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 Claims
Claims 21 – 27, 29 – 37, & 39 – 42 were previously pending and subject to a final office action mailed 02/19/2026. Claims 21 & 31 were amended in a reply filed 06/22/2026. Claims 21 – 27, 29 – 37, & 39 – 42 are currently pending and subject to the non-final office action below.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed after final rejection on 06/22/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 06/22/2026 with respect to the previous rejection of the claims under 35 USC 101 have been considered but are not persuasive.
Applicant initially argues, on pg. 10, that “Regarding Step 2A - Prong One, Applicant respectfully disagrees that the claims recite an abstract idea or otherwise fall within the "certain methods of organizing human activity" grouping.”
Examiner respectfully asserts that the claims recite a judicial exception, characterized by the following limitations: “preserving the quality of a transplantable human organ: receiving… shipment data associated with the organ; receiving… a plurality of data inputs from one or more of the disparate data sources of the plurality of disparate data sources; aggregating, in association with the unique tracker identifier, the shipment data and the plurality of data inputs, including real-time information associated with one or more of the plurality of data inputs; transmitting… at least a subset of the aggregated data associated with the unique tracker identifier; causing generation… of a predictive correlation between organ quality and patient outcome for the organ contained within the organ transport container; transmitting… a status notification based on the aggregated data and the generated predictive correlation to one or more authenticated user{s}; and receiving… from at least one of the one or more authenticated user{s}… reallocation instructions associated with the organ; and causing, based on the reallocation instructions, reallocation of the organ from a first transportation asset to a second transportation asset.” Because these limitations are steps that would occur as part of a commercial interaction of managing a shipment transaction, the claims, under the broadest reasonable interpretation, cover performance of the limitations in a commercial interaction. Therefore, the claims recite an abstract idea that falls within the "Certain Methods of Organizing Human Activity" grouping of abstract ideas e.g., “commercial or legal interactions (including marketing or sales activities or behaviors; business relations).” Accordingly, the claim recites an abstract idea.
Applicant next argues, on pp. 10 – 11, that “the claim recites a combination of additional elements that improves a technical field such that the claim as a whole integrates any alleged abstract idea into a practical application that is patent eligible under 35 U.S.C. §101. Claim 21 includes a number of features that provide improvements to a technical field and the improvements are described in the Specification as filed. See e.g., Specification at Paras. [0013], [0015], and [0029].”
Examiner respectfully disagrees, as Applicant’s invention does not entail any improvements to the functionality of a computing device or any other technology. The additional elements, as a whole amount to merely invoking generic components as a tool to perform the abstract idea or “apply it” (or an equivalent), adding insignificant extra-solution activity to the judicial exception, as well as generally linking the judicial exception to a particular technological environment or field or use. Therefore, these additional elements, when viewed as a whole/ordered combination, do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea.
As per paragraph 13 of the instant specification, the instant invention is directed to the following benefits: “to optimize logistics and allocate the assets responsible for organ transportation,” “methods designed to improve outcomes and save lives,” “to provide visibility to the movement of assets through the supply chain and enable rerouting and the deployment of assets for reallocation when necessary to improve the likelihood of successful transplantations.” Examiner respectfully submits that these are improvements to the recited abstract idea itself, or “on economic or other tasks for which a computer is used in its ordinary capacity,” as described in Enfish. Paragraph 15 is equally as deficient. Paragraph 29 likewise lists improvements to the judicial exception itself – and additionally states the purported benefit of “to facilitate machine learning”; however, the claims are not directed to a new type of machine learning or to an improvement thereof. Rather, machine learning is used merely as a tool to perform the functionality of a generating a predictive correlation between organ quality and patient outcome for the organ contained within the organ transport container – which is a mere instruction to “apply it.” As stated by the court in Enfish, “the first step in the Alice inquiry in this case asks whether the focus of the claims is on the specific asserted improvement in computer capabilities (i.e., the self-referential table for a computer database) or, instead, on a process that qualifies as an “abstract idea” for which computers are invoked merely as a tool. As noted infra, in Bilski and Alice and virtually all of the computer-related § 101 cases we have issued in light of those Supreme Court decisions, it was clear that the claims were of the latter type—requiring that the analysis proceed to the second step of the Alice inquiry, which asks if nevertheless there is some inventive concept in the application of the abstract idea.” See Alice, 134 S. Ct. at 2355, 2357–59. In this case, however, the plain focus of the claims is not to an improvement to computer functionality itself, but “on economic or other tasks for which a computer is used in its ordinary capacity.” The instant claims are directed to a method of organizing human activity, which invokes generic computer components as a mere tool for implementation, rather to an improvement thereof. For example, the claims are not directed to an improvement in the functionality of a computing device or other technology; thus, the claims are directed to a judicial exception without significantly more.
