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 .
DETAILED ACTION
2. The amendment filed 08/27/2026 is acknowledged and has been entered.
Claims 1 and 7-8 have been amended. Claims 2, 5-6 and 11 have been cancelled. New claims 17-19 have been added.
Claims 1, 3-4, 7-10 and 12-19 are pending in the application. Claims 12-16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/16/2026.
4. Claims 1, 3-4, 7-10 and 17-19 have been examined.
Grounds of Objection and Rejection Withdrawn
5. Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 06/17/2026.
Grounds of Rejection Maintained
Claim Rejections - 35 USC § 112
6. The following is a quotation 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.
7. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
8. Claims 1, 3-4, 7-10 and 17-19 remain/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 “written description” rejection.
The considerations that are made in determining whether a claimed invention is supported by an adequate written description are outlined by the published Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, ``Written Description'' Requirement (Federal Register; Vol. 66, No. 4, January 5, 2001; The 2015 Written Description Workshop materials; hereinafter “Guidelines”).
These guidelines state that rejection of a claim for lack of written description, where the claim recites the language of an original claim should be rare. Nevertheless, these guidelines further state, “the issue of a lack of written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant has possession of the claimed invention” (Id. at 1105). The “Guidelines” continue:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
With further regard to the proposition that, as original claims, the claims themselves provide in haec verba support sufficient to satisfy the written description requirement, the Federal Circuit has explained that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement:
Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). See also: University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 1892 (CA FC 2004).
Thus, an original claim may provide written description for itself, but it must still be an adequate written description, which establishes that the inventor was in possession of the invention.
The claims are herein drawn to a method of treating a T-cell lymphoma in a patient in need thereof comprising administering to the patient a therapeutically effective amount of an agent capable of inducing cell death of CCR8 expressing cancer cells.
In this instance, the claims are herein drawn to a method of treating a T-cell lymphoma in a patient comprising administering to the patient an antibody that inhibits CCR8.
The specification teaches a method of determining CCR8 Expression in fresh peripheral blood tumor Cells from patients with Sézary Syndrome; see Examples 1-2. The specification does not provide experiment data showing how to treat a patient comprising administering to the patient an antibody that inhibits CCR8 or a multi-specific antibody that binds to CCR8 and NKp46. The specification only generally states a method of treating a T-cell lymphoma in a patient using an anti-CCR8 antibody.
Thus, the claims are broadly drawn to a method of treating a T-cell lymphoma in a patient comprising administering to the patient an antibody that inhibits CCR8.
It is well known that therapeutic art is highly unpredictable. Given the unpredictability of therapeutic art and the teachings of the specification, it is clear that it is not possible to predictably extrapolate the claimed invention. Therefore, it is submitted that the claimed method is not adequately described with the requisite clarity and particularity to reasonably convey to the skilled artisan that Applicant had possession of the claimed invention as of the filing date of the application.
Thus, it is submitted that the instant claims, and the disclosure describing the claimed subject matter, fails to satisfy the written description requirement set forth under 35 U.S.C. § 112, first paragraph.
The Applicant’s arguments:
The "Clinical trial" pdf shows and discusses the successful results of a Phase 1 clinical trial of the presently claimed invention. The pdf describes the in vivo dose-escalation stage of the trial using an anti-CCR8 antibody in human patients with refractory cutaneous T cell lymphoma. The present inventors described the method and said it would work (i.e. they had possession of the claimed subject matter) at the time of filing the present application.
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
The claims are herein drawn to a method of treating a T-cell lymphoma in a patient comprising administering to the patient an antibody that inhibits CCR8.
The specification only teaches a method of determining CCR8 Expression in fresh peripheral blood tumor Cells from patients with Sézary Syndrome; see Examples 1-2. The specification does not provide experiment data showing how to treat a patient comprising administering to the patient an antibody that inhibits CCR8 or a multi-specific antibody that binds to CCR8 and NKp46.
The "Clinical trial" which the Applicant argued, is in 2025 ASCO annual meeting, which is 4 years after the time of filing the present application.
Because of factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; Applicant has not shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; and Applicant has not described distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention at the time the application was filed. Therefore, the rejection is maintained for reasons of record.
Claim Rejections - 35 USC § 102
9. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 1, 3-4, 7-10 and 17 remain/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lan et al. (WO 2021194942, filed on 22 March 2021).
Claims 1, 3-4, 7-10 and 17 are herein drawn to a method of treating a T-cell lymphoma in a patient in need thereof comprising administering to the patient a therapeutically effective amount of an anti-CCR8 antibody.
Lan et al. teach phase I/II clinical study of anti-CCR8 antibody in treating T-cell lymphoma; see entire document, e.g., Example 34, bridging paragraph of pages 78-79, claims 1 and 31-35.
Lan et al. teach that anti-CCR8 antibody binds to extracellular of CCR8; see last paragraph of page 112.
For claims 3-4, Lan et al. teach T-cell lymphomas is cutaneous T-cell lymphoma (e.g., Sezary syndrome); see last paragraph of page 78.
For claim 8, Lan et al. teach that anti-CCR8 antibody depletes the CCR8-expressing cell by antibody-dependent cellular cytotoxicity (ADCC); see abstract.
For claim 9, Lan et al. teach that anti-CCR8 antibody is a bispecific antibody; see second paragraph of page 68.
For claim 10, Lan et al. teach anti-CCR8 antibody is conjugated to cytotoxins; see bridging paragraph of pages 67-68.
For claim 17, Lan et al. teach anti-CCR8 antibody is an IgG antibody; see page 6.
The Applicant’s arguments:
Lan is not an enabling disclosure of the claimed subject matter.
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
It is noted that prior art is presumed to be operable/enabling MPEP 2121. MPEP 2121, part III states
A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm . Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). See also MPEP § 2122.
Applicant is reminded that when the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to provide facts rebutting the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Thus, Applicants’ arguments that “Lan is not an enabling disclosure of the claimed subject matter” are not found persuasive in the absence of objective evidence factually supported by an appropriate affidavit or declaration.
Conclusion
11. No claim is allowed.
12. 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642
