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 .
Status of Claims
The submitted claim set on 06/07/2026 is acknowledged and considered. Claims 1-4 are ‘currently amended’ and claims 5-11 are ‘withdrawn’, where claims 9-11 are ‘currently amended’.
Currently, pending claims are Claims 1-11 are considered on the merits below.
Election/Restrictions
Applicant’s election of Claims 1-4 in the reply filed on 06/07/2026 is acknowledged. Claims 5-11 are withdrawn from further consideration. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the requirement is still deemed proper and is therefore made FINAL.
Response to Amendments/Arguments
Applicant' s arguments with respect to claim(s) 1-4 have been considered but are moot because the amendment to the claim 1 prompts a new ground of rejection. The rejection below has been modified to reflect the amendments to the claims; however, still in part relies on the previously applied prior art.
The applicant amended claim 1 in the claims filed on 06/07/2026. The phrase "a gold nanorod functionalized by an aptamer and a gold nanorod functionalized by an aptamer complementary chain" is amended to "a first gold nanorod functionalized by an aptamer and a second gold nanorod functionalized by a chain complementary to the aptamer". Claims 2-4 are amended accordingly to claim 1.
The amendment to claim 1 changes the scope of the limitation. The amended claim recites the “second gold nanorod functionalized by a chain complementary to the aptamer” which is narrower in scope than the original claim. The examiner interprets the original claim to be broader in scope since the original claim recites “a gold nanorod functionalized by an aptamer complementary chain”, which does not limit the “aptamer complementary chain” to be complementary to the original aptamer.
Applicant asserts that previously applied reference Weng in view of Konig does not disclose the following limitations:
(i) "[comprising]a gold nanorod dimer";
(ii) "the gold nanorod dimer is formed by self-assembling a first gold nanorod functionalized by an aptamer and a second gold nanorod functionalized by a chain complementary to the aptamer"; and
(iii) "[comprising]a quartz sheet; ... [comprising]a Raman signal molecule".
Applicant argues that there is no sufficient motivation for those skilled in the art to modify the nanorods of Weng with the dimers in view of Konig. Applicant argues that Konig recites advantages as well as disadvantage of dimers. Applicant further argues that Konig fails to provide advantage of dimer over monomers in terms of hybridization with the target molecules using the silicon nitride nanopore sensor.
The argument is respectfully not found persuasive by the examiner. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Konig recites the using nanoparticles, monomer or dimers, being dropped on a quartz plate to see the scattered light from targeted particles (para 0219). Konig suggests that a dimer can be used in the field of detection of analytes using nanoparticles.
Applicant argues that Weng reads on the gold nanorods having good dispersibility and uniformity. Applicant asserts that monomers are significantly superior to dimer in the dispersibility and uniformity, while dimers require specific design and precise control to ensure the dispersibility an uniformity, which requires excessive experimentation and effort.
The argument is not found persuasive by the examiner. According to the MPEP 2143(I)(A), “obviousness does not require absolute predictability of success”. Konig reads on using nanoparticles, monomer or dimer, to detect targeted particles (para 0219). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that Weng uses solid state nanopore detection, while Konig reads on Raman spectroscopy for detection of analytes.
The argument is not found persuasive by the examiner. In order for a rejection reference to be proper for use in an obviousness rejection, the reference must be analogous art to the claimed invention (See MPEP 2141.01(a)). Konig is analogous art to the claimed invention as Konig teaches dimer nanoparticles and nanoparticle assemblies as well as functionalized nanoparticles that can be used for detection of a variety of target molecules (para 0001-0002). The rejection for claim 1 is maintained.
Applicant argues that claim 2 of the present application in nonobvious over Weng and Konig in view of Gilboa-Geffen. Applicant argues Gilboa-Geffen teaches detection mainly based on binding affinity and specificity of aptamer to the allergens, while Weng teaches detection based on the hybridization of nucleic acid probes.
The argument is not found to be persuasive by the examiner. As mentioned above, the reference must be analogous art to the claimed invention (See MPEP 2141.01(a)). Gilboa-Geffen is analogous art to the claimed invention as Gilboa-Geffen teaches gold nanoparticles that are conjugated with aptamers for the detection of a variety of target analytes (para 0089). Gilboa-Geffen also further teaches aptamer for detecting allergens such as wheat (pg 6, Table 1).
Applicant further argues that it is well known in the art that even a single base difference can lead to dramatic change in function and property and the result cause by base difference in unpredictable.
