CTNF 18/234,328 CTNF 83718 DETAILED ACTION Information Disclosure Statement The information disclosure statements (IDS) submitted on 02/12/2024, 05/02/2024 and 03/26/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Election/Restrictions 08-08 AIA Restriction to one of the following inventions is required under 35 U.S.C. 121: I. Claim s 1-19 , drawn to system/device for culturing cells , classified in C12M 47/04 . II. Claim 20 , drawn to a method of culturing cells , classified in C12N 5/06 . 08-09 AIA III. Claim 21 , drawn to a computer product , classified in G06N 3/002 . 08-13 AIA The inventions are independent or distinct, each from the other because: 08-17 AIA Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another and materially different process of storing a liquid . Inventions II and III are directed to a related process and product. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design as the computer readable storage medium of Invention III is not required by the method of Invention II. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants. Inventions I and III are directed to a related system/apparatus and product. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed the inventions as claimed have a materially different design as the computer readable storage medium of Invention III is not required by the system/apparatus of Invention I. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants . 08-21 AIA Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; . Applicant is advised that the reply to this requirement to be complete must include (i) an election of a invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention . The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. 08-23-02 AIA Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). 08-21-04 AIA The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01. 08-23 AIA During a telephone conversation with Lee Chedister on 03/24/2026 a provisional election was made without traverse to prosecute the invention of Group I , claim s 1-19 . Affirmation of this election must be made by applicant in replying to this Office action. Claim s 20-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-8 and 17-19 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Kelso et al. (hereinafter Kelso) WO 2021/150631 . Regarding claim 1 , Kelso discloses a system for culturing cells, comprising: a cell culture container comprising a first surface configured for one or more cell colonies to adhere thereto ( The microfluidic devices (or cartridges ) disclosed herein provide for integrated cell processing functionality packaged in a compact format that, in some instances, are disposable and/or compatible for use with standard laboratory automation equipment. The functional components of the devices or cartridges may comprise: a cell transfection compartment, a cell selection compartment, a clonal cell expansion compartment, a growth medium compartment, a waste compartment, or any combination thereof . [0033]); an image sensor configured to capture one or more time-series images of a first cell colony in the one or more cell colonies ( a microscope or other imaging unit (including a light source and one or more image sensors or cameras) that is configured for viewing cells on a surface or within a compartment, e.g., a cell transfection compartment, a cell selection compartment, and/or a cell expansion compartment; Any of a variety of image sensors may be used for imaging purposes, including but not limited to, charge-coupled device (CCD) cameras or sensors, image intensified CCD cameras or sensors, CMOS image cameras or sensors, and the like . [0163, 0167 and 0168]); a computing subsystem configured to iteratively manage a surface area of the first cell colony according to a method comprising: calculating the surface area of the first cell colony as the first cell colony proliferates, selecting a portion of the first cell colony to remove to reduce the surface area of the first cell colony when its surface area is above a predetermined threshold, and removing, using a cell removal tool ( Disclosed herein are non-transitory computer-readable media storing a set of instructions which, when executed by a processor, cause a processor-controlled system to perform steps comprising: a) controlling timing and flowrate for one or more fluids flowing through a cartridge comprising at least one compartment configured to perform cell transfection, cell selection, cell expansion, or any combination thereof; b) performing image processing of images acquired by an imaging unit configured to image a surface or volume within the at least one compartment and, based on data derived from the processed images, selecting: (i) a first subset of cells growing on a surface of or in a volume within the at least one compartment for laser-based photodetachment and (ii) a second subset of cells growing on a surface of or in a volume within the at least one compartment for laser-based photoablation; and c) controlling one or more operating parameters of one or more lasers and a laser targeting unit such that the first subset of cells is photodetached and the second subset of cells is photoablated . In some embodiments, the selecting in (b) comprises randomly-selecting one or more clonal cell colonies. In some embodiments, the selecting in (b) comprises selecting one or more clonal cell colonies based on a position on an interior surface of the cell selection compartment. In some embodiments, the selecting in (b) is based on a number of cells within a clonal cell colony, a morphology of cells within a clonal cell colony, a surface density of cells within a clonal cell colony, a growth pattern of cells within a clonal cell colony, a growth rate of cells within a clonal cell colony, a division rate of cells within a clonal cell colony, expression of an exogenous reporter by cells within a clonal cell colony, or any combination thereof. In some embodiments, the processor-controlled system is operably switched between a photodetachment operating mode and a photoablation operating mode by: controlling a laser spot size, a laser spot shape, a laser light intensity, a laser pulse frequency, a laser pulse energy, a total number of laser pulses delivered at a specified position on a surface or within the volume of the at least one compartment, a position of a laser focal point relative to the surface within the at least one compartment, a position of a laser focal point within the volume of the at least one compartment, or any combination thereof . [0013-0014], the selected portion of the first cell colony from the first surface. Also see [0012, 0014, 0133, 0153, 0159, 0171, 0188, 0193 and 0195]. In some instances, one or more lasers may be used for performing laser-induced photoporation. In some instances, one or more of the lasers used may be continuous wave lasers. [0106]) Regarding claim 2 , the processor controlled system disclosed by Kelso is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Kelso is capable of providing the operating conditions i.e., calculating the surface area based on the one or more time-series images of the first cell colony in view of [0163, 0168-0170 and 0188-0195]. Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Regarding claim 3 , the processor controlled system disclosed by Kelso is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Kelso is capable of providing the operating conditions i.e., wherein iteratively managing the surface area of the first cell colony comprises increasing clonality of the first cell colony over time in view of [0163, 0168-0170 and 0188-0195]. Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Regarding claim 4 , the processor controlled system disclosed by Kelso is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Kelso is capable of providing the operating conditions i.e., wherein the portion of the first cell colony is selected such that a remainder of the first cell colony translates across the first surface as it proliferates in view of [0113-0114, 0127, 0130-0131, 0163, 0168-0170 and 0188-0195]. Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Regarding claim 5 , Kelso discloses wherein the first surface comprises an extracellular matrix ( cell attachment and colony formation (in some instances, cells may be grown in suspension or in a gel-like matrix rather than on a surface), [0091]). As to wherein cell removal tool is configured to remove the extracellular matrix from under the selected portion of the first cell colony, the processor controlled system disclosed by Kelso is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Kelso is capable of providing the claimed operating conditions in view of [0163, 0168-0170 and 0188-0195]. Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Regarding claim 6 , Kelso implicitly discloses wherein an absence of the extracellular matrix over a region inhibits cells from proliferating in the region [0091]. Regarding claim 7 , Kelso discloses wherein the cell removal tool comprises a continuous wave laser [0106]. Regarding claim 8 , Kelso discloses wherein the cell removal tool comprises a pulsed laser [0106]. Regarding claim 17 , Kelso discloses wherein the first surface is configured for the cell colony to remain continuously adhered thereto during said iterative management [0010, 0064 and 0067]. Regarding claim 18 , the processor controlled system disclosed by Kelso is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Kelso is capable of providing the operating conditions i.e., wherein iteratively managing the surface area of the first cell colony comprises managing a cell density of the first cell colony in view of [0014, 0115 and 0121]. Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Regarding claim 19 , the processor controlled system disclosed by Kelso is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Kelso is capable of providing the operating conditions i.e., wherein the predetermined threshold is an increase in surface area that is one of 5, 10, 20, 30, 50, or 100 times an initial surface area of the first cell colony in view of [0153, 0159 and 0209]. Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114 . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-22-aia AIA Claim s 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso WO 2021/150631 as applied to claim s 1-8 and 17-19 above, and further in view of Wang et al. (hereinafter Wang) US 2021/0403942 cited in the IDS filed 03/26/2026 . Regarding claims 9-11 , Kelso does not disclose that the first surface comprises a laser film. However, Kelso does disclose that in some instances, the cell selection/expansion compartments may be configured to include a surface coating layer designed to facilitate cell attachment, or to facilitate laser-based photodetachment or photoablation. Examples include, but are not limited to, a plasma treatment [0064 and 0067-0068]. Wang discloses a system for cell control comprising continuous thin film of absorbing material that is deposited onto the transparent surface of the substrate. [0482-0483 and 0491]. Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Kelso to include a thin film of absorbing material as taught by Wang, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07. As to claims 10 and 11 , the device disclosed by Kelso and Wang is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Kelso and Wang is capable of providing the operating conditions i.e., wherein the laser film is absorptive of optical energy from the pulsed laser, thereby removing the one or more cells adhered to the laser film and wherein the laser film is at least partially absorptive of optical energy from the pulsed laser within a first range of wavelengths and at least partially transmissive of optical energy to the imaging sensor within a second range of wavelengths. Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Regarding claim 12 , Wang discloses wherein the laser film is semi-transparent and has wavelength selective absorption [0490-0491]. Regarding claim 13 , Wang discloses wherein the laser film is a plasmonic film [0490-0491]. Regarding claim 14 , Wang wherein the laser film is configured to enable light-based cell imaging [0490-0491]. It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Regarding claim 15 , Kelso in view of Wang discloses wherein the light-based cell imaging is within an imaging wavelength range emitted by the image sensor [0075-0076, 0116 and 0168 of Kelso]. It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Regarding claim 16 , Kelso in view of Wang discloses wherein the laser film is further configured to enable light-based cell removal within a removal wavelength range emitted by the source of electromagnetic radiation, the removal wavelength range different from the imaging wavelength range [0075-0076, 0116, 0168 and 0170-0174 of Kelso]. It is noted that apparatus claims cover what a device is, not what a device does or how it is to be used . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST. 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, Curtis Mayes can be reached on 571-272-1234. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LYDIA EDWARDS/Primary Examiner, Art Unit 1796 Application/Control Number: 18/234,328 Page 2 Art Unit: 1796 Application/Control Number: 18/234,328 Page 3 Art Unit: 1796 Application/Control Number: 18/234,328 Page 4 Art Unit: 1796 Application/Control Number: 18/234,328 Page 5 Art Unit: 1796 Application/Control Number: 18/234,328 Page 6 Art Unit: 1796 Application/Control Number: 18/234,328 Page 7 Art Unit: 1796 Application/Control Number: 18/234,328 Page 8 Art Unit: 1796 Application/Control Number: 18/234,328 Page 9 Art Unit: 1796 Application/Control Number: 18/234,328 Page 10 Art Unit: 1796 Application/Control Number: 18/234,328 Page 11 Art Unit: 1796 Application/Control Number: 18/234,328 Page 12 Art Unit: 1796 Application/Control Number: 18/234,328 Page 13 Art Unit: 1796 Application/Control Number: 18/234,328 Page 14 Art Unit: 1796 Application/Control Number: 18/234,328 Page 15 Art Unit: 1796