Applicant next argues, on pg. 11, that “that the claims improve the technical field of organ transport monitoring by enabling ML-informed dynamic intervention to preserve organ quality and effecting a real world remedial action. The claims do not merely use computers as a tool to automate a business process; rather, they recite a specific technical system-integrating physical sensors, tracker devices, transceivers, API-connected data sources, and machine learning trained on clinical outcome data-that enables real-time, ML-informed physical reallocation of organs between transportation assets. This is an improvement to organ transport technology itself, not merely using computers to automate a business process.”
Examiner respectfully disagrees that the claims are directed to an improvement in the functionality of a computing device or other technology. In particular, the use of machine learning merely invokes generically-recited components as a tool to perform the abstract idea or “apply it,” and therefore does not provide an inventive concept at Step 2B. Machine learning is used to perform the functionality of “causing generation… of a predictive correlation between organ quality and patient outcome for the organ contained within the organ transport container,” which is a part of the recited judicial exception. There are also no limitations associated with any level of detail on the training of a machine learning system. “Simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).” (See MPEP § 2106.05(f)). Furthermore, the gathering of sensor data amounts to insignificant extra-solution activity, such as mere data gathering (See MPEP 2106.05(g)), and has also been found by the courts to be well-understood, routine, and conventional activity (See MPEP § 2106.05(d)(II), noting: “Receiving or transmitting data over a network, e.g., using the Internet to gather data,” “Electronic recordkeeping,” “Performing repetitive calculations,” and “Storing and retrieving information in memory”), and thus do not amount to significantly more under Step 2B. Therefore, the claims are directed to an abstract idea without significantly more.
Regarding Applicant’s remarks associated with Ex Parte Desjardins, on pg. 12, Examiner respectfully notes that a full analysis of the claims, including every claimed element, both individually and in an ordered combination, has been performed in accordance with the MPEP and the Alice/Mayo analysis – which has led to the conclusion that the currently-amended claims are not patent-eligible under 35 USC 101.
Applicant next argues, on pg. 12, that “the Office Action's characterization of the present claims oversimplifies them by ignoring their specific operational elements that, if considered, would demonstrate the technical improvements in organ transport technology itself rather than merely automating an abstract business process.”
Examiner respectfully submits that Applicant has not identified any specific operational elements that have been ignored in the Alice Mayo analysis of the claimed invention. Examiner reiterates that that a full analysis of the claims, including every additional element, both individually and in an ordered combination, has been performed in accordance with the MPEP and the Alice/Mayo analysis. Therefore, Examiner finds this argument unpersuasive.
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 21 – 27, 29 – 37, & 39 – 42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 21 – 27, 29 – 30 & 41 are directed to a method (i.e., a process). Claims 31 – 37, 39 – 40 & 42 are directed to a product. Therefore, claims 21 – 27, 29 – 37, & 39 – 42 all fall within the one of the four statutory categories of invention.
Step 2A, Prong One
Independent claims 21 & 31 substantially recite: “preserving the quality of a transplantable human organ: receiving… shipment data associated with the organ; receiving… a plurality of data inputs from one or more of the disparate data sources of the plurality of disparate data sources; aggregating, in association with the unique tracker identifier, the shipment data and the plurality of data inputs, including real-time information associated with one or more of the plurality of data inputs; transmitting… at least a subset of the aggregated data associated with the unique tracker identifier; causing generation… of a predictive correlation between organ quality and patient outcome for the organ contained within the organ transport container; transmitting… a status notification based on the aggregated data and the generated predictive correlation to one or more authenticated user{s}; and receiving… from at least one of the one or more authenticated user{s}… reallocation instructions associated with the organ; and causing, based on the reallocation instructions, reallocation of the organ from a first transportation asset to a second transportation asset.”
