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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Regarding Claim 1 – The claim recites a first communication device for wireless data exchange...” See MPEP 2181. The claim limitation uses the term first communication. The “first communication device” is modified by functional language “for wireless data exchange….” The first communication device is not modified by sufficient structure, material or act for performing the claim. Therefore 112(f) is invoked. See Spec. [0064] describes the communication device can be a computing device. For examination purposes the first communication device is construed to be hardware such as a computer.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 3 is objected to because of the following informalities: the claim recites “a portable computing device, which comprises: this user interface device, this data processing device, this first communication device, and optional: this data storage device.” in the last paragraph of the claim. The word “this” appears to be a typographical error. For examination purposes this limitations are construed as “the”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: the claim recites “transmitt” in the last paragraph of the claim. This appears to be a typographical error. For examination purposes this limitation is construed as “transmit”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: the claim recites “recording recording” in limitation “c)” of the claim. This appears to be a typographical error of the repeated word. For examination purposes the repeated recording is construed to be deleted. Thus, this limitation is construed as “recording”. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: the specification mentions Figures 1-11 however, the description of those figures do not seem to align with the drawings. For example, the specification at [0071] discusses Fig. 7 but the figures provided only number to Fig. 5e. There is not one single figure in the replacement drawings provided that have element numbers in the 700’s. Only figures 1a and 1b have any element numbers, but these still don’t align with what is discussed in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show any of the element numbers of the figures as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Appropriate correction is required.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 1-14 are drawn to a system, which is within the four statutory categories (i.e. apparatus). Claims 15 is drawn to a method, which is within the four statutory categories (i.e. process).
Step 2A of the Alice/Mayo Test - Prong One
The independent claims recite an abstract idea. For example, claim 1 (and substantially similar with independent claim 15) recites:
A system for recording pipetting operations in user-defined experiments in which at least one hand-held usable pipetting device is used for pipetting at least one sample, wherein a parameter set of pipetting parameters defines a programmable pipetting operation of the pipetting device, and wherein an experiment includes a method defined by a sequence of pipetting operations, where the system includes:
a user interface device with a display, in particular a touch screen,
a data processing device,
a data storage device,
a first communication device {construed as a computer} for wireless data exchange between the data processing device and a second communication device of at least one pipetting device,
wherein the data processing device is programmed to,
receive, by means of the first communication device, after the execution of at least one pipetting operation associated with a first method, from the at least one second communication device recording data containing the parameter values on the basis of which the at least one pipetting operation was configured and executed by at least one pipetting device,
perform, by storing the recording data as a first method data set in the data storage device, a first method recording to which first method identification data is assigned,
pause the execution of the first method recording in response to a user input occurring at the user interface device, and
continue the paused, first method recording in response to a user input occurring at the user interface device, or terminate the paused, first method recording in response to a user input occurring at the user interface device.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules to facilitate performing and recording pipetting operations), but for the recitation of generic computer components. For example, but for the system, user interface, data processing device, data storage device, first communication device, pipetting device, programming the data processing device, second communication device, the limitations in the context of this claim encompass an automation of following rules or steps to perform pipetting operations in order to record the information for the experiment on the sample. If a claim limitation, under its broadest reasonable interpretation, covers management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-14 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, claim 1 (and substantially similar with independent claim 15) recites:
A system (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) for recording pipetting operations in user-defined experiments in which at least one hand-held usable pipetting device is used for pipetting at least one sample, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) wherein a parameter set of pipetting parameters defines a programmable pipetting operation of the pipetting device, and wherein an experiment includes a method defined by a sequence of pipetting operations, where the system includes: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a user interface device with a display, in particular a touch screen, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a data processing device, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a data storage device, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
a first communication device {construed as a computer} for wireless data exchange between the data processing device and a second communication device of at least one pipetting device, (merely data-gathering steps as noted below, see MPEP 2106.05(g)) and (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
wherein the data processing device is programmed to, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
receive, by means of the first communication device, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) after the execution of at least one pipetting operation associated with a first method, from the at least one second communication device (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) recording data containing the parameter values on the basis of which the at least one pipetting operation was configured and executed by at least one pipetting device,
perform, by storing the recording data as a first method data set in the data storage device, (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g)) a first method recording to which first method identification data is assigned,
pause the execution of the first method recording in response to a user input occurring at the user interface device, and
continue the paused, first method recording in response to a user input occurring at the user interface device, or terminate the paused, first method recording in response to a user input occurring at the user interface device.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the system, user interface, data processing device, data storage device, first communication device, pipetting device, programming the data processing device, second communication device, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification [0002]-[0004], [0012], [0028], [0064], [0118]-[0119], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of wirelessly exchanging data amounts to selecting a particular data source or type of data to be manipulated, and storing the recorded data in storage amounts to insignificant extrasolution activity, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-14 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea, and claims 2-14 recite additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and add insignificant extra-solution activity to the abstract idea. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the system, user interface, data processing device, data storage device, first communication device, pipetting device, programming the data processing device, second communication device, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. [0002]-[0004], [0012], [0028], [0064], [0118]-[0119]); using the system, user interface, data processing device, data storage device, first communication device, pipetting device, programming the data processing device, second communication device, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application. The following represent examples that courts have identified as insignificant extrasolution activities (e.g. see MPEP 2106.05(g)): wirelessly exchanging data, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); and storing the recorded data in storage, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
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 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.
