably pertinent to the immunoPCR of Barletta, one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because they have enhanced binding efficiencies and the potential to improve the analytical performance of solid-phase immunoassays (Page 616, column 1, paragraph 1).
Regarding instant claim 2, Barletta, in view of Qiu and Zhang, teaches the method according to claim 1. Qiu further teaches wherein in step (a), the plasmonic immunomagnetic nanoparticles have magnetism and photothermal properties (Page 2, column 1, paragraph 2).
Regarding instant claim 3, Barletta, in view of Qiu and Zhang, teaches the method according to claim 1. Barletta further teaches wherein in step (a), the capture antibody is covalently bound to the surface of the nanoparticle (Page 123, column 2, paragraph 3). As evidenced by ThermoFisher, Dynabeads M-280 Tosylactivated beads can have antibodies covalently coupled to them (Page 1).
Regarding instant claim 4, Barletta, in view of Qiu and Zhang, teaches the method according to claim 1. Barletta further teaches wherein in step (b), the detection antibody is biotinylated (Page 124, column 2, paragraph 3; Figure 1).
Regarding instant claim 5, Barletta, in view of Qiu and Zhang, teaches the method according to claim 1. Barletta further teaches wherein in step (c), the nanoparticles and the complex are mixed in a sandwich structure (Figure 1).
Regarding instant claim 6, Barletta, in view of Qiu and Zhang, teaches the method according to claim 1. Barletta further teaches wherein in step (e), the polymerase is Taq polymerase (Page 125, column 2, paragraph 1).
Regarding instant claim 7, Barletta, in view of Qiu and Zhang, teaches the method according to claim 1.
None of the references as currently presented teach wherein in step (e), the amplification is performed through photothermal cyclic amplification.
Qiu teaches wherein amplification is performed through photothermal cyclic amplification (Page 3, column 1, paragraph 5 to column 2, paragraph 1; Page 4, column 1, paragraph 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the amplification of Barletta with the amplification of Qiu. Since both Barletta and Qiu are in the same field of endeavor (e.g. immunoPCR), one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because it shows great potential as a powerful and practical method for immunoassay to reduce the necessary thermocycling time without compromising sensitivity of immunoPCR (Page 7, column 2, paragraph 2).
Regarding instant claim 8, Barletta, in view of Qiu and Zhang, teaches the method according to claim 1. Barletta further teaches wherein in step (f), the detection is performed through a fluorescence assay (Page 123, column 2, paragraph 2: FAM used on TaqMan probe; Figures 1 and 2).
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683 /Robert T. Crow/Primary Examiner, Art Unit 1683
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