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 Claims
Claims 1-20 are pending.
Claims 1-20 are rejected.
Claims 7, 11, 18, and 20 are objected to.
Priority
Applicant’s claim for the benefit of a prior-filed application, U.S. Provisional App. No. filed 63/000,319 filed 26 March 2020 and PCT/1B2021/052398 Filed 21 March 2021, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Accordingly, the effective filing date of the claimed invention is 26 March 2020.
Drawings
The drawings were received on 18 Aug. 2022. These drawings are accepted.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because:
it contains phrases which can be implied, including “Aspects of the present disclosure relate…”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 7, 11, 18, and 20 are objected to because of the following informalities:
The return before the last line in claim 7 should be removed such that “the plurality of worklist fields” is on the same line as “apparatus or plate reader….using”.
Claim 11 recites “associating a threshold value…, the threshold value is a product…”, which is grammatically incorrect and should recite”…, wherein the threshold value is a product…”.
Claim 18 recites “the autoloader attachment comprises”, which should recite “wherein the autoloader attachment comprises…” to correct grammar.
Claim 20 recites “; receiving sample data…” on the same line as the “determining step”. A return should be placed after the determining step, such that the “receiving” step is on a new line, in according MPEP 608.01(m) (where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation).
Appropriate correction is required.
Claim Interpretation
Independent claims 1 and 12 recite “dilution factor”, “dilution profile”, “worklist” “culture devices”, “test instance”, and “plate type”.
Applicant’s specification at para. [0121] defines a “Dilution factor” to refer to the factor by which a stock solution is diluted.
Applicant’s specification at para. [0122] defines a “Dilution profile” to refer to a collection of test instances for a given microorganic sample.
Applicant’s specification defies “worklist” to refer to a list of operations to be performed by the plate reader and/or computing apparatus on one or more microorganic samples.
Applicant’s specification at para. [0116] defines “culture device” to refer to an article adapted to house a nutrient medium that facilitates growth of a microorganism.
Applicant’s specification at para. [0145] defines a “test instance” to refer to a single occurrence of reading a culture device.
Applicant’s specification at para. [0136] discloses a plate type to refer to properties of a culture device that allow the culture device to proliferate selected microorganisms.
Therefore, these terms will be interpreted according to the definitions provided in the specification.
Claim 19 recites “The system of claim 18…wherein the autoloader attachment is configured to load the culture device to be read by the image processing circuitry of the plate reader according to the worklist sequence”. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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 2144 II. Here, the autoloader attachment is only required to be capable of loading the culture device, and the limitations of “to be read by the image processing circuitry” is merely describing how the device is intended to be used, which does not have patentable weight. Similarly, the wherein clause of “a worklist sequence is the same as the sequence of culture devices” only limits the intended use of the autoloader attachment.
Claim Rejections - 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 1-11, 13-14, 16-17, and 19-20 are 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.
Claim 1, and claims dependent therefrom, are indefinite for recitation of “receiving a request…for reading the culture device”. Claim 1, previously recites “a plurality of culture devices” in the first limitation of the claims, and as a result, it is not clear which culture device of the plurality of culture devices a request is received for. Dependent claims 4, 7-8, and 9 also recite “the culture device” and thus are indefinite for the same reasons discussed above for claim 1. For purpose of examination, the limitation in claim 1 is interpreted to mean receiving a request for reading a first culture device of the plurality of culture devices, and the recitation of “the culture device” in dependent claims 4, 8, and 9 is interpreted to refer to “the first culture device”.
Claims 14 and 19 are also indefinite for recitation of “the culture device” in line 3 of claim 14 and liens 2-3 of claim 19 for similar reasons discussed above for claim 1. Claim 12, from which claims 14 and 19 depend, recites “a plurality of culture devices” and thus it is not clear which culture device is being referenced.
