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 the Claims
Claims 1-7 are currently pending. Claims 8-20 are withdrawn via the Claims and Remarks filed on May 19, 2025.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 of the present application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 2-4 and 6-7 of U.S. Patent No. 11,742,061 (“the ‘061 patent”) in view of Wynden (US 11,107,559).
Regarding Claim 1 of the present application, Claim 2 of the ‘061 patent recites the following:
Claim 1 of the present application
Claim 2 of the ‘061 patent
A system for allowing computing devices associated with sponsors of a trial to access data for the trial collected by devices of multiple geographically distributed practice sites, the devices of the geographically distributed practice sites located remotely from the computing devices associated with the sponsors, the system comprising:
A system for creating a query for a trial, the system comprising:
at least one processor programmed to:
at least one processor programmed to:
cause the computing devices associated with the sponsors of the trial to display graphical user interfaces;
cause a computing device associated with a sponsor of the trial to display a graphical user interface comprising a plurality of patient identifiers associated with the trial;
receive, from the computing devices through the graphical user interfaces, selections of patient identifiers and requests for data related to patients associated with the patient identifiers; and
receive, from the computing device, a selection of one of the plurality of patient identifiers;
responsive to receiving the selections of patient identifiers and the requests for data related to the patients associated with the patient identifiers through the graphical user interfaces:
generate, using the requests for data related to the patients, queries for the patient identifiers;
receive, from the computing device, a query comprising an inquiry relating to the selected patient identifier;
route the queries through a network to devices of the practice sites, wherein the routing comprises:
automatically determine, for each selected patient identifier, a practice site associated with the selected patient identifier; and
determine a practice site associated with the selected patient identifier based on a database storing information associated with a plurality of trials; and
transmit, through the network, each of the queries to a device of a practice site determined to be associated with the selected patient identifier for which the query was generated; and
transmit the query to the practice site associated with the selected patient identifier;
receiving, from the devices of the geographically distributed practice sites, responses to the queries; and
receive, from the practice site, a response to the query; and
update, the graphical user interfaces displayed by the computing devices associated with the sponsors to display query status changes responsive to receiving responses to the queries from the devices of the geographically distributed practice sites.
cause at least a portion of the received response to be displayed by the computing device associated with the sponsor.
Hence, Claim 2 of the ‘061 patent does not explicitly disclose that the devices of the practice sites are geographically distributed and located remotely from the computing devices associated with the sponsors, or that the routing the queries to devices of the practice sites is done through a network. Wynden teaches a system comprising a clinical trial sponsor computing devices and site computing devices, wherein the site computing devices are able to communicate with the sponsor computing devices via a network, e.g. see Wynden col. 4, line 64 through col. 5, line 6, and col. 5, lines 40-44, Fig. 1A. Furthermore, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Claim 2 of the ‘061 patent to incorporate the clinical trial sponsor and site devices in communications with one another a network as taught by Wynden in order to enable each organization to access medical records of patients with little or no risk of protected or private information being released to unauthorized entities, e.g. see Wynden col. 12, lines 1-4 and col. 17, lines 52-62.
Hence, Claim 1 of the present application is obvious in view of Claim 1 ‘061 patent and Wynden.
Regarding Claims 2-4 of the present application, Claims 2-4 of the ‘061 patent recites all the limitations of Claim 2-4 of the present application. Hence, the combination of Claims 2-4 of the ‘061 patent and Wynden renders Claims 2-4 of the present application obvious.
Regarding Claim 5 of the present application, Claim 6 of the ‘061 patent recites all of the limitations of Claim 5 of the present application. Hence, the combination of Claim 6 of the ‘061 patent and Wynden renders Claim 5 of the present application obvious.
