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 06/05/2026 is in accordance with the provisions of 37 CFR 1.97 and are considered by the Examiner.
Respond to Applicant Arguments
The Examiner has fully considered Applicant’s arguments presented with respect to the claim objections for claims 1 and 17 in the Remarks filed on 06/05/2026 at page 7 and responds as follows:
Applicant argues that claims 1 and 17 overcome the antecedent-basis objections because the claims were amended. Applicant’s position is persuasive; the claim objections are withdrawn.
The Examiner has fully considered Applicant’s arguments presented with respect to the rejection of claims 16-21 under 35 U.S.C. § 112(b) in the Remarks filed on 06/05/2026 at page 7 and responds as follows:
Applicant argues that claims 16-21 overcome the § 112(b) rejection because claim 19 was amended. The Examiner respectfully agrees. That clause supplies a predicate and clear antecedent basis, so the metes and bounds are no longer the § 112(b) rejection is withdrawn.
The Examiner has fully considered Applicant’s arguments presented with respect to subject matter eligibility under 35 U.S.C. § 101 in the Remarks filed on 06/05/2026 at pages 7-12 and responds as follows:
Applicant argues that claims 1 and 14 overcome § 101 because the selected separator program is integrated into actual blood separation.
The Examiner answers by respectfully agreeing. Claim 1 recites separators "separating a type of blood component ... from the whole blood" and collecting it; claim 14 recites a separator that "separates the whole blood ... " the manufactured component. Under MPEP 2106.05(c), those limitations transform whole blood using particular separator machines. Applicant’s argument is persuasive; the § 101 rejection is withdrawn as to claims 1 and 14.
Applicant argues that claim 16 and claims 19-21 likewise overcome § 101 because claim 16 recites using the retrieved process to separate blood.
Examiner respectfully disagrees. Claim 16 adds only generic "memory circuit" and "processing circuit" operations of storing, selecting, receiving, and retrieving, followed by "using the blood separator process ... to separate" without reciting a particular separator, new separation mechanism, or technical interaction. Under MPEP 2106.05(f), this is an instruction to apply the abstract selection with generic additional elements. Applicant’s argument is not persuasive; the § 101 rejection is maintained for claims 16 and 19-21.
The Examiner has fully considered Applicant’s arguments presented with respect to the prior art rejections under 35 U.S.C. §§ 102 and 103 in the Remarks filed on 06/05/2026 at pages 13-16 and responds as follows:
Applicant argues that claim 1, “receive a batch of donation identifiers” and “identify, for each donation identifier in the batch, a whole blood separation program” is not taught because Fletcher-Haynes allegedly operates only on a “donor-by-donor basis” and requires each procedure to be manually selected.
Examiner respectfully disagrees because, under BRI, claim 1 requires processing a plurality of donation identifiers and identifying associated programs; it does not require fully automatic assignment without operator involvement. Fletcher-Haynes teaches multi-donor records through a “reference donor list, and/or ranges of donors” (Fletcher-Haynes, col. 5, ll. 1-37), generates “procedure lists” (col. 29, ll. 25-35), stores/searches by “donor ID or unit number” (col. 37, ll. 1-25), and transfers an “initial procedure order” (col. 53, ll. 8-17). Applicant’s donor-by-donor characterization is therefore not persuasive, and the rejection is maintained.
Applicant argues that the batch feature streamlines clinician work because the clinician need not manually assign a program to each whole blood unit in a batch.
Examiner respectfully disagrees because the relied-upon “clinician need not manually assign” statement is not a separate limitation of claim 1. Under BRI, claim 1 requires receiving batch identifiers and identifying programs for the identifiers; it does not require excluding operator review, operator selection, or manual involvement. Fletcher-Haynes teaches manipulating donor statistics against “a large plurality of procedure types” and comparing them with blood center prioritizations to obtain “procedure lists” (Fletcher-Haynes, col. 29, ll. 25-35). Thus, Applicant’s manual-assignment argument does not distinguish the claimed batch-identification limitations, and the rejection is maintained.
Applicant argues that claim 10, “display screen showing each of a plurality of donation identifiers and associated different whole blood separation programs” is not taught because Fletcher-Haynes Fig. 5A merely monitors procedure/machine status after manual assignment.
