DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/19/2025 and 07/16/2025 are in accordance with the provisions of 37 CFR 1.97 and are considered by the Examiner.
Priority
Claim PRO app# PRO 63/555,296 priority is acknowledged.
Claim Objections
Claim 1 and 17 is objected because of the following informalities: Claim 1 introduces "a whole blood separation program" in the processing circuit limitation and then instructs the blood component separator to "operate the identified blood separator program." The term "blood separator program" has no antecedent in the claim because the only program previously introduced is "a whole blood separation program" a different string of words.
Claim 17 mirrors the same problem within its own dependency chain. Claim 16 the independent claim from which Claim 17 depends uses "blood separator process" throughout each of its three limitations. Claim 17 then recites "programming a blood component separator with the selected blood separator program." No prior limitation in the dependency chain introduces an element called "the selected blood separator program" because Claim 16 uses "process," not "program."
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16 and 19, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The final clause of Claim 19 reads "wherein the at least one blood component which is collected in the blood component container." MPEP § 2173.05(g) requires that each claim limitation impose an ascertainable condition or restriction on the claimed subject matter; a clause that identifies a subject "the at least one blood component" but states no predicate, imposes no condition, describes no relationship, and sets no boundary cannot be given a definite meaning
"The blood component container" lacks antecedent basis.
Claim 16 introduces the collection vessel as "a second container or multiple containers." Claim 19 refers to "the blood component container" using the definite article "the," which under MPEP § 2173.05(e) signals reference to a previously introduced element but no prior limitation in the dependency chain introduces any element called "the blood component container."
Note: Claims 16-21 rejected on the same ground above.
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.
Subject Matter Analysis:
Claims 1–21 are rejected under 35 U.S.C. § 101 because the claimed subject matter is directed to a judicial exception specifically, an abstract idea and the claims do not include additional elements sufficient to amount to significantly more than the abstract idea itself.
Step 1.
The claims fall within the following statutory categories:
Process (Claims 16–21): The language reciting "storing whole blood characteristic data and at least one of inventory data and a prioritization list in a memory circuit; selecting a blood separator process with a processing circuit based on the whole blood characteristic data...and using the selected blood separator process to separate at least one blood component from whole blood" defines a series of acts or steps, aligning with the definition of a process under MPEP § 2106.03.
Machine (Claims 1–15): The language reciting "a processing circuit configured to receive whole blood characteristic data and inventory data and to identify a whole blood separation program" and "a blood component separator configured to receive a container comprising whole blood and to operate the identified blood separator program" describes a concrete assembly of parts, aligning with the definition of a machine under MPEP § 2106.03.
Having confirmed the claims are directed to statutory subject matter, the analysis proceeds to Step 2A, Prong One.
Prong One
Prong One determines whether claims are directed to a judicial exception by examining what the claim, as a whole, is focused on. MPEP § 2106.04. Across all three independent claims, the focus is a data-driven selection system: gather blood and inventory data, compare to targets, choose which separation program to run.
The invention selects the best blood separation program for each donated whole blood unit by evaluating blood characteristics (blood type, collection time, temperature) against real-time inventory levels and facility goals. See Spec. 0022–0024, 0051; FIG. 2; FIG. 7. This is a decision-making process choosing which manufacturing protocol best fits what you have against what you need.
Recitation of Claim 1:
Note: Non-bold, represent abstract idea, bold represent additional elements.
Claim 1.
A system for optimizing the separation of whole blood into blood components, comprising:
a processing circuit configured to receive whole blood characteristic data and
inventory data and
to identify a whole blood separation program based on the whole blood characteristic data and
the inventory data;
and
a blood component separator configured to receive a container comprising whole blood and
to operate the identified blood separator program to separate at least one blood component from the whole blood for collection in a blood component container.
Classification Abstract Idea Rationale:
Under BRI (MPEP § 2111), independent Claims 1, 14, and 16 recite receiving blood characteristic and inventory data, comparing inputs against thresholds or priorities, and selecting a blood separation program. This aligns with the following abstract idea categories:
Mental Process - MPEP § 2106.04(a)(2)(III): A mental process is a step or series of steps that can be performed in the human mind or by a person with pen and paper. Claims 1, 14, and 16 respectively recite "identify a whole blood separation program based on the whole blood characteristic data and the inventory data," "select a blood separator process based on the whole blood characteristic data and at least one of inventory data and priority data," and "selecting a blood separator process...based on the whole blood characteristic data and the at least one of inventory data and the prioritization list" each is a cognitive selection act: comparing what blood is available against inventory needs and deciding which protocol fits. The specification confirms: "processing circuit 22 may determine, identify, or select which blood components (and/or quantities thereof) are to be manufactured from whole blood units...based on whole blood unit characteristics, center inventory needs, blood center goals, prioritization lists and/or other data" (Spec., 0022). This paragraph frames the claimed operation as judgment the same comparative reasoning a blood bank supervisor performs with a donation log, a stock sheet, and a pencil mirroring every non-bold limitation without software or hardware.
Certain Method of Organizing Human Activity Commercial or Legal Interactions (MPEP § 2106.04(a)(2)(II)):
Commercial or legal interactions include managing commercial inventory and coordinating manufacturing workflows across a supply chain. Claims 1, 14, and 16 recite "inventory data" as a core decision input; Claim 16 adds "prioritization list" - limitations that, under BRI, describe managing a blood product supply chain: tracking stock, setting manufacturing targets, and sequencing production. The specification states: "one or more embodiments described herein may improve the management of inventories of blood components" and "may improve the predictability, efficiency, and/or automation of blood component supply chains" (Spec., 0016–0017). These paragraphs confirm the claimed purpose is supply-chain and inventory management a commercial organizational activity which a blood bank manager mirrors by assigning batch work orders from a stock sheet and a customer demand list without any computing hardware.
