Prosecution Insights
Last updated: July 17, 2026
Application No. 18/696,848

COMPOSITION FOR INCREASING REGULATORY T CELLS

Non-Final OA §102§112
Filed
Mar 28, 2024
Priority
Sep 30, 2021 — JP 2021-160293 +1 more
Examiner
HOFFMAN, SUSAN COE
Art Unit
1655
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Toyo Shinyaku Co., Ltd.
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
7m
Est. Remaining
80%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allowance Rate
581 granted / 1073 resolved
-5.9% vs TC avg
Strong +26% interview lift
Without
With
+25.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
67 currently pending
Career history
1148
Total Applications
across all art units

Statute-Specific Performance

§101
3.1%
-36.9% vs TC avg
§103
67.4%
+27.4% vs TC avg
§102
8.7%
-31.3% vs TC avg
§112
7.5%
-32.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1073 resolved cases

Office Action

§102 §112
DETAILED ACTION 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 2. Claims 5-8 are currently pending. Election/Restrictions 3. Applicant’s election without traverse of Group I, claim 5, in the reply filed on March 19, 2026 is acknowledged. 4. Claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. 5. Claim 5 is examined on the merits. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 6. Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 5 is indefinite because it is unclear what ages are encompassed by “young.” Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. 7. Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zeng (Oxidative Medicine and Cellular Longevity (2018), vol. 2018, article ID 3232080, 15 pages). Zeng teaches that barley grass is a commonly used food for humans. The reference teaches that barley grass has immune regulatory effects (see abstract; page 2, column 1; page 7, section 3.21). The reference does not specifically teach that the administration of the barley grass increases regulatory T cells. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. All humans with an immune systems have the ability to produce regulatory T cells. Thus, administration of barley grass as taught by the reference should inherently result in the increase in regulatory T cells if applicant’s invention functions as claimed. Therefore, the reference is considered to properly anticipate claim 5. 8. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm. 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, Anand Desai can be reached at 571-272-0947. 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. /SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
Read full office action

Prosecution Timeline

Mar 28, 2024
Application Filed
Apr 20, 2026
Non-Final Rejection mailed — §102, §112 (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
54%
Grant Probability
80%
With Interview (+25.7%)
2y 11m (~7m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1073 resolved cases by this examiner. Grant probability derived from career allowance rate.

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