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 .
DETAILED ACTION
Response to Amendment
In the amendment dated 06/03/2026, the following occurred: Claims 1, 15, 17 and 23 have been amended; and claim 14 has been cancelled.
Claims 1-13 and 15-23 are pending and have been examined.
Priority
This application claims priority to U.S. Provisional Patent Application No. 63/602,005 filed 11/22/2023.
Note: 35 USC § 101 – Claims 6-8 and 22
Claims 6 and 22 recite the “system of claim 1, wherein: the wearable device is further configured to receive a voice command from the operator to navigate between instructions of the plurality of instructions, and transmit the voice command to the workflow controller, and the workflow controller is configured to receive the voice command from the wearable device, and navigate within the workflow based on the voice command” (claim 6 being representative). The wearable device transmitting a voice command to the workflow controller and causing the workflow controller to navigate within the sequentially displayed workflow instructions of the system for automating hands-free workflow procedures of claim 1 based on the voice command provides a practical application under subject eligibility analysis Step 2A2, since the wearable device controls the workflow controller’s navigation of sequentially displayed workflow instructions, thereby improving another technology or technological field. As such, the claim 6 is subject matter eligible. The subject matter eligibility of claim 6 also applies to its dependent claims 7-8.
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 1-23 are rejected under 35 U.S.C. §101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 17 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 (YES)
Claims 1 and 17 fall into at least one of the statutory categories (i.e., machine or process).
Step 2A1 (YES)
The limitations of receive a selection of a laboratory procedure, wherein the laboratory procedure comprises an assay; extract a workflow for the selected laboratory procedure, the workflow comprising a plurality of instructions arranged in a specified sequence for performing a sample for the assay; and sequentially deliver one or more instructions of the plurality of instructions for an operator to follow, wherein the one or more instructions comprise a visual indicator configured to be displayed; provide information relating to a next step of the assay; and direct to provide instructions for completing the next step in response to receiving the information (claim 1 being representative), as drafted, is a process that under the broadest reasonable interpretation (BRI) covers a method of organizing human activity (i.e., managing personal behavior or relationships or interactions between people including following rules or instructions) but for the recitation of generic computer component language (discussed below in 2A2). That is, other than reciting the generic computer component language, the claimed invention amounts to managing personal behavior or relationships or interactions between people. For example, but for the generic computer component language, the claims encompass a person receiving, extracting, delivering, displaying, or communicating data or instructions. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP § 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people but for the recitation of generic computer component language, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. See additionally MPEP § 2106. Accordingly, the claims recite an abstract idea.
Step 2A2 (NO)
The judicial exception, the above-identified abstract idea, is not integrated into a practical application. In particular, the claims recite the additional elements of a workflow controller / workflow computer; and a workflow repository that implement the identified abstract idea (represented by claim 1). The additional elements aforementioned are not described by the applicant and are recited at a high-level of generality (i.e., a generic computer or computer component performing a generic computer or computer component function that facilitates the identified abstract idea) such that these amount no more than mere instructions to apply the exception using a generic computer component (see Specification, e.g., at para. 0030). See MPEP § 2106.04(d)(I). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claims further recite the additional elements of a wearable device comprising a display for displaying instructions; and a lab device as collecting, transmitting or outputting data. The additional elements are recited at a high-level of generality (i.e., each as a general means of collecting, transmitting or outputting data) and each amounts to a location from which data is received or to which data is transmitted or outputted, each of which represents an insignificant extra-solution activity (e.g., mere data gathering and outputting). MPEP § 2106.04(d)(I) indicates that adding insignificant extra-solution data gathering and outputting activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claims are directed to an abstract idea.
The claims further recite the additional element of a lab device configured to perform the assay and to detect completion of a processing step of the assay. The claim limitation, which is considered an additional element, is merely reciting the words “apply it” (or an equivalent) with the judicial exception, which is insufficient to provide a practical application. See MPEP § 2106.04(d)(I). Accordingly, the additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B (NO)
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 integration of the abstract idea into a practical application, the additional elements of a workflow controller / computer; and a workflow repository to perform the method (represented by claim 1) amount no more than mere instructions to apply the exception using a generic computer or generic computer component. Mere instructions to apply an exception using generic computer(s) and/or generic computer component(s) cannot provide an inventive concept (“significantly more”). See MPEP § 2106.05(f).
