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 .
Claim Status
Claims 1-28 are pending and are examined on the merit.
Claim 1 is the independent claim.
Priority
As recorded on 03/07/2024 filing receipt, the instant application claims the benefit of priority to provisional application 63/439,562 filed 01/17/2023. Accordingly, the effective filing date of the claimed invention is 01/17/2023. At this point in examination, all claims have been interpreted as being accorded this priority date. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/12/2024 and 06/29/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the list of cited references was considered in full by the examiner. A signed copy of the corresponding 1449 form has been included with this Office action.
Drawings
The drawings filed 01/16/2024 are accepted.
Specification
The specification filed 01/16/2024 accepted.
Claim rejection - 35 USC§ 112(b)
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.
Claims 1, 2, 6, 9, 11, 16, 18, 20, 25, 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.
Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However, equivalent amendments also would be acceptable.
Claim 1 recite “… executable instructions (e.g., LIMS instructions) that…” in line 5, and “…as part of (e.g., during or after) the in situ assembly…” in line 9, render the claim indefinite because relationship is unclear between the recited " executable instructions" and “in situ assembly part”, respectively, and the parenthetical at least because it is unclear whether the parenthetical is merely exemplary or is intended as a definition.
Claim 2 recites “… (and preferably become uniform throughout) …” in line 8 renders the claim indefinite because relationship is unclear between the recited " detectable levels" and the parenthetical at least because it is unclear whether the parenthetical is merely exemplary or is intended as a definition.
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.
Claims 1-28 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner US20220282201A1; as cited in the 09/12/2024 IDS form).
Regarding claim 1, the recited system for qualitative and/or quantitative microbiological assessment comprising: an integrated automated system comprising sterile media and/or buffer reagents, culture device parts, and automated components for media and/or buffer handling, test sample handling, culture device assembly, and microbial enumeration and/or detection, all within a sterile environment, is taught as, platforms, systems, and methods for biological manufacturing, … automated cell culture, enhanced cell/colony imaging techniques for detection of cell quality features, machine learning image analysis for objective determination of cell product quality, closed-environment cell culture systems allowing end-to-end sterile manufacturing (Wagner: [0006-0007]); a cassette system for cell culture processing, comprising a) one or more cell culture chambers… and b) a liquid system coupled to the one or more cell culture chambers … wherein the liquid system is configured to provide a closed, sterile liquid environment for the adherent cell cultures in each cell culture chamber… the input fluid media and the output fluid media comprises at least one of growth media, reagents, buffers, fluid waste, and cell collection media (Wagner: [0019]); input cells are analyzed to quantify the state of the input cells (such as cell counting) … sample extraction can be performed using automated processes within a closed cell culture environment to enable continued propagation of the cell culture within a sterile environment (Wagner: [0149]); identifying individual colonies, and categorize cells by colony membership (Wagner: 0624).
The recited and one or more processors and memory, including computer-executable instructions (e.g., LIMS instructions) that, if executed by the one or more processors, cause the integrated automated system to determine that a coded test sample, loaded into the system, is to be quantitatively and/or qualitatively assessed, is taught as, implementing the described method using a processor, … the described methods implemented on a tangible, non-transitory computer readable medium having instructions stored thereon that when executed by one or more processors perform the methods (Wagner: [0694]); a loading area to load/unload the micro plate, flask, cell culture vessel, or cell culture cassette … The modular bioprocessing system may also include vertical transport mechanisms to move cell culture containers (e.g., microwell plates) in and out of bioprocessing modules … bioprocessing modules configured to accept one or more cell culture containers… container interfaces for accepting and holding cell culture containers include a plate holder for loading/unloading microwell plates. The microwell plates are then retracted into each bioprocessing module for processing or storage (Wagner: [0525-0528]; see also FIG. 58 D-H for labeled/coded test samples); the cell culture container includes a barcode or an electronic tag (which could include nonvolatile memory on board) that presents a container ID to the process module, and the process module retrieves a process recipe and history from a server when the container is inserted, so that it may immediately resume the process (Wagner: [0554]).
The recited A) add an amount of a media or concentrated media into at least a portion of the coded test sample or extraction thereof, to provide a coded enrichment culture is taught as, platforms, systems, and methods for automated cell culture carried out by a cell culture system comprising a cell culture container comprising a cell culture (e.g., a cell culture chamber comprising one or more adherent or semi-adherent cells), the cell culture configured to receive input cells … the computing subsystem can control a cell editing subsystem to perform the cell culture process. The cell culture process may include addition of fresh media, removal of old media, mixing of media within the cell culture container (Wagner: [0008] and [0019]).
Rationale for combining embodiments taught within Wagner:
To the extent that the limitations within claim 1 are taught individually but are not explicitly taught with the recited relationships and sequencing among limitations -- as examples, (i) separately teaching automation of the cell culture system components versus teaching particular cell culture steps such as addition of media, (ii) determination that the loaded sample is to be assessed, etc. -- then in the absence of a secondary consideration to the contrary, it would have been prima facie obvious to PHOSITA to try the recited combination of limitations as those limitations are taught individually as described above. Trying the recited combinations would have been examples of combining prior art elements, elements taught within the same reference, according to known methods to yield predictable results and choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (MPEP 2143.I pertains).