Claim 1-2, 4-5, 7-12, 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Longden Heather: "Traceability in OneLab: Tracking the Analyst's Completion of an Experiment", 7 August 2020 (2020-08-07), in view of Natsume et al. (EP 3189896 A1).
Regarding claim 1, Longden discloses a system for recording pipetting operations in user-defined experiments in which at least one hand-held usable pipetting device is used for pipetting at least one sample, wherein a parameter set of pipetting parameters defines a programmable pipetting operation of the pipetting device, and wherein an experiment includes a method defined by a sequence of pipetting operations, where the system includes:
a user interface device with a display, in particular a touch screen, (page 2, final paragraph: graphical instructions)
a data processing device, a data storage device, (page 1, first paragraph: computer in "computer validation/assurance evaluations" construed as the data processing device and data storage device; page 2, final paragraph: critical information will be recorded for the duration of the protocol),
a first communication device {construed as a computer} for data exchange between the data processing device and a second communication device of at least one pipetting device, (Pg. 2 sharing data with devices that access a designated lab workspace; page 3, figure "Experiment timeline": Dispense ... with Picus 500-10000 μl"; Picus pipettes construed as the second communication device; page 1, first paragraph: computer in "computer validation" construed as first communication device)
wherein the data processing device is programmed to, receive, by means of the first communication device, after the execution of at least one pipetting operation associated with a first method, from the at least one second communication device recording data containing the parameter values on the basis of which the at least one pipetting operation was configured and executed by at least one pipetting device, (page 2, final paragraph: critical information will be recorded for the duration of the protocol; page 3, first paragraph: all analyst actions are recorded… timestamps and information about the duration of each specific step)
perform, by storing the recording data as a first method data set in the data storage device, a first method recording to which first method identification data is assigned, (page 2, final paragraph: critical information will be recorded for the duration of the protocol),
pause the execution of the first method recording in response to a user input occurring at the user interface device, and (page 3, second paragraph: " ... the analyst can document the error with an explanation, and then document a remediation step ... The experiment can then continue", i.e. the pipette operation was paused; pg. 5 figure “The OneLab Lab Workspace displays all work in progress or recently completed by the team”)
continue the paused, first method recording in response to a user input occurring at the user interface device, or terminate the paused, first method recording in response to a user input occurring at the user interface device. (page 3, second paragraph: " ... The experiment can then continue, or alternatively, the protocol may force the analyst to restart the step or the entire experiment." page 2, final paragraph: critical information will be recorded for the duration of the protocol; pg. 5 figure “The OneLab Lab Workspace displays all work in progress or recently completed by the team”).
Longden teaches sharing data but does not explicitly teach wirelessly exchanging data. However, Natsume teaches it is old and well known in the art of data processing for:
wirelessly data exchange (Natsume pg. 4 cols. 5-6, [0029] The input device 2e is a device that allows the user to input information. The input device 2e is, for example, a keyboard, a mouse, or a touch panel. The I/O 2f is an interface that allows the operating procedure display device 2 to transmit and receive information to and from an external device. In this example, because the operating procedure display device 2 performs information communication to and from the electric pipette 1 wirelessly, the I/O 2f includes at least a communication controller and an antenna).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing, before the effective filing date of the claimed invention, to modify Longden to incorporate wirelessly data exchange, as taught by Natsume, in order to communicate information from a remote location over a communication network. See Natsume pg. 5 col. 7 [0032].
