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 .
Status of Application
This action is in reply to the correspondence received through July 15, 2025.
Claims 1-20 are pending.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1-3, 5, 7, 9, 14, and 18: The term “BECS” in claims 1-3, 5, 7, 9, 14, and 18 is an undefined acronym or abbreviation that renders the claims indefinite. The term “BECS” is not defined by the claims, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes, “BECS” will be interpreted as “blood establishment computer system.” Amending “BECS” to recite “blood establishment computer system” would overcome this deficiency in these claims.
Claims 2-8, 10-17, 19, and 20 are rejected for incorporating the deficiencies of the rejected claims on which they respectively depend.
Claim Rejections - 35 U.S.C. § 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 non-statutory subject matter. Claims 1-20 are directed to an abstract idea without significantly more as required by the Alice test as discussed below.
Step 1
Claims 1-20 are directed to a process, machine, manufacture, or composition of matter.
Step 2A
Claims 1-20 are directed to abstract ideas, as explained below.
Prong one of the Step 2A analysis requires identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea; and determining whether the identified limitation(s) falls within at least one of the groupings of abstract ideas of mathematical concepts, mental processes, and certain methods of organizing human activity.
The claims recite the following limitations that are directed to abstract ideas. Claim 9 recites determining that a donor is at a location associated with a given vitals device at a given time, the given vitals device being one of a plurality of vitals devices positioned at a physical blood processing site, each vitals device having a unique identifier, […] determine a human physiological measurement including one or more of donor blood pressure, pulse, temperature, and weight; receiving a vitals message with vitals information relating to the donor, the vitals message being deidentified to include deidentified information about the donor, the vitals information including at least one of the human physiological measurements, manage donor information and donation processes; accessing a donor records database using the location associated with the given vitals device at the given time, the donor records database being indexed and configured with the unique identifiers of the plurality of vitals devices; fetching a donor identity of the donor from the donor records database using the location associated with the identifier of the given vitals device and the given time as database indices to identify the donor with donor identification information; fetching, from a donor record accessible by the BECS, additional donor information related to the donor as a function of the donor identification information; and using a decision-making framework to determine whether the donor can donate blood as a function of the received vitals information and additional donor information. Claims 1 and 18 recite similar features as claim 9. Claims 2-8, 10-17, 19, and 20 further specify features of the identified abstract ideas or characteristics of the data used thereby.
These limitations describe abstract ideas that correspond to concepts identified as abstract ideas by the courts as mental processes—such as concepts performed in the human mind (including an observation, evaluation, judgment, or opinion)—because the claimed features identified above are concepts performed in the human mind (including an observation, evaluation, judgment, or opinion).
These limitations describe abstract ideas that correspond to concepts identified as abstract ideas by the courts as certain methods of organizing human activity—such as fundamental economic principles or practices (including hedging, insurance, mitigating risk), commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations), managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)—because the claim features identified above manage personal behavior or relationships or interactions between people including following rules or instructions.
Thus, the concepts set forth in claims 1-20 recite abstract ideas.
Prong two of the Step 2A requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. Further, “integration into a practical application” uses the considerations laid out by the Supreme Court and the Federal Circuit to evaluate whether the judicial exception is integrated into a practical application, such as considerations discussed in M.P.E.P. § 2106.05(a)-(h).
The claims recite the following additional elements beyond those identified above as being directed to an abstract idea. Claim 1 recites a plurality of vitals devices, a BECS database client, a messaging client configured to transmit across a network a go/no-go message. Claim 2 recites a BECS memory controller. Claims 8 recites an apheresis device. Claim 9 recites similar features as claim 1 and further recites a network interface, and a BECS. Claim 18 recites similar features as claim 1 and further recites a tangible, non-transient computer usable medium, and a BECS. Several claims specify sending or receiving information.
The identified judicial exception(s) are not integrated into a practical application for the following reasons.
First, evaluated individually, the additional elements do not integrate the identified abstract ideas into a practical application.
