DETAILED ACTION
Priority
Acknowledgment is made of applicant’s claim for priority. The current application claims benefit of provisional application 63/591,694, filed on 10/19/2023. Examiner acknowledges the applicant’s claim for priority.
Examiners Notes
Examiners interpretation of the user device is based on the specification “the user device 610 includes one or more of a smart device, a computer, and a server”
Examiners interpretation of the processing device is based on the specification “the processing device 604 may be an electronic device which may be configured to execute a set of instruction”
Examiners interpretation of the data source device is based on the specification “the data source device 608 includes a smart device, a computer, and a server”
Examiners interpretation of the communication device is based on the specification “the communication device 602 may be an electronic device which may be configured to one or more of transmit and receive a data.”
Examiners interpretation of the storage device is based on the specification “the storage device 606 includes a non-volatile memory”
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 21, 2024 is being considered by the examiner.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1
The claims recite subject matter within a statutory category as a process, machine, and/or article of manufacture. However, it will be shown in the following steps, that claims 1-20 are nonetheless unpatentable under 35 U.S.C. 101.
Step 2A Prong One
Claim 1 states:
A method of facilitating management of a donor process, the method comprising:
receiving, using a communication device, a donor information associated with a donor from a data source device;
retrieving, using a storage device, an eligibility data;
analyzing, using a processing device, the donor information and the eligibility data;
determining, using the processing device, a donor eligibility data associated with the donor based on the analyzing, wherein the donor eligibility data corresponds to a biological donation performable by a donor; and
transmitting, using the communication device, the donor eligibility data to a user device.
The broadest reasonable interpretation of these steps includes organizing human activity because each bolded component can practically be performed by the human mind or with pen and paper. Other than generic terms like “user device”, “data source device”, “processing device”, or “storage device”, nothing in the claims precludes the bold-font portions from practically being performed in the mind. For example, “transmitting, using the communication device, the donor eligibility data” in the context of this claim encompasses a user sharing eligibility information to providers while screening blood donors. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
A method of facilitating management of a donor process, the method comprising:
receiving, using a communication device, a donor information associated with a donor
retrieving … an eligibility data;
analyzing … the donor information and the eligibility data;
determining… a donor eligibility data associated with the donor based on the analyzing, wherein the donor eligibility data corresponds to a biological donation performable by a donor; and
transmitting, using the communication device, the donor eligibility data
as drafted, could lay out the entire intake process of a blood donor for a mobile clinic, using paper files and word of mouth correspondence to communicate eligibility and donor information. Therefore, under the broadest reasonable interpretation, these steps include managing personal behavior as an abstract idea.
Independent claim 11 covers similar steps of receiving donor information, retrieving eligibility data, analyzing donor information, determining, donor eligibility data, and transmitting, eligibility data. These claims fall under the same category of an abstract idea and follows the same rationale as claim 1.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim 6, reciting particular aspects of how “the eligibility data is stored in a hierarchical data structure comprising a plurality of eligibility data, wherein each of the plurality of eligibility data comprises an index data configured to allow accessing a corresponding eligibility data within the hierarchical data structure” may be performed in the mind but for recitation of generic computer components).
Dependent claims 2, 3, 5, 7, 9, 10, 12, 13, 15, 17, 19, and 20 add additional elements to their parent claims which will be further inspected in the following steps for a practical application to their abstract idea.