Regarding Claims 6-7 of the present application, Claim 7 of the ‘061 patent recites all of the limitations of Claims 6-7 of the present application. Hence, the combination of Claim 7 of the ‘061 patent and Wynden renders Claims 6-7 of the present application obvious.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1-7 are within the four statutory categories. Claims 1-7 are drawn to a system for creating a query for a clinical trial, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 1, which is representative of the inventive concept, recites: A system for allowing computing devices associated with sponsors of a trial to access data for the trial collected by devices of multiple geographically distrusted practice sites, the system comprising:
at least one processor programmed to:
cause the computing devices associated with the sponsors of the trial to display graphical user interfaces;
receive, from the computing devices through the graphical user interfaces, selections of patient identifiers and requests for data related to patients associated with the patient identifiers; and
responsive to receiving the selections of patient identifiers and the requests for data related to the patients associated with the patient identifiers through the graphical user interfaces:
generate, using the requests for data related to the patients, queries for the patient identifiers;
route the queries through a network to devices of the practice sites, the routing comprises:
automatically determine, for each selected patient identifier, a practice site associated with the selected patient identifier;
transmit, through the network, each of the queries to a device of a practice site that is associated with a selected patient identifier for which the query was generated; and
receiving, from the devices of the geographically distributed practice sites, responses to the queries; and
update, the graphical user interfaces displayed by the computing devices associated with the sponsors to display query status changes responsive to receiving responses to the queries from the devices of the geographically distributed practice sites.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a mental process and/or a certain method of organizing human activity because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions – in this case, the steps of receiving a selection of patient identifiers and requests for data related to patients, generating queries for the patient identifiers, routing the queries to practice sites by determining a practice site associated with the patient identifier and transmitting the queries to the practice site, receiving responses to the queries, and displaying query status changes in response to receiving the responses to the queries recite at least observations and evaluations, and/or collecting data, analyzing the data, and displaying certain results of the analysis) or using a pen and paper, but for the recitation of generic computer components (i.e. the processor, the computing devices, the graphical user interfaces, the network) as a tool to perform the mental process, and/or managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of receiving a selection of patient identifiers and requests for data related to patients, generating queries for the patient identifiers, routing the queries to practice sites by determining a practice site associated with the patient identifier and transmitting the queries to the practice site, receiving responses to the queries, and displaying query status changes in response to receiving the responses to the queries recite following rules or instructions for communications between entities in relation to clinical trials), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Dependent Claims 2-7 include other limitations, for example Claim 2 recites receiving and displaying a response to the query, Claim 3 recites the identifier being associated with an electronic health record, Claim 4 recites a configuration of a graphical user interface, Claim 5 recites displaying additional information pertaining to the query, Claim 6 recites various query types, and Claim 7 recites various query statuses, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04, and/or do not further narrow the abstract idea and instead only recite additional elements, which will be further addressed below. Hence dependent Claims 2-7 are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1.
Hence Claims 1-7 are directed towards the aforementioned abstract idea.
Prong 2 of Step 2A
Claims 1-7 are not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the processor, the computing device, and the displaying of the graphical user interface) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the processor, computing devices, graphical user interfaces, and network, which amount to merely invoking a computer or computer components as a tool to perform the abstract idea, e.g. see [0019], [0038], and [0090]-[0091] of the as-filed Specification, and see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language of the clinical device being associated with a sponsor of a clinical trial, which amounts to limiting the abstract idea to the field of clinical trials/healthcare, e.g. see MPEP 2106.05(h).
Additionally, dependent Claims 2-7 include other limitations, but these limitations also amount to no more than mere instructions to apply an exception (e.g. the display of the response on the computing device recited in dependent Claim 2, the link to the electronic health record recited in dependent Claim 3, the graphical user interface including a selectable area recited in dependent Claim 4), generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data processed recited in dependent Claims 5-7), and/or do not include any additional elements beyond those already recited in independent Claim 1, and hence also do not integrate the aforementioned abstract idea into a practical application.
Hence Claims 1-7 do not include additional elements that integrate the judicial exception into a practical application.
Step 2B
Claim 1 does not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the processor, the computing device, and the displaying of the graphical user interface), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, wherein the additional elements comprise limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The present Specification expressly disclosing that the structural additional elements are well-understood, routine, and conventional in nature:
[0019], [0038], and [0090]-[0091] of the as-filed Specification discloses that the additional elements (i.e. the processor, computing devices, graphical user interfaces, and network) comprise a plurality of different types of generic computing systems;
Relevant court decisions: The functional limitations interpreted as additional elements are analogized to the following examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives inquiries regarding the patient identifiers from the sponsors of a trial, transmits the inquiries to practice sites, and transmits the responses from the practice sites to the sponsors, e.g. see [0035] of the as-filed Specification; and/or
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the additional elements recite receiving the inquiries, and retrieving response data responsive to the received inquiries in order to transmit the response data to update the graphical user interface of the computing devices of the sponsors;
Dependent Claims 2-7 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. the display of the response on the computing device recited in dependent Claim 2, the link to the electronic health record recited in dependent Claim 3, the graphical user interface including a selectable area recited in dependent Claim 4), generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data processed recited in dependent Claims 5-7), electronic recordkeeping (e.g. the link to the electronic health record recited in dependent Claim 3), and/or the limitations recited by the dependent claims do not recite any additional elements not already recited in independent Claim 1, and hence do not amount to “significantly more” than the abstract idea.
