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
Status of Claims
Original claims 1-23 filed 11/19/2024 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 22-23 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 22 recites “the workflow computer”, which lacks antecedent basis. The rejection of claim 22 also applies to dependent claim 23. Claim 23 is also rejected for reciting “database” (not “a” database or “the” database). It is unclear if “database” refers to the previously recited “workflow repository” 130 or the disclosed database 140. 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 1-23 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; extract a workflow for the selected laboratory procedure, the workflow comprising a plurality of instructions arranged in a specified sequence; and sequentially deliver one or more instructions of the plurality of instructions for an operator to follow, wherein the one or more instructions comprises a visual indicator configured to be displayed (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, or displaying 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 are recited 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.
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 (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.
Dependent claims 2-5, 9-16, 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 14 recites the additional element of a lab device that collects data (i.e., performs an assay). The additional element is recited at a high-level of generality (i.e., as a general means of collecting data or performing an assay) and amounts to mere data gathering, which represents an extra-solution activity (see Applicant’s disclosure at para. 0027, “lab device 160 can comprise a device controllable by a user to perform an operation, test, assay, analysis, or the like. In some embodiments, the lab device 160 can include a device for performing automated Polymerase Chain Reaction (PCR) and/or for performing automated digital PCR”. MPEP § 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, the additional elements do not integrate the abstract idea into a practical application. The claims are directed to an abstract idea.
Also discussed above with respect to integration of the abstract idea into a practical application, the additional element of the lab device (i.e., a device that collects data or performs an assay) is 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 certain laboratory techniques are well-understood, routine, conventional activity (e.g., using polymerase chain reaction to amplify and detect DNA). See also MPEP 2106.05(g) (citing In re Grams, Mayo, PerkinElmer, Inc.) Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such, the claims are not patent eligible.
Claim 15 merely further recites the additional element of the lab device comprises the workflow controller, which amounts to no more than a location to which data is received (including collecting assay data in a generic manner) or from which data is transmitted (the lab device); and mere instructions to apply an exception using a generic computer or generic computer component (the workflow computer). See analysis, supra. Also, MPEP § 2106.05(d)(II) indicates computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity to include: Receiving or transmitting data over a network, e.g., using the Internet to gather data; storing and retrieving information in memory; electronically scanning or extracting data. MPEP § 2106.05(d)(II) also indicates certain laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity to include: using polymerase chain reaction to amplify and detect DNA, etc. See also MPEP 2106.05(g).
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, a workflow controller, a database, and a display of the wearable device as either performing well-understood, routine, conventional computer functions and/or laboratory techniques in a merely generic manner (e.g., at a high-level of generality) or as insignificant extra-solution activity (e.g., mere data gathering and outputting). See analysis, supra.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 6-9, 11, 17 and 21-23 are rejected under 35 U.S.C. §§ 102(a)(1) and 102(a)(2) as being anticipated by Jacobs et al. (US 2023/0298721 A1; “Jacobs” 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 (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 (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 comprises 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.)
Re. Claim 2, Jacobs 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 (Abstract, Fig. 2 teach the wearable heads-up display (HUD) may be smart-glasses. [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 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 (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…” (action indicator), an identification of needed verification information, and a picture of a barcode. Fig. 6 also shows the displayed instructions of examples 604, 606, 608.)
Re. Claim 6, Jacobs 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 (abstract teaches the 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. [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. 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 Fig. 13A, [0104], teaching “[w]hen a next step is to be displayed” (transmit the voice command). Fig. 13A, [0094] teach 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 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, [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 teaches the system of claim 7, wherein the navigation commands comprises left, right, up, down, next, and/or cancel (see [0072], “Select”, “Open”, “Next”, “Confirm”, “Cancel”, “Record”, “Scroll Down”, “Enter”, etc.)
Re. Claim 9, Jacobs 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 (Abstract teaches the smart-glasses include at least one camera and/or barcode scanner. [0008], [0014] teach processing images from camera to identify/read barcodes of ingredient containers / various containers (sample containers). [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 ([0022] teaches a step requiring entry of verification information… and display of options for voice entry or barcode scanning. [0021], [0023] teach 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 Figs. 10, 22, [0084].)