Regarding claim 2, Longden-Natsume teaches the system according to claim 1, wherein the data processing device is programmed to continue the first method recording by depending on the user input and the first method identification data, the first method data set stored during a first recording portion of the first method recording is selected and the recording of a second recording portion of the first method recording is started, in particular by receiving, by means of the first communication device, after the execution of at least one further pipetting operation, further recording data from the at least one second communication device which contain the parameter values on the basis of which the at least one further pipetting operation was configured and executed, and by continuing the first method recording by means of adding the further recording data to the first method data set and storing them in the data storage device. (page 3, second paragraph: " ... the analyst can document the error with an explanation, and then document a remediation step ... The experiment can then continue"; page 3, first paragraph: "all analyst actions are recorded"; pg. 5 figure “The OneLab Lab Workspace displays all work in progress or recently completed by the team”; page 2, final paragraph: critical information will be recorded for the duration of the protocol; page 3, first paragraph: all analyst actions are recorded… timestamps and information about the duration of each specific step).
Regarding claim 4, Longden-Natsume teaches the system according to claim 1, wherein the data processing device is programmed to, after the start of and during the pause in the recording of the first method recording, detect by means of the user interface device at least one further parameter set of at least one further pipetting operation which does not form part of the first method, and wherein the at least one pipetting device, in particular its control device, is set up to control at least one pipetting operation, in particular a moving member of the pipetting device, as a function of the at least one further parameter set during the pause in the first method recording. (page 3, second paragraph: " ... The experiment can then continue"; page 3, first paragraph: "all analyst actions are recorded").
Regarding claim 5, Longden-Natsume teaches the system according to claim 2, wherein the data processing device is programmed to, after pausing the first method recording prior to starting recording of the second recording portion of the first method recording, perform a second method recording associated with second method identification data different from the first method identification data, in particular by programming the data processing device to, receive, by means of the first communication device, after the execution of at least one pipetting operation associated with a second method, from the at least one second communication device recording data containing parameter values on the basis of which the at least one pipetting operation of the second method was configured and executed, perform the second method recording by storing this recording data as a second method data set in the data storage device, pause the execution of the second method recording in response to a user input occurring at the user interface device, and continue the paused second method recording in response to user input at the user interface device, or terminate the paused second method recording in response to user input at the user interface device. (page 3, second paragraph: " ... the analyst can document the error with an explanation, and then document a remediation step ... The experiment can then continue"; page 3, first paragraph: "all analyst actions are recorded"; pg. 5 figure “The OneLab Lab Workspace displays all work in progress or recently completed by the team”).
Regarding claim 7, Longden-Natsume teaches the system according to claim 1, wherein the data processing device is programmed to, on the display of the user interface device, display a screen page with a button, the pressing or touching of which starts a method recording. (page 3, penultimate paragraph: "An analyst might not be able to complete an experiment in one session. Upon login, OneLab allows an analyst to view all their own experiments that are in process and those that were recently completed."; see also page 5, figure at the bottom "The OneLab Lab Workspace displays all work in progress or recently completed by the team": buttons at top of screen to execute experiment and begin the recording of the experiment steps).
Regarding claim 8, Longden-Natsume teaches the system according to claim 1, wherein the data processing device is programmed to, on the display of the user interface device, display a screen page in which the title of at least one running, i.e. started and not terminated, method recording is displayed, in particular in which the titles of several running method recordings are listed, display at least one information field indicating the status of the corresponding method recording, which may include: Recording is paused or Recording is running or Recording is terminated. (page 3, penultimate paragraph: "An analyst might not be able to complete an experiment in one session. Upon login, OneLab allows an analyst to view all their own experiments that are in process and those that were recently completed."; see also page 5, figure at the bottom "The OneLab Lab Workspace displays all work in progress or recently completed by the team": some experiments running and paused for not being completed).