However, according to MPEP 2144.09 (III), prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. The sequences of Gilboa-Geffen perform the same function as the instant invention of detecting an allergen such as wheat. One of ordinary skill in the art would have been motivated to make the claimed sequence in searching for aptamers to detect wheat. The rejection for claim 2 is maintained.
As mentioned above, independent claim 1 filed on 9/5/23 was amended. Based on the interpretation of the claim as amended, the amendment overcomes the previous rejection. The rejection below has been modified to reflect that amendment to the claims; however, still in part relies on the previously applied prior art.
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 non-obviousness.
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, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Weng et al. (Chinese Application No. CN202110159773A, see English translation) in view of Konig et al. (US 20210140953) and Invanov et al (WO 2021239912 A1).
Regarding claim 1, Weng teaches a gold nanorod combined with aptamers (“gold nanorods with molecular probes”, pg 10-11, paragraph n0047) and an aptamer complementary chain (“nucleic acid probes”, page 11, paragraph n0045) by self-assembly to identity and detect biological molecules (pg 10-11, paragraph n0047).
Weng does not explicitly teach the gold nanorods as nanorod dimers.
However, Konig teaches gold nanoparticles of various shapes (para 0021), and further teaches providing the gold nanoparticles as dimers, for the benefit of permitting just one bright mode and reducing complexity in result interpretation (para 0008). Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the gold nanorods of Weng as gold nanorod dimers, as taught by Konig, for the benefit of permitting just one bright mode and reducing complexity in result interpretation.
Weng also does not teach detection by Raman spectroscopy on a quartz sheet.
However, Konig further teaches that gold nanoparticle dimers (paragraph 0036) can be detected through Raman with the combination of a Raman-active molecule (paragraph 0077) which can be analyzed on a quartz sheet (paragraph 0219) for the benefit of very high sensitivity (paragraph 0003). Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to use Raman spectroscopy in the kit of the prior art combination above to detect gold nanorod dimers, as taught by Konig, for the benefit of detection at a high sensitivity.
Weng in view of Konig do not further teach gold nanorod dimer is formed a first gold nanorod functionalized by an aptamer and a second gold nanorod functionalized by a chain complementary to the aptamer.
However, Ivanov teaches a method of detecting analyte in target sample with nanoparticle dimer adapted to bind to the analyte (Abstract). Ivanov further teaches dimer comprises two nanoparticles linked by one or more nucleic acids, wherein at least one of the nucleic acids includes an aptamer specific for the analyte and the nanoparticles may be linked by partially complementary nucleic acids (pg 2, Section: Summary of Invention) for the benefit of detecting biomarkers in trace amounts with high selectivity (pg 22. Conclusion). Thus, It would be obvious to one of ordinary skill in the art before the effect filing date to modify Weng and Konig with a gold nanorod dimer being made of a first gold nanorod functionalized by an aptamer and a second gold nanorod functionalized by a chain complementary to the aptamer as taught by Ivanov for the benefit of detecting biomarkers in trace amounts with high selectivity (pg 22, Conclusion).
Regarding Claim 3, Weng in view of Konig and Ivanov teaches the invention of claim 1. Weng further teaches that a preferably molar ratio of the gold nanorod to the aptamer or the aptamer complementary chain could be 1:60 (paragraph n0031).
Regarding Claim 4, Weng in view of Konig and Ivanov teaches the invention of claim 1. Weng further teaches a length-diameter ratio of the gold nanorod is about 3.7 (n0008).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Weng et al. (Chinese Application No. CN202110159773A) in view of Konig et al. (US 20210140953) and Invanov et al (WO 2021239912 A1) as applied to claim 1 above, and in further view of Gilboa-Geffen (US 20180128835).
With respect to Claim 2, Weng in view of Konig and Ivanov teaches the claimed invention as shown above, however, Weng in view of Konig and Ivanov does not teach the nucleic acid sequences (i.e., SEQ ID NO:1) used for the aptamer and aptamer complementary chain (i.e., SEQ ID NO:2) recited in claim 2.
However, Gilboa-Geffen teaches nucleic acid aptamers for allergen detection. The sequences presented in Gilboa-Geffen show a 66.4% query match to SEQ ID NO:1 and 68% query match to SEQ ID NO:2. Although, the sequence id of Gilboa-Geffen only have about 66-68% similarity, it still performs the same function as the instant invention of detecting an allergen such as wheat. Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Weng in view of Konig and Ivanov to use the nucleic acid aptamers taught by Gilboa-Geffen for detecting wheat gluten in a sample in addition to the other allergens disclosed. See MPEP 2141(I).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/H.R.B./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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