Re. Claim 11, Jacobs 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 ([0007] teaches the smart-glasses have at least one camera… configured to record images of technician gestures (captured). [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 ([0073] teaches the identified gesture is compared to a library of gestures, which correspond to certain navigation commands and/or text entry commands. [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 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 teaches via a wireless network (Fig. 3, [0008], [0069] teach the client device and the smart-glasses are communicatively coupled via a wired or wireless connection… via a network 350.)
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 3, 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs in view of Byford et al. (US 2010/0036667 A1; “Byford” herein).
Re. Claim 3, Jacobs 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. 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 does 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 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 teaches the system of claim 1, wherein: the wearable device further comprises a speaker configured to deliver an audio (see [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., Fig. 13A), and deliver the […] instructions (see, e.g., Fig. 13A, [0061]) via the speaker of the wearable device (see again [0049], [0060].)
Jacobs 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 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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobs in view of Jost et al. (US 2017/0142324 A1; “Jost” herein).
Re. Claim 10, Jacobs teaches the system of claim 9, wherein the information related to the sample container comprises: a batch number, an expiration date, […] (Fig. 4, [0070] teach a list 400 that includes a plurality of dose orders 362 including a patient name or identifier. [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. 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. [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.)
Jacobs does not explicitly teach retrieve, based on the scanned code, information related to the sample container, wherein the information related to the sample container comprises… a patient identifier.
Jost teaches
the information related to the sample container comprises… a patient identifier ([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.)
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 perform barcode scanning to obtain the required information 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 laboratory workflow (see Jost at least at para. 0003).
Claims 12-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs in view of Rasab et al. (WO 2022/076,607 A1; “Rasab” herein).
Re. Claim 12, Jacobs teaches the system of claim 1, wherein the laboratory procedure comprises […] (see claim 1 prior art rejection, Fig. 13A (block 1374) and [0106].)
Jacobs 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 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/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 14, Jacobs teaches the system of claim 1, further comprising […]. Jacobs does not teach a lab device configured to perform an assay. Rasab teaches a lab device configured to perform an assay ([00104], system, e.g., bench top lab. [00102] teaches the system may permit multiplexed assays. See also [00103].) 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 a system configured to perform assay(s) 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 15, Jacobs/Rasab teaches the system of claim 14, wherein the lab device comprises the workflow controller (Rasab [00103] teaches the system (lab device) may be in communication with or coupled to external user devices, a cloud server, or both… The cloud server may be configured to otherwise permit a user of the system to remotely monitor and control the system… Fig. 3 shows an example infrastructure coupling the system to the cloud server… The cloud server may provide access of the system to a patient messaging service 1, test ordering tracking and results access application 2, sample scheduling, tracking, and meta data application 3, a lab management application 4, or any combination… the lab management application may permit a lab technician to manage the operations of the laboratory. Rasab [00104] teaches the system may include the laboratory information management system (LIMS) 5 (workflow controller).)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the noted features of Rasab with teachings of Jacobs, since the combination of the two references is merely combining prior art elements according to known methods to yield predictable results (KSR rational A). It can be seen that each element claimed is present in either Jacobs or Rasab. Providing laboratory technology (as taught by Rasab) (see at least para. 00103-00104) does not change or affect the normal computer-related functionality of the client device of Jacobs (see at least Fig. 13A-13B; and Fig. 4, [0061], [0093] (block 1304).) The functionalities of connecting to a server, displaying orders, selecting an order, receiving a preparation protocol, progressing through steps of the protocol, verifying a modality, enabling modality options and storing verification information would be performed the same way even with the addition of laboratory technology. Since the functionalities of the elements in Jacobs and Rasab do not interfere with each other, the results of the combination would be predictable.
Re. Claim 16, Jacobs/Rasab 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 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Handique et al. (US 2020/0354715 A1) for teaching system and method for automated single cell processing.
Chirica et al. (US 8,645,167 B2) for teaching systems and methods for tracking and providing workflow information.
Cauley, III et al. (US 2022/0020455 A1) for teaching point-of-care diagnostic instrument workflow.
Friebe (US 2021/0202079 A1) for teaching Pharmaceutical Manufacturing Process Control, Support And Analysis.
Evans et al. (US 2020/0365241 A1) for teaching SYSTEMS FOR MANAGING BIOPSY SPECIMENS.
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/J.M.W./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683