Regarding claim 2, the recited for qualitative assessment, execution of the computer-executable instructions further causes the system to perform B and C, is taught as, a modular bioprocessing system comprising : a) one or more process modules, each process module configured to manage and monitor a cell culture process… each process module is configured to removably couple to a cell culture cassette hosting the cell cultures via one or more pluggable connectors … the one or more shared subsystems comprise at least one of a computing subsystem, a data storage subsystem, an environmental control subsystem … process modules comprises at least one of a cell imaging subsystem, and a temperature control subsystem…, a quantitative phase imaging system… [0021].
The recited B) direct the enrichment culture for incubation in an incubator at a temperature and for a time suitable to promote the growth of one or more target microorganisms to reach detectable levels (and preferably become uniform throughout) to provide an enriched sample, is taught as, the system further comprises a temperature control subsystem configured to manage a temperature of at least one of the cell culture process and a reagent … the cell culture process comprises cell reprogramming, cell differentiation, cell gene editing, cell incubation [0021]… the cell culture process comprises incubation … sensors to measure cell culture media constituents (such as nutrients, waste products, vitamins, metabolites, proteins, extracellular vesicles, cell mass, or cell debris) [0155].
The recited C) detect, using at least an aliquot of the enriched sample, the one or more target microorganisms using the detection components in situ, is taught as, plurality of images of a cell culture, identifying a plurality of cells from the plurality of images, identifying one or more cell colonies from the plurality of cells, tracking the one or more cell colonies through the plurality of points of time (Wagner: [0013]); the computing subsystem is configured to compute structural information on individual cells, groups of cells, or regions or colonies using the quantitative phase images of the sample (Wagner: [0022]).
The recited D) store and/or transmit the detection data attributed to the coded test sample for storage and/or reporting and/or analysis, is taught as, the computing subsystem includes data storage for storing image data, sensor data, the results of data analysis, and program code that the computing subsystem executes (Wagner: [0163]).
Regarding claim 3, the recited directing, in B), the enrichment culture for incubation, comprises incubating in situ using an incubator integrated into the system, and/or incubating ex situ using a non-integrated incubator, is taught as, the cell culture process comprises incubation (Wagner: [0021] [0198]).
Regarding claims 4 and 5, the recited detecting, in C), the one or more target organisms in situ comprises using a suitable detection assay in situ; and/or detecting in C1), the one or more extracted analytes in situ comprises using a suitable detection assay in situ, is taught as, the input cells are analyzed with one or more input cell assays including genomic profiling, gene expression assays such as PCR, qPCR, microarray, single-cell RNA sequencing, whole exome sequencing (WES), whole genome sequencing (WGS), karyotyping, short tandem repeat (STR) analysis, sterility testing (testing for bacteria and viruses), or other phenotype analysis including but not limited to cell surface antigen or intracellular staining-based immunofluorescence or flow analysis, and cell viability, morphology and migration assays, or any other implementations known to persons of ordinary skill in the art [0149].
Regarding claim 6, the recited for qualitative assessment, when the coded test sample loaded into the system is a primary sample, execution of the computer-executable instructions further causes the system to: prior to A), mix or homogenize the coded test sample with a suitable amount of a specified buffer to provide an extracted sample, is taught as, the closed liquid loop include a plurality of reservoirs … the reservoirs include a fresh media reservoir which supplies cell culture nutrients, vitamins, and other factors … additional reagents or buffers (for example for pH control) are shown as reservoirs (Wagner: [0486] [0550-0553]; FIG. 67).
Regarding claim 7, the recited one or more LIMS instructions, PLC instructions, firmware, and programed instructions and logics, is taught as, the computing subsystem may also include data storage for storing image data, sensor data, the results of data analysis, and program code that the computing subsystem executes (Wagner: [0163], [0557] and [0693-0694]).
Claims 8-28 are rejected as described above for claim 1. Claims 8-28 do not further limit the embodiment examined in claim 1, according to the alternative limitations described above for claim 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, and 6-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Application No. 18/414,388.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '388 application are directed to an integrated automated system for microbiological assessment for use with sterile media, buffer reagents, and culture device parts, the integrated automated system comprising: automated components for media and/or buffer handling, sample handling, culture device assembly, and microbiological enumeration, all within a sterile environment; and one or more processors; and memory, including computer-executable instructions that, executed by the one or more processors, cause the integrated automated system to determine that a coded test sample, loaded into the system, is to be quantitatively assessed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GHAZAL SABOUR whose telephone number is (703)756-1289. The examiner can normally be reached M-F 7:30-5:00.
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/G.S./Examiner, Art Unit 1686
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
