DETAILED ACTION
The present office action represents a final action on the merits.
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 .
Priority
This application claims the priority date of a Korean Foreign Application KR2020-0083340 of July 7, 2020, 371 of PCT/KR2021/008507 of July 5, 2021.
Status of Claims
Claims 1, 6, and 11 are amended, claims 12-14 are cancelled, and claims 1, 4-6, and 9-11 are pending.
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, 4-6, and 9-11 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.
Claims 1 and 4-5 are drawn to a method for selecting a clinical trial subject using an apparatus, which is within the four statutory categories (i.e., process), Claims 6 and 9-10 are drawn to a non-transitory computer-readable recording medium having a computer program stored therein, which is within the four statutory categories (i.e., machine), and Claim 11 is drawn an apparatus for selecting a clinical trial subject, which is within the four statutory categories (i.e., machine),
Claims 1 and 4-5 recite method for selecting a clinical trial subject to be performed by an apparatus, for selecting a clinical trial subject comprising a processor, a communication interface, and an input/output interface, the method comprising:
extracting a plurality of first data corresponding to a plurality of first candidate subjects from medical data stored in a database by using a first query, and storing the extracted first data in a database;
displaying a plurality of unit queries on a screen for setting a second query based on the plurality of first data;
receiving a user input in response to the displaying the plurality of unit queries through the input/output interface;
generating the second query based on the user input;
changing the at least some of the plurality of unit queries or the combination of the at least some of the plurality of unit queries based on the user input;
selecting a plurality of second candidate subjects from among the plurality of first candidate subjects by using the second query corresponding to the plurality of first data and a plurality of variable conditions;
selecting a plurality of third candidate subjects from among the plurality of second candidate subjects based on a displaying of information corresponding to at least a part of second data corresponding to the plurality of second candidate subjects; and
selecting at least one clinical trial subject based on the displaying of information corresponding to at least a part of third data corresponding to each of the plurality of third candidate subjects,
wherein the information corresponding to the at least a part of the second data corresponding to the plurality of second candidate subjects includes information classified by preset items and displayed,
wherein the selecting of the plurality of third candidate subjects from among the plurality of second candidate subjects comprises:
changing a condition corresponding to at least one item among the preset items based on receiving the user input regarding at least a part of the information classified by the preset items and displayed; and
selecting the plurality of third candidate subjects based on the changed condition;
wherein the information classified by the preset items and displayed includes statistical information for each item of the plurality of second candidate subjects,
wherein the preset items include age, gender, diagnosis, a physician in charge, a medical department, hospital visit history, medication history, or test information,
wherein the plurality of variable conditions include a combination of at least some of a plurality of unit queries,
wherein the second query is generated based on the combination of the at least some of the plurality of unit queries,
wherein each of the plurality of unit queries corresponds to one of preset simple conditional queries,
wherein the first data includes scheduled visit dates of the plurality of first candidate subjects,
wherein the screen displays, for each month, a cumulative number of the scheduled visit dates corresponding to the plurality of second candidate subjects, and
wherein the cumulative number is updated in real time, based on the second query, which is interactively modified in response to the user input,
wherein the method further comprises:
performing data-type-specific filtering, including determining, according to a data type, whether a predetermined word is included for text data, whether one or more categories are included for categorical data, and whether a numerical range is widened or narrowed for numerical data,
performing, in real time, a simulation of a number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates based on the first query, the second query, the changed condition and the data-type-specific filtering,
updating, in real time, the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates,
displaying, in real time, the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates through the input/output interface, and
communicating, via the communication interface, information on the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates to an external device, thereby enabling coordination of clinical trial participation without requiring physical co-location of the apparatus and the external device
Claims 6 and 9-10 recite a non-transitory computer-readable recording medium having a computer program stored therein,
wherein the computer program is, when being executed by a processor, configured to perform a method comprising:
extracting a plurality of first data corresponding to a plurality of first candidate subjects from entire medical data stored in a database by using a first query, and store the extracted first data in the database;
displaying a plurality of unit queries on a screen for setting a second query based on the plurality of first data;
receiving a user input in response to the displaying the plurality of unit queries through an input/output interface;
generating the second query based on the user input;
changing the at least some of the plurality of unit queries or the combination of the at least some of the plurality of unit queries based on the user input;
selecting a plurality of second candidate subjects from among the plurality of first candidate subjects by using the second query corresponding to the plurality of first data and a plurality of variable conditions;
selecting a plurality of third candidate subjects from among the plurality of second candidate subjects based on displaying of information corresponding to at least a part of second data corresponding to the plurality of second candidate subjects; and
selecting
wherein the information corresponding to the at least a part of the second data corresponding to the plurality of second candidate subjects includes information classified by preset items and displayed,