Also discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a wearable device comprising a display for displaying instructions; and a lab device (i.e., each a device that collects, transmits or outputs data) are each considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2106.05(d)(II) indicates that receiving, transmitting or outputting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). See also MPEP 2106.05(g) (citing Cybersource, Mayo, OIP Techs.) Further, the MPEP 2106.05(g) indicates that selecting a particular data source or type of data to be manipulated, i.e., collecting, analyzing, or displaying data is a well-understood, routine, and conventional process (citing Electric Power Group). Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such, the claims are not patent eligible.
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of a lab device configured to perform the assay and to detect completion of a processing step of the assay to perform the method amounts no more than merely reciting the words “apply it” (or an equivalent) with the judicial exception, which is insufficient to provide a practical application. See MPEP §§ 2106.05(a) and (f). Merely reciting the words “apply it” (or an equivalent) with the judicial exception cannot provide an inventive concept (“significantly more”).
Dependent claims 2-5, 9-13, 15-16, 18-21 and 23, when analyzed as a whole, are similarly rejected under 35 U.S.C. §101 because the additional limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. The claims, when considered alone or as an ordered combination, either (1) merely further define the abstract idea, (2) do not further limit the claim to a practical application, or (3) do not provide an inventive concept such that the claims are subject matter eligible.
Claim 2 merely further describes the additional element of the wearable device as a head mounted device with the display positioned in the field of view of the operator, which amounts to a location from which data is received or to which data is transmitted or outputted, each of which represents an insignificant extra-solution activity. See analysis, supra.
Claims 3-4 and 20-21 merely further describe the abstract idea (e.g., the one or more instructions, the audio instruction being delivered simultaneously with the visual indicator, the visual indicator comprising a location indicator and an action indicator). See analysis, supra.
Claim 5 merely further describes the additional element of the wearable device further comprising a speaker that transmits or outputs data at a high-level of generality and thus amounts to no more than a location from which data is transmitted or outputted. See analysis, supra.
Claim 9 further describes the additional elements of the wearable device further comprises a camera for scanning a code from a sample container as receiving, transmitting or outputting data at a high-level of generality, such that these amount to locations to which data is received or from which data is transmitted or outputted. See analysis, supra. Also, MPEP § 2106.05(d)(II) indicates that electronically scanning or extracting data and storing/retrieving information in memory is well-understood, routine, and conventional activity; and MPEP 2106.05(g) indicates that selecting information, based on types of information and availability of information in a technological environment, for collection, analysis and display, is an insignificant extra-solution activity. Claim 9 also further describes the workflow controller and the wearable device display as receiving, retrieving, transmitting or displaying data at a high level of generality (mere data gathering and data outputting activities). See analysis, supra.
Claim 10 merely further describes the abstract idea (e.g., the information related to the sample container).
Claim 11 merely further describes the additional elements of the wearable device camera (e.g., collecting or transmitting data) and the workflow controller (e.g., retrieving information, transmitting information).
Claim 12-13 and 18-19 merely further describe the abstract idea (e.g., the laboratory procedure, the plurality of instructions, NIPT, sequential delivery comprises delivering an audio instruction simultaneously with the visual indicator).
Claim 15 merely further recites the additional element of the lab device comprises the workflow controller. See analysis in parent claim 1, supra.
Claim 16 merely further describes the additional elements of the lab device’s workflow computer (e.g., transmitting data) and the wearable device (e.g., receiving data, displaying a timer indicating an amount of time for successful completion of a current step in the workflow).
Claim 23 merely further recites a camera of the wearable device, a sample container, a wireless network, the workflow controller, the workflow repository, and the display of the wearable device as insignificant extra-solution activity (e.g., mere data gathering and outputting). See analysis, supra.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, 6-11, 15-17 and 21-23 are rejected under 35 U.S.C. § 103 as being unpatentable over Jacobs et al. (US 2023/0298721 A1; “Jacobs” herein) in view of Jost et al. (US 2017/0142324 A1; “Jost” herein).