The additional computer elements identified above—the vitals devices, BECS, BECS database client, a messaging client, BECS memory controller, apheresis device, network interface, and tangible, non-transient computer usable medium—are recited at a high level of generality. Inclusion of these elements amounts to mere instructions to implement the identified abstract ideas on a computer. See M.P.E.P. § 2106.05(f). The use of conventional computer elements to transmit a message across a network or to send or receive information is the insignificant, extra-solution activity of mere data gathering or outputting in conjunction with a law of nature or abstract idea. See M.P.E.P. § 2106.05(g). To the extent that the claims transform data, the mere manipulation of data is not a transformation. See M.P.E.P. § 2106.05(c). Inclusion of the computing system in the claims amounts to generally linking the use of the judicial exception to a particular technological environment or field of use. See M.P.E.P. § 2106.05(h). Thus, taken alone, the additional elements do not amount to significantly more than a judicial exception.
Second, evaluating the claim 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. See M.P.E.P. § 2106.05(a). Their collective functions merely provide an implementation of the identified abstract ideas on a computer system in the general field of use of managing blood donations. See M.P.E.P. § 2106.05(h).
Thus, claims 1-20 recite mathematical concepts, mental processes, or certain methods of organizing human activity without including additional elements that integrate the exception into a practical application of the exception.
Accordingly, claims 1-20 are directed to abstract ideas.
Step 2B
Claims 1-20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, when considered both individually and as an ordered combination, do not amount to significantly more than the abstract idea.
The analysis above describes how the claims recite the additional elements beyond those identified above as being directed to an abstract idea, as well as why identified judicial exception(s) are not integrated into a practical application. These findings are hereby incorporated into the analysis of the additional elements when considered both individually and in combination. Additional features of these analyses are discussed below.
Evaluated individually, the additional elements do not amount to significantly more than a judicial exception. In addition to the factors discussed regarding Step 2A, prong two, these additional computer elements also provide conventional computer functions that do not add meaningful limits to practicing the abstract idea. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to transmit a message across a network or to send or receive information is the well-understood, routine, and conventional computer functions of receiving or transmitting data over a network, e.g., the Internet, and does not impose any meaningful limit on the computer implementation of the identified abstract ideas. See M.P.E.P. § 2106.05(d)(II). Thus, taken alone, the additional elements do not amount to significantly more than a judicial exception.
Evaluating the claim limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. In addition to the factors discussed regarding Step 2A, prong two, there is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely amount to mere instructions to implement the identified abstract ideas on a computer.
Thus, claims 1-20, taken individually and as an ordered combination of elements, are not directed to eligible subject matter since they are directed to an abstract idea without significantly more.
Statement Regarding the Prior Art
The independent claims recite features for a blood donation system including an association engine configured to determine that a donor is at a location associated with a given vitals device at a given time, the association engine also configured to produce a vitals message with vitals information of the donor obtained from the given vitals device, the vitals message being deidentified to include deidentified information about the donor, the vitals information including at least one of the human physiological measurements; a BECS database client operatively configured to access a BECS donor records database accessible by a BECS, the donor records database being indexed and configured with the unique identifiers of the plurality of vitals devices, the BECS database client configured to fetch a donor identity of the donor from the donor records database using a location associated with the identifier of the given vitals device and the given time as database indices to identify the donor, the BECS database client producing donor information, the BECS database client also configured to fetch as a function of the donor identification information, from the donor records database, additional donor information related to the donor; and a decision-making framework operatively coupled with the BECS database client, the decision-making framework configured to determine whether the donor can donate blood as a function of the received vitals information and additional donor information.
Case et al. (U.S. Pub. No. 2023/0402171 A1) discloses techniques for plasma collection. In Case, when the subject has provided the identity input 126 to the system 110, the controller 118 compares the identity input 126 to the subject data entries 120 stored in the database 112. As described above, if the identity input 126 corresponds to the subject-specific information 122 stored in one or more of the subject data entries 120, as required by the system 110, the system 110 has successfully identified the subject. The controller 118 will then command the treatment device 116 to perform a medical procedure (e.g., plasma collection, red blood cell collection, etc.) with respect to the subject, which may include the controller 118 computing, retrieving, or accessing the parameter(s) 124 associated with that particular subject data entry 120 and sending it/them to the treatment device 116 for use in performing the medical procedure. However, Case does not disclose the features recited in the independent claims.
