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 Application/Amendment/Claims
This Office action is in response to the communications filed on May 22, 2026.
Currently, claims 1-4 and 6-8 are pending and under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 102
Claims 1-4 and 6-8 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. for the reasons as set forth in the Office action mailed on February 24, 2026 and for the reasons stated below.
Applicant's arguments filed on May 22, 2026 have been fully considered but they are not persuasive. Applicant argues that the Kim reference does not qualify as prior art as the instant claims are entitled to the priority filing date of the foreign priority document in light of the English language translation of the document. In response, it is noted that the asserted English language translation of the KR foreign priority document is improper because a statement by the person who translated the document that the English translation of the certified KR foreign priority copy is accurate is not concurrently filed with the translation thus is not accepted. See MPEP §215 and 216. Accordingly, December 12, 2022 remains as the effective filing date for claims 1-4 and 6-8 thus the Kim reference fully qualifies as the 102(a)(1) prior art as it was published more than one year prior to the effective filing date granted for the rejected claims. Therefore, this rejection is maintained.
Claim Rejections - 35 USC § 103
Claims 1-4 and 6-8 remain rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. in view of Han et al., Jang et al., and Lee et al. for the reasons as set forth in the Office action mailed on February 24, 2026 and for the reasons stated below.
Applicant's arguments filed on May 22, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious because Guo differs from the claimed subject matter because Guo’s structure is not activated by an RNA polymerase; Han does not teach a structure having a bound gold but instead teaches a fluorescence dye system; Jang does not teach an RNA membrane with RdRP; and Lee’s nucleic acid is not a functional membrane because it is not activated by an RNA polymerase. 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 the cited references in combination fail to render the claimed subject matter obvious because Lee’s “highly condensed” AuNPs are “unsuitable” for making the claimed structure because “it would be difficult to expose a terminal region to which an RNA polymerase could bind” as shown in Figure 7. In response, it is noted that Lee’s Figure 7 illustrates three different types/shapes of AuNPs (cracked; bowl-shaped; and spherical covered with small AuNPs), wherein Lee’s teachings pertaining to the “uniform gold nanostructures having “better performance in sensitivity” with “strong” signal intensity” provided by AuNPs synthesized by reacting Au3+ ions with nucleic acid template membranes that are relied on as set forth at page 14 of the last Office action pertain to the “cracked AuNPs” (see pages 166 and 171 of Lee), which have DNA fragments with free ends before templated DNA removal. See page 171 and the “i)” in Figure 7E. That is, the “highly condensed” AuNP structure that is “unsuitable” as argued by applicant pertains to the spherical AuNP, which is not the basis for rejecting claim 8, which is the only claim reciting “mixing the nucleic acid membrane with a gold ion to prepare a nucleic acid membrane to which the gold ion is bound”. For completeness, the following at page 171 of Lee is reproduced, wherein underline has been added for emphasis:
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See also the following structure in Figure 5 before DNA template removal, which corresponds to the same structure in Figure 7Ei).
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As shown above, Lee’s Au3+-DNA NP synthesis methodology pertaining to the cracked AuNP structure does provide DNA strands with free 3’ ends, which would enable activation by RdRP that initiates efficient RNA synthesis without a primer as taught by Han. Hence, applicant’s arguments alleging that Lee taught away from the claimed subject matter as Lee’s AuNP is “unsuitable” are not found persuasive.
Applicant argues that Lee and Guo do not provide a motivation to combine with Han because Han relates to detecting virus thus it would not have been obvious to combine Lee and Guo with Han to arrive at the claimed structure. In response, applicant’s attention is directed to the fact that the rejected claims in the instant case do fully encompass and do claim a “biosensor” and a “kit for virus detection”, which fully read on a biosensor/kit that detects SARS-CoV-2, which is included in the ground of the instant rejection, wherein Guo also taught using AuNP-functionalized RNA membrane-based platform for “diagnosis” applications. Hence, the examiner fails to understand as to why Han is irrelevant to and is uncombinable with Guo and Lee.
Applicant argues that the claimed subject matter “can only be derived from hindsight with information gleaned from Applicant’s disclosure.” In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In view of the foregoing, this rejection is maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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