Hence, Claims 1-7 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-7 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over MacClary (US 2017/0161436) in view of Naveed (US 2013/0145479).
Regarding Claim 1, MacClary teaches the following: A system for allowing computing devices associated with sponsors of a trial to access data for the trial collected by devices of multiple geographically distrusted practice sites, the system comprising:
at least one processor (The system includes at least one programmable processor, e.g. see MacClary [0071] and [0073]-[0075].) programmed to:
cause the computing devices to display graphical user interfaces (The system includes at least one client computer that has a graphical user interface, e.g. see MacClary [0077]-[0078].);
receive, from the computing devices through the graphical user interfaces, selections of patient identifiers and requests for data related to patients associated with the patient identifiers (The system displays a screen showing various patient information along with the patient identifiers, e.g. see MacClary Fig. 2, wherein the user may select a patient or encounter, and after making the selection the user he or she can click on a graphical icon to initiate a new query to send to a clinician (i.e. the selection of the patient and/or the clicking of the icon is interpreted as “requests for data”), e.g. see MacClary [0034].);
responsive to receiving the selections of patient identifiers and the requests for data related to the patients associated with the patient identifiers through the graphical user interface:
generate, using the requests for data related to the patients, queries for the patient identifiers (The system generates a query based on the patient selection and/or the query initiation command from the user and sends the query to the clinician, e.g. see MacClary [0034]-[0035].);
route the queries through a network to devices of the practice sites (The system transmits the query from a query author to a query receiver through a network, e.g. see MacClary [0025], Figs. 1 and 7.), wherein the routing comprises:
automatically determine, for each selected patient identifier, a practice site associated with the selected patient identifier (The system generates a suggested list of possible clinicians that have documented on the patient for selection (i.e. practice sites associated with the selected patient identifier), e.g. see MacClary [0034].); and
transmit, through the network, each of the queries to a device of a practice site determined to be associated with the selected patient identifier for which the query was generated (The system transmits the query to a clinician’s inbox (i.e. a practice site determined to be associated with the selected patient identifier), e.g. see MacClary [0035].);
receiving, from the devices of the geographically distributed practice sites, responses to the queries (The system receives responses to the queries for the patients, e.g. see MacClary [0040] and [0053].); and
update the graphical user interfaces displayed by the computing devices to display query status changes responsive to receiving responses to the queries from the devices of the geographically distributed practice sites (The system displays queries that are pending and queries that have been responded to by clinicians (i.e. status changes) and enables users to archive the responses after reviewing them, e.g. see MacClary [0038], [0040], Fig. 2.).
But MacClary does not teach but Naveed teaches the following:
wherein the computing devices are associated with sponsors of the trial (The system includes a clinical trial sponsor computer, e.g. see Naveed [0028], Fig. 3.); and
the devices of the geographically distributed practice sites located remotely from the computing devices associated with the sponsors (The system includes mobile computing devices for primary investigators and computers for auditors, both of which are separate from the sponsor computers, e.g. see Naveed [0028], Fig. 3, and wherein the devices used by the users may be located where the clinical study is located or any other location, e.g. see Naveed [0009], [0024], [0026], and [0033].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify MacClary to incorporate the clinical trial sponsors remote from the practice sites as taught by Naveed in order to efficiently and securely manage a clinical study, e.g. see Naveed [0006] and [0009].
Regarding Claim 4, the combination of MacClary and Naveed teaches the limitations of Claim 1, and MacClary further teaches the following:
The system of claim 1, wherein the graphical user interfaces each further comprises a selectable area for creating the query (The system includes a query command graphic that a user may select to generate a query to be sent, e.g. see MacClary [0034], Fig. 2.).
