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 .
Claim Status and Action Summary
This action is in response to the papers filed February 13, 2026.
Currently, claims 1-2 and 5-10 are pending.
Claims 5 and 9 were withdrawn as directed to a non-elected invention.
Claims 1-2, 6-8, and 10 are under examination.
Any objections and rejections not reiterated below are hereby withdrawn.
Election/Restrictions
Applicant’s election without traverse of “Group I, claims 1-2 and 6-10” and “HERES” in the reply filed on December 6, 2024 is acknowledged.
Claims 5 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 December 6, 2024.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Priority/Effective Filing Date
This application is a 371 of PCT/KR2020/006063, filed May 8, 2020 and claims foreign priority to Korean Patent Application No. 10-2019-0062423, filed May 28, 2019.
A certified copy of the foreign priority application was received on November 29, 2021.
A translation of the foreign priority document was received on April 15, 2025 along with a statement that the translation of the certified copy is accurate.
Therefore, the effective filing date of the application is determined to be May 28, 2019.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 as amended includes the phrase “…contacting a primer pair specifically recognize the at least one lncRNA and the RNA sample…”. It appears that “a primer pair specifically recognize” may be a typographical error for a phrase such as “a primer pair that specifically recognizes” or “a primer pair specifically recognizing”, Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6-8, and 10 are/remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chinnaiyan et al. US 2016/0160295 A1, published June 9, 2016.
This rejection has been updated as necessitated by the amendments to the claims.
Regarding claim 1, Chinnaiyan teaches a method of diagnosing lung squamous cell cancer and head and neck cancer (i.e. squamous cell carcinoma) comprising measuring an expression level of one or more non-coding RNAs (Chinnaiyan, 0010) using a probe set comprising probes that hybridize to at least a portion of one or more of a set of non-coding RNAs (Chinnaiyan, 0013) OR primers and primer pairs capable of amplifying (i.e. specifically recognizing) said non-coding RNAs (Chinnaiyan, 0110). Chinnaiyan further teaches a non-coding RNA, SEQ ID NO 1215 with a 1301 nucleotide long, 100% sequence identity match to SEQ ID NO 3 of the present disclosure (i.e. HERES.1).
The claimed lncRNA “HERES”, encoded by SEQ ID NO: 3 of the instant application is a splice variant of the lncRNA “HNCAT25.1” encoded by SEQ ID NO: 1215 taught by Chinnaiyan et al.
The following whole-sequence alignment between the two sequences (Query = “HERES, SEQ ID NO: 3 and Sbjct = “HNCAT25.1, SEQ ID NO: 1215) and the alignment of both sequences to the human genome demonstrates that the terminal sequences of HERES are comprised within the sequence taught by Chinnaiyan et al. Specifically, HERES utilizes an alternative splice site to the 5’ site used in HNCAT25.1, leading to the inclusion of about 450 additional nucleotides within the sequence of HNCAT25.1.
Therefore, the methods comprising measuring the expression of HNCAT25.1 taught by Chinnaiyan et al. would have inherently also measured the expression of the claimed lncRNA HERES, SEQ ID NO: 3 because as shown in the alignment below, the extra nucleotide sequences 411-859 of Query (HERES, SEQ ID NO: 3) corresponds to the extra nucleotide sequences present in pre-mRNA/DNA sequence before a mature splice variant of the lncRNA “HNCAT25.1” (Sbjct: HNCAT25.1, SEQ ID NO: 1215, taught by Chinnaiyan et al.) is generated. Any and all of the primers or probes used by Chinnaiyan et al. to measure HNCAT25.1 (SEQ ID NO:1215) expression would have necessarily also measured HERES expression.
Chinnaiyan teaches that expression of the long non-coding RNA encoded by SEQ ID NO 1215, “HNCAT25.1”, is associated with head and neck cancer (HNSC) (Chinnaiyan, page 51, Table 2, line 34). Finally, Chinnaiyan teaches determining and administering a therapeutic regimen based on the expression level(s) of the measured lncRNAs wherein the treatment(s) comprise anti-cancer chemotherapy and/or radiation therapy (Chinnaiyan et al., paragraph 0168).
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Regarding claims 2 and 7, Chinnaiyan teaches HNCAT25.1 (SEQ ID NO 1215), which comprises a base sequence represented by SEQ ID NO: 3.
Regarding claim 6, Chinnaiyan teaches a method of treating squamous cell carcinoma with anti-cancer chemotherapy and/or radiation therapy (Chinnaiyan et al., paragraph 0168) comprising measuring the expression of a splicing variant of HERES from a sample of a patient with squamous cell carcinoma (Chinnaiyan, 0010) and comparing the expression level to a control (Chinnaiyan, 0012).
Regarding claim 8, Chinnaiyan teaches that expression of HNCAT25.1 (which is a splicing variant of HERES SEQ ID NO:3) is significantly associated with head and neck cancer (Chinnaiyan, 0302 and page 51, Table 2, line 34).
Regarding claim 10, Chinnaiyan teaches measuring lncRNA expression by reverse transcription PCR (Chinnaiyan, 0080), RNA FISH, Northern blotting (Chinnaiyan, 0073), and microarrays (Chinnaiyan, 0078).
Thus, the rejection of claims 1-2, 6-8, and 10 is maintained and updated to address claim amendments and applicant’s arguments filed on April 15, 2025.
Response to arguments
The response traverses the rejection of claims 1-2, 6-8, and 10 under U.S.C. 102 as being anticipated by Chinnaiyan et al. on the grounds that the preferred primers of Chinnaiyan should be constructed such that primers designed against multiexonic transcripts span exon junctions and asserts that this requires that one of the primers hybridizes across the specific exon-exon junction where the intron has been removed (i.e. one of the primers hybridizes to a sequence that is generated by the splicing reaction).
However, Chinnaiyan et al. do not teach the sequence of the primers in question, and do not explicitly define that primers… spanned exon junctions requires that one of the primers comprises a sequence that is generated by a splicing reaction (i.e. contains an exon-exon junction) and thus encompasses embodiments wherein one primer hybridizes to a first exon and the second primer hybridizes to a second exon such that the primers “span” the exon junction (i.e. are on either side of the exon junction). Therefore, Chinnaiyan et al. do not “structurally… preclude inherent detection”, as the teachings of Chinnaiyan et al. do not exclude embodiments described above that do hybridize to both HNCAT25.1 and HERES.
Furthermore, the claims do not require primers having any particular sequence, or that the claimed primers “span” or “comprise a sequence complementary to an exon-exon junction”, but only that the “primer pair specifically recognize[s] the at least one lncRNA (i.e. the elected species HERES).
The response further asserts that “the claims now explicitly exclude the prior art” because the amended claims “recite that the primer pair “amplifies a sequence of the HERES (SEQ ID NO: 3) but does not amplify the sequence of SEQ ID NO: 1215 of US 2016/0160295.”… this amendment constitutes a specific negative limitation that excludes the prior art…”
However, this limitation does not appear in the most recently amended claim set submitted with these arguments on February 13, 2026.
Therefore, these assertions/arguments rely on features (i.e. the “specific negative limitation that excludes the prior art” discussed above) which are neither recited in the rejected claims nor in the amended claims. Although the claims are interpreted in light of the specification, limitations from the specification (or attorney arguments) are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
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/Z.M.T./Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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