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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/12/2024 and 05/02/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election of Group I, claims 1-19 in the reply filed on10/31/2025 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)).
Claims 20 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/31/2025.
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.
Claims 1-12 and 16-19 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 closed cell culture chamber enclosing a fluid media and a first surface configured for a cell culture 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]); a cell removal tool configured to selectively remove one or more cells from the first surface of the cell culture container (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]); and a controller configured to iteratively remove one or more cells using the cell removal tool and thereby maintain the cell culture below a threshold density throughout a cell culture process (In some instances, the disclosed systems may comprise one or more processors, controllers, and/or computers that are configured to execute programmable, software- encoded instructions [0153, 0159, 0188, 0193 and 0195]), wherein the cell culture chamber is configured to seal during the cell culture process (In some instances, a “compartment”, “chamber”, “reservoir”, or “region” may be enclosed and sealed by a lid. In some instances, a “compartment”, “chamber”, “reservoir”, or “region” may be enclosed by a removable lid so that the interior of the “compartment”, “chamber”, “reservoir”, or “region” is accessible. [0044]). Also see [0133].
Regarding claim 2, Kelso discloses wherein the cell culture comprises one or more cell colonies [0012, 0014 and 0033].
Regarding claim 3, the device 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 iterative removal of one or more cells comprises removing a portion of a first cell colony of the one or more cell colonies in view of [0113-0114 and 0127].
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 device 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 is selected such that a remainder of the first cell colony after removal of the portion of the first cell colony translates across the first surface in view of [0113-0114, 0127 and 0130-0131].
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, the device 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 iterative removal of one or more cells comprises splitting a first cell colony in the one or more cell colonies into a plurality of sub-colonies in view of [0113-0114, 0127 and 0130-0131].
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, the device 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 cell removal tool is further configured to detach a first sub-colony in the plurality of sub-colonies from the first surface in view of [0113-0114, 0127 and 0130-0131].
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 7, Kelso discloses wherein the cell culture container further comprises a fluid port configured to remove the first sub-colony (In some instances, the disclosed devices or cartridges may further comprise a cell removal port for removing cells that have been selectively detached from one or more clonal colonies [0033]). Also see [0054].
Regarding claim 8, the device 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 cell removal tool is further configured to translate the first sub-colony to a first region of the first surface, wherein the fluid media flushes cells from the first region through the fluid port in view of [0033, 0054, 0129, 0136 and 0214].
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 9, the device 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 iterative removal of the one or more cells comprises increasing a size and a confluence of the cell culture 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.
Regarding claim 10, Kelso discloses wherein the cell removal tool comprises a continuous wave laser [0106].
Regarding claim 11, Kelso discloses wherein the cell removal tool comprises a pulsed laser [0106].
Regarding claim 12, Kelso discloses wherein the pulsed laser comprises one or more ultraviolet visible light lasers [0047 and 0105].
Regarding claim 16, Kelso discloses wherein the first surface is configured for the cell culture to remain continuously adhered thereto throughout the cell culture process [0010, 0064 and 0067].
Regarding claim 17, Kelso discloses wherein the cell culture process comprises reprogramming and expanding of induced pluripotent stem cells [0050].
Regarding claim 18, the device 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 threshold density is one of 750,000 cells/cm2,500,000 cells/cm2, 400,000 cells/cm2, 300,000 cells/cm2, or 250,000 cells/cm2 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.
Regarding claim 19, the device 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 cell culture process has a duration of one of: at least 7 days, at least 10 days, at least 20 days, at least 30 days, at least 45 days, or at least 60 days in view of [0033, 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
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.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso WO 2021/150631 as applied to claims 1-12 and 16-19 above, and further in view of Wang et al. (hereinafter Wang) US 2021/0403942.
Regarding claim 13-15, 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 14 and 15, 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 from the first surface 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 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.
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.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796