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 Claims
This action is written in response to applicant’s correspondence received on 06/25/2026. Claims 1-15, 20, 26, 33-34 are pending and examined herein. Claims 20, 26 are previously withdrawn from prosecution as being drawn to nonelected subject matter. Accordingly, claims 1-3, 5-15, 33-34 are examined herein. The restriction requirement mailed on 12/03/2025 is still deemed proper. Election was made without traverse in the reply filed on 01/28/2026.
Any rejection or objection not reiterated herein has been overcome by amendment.
Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in JP2020-039614 on 03/09/2020.
Claim Rejections - 35 USC § 112 Written Description
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.
Claims 1-3, 5-15, 33-34 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 claims contain 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. This is a NEW MATTER rejection.
MPEP 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims” and “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112a, as lacking adequate written description". According to MPEP § 2163.I.B, "While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure" and "The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117".
Regarding claim 1, the amended claim recites an exogenous barcode sequence inserted “between a 5S rDNA sequence and an E-pro sequence”. Absent a limitation confining this insertion site to a single repeat unit of the rDNA tandem array, e.g., the now deleted limitation “…an intergenic region 1 (IGS1) of the intergenic regions comprises…”, which locates the barcode insertion site within IGS1 of one rDNA repeat unit, the broadest reasonable interpretation (BRI) of “between a 5S rDNA sequence and an E-pro sequence” encompasses insertion at any position located between any 5S rDNA sequence and any E-pro sequence present in the genome, including positions spanning multiple, non-adjacent repeat units of the tandem rDNA array, e.g. IGS2.
However, the specification only describes the barcode(s) inserted in IGS1 (FIGs. 3 and 8) by reciting “The barcode sequence insertion site may be any within the IGS1 that does not affect the desired effects…” (Page 14, ¶[0033]). The specification is silent as to, and does not demonstrate possession of, an exogenous barcode sequence inserted at any of the other positions encompassed by the claim’s broadened language. Indeed, ¶[0006] of the specification identifies insertion within IGS2, citing Kang (WO2016027943A1, published on 02/25/2016), as associated with a specific technical disadvantage, i.e. potential disruption of a cohesin binding sequence, further supporting that the applicant did not regard insertion outside IGS1 as part of the invention. Because the claim as amended is broader than the disclosure reasonably conveys applicant had possession of as of the filing date, claim 1 lacks adequate written description support under 35 U.S.C. § 112(a).
Regarding claim 15, a limitation to IGS1 is now deleted after amendment. The specification only teaches “a method for manufacturing an artificial chromosome vector, comprising a step of inserting a barcode sequence into an IGS1” with stepwise teachings in the specification only involving inserting barcodes in IGS1 (Page 18, ¶[0052]-¶[0054]). There is no teaching regarding a method for manufacturing an artificial chromosome vector, comprising a step of inserting a barcode sequence outside IGS1. Because the claim as amended is broader than the disclosure reasonably conveys applicant had possession of as of the filing date, claim 15 lacks adequate written description support under 35 U.S.C. § 112(a).
Claims 2-3, 5-14, 33-34 are also rejected for depending from a rejected claim 1 and incorporating the new matter of claim 1 by virtue of dependency under 35 U.S.C. §112(d), while failing to provide adequate written description support thereof under 35 U.S.C. § 112(a).
Response to Arguments
Applicant’s arguments, see pages 7-13 filed on 06/25/2026, with respect to the rejections of claims 1-15, 33-34 under 35 U.S.C. § 101/102/103 have been fully considered but are moot in view of the amendment.
“the claimed site in IGS 1 between 5S and E-pro avoids such disruption while still permitting stable maintenance and amplification of the rDNA array” (Page 8, last 2 lines) and “The claimed subject matter is not merely directed to placing a barcode sequence somewhere in an IGS 1 region. It specifically requires insertion of an exogenous barcode sequence into a restriction enzyme site located between the 5S rDNA sequence and the non-coding promoter sequence (E-pro)” (Page 11, 3rd ¶, lines 1-4).
These arguments have been considered, but are not persuasive to place the claims under conditions of allowance. These arguments are further evidence that only IGS1 is the fully supported region for the barcode insertions in the disclosure, highlighting the lack of written description of embodiments having an exogenous barcode sequence inserted at positions outside of a region between a 5’ 5S rDNA and its immediate 3’ E-pro, which are now encompassed by the claim’s broadened language.
“Request for Rejoinder (Page 13)
It is respectfully requested that withdrawn claims 20 and 26 are rejoined and examined. Specifically, claims 1-15, 20, 26, and 33-34 are believed to be allowable and withdrawn claims 20 and 26 are dependent thereon. Therefore, claims 20 and 26 are similarly allowable”.
Rejoinder of withdrawn claims is proper only where the elected claims are in condition for allowance. See MPEP §821.04(b). As claim 1 stands rejected under 35 U.S.C. §112(a) as set forth in the office action above, the elected invention is not currently in condition for allowance. Accordingly, rejoinder of claims 20 and 26 is denied at this time. Should the elected claims subsequently be found allowable, rejoinder of claims 20 and 26 will be reconsidered at that time.
“Request for Interview (Page 13)
Either a telephonic or an in-person interview is respectfully requested should there be any remaining issues.”.
Due to time constraints, there was no opportunity to initiate an interview. Upon receiving the office action, applicant is encouraged to follow the guidelines below to schedule an examiner interview at the earliest convenience if deemed beneficial to advance prosecution.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Delphinus D. Yu whose telephone number (571) 272-1576. The examiner can normally be reached Mon-Thr 7:30am to 4:30pm Fri 10am to 2pm ET.
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, Neil P Hammell can be reached on (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DELPHINUS DOU YI YU/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636
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