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. Status of the Claims Claims 113-128 are pending (claim set as filed on 11/05/2025 ). Election /Restrictions Applicant’s election without traverse of Group I , claims 113-115 , in the reply filed on 11/05/2025 is acknowledged. Claims 116-128 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Therefore, clai ms 113-115 are pre sented for examination. Priority This application is a 371 of PCT/JP2021/006464 filed on 02/19/2021 , which has foreign applications to JP 2020-027595 filed on 02/20/2020 and JP 2020-081523 filed on 05/01/2020. Drawings The drawings filed on 08/19/2022 h ave been accepted. Information Disclosure Statement The Information Disclosur e Statement s (IDS) submitted on 08/19/2022, 04/15/2024, 02/24/2025, and 10/13/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement s are being considered by the Examiner. Claim Rejections - 35 USC §112, Indefinite 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. Claim 11 4 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Regarding claim 114 , the term “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention (see MPEP 2173.05(d): Exemplary Claim Language). Claim Rejections - 35 USC §102, Anticipation 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. Cl aim 113 is reje cted under 35 U.S.C. 102(a)(1) as being anticipated by Ladtkow (US 2018/0093270 A1). Ladtkow ’s general disclosure relates to a centrifugal fluid separation device including one or more modular fluid separation cassettes disposed radially about a rotor assembly of a centrifuge and related system and method (see ¶ [0002]). Ladtkow discloses “ size and density relationships are important insofar as most current separation devices and techniques rely upon them, or upon differences in particle surface chemistry characteristics, in order to effectively and reliably separate and/or filter the blood components ” (see ¶ [0003] -[ 0004]). Ladtkow teaches “ fluids carrying particle substances must be filtered or processed to obtain either a purified liquid or a purified particle end product ” (see ¶ [0003]) and “in the medical field, it is often necessary to filter or separate blood” (see ¶ [0004]). Ladtkow further teaches o f particular interest in whole blood separation is the ability to obtain purified Peripheral Blood Mononuclear Cells (PBMCs) which include monocytes , lymphocytes, and macrophages (see ¶ [0005], [0015]). Ladtkow teaches “as shown in Fig. 1, the centrifuge 102 is a floor standing-type centrifuge. Examples of suitable floor-standing-type centrifuges include those used in the Spectra Optia apheresis system … manufactured by Terumo BCT, Inc.” (see ¶ [0074]). Claim interpretation : the instant pre-grant specification at ¶ [0283] -[ 0285] describes utilizing the separation apparatus of Spectra Optia: Terumo BCT for obtaining a monocyte fraction (i.e., the same device is also used by the prior art of Ladtkow at ¶ [0074]) . Therefore, the MPEP 2112.02(I) states that “ Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process ” . Therefore, the prior art’s step of enriching a monocyte will inherently be based on specific gravity and cell size. Cl aim s 113 and 115 are reje cted under 35 U.S.C. 102(a)(1) as being anticipated by Macpherson (US 2010/0210989 A1). Macpherson ’s general disclosure relates to methods and apparatuses for processing blood and more particularly to methods and devices for leukapheresis (see ¶ [0002]). Regarding claim 113 and 115(a) , Macpherson teaches “a method of processing blood. The method comprises the steps of: obtaining blood from a patient coupled to a single blood processing device to form a closed loop between the patient and the blood processing device; collecting bulk mononuclear blood cells from the blood by leukapheresis implemented using the blood processing device in the closed loop; and enriching concurrently target cells separated from non-target cells in the bulk mononuclear blood cells using the blood processing device in the closed loop ” (see ¶ [0020] , & Figure 2 ). The target cells may be monocytes (see ¶ [0045], [0074], [0090], Table 1). Claim interpretation : the instant pre-grant specification at ¶ [0283] -[ 0285] describes utilizing the separation apparatus of Spectra Optia: BCT for obtaining a monocyte fraction (i.e., the same device is also used by the prior art of Macpherson at ¶ [0005], [0009], [0059]). Therefore, the MPEP 2112.02(I) states that “ Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process ” . Therefore, the prior art’s step of enriching a monocyte will inherently be based on specific gravity and cell size. Claim Rejections - 35 USC §103, Obviousness 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 set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness. Claim 114 is rejected under 35 U.S.C. 103 as being unpatentable over Macpherson as applied to claims 113 and 115 above, and in view of Donahue ( Optimization of the Spectra Optia for Leukapheresis of Very Small Subjects , 2014). Macpherson ’s disclosure is taught above as it pertains to a method of producing a monocyte preparation comprising obtaining blood and enriching monocyte based on specific gravity and cell size. Howeve r, Macpherson do es not teach : wherein the collection preference is set to be higher than a predetermined value by 10 to 30 ( claim 114(iv) ). Donahue teaches an optimization procedure for the Spectra Optia apheresis sytem and its mononuclear cell (MNC) collection set (see abstract at first ¶). Donahue teaches “A Collection Preference (CP) setting of 20 was selected using the automatic interface management mode. In the last procedure a semiautomatic mode was utilized so that collection deeper than CP of 20 was possible. Procedures were terminated at 120 mi n” (claim 115(b)-(c)) (see page 2, 1 st ¶). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the collection preference to a value of 20 such as taught Donahue in the method of Macpherson. The ordinary artisan would have been motivated to make optimization of the collection preference setting because Donahue discloses MNC collections through the process of leukapheresis have proven to be effective in isolating cells for transplantation and cellular therapeutics (see page 2, last ¶). The ordinary artisan would have had a reasonable expectation of success is because both references utilized the Spectra Optia apparatus for leukapheresis. Conclusion No claims were allowed. Correspondence Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NGHI V NGUYEN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3055 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri: 9 - 3 pm (ET) . 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 Sharmila Landau can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-0614 . 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