The limitations stated above are processes / functions that under broadest reasonable interpretation covers performance of the limitation in a commercial interaction. That is, nothing in the claim elements precludes the steps from practically being performed in a commercial interaction. For example, the functions in the context of claims 21 & 31 encompass managing a shipment transaction for an organ. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in a commercial interaction, then it falls within the "Certain Methods of Organizing Human Activity" grouping of abstract ideas e.g., “commercial or legal interactions (including marketing or sales activities or behaviors; business relations).” Accordingly, the claim recites an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. Claims 21 & 31, as a whole amount to: merely invoking generic components as a tool to perform the abstract idea or “apply it” (or an equivalent), adding insignificant extra-solution activity to the judicial exception, as well as generally linking the judicial exception to a particular technological environment or field or use. Claim 21 recites the additional computer-related elements of: “computing entities” and “central software application.” Claim 31 recites the additional computer-related elements of: “computer program product,” “non-transitory computer-readable storage medium having computer executable program code instructions therein, the computer executable program code instructions comprising program code instructions,” “computing entities,” and “central software application.”
Claim 21 recites the additional elements of: “the organ contained within an organ transport container in transit,” “receiving, via a central software application, shipment data associated with the organ,” “establishing network communications between the central software application and each of a plurality of disparate data sources, the plurality of disparate data sources comprising at least one or more external data sources, wherein the network communication with each external data source is established through a corresponding application programming interface (API), and wherein at least one of the disparate data sources of the plurality of disparate data sources is a tracker device positioned within or about an external packaging of the organ transport container, the tracker device associated with a unique tracker identifier and in communication, via a transceiver, with a plurality of environmental sensors associated with the organ transport container,” “receiving, by the central software application, a plurality of data inputs,” “transmitting, by the central software application to a machine learning input database, at least a subset of the aggregated data,” “wherein the machine learning input database comprises data related to transplant clinical success for each of a plurality of transported organs and aggregated data associated with each of the corresponding transported organs,” “via application of one or more machine learning algorithms to the machine learning input database,” “transmitting, via at least one established network communication, a status notification,” and “receiving, by the central software application, from at least one of the one or more authenticated user computing entities, reallocation instructions.”
Claim 31 recites the additional elements of: “receive, via a central software application, shipment data associated with the organ,” “wherein the organ is contained within an organ transport container,” “establish network communications, between the central software application and each of a plurality of disparate data sources, the plurality of disparate data sources comprising at least one or more external data sources, wherein the network communication with each external data source is established through a corresponding application programming interface (API), and wherein at least one of the disparate data sources of the plurality of disparate data sources is a tracker device positioned within or about an external packaging of the organ transport container, the tracker device associated with a unique tracker identifier and in communication, via a transceiver, with a plurality of environmental sensors associated with the organ transport container,” “receive, by the central software application, a plurality of data inputs,” “transmit, by the central software application to a machine learning input database, at least a subset of the aggregated data,” “wherein the machine learning input database comprises data related to transplant clinical success for each of a plurality of transported organs and aggregated data associated with each of the corresponding transported organs,” “via application of one or more machine learning algorithms to the machine learning input database,” “transmit, via at least one established network communication, a status notification,” and “receive, by the central software application, from at least one of the one or more authenticated user computing entities, reallocation instructions.”
The additional computer-related elements of “computing entities,” “central software application,” “computer program product,” and “non-transitory computer-readable storage medium having computer executable program code instructions therein, the computer executable program code instructions comprising program code instructions” are recited at a high-level of generality, such that, when viewed as whole/ordered combination, amount to no more than mere instruction to apply the judicial exception using generic computer components or “apply it” (See MPEP 2106.05(f)).
The additional elements of “the organ contained within an organ transport container in transit,” “wherein the machine learning input database comprises data related to transplant clinical success for each of a plurality of transported organs and aggregated data associated with each of the corresponding transported organs,” “wherein the organ is contained within an organ transport container,” and “wherein at least one of the disparate data sources of the plurality of disparate data sources is a tracker device associated with the organ transport container” amount to merely generally linking the recited judicial exception to a particular technological environment or field of use (See MPEP 2106.05(I)(A) & MPEP 2106.05(h)).