wherein the selecting of the plurality of third candidate subjects from among the plurality of second candidate subjects comprises:
changing a condition corresponding to at least one item among the preset items based on receiving the user input regarding at least a part of the information classified by the preset items and displayed; and
selecting the plurality of third candidate subjects based on the changed condition;
wherein the information classified by the preset items and displayed includes statistical information for each item of the plurality of second candidate subjects,
wherein the preset items include age, gender, diagnosis, a physician in charge, a medical department, visit history, medication history, or test information,
wherein the plurality of variable conditions include a combination of at least some of a plurality of unit queries,
wherein the second query is generated based on the combination of the at least some of the plurality of unit queries,
wherein each of the plurality of unit queries corresponds to one of preset simple conditional queries,
wherein the first data includes scheduled visit dates of the plurality of first candidate subjects,
wherein the screen displays, for each month, a cumulative number of the scheduled visit dates corresponding to the plurality of second candidate subjects, and
wherein the cumulative number is updated in real time, based on the second query, which is interactively modified in response to the user input,
wherein the method further comprises:
performing data-type-specific filtering, including determining, according to a data type, whether a predetermined word is included for text data, whether one or more categories are included for categorical data, and whether a numerical range is widened or narrowed for numerical data,
performing, in real time, a simulation of a number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates based on the first query, the second query, the changed condition and the data-type-specific filtering,
updating, in real time, the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates,
displaying, in real time, the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates through the input/output interface, and
communicating, via the communication interface, information on the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates to an external device, thereby enabling coordination of clinical trial participation without requiring physical co-location of the apparatus and the external device.
Claim 11 recites an apparatus for selecting a clinical trial subject, the apparatus comprising:
a communication interface;
a display;
an input/output interface;
a processor electrically connected to the communication interface and the display; and
a memory electrically connected to the processor,
wherein the processor is, when the memory is executed, configured to:
extract a plurality of first data corresponding to a plurality of first candidate subjects from medical data stored in a database by using a first query, and store the extracted first data in a database;
display a plurality of unit queries on a screen for setting a second query based on the plurality of first data;
receive a user input in response to the displaying the plurality of unit queries through an input/output interface;
generate the second query based on the user input;
change the at least some of the plurality of unit queries or the combination of the at least some of the plurality of unit queries based on the user input;
select a plurality of second candidate subjects from among the plurality of first candidate subjects by using ;
select a plurality of third candidate subjects from among the plurality of second candidate subjects based on displaying of information corresponding to at least a part of second data corresponding to the plurality of second candidate subjects; and
select
wherein the information corresponding to the at least a part of the second data corresponding to the plurality of second candidate subjects comprises information classified by preset items and displayed,
wherein the selecting of the plurality of third candidate subjects from among the plurality of second candidate subjects comprises:
changing a condition corresponding to at least one item among the preset items based on receiving the user input regarding at least a part of the information classified by the preset items and displayed; and
selecting the plurality of third candidate subjects based on the changed condition;
wherein the information classified by the preset items and displayed includes statistical information for each item of the plurality of second candidate subjects,
wherein the preset items include age, gender, diagnosis, a physician in charge, a medical department, hospital visit history, medication history, or test information,
wherein the plurality of variable conditions include a combination of at least some of a plurality of unit queries,
wherein the second query is generated based on the combination of the at least some of the plurality of unit queries,
wherein each of the plurality of unit queries corresponds to one of preset simple conditional queries,
wherein the first data includes scheduled visit dates of the plurality of first candidate subjects,
wherein the screen displays, for each month, a cumulative number of the scheduled visit dates corresponding to the plurality of second candidate subjects, and
wherein the cumulative number is updated in real time, based on the second query, which is interactively modified in response to the user input,
wherein the processor is configured to:
perform data-type-specific filtering, including determining, according to a data type, whether a predetermined word is included for text data, whether one or more categories are included for categorical data, and whether a numerical range is widened or narrowed for numerical data,
perform, in real time, a simulation of a number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates based on the first query, the second query, the changed condition and the data-type-specific filtering,
update, in real time, the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates,
display, in real time, the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates through the input/output interface, and
communicating, via the communication interface, information on the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates to an external device, thereby enabling coordination of clinical trial participation without requiring physical co-location of the apparatus and the external device.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity (e.g., gathering candidate information; managing candidate information, in this case selecting a clinical trial subject.). The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 4-5 and 9-10 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
The additional elements from claim 1 include:
an apparatus (apply it, MPEP 2106.05(f)).