Claims 2 and 13, and claims dependent therefrom, are indefinite for recitation of “a profile field that corresponds to each test instance”. Claims 1 and 12, from which claims 2 and 13 depend, recite “a series of test instances” related to a plurality of profile fields, “a first test instance with a different plate type…”, and “ a second test instance”. Dependent claims 2 and 13 also previously recite “a worklist test instance”. It is unclear if “each test instance” is referring to (1) the series of test instances, (2) the series of test instances in addition to the first test instance, second test instance, and worklist test instance, or (3) some other combination of test instances. Clarification is requested. For purpose of examination, “each test instance” is interpreted to mean “each test instance of the series of test instances”.
Claim 4 is indefinite for recitation of “the user interface”. There is insufficient antecedent basis for this limitation in the claim because claim 1, from which claim 4 depends, does not recite a user interface. The claim will be interpreted to mean “via a user interface”.
Claims 4 and 14 are indefinite for recitation of “the partially populated worklist”. There is insufficient antecedent basis for this limitation in the claim because claims 1 and 12, from which claims 4 and 12 depend, do not recite a user interface. It is noted that dependent claims 2 and 3 do recite “a partially populated worklist”. The claims are interpreted to mean “from a partially populated worklist”.
Claims 6 and 16 are indefinite for recitation of “selecting/select a different test instance of the worklist”. The term “different” in claims 6 and 16 s a relative term which renders the claim indefinite. The term “different” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, claims 1, 5, 12, and 15, from which claims 6 and 16 depend, do not previously recite selecting any particular test instance. As a result, it is not clear what the selected test instance of claims 6 and 16 is intended to be different from, such that it would be considered a “different test instance”.
Claim 10 is indefinite for recitation of “the worklist test instance” in lines 5 and 6. Claim 7, from which claim 10 depends, recites “the culture device associated with a worklist test instance” and claim 10 also previously recites “determining whether a worklist test instance in a worklist sequence”. Therefore, it is unclear if “the work list test instance” in each of lines 5 and 6 is referring to the worklist test instance recited in claim 7 or the worklist test instance in a worklist sequence of claim 10. For purpose of examination, the limitation is interpreted to refer to the worklist test instance in the worklist sequence.
Claim 10 is indefinite for recitation of “the reading” in line 6. It is unclear if “the reading” is referring to the reading corresponding to the received sample data from the plate reader for a culture device in lines 3-4 of claim 7 or the step of “reading” in claim 7, from which claim 10 depends. Clarification is requested.
Claim 11 is indefinite for recitation of “the plate reader” in line 4. There is insufficient antecedent basis for this limitation in the claim because claim 1, from which claim 11 depends, does not recite a plate reader. The claim will be interpreted to refer to a plate reader of a culture device.
Claim 17 is indefinite for recitation of “The system of claim 15, wherein the instructions further configure the computing apparatus to perform at least one action by:…reading the culture device in response to…”. Claim 15, from which claim 17 depends, recites “A system comprising the computer apparatus of claim 12, further comprising: a plate reader…”, such that the plate reader appears to be a different component of the system than the computer apparatus. However, claim 17 recites that the computing apparatus is configured to perform the reading of the culture device. As a result, it is unclear if the plate reader is intended to be part of the computing apparatus of claim 12, such that the computing apparatus could read plates, or if the plate reader is a separate component of a system that includes the computer apparatus as suggested by claim 15 and claim 17 is intended to require the instructions cause the plate reader to read the culture device. Clarification is requested. For purpose of examination, claim 17 is interpreted to mean the computing apparatus transmits instructions to the plate reader that causes reading the culture device as claimed.
Claim 20 is indefinite for recitation of “the worklist test instance in the worklist sequence”. There is insufficient antecedent basis for both the work list test instance and the work list sequence because claims 12 and 15, from which claim 20 depends, do not recite a worklist test instance or a worklist sequence. It is noted that claim 17 recites “a worklist test instance” and claim 19 recites “a worklist sequence”. For purpose of examination, claim 20 is interpreted to mean determining whether a worklist test instance in a worklist sequence is completed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106.
