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. Restriction/Election Applicant’s election of Group I in the reply filed on November 11, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant did not specify that the election was made without traverse and did not put forth arguments against the restriction. Claims 30-32,37,40-42, and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 11, 2025. Claim Rejections - 35 USC § 112 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. Clai ms 1,3,6,8,10-11,13,15-18,22, and 28 are 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. Independent claim 1 states, “contacting the population of particles, or the one or more subpopulations thereof, with the liquid, the liquid supplemented with a specific gravity-modifying means and having a specific gravity that is not equal to unity .” Claim 16 states that “wherein the specific gravity of the liquid is more than or less than +/- 3% from unity .” Applicants specification on Page 9, Paragraph 53 states that, “By way of example, a specific gravity of a liquid of this disclosure that is not equal to unity means the density of a liquid of this disclosure is different from the density of a reference liquid. As a more specific example, a specific gravity of 1.3 for a liquid of this disclosure may equate to the liquid having a density of 1.3 g/ml, when water (1.0 g/ml) is used as the reference liquid.” The specification just provides examples of unity without a solid definition of unity . Claims 1 and 16 do not recite what g/ml value unity is or what the reference liquid is. One cannot determine the metes and bounds of the claims or the acceptable specific gravity values. Because unity or unity’s specific gravity has not been clearly recited in the claims, the examiner will interpret it as being any value for purposes of examination. Claim 8 uses the terminology “within about 80% or more ” Within means 80% or less; however, the term “ about ” makes the claim indefinite because about means that the actual value can be less than or greater than the value of 80%. The term “more” means that the amount can be greater than 80% which conflicts with the terminology “within”. Furthermore, “more” than 80% can be significantly greater than “about 80%”. For purposes of examination, examiner will interpret this to mean that the aliquots can have any concentration of cells. Claim 8 is further indefinite because it is not clear if the first and the second aliquot of cells are drawn from the same cell population /subpopulation/type or distinct population /subpopulation . For example, it is not clear if the aliquots are taken from the same location containing the same subpopulations / population of cells or the first and second aliquots are taken at different places in the liquid where distinct subpopulations /populations reside . Claim 13 is indefinite because it recites “wherein the population or subpopulations of particles is sedimented within the volume of the liquid prior to contacting the population or subpopulations of particles with the liquid…..” This is indefinite beca use claim 13 recites that the particles are sedimented within the liquid before even being contacted with the liquid. For purposes of examination, examiner will interpret the claim to mean that the cells are exposed to liquid and that some cells/populations/subpopulations are able to sediment within the volume of the liquid after being first contacted with the liquid . Claim 28 depends from claim 27 which has since been canceled. The claim dependency for claim 28 needs to be amended so that the true metes and bounds of claim 28 can be established. For purposes of examination and to further prosecution, examiner will assume that claim 28 now depends from claim 1. Claim Rejections - 35 USC § 102 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. Claim s 1,3,6,10-11,13,15-18, 22, and 28 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Woodside (CA 2405881) Woodside discloses a method of manipulating the localization of a population of particles, or one or more subpopulations thereof (subpopulations of cells), within a volume of a liquid, comprising: contacting the population of particles, or the one or more subpopulations thereof, with the liquid, the liquid supplemented with a specific gravity-modifying means (iodixanol) and having a specific gravity that is not equal to unity (Abstract and Pages 5-9 of Woodside ); and b) influencing buoyancy of the population of particles, or the one or more subpopulations thereof, within the volume of the liquid (Abstract and Pages 5-9 of Woodside ) . Woodside discloses wherein the specific gravity of the liquid is adjusted either before or after contacting the population of particles, or the one or more subpopulations thereof, with the liquid, by varying a concentration of the specific gravity-modifying means in the liquid ( Pages 5 -11 and Page 13-Page 14, Example 1—illustrates that the density separation medium/”the liquid” is adjusted before contacting the population of particles) as in instant Claim 1 . Woodside discloses applying an energy input to the liquid to distribute the population or subpopulation s of particles throughout the volume of the liquid, wherein the energy input is a turbulent mixing force (Woodside states that distribution of the cells can occur by centrifugation, Page 6, lines 15-16) as in instant Claim 3 . Woodside discloses deactivating the energy input, wherein distribution of the population or subpopulation(s) of particles is maintained throughout the volume of the liquid after deactivating the energy input (Page 8, lines 5-15 disclose that the cells remain in a certain layer after the centrifuge process/deactivating the energy input occurred) as in instant Claim 6 . Woodside discloses wherein an average density of the particles of the population, or the one or more subpopulations thereof, is the same as or within about +/- 3% of the specific gravity of the liquid, and the population or subpopulation(s) is neutrally buoyant within the volume of the liquid (Page 5, lines 22-32 ; Page 7 ; Page 9, lines 20-27 ) as in instant Claim 10 . Woodside discloses an average density of the particles of the population, or the one or more subpopulations thereof, is higher than the specific gravity of the liquid and the population or subpopulations sediments within the volume of the liquid (Page 5, lines 22-32 and Page 7 ; Page 9, lines 20-27 ) as in instant Claim 11. Woodside discloses wherein the population or subpopulation(s) of particles is sedimented within the volume of the liquid after contacting the population or subpopulation(s) of particles with the liquid, and is biased upward within the volume of the liquid after coming into contact with the liquid (Page 5, lines 22-32, Pages 7-9 —one population of cells settles out below the interface between the DSM and the sample and another population/subpopulation will settle at the interface between the DSM and the sample—more upward bound ) as in instant Claim 13 . Woodside discloses wherein the specific gravity of the liquid is between about 1.0 g/mL and 1.5 g/ mL (Page 17-Page 18, Example 6) as in instant Claim 15 . Woodside discloses wherein the specific gravity of the liquid is more than or less than +/- 3% from unity (Pages9-11; Page 17 bridging Page 18, Example 6) as in instant Claim 16 . Woodside discloses wherein the specific gravity-modifying means is a specific gravity-modifying soluble solid or miscible solution (Page 9 , line 18 ) as in instant Claim 17 . Woodside discloses wherein the specific gravity- modifying soluble solid is iodixanol, or the specific gravity-modifying miscible solution comprises iodixanol (Page 9, line 18) as in instant Claim 18 . Woodside discloses wherein the population or subpopulation(s) of particles is a population or subpopulation(s) of single cells or aggregates of cells (Page 7, line 31-Page 8, line 1) as in instant Claim 22 . Woodside discloses culturing and/or expanding the population or subpopulation(s) of cells within the volume of the liquid, wherein the liquid is a cell culture medium (Examples 2-5,7-8 describe medium that will support cell growth/expansion; for example many of the mediums have FBS which supports cell growth and expansion) as in instant Claim 28 . The reference anticipates the claim limitations Claim Rejections - 35 USC § 103 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 1,3,6,8,10-11,13,15-18,22 ,28 are rejected under 35 U.S.C. 103 as being unpatentable over Woodside (CA 2405881) Claim s 1,3,6,10-11,13,15-18,22 ,28 apply as above. Woodside teaches that the particles /cells can be removed /harvested once relocated to their specific layers by centrifugation (Page 8 of Woodside) . Woodside does not teach the exact cell concentration of each aliquot that is removed or how many aliquots are required to remove cells . MPEP § 2144.05 (II) states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”). A review of the specification fails to provide evidence that the claimed cell concentration of each aliquot or the number of aliquots required to remove cells are critical. Absent such evidence it would have been obvious to an artisan of ordinary skill at the time of effectively filing Woodside to try a finite number of possible concentration s of cells in each aliquot to predictably arrive at the claimed concentration through routine optimization. An artisan would have been expected to have optimized the number of aliquots needed to fully remove the segregated cells. An artisan would have a reasonable expectation of success in optimizing the cell concentrations /number of aliquots needed for cell removal because determining cell removal methods were long established in the art as determined by Woodside (Page 8) . Thus, Woodside renders claim 8 obvious . Given the teachings of the cited references and the level of skill of an artisan at the time of applicant’s invention, it must be considered absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention. All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in particle separation and cell culture. Conclusion All claims stand rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LAUREN K VAN BUREN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1025 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F:9:30am-5:40pm; 9:00-10:00pm . 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. FILLIN "Examiner Stamp" \* MERGEFORMAT LAUREN K. VAN BUREN Examiner Art Unit 1638 /Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638