Re. Claim 1, Jacobs teaches a system for automating hands-free workflow of laboratory procedures (see abstract), the system comprising:
a wearable device comprising a display for displaying instructions (202, 320/322) (Fig. 2, [0061] teach the eyewear device 202 includes an embedded display module 320 with a display screen 322 configured to display graphical user interfaces); and
a workflow controller in communication with the wearable device (204)(Fig. 2, [0052] teach the eyewear device 202 is communicatively coupled to a client device 204.), the workflow controller configured to:
receive a selection of a laboratory procedure, wherein the laboratory procedure comprises […] (Fig. 13A, [0106] teach after receiving a selection of a dose order from the client device 204, the pharmacy server 302 determines a corresponding preparation protocol 366 (block 1374).);
extract, from a workflow repository, a workflow for the selected laboratory procedure (Fig. 13A, [0074], [0106] teach the client device 204 receives the determined preparation protocol 366, stored on a memory device 362/364, from the pharmacy server 302 (block 1308). See also [0093].), the workflow comprising a plurality of instructions arranged in a specified sequence for performing […] (Fig. 5, [0074] teach the preparation protocols 366 each defines a sequence of steps, e.g., graphical user interface instructions.); and
sequentially deliver one or more instructions of the plurality of instructions to the wearable device for an operator to follow (Fig. 13A, [0094] teach the application 344 of the client device 204… sequentially progresses through the steps (block 1310)… For each step, the application 344 identifies information needed for verification, and transmits one or more messages 1311 to the eyewear device 202 with graphical user interfaces for display on the display screen 322. See also [0104].), wherein the one or more instructions comprise a visual indicator configured to be displayed within the display of the wearable device (Fig. 6, [0077] teach example instructions that are displayed on the display screen 322 of the eyewear device 202… In the first example 602, the instructions specify “Prepare ingredients…”, an identification of needed verification information, and a picture (visual indicator) of a barcode. Fig. 6 also shows pictures in the displayed instructions of examples 604, 606, 608.); and
[…],
wherein […] is configured to detect completion of a processing step of the assay ([0112], [0135] teach the HUD system 200 is configured to… track user-specific, workstation-specific and area specific tasks, prompt for their completion, and record the results of their completion (necessarily detected)) and provide information relating to a next step of the assay to […] ([0112], [0136] teach the HUD system 200 is configured to… display pending tasks with the time until they are due for completion.), and
[…] the wearable device to provide instructions for completing the next step in response to receiving the information […] ([0112], [0136] teach the HUD system 200 is configured to… display pending tasks with the time until they are due for completion.)
Jacobs does not teach
wherein the laboratory procedure comprises an assay;
the workflow comprising a plurality of instructions arranged in a specified sequence for performing a sample for the assay; or
a lab device configured to perform the assay,
wherein the lab device is configured to detect completion of a processing step of the assay and provide information relating to a next step of the assay to the workflow controller, and
wherein the workflow controller is further configured to direct the wearable device… in response to receiving the information from the lab device.
Jost teaches
wherein the laboratory procedure comprises an assay; the workflow comprising a plurality of instructions arranged in a specified sequence for performing a sample for the assay ([0032] teaches an ‘analyzer’/ ‘analytical work cell’, an apparatus or apparatus component that can induce a reaction of a biological sample with a reagent for obtaining a measurement value (for performing a sample for the assay). Abstract and [0003], [0021], [0028] teach selecting a laboratory workflow that comprises steps that correspond to pieces of laboratory equipment including sample holders for holding biological samples or reagents. See additionally [0034]-[0035].); and
the lab device configured to perform the assay ([0032] teaches the analyzer performs one of various assays.)
wherein the lab device is configured to detect completion of a processing step of the assay and provide information relating to a next step of the assay to the workflow controller ([0034]-[0035] teach a control unit of an automated piece of lab equipment may control the piece of lab equipment in a way that the steps for the processing protocols can be conducted by the automated piece of lab equipment… the control unit may include a scheduler, for executing a sequence of steps within a predefined cycle time. The Examiner interprets conducting the steps as necessitating detection of completion of a processing step. The Examiner also interprets the scheduler as providing the control unit with the next step in the sequence.), and
wherein the workflow controller is further configured to direct the wearable device… in response to receiving the information from the lab device ([0035] also teaches an augmented reality device can be configured to communicate with a control unit of an automated piece of laboratory equipment to retrieve information regarding a laboratory workflow for storage in an electronic journal.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the wearable heads-up display for a pharmacy workflow management system of Jacobs to include the particular type of laboratory procedures for performing an assay, utilize laboratory equipment for performing laboratory techniques, and provide communication between electronic systems (see Jost para. 0033) and to use this information as part of a method for generating an entry for an electronic laboratory journal as taught by Jost, with the motivation of improving actual laboratory workflow and the documentation process (see Jost at para. 0003, 0016-0019).
Re. Claim 2, Jacobs/Jost teaches the system of claim 1, wherein the wearable device is a head mounted device with the display positioned in a field of view of the operator (Jacobs at abstract and Fig. 2 teaches the wearable heads-up display (HUD) may be smart-glasses. Jacobs [0009] teaches the HUD system provides voice and/or gesture data entry and step progression… presenting instructions… to the technician without requiring them to look away from their field of view.)