Examiner respectfully disagrees because Fig. 5A is not limited to machine status; it shows a displayed table that associates multiple identified donors with respective procedures and status information. Fletcher-Haynes explains that, in the “Monitor Procedure task window 501,” procedures are displayed in table format and the displayed information includes “machine ID,” “collection stage and status,” “donor name,” “procedure name,” and “time remaining” (Fletcher-Haynes, col. 35, ll. 1-15; Fig. 5A). Thus, the attached figure shows plural donor entries, each linked on the same screen to a corresponding procedure name, e.g., donor “Eugene Anders” associated with “Large Platelet/Large Plasma/RBC,” and donor “Kathleen Falde” associated with “Small Platelet/Med Plasma” (Fig. 5A). Fletcher-Haynes further teaches that system 140 manipulates donor statistics against “a large plurality of procedure types” to obtain “procedure lists” (col. 29, ll. 25-35), so the displayed procedure names are not merely labels typed after the fact, but procedures generated/selected in the system workflow. Under BRI, claim 10 does not require the display to omit status information or to be limited to a pre-assignment screen; it requires a screen showing plural donation identifiers associated with different identified programs. Applicant’s Fig. 5A argument is therefore not persuasive, and the rejection is maintained..
Applicant argues that claims 2, 4, 6-7, and 9-13 are allowable because they depend from claim 1.
Examiner respectfully disagrees because the argument against claim 1 is not persuasive, and Applicant does not separately identify a missing added limitation for these dependent claims. The current rejection maps the added limitations to Fletcher-Haynes’ refer to 35 USC 102 rejection below. The dependent-claim argument is therefore not persuasive, and the rejection is maintained.
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.
Claim 16 and claims 19-21 should remain rejected under § 101 because claim 16 recites data-driven process selection, but not a positive separator operation or specific separation mechanism.
Step 1.
Claim 16 recites a statutory process because it claims “A method of separating whole blood into blood components.” Claims 19-21 depend from that method and remain within the process category.
Step 1 is satisfied, so the analysis turns on whether the claim integrates the abstract selection into a practical application.
Prong One:
Independent Claims Analysis:
Claim 16:A method of separating whole blood into blood components, comprising:
storing a batch of donation identifiers for whole blood units and whole blood characteristic data for each donation identifier in a memory circuit;
storing at least one of inventory data and a prioritization list in athe memory circuit;
selecting a blood separator process for each of a plurality of the donation identifiers with a processing circuit based on the whole blood characteristic data and the at least one of inventory data and the prioritization list;
storing a blood separator process identifier for the selected blood separator in the memory circuit in association with each donation identifier;
later, receiving one of the donation identifiers at the processing circuit;
retrieving the blood separator process identifier from the memory circuit based on the received one of the donation identifiers;
and using the blood separator process identified by the retrieved blood separator process identifier to separate at least one blood component from whole blood in a first container for collection in a second container or multiple containers.
The non-bold language means receiving blood/inventory data, selecting a process identifier for each donation, associating the identifier with the donation, and retrieving it later.
Claim 16 recites mental processes and certain methods of organizing human activity (MOHOA), because limitations 1-6, under BRI, collect, store, associate, select, and retrieve donation, inventory, priority, and process-assignment information. The MOHOA sub-category is commercial or legal interactions, specifically business relations / inventory and supply-chain production management, because the specification frames the invention as helping workers select manufacturing programs, streamline manufacturing workflow, prioritize blood-product manufacturing, improve inventories, and improve blood-component supply chains. Refer to Spec. 0013-0017
For example a blood-bank worker can review a batch list, blood type data, inventory shortage data, and priority list, then write the selected process beside each donation ID. That mirrors the non-bold selection logic.
Dependent Claims Analysis:
Claim 19 adds threshold-based inventory selection, which is still an abstract inventory judgment because it selects based on whether “a number of blood components is less than a predetermined number.” Claims 20-21 add an inventory goal and ABO Rh target, which organize blood-bank manufacturing priorities.
Prong One is satisfied for claims 16 and 19-21, examination continue with prong two below.
Prong Two:
Independent Claims Analysis:
The additional elements do not integrate the abstract selection because claim 16 does not positively claim a separator as the actor or a concrete separation process.