Step 1: The instantly claimed invention (claim(s) 1 and 12 being representative) is directed a method and system. Therefore, the instantly claimed invention falls into one of the four statutory categories. [Step 1: YES]
Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon.
Claim(s) XX recite the following steps which fall under the mental processes groupings of abstract ideas:
determining/determine that the dilution profile applies to the worklist;
populating/populate responsive to the determination that the dilution profile applies, at least some of the plurality of worklist fields with the plurality of profile fields in the dilution; and
performing at least one action responsive to the population.
The identified claim limitations falls into the group of abstract ideas mental processes for the following reasons. In this case, determining that a dilution profile applies to a worklist can be practically performed in the mind by performing comparisons between test instances of the dilution profile and test instances of the worklist to identify a match, as recited in dependent claim 2. Furthermore, populating worklist fields with the plurality of profile fields in the dilution can be practically performed in the mind aided with pen and paper by identifying a profile field that corresponds to a worklist field and writing down the profile field information into the corresponding worklist field. Last, performing at least one action responsive to the population is broadly recited and encompasses simply further analyzing the populated worklist (see dependent claim 2). That is, other than reciting these limitations are carried out with a computing apparatus, nothing in the claims precludes the steps from being practically performed in the mind.
Dependent claims 2-4, 6-7, 10-11, 13-14, 16-17, and 20 further recite an abstract idea and/or further limit the abstract idea of claims 1 and 12. Dependent claims 2 and 13 further recite the mental process of determining the worklist test instance corresponds to a profile test instance, and comparing a value to a threshold, and further limits the mental process of populating the plurality of worklist fields to be performed for each test instance. Dependent claim 3 further recites the mental process of determining if the plurality of worklist fields matches the plurality of profile fields for a single test instance. Dependent claims 4 and 14 further recite the mental process of requesting worklist fields relating to the culture device for any missing worklist field from the partially populated worklist, which involves identifying missing fields from the partially populated worklist. Dependent claims 6 and 16 further recite the mental process of analyzing the sample data to determine a result using at least one of the plurality of worklist fields and selecting a different test instance of the worklist. Dependent claim 7 further recite the mental process of analyzing the sample data, to determine a result using the plurality of worklist fields. Dependent claims 10 and 20 further recite the mental process of determining whether a worklist test instance is completed, marking an indication of the worklist test instance completed in response to the reading, and analyzing the sample data using the worklist fields to produce a result. Dependent claim 11 further recites the mental process of associating a threshold value with a worklist test instance, determining a result based on sample data received from the plate reader, and determining whether the result meets the threshold value. Dependent claim 17 further recites the mental process of determining whether a plate type of a culture device matches a plate type from a worklist test instance. Therefore, claims 1-20 recite an abstract idea. [Step 2A, Prong 1: YES]
Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. This judicial exception is not integrated into a practical application for the following reasons.
The additional elements of claims 1 and 12 include:
receiving/receive a dilution profile that includes a plurality of profile fields relating to a series of test instances for a plurality of culture devices;
storing the dilution profile in a memory of a computing apparatus/store the dilution profile in the memory;
receiving/receive a request to form a worklist for reading the culture device, the worklist having a first test instance with a different plate type and a dilution factor from a second test instances, wherein the worklist comprises a plurality of worklist fields that correspond to at least some of the plurality of profile fields in the dilution profile;
a computing apparatus;
a display device configured to display a user interface (claim 12 only);
an input device communicatively coupled to the user interface (claim 12 only);
a memory;
The additional element of claims 4 and 14 include:
via the user interface
The additional element of claims 5-6, 8, 10-11, and 16 include:
transmitting instructions to a plate reader, using the worklist, that causes image processing circuitry of the plate reader to capture an image of a culture device that is described in the worklist (i.e. transmitting data) (Claim 5);
receiving/receive, by the computing apparatus, the image as sample data (claims 6 and 16);
receiving a time condition to begin reading the culture device (claim 8);
save the result into a data store (claim 10) (i.e. storing data);
displaying a pass indication for the worklist test instance via the user interface based on the result meeting the threshold (claim 11).
