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 49-70 are pending and are the subject of this Office Action. 2. Claim Objections Claim 58 is objected to since “otelixizumab” is capitalized. 3 . 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim s 49-70 are rejected under 35 U.S.C. 103 as being unpatentable over Wardell et al. (US 2018/0325954) . The claims are essentially drawn to producing an immune composition by culturing a tumor sample in medium comprising serum and IL2 along with subsequent seeding. Wardell teaches a method of expanding tissue infiltrating lymphocytes into a therapeutic TIL population by processing a resected tumor into multiple tumor fragments and expanding them between 3 and 14 days in a closed system provided with a gas-permeable surface . Il2 and OKT3 are added to the system (culture) in order to produce a second TIL population. This transfer procedure is performed without opening the system. The second culture is grown and transferred in the same manner in order to produce a third population of TILs. The resultant cells can be cryopreserved. Irradiated allogenic PBMCs (feeder cells) may also be added [0457] . Paragraphs [0423] and [0426] teach a culture medium comprising serum and IL2 , wherein the IL2 concentration can be about 1000 IU/ml, 1500 IU/ml, 2000 IU/ml, 2500 IU/ml or 3000 IU/ml ([0427]) where, after day 5, the media with added IL2 and changed every 2-3 days thereafter ([0433]). A second expansion comprising 30 mg/ml OKT3, PBMCs and 3000 IU/ml IL2 is also taught ([0461]). Cryopreservation is taught in paragraph [0526]. More specifically, regarding the individual claims – Claim s 49 , 50 , 54, 58 , 59, 64 and 68 are met as discussed above. In addition, see paragraphs [0005] – [0015] which teach the general protocol. The resected tumor was obtained from a patient . Regarding claim 51, Wardell does not teach the number of samples cultured, nor do they teach 1mm 2 to 4mm 2 . However, it would have been obvious to have cultured any number of samples depending on the capacity of the systems used, as well as on the desired goal of the artisan. A larger number of samples would provide for more of the desired immune cells for research and therapeutic purposes. Though the cross-sectional area is not taught, paragraph [2599] teaches a volume of 1-3mm 3 . Paragraph [0414] teaches a range of 1-10mm 3 . Given this, the artisan would have known the general size of the cross-sections which can be produced. Regardless, w here the general conditions of a claim are disclosed in the prior art, it is not inve ntive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955) . Furthermore, "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and, therefore, obvious) and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018) (“it is not inventive to discover the optimum or workable ranges by routine experimentation.”). C laims 52 and 57 are taught in paragraphs [0460] and [0461]. Regarding claim s 53 and 63 , the volume is not taught. However, this is not inventive ( In re Aller ; In re Boesch ; Merck & Co. v. Biocraft Labs. Inc.; E.I. DuPont de Nemours & Co. v. Synvina C.V.) , as it would have been obvious to have determined the ideal volume in order to maximize cell growth . Regarding claims 55, 56, 66 and 67, paragraph [0433] teaches that, after day 5, the media with added IL2 and changed every 2-3 days thereafter. Given 14 days, the media would be changed once on day 7 or 8, the again on approximately day 9-11 and again on day 9 -14 - up until cell transfer. As for claim 67, paragraph [0461] teaches that IL2 is added at day 4 after the second expansion. Regarding using the same , or increasing concentrations at each time point, identical and varying compositions are taught between the first and second sets of cells (i.e. before and after the first expansion) in paragraphs 0 425- 0 427, 0 430, 0 433 (first set) and paragraphs 0 446, 0 448- 0 450 , 0461 and 0462 (second set). See also In re Aller . Regarding claim 60, PBMC (feeder cells) are taught in paragraphs [0015] and [0457]. Claim 61 is taught in paragraph [0458], which recites using a 200-fold excess (i.e. 200:1) of feeder cells to TILs. Claim 62 is taught in paragraph [0425], as 10E5 is identical to 1x10 6 . Regarding claim 65, it is noted that Wardell teaches that the CD3 antibody is optional in the second composition ([0010]). Claim 69 is taught in paragraph [0071]. Claim 70 is taught in paragraph [0015] and [0526]. 4. Prior Art of Interest Not Relied Upon Besser et al. teaches modifying IL2 concentrations to improve T cells for therapy. Besset teaches expansion of immune cells (1-2mm 3 ) using the same, as well as varying IL2 concentrations, anti-CD3 antibodies, a 14-day culture, a 200:1 feeder cell:TIL ratio, a cell number of 0.5 – 1 x 10 6 and the addition of IL2 every 2-3 days (see “Generation of TIL cultures” and “ Rapid expansion protocol of T lymphocytes”). 5 . 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 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