The examiner of this application in the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Peter Johansen, Group Art Unit 1642, Technology Center 1600.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 3, 2026 has been entered. By way of this reply, Applicant has amended claim 10 and introduced new claim 25.
Claims 10-20 and 23-25 are currently pending in the application and under examination before the Office.
The rejections of record can be found in the previous Office action, dated December 3, 2025.
Claim Objections
Claim 10 is objected to because of the following informalities: the claim recites an “engineered immune cell” at lines 3-4, which is inconsistent with the engineered T-cell introduced in the claim. This terminology should be made consistent for clarity.
Additionally, claim 10 is missing a hyphen in “engineered T cell” at line 2. 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.
Claims 10-20 and 23-24 were previously 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, concerning possession of the claimed method.
Applicant's arguments in view of the amendments to the claims have addressed this issue, and this rejection is hereby withdrawn.
Claims 10-20 and 23-25 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. This is a new matter rejection.
Claim 10 recites that the hinge of the blocking receptor used in the method consists of a peptide of between 31 and 65 amino acids and comprises an LILRB1 peptide of between 31 amino acids and 64 amino acids, said LILRB1 peptide consisting of a contiguous amino acid sequence from a hinge domain of leukocyte immunoglobulin-like receptor subfamily B member 1 (LILRB1) having an amino acid sequence as set forth in SEQ ID NO: 84. However, the disclosure does not provide sufficient written description for the recitation of the above hinge.
Applicant's specification at Figure 25 and page 36 describes a truncated hinge domain ("2B1 trunc") with a length of 32 amino acids, and a full-length hinge ("2B1") with a length of 64 amino acids. This does not disclose the entire range claimed, which can be any number of amino acids between 31 and 64. At no point was any other truncated linker derived from LILRB1 contemplated, nor does the specification teach which sequence of Applicant's SEQ ID NO: 84 would be able to perform their required function in the context of the claimed method.
As such, the claims now recite a limitation which was not clearly disclosed in the specification as-filed and now change the scope of the instant disclosure as-filed. Such a limitation recited in the present claims, which did not appear in the specification, as-filed, introduces a new concept and violates the description requirement of the first paragraph of 35 U.S.C. 112.
Applicant argues that the disclosure recites, at page 60, that the one or more domains of LILRB1 comprise an amino acid sequence that is at least 80%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99% or is identical to a sequence or subsequence of SEQ ID NO: 65, 77, 78, 79, 80, 81, 82, 83, 84, or 85.
Applicant's arguments have been considered fully but are not found to be persuasive.
The claim requires a contiguous amino acid sequence from LILRB1. The disclosure only recites a minimum of 80% identity, without guidance as to what or where any alterations may be permitted within the sequence. There is nothing in the disclosure which recites a contiguous amino acid sequence from LILRB1.
Furthermore, a peptide of 31 amino acids would be less than 50% of the full-length sequence of LILRB1 (Applicant's SEQ ID NO: 84). This is far in excess of the 80% identity taught at page 60 of the disclosure.
There is nothing in the disclosure to indicate that a contiguous amino acid sequence from a hinge domain of LILRB1 of the entire genus from 31 amino acids and 64 amino acids was contemplated by Applicant. The disclosure of two members of a genus cannot be extrapolated to mean disclosure of the genus itself.
This rejection is therefore maintained and extended to encompass new claim 35.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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