The above additional elements of a computer, memory, input device, user interface, storing data, receiving data, transmitting instructions, and displaying data are generic computer components and/or functions. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See MPEP 2106.05(f).
Furthermore, the steps of receiving data in independent claims 1 and 12 only serve to collect necessary data for use by the abstract idea, which amounts to insignificant pre-solution activity that does not provide integration. Similarly, save a result in a data store and displaying a pass indication for the worklist test instance via the user interface based on the result meeting the threshold only serve to output data generated by the abstract idea, which also amounts to insignificant post-solution activity that does not provide integration. See MPEP 2106.05(g).
The additional element of claims 5, 7-8, 15, and 17-19 further include:
reading, by a plate reader, the culture device associated with a worklist test instance to obtain sample data (claim 7);
reading the culture device at the time condition (claim 8);
a system...further comprising: a plate reader comprising image processing circuitry; wherein performing the at least one action comprises transmitting instructions to a plate reader, using the worklist, that causes image processing circuitry of the plate reader to capture an image of a culture device that is described in the worklist (i.e. control the plate reader to capture an image) (Claim 15);
reading the culture device in response to the plate type of the culture device matching the worklist test instance (claim 17);
the plate reader comprises an autoloader attachment, the autoloader attachment comprises a sequence of culture devices loaded therein (claim 18);
the autoloader attachment is configured to load the culture device to be read by image processing circuitry of the plate reader according to a worklist sequence that is the same as the sequence of culture devices (claim 19).
The above additional elements of reading the culture device associated with a worklist test instance to obtain sample data and reading the culture device at the time condition (claims 7-8) and controlling a plate reader to capture an image of a culture device described in the worklist (claim 15) are not sufficient to integrate the judicial exception into a practical application for the following reasons. Regarding claims 7 and 15, the limitation only serves to generally link the abstract idea of generating a worklist to the technological environment of culture imaging, which does not provide integration. See MPEP 21.605(h). The claims do not recite any details regarding how the worklist populated with the plurality of profile fields is actually applied or relates to reading a culture device. Rather, the claims just state the plate reader captures an image “of the culture device associated with a worklist test instance to obtain sample data” without any details of what the image is, how the culture device is associated with the worklist, and/or how the capturing of the image is actually affected by the worklist being populated with profile fields of a dilution profile. Therefore, this limitation also amounts to mere instructions to apply the exception in a generic way. See MPEP 2105.(f). Regarding claim 8, the limitation of receiving a time condition and reading the culture device at the time condition does not appear to rely on the populated worklist at all such that it would provide integration. Instead, the limitation similarly only generally links the abstract idea to the technological environment of culture imaging, which does not provide integration as discussed above. See MPEP 21.605(h).
Regarding claim 17, the step of “reading the culture device in response to the plate type of the culture device matching the worklist test instance” similarly only serves to generally link abstract idea of generating a worklist to the technological environment of culture imaging, which does not provide integration. See MPEP 21.605(h). However, the reading step does not clearly integrate the steps of populating worklist fields of the worklist with profile fields of the dilution profile recited in claim 12, as there is no limit to what these worklist fields or profile fields even are, and furthermore, claim 17 encompasses using any “worklist test sequence”.
Regarding claims 18-19, the limitation generally links the abstract idea to the technological environment of image processing. Claim 18 further requires the plate reader comprises a sequence of culture devices, which serves to link the abstract idea of claim 12 to a sequence of culture devices, but does not apply the judicial exception relating to populating a worklist. As discussed above in claim interpretation, claim 19 only requires the autoloader is configured to load the culture device, which serves to generally link the abstract idea to a liquid handling robot. Furthermore, the claims does not relate the sequence of culture devices and/or “a worklist sequence” to the populated worklist in claim 12.
