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 Claims 8-20 are withdrawn via the Claims and Remarks filed on May 19, 2025.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 1-4, 6, and 7 of U.S. Patent No. 11,742,061 (“the ‘061 patent”) in view of MacClary (US 2017/0161436).
Regarding Claim 1 of the present application, Claim 1 of the ‘061 patent recites the steps of causing of the display of the graphical user interface comprising a plurality of patient identifiers associated with the trial, receiving of a query relating to a patient identifier, and transmitting the query to the practice site associated with a selected patient identifier. However, Claim 1 of the ‘061 patent does not teach but MacClary teaches the following features of Claim 1 of the present application:
responsive to receiving the inquiries related to the patient identifiers through the graphical user interface:
generate, using the inquiries, queries for the patient identifiers (The system generates a query based on 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.), the routing comprises:
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 (The system transmits the query to a clinician’s inbox (i.e. a practice site), e.g. see MacClary [0035].); and
update the graphical user interfaces displayed by the computing devices responsive to receiving responses to the queries from the devices of the practice sites (The system displays queries that have been responded to by clinicians and enables users to archive the responses after reviewing them, e.g. see MacClary [0038], [0040], Fig. 2.).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Claim 1 of the ‘061 patent to incorporate the aforementioned features of routing the queries and updating the graphical user interface as taught by MacClary in order to provide a system for standardized query review and response workflow that is easy and fast for clinicians that allows them to handle increasing query volume and to collaborate with query authors, e.g. see MacClary [0009]-[0010].
Hence, Claim 1 of the present application is obvious in view of Claim 1 ‘061 patent and MacClary.
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, Claims 2-4 of the ‘061 patent anticipate Claims 2-4 of the present application.
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 Claim 6 of the ‘061 patent anticipates Claim 5 of the present application.
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 Claim 7 of the ‘061 patent anticipates Claims 6-7 of the present application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 1, Claim 1 recites “responsive to receiving the inquiries…[generating], using the inquiries, queries for the patient identifiers.” This constitutes new matter, as this limitation is not disclosed in the as-filed Specification. For example, [0028], [0030], and [0077] of the as-filed Specification disclose receiving a query including an inquiry relating to the selected patient identifier, but receiving a query including an inquiry is not equivalent to first receiving an inquiry, and responsive to receiving the inquiry, generating a query. Furthermore, although the as-filed Specification discloses receiving a patient selection and generating a query for the selected patient identifier, e.g. see [0074]-[0077] of the as-filed Specification and Fig. 7 of the present Drawings, there is no disclosure that the selection of the patient identifier comprises an “inquiry.” The as-filed Specification provides no definition of an “inquiry” beyond the fact that the inquiry is included in the query, and that the inquiry is “associated with” patients, e.g. see [0032] and [0077] of the as-filed Specification. In the interest of compact prosecution and in line with the disclosures of the Specification, Examiner will interpret the step of receiving “inquiries” as receiving a request to generate a query or a selection of patient identifiers, and the generating of the queries “using the inquiries” as the queries generated being for particular patients. Appropriate correction is required.
Dependent Claims 2-7 are also rejected under 35 U.S.C. 112(a) due to their dependence from independent Claim 1.
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 comprising a plurality of patient identifiers associated with the trial;
receive, from the computing devices through the graphical user interfaces, inquiries relating to patient identifiers; and
responsive to receiving the inquiries related to the patient identifiers through the graphical user interface:
generate, using the inquiries, queries for patient identifiers;
route the queries through a network to devices of the practice sites, the routing comprises:
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
update the graphical user interfaces displayed by the computing devices associated with the sponsors responsive to receiving responses to the queries from the devices of the practice sites.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite 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 displaying patient identifiers for a trial, receiving inquiries relating to the patient identifiers, generating queries for the inquiries, and routing the queries to practice sites associated with the patient identifier are reasonably interpreted as following rules or instructions for submitting a query for a patient of a clinical trial), 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);
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); and/or
add insignificant extra-solution activity to the abstract idea – for example, the recitation of the updating of the graphical user interfaces of the computing devices of the sponsors responsive to receiving responses to the queries from the devices of the practice sites, which amounts to an insignificant application, e.g. see MPEP 2106.05(g).
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, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, 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 following are 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 Fermin (US 2019/0155994).
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].) comprising a plurality of patient identifiers (The system generates a work list including a plurality of patients including patient names (i.e. identifiers), e.g. see MacClary [0038] and [0049], Fig. 2.);
receive, from the computing devices through the graphical user interfaces, inquiries relating to 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 “inquiries”), e.g. see MacClary [0034].);
responsive to receiving the inquiries related to the patient identifiers through the graphical user interface:
generate, using the inquiries, 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.), the routing comprises:
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 (The system transmits the query to a clinician’s inbox (i.e. a practice site), e.g. see MacClary [0035].); and
update the graphical user interfaces displayed by the computing devices responsive to receiving responses to the queries from the devices of the practice sites (The system displays queries that have been responded to by clinicians and enables users to archive the responses after reviewing them, e.g. see MacClary [0038], [0040], Fig. 2.).