Regarding claim 9, Longden-Natsume teaches the system according to claim 1, wherein the data processing device is programmed to, on the display of the user interface device, display a screen page in which the title of at least one running method recording is displayed, in particular in which the titles of several running method recordings are listed, display at least one button, the pressing or touching of which selects the at least one previously paused method recording associated with the button; and display a button, the pressing or touching of which resumes the selected paused method recording, in particular while at least one other method recording is paused. (page 3, penultimate paragraph: "An analyst might not be able to complete an experiment in one session. Upon login, OneLab allows an analyst to view all their own experiments that are in process and those that were recently completed."; see also page 5, figure at the bottom "The OneLab Lab Workspace displays all work in progress or recently completed by the team": buttons at top of screen to running experiments).
Regarding claim 10, Longden-Natsume teaches the system according to claim 1, wherein the data processing device is programmed to, on the display of the user interface device, display a screen page in which the title of at least one running method recording is displayed, in particular in which the titles of several running method recordings are listed, display at least one button, the pressing or touching of which selects the at least one previously paused method recording associated with the button and causes the display of information about this method recording, which in particular contains information about, in each case preferably: the events of a method, in particular its time sequence, time data of the method, in particular time stamps of one or more events, in particular of the start, pause, and/or end of the method, the user of a method, the pipetting devices used and/or not used in the method. (page 3, penultimate paragraph: "An analyst might not be able to complete an experiment in one session. Upon login, OneLab allows an analyst to view all their own experiments that are in process and those that were recently completed."; see also page 5, figure at the bottom "The OneLab Lab Workspace displays all work in progress or recently completed by the team").
Regarding claim 11, Longden-Natsume teaches the system according to claim 1, wherein the data processing device is programmed to provide at least one method data set of at least one terminated method recording as a file transferable to an external data processing device, or the contents of which are outputable by printing, displaying on the screen, or transferring to an external data processing device of the system or to a server which is not part of the system. (page 1, penultimate paragraph: internal and external auditors… electronic record and electronic signature (ERES) regulations (e.g. ISO 17025, EU Annex 11 or 21 CFR Part 11)).
Regarding claim 12, Longden-Natsume teaches the system according to claim 1, wherein the data processing device is programmed to, obtain, by means of the user interface device, parameter values of user-definable pipetting parameters of at least one parameter set, which define the at least one pipetting operation of a method, in particular first, second, and still further methods, to be performed by means of the at least one pipetting device, transmit, by means of the first communication device, these parameter values of the at least one parameter set to the at least one hand-held pipetting device in order to enable its configuration by means of these parameter values for carrying out at least one pipetting operation of the method. (page 3, penultimate paragraph: "An analyst might not be able to complete an experiment in one session. Upon login, OneLab allows an analyst to view all their own experiments that are in process and those that were recently completed."; see also page 5, figure at the bottom "The OneLab Lab Workspace displays all work in progress or recently completed by the team").
Regarding claim 14, Longden-Natsume teaches the system according to claim 1, wherein the data processing device is programmed to not store data, in particular recording data, transmitted from the second communication device to the first communication device as part of the first method recording in the first method data set during a recording pause of the first method recording, and/or in particular to store the data, in particular recording data, transmitted from the second communication device to the first communication device during the recording pause of the first method recording, as a component of another, in particular a second, method recording in a further, in particular second, method data set assigned to the second method recording. (page 3, penultimate paragraph: "An analyst might not be able to complete an experiment in one session. Upon login, OneLab allows an analyst to view all their own experiments that are in process and those that were recently completed."; see also page 5, figure at the bottom "The OneLab Lab Workspace displays all work in progress or recently completed by the team").
Regarding claim 15, recites substantially similar limitations as those recited in the rejection of claim 1, and, as such, are rejected for similar reasons as given above.
Claims 3, 6, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Longden-Natsume in view of Zucchelli et al. (US 2013/0280143).
