2025DETAILED ACTION
This action is in reply to papers filed 10/20/2025. Claims 74-94 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230095569A1, Published 3/30/2023.
Withdrawn Rejection(s)
The 112 (b) rejection of claims 86 and 89-93 are withdrawn in view of amendments made to the claims.
Maintained Rejection(s)
The 112 (a) enablement rejection of claims 89-91 is maintained. Applicant’s arguments will be addressed following maintained rejection.
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 89-91 remain and new claim 94 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The claims remain rejected for reasons advanced in the previous office action and will not be reiterated herein.
Applicant’s Arguments/Response to Arguments
Applicant argues: Amended claim 89 seeks to protect treating a CLDN 18-related condition in a subject with the claimed antibody. According to the specification, the CLDN 18-related condition is any disease or condition that is susceptible to treatment with a CLDN 18
modulator, or is associated with expression or over-expression of CLDN-18. That is to say,
amended claim 89 only seeks to cover diseases or conditions that are associated with CLDN-
18 expression, and not those that do not express CLDN-18.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. As previously noted, none of the specification discloses six examples. The first example is drawn to hybridoma development. The second, third, fourth and fifth examples are drawn to antibody characterizations. The last example is drawn to antibody humanization. None of the examples are drawn to a method of treating a CLDN 18 related condition. Furthermore, Applicant’s argument that the claimed invention only seeks to cover diseases or conditions that are associated with CLDN-18 expression is contradicted by the specification, which teaches the following at para. 250.
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The specification clearly embraces any disease or condition that is susceptible to treatment with a CLDN modulator in addition to any disease or condition that is associated with expression or over-expression of CLDN. Here, the specification makes a distinction between the a disease or condition that is susceptible to treatment with a CLDN modulator and a disease or condition that is associated with expression or over-expression of CLDN.
Moreover, note that although the term ‘prevention’ has been canceled, the specification definition of the term ‘treating’ clearly embraces a method of prevention. See para. 249 copied below.
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Applicant argues: Second, the instant application has validated the claimed antibody in cells exhibiting both high and low levels of CLDN 18.2 expression. The cell lines used for validation include both CLDN18.2-over expressing cell lines (e.g., CHOKl-18.2, and MC38-hClaudin 18.2) and CLDN 18.2-low expressing cell lines (e.g., GAXC031, SNU620, and KATOH cell
lines). Under both circumstances, the claimed antibody demonstrated potent activity, even
better than the benchmark antibody IMAB362.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. This is because the claimed invention is not drawn to a validation method; rather, the claimed invention is drawn to a method of treating. As noted in para. 249 of the PgPub, “treating” or” treatment” requires prevention or alleviation of a condition, slowing the onset or rate of development of a condition, reducing the risk of developing a condition, preventing or delaying the development of symptoms associated with a condition, reducing or ending symptoms associated with a condition, generating a complete or partial regression of a condition, curing a condition, or some combination thereof. The validation of the claimed antibody cannot be equated to any of what is recited para. 249.
Per MPEP 2164.02, the issue of “correlation” is related to the issue of the presence or absence of working examples. “Correlation” as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a “working example” if that example “correlates” with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute “working examples.” Applicant has not correlated any of the validation assays to treatment, as set forth in para. 249, of a CLDN 18 related condition.
Applicant argues: Third, the instant application showed the effect of the claimed antibody on both gastric cancer cell lines and other types of cancerous cells, such as colon cells. The previously mentioned low-expressing cell lines, GAXC03 l, KATOIII, and SNU620, are all gastric cancer cells. And the MC38-hClaudin 18.2 cells used in Example 7.2 are murine colon adenocarcinoma cells with overexpressed hClaudin 18.2.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. Applicant has not provided a nexus between the effect of the claimed antibody on the gastric cancer and colon cells and the treatment of a CLDN 18 condition.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
Claims 89-91 and 94 are rejected.
Claims 74-88, 92 and 93 are allowed.
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632