But MacClary does not teach but Fermin teaches the following:
wherein the computing devices are associated with sponsors of the trial (The system includes a sponsor PC device that a clinical trial sponsor uses to perform various tasks including sending and requesting information and generating reports, e.g. see Fermin [0024] and [0026], Fig. 1.); and
wherein the plurality of patient identifiers are associated with the trial (The system includes a data-reporting process that provides a clinical trial site with information including a number of subjects, e.g. see Fermin [0035], and further wherein the generated reports include a listing of subject identifiers, e.g. see Fermin [0042].).
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 sponsor as taught by Fermin in order to facilitate communication of data between entities, e.g. see Fermin [0002] and MacClary [0028].
Regarding Claim 4, the combination of MacClary and Fermin 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 Fermin 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 Fermin 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 Fermin 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 Fermin in view of Bleicher (US 2005/0149852).
Regarding Claim 2, the combination of MacClary and Fermin 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 MacClary and Fermin 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 Fermin in view of Luter (US 2014/0142961).
Regarding Claim 3, the combination of MacClary and Fermin 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 MacClary and Fermin 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 September 12, 2025, 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 September 12, 2025, 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 the Specification discloses technical problems that are solved by the claimed invention, specifically enabling clinical trial sites to efficiently manage large volumes of clinical data, and hence the claimed invention is not properly characterized as reciting an abstract idea, e.g. see pgs. 9-11 of Remarks – Examiner disagrees.
Initially, Examiner notes that 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 they improve the way in which clinical trials (i.e. given the broadest reasonable interpretation, rules or instructions dictating human behaviors) are conducted, rather than a technological improvement.
Additionally, the features upon which applicant relies (i.e., “large volumes of clinical data”) are not recited in the rejected claims. For example, as presently claimed, Claim 1 merely recites the receiving and processing of data from multiple sources, without any requirement that the data be different and/or without reciting any limitations disclosing the amount of data. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Moreover, even assuming, arguendo, that the Specification’s disclosure that “managing clinical data is technically challenging for trial sponsors, given that trial data is typically collected at numerous practice sites,” the claimed invention (i.e. the solution to the aforementioned problem) does not disclose sufficient details regarding how this problem is actually solved. For example, Claim 1 merely recites “receiving, from the computing devices through the graphical user interfaces, inquiries relating to patient identifiers,” which merely states that data is received from a plurality of devices and does not recite any technical details that enable this operation in a way such that previous conventional systems were incapable of. That is, there is an insufficient nexus between the claim limitations and the alleged improvements.
Furthermore, MPEP 2106.04(a)(2)(II)(C) states that managing personal behavior or relationships or interactions between people is further characterized by following rules or instructions. The claimed invention is properly characterized as reciting a plurality of rules or instructions to follow in order to enable the submission and resolving of a query between clinical trial sponsors and practice sites. Hence, Claims 1-7 are properly interpreted as reciting an abstract idea.
Applicants further allege that the claimed invention is patent eligible because it integrates any recited abstract idea into a practical application, specifically by enabling the automated transmission of queries from sponsor devices to appropriate devices of practice sites and the display of relevant query response data, e.g. see pg. 11 of Remarks – Examiner disagrees.
For the reasons disclosed above, the aforementioned features are not properly interpreted as achieving technological improvements because the alleged improvements are improvements to the abstract idea of organizing human activities rather than technological improvements, and because even if the improvements were properly considered technical in nature, there is an insufficient nexus between the present claim language and any alleged improvements disclosed in the present Specification.
For the aforementioned reasons, Claims 1-7 are rejected under 35 U.S.C. 101.
Applicant’s arguments, see Remarks, filed September 12, 2025, 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 the generation of queries responsive to receiving inquiries, routing the queries to devices of practice sites, or updating GUIs of the sponsor devices, e.g. see pg. 8 of Remarks – Examiner disagrees.
As an initial matter, Examiner notes that the feature of generating queries responsive to and using received inquiries represents new matter, e.g. see Rejections under 35 U.S.C. 112(a) as shown above. However, MacClary teaches receiving patient selections and/or a selection of a graphical icon initiating a new query (i.e. either of which, given the broadest reasonable interpretation, is reasonably interpreted as “inquiries”), and in response generating a query to be sent to clinicians, e.g. see MacClary [0034]-[0035], Fig. 2. Additionally, the system sends the queries to the appropriate parties, e.g. see MacClary [0025] and [0035], and displays queries that have been responded to and those that are still pending, e.g. see MacClary [0038], Fig. 2. Hence, MacClary is not deficient to teach the limitations it has been cited for.
For the aforementioned reasons, Claims 1-7 are rejected under 35 U.S.C. 103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 PST.
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.
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/JOHN P GO/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681