Re. Claim 4, Jacobs/Jost teaches the system of claim 1, wherein the visual indicator comprises: a location indicator related to a location of a sample or a tool in a laboratory, an action indicator related to the laboratory procedure, and/or, data related to the sample or the tool (Jacobs Fig. 6, [0077] teaches example instructions that are displayed on the display screen 322 of the eyewear device 202… In the first example 602, the instructions specify “Prepare ingredients…” (action indicator), an identification of needed verification information, and a picture of a barcode. Jacobs Fig. 6 also shows the displayed instructions of examples 604, 606, 608.)
Re. Claim 6, Jacobs/Jost teaches the system of claim 1, wherein: the wearable device is further configured to receive a voice command from the operator to navigate between instructions of the plurality of instructions (Jacobs at abstract teaches an application on the client device and/or the smart-glasses is configured to recognize and use voice commands (received) to provide navigation for the embedded display screen. Jacobs [0072] teaches, for voice commands, the application 344 is configured to… compare… Based on the matching command, e.g., “Next”… perform an operation with respect to a graphical user interface (instruction) shown on the display screen 322. Jacobs Fig. 13A, [0104] teach the eyewear device 202 determines if a next step is to be displayed on the display screen (block 1362) (receives the voice command)… the procedure 1350 returns to blocks 1352 and 1354 to display the corresponding graphical user interface.), and transmit the voice command to the workflow controller, and the workflow controller is configured to receive the voice command from the wearable device, and navigate within the workflow based on the voice command (see Jacobs Fig. 13A, [0104], teaching “[w]hen a next step is to be displayed” (transmit the voice command). Jacobs Fig. 13A, [0094] teaches the application 344 of the client device progresses through steps of the protocol 1310 (receive the voice command)… For each step… transmits one or more messages 1311 to the eyewear device 202 with graphical user interfaces for display on the display screen (navigate within the workflow).)
Re. Claim 7, Jacobs/Jost teaches the system of claim 6, wherein the voice command comprises navigation commands to navigate through the plurality of instructions of the workflow in a hand-free manner (see claim 6 prior art rejection. Also, Jacobs [0007] teaches the embedded display provides the steps… Further, the microphone is configured to record the voice commands… to provide hands-free interaction.)
Re. Claim 8, Jacobs/Jost teaches the system of claim 7, wherein the navigation commands comprises left, right, up, down, next, and/or cancel (see Jacobs [0072], “Select”, “Open”, “Next”, “Confirm”, “Cancel”, “Record”, “Scroll Down”, “Enter”, etc.)
Re. Claim 9, Jacobs/Jost teaches the system of claim 1, wherein: the wearable device further comprises a camera for scanning a code from a sample container, and transmit the scanned code to the workflow controller (Jacobs at abstract teaches the smart-glasses include at least one camera and/or barcode scanner. Jacobs [0008], [0014] teaches processing images from camera to identify/read barcodes of ingredient containers / various containers (sample containers). Jacobs [0021] teaches execution of the instructions cause the processor of the client device to store… data from scanned barcodes (transmitted to). The Examiner notes that “for scanning…” is an intended use of “a camera”, and “transmit” is an intended result of “for scanning…”. Each is not required for the claim to be met.), and the workflow controller is configured to retrieve, based on the scanned code, information related to the sample container, and transmit the information to the display of the wearable device (Jacobs [0022] teaches a step requiring entry of verification information… and display of options for voice entry or barcode scanning. Jacobs [0021], [0023] teaches the processor of the client device… compares verification information to verification limits specified in the preparation protocol… when at least some of the verification information is outside of the respective verification limits, causes an error message (retrieved) to be displayed by the display screen of the eyewear device (transmitted to). See also Jacobs Figs. 10, 22, [0084].)
Re. Claim 10, Jacobs/Jost teaches the system of claim 9, wherein the information related to the sample container comprises: a batch number, an expiration date, […] (Jacobs Fig. 4, [0070] teaches a list 400 that includes a plurality of dose orders 362 including a patient name or identifier. Jacobs [0022] teaches when the step of the preparation protocol requires user entry of the verification information, the processor is configured to display… options for… barcode scanning using the barcode scanner. Jacobs Fig. 7, [0080] teaches the user interface includes a section 706 with the needed verification information (the information related to the sample container), e.g., lot number, expiration date, and corresponding modalities. Jacobs [0100] teaches the eyewear device 202 receives a selection of a modality option to provide verification information (block 1356) … this can include a selection to perform a barcode scan. Jost [0110] teaches the operator can scan a barcode on the sample tubes 20 included in the rack 22 containing to determine an identity of the respective sample (e.g., information identifying a patient) and an arrangement of the respective samples in the rack 22.)