Step 2A Prong Two
This judicial exception of “Mental Processes” or “Organizing Human Activity” is not integrated into a practical application. Independent claim 1’s method recites additional elements such as a data source device, processing device, storage device, and user device. Independent claim 11’s system recites the same structure. The data source device, processing device, storage device, and user device will be treated as generic computer components. In particular, these additional elements do not integrate the abstract idea into a practical application because the additional elements:
amount to mere instructions to apply an exception (such as recitation of “from a data source device”, “using a processing device”, “using a storage device”, and “to a user device” amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification “the user device 610 includes one or more of a smart device, a computer, and a server”, “the processing device 604 may be an electronic device which may be configured to execute a set of instruction”, “the data source device 608 includes a smart device, a computer, and a server”, “the communication device 602 may be an electronic device which may be configured to one or more of transmit and receive a data.”, and “the storage device 606 includes a non-volatile memory”, see MPEP 2106.05(f))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For instance, dependent claims 3 and 13 add additional elements of a medical instrumentation device to their parent claims. Additionally, claim 2 “wherein the data source device comprises an electronic health records database, wherein the method further comprises transmitting, using the communication device, a user identifier corresponding to the donor to the electronic health records database” and claim 12 “wherein the data source device comprises an electronic health records database, wherein the communication device is further configured to transmit a user identifier corresponding to the donor to the electronic health records database” and claim 7 “generating, using the processing device, a query data based on the donor information; and identifying, using the processing device, the index data corresponding to the query data, wherein the retrieving of the eligibility data is based on identifying.” and claim 17 “generate a query data based on the donor information; and identify the index data corresponding to the query data, wherein the retrieving of the eligibility data is based on identifying” add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering, claim 5 “transmitting, using the communication device, a user interface data to the user device comprising a user processing device, a user communication device, and a user presentation device, wherein the user presentation device is configured to present a user interface based on the user interface data, wherein the user interface is configured to receive the donor information, wherein the user communication device is configured to transmit the donor information to the communication device” and claim 15 “the communication device is further configured to transmit a user interface data to the user device comprising a user processing device, a user communication device, and a user presentation device, wherein the user presentation device is configured to present a user interface based on the user interface data, wherein the user interface is configured to receive the donor information, wherein the user communication device is configured to transmit the donor information to the communication device” and claim 9 “transmitting, using the communication device, a user interface to the user device, wherein the user interface is configured to present the plurality of donor information and the plurality of deferral periods.” and claim 19 “the communication device is further configured to transmit a user interface to the user device, wherein the user interface is configured to present the plurality of donor information and the plurality of deferral periods” amounts to necessary data outputting, see MPEP 2106.05(g), recitation of claim 10 “receiving, using the communication device, a biological sample data corresponding to the biological product of the donor, wherein the biological sample data represents a medical diagnosis of the biological product; analyzing, using the processing device, the biological sample data, wherein the determining of the donor eligibility data is further based on the analyzing of the biological sample data” and claim 20 “the communication device is further configured to receive a biological sample data corresponding to the biological product of the donor, wherein the biological sample data represents a medical diagnosis of the biological product, wherein the processing device is further configured to analyze the biological sample data, wherein the determining of the donor eligibility data is further based on the analyzing of the biological sample data” amounts to insignificant application, and claim 3 “wherein the data source device comprises a medical instrumentation device configured to generate a medical data corresponding to the donor, wherein the medical data represents a physiological condition of the donor, wherein the medical instrumentation device is further configured for transmitting the medical data, wherein the donor information comprises the medical data.” and claim 13 “wherein the data source device comprises a medical instrumentation device configured to generate a medical data corresponding to the donor, wherein the medical data represents a physiological condition of the donor, wherein the medical instrumentation device is further configured for transmitting the medical data, wherein the donor information comprises the medical data”, generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The remaining dependent claims 4, 6, 8, 14, 16, and 18 do not recite additional elements or activity but further narrow or define the abstract idea embodied in the claims and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than a recitation of mere instructions to apply an exception using generic computer components.
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. These additional limitations amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As previously noted, the claim recites an additional element of medical instrumentation device. Clement (Pat. 5167636) demonstrates “Contemplated medical devices can include secondary cannulas for injection or extraction of fluids, needles, graspers, tweezers, cutters, knives, baskets, or other conventional medical instrumentation.” that medical instrumentation devices were conventional long before the priority data of the claimed invention. As such, this additional element, individually and in combination with the prior additional element, does not amount to significantly more.
