DETAILED ACTION 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. 1. Formal Matters Claims 2, 4, 6-9, 11, 14, 22, 24, 25, 31, 33, 40, 50, 54, 60, 63, 67 and 75 are pending and are the subject of this Office Action. 2 . Specification A . The use of at least the terms Glutmax TM (page 58, line 8), GentleMACS TM (page 58, line 9) and G-Rex®10, (page 59, lines 5 and 8 ; page 59, lines 25, 27 and 31 ; page 60, lines 1, 3, 4, 6 ) which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. B. The specification is objected to since there is a space between “G -“ and “Rex” on page 59, line 25. C . The listing of references on page 61 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. D . The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware. 3. Claim Objections A. Claims 2, 4, 11, 22, 24, 33 , 40, 50, 60 and 75 are objected to since “antigen binding” should be hyphenated in all occurrences. Claims 6-9, 14, 25, 31, 54, 63 and 67 are objected to since they depend from these claims. B. Claim 7 is objected to since “ cabazitaxel ” should not be capitalized. C. Claim 75 is objected to since it is believed “SEQ ID NO:61” should recite “SEQ ID NO:6”. 4. Claim Rejections - 35 USC § 112(a) – scope of enablement 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. 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. Claims 2, 4, 6-9, 11, 14, 22, 24, 25, 31, 33, 40, 50, 54, 60, 63, 67 and 75 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for expanding TILs in vitro, resulting in IFN g produciton , does not reasonably provide enablement for treating cancer in a subject by administering the subject’s TILs after treatment with anti- clusterin antibody . 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 the invention commensurate in scope with these claims. In In re Wands , 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. The breadth of the claims is excessive with regard to claiming treating a subject having cancer by administering a TIL preparation from a subject previously treated with an anti- clusterin antibody. No example administers expanded TILs, nor do Applicants provide any guidance of such treatment, as these factors are limited to in vitro studies as discussed below. Furthermore, as discussed below, it is not predictable to one of ordinary skill in the art how to treat cancer based on in vitro TIL expansion. Regarding the examples, Example 1 only demonstrates that mice administered an anti- clusterin antibody had TIL infiltration (page 52, lines 5-10) . However, the claims are drawn t o adding back TIL expanded cells post-a ntibody. Example 2 is similar to Example 1, but includes docetaxel along with the antibody. Example 3 provides for the expansion of TILs b y excising tumors from antibody-docetaxel-treated mice , but there is no evidence that expanded cells would be effective when administered in vivo . It would stand to reason that TILs in the patient after a ntibody treatment were perhaps altered, but it is unclear if this “tumor-treating” characteristic would be passed down to next generation (i.e. expanded) cells. Examples 4 and 5 culture TILs with tumor cells and show that various cultures produce INF g . H owever, predicting in vivo TIL activity based on in vitro studies is not straightforward . Poschke (Abstract) teaches – TIL TCR repertoire changes dramatically during in vitro expansion, leading to loss of tumor dominant T-cell clones and overgrowth by newly emerging T-cell clones that are barely detectable in the tumor. These changes are primarily driven by differences in the intrinsic in vitro expansion capacity of T-cell clones. Single-cell experiments showed an association between poor proliferative capacity and expression of markers related to antigen experience and dysfunction. Furthermore, we found that spatial heterogeneity of the TIL repertoire resulted in TCR repertoires that are greatly divergent between TIL cultures derived from distant tumor samples of the same patient. These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed. 5 . Claim Rejections - 35 USC § 112(b) 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. Claim 7 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. The claim contains the trademark/trade name Abraxane® . According to MPEP 2173.05(u), where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a n organic compound and, accordingly, the identification/description is indefinite. . 6. Conclusion No claim is allowable. Advisory information Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ROBERT S LANDSMAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT 571-272-0888 . The examiner can normally be reached M-F 8 AM – 6 PM (eastern). 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, Joanne Hama, can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-2911 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /ROBERT S LANDSMAN/ Primary Examiner, Art Unit 1647