Dependent Claims Prong one Analysis:
Claims 2 and 18 recite "inventory data comprises a number of blood products in inventory at an entity/blood bank" specifying the content type of the data input. This narrows the abstract data-gathering step to a blood bank domain, fitting the mental process category as a data gathering sub-step.
Claims 3 and 19 recite "identify/select...based on...indication that a number of blood products is less than a predetermined number" a conditional threshold comparison driving the program selection. This is a mental process of comparison and decision performable by a person reviewing a stock sheet against a target number.
Claim 4 recites "donation characteristic comprising one or more of donor ABO Rh blood type, donor gender, donor antibodies, donor hgb or hct, donor pregnancy history, collection time, collection duration, product type, transportation temperature, storage temperature" - specifying the data fields that feed the selection judgment. This is a mental process of data characterization restricted to a blood bank field-of-use.
Claim 5 recites "identify the blood separator program based on an indication that a number of blood component products of the ABO Rh blood type...is less than a predetermined number" - a blood-type-specific threshold comparison. These further narrows Claim 3's mental process comparison to a specific blood type sub-domain.
Claim 6 recites "blood component separator...transmit a request message...processing circuit...transmit a response message comprising the identity of the blood separator program" - a request-response program lookup exchange. This describes a managed commercial workflow interaction between devices coordinating a manufacturing decision.
Claim 7 recites "inventory data comprises labeled blood component inventory data and non-labeled blood component inventory data" - sub-classifying inventory by labeling status. This is a mental process of data classification narrowing the abstract inventory input without adding a new technical mechanism.
Claims 8 and 20 recite "client computer configured to receive an inventory goal from a worker and to transmit the inventory goal to the processing circuit" - a worker entering a manufacturing target that the system receives. This describes a commercial inventory goal-setting interaction, fitting the commercial or legal interactions sub-category of organizing human activity.
Claim 9 recites "whole blood characteristic data is received from a blood bank information system...comprising donation identifiers and ABO Rh blood type for a plurality of whole blood products" - specifying the external source and content of the abstract data input. This is a mental process data acquisition sub-step restricted to the blood bank field-of-use.
Claims 10 and 13 recite "generate a display screen showing each of a plurality of donation identifiers and associated different blood separator programs" and "status to goals, work in progress and/or manufacturing statistics" - presenting the abstract selection's output to a user. This is a mental process of post-selection display - showing the result of the abstract decision after it is already complete.
Claim 11 recites "client computer configured to receive a blood product type priority from a worker and to transmit the blood product type priority to the processing circuit" - a worker submitting a priority weighting that shapes the abstract selection. This is a commercial or legal interaction fitting manufacturing prioritization within a blood bank supply-chain workflow.
Claim 12 recites "processing circuit...configured to receive hospital blood component demand and to update the inventory data based on the demand" - intake of external demand data followed by a data update. This is a mental process of data collection and updating, narrowing the abstract data inputs without introducing a specific technical mechanism.
Claim 15 recites "computing device configured to transmit a request...receive the selected blood separator process, and to display the selected blood separator process to the worker on a display" - a retrieve-and-display communication step. This combines a commercial workflow interaction with post-selection display, fitting both the commercial or legal interactions sub-category and the mental process post-selection display category.
Claim 17 recites "scanning a donation identifier from the first container; transmitting the donation identifier...to a remote processing circuit; and receiving from the remote processing circuit the selected blood separator process" This combines a mental process data acquisition sub-step with a commercial workflow interaction coordinating the program lookup between devices.
Claim 21 recites "inventory goal comprises a predetermined number or amount of blood component product of an ABO Rh blood type" - specifying the content of the abstract inventory goal by blood type. This is a mental process data content specification restricted to a blood bank field-of-use.
Because all claims recite abstract ideas mental processes of data collection, threshold comparison, and program selection, and commercial organizational activities of inventory management the analysis proceeds to Step 2A, Prong Two, to determine whether the additional elements integrate those exceptions into a practical application.
Prong Two
Prong Two determines whether the additional elements alone or in combination apply the judicial exception through a specific technical mechanism reflecting a real technological improvement, not merely a goal or result. MPEP § 2106.05. The additional elements "processing circuit," "memory circuit," "blood component separator," "a container," "blood component container" each apply the abstract selection in the blood bank setting without a specific technical mechanism improving the underlying technology, and therefore do not integrate the exception.
Independent Claims 1, 14, and 16 Additional Elements
Processing Circuit / Memory Circuit: The recitation of "a processing circuit configured to receive...and to identify" (Claim 1), "a processing circuit configured to store...and to select" (Claim 14), and "storing...in a memory circuit; selecting...with a processing circuit" (Claim 16) does not integrate the abstract idea because:
The claims recite what the circuit achieves receiving data and identifying a program not how the circuit is technically improved to achieve it. According to MPEP § 2106.05(f), simply instructing the use of the exception with a computer component does not transform the exception into a practical application. No specific algorithm, novel data structure, or technical mechanism distinguishes this processing from general computation, and no limitation describes a change to how the processing circuit itself functions.