To elaborate:
claim 2 “wherein the data source device comprises an electronic health records database, wherein the method further comprises transmitting, using the communication device, a user identifier corresponding to the donor to the electronic health records database” , is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
claim 12 “wherein the data source device comprises an electronic health records database, wherein the communication device is further configured to transmit a user identifier corresponding to the donor to the electronic health records database” , is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
claim 7 “generating, using the processing device, a query data based on the donor information; and identifying, using the processing device, the index data corresponding to the query data, wherein the retrieving of the eligibility data is based on identifying.” and claim 17 “generate a query data based on the donor information; and identify the index data corresponding to the query data, wherein the retrieving of the eligibility data is based on identifying” add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering,
claim 5 “transmitting, using the communication device, a user interface data to the user device comprising a user processing device, a user communication device, and a user presentation device, wherein the user presentation device is configured to present a user interface based on the user interface data, wherein the user interface is configured to receive the donor information, wherein the user communication device is configured to transmit the donor information to the communication device” , is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
claim 15 “the communication device is further configured to transmit a user interface data to the user device comprising a user processing device, a user communication device, and a user presentation device, wherein the user presentation device is configured to present a user interface based on the user interface data, wherein the user interface is configured to receive the donor information, wherein the user communication device is configured to transmit the donor information to the communication device” , is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
claim 9 “transmitting, using the communication device, a user interface to the user device, wherein the user interface is configured to present the plurality of donor information and the plurality of deferral periods.” , is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
claim 19 “the communication device is further configured to transmit a user interface to the user device, wherein the user interface is configured to present the plurality of donor information and the plurality of deferral periods” , is equivalently, receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i);
claim 10 “receiving, using the communication device, a biological sample data corresponding to the biological product of the donor, wherein the biological sample data represents a medical diagnosis of the biological product; analyzing, using the processing device, the biological sample data, wherein the determining of the donor eligibility data is further based on the analyzing of the biological sample data” , is equivalently, performing clinical tests on individuals to obtain input for an equation, In re Grams, MPEP 2106.05(g)(3)(i)
claim 20 “the communication device is further configured to receive a biological sample data corresponding to the biological product of the donor, wherein the biological sample data represents a medical diagnosis of the biological product, wherein the processing device is further configured to analyze the biological sample data, wherein the determining of the donor eligibility data is further based on the analyzing of the biological sample data” , is equivalently, performing clinical tests on individuals to obtain input for an equation, In re Grams, MPEP 2106.05(g)(3)(i)
claim 3 “wherein the data source device comprises a medical instrumentation device configured to generate a medical data corresponding to the donor, wherein the medical data represents a physiological condition of the donor, wherein the medical instrumentation device is further configured for transmitting the medical data, wherein the donor information comprises the medical data.” , is equivalently, performing clinical tests on individuals to obtain input for an equation, In re Grams, MPEP 2106.05(g)(3)(i)
claim 13 “wherein the data source device comprises a medical instrumentation device configured to generate a medical data corresponding to the donor, wherein the medical data represents a physiological condition of the donor, wherein the medical instrumentation device is further configured for transmitting the medical data, wherein the donor information comprises the medical data” , is equivalently, performing clinical tests on individuals to obtain input for an equation, In re Grams, MPEP 2106.05(g)(3)(i)
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, 8, 11, 12, 14, 15, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Case et al. (US20230282346).
Regarding claim 1, Case teaches.