Therefore, the additionally recited elements amount to mere instructions to apply the exception, amount to insignificant extra-solution activity, and/or generally link the abstract idea to a technological environment, and, as such, the claims as a whole do no integrate the abstract idea into practical application. Thus, claims 1-20 are directed to an abstract idea. [Step 2A, Prong 2: NO]
Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP § 2106.05.
The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception for the following reasons. The additional elements of claims 1, 4-6, 7-8, 10-12, 14-15, and 16-19 are outlined above under step 2A, Prong 2.
The above additional elements of a computer, memory, input device, user interface, storing data, receiving data, transmitting instructions, and displaying data are generic computer components and/or functions. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
The additional elements of a plate reader comprising image processing circuitry and an autoloader attachment comprising a sequence of culture devices that takes an image of a culture device is well-understood, routine, and conventional. Applicant’s specification defines a “plate reader” to refer to an instrument used to detect biological events of samples on a culture device, and provides examples of think-film plate readers such as the 3M Petrifilm Plate Reader or other agar-based reader. Applicant’s specification at para. [0114] similarly defines a “autoloader attachment” to be an attachment for facilitating the transfer of a culture device into the plate reader, and that the autoloader attachment may include one or more controllers to load the culture device. However, the specification does not provide not any actual details regarding the plate readers or autoloader attachments, thus demonstrating the conventionality of these additional elements. See MPEP 2106.05(d), explaining the analysis as to whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification. See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. 2016). Furthermore, MPEP 2106.05(h) states limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself.
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. [Step 2B: NO]
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. For additional guidance, applicant is directed generally to applicant is directed generally to the MPEP § 2106.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Drake (2005).
Cited reference: Drake et al. US 2005/0260743 A1.
Regarding claims 1 and 12, Drake discloses a method, and system for performing the method, for automated cultivating cells in cell cultures (Abstract; [0001]). Drake discloses the system comprises a processor (i.e. computer apparatus), user interface, and an app central and scheduler (i.e. requiring memory for storing software) ([0143]; FIG. 7).
Drake discloses the method comprises the following steps:
Drake discloses receiving plate data including information on which plates include which cells and the location (e.g. the hotel) of each plate in the system (i.e. profile fields) ([0242]; [0247]-[0248]), and then monitoring a state of each cell culture, including measuring optical density (OD), confluence, cell , pH, oxygen level, and/or temperature (i.e. a series of test instances for which the profile fields relate) ([0084]-[0086]). The monitored information of the various cell cultures is considered a “dilution profile”, based on Applicant’s definition of a dilution profile in the specification at para. [0122] (a collection of test instances for a given microorganic sample).
Drake discloses loading the profiles onto the system and storing corresponding data for the cells in a database (i.e. storing the profiles in memory) ([0035]; [0247]-[0248]; Fig. 7)
Drake discloses forming lifecycles defining procedures and functions to be performed on the cells of the cultures (i.e. a worklist) ([0106]-[0109]; FIG. 3), including a read plate function defining operations to be performed by the culture device (i.e. a worklist for reading the culture device) ([0130]; [0141]). Drake discloses an operator starts new instances of lifecycles ([0182]), demonstrating the worklist is requested to be performed. Drake further discloses the different operation rules of the lifecycles include a seeding density, type of media, split ratio to use when dividing cells, and the culture vessel type (e.g. 1:5 split) (i.e. a dilution ratio) ([0129]; [0224], e.g. different analyses for a range of plate formats), which teaches different worklist test instances have different dilution ratios and plate types. Drake discloses the lifecycles include rules specifying which different procedures should be applied and to which set of items (i.e. worklist fields) ([0109]).
