DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on October 29, 2025 has been entered. The claims pending in this application are claims 47, 48, 55, 57-59, 61, 62, 64-67, and 69-72. Rejections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on October 29, 2025. Claims 47, 48, 55, 57-59, 61, 62, 64-67, and 69-72 will be examined.
Claim Objections
Claim 47 is objected to because of the following informality: “conducting a second amplification reaction with second primers that anneal to the duplex portion of the adaptors and the 5' tail” should be “conducting a second amplification reaction with second primers that anneal to the duplex portion of the adaptors and the 5’ tail in the presence of the tailed amplicons”.
Appropriate correction is required.
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 47, 48, 55, 57-59, 61, 62, 64-67, and 69-72 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.
Newly amended independent claim 47 contains a limitation “wherein each of the adaptors comprises a duplex portion that includes a sample barcode unique for the sample and a single-stranded segment that includes a universal primer site”, newly amended dependent claim 48 contains a limitation “the second primers are bound to the surface of a flow cell and the method includes capturing the tailed amplicons to the flow cell by the second primers”, newly amended independent claim 65 contains a limitation “wherein the adaptors comprises a duplex portion and a single stranded segment comprising a universal site”, and newly amended independent claim 66 contains a limitation “attaching barcodes and copies of a partially duplex adaptor to nucleic acid fragments, wherein a single-stranded segment of the partially duplex adaptor comprises a universal site, to yield adaptor-ligated fragments”. Although the adaptors in claim 47 and 65 or copies of a partially duplex adaptor in claim 66 can be read as adaptors or adaptor which comprise/ comprises a duplex portion and only one single-stranded segment having a universal primer site, page 1, line 21-page 2, line 27, page 4, lines 4-9, page 17, lines 26-29, page 21, lines 14-15, page 22, lines 4-11 and Figures 3-5 the specification suggested by applicant do not describe such adaptors recited in claim 47 and 65 and such copies of a partially duplex adaptor recited in in claim 66 since Figure 3 of specification only describes a Y shaped adaptor comprising a duplex portion. Furthermore, nowhere in the specification describes that the second primers are bound to the surface of a flow cell and the tailed amplicons are captured to the flow cell by the second primers as recited in claim 48.
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).
Conclusion
No claim is allowed.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
February 2, 2026