The additional elements of “receive/receiving, via a central software application, shipment data associated with the organ,” “establish/establishing network communications between the central software application and each of a plurality of disparate data sources, the plurality of disparate data sources comprising at least one or more external data sources, wherein the network communication with each external data source is established through a corresponding application programming interface (API), and wherein at least one of the disparate data sources of the plurality of disparate data sources is a tracker device positioned within or about an external packaging of the organ transport container, the tracker device associated with a unique tracker identifier and in communication, via a transceiver, with a plurality of environmental sensors associated with the organ transport container,” “receive/receiving, by the central software application, a plurality of data inputs,” “transmit/transmitting, by the central software application to a machine learning input database, at least a subset of the aggregated data,” “wherein the machine learning input database comprises data related to transplant clinical success for each of a plurality of transported organs and aggregated data associated with each of the corresponding transported organs,” “via application of one or more machine learning algorithms to the machine learning input database,” “transmit/transmitting, via at least one established network communication, a status notification,” and “receive/receiving, by the central software application, from at least one of the one or more authenticated user computing entities, reallocation instructions” are recited at a high-level of generality, and when viewed as whole/ordered combination, amount to insignificant extra-solution activity, such as mere data gathering (See MPEP 2106.05(g)). Furthermore, these additional elements merely generally link the judicial exception to a particular technological environment, and likewise does not provide integration into a practical application (see MPEP 2106.04(d)(I)).
Accordingly, these additional elements, when viewed as a whole/ordered combination, do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea.
Step 2B
As discussed above with respect to Step 2A Prong Two, the additional elements amount to no more than: (i) merely invoking generic components as a tool to perform the abstract idea or “apply it” (or an equivalent), (ii) adding insignificant extra-solution activity (e.g., pre-solution activity), and (iii) generally linking the judicial exception to a particular technological environment or field or use. The same analysis applies here in Step 2B: merely invoking the generic components as a tool to perform the abstract idea or “apply it” (See MPEP 2106.05(f)), adding insignificant extra-solution activity to the judicial exception, as well as generally linking the judicial exception to a particular technological environment or field of use (See MPEP 2106.05(I)(A) & MPEP 2106.05(h)), does not integrate the abstract idea into a practical application at Step 2A or provide an inventive concept at Step 2B.
Furthermore, the insignificant extra-solution activity of “receive/receiving, via a central software application, shipment data associated with the organ,” “establish/establishing network communications between the central software application and each of a plurality of disparate data sources, the plurality of disparate data sources comprising at least one or more external data sources, wherein the network communication with each external data source is established through a corresponding application programming interface (API), and wherein at least one of the disparate data sources of the plurality of disparate data sources is a tracker device positioned within or about an external packaging of the organ transport container, the tracker device associated with a unique tracker identifier and in communication, via a transceiver, with a plurality of environmental sensors associated with the organ transport container,” “receive/receiving, by the central software application, a plurality of data inputs,” “transmit/transmitting, by the central software application to a machine learning input database, at least a subset of the aggregated data,” “wherein the machine learning input database comprises data related to transplant clinical success for each of a plurality of transported organs and aggregated data associated with each of the corresponding transported organs,” “via application of one or more machine learning algorithms to the machine learning input database,” “transmit/transmitting, via at least one established network communication, a status notification,” and “receive/receiving, by the central software application, from at least one of the one or more authenticated user computing entities, reallocation instructions” has been found by the courts to be well-understood, routine, and conventional activities (See MPEP § 2106.05(d)(II), noting: “Receiving or transmitting data over a network, e.g., using the Internet to gather data,” “Electronic recordkeeping,” “Performing repetitive calculations,” and “Storing and retrieving information in memory”), and thus do not amount to significantly more under Step 2B.
