DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on June 11, 2026 has been entered. The claims pending in this application are claims 23-25, 27 and 30-45. The objection and rejection not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on June 11, 2026. Claims 23-25, 27, and 30-45 will be examined.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New Matter
Claims 23-25, 27, and 30-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
A limitation “the first amplification primer comprises a nucleic acid sequence that is not present in the primer and comprises SEQ ID NO: 03 or SEQ ID NO: 04, and the second amplification primer comprises a nucleic acid sequence that is not present in the template switch oligonucleotide and comprises SEQ ID NO: 03 or SEQ ID NO: 04” is added to independent claim 23 while a limitation “wherein the first amplification primer further comprises one or more of SEQ ID NO: 1, 2, 5, or 6 and the second amplification primer comprises one or more of SEQ ID NO: 1, 2, 5, or 6” is present in newly added dependent claim 45. Although the specification describes that “[T]he nucleic acid domains may have a length and sequence that enables a polynucleotide (e.g., an oligonucleotide) employed by the sequencing platform of interest to specifically bind to the nucleic acid domain, e.g., for solid phase amplification and/or sequencing by synthesis of the cDNA insert flanked by the nucleic acid domains. Example nucleic acid domains include the P5 (5’AATGATACGGCGACCACCG A-3’) (SEQ ID NO:01), P7 (5’-CAAGCAGAAGACGGCA TACGAGAT-3’) (SEQ ID NO:02), Read 1 primer (5’-ACACTCTTTCCCTACACGACGCTCT TCCGATCT-3’) (SEQ ID NO:03) and Read 2 primer (5’-GTGACTGGAGTTCAGACGTGTGC TCTTCCGATCT-3’) (SEQ ID NO:04) domains employed on the Illumina®-based sequencing platforms. Other example nucleic acid domains include the A adapter (5’-CCATCTCATCCCTGCGTGTCTCCGACTCAG-3’) (SEQ ID NO:05) and P1 adapter (5’-CCTCTCTATGGGCAGTC GGTGAT-3’) (SEQ ID NO:06) domains employed on the lon Torrent™-based sequencing platforms” (see page 15, second paragraph), since claim 23 requires combining: the template nucleic acid; a primer comprising a domain that hybridizes to the template nucleic acid; a template switch oligonucleotide; a polymerase having a terminal transferase activity; and dNTPs into a reaction mixture under conditions sufficient to produce a complex comprising the template nucleic acid and the template switch oligonucleotide wherein each of the template nucleic acid and the template switch oligonucleotide hybridizes to a single product nucleic acid polymerized from the dNTPs in a template switching reaction and amplifying the single product nucleic acid by contacting the single product nucleic acid with a first amplification primer comprising at least a portion of a sequence present in the primer and a second amplification primer comprising at least a portion of a sequence present in the template switch oligonucleotide, and it is known that, in a PCR reaction, a forward primer binds to the start of a target nucleic acid on the bottom strand while the reverse primer binds to the end of the target nucleic acid on the top strand, in view of Figures 1 and 5 of the specification, the first amplification primer in claim 23 should be a reverse primer which is Read Primer 2 consisting of SEQ ID NO:4 and the second amplification primer recited in claim 23 should be a forward primer which is Read Primer 1 consisting of SEQ ID NO:3. Since page 14, line 29 to page 15, line 18, page 21 line 18 to page 22, line 12, and page 24 lines 11-24, and Figure 1 suggested by applicant do not describe that SEQ ID NO: 3 is used as a reverse primer and SEQ ID NO: 4 is used as a forward primer and each of SEQ ID NOS:1, 2, 5, and 6 is used as a part of a forward primer or a reverse primer, the limitation “the first amplification primer comprises a nucleic acid sequence that is not present in the primer and comprises SEQ ID NO: 03 or SEQ ID NO: 04, and the second amplification primer comprises a nucleic acid sequence that is not present in the template switch oligonucleotide and comprises SEQ ID NO: 03 or SEQ ID NO: 04” recited in claim 23 and a limitation “wherein the first amplification primer further comprises one or more of SEQ ID NO: 1, 2, 5, or 6 and the second amplification primer comprises one or more of SEQ ID NO: 1, 2, 5, or 6” recited in claim 45 are new matters.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.” MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure” (emphasis added).
Response to Arguments
Applicant’s arguments with respect to claims 23-25, 27, and 30-44 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
6. No claim is allowed.
7. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993)(See 37 CAR § 1.6(d)). The CM Fax Center number is (571)273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph.D., whose telephone number is (571)272-0746. The examiner can normally be reached on Monday-Friday from 9 A.M. to 5 P.M.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Dr. Anne Gussow, Ph.D., can be reached on (571)272-6047.
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/FRANK W LU/Primary Examiner, Art Unit 1683
August 25, 2026
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