The additional elements from claims 1, 6, and 11 include:
a processor (apply it, MPEP 2106.05(f)).
a communication interface (apply it, MPEP 2106.05(f)).
an input/output interface (apply it, MPEP 2106.05(f)).
stored in a database (apply it, MPEP 2106.05(f)).
storing the extracted first data in a database (apply it, MPEP 2106.05(f)).
a screen (apply it, MPEP 2106.05(f)).
an external device
The additional elements from claim 6 include:
non-transitory computer-readable recording medium having a computer program stored therein (apply it, MPEP 2106.05(f)).
wherein the computer program is, when being executed by a processor, configured to (apply it, MPEP 2106.05(f)).
The additional elements from claim 11 include:
an apparatus for selecting a clinical trial subject, the apparatus comprising (apply it, MPEP 2106.05(f)).
a processor electrically connected to the communication interface and the display (apply it, MPEP 2106.05(f)).
a memory electrically connected to the processor, wherein the processor is, when the memory is executed, configured to (apply it, MPEP 2106.05(f)).
Claims 1, 4-6, and 9-11 are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of “an apparatus”, “a database”, “a processor”, “communication interface”, “a display”, “a memory”, “processor”, “an input/output interface”, and “screen” which amounts to merely invoking a computer as a tool to perform the abstract idea e.g. see Specification Pages [3-5 and 7-9]. (see MPEP 2106.05(f));
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., Pages [3-5 and 7-9], of the Specification discloses that the additional elements (i.e., an apparatus, a database, a processor, communication interface, a display, a memory, processor, an input/output interface, and screen) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention extracts medical data;
Storing and retrieving information in memory, e.g., see Versata Dev. Group, Inc., v. SAP Am., Inc. – the current invention stores extracted data in a database.
Dependent claims 4-5 and 9-10 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than those found in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. 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 selecting a clinical trial subject 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, 4-6, and 9-11 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free from Prior Art
Examiner acknowledges the limitations in claims 1, 6, and 11:
extracting a plurality of first data corresponding to a plurality of first candidate subjects from medical data stored in a database by using a first query, and storing the extracted first data in a database;
displaying a plurality of unit queries on a screen for setting a second query based on the plurality of first data;
receiving a user input in response to the displaying the plurality of unit queries through the input/output interface;
generating the second query based on the user input;
changing the at least some of the plurality of unit queries or the combination of the at least some of the plurality of unit queries based on the user input;
selecting a plurality of second candidate subjects from among the plurality of first candidate subjects by using the second query corresponding to the plurality of first data and a plurality of variable conditions;
selecting a plurality of third candidate subjects from among the plurality of second candidate subjects based on a displaying of information corresponding to at least a part of second data corresponding to the plurality of second candidate subjects;
selecting at least one clinical trial subject based on the displaying of information corresponding to at least a part of third data corresponding to each of the plurality of third candidate subjects,
wherein the information corresponding to the at least a part of the second data corresponding to the plurality of second candidate subjects includes information classified by preset items and displayed,
wherein the selecting of the plurality of third candidate subjects from among the plurality of second candidate subjects comprises:
changing a condition corresponding to at least one item among the preset items based on receiving the user input regarding at least a part of the information classified by the preset items and displayed; and
selecting the plurality of third candidate subjects based on the changed condition;
wherein the information classified by the preset items and displayed includes statistical information for each item of the plurality of second candidate subjects,
wherein the preset items include age, gender, diagnosis, a physician in charge, a medical department, hospital visit history, medication history, or test information,
wherein the plurality of variable conditions include a combination of at least some of a plurality of unit queries,
wherein the second query is generated based on the combination of the at least some of the plurality of unit queries,
wherein each of the plurality of unit queries corresponds to one of preset simple conditional queries,
wherein the first data includes scheduled visit dates of the plurality of first candidate subjects,
wherein the screen displays, for each month, a cumulative number of the scheduled visit dates corresponding to the plurality of second candidate subjects, and
wherein the cumulative number is updated in real time, based on the second query, which is interactively modified in response to the user input,
performing data-type-specific filtering, including determining, according to a data type, whether a predetermined word is included for text data, whether one or more categories are included for categorical data, and whether a numerical range is widened or narrowed for numerical data,
performing, in real time, a simulation of a number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates based on the first query, the second query, the changed condition and the data-type-specific filtering,
updating, in real time, the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates,
displaying, in real time, the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates through the input/output interface, and
communicating, via the communication interface, information on the number of the at least one clinical trial subject and the cumulative number of the scheduled visit dates to an external device, thereby enabling coordination of clinical trial participation without requiring physical co-location of the apparatus and the external device.