Re. Claim 11, Jacobs/Jost teaches the system of claim 9, wherein: the wearable device is further configured to capture, via the camera, an image of an object in the laboratory, and transmit the image to the workflow controller (Jacobs [0007] teaches the smart-glasses have at least one camera… configured to record images of technician gestures (captured). Jacobs [0008] teaches the application on the client device is… also configured to process images from the camera (transmitted) to interpret gestures.), and the workflow controller is configured to retrieve information related to the object, and transmit the information to the display of the wearable device (Jacobs [0073] teaches the identified gesture is compared to a library of gestures, which correspond to certain navigation commands and/or text entry commands. Jacobs [0081] teaches using the hand gesture recorded… to select a verification option, which causes the application 344 (of workflow controller) to trigger the corresponding verification modality (retrieved and transmitted)… As shown in Fig. 8, this includes the display of a text box 800… After the technician… provides an approval gesture (also captured and transmitted)… the application 344 is configured to cause the user interface 700 to be displayed again with an indication that the verification information has been recorded (retrieved and transmitted).)
Re. Claim 15, Jacobs/Jost teaches the system of claim 1, wherein the lab device comprises the workflow controller (see Jost in claim 1 prior art rejection. See additionally Jost [0020], [0031].)
Re. Claim 16, Jacobs/Jost teaches the system of claim 15, wherein the workflow controller is configured to deliver instructions to the wearable device to cause the wearable device to provide a timer to a user, wherein the timer indicates an amount of time for successful completion of a current step in the workflow (see claim 1 prior art rejection. Jacobs [0124] teaches tracking and displaying the amount of time a pending STAT order has remained in queue. Jacobs [0136] also teaches displaying pending tasks (workflow steps) with the time until they are due for completion. See also Jacobs [0137], [0153]-[0157].)
Re. Claim 17, the subject matter of claim 17 is essentially defined in terms of a method, which is technically corresponding to system claim 1. Since claim 17 is analogous to claim 1, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Re. Claim 21, the subject matter of claim 21 is essentially defined in terms of a method, which is technically corresponding to system claim 4. Since claim 21 is analogous to claim 4, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 4.
Re. Claim 22, the subject matter of claim 22 is essentially defined in terms of a method, which is technically corresponding to system claim 6. Since claim 22 is analogous to claim 6, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 6.
Re. Claim 23, the subject matter of claim 23 is essentially defined in terms of a method, which is technically corresponding to system claim 11. Since claim 23 is analogous to claim 11, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 11. Further, Jacobs/Jost teaches via a wireless network (Jacobs Fig. 3, [0008], [0069] teaches the client device and the smart-glasses are communicatively coupled via a wired or wireless connection… via a network 350.)
Claims 3, 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs in view of Jost and Byford et al. (US 2010/0036667 A1; “Byford” herein).
Re. Claim 3, Jacobs/Jost teaches the system of claim 1, wherein the one or more instructions comprises […] of the laboratory procedure, […] being delivered simultaneously with the visual indicator (see claim 1 prior art rejection. Jacobs Fig. 2, [0060] teaches the eyewear device 202 includes a microphone and speaker module 318… The speaker may include any speaker and is located… next to the wearer’s ear.)
Jacobs/Jost may not teach an audio instruction related to a task.
Byford teaches
an audio instruction related to a task ([0011], [0040] teach voice assistant system to assist a user in the performance of a plurality of tasks… the method comprises storing a care plan in a voice assistant carried by a user, the care plan defining a plurality of tasks to be performed by the user as part of a workflow… capturing speech input from the user with the voice assistant determining, from the speech input, a selected interaction with a care plan, and, in response to the selected interaction, providing a speech dialog with the user through the voice assistant that is reflective of the care plan.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the wearable heads-up display for a pharmacy workflow management system of Jacobs/Jost to perform voice-directed work and to use this information as part of a voice assistant system as taught by Byford, with the motivation of improving workflows by efficiently delivery information and communications regarding the work tasks to increase efficiency and accuracy in the environment (see Byford at para. 0003, 0006, 0010).
Re. Claim 5, Jacobs/Jost teaches the system of claim 1, wherein: the wearable device further comprises a speaker configured to deliver an audio (see Jacobs [0049], [0060]), and the workflow controller is configured to generate […] instructions related to a task of the laboratory procedure (see claim 1 prior art rejection, e.g., Jacobs Fig. 13A), and deliver the […] instructions (see, e.g., Jacobs Fig. 13A, [0061]) via the speaker of the wearable device (see again Jacobs [0049], [0060].)