Blood Component Separator / Container / Blood Component Container: The recitation of "a blood component separator configured to receive a container comprising whole blood and to operate the identified blood separator program to separate at least one blood component from the whole blood for collection in a blood component container" does not integrate the abstract idea because:
The claims merely direct the separator to run a pre-selected program, but the separator's operation and output remain unchanged from its generic function that merely apply the abstract idea for example “a method of assigning hair designs to balance head shape with a final step of using a tool (scissors) to cut the hair” which is similar to this case’s method of selecting a blood separator program with a final step of using a tool (blood separator) to separate the blood; no claim limitation recites a new separation technique or a technical change to the equipment. The selection system determines which existing program to execute, but this choice is made before the separator acts, and the physical process is not altered or improved by the claimed system. All that is added is the application of an abstract idea-program selection to a generic laboratory process, with no meaningful technical integration or advancement. Therefore the limitation above do not overcome Prong Two because they do not apply the judicial exception through any specific technical mechanism or result in a technological improvement.
Viewed as a whole, the combination of a processing circuit performing abstract data analysis and a separator physically executing the selected program on a whole blood container produces no technical improvement beyond what each component does independently. The abstract selection is complete; the separator executes its output in its physical capacity; the containers receive the separated components as designed. No claim limitation describes a technological advancement in how any component functions as a result of their combination.
Dependent Claims Analysis
The dependent claims do not overcome Prong Two.
Claims 2, 3, 4, 5, 7, 18, 19, 21: No new additional element these claims narrow the abstract data inputs, comparison thresholds, or goal content to blood bank sub-domains. Refer to prong one to further details
Claim 6 Request/Response Messages: Adds standard network message exchange between the separator and processing circuit. Under MPEP § 2106.05(f), transmitting the abstract program selection over a network is a mere instruction to apply the exception no specific improvement to communication architecture or function is claimed.
Claims 8, 20 Client Computer: Adds a generic input device receiving and transmitting a worker-entered inventory goal. Under MPEP § 2106.05(f), receiving user input and transmitting it to a server is a basic computing function - a mere instruction to apply the exception - not a specific technical mechanism that improves the technology.
Claim 9 Blood Bank Information System: Names a pre-existing external data source without describing a technically improved interaction with it. This is a field-of-use limitation specifying where the abstract data originates. MPEP § 2106.05(h).
Claims 10, 13 Display Screen: Generating a display showing selection results or manufacturing statistics after the abstract selection is complete is post-solution activity presenting the output of the abstract idea without altering the claimed process. MPEP § 2106.05(g).
Claim 11 Blood Product Type Priority: Identical in technical character to Claims 8 and 20 a generic client computer transmitting abstract priority data to the processing circuit. No new technical mechanism. MPEP § 2106.05(f).
Claim 12 Hospital Demand Data: Receiving demand data and updating stored inventory uses a generic processing circuit for basic data intake and memory write a mere instruction to apply the exception using generic computing. MPEP § 2106.05(f).
Claim 15 Computing Device: Combines the generic client-server request of Claims 8, 20 with the post-solution display of Claims 10, 13 neither function individually nor their combination applies the exception through a specific technical mechanism. MPEP §§ 2106.05(f), (g).
Claim 17 Scanning + Network Retrieval: Adds scanning a donation identifier from the container and transmitting it to retrieve the selected program. This extends the physical laboratory context scanning an identifier from a blood bag but does not describe how the scanning or retrieval is technically improved by the claimed system. The scan acquires an identifier; the network retrieves a stored selection; neither step changes how the physical separation operates. MPEP § 2106.05(f).
When viewed as a whole, the combination of independent and dependent claim elements - processing circuits, separators, containers, client computers, network messages, display screens, and scanners applies the abstract selection in the blood bank field; none introduces a specific technical mechanism improving how any component functions, and the physical separation step executes the abstract selection's output in the separator's ordinary capacity without alteration.
Because no additional element including the physical blood separation step alone or in combination integrates the abstract idea through a specific technical mechanism reflecting a technological improvement, the analysis proceeds to Step 2B.
Step 2B
Step 2B asks whether the additional elements individually or as an ordered combination amount to "significantly more" than the abstract idea itself. MPEP § 2106.05. Each additional element is expressly admitted in the specification as pre-existing; their combination, including the physical separation step, does not cross the significantly-more threshold.
Independent Claims 1, 14, and 16 Additional Elements
Additional elements: "processing circuit" (Claims 1, 14, 16), "memory circuit" (Claim 16), "blood component separator," "a container," "blood component container" (Claims 1, 14, 16).
Processing Circuit + Memory Circuit: The specification admits: "Processing circuit 22 may comprise a server computer, shared server resources, cloud computing, a database, and/or other computing resources" (Spec., 0021) and "a general-purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device" (Spec., 0058). Under MPEP § 2106.05(f), a claim that applies a judicial exception using a generic computer component without a specific technical improvement does not amount to significantly more. No limitation describes a specific algorithm, improved data structure, or technical mechanism distinguishing this circuit's operation from general computation the claims use the circuit as a tool to execute the abstract selection, not to improve computing itself.
Blood Component Separator + Container + Blood Component Container: The specification admits: "Blood component separators are programmable to separate whole blood in a whole blood container into different sets of manufactured blood components" (Spec., 0003) and identifies the CompoMat G5 Plus as a "non-limiting example" of an "automated blood component separator" (Spec., 0019). These are express applicant admissions that the separator, its containers, and its physical separation function were pre-existing at the time of filing. Under MPEP § 2106.05(g), executing a pre-existing program on a pre-existing separator to perform a pre-existing physical separation after the abstract selection is complete is the ordinary use of that admitted pre-existing device. No claim limitation describes a new physical separation mechanism, a new container configuration, or a new way the separator interacts with the selection system that adds technical capability the separator did not already possess. The physical separation step, while non-abstract, does not amount to significantly more because it contributes only what the admitted pre-existing separator was already designed to do.