are free from prior art when considered in combination with the other limitations, and are not subject to any prior art rejections under 103. The closest prior art is:
Fusari (U.S. Pub. No. 2016/0314280 A1) Paragraphs [0043], [0049], [0065], [0101]-[0102] and FIGS 9a-9b discuss the users can query the data contained in one or more databases where the query can relate to an identification of candidates for clinical trial and the patient data can be stored locally in one or more databases of the data providers and a query for patient candidates and the results can be displayed; to identify a cohort of patient candidates the user can issue a query and the user can begin with broad criteria search and then narrow the criteria as the user understands characteristics of patients meeting the criteria entered by the user
Fusari (U.S. Pub. No. 2016/0314280 A1) (Paragraphs [0058], [0065], [0104], [0107] and FIGS 9d-9i discuss an input/output device can include a display unit for displaying graphical user interfaces and predetermined criteria can be inputted directly into the query, and additional criteria can be realized and considered while exploring the characteristics of the patient cohort. Search results can be saved, and different versions of queries for a study can be compared (either overlaid or show a side-by-side) to demonstrate how changes in query criteria affect the cohort populations and a query for patient candidates and the user can also narrow down and/or expand search results by entering “must have” and/or “cannot have” criteria; the user can issue queries that can begin with broad criteria search and then narrow the criteria as the user understands characteristics of patients meeting the criteria entered by the user.);
Fusari (U.S. Pub. No. 2016/0314280 A1) (Paragraph [0065] discusses the user can issue a query that can perform a search using various inclusion and/or exclusion parameters that can relate to clinical data including for example, but not limited to, demographic data, diagnoses, procedures, vital statistics such as blood pressure and weight, medications, lab test results and/or values, genomic sequence, mutations, variants, biomarkers, gene and/or protein expression levels, and/or any other information, the query can begin with broad criteria and then.);
Fusari (U.S. Pub. No. 2016/0314280 A1) (Paragraphs [0065] and [0104] discuss to identify the patients, the user can issue a query that can perform a search using various inclusion and/or exclusion parameters that can relate to clinical data and the user can begin with broad criteria search and then narrow the criteria as the user understands characteristics of patients meeting the criteria entered by the user.);
Fusari (U.S. Pub. No. 2016/0314280 A1) (Paragraph [0104] and FIGS. 9c-9h discuss the user interface can allow the user to narrow the searching criteria by entering various parameters (e.g., “potential patient candidates must have acute myocardial infraction”) and the result of such narrowing is shown in the map of potential patient candidates in an exemplary user interface can candidates can be further narrowed using information about laboratory results of and other user interfaces can contain information about “demographics”, “diagnoses”, “medications”, “procedures”, etc. can also be generated for the user to view. The user can also narrow down and/or expand search results by entering “must have” and/or “cannot have” criteria.)
Fusari (U.S. Pub. No. 2016/0314280 A1) (Paragraphs [0101]-[0104] discuss the user can select various criteria and the interface can show a distribution of potential patient candidates for example, based on a distance from a particular location (e.g., the user, a potential site, etc.), then broken down by various criteria (e.g., age, gender, medical condition, diagnosis, etc.), a histogram of diagnoses associated with potential patient candidates and allow the user to narrow the searching criteria by entering various parameters.)
Fusari (U.S. Pub. No. 2016/0314280 A1) in view of Walpole (U.S. Pub. No. 2019/0206521 A1) (Paragraphs [0064] and [0066] discuss schedule of future actions to be taken under the trial is updated and fed back to the scheduling system and any deviation between the actual and estimated time and events table can be used to more accurately estimate both actual and estimated times and generate a forecast for future estimated times and the completion of those events, which is critical for the study coordinator to monitor during the clinical trial and, as such, the coordinator is notified about progress.
Fusari (U.S. Pub. No. 2016/0314280 A1) in view of Walpole (U.S. Pub. No. 2019/0206521 A1) and Schmidt (U.S. Pub. No. 2009/0198504 A1) (Paragraphs [0003], [0097] and FIGS. 5, 17-18 discuss subsequent assessment visits and a GUI for a subject that displays visit dates scheduled including a baseline visit and subsequent visits for example, scheduled visits at increments of 7 days or weeks; a visit week is assigned for each visit (e.g., week 0, week 1, week 2, etc.).).