Jacobs/Jost does not teach audio instructions related to a task… and deliver the audio instructions.
Byford teaches
audio instructions related to a task… and deliver the audio instructions ([0011], [0040] teach voice assistant system to assist a user in the performance of a plurality of tasks… the method comprises storing a care plan in a voice assistant carried by a user, the care plan defining a plurality of tasks to be performed by the user as part of a workflow… capturing speech input from the user with the voice assistant determining, from the speech input, a selected interaction with a care plan, and, in response to the selected interaction, providing a speech dialog with the user through the voice assistant that is reflective of the care plan.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the wearable heads-up display for a pharmacy workflow management system of Jacobs/Jost to perform voice-directed work and to use this information as part of a voice assistant system as taught by Byford, with the motivation of improving workflows by efficiently delivery information and communications regarding the work tasks to increase efficiency and accuracy in the environment (see Byford at para. 0003, 0006, 0010).
Re. Claim 20, the subject matter of claim 20 is essentially defined in terms of a method, which is technically corresponding to system claim 3. Since claim 20 is analogous to claim 3, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 3.
Claims 12-13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs in view of Jost and Rasab et al. (WO 2022/076,607 A1; “Rasab” herein).
Re. Claim 12, Jacobs/Jost teaches the system of claim 1, wherein the laboratory procedure comprises […] (see claim 1 prior art rejection, Fig. 13A (block 1374) and [0106].)
Jacobs/Jost does not explicitly teach a noninvasive prenatal testing (NIPT).
Rasab teaches a noninvasive prenatal testing (NIPT) (The Examiner notes that the laboratory procedure information is non-functional descriptive information because the claims, as drafted, do not require use of the NIPT information to select the lab procedure. Regardless, [00184] teaches a NIPT assay.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the wearable heads-up display for a pharmacy workflow management system of Jacobs/Jost to receive a selection of an order corresponding to a noninvasive prenatal testing assay protocol and to use this information as part of a system and methods for processing a sample as taught by Rasab, with the motivation of improving healthcare diagnostics, health outcomes, process safety, compliance; and reducing hospital operating costs (see Rasab at para. 0003, 00155, 00157, 00179, 00189).
Re. Claim 13, Jacobs/Jost/Rasab teaches the system of claim 12, wherein the plurality of instructions related to the NIPT comprises: […] (Jacobs Fig. 13A, [0106] teaches after receiving a selection of a dose order from the client device 204, the pharmacy server 302 determines a corresponding preparation protocol 366 (block 1374). Jacobs teaches Fig. 13A, [0074], [0106] teach the client device 204 receives the determined preparation protocol 366, stored on a memory device 362/364, from the pharmacy server 302 (block 1308). Rasab [0029], [0170], [0184] teaches the computer server (Jacob’s pharmacy server 302) queries the database to (i) retrieve the test information and the clinical information (Jacob’s selection) and (ii) use the test information and the clinical information to generate pre-collection constraints and a sample collection protocol (Jacob’s corresponding protocol), e.g., a NIPT assay.)
Jacobs/Rasab does not explicitly teach the plurality of instructions related to the NIPT comprises: collect blood sample; separate plasma; extract cfDNA; prepare ddPCR assay; transfer the cfDNA to the ddPCR assay; generate a droplet; and analyze the droplet.
However, the limitation claims information/labels that constitute nonfunctional descriptive information that is/are not functionally involved in the recited system (see MPEP §2111.05). The function described by the system would be performed the same regardless of whether the claimed information/labels was substituted with nothing. Because Jacobs (and Rasab) teaches determining a preparation protocol (i.e., a workflow) corresponding to a selection of a dose order (i.e., a laboratory procedure) and because NIPT is non-functional descriptive information (regardless, it is taught by Rasab), substituting the information/labels of the claimed invention for the information/labels of the prior art would be an obvious substitution of one known element for another, producing predictable results. Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date, to have substituted the information/labels applied to the selected dose order / test information and clinical information of the prior art with any other information/labels because the results (i.e., determining a corresponding protocol / generating a sample collection protocol) would have been predictable. MPEP 2112.01, Section III (see also In re Ngai, Ex Parte Breslow).
Re. Claim 18, the subject matter of claim 18 is essentially defined in terms of a method, which is technically corresponding to system claim 12. Since claim 18 is analogous to claim 12, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 12.
Re. Claim 19, the subject matter of claim 19 is essentially defined in terms of a method, which is technically corresponding to system claim 13. Since claim 19 is analogous to claim 13, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 13.