Together, a general-purpose processing circuit performing abstract selection combined with a pre-existing separator physically executing the selected program on a pre-existing whole blood container - each operating exactly as the specification admits they were designed to operate - adds no combined capability beyond each component alone, and does not amount to significantly more than the abstract idea.
Dependent Claims Analysis
New additional elements in dependent claims: "client computer" (Claims 8, 11, 15, 20), "display screen" (Claims 10, 13, 15), "blood bank information system" (Claim 9), "request/response messages" (Claims 6, 17), "scanning a donation identifier" (Claim 17).
Claims 2, 3, 4, 5, 7, 18, 19, 21: No new additional element - these claims merely narrow the abstract idea as established in Prong One and require no further Step 2B evaluation.
Claims 8, 20 Client Computer: The specification admits client computers are "desktop computers, laptop computers, and/or mobile devices such as tablets or smartphones" (Spec., 0020). Under MPEP § 2106.05(f), receiving user input and transmitting it to a server is a basic function of any client-server architecture - not significantly more.
Claim 6 Request/Response Messages: The specification admits standard protocols: "REpresentational State Transfer (REST), Hypertext Transfer Protocol Secure (HTTPS), socket communication" (Spec., 0020). Transmitting an abstract selection result using admitted standard protocols is generic communication - not significantly more. MPEP § 2106.05(f).
Claim 9 Blood Bank Information System: The specification admits BIS/BECS is a pre-existing system: "Blood Establishment Computer System (BECS) or other system configured to run applications used by facility 10" (Spec., 0021). Receiving data from an admitted pre-existing external system in its ordinary capacity is not significantly more. MPEP § 2106.05(f).
Claims 10, 13 Display Screen: Generating and displaying selection results or manufacturing statistics after the abstract selection is complete is insignificant post-solution activity presenting the result of the abstract idea without altering the claimed process. MPEP § 2106.05(g).
Claim 11 Blood Product Type Priority: Identical in technical character to Claims 8 and 20 an admitted generic client computer receiving and transmitting abstract priority data. Not significantly more. MPEP § 2106.05(f).
Claim 12 Hospital Demand Data: Receiving external demand data and writing to stored inventory uses a generic processing circuit for basic data intake and memory update - not significantly more. MPEP § 2106.05(f).
Claim 15 Computing Device: Combines the generic client-server request of Claims 8, 20 with the post-solution display of Claims 10, 13 their combination reaches no further than each component alone. MPEP §§ 2106.05(f), (g).
Claim 17 Scanning + Network Retrieval: The specification admits: "Each blood component separator 14 may comprise an integrated code scanner to scan barcodes or other identifying data" (Spec., 0019). Scanning an identifier from a pre-existing blood bag label and retrieving a stored program selection via admitted standard network transmission uses each component in its admitted ordinary capacity not significantly more. MPEP § 2106.05(f).
The combination of admitted pre-existing client computers, standard network communications, display screens, pre-existing code scanners, admitted pre-existing BIS/BECS systems, and a pre-existing blood component separator performing its admitted physical separation function each operating in its admitted ordinary capacity adds no combined capability amounting to significantly more than the abstract idea of collecting blood characteristic and inventory data, comparing against thresholds, and selecting a separation program.
No additional element including the physical blood separation step alone or in combination across independent and dependent claims, provides an inventive concept beyond the abstract idea. Therefore, Claims 1–21 are rejected under 35 U.S.C. § 101.
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.
Claim(s) 1-2, 4, 6-7, and 9-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fletcher-Haynes - US7072769B2.
Claims:
Fletcher-Haynes teaches, Claim 14.
A system for manufacturing a blood component from whole blood, comprising:(Collection system…separate, remove, and collect at least one type of blood component, Fletcher-Haynes, Col. 9, ll. 35-42)
a processing circuit configured to store whole blood characteristic data and at least one of inventory data and priority data (Fletcher-Haynes, centralized computing/data storage assembly, Col. 9, ll. 52-67, may include input/entry devices… data manipulation device…Col. 10, ll. 49-67, storage medium…used for data storage… Donor entry/edit element 221… procedure data… last hematocrit…last platelet count, figure 2D, blood component inventory control…blood component to be collected…demand…existing inventory… adapted to provide…donor management, Col.3, ll. 10-20, capability…providing a prioritization, Col. 4, ll. 38-47)
,the processing circuit configured to select a blood separator process based on the whole blood characteristic data and at least one of inventory data and priority data;( Fletcher-Haynes, See at least, blood centers may prefer or determine to require certain combinations of products from certain blood type donors; col. 12, lines 38–45; the system 140 and manipulation device 144 can manipulate the donor statistics against a large plurality of procedure types and compare with blood center prioritizations to obtain various sorts of procedure lists Col. 29, lines 25–35; blood component inventory control by basing donor selection and/or collection procedure selection on blood component demand and/or existing inventory Col. 3, lines 10–16.)
and
an automated or manual blood component separator configured to be operated by a worker to receive whole blood in a first container and separate the whole blood into the manufactured blood component and to deposit the manufactured blood component in a second container or multiple containers.(Fletcher-Haynes, See at least, blood component separation and collection device 18 Col. 9, lines 60–65; the source of blood may be provided to the blood component collection device from an appropriate blood container...interconnected with the blood component collection device 18 versus receiving such directly from a human donor Col. 61, lines 50–66 to Col. 62, line 1; platelets collected from the blood component device 18 are directed through a platelet collect line 34 to one or more platelet collect bags 38 Col. 45, lines 41–43; a plasma collect bag 54 may be provided Col. 45, lines 39–50.)