It would not be obvious to combine all of the references, accordingly, the 103 rejection is withdrawn.
Response to Arguments
Applicant’s arguments filed 2/20/2026 have been fully considered.
Rejections under 35 U.S.C. 101:
With respect to claim 1 and the Prong 1 35 U.S.C. 101 rejection, Applicant’s amendment fails to overcome the previous rejection. Claim 1 as amended recites an abstract idea, a method of organizing human activity. See MPEP 2106.04(a)(2)(II)(C) Managing Personal Behavior or Relationships or Interactions Between People. Applicant argues, “the Office did not examine the claims as a whole nor in light of the specification. Applicant respectfully submits that the claims pass Step 2A, Prong 1 of the Alice/Mayo Test and/or Step 2A, Prong 2 of the Alice/Mayo test and are therefore eligible subject matter under 35 U.S.C. § 101.” (Remarks, page 13). Examiner respectfully disagrees. Here, Applicant’s claims are managing personal behavior or relationships or interactions between people - the claims are directed to selecting a clinical trial subject. “Extracting a plurality of first data corresponding to a plurality of first candidate subjects ... selecting a plurality of second candidate subjects from among the plurality of first candidate subjects ... selecting a plurality of third candidate subjects from among the plurality of second candidate subjects ... selecting a clinical trial subject based on the displaying of information corresponding to at least a part of third data corresponding to each of the plurality of third candidate subjects ... display the plurality of unit queries .. .receiving a user input in response to the displaying the plurality of unit queries ... generating the second query based on the user input; and changing the at least some of the plurality of unit queries ..." is not a technical problem rooted in the technology.
Practical application is a way to overcome the Prong 2 35 U.S.C 101 rejection, however, here, as written, the claims do not result in a practical application. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicate that a practical application may be present where the claimed invention provides a technical solution to a technical problem. Applicant states, “the methods described above, when viewed either individually or as an ordered combination, as a whole do amount to significantly more than any abstract idea which may be present in the claims and are therefore eligible under Step 2A, Prong 2. The present claims integrate any abstract idea into a practical application, such as screening high-accuracy medical data from a large amount of medical data of medical institutions to select a clinical trial subject.” (Remarks, page 14). Examiner respectfully disagrees. The limitations in the Application, are part of the abstract idea and the abstract idea cannot be used to integrate itself into a practical application and therefore is not an additional element. Here, the additional elements, including “an apparatus”, “a database”, “a processor”, “communication interface”, “a display”, “a memory”, “processor”, “an input/output interface”, and “screen”, do not result in a practical application or technical improvement, as they are recited at an apply it level, as stated above. The Application is an improvement to the abstract idea and does not improve any computer element or any other technology.
All components in the claims are being used for their intended purpose and as written do not result in a practical application or significantly more than the abstract idea. Applicant states, “As a useful analogy, Applicant points to Example 42 in the Revised Guidance, which is directed to a method for transmission of notifications when medical records are updated. In particular, the claim at issue in Example 42 is directed to a method comprising (1) storing information in a standardized format about a patient's condition; (2) providing more access to users over a network so that any one of the users can update the information about the patient's condition in the collection of medical records in real time through a graphical user interface; (3) converting the non-standardized updated information into a standardized format; (4) storing the standardized updated information; (5) automatically generating a message containing the updated information about the patient's condition; and (6) transmitting the message to all of the users over the computer network in real time, so that each user has immediate access to up-to- date patient information.” (Remarks, page 14). Examiner respectfully disagrees. Here, Example 42 is distinguishable from Applicant’s limitations, specifically, the current application does not convert the non-standardized updated information into a standardized format. Further, the Application is not directed to a method for transmission of notifications when medical records are updated. Accordingly, individually and in combination, the additional elements do not provide significantly more than the abstract idea. The claims recite features that are "well-understood, routine, conventional activities”. There is no technological improvement to any additional element – reducing the burden of data processing and improving the speed, accuracy, convenience, and efficiency of selection of a clinical trial subject is not a technical improvement. For the reasons stated above, claims 6 and 11 similarly fails to overcome the 35 U.S.C. 101 rejection.
Rejections under 35 U.S.C. 103:
Applicant’s arguments with regard to 103 are moot because the 103 rejection has been withdrawn.
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 DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:15PM.
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686