Regarding Claim 5, the combination of MacClary and Naveed teaches the limitations of Claim 1, and MacClary further teaches the following:
The system of claim 1, wherein the graphical user interfaces comprise a creation date for at least one of the plurality of queries, a response date for at least one of the plurality of queries, a patient identifier for each of the plurality of queries, a query type of each of the plurality of queries, or a query status of each of the plurality of queries (The system displays a date and time the query was sent (i.e. a creation date for the queries), patient names (i.e. patient identifiers) for the queries, a query subject (i.e. a query type) such as “Chronic Kidney Disease,” “Malnutrition,” “Anemia,” and/or “Sepsis,” and a query category (i.e. a query status) such as “pending,” e.g. see MacClary [0035] and [0038], Fig. 2.).
Regarding Claim 6, the combination of MacClary and Naveed teaches the limitations of Claim 5, and MacClary further teaches the following:
The system of claim 5, wherein the query type for each of the plurality of queries comprises at least one of a trial inclusion criteria type, a trial exclusion criteria type, a consent process type, a patient status type, or tissue sample type (The system displays a query subject (i.e. a query type) such as “Chronic Kidney Disease,” “Malnutrition,” “Anemia,” and/or “Sepsis,” wherein the aforementioned query subjects include a tissue such as a Kidney and/or a patient status such as “Chronic Kidney Disease,” “Malnutrition,” “Anemia,” and/or “Sepsis,” e.g. see MacClary [0038], Fig. 2.).
Regarding Claim 7, the combination of MacClary and Naveed teaches the limitations of Claim 5, and MacClary further teaches the following:
The system of claim 5, wherein the query status for each of the plurality of queries comprises at least one of an open status, a closed status, an answered status, or a cancelled status (The system displays a query category (i.e. a query status) such as “pending” (i.e. open), “responded” (i.e. answered), and/or “archived” (i.e. closed), e.g. see MacClary [0038], Fig. 2.).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of MacClary and Naveed in view of Bleicher (US 2005/0149852).
Regarding Claim 2, the combination of MacClary and Naveed teaches the limitations of Claim 1, but does not teach and Bleicher teaches the following: The system of claim 1, wherein updating the graphical user interfaces displayed by the computing devices associated with the sponsors responsive to receiving the responses to the queries from the devices of the practice sites comprises:
causing at least a portion of the received responses to be displayed by the computing devices associated with the sponsors (The system includes a Clinical Research Organization (CRO) or sponsor that receives a response to the query from the investigation site, e.g. see Bleicher [0065], wherein the parties have computers that enable communications over the Internet, wherein documents may be displayed over the Internet via a Web browser, e.g. see Bleicher [0051]-[0052].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of MacClary and Naveed to incorporate providing and displaying the response to the sponsor as taught by Bleicher in order to satisfy the needs of a clinical trial and/or various entities, e.g. see Bleicher [0069], [0071], and [0100].
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of MacClary and Naveed in view of Luter (US 2014/0142961).
Regarding Claim 3, the combination of MacClary and Naveed teaches the limitations of Claim 1, but does not teach and Luter teaches the following:
The system of claim 1, wherein the patient identifiers are each associated with a link configured to enable a user associated with a respective sponsor to access an electronic health record associated with the patient identifier (The system includes a plurality of patient data fields comprising an EMR clinical patient medical record number field and/or a sponsor clinical patient ID field, wherein the patient data fields can be used to link EMR data, e.g. see Luter [0008] and [0087].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of MacClary and Naveed to incorporate linking the patient identifier with the EMR data as taught by Luter in order to increase the transparency of clinical trial data and improve oversight and drug safety, e.g. see Luter [0007].
Response to Arguments
Applicant’s arguments, see Remarks, filed April 14, 2026, with respect to the rejections of Claims 1-7 under nonstatutory obviousness type double patenting have been fully considered but are not persuasive. For the reasons disclosed above, as presently amended, Claims 1-7 of the present application are rejected under nonstatutory obviousness type double patenting in view of Claims 1-4, 6, and 7 of the ‘061 patent in view of MacClary.
Applicant’s arguments, see Remarks, filed April 14, 2026, with respect to the rejections of Claims 1-7 under 35 U.S.C. 112(a) have been fully considered and, in combination with the claim amendments, are persuasive. The rejections of Claims 1-7 under 35 U.S.C. 112(a) have been withdrawn.