A method of facilitating management of a donor process, the method comprising: ([0166] “provide flow diagrams for methods for donors, operators, and administrators to review and manage blood collection and associated instrument information.”)
receiving, using a communication device, a donor information associated with a donor from a data source device; ([0039] “based on tracking of a donor's location, a nearby donation facility can compare a current inventory (and associated need) with the tracked donor information (e.g., blood type, eligibility, etc.)”)
retrieving, using a storage device, an eligibility data; ([0196] “Data storage can include any variety of internal and/or external memory, disk, remote storage communicating with the system 2600”; see also [0037] “The application can notify a donor when he/she is able/available (e.g., based on donation guideline eligibility”)
analyzing, using a processing device, the donor information and the eligibility data; ([0131] “In some examples, an application enables donor screening for automated component collections by, for example, providing a brief donor questionnaire to determine if a donor qualifies for apheresis donations based on donor sex, height, weight, blood type, CMV +/−,etc., and identify any special needs for donor's blood type or specific components”)
determining, using the processing device, a donor eligibility data associated with the donor based on the analyzing, wherein the donor eligibility data corresponds to a biological donation performable by a donor; ([0045] “The application 101 includes a menu 110 indicating, for example, a remaining time and date for next donation eligibility.”; see also [0054] “A history view 320 provides an indication of last donation 321, next donation eligibility 322, etc., along with a complete donation history 323”)
and transmitting, using the communication device, the donor eligibility data to a user device. ([0037] “For a donor, an example application can track donation history. The application can notify a donor when he/she is able/available (e.g., based on donation guideline eligibility and/or schedule availability) to donate.”)
Regarding claim 2, Case teaches all of the limitations of claim 1. Case also teaches:
wherein the data source device comprises an electronic health records database, wherein the method further comprises transmitting, using the communication device, a user identifier corresponding to the donor to the electronic health records database. ([0120] “In some examples, using a phone (e.g., an iPhone™, or some other mobile device), the operator can record a DIN (donor identification number) and collection time. In some examples, using a phone or some other mobile device, the operator can record additional optional information such as gender, blood (ABO) type if known, weight of the unit, etc.”)
Regarding claim 4, Case teaches all of the limitations of claim 1. Case also teaches:
wherein the donor eligibility data comprises a deferring data corresponding to a deferral of the biological donation, wherein the deferring data indicates an ineligibility time period associated with the donor, wherein the donor is not eligible to donate a biological product at least till expiration of the ineligibility time period from a time of an initiation of the donor process. ([0055] “Selection of the donation history option 113 allows the user to see his or her last donation along with real time or substantially real time given some system access, processing, and/or transmission delay) information regarding a remaining deferral period.”)
Regarding claim 5, Case teaches all of the limitations of claim 1. Case also teaches:
transmitting, using the communication device, a user interface data to the user device comprising a user processing device, a user communication device, and a user presentation device, wherein the user presentation device is configured to present a user interface based on the user interface data, wherein the user interface is configured to receive the donor information, wherein the user communication device is configured to transmit the donor information to the communication device. ([Figure 1]; see also [0037] “FIGS. 1-5 show example interfaces for current and/or potential blood donors (e.g., with respect to Donors A-E). For a donor, an example application can track donation history. The application can notify a donor when he/she is able/available (e.g., based on donation guideline eligibility and/or schedule availability) to donate.”)
Regarding claim 8, Case teaches all of the limitations of claim 1. Case also teaches:
wherein the donor eligibility data comprises an eligible biological product indicator corresponding to an eligible biological product, wherein the eligible biological product comprises a biological product eligible to be received from the donor. ([0037] “The application can also enable tracking of different blood components (e.g., red blood cells (RBC), plasma, platelets)”)
Regarding claim 11, Case teaches:
A system for facilitating management of a donor process, the system comprising: ([0166] “provide flow diagrams for methods for donors, operators, and administrators to review and manage blood collection and associated instrument information.”)
a communication device configured to: receive a donor information associated with a donor from a data source device; ([0039] “based on tracking of a donor's location, a nearby donation facility can compare a current inventory (and associated need) with the tracked donor information (e.g., blood type, eligibility, etc.)”)
transmit a donor eligibility data to a user device; ([0037] “For a donor, an example application can track donation history. The application can notify a donor when he/she is able/available (e.g., based on donation guideline eligibility and/or schedule availability) to donate.”)