Fletcher-Haynes’ blood component separation and collection device 18 is an automated centrifugal separator operated by operators, reading on automated blood component separator configured to be operated by a worker. Fletcher-Haynes explicitly states the source of blood may be provided to the blood component collection device from an appropriate blood container-this blood container is the first container holding whole blood. The separated platelets flow to platelet collect bags 38 and plasma to plasma collect bag 54, which are the second container or multiple containers receiving manufactured components.
Fletcher-Haynes teaches, Claim 15.
The system of Claim 14, further comprising a computing device configured to transmit a request for a blood separator process to the processing circuit, to receive the selected blood separator process, and to display the selected blood separator process to the worker on a display. (Fletcher-Haynes, See at least, one or more data input/output/manipulation stations 149C Col. 13, lines 29–36; operator is presented with the Target Procedure page 351 Col. 28, lines 50-67; the system 140 running the apheresis time and/or product yield optimization routines...the parameters for the highlighted procedure are preferably shown above the procedure list Col.29, lines 1–25.)
Fletcher-Haynes’ client stations are separate workstations connected to a central server. When an operator starts the process, the station communicates with a device that runs optimization routines and suggests a target procedure. The result is displayed on the screen for the operator to see and follow.
Fletcher-Haynes teaches, Claim 16.
A method of separating whole blood into blood components, comprising: (Fletcher-Haynes, see at least, a blood component collection system and the provision of management capabilities which may include the incorporation of data manipulation and/or optimization principles, Col. 2, ll. 55-67)
storing whole blood characteristic data and at least one of inventory data and a prioritization list in a memory circuit;
Fletcher-Haynes’ storage medium 142 is the central database that stores all system data-this is the memory circuit. Donor biological data stored therein reads on whole blood characteristic data. The system stores both inventory demand data and product prioritizations. The phrase a prioritization of which products are preferred to be collected directly reads on prioritization list because it describes a ranked preference for blood products. All three data types reside in the same central database 142.
selecting a blood separator process with a processing circuit based on the whole blood characteristic data and the at least one of inventory data and the prioritization list; ( Fletcher-Haynes, See at least, blood centers may prefer or determine to require certain combinations of products from certain blood type donors; Col. 12, lines 38–45; the system 140 and manipulation device 144 can manipulate the donor statistics against a large plurality of procedure types and compare with blood center prioritizations to obtain various sorts of procedure lists Col. 29, lines 25–35; blood component inventory control by basing donor selection and/or collection procedure selection on blood component demand and/or existing inventory Col. 3, lines 10–16.)
and
using the selected blood separator process to separate at least one blood component from whole blood in a first container for collection in a second container or multiple containers. (Fletcher-Haynes, See at least, blood component separation and collection device 18 Col. 9, lines 60–65; the source of blood may be provided to the blood component collection device from an appropriate blood container...interconnected with the blood component collection device 18 versus receiving such directly from a human donor Col. 61, lines 50–66 to Col. 62, line 1; platelets collected from the blood component device 18 are directed through a platelet collect line 34 to one or more platelet collect bags 38 Col. 45, lines 41–43; a plasma collect bag 54 may be provided Col. 45, lines 39–50.)
Fletcher-Haynes’ blood component separation and collection device 18 is an automated centrifugal separator operated by operators, reading on automated blood component separator configured to be operated by a worker. Fletcher-Haynes explicitly states the source of blood may be provided to the blood component collection device from an appropriate blood container-this blood container is the first container holding whole blood. The separated platelets flow to platelet collect bags 38 and plasma to plasma collect bag 54, which are the second container or multiple containers receiving manufactured components.
Fletcher-Haynes teaches, Claim 17.
The method of Claim 16, further comprising:
programming a blood component separator with the selected blood separator program; ( Fletcher-Haynes, See at least, the initial procedure order may be transferred/downloaded onto the internal control of a blood component collection device 18 Col. 53, lines 15–17.)
Fletcher-Haynes describes transferred/downloaded onto the internal control of a blood component collection device 18 which is the act of loading procedure parameters into the machine. Downloading a procedure order to the device’s internal control is functionally identical to programming a blood component separator with the selected program.
scanning a donation identifier from the first container; (Fletcher-Haynes, See at least, Any field entry point which could/would require keyboard data entry could be filled using a bar code reader. Any field entry point which could/would require keyboard data entry could be filled using a bar code reader. Col. 5, lines 42–55;, figure 2A)
Fletcher-Haynes describes scanning a donation identifier from the first contain, because said that each data entry could be filled using a bar code, and then one data entry is for example Donor/Name, Donor Id.
transmitting the donation identifier from the blood component separator to a remote processing circuit;(Fletcher-Haynes, figure 9A, DATA TRANSFER BACK TO CENTRAL Station; Col. 54, ll. 6-25, back to the manipulation device 144… initial input may be used to generate various types of reports… donor/patient…; Any field entry point which could/would require keyboard data entry could be filled using a bar code reader. Any field entry point which could/would require keyboard data entry could be filled using a bar code reader. Col. 5, lines 42–55;, figure 2A; communicate in the reverse direction with each machine, col. 5, ll. 4-27, figure 6c, 6D)
Fletcher-Haynes describes a local blood separation machine capturing donor IDs via barcode and subsequently executing a "DATA TRANSFER BACK TO CENTRAL Station" to update remote donor reports.
and
receiving from the remote processing circuit the selected blood separator process for the scanned donation identifier. (Fletcher-Haynes, initial procedure order may be transferred/downloaded…, Col. 53, ll. 15-24; the donor-related data and/or initial procedure order is preferably generated by the central computer/database assembly 140 and then transferred to one of the apheresis machines 10 col. 11, ll. 50-67; blood collection device 18 such that the collection procedure may be initiated… Col. 54, ll. 6-30)
Fletcher-Haynes teaches, Claim 18.
