DETAILED ACTION
1. This action is written in response to applicant’s correspondence filed 6/24/2026. Applicant has amended claims 32, 40-41, 43 and 45. Claims 32-58 are currently pending for examination. All the amendments and arguments have been thoroughly reviewed but are found insufficient to place the instantly examined claims in condition for allowance. In view of applicant’s amendment to claim 32, all the rejections from the previous Office action have been withdrawn. However, new ground of rejection under 35 USC 112(a) is presented as set forth below.
Claim Rejections - 35 USC § 112
2. 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.
3. Claims 32-58 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 32 has been amended to recite “wherein the nucleic acid barcode molecule comprises a partially double-stranded region and an overhang sequence extending beyond the partially double-stranded region” (see lines 4-6, emphasis provided). However, no support for such newly added feature(s) could be found in the disclosure as filed. Since claims 33-58 depend from claim 32, these claims also require the same newly added feature(s) that lacks support in the disclosure as filed.
Applicants submit that “[t]his amendment is fully supported by the application as originally filed, such as, for example, paragraph [0073]” (see page 8 of applicant's response filed on 6/24/2026).
The original disclosure, in particular paragraph [0073], has been thoroughly reviewed, but no support for the newly added feature(s) (i.e., “wherein the nucleic acid barcode molecule comprises a partially double-stranded region and an overhang sequence extending beyond the partially double-stranded region”) could be found. Paragraph [0073] merely states that “the first plurality of nucleic acid barcode molecules each comprise an overhang sequence”, but does NOT indicate in any way that the nucleic acid barcode molecule comprises a partially double-stranded region and an overhang sequence extending beyond the partially double-stranded region.
It is noted that many of the features recited in the method of claim 32 are shown in panel 1800 of Figure 18 or panel 1900 of Figure 19 (which is described in paragraph [00210] or [00213]). However, the nucleic acid barcode molecule shown in panel 1800 of Figure 18 or panel 1900 of Figure 19 is single-stranded, without any partially double-stranded region. As described in paragraph [00210] (for panel 1800 of Figure 18) or paragraph [00213] (for panel 1900 of Figure 19), a partially double-stranded nucleic acid molecule comprising the sequences of nucleic acid barcode molecule and the template nucleic acid fragment is formed only after the hybridization of both the nucleic acid barcode molecule and the template nucleic acid fragment to the splint sequence.
Applicants are reminded that it is their burden to show where the specification supports any amendments to the disclosure. See MPEP 714.02, paragraph 5, last sentence and also MPEP 2163.06.I.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a) or pre-AIA 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(a) or pre-AIA 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. Applicants should therefore specifically point out the support for any amendments made to the disclosure.
Response to Arguments
4. Applicant’s arguments filed 6/24/2026 have been considered but are moot because the arguments do not apply to the currently presented rejection.
Conclusion
5. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
Prosecution Insights