a processing device communicatively coupled with the communication device, wherein the processing device is configured to: analyze the donor information and an eligibility data; and ([0131] “In some examples, an application enables donor screening for automated component collections by, for example, providing a brief donor questionnaire to determine if a donor qualifies for apheresis donations based on donor sex, height, weight, blood type, CMV +/−,etc., and identify any special needs for donor's blood type or specific components”)
determine the donor eligibility data associated with the donor based on the analyzing, wherein the donor eligibility data corresponds to a biological donation performable by a donor; and ([0045] “The application 101 includes a menu 110 indicating, for example, a remaining time and date for next donation eligibility.”; see also [0054] “A history view 320 provides an indication of last donation 321, next donation eligibility 322, etc., along with a complete donation history 323”)
a storage device communicatively coupled with the processing device, wherein the storage device is configured to retrieve the eligibility data. ([0196] “Data storage can include any variety of internal and/or external memory, disk, remote storage communicating with the system 2600”; see also [0037] “The application can notify a donor when he/she is able/available (e.g., based on donation guideline eligibility”)
Regarding claim 12, Case teaches all of the limitations of claim 11. Case also teaches:
wherein the data source device comprises an electronic health records database, wherein the communication device is further configured to transmit a user identifier corresponding to the donor to the electronic health records database. ([0120] “In some examples, using a phone (e.g., an iPhone™, or some other mobile device), the operator can record a DIN (donor identification number) and collection time. In some examples, using a phone or some other mobile device, the operator can record additional optional information such as gender, blood (ABO) type if known, weight of the unit, etc.”)
Regarding claim 14, Case teaches all of the limitations of claim 11. Case also teaches:
wherein the donor eligibility data comprises a deferring data corresponding to a deferral of the biological donation, wherein the deferring data indicates an ineligibility time period associated with the donor, wherein the donor is not eligible to donate a biological product at least till expiration of the ineligibility time period from a time of an initiation of the donor process. ([0055] “Selection of the donation history option 113 allows the user to see his or her last donation along with real time or substantially real time given some system access, processing, and/or transmission delay) information regarding a remaining deferral period.”)
Regarding claim 15, Case teaches all of the limitations of claim 11. Case also teaches:
wherein the communication device is further configured to transmit a user interface data to the user device comprising a user processing device, a user communication device, and a user presentation device, wherein the user presentation device is configured to present a user interface based on the user interface data, wherein the user interface is configured to receive the donor information, wherein the user communication device is configured to transmit the donor information to the communication device. ([Figure 1]; see also [0037] “FIGS. 1-5 show example interfaces for current and/or potential blood donors (e.g., with respect to Donors A-E). For a donor, an example application can track donation history. The application can notify a donor when he/she is able/available (e.g., based on donation guideline eligibility and/or schedule availability) to donate.”)
Regarding claim 18, Case teaches all of the limitations of claim 11. Case also teaches:
wherein the donor eligibility data comprises an eligible biological product indicator corresponding to an eligible biological product, wherein the eligible biological product comprises a biological product eligible to be received from the donor. ([0037] “The application can also enable tracking of different blood components (e.g., red blood cells (RBC), plasma, platelets)”)
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 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Case et al. (US20230282346) in view of Cork et al. (US20130138452).
Regarding claim 3, Case teaches all of the limitations of claim 1. Case does not explicitly teach, as taught by Cork:
wherein the data source device comprises a medical instrumentation device configured to generate a medical data corresponding to the donor, wherein the medical data represents a physiological condition of the donor, wherein the medical instrumentation device is further configured for transmitting the medical data, wherein the donor information comprises the medical data. ([0035] “medical device 104 may be an apheresis machine configured to draw blood from subject 102 (i.e., subject 102 is a donor or receiver of blood components). In some implementations, medical device 104 may use measurements taken from subject 102 to control the medical procedure. The measurements may be taken directly by medical device 104 or may be received by medical device 104 via data link 112 from a measurement device. For example, medical device 104 may use the body temperature, pulse rate, blood pressure, respiratory rate, blood glucose level, pupil dilation, pulse oximetry information, ECG information, or other physical characteristic of subject 102 during the medical procedure.”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Case with the teachings of Cork, with a reasonable expectation of success, by explicitly integrating medical device monitoring instruments to associate physiological data with the blood donor process. This would reduce the risk of collecting hazardous donations. Cork is adaptable to Case as both inventions use a mobile application system to integrate donor information for improving blood donation systems. Case would have found Cork’s teaching while collaborating on the shared patent to improve efficiencies in patient treatments in the healthcare setting.