The method of Claim 16, wherein the inventory data comprises a number of blood components in inventory at a blood bank. (Fletcher-Haynes, Col. 61, ll. 31-53, information relating to the inventory of the various types of blood components in the blood bank/center and/or the demand for one or more blood component types could be maintained such that specific collection procedures could be selected to accommodate for a low supply of a given blood component type and/or a high demand for such blood component type; Col. 8, ll. 11 -25, compare blood bank/center component inventories; )
Fletcher-Haynes discloses maintaining blood component inventory data at the blood bank/center, including counts to identify low supplies. Tracking quantities is confirmed by comparing inventories with projected needs, which requires numerical data for each component.
Note: Claims 1-2, are rejected with claims 14-16 for being very similar.
Fletcher-Haynes teaches, Claim 4.
The system of Claim 1, wherein the whole blood characteristic data comprises a donation characteristic of the whole blood, the donation characteristic comprising one or more of donor ABO Rh blood type, donor gender, donor antibodies, donor hgb or hct, donor pregnancy history, collection time, collection duration, product type, transportation temperature, storage temperature. (Fletcher-Haynes, …required by the blood separation/collection assembly… blood type… platelets and/or hematocrit…, Col. 20, ll. 1-30; Blood Type…O+, O-, A+, A-, B+, B-, AB+, AB…Col. 21, ll. 10-30 )
Fletcher-Haynes teaches, Claim 6.
The system of Claim 1, wherein the blood component separator is configured to transmit a request message to the processing circuit, wherein the processing circuit is configured to transmit a response message comprising the identity of the blood separator program. (Flectcher-Haynes, communicate in the reverse direction with each machine, Col. 5, ll. 17–27; two-way communications, Col. 5, ll. 4–16, initial procedure order…transferred/downloaded onto the internal control of a blood component collection device 18, Col. 53, ll. 15–17)
Fletcher-Haynes establishes two way communications between the central system 140 and each machine 10, and the system can communicate in the reverse direction with each machine. The central system generates the initial procedure order and transfers it to one of the apheresis machines 10. The machine communicates back to the central system to retrieve or exchange data, and the central system responds by downloading procedure information. This two-way communication pattern machine sends data to the server, server sends back the procedure functions as a request-response exchange where the response contains the identity of the separator program.
Fletcher-Haynes teaches, Claim 7.
The system of Claim 1, wherein the inventory data comprises labeled blood component inventory data and non-labeled blood component inventory data. (Fletcher-Haynes, See at least, information relating to the inventory of the various types of blood components in the blood bank/center, Col. 61, ll. 31–53; the present invention can be used to compare blood bank/center component inventories with projected needs, and adjust collection procedures to meet these needs Col. 8, ll. 11–16; Figure 6M; storing and maintaining data relevant to the entire blood component… Col. 6, ll. 15-25, but for which not all required finalization data may have been entered in the procedure record, Col. 34, Ll. 34-56, lab information may be entered/edited in screen 701 according to the product types…the estimated volume for platelet, plasma and RBC products… reminder to label LRS platelet… Col. 40, ll.15-67; Unit Number is preferably a required field entry, Col. 27, ll. 5-30; History tab. 299 to view product information for all procedures run for this donor since the donor record was created in the present system… Col. 23, ll. 24-46 )
Fletcher-Haynes stores data continuously from the moment a collection procedure begins through finalization, covering products in every described production state (non-labeled inventory data). The central database captures run information, product volumes, and yield estimates all data about blood products while those products sit in their collection bags awaiting downstream handling. Fletcher-Haynes stores unit numbers entered by barcode reader directly into the central database alongside product volumes, yields, and identifiers(labeled inventory data).
Fletcher-Haynes teaches, Claim 9.
The system of Claim 1, wherein the whole blood characteristic data is received from a blood bank information system dedicated to a blood bank, wherein the whole blood characteristic data comprises donation identifiers and ABO Rh blood type for a plurality of whole blood products. (Fletcher-Haynes, See at least, the present system has been developed with an open architecture to provide integration capabilities and collaborative capabilities with other computing environments such as Mak and/or Wyndgate donor database information systems, Col. 5, ll. 35–42; Donor ID 559444, Figure 2D; Blood Type, Figure 2D; Blood Type…O+, O-, A+, A-, B+, B-, AB+, AB-, Col. 27, ll. 45–67; donor data will preferably be down-loadable to the central server system of the present invention from the blood center information system, Col. 6, ll. 63–67 to Col. 7, l. 10)
Fletcher-Haynes teaches, Claim 10.