Additional elements: “memory circuit,” “processing circuit,” “first container,” “second container or multiple containers,” and the result-level phrase “using the identified blood separator process to separate.”
Individual Additional Elements Evaluation:
Claim 16 remains directed to the abstract selection, not to a particular technical blood-separation implementation. The memory and processing circuit only store, select, associate, receive, and retrieve data. The final using the blood separator process identified by the retrieved blood separator process identifier to separate phrase is only an apply-it endpoint because Claim 16 does not recite programming a separator, transmitting the process to a separator, operating a particular separator, or any specific separation mechanism. The specification treats those technical acts as separate optional steps: block 108 concerns programming, and block 110 concerns operating the selected program.
Claim 16 does not integrate an exception merely by adding a tool-use step after an abstract assignment, as illustrated by the hair-design example where assigning a hair design and then using scissors to cut hair remains an abstract idea with an apply-it step (see MPEP 2106.05(f)). Here, selecting a separator process and then stating its use to separate blood is the same kind of result-level application. As a whole, Claim 16 lacks a meaningful machine, transformation, or technical-improvement limitation.
Dependent Claims Analysis:
Claim 19 threshold and collection language does not overcome Prong Two because it only narrows the abstract inventory trigger and states the collection result. Claims 20-21 add a client inventory goal and ABO Rh target; these are input/priority data, not practical application.
Claims 16 and 19-21 do not integrate the exception into a practical application. The analysis proceeds to Step 2B.
Step 2B:
Independent Claims Analysis:
The same additional elements do not provide an inventive concept because the claim uses generic computing to implement the abstract assignment and states a result.
Additional elements: “memory circuit,” “processing circuit,” “first container,” “second container or multiple containers,” and “using the identified blood separator process to separate.”
Individual Additional Elements Evaluation:
At Step 2B, claim 16 does not add an inventive concept. The additional “memory circuit” and “processing circuit” perform only storage, selection, receipt, and retrieval: “storing,” “selecting,” “receiving,” and “retrieving” a process identifier. The record supports generic implementation because the specification describes the processing circuit as “server computer,” “cloud computing,” and “database” resources (Spec. [0021]), and later admits processors may be a “general-purpose processor,” with memory storing “software code” and computers executing an “operating system” (Spec. [0058], [0060]). Those generic computer functions do not supply significantly more.
The claim therefore remains abstract selection implemented with generic computer components, not an unconventional processor-memory arrangement, new separator interaction, or improved separation technology.
Dependent Claims Analysis:
Claim 19 threshold selection does not overcome Step 2B because inventory comparison is part of the abstract selection itself. Claims 20-21’s client inventory goal and ABO Rh target do not add an inventive concept because they only provide business/manufacturing priority data for the same selection.
Claims 16 and 19-21 are rejected for being directed to a judicial exception and does not integrate or have inventive concept as explain above.
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 9-16 and 18 are rejected under 35 U.S.C. 102(a)(l) as being anticipated by Fletcher-Haynes - US7072769B2.
Claim 14.
Fletcher-Haynes teaches,
A system for manufacturing a blood component from whole blood, comprising (Fletcher-Haynes, Col. 2, ll. 55-67, a blood component collection system and the provision of management capabilities which may include the incorporation of data manipulation and/or optimization principles.):
a processing circuit configured to store whole blood characteristic data comprising donation
identifiers for a batch of whole blood units in a memory, (Fletcher-Haynes, col. 4, ll. 65-67 … log of each donation…; col. 3, ll. 55-67 donor data storage and control as well as communications with actual blood component collection machines; col. 5 ll. 1-37… configuration information of both temporary and permanent natures, procedural lists and priority information, donor vital information including height, weight, gender, blood component pre-counts and total blood volume (TBV), as well as donor identification… individual donors, a reference donor list, and/or ranges of donors within the database…; col. 6, ll.19-30 The central database provides the system with the capability of storing and maintaining data relevant to the entire blood component collection process such as, donor demographic information, machine configuration information, run information and lab result information; Col. 37, ll. 1-20… ID or unit number…)
Fletcher’s donor lists, ranges, procedure records, central database, donor IDs, and unit numbers as describing multiple whole-blood-source records stored in memory.