Applicant’s arguments, see Remarks, filed April 14, 2026, with respect to the rejections of Claims 1-7 under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicants first allege that the claimed invention is patent eligible because it is not directed towards an abstract idea, specifically because the limitations recite specific computational steps performed by a distributed query management system, in particular the steps of generating queries, routing the queries, and updating the display in response to the responses to the queries, e.g. see pgs. 11-12 of Remarks – Examiner disagrees.
Examiner does not dispute the specificity or narrowness of the aforementioned limitations, but notes that the Claims being narrowly claimed is not dispositive in determining the eligibility of the Claims. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena, even if the judicial exception is narrow, e.g. see MPEP 2106.04. That is, a claim reciting a narrow abstract idea nonetheless recites an abstract idea, and must be evaluated under the remainder of the requirements under 35 U.S.C. 101.
Additionally, as shown above, the aforementioned limitations recite at least observations and evaluations, and/or collecting data, analyzing the data, and displaying certain results of the analysis (i.e. a mental process), and/or following rules or instructions for communications between entities in relation to clinical trials (i.e. a certain method of organizing human activities).
Hence, Claims 1-7 do recite an abstract idea.
Applicant further alleges that the claimed invention is patent eligible because it recites an improved query management system, and a technological improvement that integrates any abstract idea into a practical application, e.g. see pgs. 12-14 of Remarks – Examiner disagrees.
Additionally, even assuming, arguendo, that the claimed invention achieved the improvements disclosed by the Specification, these improvements represent improvements to the abstract idea of organizing human activities because rather than a technological improvement, they improve the way in which clinical trials (i.e. rules or instructions dictating human behaviors) are conducted, and/or an improvement to the abstract idea of a mental process because it improves the processing of the data (i.e. collecting and analyzing data, and displaying certain results of the analysis), and an improvement in the abstract idea itself is not an improvement in technology, e.g. see MPEP 2106.05(a)(II).
Additionally, regarding the improvement of “autonomously determining the proper practice site to which the query should be routed, without requiring known routing information as in conventional systems,” Examiner notes that the current claim language is part of the abstract idea of a mental process and/or a certain method of organizing human activities because determining a site for a patient is a process that could be performed mentally and/or recites a rule or instruction to be followed in order to ultimately enable data exchange between entities as part of a clinical trial.
Furthermore, even assuming, arguendo, that the aforementioned limitation were considered to be an additional element rather than part of the abstract idea, the present claim language does not provide any details regarding how this determination is performed. That is, the claimed limitation of determining the practice site which is alleged to achieve the improvement of routing the query to the proper destination is claimed at such a high level of generality so as to not properly be interpreted as an improvement to the functioning of a computer or any other technology or technical field and/or a technological improvement.
For the aforementioned reasons, Claims 1-7 are rejected under 35 U.S.C. 101.
Applicant’s arguments, see Remarks, filed April 14, 2026, with respect to the rejections of Claims 1-7 under 35 U.S.C. 103 have been fully considered but are not persuasive.
Applicants allege that the MacClary is deficient because it does not teach automatically determining a practice site associated with a selected patient identifier, and transmitting the queries to a device of a practice site associated with the selected patient identifier, e.g. see pgs. 8-9 of Remarks – Examiner disagrees.
As shown above, MacClary teaches that the system generates a list of possible clinicians that have documented on the patient for selection (i.e. automatically determining a practice site associated with the patient identifier), e.g. see MacClary [0034], and transmits the query to a clinician’s inbox (i.e. a practice site determined to be associated with the selected patient identifier), e.g. see MacClary [0035]. Hence, MacClary is not deficient to teach these limitations.
Furthermore, any arguments pertaining to Fermin are moot, as Fermin is no longer cited to teach any claimed limitations.
For the aforementioned reasons, Claims 1-7 are rejected under 35 U.S.C. 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Wynden (US 11,107,559) – teaches a system for clinical trials including sponsors and sites that is connected via a communications network that enables communications between the sponsors and sites.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P GO whose telephone number is (703)756-1965. The examiner can normally be reached Monday-Friday 9am-6pm Pacific.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H CHOI can be reached at (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN P GO/Primary Examiner, Art Unit 3681
Prosecution Insights