Response to Arguments
Rejections under 35 U.S.C. §112(b)
Regarding the rejections, the Applicant has amended the claims to overcome the previous issues of indefiniteness. The amended claims as considered do not cause any new issues.
Rejections under 35 U.S.C. §101
Regarding the rejection of claims 1-23, the Applicant has cancelled claim 14, rendering the rejection of that claim moot. Regarding the remaining claims 1-13 and 15-23, the Examiner has considered the Applicant’s arguments but does not find them persuasive for at least the following reasons. Applicant argues:
A1. “Claim 1 has been amended to explicitly recite a hardware-based feedback loop wherein "the lab device is configured to detect completion of a processing step of the assay and provide information relating to a next step of the assay to the workflow controller," and the workflow controller is configured to "direct the wearable device to provide instructions for completing the next step in response to receiving the information from the lab device." … Here, the amended claims do not merely recite the concept of organizing human activity (i.e., managing personal behavior or relationships or interactions between people including following rules or instructions) using generic computer components. Rather, Claim 1 now claims a highly specific technological architecture: a closed-loop control system where the physical operational state of a laboratory assay device dynamically dictates the graphical user interface output sequence on a wearable device” (Remarks, pg. 7-8).
Re. argument A1: The Examiner respectfully disagrees and submits the basis of rejection as necessitated by amendment. Given the broadest reasonable interpretation in light of the specification, the directing encompasses communication of instructions without necessarily commanding the other device perform the instructions. The lab device operates in its ordinary capacity and then communicates data to the workflow controller at a high level. The workflow controller then communicates data to the wearable device at a high level, which the wearable device displays at a high level. Unlike claim 6, claim 1 does not describe directing in sufficient detail for the Examiner to determine whether the claim recites control of another technology. As such, the additional elements do not provide an integration of the abstract idea into a practical application.
A2. “The lab device acts as an automated trigger mechanism within a distributed hardware system; it performs a physical assay, detects the completion of a processing step of that assay, and transmits information to the workflow controller that directly governs the sequential delivery logic of the instructions displayed to the operator” (remarks, pg. 8).
Re. argument A2: The performance of an assay and the detection of completion of a processing step of the assay are both limitations that amount to merely reciting the words “apply it” with the abstract idea, which is also insufficient to provide a practical application. Also, the communication of data at a high level by the lab device, workflow controller, and the wearable device in each instance represents insignificant extra-solution activity.
A3. “This… improves the technological process of executing error-sensitive laboratory workflows by tying the delivery of step-by-step instructions directly to the machine-verified completion state of the assay hardware” (emphasis added) (remarks, pg. 8).
Re. argument A3: Please refer to previous responses A1-A2. In addition, detecting completion is unrelated to performing the assay because detecting can be achieved by a user clicking a “done” button at the end of the assay process. Likewise, providing information relating to a next step of the assay to the workflow controller is unrelated to the detection of assay completion because providing can be achieved by a user clicking a “send” button. Also, providing instructions is unrelated to receiving instructions because providing instructions can be achieved by a user clicking an “open” button.
A4. “Furthermore, this amendment satisfies the requirement of applying the judicial exception to effect a particular treatment or transformation for a particular article. See MPEP § 2106.04(d)(2). The claim is inextricably tied to the physical transformation occurring during sample preparation and execution within the assay, and the workflow system's operation is functionally dependent upon the lab device detecting the completion of that physical step” (remarks, pg. 8).
Re. argument A4: On both counts, the Examiner respectfully disagrees. See also response to argument A3.
MPEP 2106.04(d)(2) indicates that a practical application may be present where the abstract idea effects a particular treatment or provides particular prophylaxis for a disease or medical condition. A particular treatment/prophylaxis is present where: (a) there is a particular (i.e., named/described) treatment/prophylaxis that occurs when the claim is implemented; (b) the treatment/prophylaxis has more than a nominal connection/correlation to the abstract idea; and (c) the administration is more than extra-solution activity or a field of use.
Applicant’s claimed invention does not provide for a particular treatment/prophylaxis because no treatment/prophylaxis is recited in the claim. The claim does not even recite that a treatment/prophylaxis is provided/administered to a patient.
Also, MPEP 2106.04(d)(2) indicates that a practical application may be present where the claimed invention effects a transformation or reduction of a particular article to a different state or thing. MPEP 2106.05(c) thereafter describes that a transformation is present where a physical object or substance is transformed to a different state or thing. Notably, the mere manipulation of data has been deemed not to be a transformation within the meaning of the term “transformation.” See MPEP 2106.05(c): “mere manipulation of basic mathematical constructs i.e., the paradigmatic abstract idea, has not been deemed a transformation” (internal quotations omitted).