the processing circuit further configured to store at least one of inventory data and priority data, ( Fletcher-Haynes, centralized computing/data storage assembly, Col. 9, II. 52-67, may include input/entry devices ... data manipulation device ... Col. 10, II. 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, II. 10-20, capability ... providing a prioritization, Col. 4, II. 38-47, Col. 5, ll. 1-25)
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 for each donation identifier in the batch; (Fletcher-Haynes, initial procedure order… donor-related data, Col. 11, ll. 25-36; 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; Col. 61, ll. 20-40 various types of blood components…; )
and to store the donation identifiers in association with each selected blood separator process in the memory,(Fletcher-Haynes, Col. 36, ll. 45-61 procedure records based on donor ID; Col. 53, ll. 8-16, associated with the selected collection procedure; abstract, collection procedure is performed with these derived process control parameters.; Col.2, ll. 15-19 Multitude of collection choices, a multitude of donors with differing physiologies, each being Subject to potential variations in collection procedures; Col.11, ll.25-45 the process control parameters 30 derived from the donor-related data and other considerations; Col. 3, ll. 1-19 in terms of the type of blood component to be collected.)
wherein the processing circuit is configured to then receive one of the donation identifiers, identify one of the blood separator processes, and transmit the one of the blood separator processes;(Fletcher-Haynes, Col. 37, ll. 1-25 entry of the donor ID or unit number; Col. 53, ll. 15-36 procedure order may be transferred; Col. 9, ll. 30-46 one or more blood component collection; Claim 1 plurality of extracorporeal blood processing machines; )
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, wherein the automated or manual blood component separator separates the whole blood based on the identified one of the selected blood separator processes in memory. (Fletcher-Haynes, Col. 45, ll. 35-57 blood component collection device; Col. 61, 55-67 provided to the blood component collection device from an appropriate blood contain)
Fletcher-Haynes describes the limitation because its blood component collection device receives whole blood, including from “an appropriate blood container,” and separates it under a selected procedure order. The device “separates the whole blood” into components, with platelets directed to “one or more platelet collect bags” and plasma to a “plasma collect bag,” i.e., second/multiple containers. The selected process is used because the “initial procedure order” specifies parameters “associated with the selected collection procedure” and is “transferred/downloaded” to the device’s “internal control,” so separation occurs based on the identified process in memory.
Claim 15.
Fletcher-Haynes teaches,
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.
Note: Claims 1-2 and 16 are rejected with the same analysis above claims 14-15.
Claim 4.
Fletcher-Haynes teaches,
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,
and storage temperature. (Fletcher-Haynes, ... required by the blood separation/collection assembly ... blood type ... platelets and/or hematocrit ... , Col. 20, II. 1-30; Blood Type ... O+, 0-, A+, A-, B+, B-, AB+, AB ... Col. 21, II. 10-30)
Claim 6.
Fletcher-Haynes teaches,
The system of Claim 1, wherein each 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 an identity of the whole blood
separation program. (Fletcher -Haynes, communicate in the reverse direction with each machine, Col. 5, II. 17-27; two-way communications, Col. 5, II. 4-16, initial procedure order ... transferred/downloaded onto the internal control of a blood component collection device 18, Col. 53, II. 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.
Claim 7.
Fletcher-Haynes teaches,
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, II. 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, II. 11-16; Figure 6M; storing and maintaining data relevant to the entire blood component ... Col. 6, II. 15-25, but for which not all required finalization data may have been entered in the procedure record, Col. 34, LI. 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, 11.15-67; Unit Number is preferably a required field entry, Col. 27, II. 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, II. 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).
Claim 9.
Fletcher-Haynes teaches,
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, II. 35-42; Donor ID 559444, Figure 2D; Blood Type, Figure 2D; Blood Type ... O+, 0-, A+, A-, B+, B-, AB+, AB-, Col. 27, II. 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, II. 63-67 to Col. 7, I. 10)
Claim 10
Fletcher-Haynes teaches,
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 whole blood separation programs identified by the processing circuit. ( Fletcher-Haynes, See at least, the operator is presented with Target Procedure page 351..., Col. 28, II. 59-67; numerous procedures are shown to Col. 29, II. 29-45; screen SOL.Machine ID ... Donor Name ... Procedure Name, Col. 35, II. 8-15; Figure 5A showing multiple donors with their assigned procedures; Monitor Procedure task ... col. 34, II. 35-44, Figure 6M, fig. 3A)
Claim 11.