The system of Claim 1, wherein the processing circuit is configured to generate a display screen showing each of a plurality of donation identifiers and associated different blood separator programs identified by the processing circuit. ( Fletcher-Haynes, See at least, the operator is presented with the Target Procedure page 351…, Col. 28, ll. 59–67; numerous procedures are shown to Col. 29, ll. 29–45; screen 501…Machine ID…Donor Name…Procedure Name, Col. 35, ll. 8–15; Figure 5A showing multiple donors with their assigned procedures; Monitor Procedure task… col. 34, ll. 35-44, Figure 6M)
Fletcher-Haynes teaches, Claim 11.
The system of Claim 1, further comprising a client computer configured to receive a blood product type priority from a worker and to transmit the blood product type priority to the processing circuit, wherein the processing circuit is configured to identify the blood separator program based further on blood product type priority. (Fletcher-Haynes, See at least, one or more data input/output/manipulation stations 149C, Col. 13, ll. 29–36; these assemblies may also generally include computing devices and/or capabilities such as may be included in standard desktop or laptop computers, including the stations 148B as shown, and potentially data storage/memory and/or data manipulation devices and/or software along with potential resident communications devices and/or software, Col. 13, ll. 38–50; the present system presents the capability of providing a prioritization of which products are preferred to be collected, Col. 4, ll. 37–45; The system also presents the capability to tailor a blood center's priorities by blood type, CMV status, and/or HLA type matching, Col. 4, ll. 47–50; blood centers may prefer or determine to require certain combinations of products from certain blood type donors 14; then the blood center 1000 can prioritize this in the computer/database 140 so that those donors will donate those combinations, Col. 12, ll. 38–45; the operator may select a product focus list from this drop-down list, Col. 31, ll. 17–19)
Fletcher-Haynes discloses a system where client workstations receive blood product type priorities from operators, transmit those priorities to the central processing system, and the processing circuit uses those priorities to select blood separation procedures.
Fletcher-Haynes teaches, Claim 12.
The system of Claim 1, wherein the processing circuit is configured to receive hospital blood component demand and to update the inventory data based on the demand. (Fletcher-Haynes, See at least, Such a system may also be used for communication with other information systems...or hospital information systems, Col. 14, ll. 1–10; as inventory is withdrawn or replenished within the hospital or blood bank, this information can be recorded, Col. 44, ll. 30–40; the present invention can be used to compare blood bank/center component inventories with projected needs, and adjust collection procedures to meet these needs, Col. 8, ll. 11–16.)
Fletcher-Haynes discloses a processing circuit that communicates with hospital information systems to receive demand data, and maintains that demand alongside inventory information to drive procedure selection.
Fletcher-Haynes teaches, Claim 13.
The system of Claim 1, wherein the processing circuit is configured to generate a display screen showing status to goals, work in progress and/or manufacturing statistics. (Fletcher-Haynes, See at least, the present system 140 preferably provides users with the ability to view the status of all procedures currently running on machines 10, Col. 34, ll. 40–44; reports are preferably generatable about donors, procedures and collected blood products, Col. 43, ll. 38–47; compare blood bank/center component inventories with projected needs, Col. 8, ll. 11–14.)
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.
Claim(s) 3, 5 and 8 and 19-21 is rejected under 35 U.S.C. 103 as being unpatentable over Fletcher-Haynes, US 7,072,769 B2, and further in view of Fenwal (EP 3,091,461 B1).
Fletcher-Haynes teaches, Claim 19.
The method of Claim 16, further comprising selecting the blood separator process based on an indication that a number of blood components is less than a predetermined number of blood components, wherein the selected blood separator process comprises a blood components process, wherein the at least one blood component which is collected in the blood component container. (Fletcher-Haynes, …apheresis procedure selection process…, Col. 29, 6-10; collected into…bag, col. 48, ll. 25-36, according to a … collection procedure…desired yield of the predetermined blood component(s)… value or magnitude … process parameters used… procedure… performed… with the input process parameters… to collect the desired yield, Col. 7, ll. 30-57; figure 9A “platelet product”; specific collection procedures could be selected to accommodate for a low supply of a given blood component type and/or a high demand for such blood component type, Col. 61, ll. 31–53; basing donor selection and/or collection procedure selection on blood component demand, col. 3, ll. 10-23;)
Fletcher-Haynes teaches selecting the blood separator process based on an indication that inventory of blood components is low, of Claim 19, selecting the blood separator process based on an indication that a number of blood components is less than a predetermined number of blood components, wherein the selected blood separator process comprises a blood components process, wherein the at least one blood component which is collected in the blood component container, that required choosing a separation procedure when the current supply of a blood component type falls below a target, running that procedure to produce blood components, and collecting those components in containers. Fletcher-Haynes discloses that the system selects collection procedures to address low inventory by matching procedure type to the blood component in short supply, and that the selected collection procedure produces blood component products that are collected in bags or containers. The system monitors existing inventory of blood component types and directs operators to collect the type that is underrepresented, which reads on selecting a blood separator process based on low inventory and producing blood components that are collected in containers.
However, Fletcher-Haynes does not describe an indication that a number of blood components is less than a predetermined number of blood components as a defined numerical threshold comparison. Fletcher-Haynes discusses accommodating "low supply" and "high demand" in general terms but does not disclose comparing a current inventory count against a specific preset numerical target to trigger the procedure selection.