Regarding claim 3, Longden-Natsume teaches the system according to claim 1, Longden further discloses which comprises: at least one hand-held pipetting device for executing at least one pipetting operation defined by the parameter values of at least one parameter set of pipetting parameters, comprising a second communication device for data exchange between the hand-held pipetting device and the data processing device, wherein the at least one pipetting device in particular comprises: (page 4, figure "Experiment timeline": Dispense ... with Picus 500-10000 μl" page 4, figure "Experiment timeline": Dispense ... with Picus 500-10000 μl"; page 1, first paragraph: computer in "computer validation" construed as first communication device; page 2, final paragraph: critical information will be recorded for the duration of the protocol; page 3, first paragraph: all analyst actions are recorded… timestamps and information about the duration of each specific step)
And Natsume further teaches:
wirelessly data exchange (Natsume pg. 4 cols. 5-6, [0029] The input device 2e is a device that allows the user to input information. The input device 2e is, for example, a keyboard, a mouse, or a touch panel. The I/O 2f is an interface that allows the operating procedure display device 2 to transmit and receive information to and from an external device. In this example, because the operating procedure display device 2 performs information communication to and from the electric pipette 1 wirelessly, the I/O 2f includes at least a communication controller and an antenna)
Longden-Natsume does teach the pipetting device (the Andrew+ robot) but does not appear to explicitly teach the following. However, Zucchelli teaches it is old and well known in the art of sample data processing to have:
a connecting portion for connecting at least one pipetting container; an electrically controlled moving member for aspirating at least one sample into the at least one pipetting container, holding the sample in the at least one pipetting container, and dispensing sample from the at least one pipetting container when performing a pipetting operation; and an electrical control device which is set up to control the moving member as a function of at least one pipetting parameter, and/or the system includes a computing device, in particular a portable computing device, which comprises: the user interface device, the data processing device, the first communication device, and optional: the data storage device. (Fig. 1 and corresponding text; [0066]-[0068] for discussion of the pipetting device with containers and control members to move the arm of the device and perform the pipetting operation and aspirate the samples)
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing, before the effective filing date of the claimed invention, to modify Longden-Natsume, as modified above, to incorporate a connecting portion for connecting at least one pipetting container; an electrically controlled moving member for aspirating at least one sample into the at least one pipetting container, holding the sample in the at least one pipetting container, and dispensing sample from the at least one pipetting container when performing a pipetting operation; and an electrical control device which is set up to control the moving member as a function of at least one pipetting parameter, and/or the system includes a computing device, in particular a portable computing device, which comprises: the user interface device, the data processing device, the first communication device, and optional: the data storage device, as taught by Zucchelli, in order to organize and process samples quickly and efficiently by controlling the pipetting device. See Zucchelli , [0065], [0082].
Regarding claim 6, Longden-Natsume teaches the system according to claim 5, but does not appear to explicitly teach the following. However, Zucchelli teaches it is old and well known in the art of sample data processing to have: which includes a first sample to be pipetted in the first method and includes a second sample to be pipetted in the second method that is not used in the first method. (Zucchelli [0082] In FIG. 8, different types of blocks are assembled together: for example, block 801 is intended for the collection of used tips, bock 802 is designed to contain and support different types of microtubes, block 803 is intended to hold and support tip racks).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing, before the effective filing date of the claimed invention, to modify Longden-Natsume, as modified above, to incorporate a first sample to be pipetted in the first method and includes a second sample to be pipetted in the second method that is not used in the first method, as taught by Zucchelli, in order to organize and process different samples simultaneously. See Zucchelli [0082].
Regarding claim 13, Longden-Natsume-Zucchelli teaches the system according to claim 3, and Zucchelli further teaches wherein the at least one pipetting device comprises a second data processing device programmed to, obtain, by means of the second communication device, the parameter values of the at least one parameter set in order to configure the pipetting device by means of these parameter values for carrying out at least one pipetting operation of the method, start, by means of the parameter values, the at least one pipetting operation configured, in particular by determining a start signal generated manually by the actuation of an actuating element, and transmit, after completion or termination of the at least one pipetting operation configured by means of the parameter values, the parameter values used to configure this pipetting operation as recording data to the first communication device. (Fig. 1 and corresponding text; [0066]-[0069] for discussion of the pipetting device with an ejection button at the tip and the actuator for setting the pipette volume and the hand starts from actuator and grabbing the pipette [0005] Traceability is defined as the property of keeping record, for a-posteriori analysis and verification, of the actual process that has been implemented, including unpredictable events during the protocol execution like possible faults or mistakes). The motivation for combining the references is discussed above and incorporated herein.
Conclusion
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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