Fletcher-Haynes teaches,
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 each whole blood
separation program based further on blood product type priority. (Fletcher-Haynes, See at least, one or more data input/output/manipulation stations 149C, Col. 13, II. 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, II. 38-50; the present system presents the capability of providing a prioritization of which products are preferred to be collected, Col. 4, II. 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, II. 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, II. 38-45; the operator may select a product focus list from this drop-down list, Col. 31, II. 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.
Claim 12.
Fletcher-Haynes teaches,
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, II. 1-10; as inventory is withdrawn or replenished within the hospital or blood bank, this information can be recorded, Col. 44, II. 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, II. 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.
Claim 13.
Fletcher-Haynes teaches,
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, II. 40-44; reports are preferably generatable about donors, procedures and collected blood products, Col. 43, II. 38-47; compare blood bank/center component inventories with projected needs, Col. 8, II. 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, 8, and 19-21 and 23 are 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 Bl).
Claim 19.
Fletcher-Haynes teaches,
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 retrieved blood separator process comprises a blood components process, wherein the at least one blood component is collected in the second container. (Fletcher-Haynes, ... apheresis procedure selection process ... , Col. 29, 6-10; collected into ... bag, col. 48, II.
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, II. 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, II. 31-53; basing donor selection and/or
collection procedure selection on blood component demand, col. 3, II. 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, II. 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).
Claim 20.
Fletcher-Haynes in combination with Fenwal teaches,
The method of Claim 19, further comprising 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, II. 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, II. 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, II. 33-47)
Claim 21.
Fletcher-Haynes teaches,
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, II. 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.
Claim 23.
Fletcher-Haynes teaches,
The system of Claim 1, wherein the whole blood separation program identified for one of the donation identifiers is based at least in part on a whole blood separation program identified for another of the donation identifiers.
Fletcher-Haynes analyzes many donors relative to many possible procedures, uses a reference donor list and ranges of donors, and compares donor statistics with blood center prioritizations to make procedure lists.
Fletcher lacks inter-donor program dependency, but Fenwal teaches the missing set-level dependency. Fenwal accesses a scheduling log containing scheduled blood component collections, then compares the scheduled blood component collections to the needed blood components to identify a donor whose scheduled collection is not for a needed component. Fenwal, paras. [0065]-[0067]. Fenwal further teaches recommending a change from Whole Blood to double RBC when RBC need is greatest. Fenwal, para. [0063].
A POSITA would have modified Fletcher-Haynes’s inventory-driven procedure-selection system with Fenwal’s set-level scheduling comparison because both references solve the same blood collection management problem: selecting collection procedures to satisfy current or anticipated inventory need. The modification uses Fenwal’s known comparison of already-scheduled collections against needed components as the batch-state input in Fletcher-Haynes’s known optimization engine. Doing so predictably causes the program selected for one donation identifier to account for programs already selected for other donation identifiers, thereby avoiding over-collection of one component and filling the remaining inventory need across the batch.
Note: Claims 3, 5, 8, are rejected with the same analysis of the claim above for being very similar.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Fletcher-Haynes, US 7,072,769 B2, and further in view of Kok-Hwee Ng (US20030078805A1).
Claim 22.
Fletcher-Haynes teaches,
The system of Claim 1, wherein the whole blood separation programs are transmitted to each of the plurality of blood component separators in response to request messages from the plurality of blood component separators received after whole blood separation programs are identified for each donation identifier in the batch.
Fletcher-Haynes teaches the base transmission with donor and procedure data is downloaded from central system 140 to an apheresis machine 10 (Col.35, ll. 1-30) and initial procedure order may be transferred/downloaded to device control (Col.53, ll. 10-55), but not expressly describe request messages from the plurality of separators received after programs are identified for each donation identifier.
Kok-Hwee Ng teaching request from the apheresis instrument, request button ... system server, and load a system configuration file. Refer NG par. 0381, 0383, 0385
A POSITA would add Kok-Hwee Ng separator-initiated server request to Fletcher’s stored procedure download so each ready separator pulls its assigned program, and NG teaches a ready apheresis instrument requesting server-held procedure information. The predictable result is each ready separator pulling its assigned program after identification. Refer NG par. 0381, 0383, 0385
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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