Regarding claim 13, Case teaches all of the limitations of claim 11. Case does not explicitly teach, as taught by Cork:
wherein the data source device comprises a medical instrumentation device configured to generate a medical data corresponding to the donor, wherein the medical data represents a physiological condition of the donor, wherein the medical instrumentation device is further configured for transmitting the medical data, wherein the donor information comprises the medical data. ([0035] “medical device 104 may be an apheresis machine configured to draw blood from subject 102 (i.e., subject 102 is a donor or receiver of blood components). In some implementations, medical device 104 may use measurements taken from subject 102 to control the medical procedure. The measurements may be taken directly by medical device 104 or may be received by medical device 104 via data link 112 from a measurement device. For example, medical device 104 may use the body temperature, pulse rate, blood pressure, respiratory rate, blood glucose level, pupil dilation, pulse oximetry information, ECG information, or other physical characteristic of subject 102 during the medical procedure.”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Case with the teachings of Cork, with a reasonable expectation of success, by explicitly integrating medical device monitoring instruments to associate physiological data with the blood donor process. This would reduce the risk of collecting hazardous donations. Cork is adaptable to Case as both inventions use a mobile application system to integrate donor information for improving blood donation systems. Case would have found Cork’s teaching while collaborating on the shared patent to improve efficiencies in patient treatments in the healthcare setting.
Claims 6, 7, 9, 16, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Case et al. (US20230282346) in view of Mickles et al. (Pat. 11755991).
Regarding claim 6, Case teaches all of the limitations of claim 1. Case does not explicitly teach, as taught by Mickles:
wherein the eligibility data is stored in a hierarchical data structure comprising a plurality of eligibility data, wherein each of the plurality of eligibility data comprises an index data configured to allow accessing a corresponding eligibility data within the hierarchical data structure. ([10] “accessing a user profile of the target scheduled donor to determine if the target scheduled donor is eligible to donate the needed blood component; and if the target scheduled donor is eligible, recommending a modification to the scheduled blood component collection.” (37) “The blood component supply chain management system 100 of various embodiments further includes a Donor Profile Module 170. Past donors and scheduled donors have donor profiles stored in the blood component supply chain management system.” where the donor profile module comprises a hierarchical structure of donor profiles containing accessible eligibility data)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Case with the teachings of Mickles, with a reasonable expectation of success, by explicitly organizing user information to easily retrieve eligibility information for multiple donors. Easily retrieving eligibility data would reduce the wait time in a facility as a donor confirms their eligibility to donate. Mickles is adaptable to Case as both inventions organize blood donor information using modular computer systems adaptable to any network. Case would have found Mickles’ teachings in cross product collaboration within their employer to improve blood donation supply efficiency.