Fenwal teaches an indication that a number of blood components is less than a predetermined number of blood components of Claim 19, that required detecting when a current inventory count of blood components falls below a preset target number. Fenwal discloses that health care facilities configure the system so that actions are triggered automatically when current supply quantities drop below a specified threshold, and that this specified amount can be a default set by the system or defined by the facility, which is a predetermined number against which the current count is compared. Fenwal further discloses tracking inventory quantities and generating need-level indicators when supplies fall below the threshold, reading directly on an indication that a number is less than a predetermined number. (Fenwal, See at least, health care facilities can set up the system such that orders for particular blood components are placed automatically by the system when current supplies fall below a specified amount. That specified amount may be a default amount determined by the system or specified by the health care facility. Para 0017; a notifications field 724 may be provided which may display an indication of blood component needs. These notifications may be generated by inventory modules 110 and/or 120 and provided to one or more workstations to assist the user in selecting the optimal procedure. The notifications may come in various forms of detail, such as "RBC needed," "O positive RBC needed," etc., as well as providing an indication of the level of need, such as using color (e.g., red for critical need, yellow for moderate need, green for little need) or other indications Para 0043)
A skilled artisan with for example a bachelor's degree in biomedical engineering or computer science and at least two years of experience designing blood banking information systems or blood component processing workflows, who read Fletcher-Haynes's disclosure, would combine Fenwal with Fletcher-Haynes because both references operate in the same field of blood component collection management and both address the same core problem, aligning blood component production with inventory demand.
Fletcher-Haynes expressly identifies the goal of selecting collection procedures based on inventory levels but leaves the mechanism for detecting …low supply…Fletcher-Haynes, col. 61, ll. 25-40, unspecified. A skilled artisan seeking to implement Fletcher-Haynes's inventory-driven procedure selection would search the field for known techniques to quantify and automate low-inventory detection and would find Fenwal's threshold-based monitoring, where a …specified amount… Fenwal, par. 0017 triggers automated action when current supplies fall below that amount.
The combination of Fletcher-Haynes + Fenwal makes obvious the full limitation selecting the blood separator process based on an indication that a number of blood components is less than a predetermined number of blood components, wherein the selected blood separator process comprises a blood components process, wherein the at least one blood component which is collected in the blood component container, because Fletcher-Haynes seeks to select collection procedures that address low inventory of specific blood component types, and Fenwal teaches the technique of comparing current blood component supply counts against a facility-defined specified amount to detect when supplies are low. the skilled artisan above would implement Fenwal's threshold-based detection within Fletcher-Haynes's procedure selection workflow as a routine configuration to make the inventory-driven selection operate on objective, quantified criteria rather than subjective assessments of supply levels. The predictable result is that the system automatically identifies when blood component inventory falls below the preset target and selects a separation procedure that produces the needed blood component type for collection in containers, exactly the inventory control function Fletcher-Haynes describes but now triggered by a specific numerical comparison.
The skilled artisan above would be motivated to incorporate Fenwal's predetermined threshold comparison into Fletcher-Haynes's inventory-driven procedure selection because Fletcher-Haynes identifies the problem of aligning blood component production with fluctuating demand but does not specify how to objectively determine when supply is "low." Without a defined numerical target, the determination of low supply remains subjective and operator-dependent, which undermines the automation and optimization goals Fletcher-Haynes expressly pursues. Fenwal solves this exact problem by providing a specified amount that can be a default amount determined by the system or specified by the health care facility, making the low-inventory detection objective, consistent, and automatable. The result is predictable: when the current count of a blood component falls below the facility-configured threshold, the system generates an indication of need and the procedure selection responds by choosing a separation process that produces the needed component the same outcome both references independently describe, now combined into a single workflow with quantified trigger criteria. (See at least, Fletcher-Haynes: use optimization as an inventory control... specific collection procedures could be selected to accommodate for a low supply of a given blood component type and/or a high demand for such blood component type Col. 61, lines 30–42; Fenwal: health care facilities can set up the system such that orders for particular blood components are placed automatically by the system when current supplies fall below a specified amount Para 0017, and a notifications field 724 may be provided which may display an indication of blood component needs... providing an indication of the level of need Para 0043).
Fletcher-Haynes in combination with Fenwal teaches, Claim 20.
The method of Claim 19, further receiving an inventory goal from a client computer, the processing circuit selecting the blood separator process based further on the inventory goal. (Fletcher-Haynes, …apheresis procedure selection process…, Col. 29, 6-10; collected into…bag, col. 48, ll. 25-36, according to a … collection procedure…desired yield of the predetermined blood component(s)… value or magnitude … process parameters used… procedure… performed… with the input process parameters… to collect the desired yield, Col. 7, ll. 30-57; figure 9A “platelet product”; basing door selection and/or collection procedures….demand and/or existing inventory, Col. 3. 10-16; a prioritization of which products are preferred to be collected. This allows the blood center to begin to incorporate the concept of demand drive where donors are used to fill existing and/or imminent product needs. This also reduces waste from the over collection of certain products, col. 4, ll. 33-47)
Fletcher-Haynes in combination with Fenwal teaches,, Claim 21.
The method of Claim 20, wherein the inventory goal comprises a predetermined number or amount of blood component product of an ABO Rh blood type. (Fletcher-Haynes, process parameters are derived from an input/configured, abstract; figure 9A; The system also presents the capability to tailor a blood center's priorities… col. 4, ll. 38-50)
The prior art describes a system where facility staff use a Central Station computer to input a target collection amount, described as a "configured predetermined blood component yield." Under standard computing terms, this Central Station acts as the claimed client computer when it receives this target yield, which serves as the facility's inventory goal, and transmits it to the system's processing network. The processing circuit then directly uses this inputted goal to "generate [an] initial procedure order" and select the correct physical blood separation process to ensure the targeted inventory amount is collected.
Note: Claims 3 and 5 and 8 are rejected with claims above same analysis for being very similar.
Conclusion
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684