Drake discloses determining measurements of a cell profile (i.e. the dilution profile) apply to the worklist by comparing a measurement level to a threshold to determine the system needs to automatically perform the next process defined in the protocol (i.e. determining the profile applies to the worklist) ([0222]).
Drake discloses the profile fields (e.g. hotel of the plates and which cells are in which plates) of the plates allow the system to automatically process each plate using the correct lifecycle ([0247]-[0248]), wherein the lifecycle (i.e. the worklist) includes rules specifying when different procedures should be applied and to which set of items ([0105]; [0109]). Drake discloses the result of applying a rule includes a job consisting of a procedure and selection of items, such as destinations of wells ([0109]). Therefore, Drake discloses that the worklist is populated with profile field information (i.e. where to perform the job/ the selection of wells) in response to determining the system needs to perform the next defined protocol process.
Drake further discloses using the correct lifestyle including processes carried out on the correct plates [0247]-[0248]).
Regarding claims 2 and 13¸ Drake discloses receiving new instances of Lifecycles from a user ([0182]). Drake discloses associated data with multiwall plates are imported directly into the system, while the operator must then load the hotels of plates and information on which plates contain which cells such that the system may automatically process each plate using the correct lifecycle ([0247]). Accordingly, the receiving a work instance is only partially populated until additional information is provided by the operator.
Drake discloses determining measurements of a cell profile (i.e. the dilution profile) apply to the worklist by comparing a measurement level of a culture (i.e. a profile test instance) to a threshold measurement (i.e. a worklist test instance) to determine the system needs to automatically perform the next process defined in the protocol (i.e. determining the profile applies to the worklist) ([0222]).
Drake discloses determining the dilution profile applies to the worklist based on one worklist test instance matching a profile test instance ([0222], e.g. if measured confluency matches threshold confluence, process in worklist is performed).
Drake discloses the profile fields (e.g. hotel of the plates and which cells are in which plates) of the plates allow the system to automatically process each plate using the correct lifecycle ([0247]-[0248]), wherein the lifecycle (i.e. the worklist) includes rules specifying when different procedures should be applied and to which set of items ([0105]; [0109]). Drake discloses the result of applying a rule includes a job consisting of a procedure and selection of items, such as destinations of wells ([0109]). This demonstrates the populating comprises populating worklist fields with the corresponding well destinations of each test instance.
Regarding claim 3, Drake discloses determining whether the worklist test instance corresponds to a profile test instance comprises determining locations of individual wells in the plurality of profile fields and determining the wells applicable to a lifecycle (i.e. worklist fields matching the profile fields ([0019]; [0105], e.g. lifecycle linked to set of cells in wells defines an experiment; [0222]).
Regarding claims 4 and 14, Drake discloses that for multiple plates, associated data can be imported directly into the system, and then the operator must load the hotels of plates and information on which plates contain which cells to enable the system automatically using the correct lifecycle ([0022];[0247]). Drake further discloses the operator must provide instructions to the system on which specific processes must be applied to particular cell lines and instruct the system on the sequence and timing of processing steps ([0022]), which shows the operator provides work fields for missing work fields not automatically determined by the system. Drake discloses that too allow user input, a user interface is displayed capable of representing resource conflicts and receive inputs for revising a forward plan of the system, which shows the missing worklist fields are requested via the user interface ([01578]).
Regarding claims 5 and 15, Drake further discloses the system includes a plate reader with image processing circuitry ([0149, e.g. reader module for plate reading; [0230]; [0223], e.g. imaging system with camera for image acquisition and image analysis software; [0232] FIG. 3), and performing the action controls the plate reader to image a culture device that is identified as needing imaging in the lifecycle ([0160]-[0161], e.g. read schedule determined by growth measurement).