Regarding claim 7, Case teaches all of the limitations of claim 6. Case does not explicitly teach, as taught by Mickles:
generating, using the processing device, a query data based on the donor information; and identifying, using the processing device, the index data corresponding to the query data, wherein the retrieving of the eligibility data is based on identifying. ([37] “The blood component supply chain management system 100 of various embodiments further includes a Donor Profile Module 170. Past donors and scheduled donors have donor profiles stored in the blood component supply chain management system. A donor profile can be created and edited via the Donor Profile Module 170. In various embodiments, the donor profile is a donor-specific data space within the memory of the blood component supply chain management system, which is accessible using a unique identifier. The donor-specific data space stores data pertaining to the donor. The donor-specific data is maintained by the blood component supply chain management system and accessible by users with proper credentials, such as a specific donor, and optionally, blood center staff. The donor profile may include: biographical data such as a donor's birth date, gender, weight, height, and blood type; and appointment history such as a log of past donations, including dates and products donated, a count of past donations, a show rate (i.e., percent of scheduled appointments the donor appeared for), etc. The donor profile may be accessible via a web-based interface or application interface, for example, to enable review of historical collections and the characteristics of scheduled donors. In some embodiments, data pertaining to each donor's past appointments (e.g., show rate, date of donation, component type and amount donated, etc.) can be aggregated for each donor or for all individuals who donated to a blood center during a particular time interval.”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Case with the teachings of Mickles, with a reasonable expectation of success, by explicitly organizing user information to easily retrieve eligibility information for multiple donors. Easily retrieving eligibility data would reduce the wait time in a facility as a donor confirms their eligibility to donate. Mickles is adaptable to Case as both inventions organize blood donor information using modular computer systems adaptable to any network. Case would have found Mickles’ teachings in cross product collaboration within their employer to improve blood donation supply efficiency.
Regarding claim 9, Case teaches all of the limitations of claim 1. Case does not explicitly teach, as taught by Mickles:
wherein the donor eligibility data comprises a plurality of donor information and a plurality of deferral periods corresponding to each of the plurality of donor information, wherein the method further comprises transmitting, using the communication device, a user interface to the user device, wherein the user interface is configured to present the plurality of donor information and the plurality of deferral periods. ([76] “the system accesses the donor profiles stored in the system's database for each of the scheduled donors whose scheduled blood component collection is not for a needed blood component. The system reviews the biographical information and donation history stored in each donor profile to determine whether a scheduled donor is eligible to donate a needed blood component. For example, to be eligible, a scheduled donor of a particular gender must meet the device criteria, for example, for double RBC donations, the scheduled donor must meet hemoglobin count, height, and weight requirements; moreover, a specified amount of time must have passed since the scheduled donor last donated”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Case with the teachings of Mickles, with a reasonable expectation of success, by explicitly organizing user information to easily retrieve eligibility information for multiple donors. Easily retrieving eligibility data would reduce the wait time in a facility as a donor confirms their eligibility to donate. Mickles is adaptable to Case as both inventions organize blood donor information using modular computer systems adaptable to any network. Case would have found Mickles’ teachings in cross product collaboration within their employer to improve blood donation supply efficiency.
Regarding claim 16, Case teaches all of the limitations of claim 11. Mickles also teaches:
wherein the eligibility data is stored in a hierarchical data structure comprising a plurality of eligibility data, wherein each of the plurality of eligibility data comprises an index data configured to allow accessing a corresponding eligibility data within the hierarchical data structure. ([10] “accessing a user profile of the target scheduled donor to determine if the target scheduled donor is eligible to donate the needed blood component; and if the target scheduled donor is eligible, recommending a modification to the scheduled blood component collection.” (37) “The blood component supply chain management system 100 of various embodiments further includes a Donor Profile Module 170. Past donors and scheduled donors have donor profiles stored in the blood component supply chain management system.” where the donor profile module comprises a hierarchical structure of donor profiles containing accessible eligibility data)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Case with the teachings of Mickles, with a reasonable expectation of success, by explicitly organizing user information to easily retrieve eligibility information for multiple donors. Easily retrieving eligibility data would reduce the wait time in a facility as a donor confirms their eligibility to donate. Mickles is adaptable to Case as both inventions organize blood donor information using modular computer systems adaptable to any network. Case would have found Mickles’ teachings in cross product collaboration within their employer to improve blood donation supply efficiency.