Therefore, the additional elements of: “computing entities,” “central software application,” “computer program product,” and “non-transitory computer-readable storage medium having computer executable program code instructions therein, the computer executable program code instructions comprising program code instructions,” “the organ contained within an organ transport container in transit,” “wherein the machine learning input database comprises data related to transplant clinical success for each of a plurality of transported organs and aggregated data associated with each of the corresponding transported organs,” “wherein the organ is contained within an organ transport container,” and “wherein at least one of the disparate data sources of the plurality of disparate data sources is a tracker device associated with the organ transport container,” “receive/receiving, via a central software application, shipment data associated with the organ,” “establish/establishing network communications between the central software application and each of a plurality of disparate data sources, the plurality of disparate data sources comprising at least one or more external data sources, wherein the network communication with each external data source is established through a corresponding application programming interface (API), and wherein at least one of the disparate data sources of the plurality of disparate data sources is a tracker device positioned within or about an external packaging of the organ transport container, the tracker device associated with a unique tracker identifier and in communication, via a transceiver, with a plurality of environmental sensors associated with the organ transport container,” “receive/receiving, by the central software application, a plurality of data inputs,” “transmit/transmitting, by the central software application to a machine learning input database, at least a subset of the aggregated data,” “wherein the machine learning input database comprises data related to transplant clinical success for each of a plurality of transported organs and aggregated data associated with each of the corresponding transported organs,” “via application of one or more machine learning algorithms to the machine learning input database,” “transmit/transmitting, via at least one established network communication, a status notification,” and “receive/receiving, by the central software application, from at least one of the one or more authenticated user computing entities, reallocation instructions” fail to integrate the abstract idea into a practical application at Step 2A or provide an inventive concept at Step 2B. Thus, even when viewed as a whole/ordered combination, nothing in the claims adds significantly more (i.e., an inventive concept) to the abstract idea. There is no indication that the combination of elements, taken both individually and as an ordered combination, improves the functioning of a computer or improves any other technology. Thus, the claims are not patent eligible.
Furthermore, the dependent claims 22 – 27, 29 – 30, 32 – 37, & 39 – 42 are merely directed to the particulars of the abstract idea and likewise do not add significantly more to the above-identified judicial exception. The additional elements of “wherein the plurality of environmental sensors comprise one or more of a temperature sensor, a pressure sensor, a vibration sensor, acceleration sensors, an impact force sensor, an orientation sensor, a light sensor, an altitude sensor, or position sensor” in claims 22 & 32 amount to merely generally linking the recited judicial exception to a particular technological environment or field of use (See MPEP 2106.05(I)(A) & MPEP 2106.05(h)). The additional elements of “wherein each environmental sensor is configured to obtain a plurality of measurements over time of a corresponding monitored environmental parameter of the organ in transit” in claims 23 & 33 are recited at a high-level of generality, and when viewed as whole/ordered combination, amount to insignificant extra-solution activity, such as mere data gathering (See MPEP 2106.05(g)), and furthermore, has been found by the courts to be well-understood, routine, and conventional activities (See MPEP § 2106.05(d)(II), noting: “Receiving or transmitting data over a network, e.g., using the Internet to gather data”). The additional computer-related element of geolocation system in claims 24 & 34 are recited at a high-level of generality, such that, when viewed as whole/ordered combination, amount to no more than mere instruction to apply the judicial exception using generic computer components or “apply it” (See MPEP 2106.05(f)). The additional computer-related element of “graphical user interface of the first authenticated user computing entity” in claims 25 & 35 are recited at a high-level of generality, such that, when viewed as whole/ordered combination, amount to no more than mere instruction to apply the judicial exception using generic computer components or “apply it” (See MPEP 2106.05(f)). The additional computer-related elements of “machine learning input database” and “via application of one or more machine learning algorithms to the machine learning input database” in claims 28 & 38 are recited at a high-level of generality, such that, when viewed as whole/ordered combination, amount to no more than mere instruction to apply the judicial exception using generic computer components or “apply it” (See MPEP 2106.05(f)). The limitations of the dependent claims, when considered both individually and as an ordered combination, do not transform the abstract idea that they recite into patent-eligible subject matter because the claims simply instruct the practitioner to implement the abstract idea with generic computer components that conduct generic computer functions within a certain field of use, and thus are ineligible.
Conclusion
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/BRYAN J KIRK/Examiner, Art Unit 3628
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