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. Claims 1-44 are pending and examined on merits. Priority Receipt is acknowledged of certified copies of JP2021-059086 filed 03/31/20 2 1 . 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. Claim s 1, 2, and 11-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for CCR8 antibodies recited in claims 3-10 , does not reasonably provide enablement for CCR8 antibodies without the CDR 1-3 from VL paired with CDR1-3 from VH. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention. The scope of the claim Claims 1, 2, and 11-44 are drawn to a genus of CCR8 antibod ies used in a CAR-T construct. An antibody claimed by reciting a target structure in this case , CCR8 causes enablement issue according to the Supreme Court Amgen Inc v. Sanofi (5/18/23) . T he scope can potentially encompass “quintillion” unique species as discussed in Amgen v. Sanofi, 598 U.S. 594 (2023 . The instant antibody claims are similar to those asserted Amgen claims in that both claims recite a n antigen structure, not the claimed antibody structures. Recitation of “ CCR8 ” does not predict its antibody structure s . Additionally, in its recent decision in Baxalta Inc. v. Genentech, Inc., No. 2022-1461, 2023 WL 6135930 (Fed. Cir. Sept. 20, 2023) the Federal Circuit found the facts of this case to be "materially indistinguishable from those in Amgen." Baxalta, 2023 WL 6135930, at *4. According to the Federal Circuit, claim 1 covers "millions of potential candidate antibodies" (id.) that bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa. The court, however, noted that the specification discloses the amino acid sequence of just 11 of those antibodies. And like the roadmap in the patents at issue in Amgen, "the '590 patent's roadmap simply directs skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the [11] antibodies they elected to disclose." (Id.) Missing from the specification, according to the Federal Circuit, was "'a quality common to every functional embodiment' ... that would allow a skilled artisan to predict which antibodies will perform the claimed functions" (id.; quoting Amgen Inc. v. Sanofi., 598 U.S. 594, 614 (2023)), such as a common structural or other feature that would allow the antibodies to perform the claimed functions, or an explanation as to why the 11 antibodies do so and others do not. (Baxalta, 2023 WL 6135930, at *4). And the Federal Circuit was not persuaded by Baxalta's argument that its disclosed hybridoma-and screening process "predictably and reliably generates new claimed antibodies every time it is performed" (id.), because "it is undisputed that to practice the full scope of the claimed invention, skilled artisans must make candidate antibodies and screen them to determine which ones perform the claimed functions." (Id.). The amount of direction provided by the inventor and existence of working examples The specification provides the structures in CCR8 antibod ies in claims 3-10. The level of predictability in the art Shionogi ( cited below under the art rejection) teach the state of art regarding CCR 8 antibodies and their functions as well as how they were made. Note Fig. 1-7. Shionogi teach CCR8 can be used as immunogen to make the claimed antibodies. The antibodies have different structures, especially at the hypervariable regions called CDRs. One cannot predict the CDR structures of an antibody by looking at an epitope structure, where the antibody binds. In order to know the structure of CCR8 antibodies, one has to sequence them. Likewise, an antibody CDR structures do not give any clue regarding its epitope structure nor its functions. Homology searching does not apply to CDR structures. US Pat.12037399 teaches a sequence identical to instant SEQ ID NO: 13 (a VH claimed in the instant claim) . However , the antibody having the same VH sequence does not bind to CCR8, which indicates that an antibody has to be have a VL and VH pair in order to bind a designated target. The Supreme Court (Amgen, 2023) held that the Amgen application was not enabled for the genus of antibodies that (1) bind to specific amino acid residues on PCSK9, and (2) block PCSK9 from binding to LDL receptors, even though Amgen disclosed numerous PCSK9 antibodies that met (1) and (2) requirements. Amgen’s arguments that scientists could make other antibodies that meet these two functions. The case law applies to the instant claims which require a genus of anti- CCR 8 antibodies . The quantity of experimentation needed to make or use the invention based on the disclosure Based on the content of the disclosure and the state of art, in view of the recent Supreme Court ruling regarding nature of an antibody invention, a skilled artisan, through extensive trial-and-error experimentation, would have to make antibodies, validate their functions as described in Mineva. For all of these reasons, the specification does not enable one of ordinary skill in the art to make and/or use what is claimed except for the antibodies claimed by structures in claims 3-10 . Limiting the scope to those antibodies claimed in claims 3-10 would obviate this rejection. 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 appl icant regards as his invention. Claims 1 2 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 12 depends on claim 2 which is limited to an anti-CCR8-scFv region”. However, the claim recites “extracellular region” and it is not clear whether the scope of claim 12 is a CD8A signal sequence is attached to something other than an anti-CCR8-scFv. Claim Rejections - 35 USC § 103 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claim (s) 1- 11, and 15- 4 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2020138489 ( IDS, p ublication date; 02/07/2020 , the equivalent s are US20220064312A1 and Application No. 17418417 ) in view of US 20190233526 A1 (hereinafter “ Perera ”). Application No. 17418417 , published as US20220064312A1 is a 371 of PCT/JP2019/051603 , published as WO2020138489 . WO2020138489 is a non-English document , therefore US20220064312A1 ( hereinafter “ Yoshikawa ”) is used as an English equivalent of WO2020138489 . Yoshikawa teaches CCR8 antibodies claimed in the instant claims 1-10. Note Figs 1-7. The difference between Yoshikawa and the instantly claimed invention is that Yoshikawa does not teach CAR construct. However, Perera teaches a CAR construct showing from N-terminal, signal peptide, VL kappa-linker (Gly-Ser)-VH, Hinge TM-4-IBB-CD3 zeta. Note Fig. 1A and Abstract. Perera teaches an antibody targeting CCR4 expressed on a tumor cell surface selectively depletes Foxp3+CD4+Treg and induces an enhanced anti-tumor response in a treated patient; that other therapeutic agents targeting CCR4 are needed; and that a chimeric antigen receptor containing an extracellular scFv that specifically binds to CCR4 was produced so as to serve as such other therapeutic agents. See in particular, the claims, paragraphs [0003]-[0005], and the examples). Perera further teaches a linker . Note paragraph [0144] . Regarding claim 15, drawn to a spacer, Perera teaches various spacers. Note paragraph [0146] . Regarding claims 16- 44 drawn to transmembrane domains, intracellular region, effector cells, pharmaceutical and nucleic acids , Perera teaches various transmembrane domain structures of CAR-T, starting at paragraph [0147] . The anti-CCR8 antibod ies described by Yoshikawa have common effect and function of CCR4 taught by Perera in that both types of antibodies target tumors and generate an enhanced anti-tumor response by removing or depleting regulatory T cells . See Paragraph [0038] of Yoshikawa . T herefore, a person of ordinary skill in the art would have been motivated to produc e a chimeric antigen receptor c omprising an extracellular scFv that specifically binds to CCR8 so as to serve as a therapeutic agent . In addition, one of ordinary skill in the art would have been arrived at the claimed CAR-T construct with a reasonable expectation of success because produc ing the scFv section of such a chimeric antigen receptor can be accomplished given the anti-CCR8 antibodies amino acid sequences taught in fig. 1 -7 of Yoshikawa . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Misook Yu whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0839 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-Th, 7-5pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT YVONNE (BONNIE) EYLER can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-1200 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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