The claim does not recite a physical object or substance being transformed to a different state or thing. The claim recites performance of an assay process using basic tools of scientific work and using the lab device in its normal capacity. The Examiner notes that Applicants cannot claim human organisms under Section 33(a) of the America Invents Act. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Because no transformation is present in Applicant’s claimed invention, a practical application is not present.
Regarding the rejection of claims 2-13 and 15-23, the Applicant has not offered any arguments with respect to these claims other than to reiterate the argument(s) present for the claim(s) from which they depend or are analogous to. As such, the rejection of these claims is also maintained.
Rejection under 35 U.S.C. §103
Regarding the rejection of claims 1-23, the Applicant has cancelled claim 14, rendering the rejection of that claim moot. Regarding the remaining claims 1-13 and 15-23, the Examiner has considered the Applicant’s arguments but does not find them persuasive for at least the following reasons. Applicant argues:
B1. “The cited references fail to teach or suggest all the features recited in amended claim 1” (Remarks, pg. 9).
Re. argument B1: The Examiner respectfully submits the basis of rejection as necessitated by amendment. Given the BRI, Jacobs in view of Jost teaches or renders obvious the recited claim limitations including the limitations. Jost ties the text-based instructions to the preparation of a sample for an assay. Jacobs teaches sequentially progressing through steps and transmitting instructions (e.g., 604, 606, 608) to the eyewear device for display. It is unclear how Jacobs in view of Jost may be deficient in any way in making the delivery of the next instruction contingent upon the completion of previous steps. See additionally Jacobs at para. 0112 and 0135.
B2. “The Examiner's characterization of the laboratory procedure information as "non-functional descriptive information" is therefore rendered incorrect” (remarks, pg. 9).
Re. argument B2: The prior art rejection of claim 1 does not indicate that any limitations are non-functional descriptive material. This argument appears to relate to a different claim, claim 13. Sequentially presenting instructions of the selected workflow is taught for claim 1 prior art rejection. As for claim 13, the claimed instructions are only provided to the wearable device for an operator to follow. Therefore, the content of the instructions to be followed by an operator is non-functional descriptive material. The Examiner suggests amending to recite in claim 1 “a lab device configured to perform the assay by performing one or more of collecting a blood sample, separating plasma, extracting cfDNA, preparing ddPCR assay, transferring the cfDNA to the ddPCR assay, generating a droplet, and analyzing the droplet” from the perspective of the lab device in a manner disclosed by the Applicant.
B3. “Jacobs contains no mechanism where an independent physical lab instrument automatically performs a step and feeds an automated electronic
completion signal back into the controller to dynamically advance the operator's interface” (remarks, pg. 10).
Re. argument B3: See basis of rejection as necessitated by amendment. Jacobs in view of Jost teaches or renders obvious the claim limitations. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the feature upon which applicant relies (i.e., an automated electronic completion signal) is not recited in the rejected claim(s). Claim 1 instead recites “wherein the lab device is configured to detect completion of a processing step of the assay and provide information relating to a next step of the assay to the workflow controller”. As previously mentioned, detecting completion is unrelated to performing the assay because detecting can be achieved by a user clicking a “done” button at the end of the assay process, which is a BRI example that utilizes manual, user-driven action. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Note: Also previously mentioned, providing information relating to a next step of the assay to the workflow controller is unrelated to the detection of assay completion because providing can be achieved by a user clicking a “send” button. Also, providing instructions is unrelated to receiving instructions because providing instructions can be achieved by a user clicking an “open” button.
Regarding the rejection of claims 2-13 and 15-23, the Applicant has not offered any arguments with respect to these claims other than to reiterate the argument(s) present for the claim(s) from which they depend or are analogous to. As such, the rejection of these claims is also maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Laubert et al. (US 2024/0013873 A1) for teaching METHOD AND SYSTEM OF MANAGING SAMPLE PRIORITIES.
Allwinn et al. (US 2023/0368874 A1) for teaching LABORATORY DATA MANAGEMENT SYSTEM.
Holmes et al. (US 11,545,241 B1) for teaching Systems And Methods For Analyte Testing And Data Management.
Yagci et al. (WO 2013/170204 A1) for teaching augmented reality for workflow assistance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica M Webb whose telephone number is (469)295-9173. The examiner can normally be reached Mon-Thurs 9:30am-3:30pm CST.
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/J.M.W./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
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