Regarding claim 17, Case-Mickles teaches all of the limitations of claim 16. Mickles also teaches:
wherein the processing device is further configured to: generate a query data based on the donor information; and identify the index data corresponding to the query data, wherein the retrieving of the eligibility data is based on identifying. ([37] “The blood component supply chain management system 100 of various embodiments further includes a Donor Profile Module 170. Past donors and scheduled donors have donor profiles stored in the blood component supply chain management system. A donor profile can be created and edited via the Donor Profile Module 170. In various embodiments, the donor profile is a donor-specific data space within the memory of the blood component supply chain management system, which is accessible using a unique identifier. The donor-specific data space stores data pertaining to the donor. The donor-specific data is maintained by the blood component supply chain management system and accessible by users with proper credentials, such as a specific donor, and optionally, blood center staff. The donor profile may include: biographical data such as a donor's birth date, gender, weight, height, and blood type; and appointment history such as a log of past donations, including dates and products donated, a count of past donations, a show rate (i.e., percent of scheduled appointments the donor appeared for), etc. The donor profile may be accessible via a web-based interface or application interface, for example, to enable review of historical collections and the characteristics of scheduled donors. In some embodiments, data pertaining to each donor's past appointments (e.g., show rate, date of donation, component type and amount donated, etc.) can be aggregated for each donor or for all individuals who donated to a blood center during a particular time interval.”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Case with the teachings of Mickles, with a reasonable expectation of success, by explicitly organizing user information to easily retrieve eligibility information for multiple donors. Easily retrieving eligibility data would reduce the wait time in a facility as a donor confirms their eligibility to donate. Mickles is adaptable to Case as both inventions organize blood donor information using modular computer systems adaptable to any network. Case would have found Mickles’ teachings in cross product collaboration within their employer to improve blood donation supply efficiency.
Regarding claim 19, Case teaches all of the limitations of claim 11. Case does not explicitly teach, as taught by Mickles:
wherein the donor eligibility data comprises a plurality of donor information and a plurality of deferral periods corresponding to each of the plurality of donor information, wherein the communication device is further configured to transmit a user interface to the user device, wherein the user interface is configured to present the plurality of donor information and the plurality of deferral periods. ([76] “the system accesses the donor profiles stored in the system's database for each of the scheduled donors whose scheduled blood component collection is not for a needed blood component. The system reviews the biographical information and donation history stored in each donor profile to determine whether a scheduled donor is eligible to donate a needed blood component. For example, to be eligible, a scheduled donor of a particular gender must meet the device criteria, for example, for double RBC donations, the scheduled donor must meet hemoglobin count, height, and weight requirements; moreover, a specified amount of time must have passed since the scheduled donor last donated”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Case with the teachings of Mickles, with a reasonable expectation of success, by explicitly organizing user information to easily retrieve eligibility information for multiple donors. Easily retrieving eligibility data would reduce the wait time in a facility as a donor confirms their eligibility to donate. Mickles is adaptable to Case as both inventions organize blood donor information using modular computer systems adaptable to any network. Case would have found Mickles’ teachings in cross product collaboration within their employer to improve blood donation supply efficiency.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Case et al. (US20230282346) in view of Hazzazi et al. (US20180294055).
Regarding claim 10, Case teaches all of the limitations of claim 1. Hazzazi also teaches:
receiving, using the communication device, a biological sample data corresponding to the biological product of the donor, wherein the biological sample data represents a medical diagnosis of the biological product; ([0103] “the unit is processed into final products, such as red blood cells, platelets, plasma etc., while the unit sample undergoes standardized testing for blood grouping, antibody screening and infectious diseases (FDA CFR 640.5, 610.4). All unit information is stored in the system and the units are labeled accordingly”)
analyzing, using the processing device, the biological sample data, wherein the determining of the donor eligibility data is further based on the analyzing of the biological sample data. ([0106] “the serology testing requirements check the donated unit against screening tests for infectious diseases that are followed based on the FDA CFR sub-part E and AABB s