Regarding claims 6 and 16, Drake discloses receiving images from storage for processing and then analyzing the images ([0246]). Drake further discloses the operator views collected images to confirm the results of the software analysis, such that the images are presented on a user interface ([0225]; FIG. 7, e.g. user interface). Drake further discloses selecting a next read task for a different plate (i.e. a different test instances of the worklist) ([0160]).
Regarding claim 7¸ Drake discloses performing the action controls the plate reader to image a culture device that is identified as needing imaging in the lifecycle (i.e. associated with a worklist test instance) ([0160]-[0161], e.g. read schedule determined by growth measurement). Drake discloses analyzing the sample data to determine a growth rate of the cells based on data and information derived from tests and measurements of the worklist (i.e. worklist fields) ([0170]-[0171]; [0246]).
Regarding claim 8, Drake discloses receiving a group of instructions defining when a particular task is to be performed ([129]), including when to read a plate, such as every 2-3 days (i.e. reading the culture device at the time condition) (Figure 3).
Regarding claims 9 and 17, Drake discloses the system provides an error message to a user if a particular plate type in a process and instead the system will perform other processes that require the available plate types (i.e. the system checks whether a plate type of a culture device matches or does not match plate types corresponding to processes in the worklist) ([0211]). Drake discloses the processes include reading a plate, and that the workflow management system directs the imaging system about which measurement type is used for specific plates (i.e. a culture device is read based on the plate type matching the plate type in the work test instance) ([0222]; [0231]).
Further regarding claim 9, the step of reading the culture device in response to the plate type matching the worklist test instance is a contingent limitation that is not required under the broadest reasonable interpretation of the claims because the condition precedent of matching is not met. See MPEP 2111.04 II.
Regarding claims 10 and 20¸ Drake discloses the worklist includes process definitions describing individuals functions a modules must perform to complete any given tasks ([0121]).
Drake discloses receiving sample data of a confluence of cells in the culture device after the task on the culture device is completed (i.e. based on the determining) in order to update the forward plan ([0148]). Given Drake updates the model after a task is completed ([0148]; Fig. 9), this shows marking an indication a worklist test instance is completed in response to the reading of the confluency data.
Drake further discloses analyzing the confluence data (i.e. sample data) using a predictive model of the workflow planner and updating the predictive model in order to change the forward plan (i.e. producing a results by analyzing the sample data and worklist fields) ([0148]).
Regarding claim 11, Drake discloses associating a threshold of cell confluence of a culture with the desired processing of plates (i.e. a product specification for the worklists) ([0222]).
Drake discloses reading the plate for confluency (a result) according to the processes in the worklist (i.e. the worklist fields) (Fig. 3; [01110]).
Drake discloses determining whether the measured cell confluency meets a threshold value ([0110], e.g. confluence > 60% ;[0222]).
The step of displaying is a contingent limitation that is not required under the broadest reasonable interpretation of the claims because the condition precedent of the result meeting the threshold value is not met. See MPEP 2111.04 II.
Regarding claim 18, Drake discloses the plate reader is connected to liquid handling robots integrated with a sequence of incubators (i.e. an autoloader attachment) ([0020]; [0028]; FIG. 13, e.g. incubators 1302 and 1304, testing module 1316, liquid handling robots 1318 and 1320; [0216], e.g. testing module takes the measurements).
Regarding claim 19, Drake discloses the liquid handling robots are configured to move liquid into a vessel ([0053] (i.e. load the culture device to be ready by image processing circuitry).
Therefore, Drake anticipates the claimed invention.
Citation of pertinent prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chao et al. US 2022/0137596 A1, effectively filed 25 July 2018; and
Bolea et al. US 2011/0151501 A1
Chao discloses systems and methods for supporting multiple automated workflows for process modules including cell culture (Abstract; [0018]).
Bolea discloses a modular system and method for detecting microorganism in cell cultures (Abstract), and implementing different processing routines based on dilution schemes, replicates per sample, type of culture device, and diluent used, in order to count biological growth ([0100]).
Conclusion
No claims are allowed.
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/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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