Nienhouse (U.S. Pub. No. 2019/0311101 A1) discloses techniques for verifying the identity of a subject. For example, Nienhouse discloses at ¶ [0190] that a Subject ID verifier 1956 may verify the identity of the test subject before, during, and/or after, the test subject has provided the test sample. In one example of operation, subject ID verifier 1956 instructs the test subject to provide identification information using one or more of a biometric reader 1950 of communication device 1930, biometric reader 152 of testing device 102/1602, an external biometric sensor 1980, and/or camera 1938. For example, one or both of biometric reader 1950 and biometric reader 152 may be used to capture one or more finger print images of the test subject and store those images as sensed biometric image 1979. In another example, camera 1638 is used to capture an image of an iris/retina of the test subject and store those images as sensed biometric image 1979. In another example, camera 1938 is used to capture a facial image of the test subject and store those images as sensed biometric image 1979. In another example, one or more biometric sensors 1980 are used to capture other biometric data (E.g., ECG, EGG, etc.) from the test subject and store those images as sensed biometric data 1978. In another example, ancillary health and environmental data is collected from other ‘smart’ devices (iWatch, FitBit, ankle bracelet, vehicle interlock, etc.) and store those images as sensed biometric data 1978. However, Nienhouse does not disclose the features recited in the independent claims.
Soon-Shiong et al. (U.S. Pub. No. 2020/0243176 A1) discloses techniques for location-based medical record management. In Soon-Shiong, some approaches include the mobile account management server receiving an electronic medical record (EMR) request associated with a mobile user account over the cellular network, querying the EMR database for a results set having EMRs satisfying the query, generating a plurality of EMR responses to the EMR request as a function of the results set and state information associated with the cellular network, and transmitting the plurality of EMR responses over the plurality of cellular network interfaces to the mobile device via the cellular network, the plurality of EMR responses being formatted for wireless protocols of the cellular network interfaces over which they are transmitted. However, Soon-Shiong does not disclose the features recited in the independent claims.
Kandan et al. (U.S. Pub. No. 2022/0167155 A1) discloses techniques for secure passive wireless communication with Bluetooth vitals devices. In Kandan, a gateway has a transceiver for communicating with Bluetooth vitals devices (BVDs) and a processor and program instructions. The gateway receives and stores pairing keys from one or more of the BVDs for provisioning the BVDs to the gateway, receives vital sign information from the BVDs, stores the pairing keys in a remote trusted server, and communicates with other gateways in the environment. The gateway also retrieves pairing keys for unprovisioned BVDs from either another gateway or the remote trusted server, and creates a remote private network for secure communications among two or more of the gateway, the remote server, an electronic health records store, caregivers, physicians, or a personalized data service. However, Kandan does not disclose the features recited in the independent claims.
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The following references have been cited to further show the state of the art with respect to blood donation monitoring.
Fryman et al. (U.S. Pub. No. 2022/0037012 A1) (server-initiated transmission of messages to medical devices);
Quynh et al. (“Toward a design of blood donation management by blockchain technologies.” International Conference on Computational Science and Its Applications. Cham: Springer International Publishing, 2021).
The closest art of record, including the combination of references discussed above, fails to teach, suggest, or render obvious each and every element of the claims as arranged in the claims. Further, one of ordinary skill in the art at the time of invention would not look to combine these references, or the other art of record, to arrive at the present claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christopher Tokarczyk, whose telephone number is 571-272-9594. The examiner can normally be reached Monday-Thursday between 6:00 AM and 4:00 PM Eastern.
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/CHRISTOPHER B TOKARCZYK/ Primary Examiner, Art Unit 3687
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