Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status Of Claims
This action is in reply to the application filed on 10/09/2024.
Claims 1-7 are currently pending and have been examined.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “unit” (a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action: Claims 1-5 recite “acquisition processing unit,” “generation processing unit,” “patient reported outcome acquisition processing unit,” “transfer processing unit,” “clinical trial object person selection processing unit,” and “transmission processing unit”. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 an abstract idea without significantly more.
Claims 1-7: Step 2A Prong One
Claim 1 recites acquiring clinical trial protocol information including a plurality of survey items defined for each clinical trial in advance, generating survey form information used to survey a prognosis of the patient by converting the plurality of survey items included in the acquired clinical trial protocol information based on a conversion rule stored in advance, distributing the generated survey form information and acquiring patient reported outcome information indicating an answer result of the patient to the survey form information, and transferring the acquired patient reported outcome information. Claims 6 and 7 recite similar limitations.
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing personal behavior by manually following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. But for the recitation of generic computer components, these limitations encompass a user acquiring clinical trial protocol information including a plurality of survey items defined for each clinical trial in advance, generating survey form information used to survey a prognosis of the patient by converting the plurality of survey items included in the acquired clinical trial protocol information based on a conversion rule stored in advance, distributing the generated survey form information and acquiring patient reported outcome information indicating an answer result of the patient to the survey form information, and transferring the acquired patient reported outcome information. These steps could be carried out manually by a user following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. Claims 6 and 7 recite similar limitations.
Claims 2-5 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. For example, but for the recitation of generic computer components, the claims further recite acquiring additional information, selecting clinical trial target patient based on clinical trial conditions, converting data item and generating survey form information, determining whether acquired patient reported outcome information includes an answer result indicating suspicious harmful phenomenon by the medicine, and if so, sending the information to a medical institution.
Claims 1-7: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with insignificant, extra-solution data gathering activity, and adding limitations similar to adding the words “apply it” to the abstract idea. Claim 1 recites the additional elements of an apparatus transmitting data between information processing apparatus and terminal apparatuses.
Claims 1-7, directly or indirectly, recite the following generic computer components: “information processing apparatus,” and “patient reported outcome collection support apparatus,” which are similar to adding the words “apply it” to the abstract idea. The written description discloses that the recited computer components encompass generic components including All the processing units 11 to 16 are implemented by causing the hardware processor of the control unit 1 to execute the pogroms stored in the program storage unit 2“ (see at least Paragraph [0066]), and “The server apparatus SV includes a control unit 1 using a hardware processor such as a central processing unit (CPU). A storage unit including a program storage unit 2 and a data storage unit 3 and a communication interface (the interface will be referred to as I/F hereinafter) 4 are connected to the control unit 1 via a bus 5“ (see at least Paragraph [0057]), and ”The network NW includes, for example, a wide area network including the Internet as a core, and an access network used to access the wide area network. As the access network, for example, a public communication network using a wires or wireless network, a local area network (LAN) using a wires or wireless network, and a cable television (CATV) network are used“ (see at least Paragraph [0055]). See MPEP 2106.05 (h). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Claims 1-7: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Receiving and transmitting data over a network (i.e. receiving and communicating data or signals) has been recognized as well-understood, routine, and conventional activity of a general-purpose computer (see MPEP 2106.05(d) and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014)).
Insignificant, extra solution, data gathering activity has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)). Therefore, the high-level recitation of an output of results also fails to include additional elements that are sufficient to amount to significantly more than the judicial exception.
Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Vries et al., U.S. Patent Application Publication 20040006553 A1.
Claim 1:
De Vries discloses the following limitations:
A patient reported outcome collection support apparatus capable of transmitting, via a network, information data between an information processing apparatus used by a clinical trial operator of a medicine and each of a plurality of terminal apparatuses used by a plurality of patients or substitutes thereof, comprising (see at least Abstract, The clinical trial consists of the inventive system (10); a computing device (12); application database (11a), the personnel database (11b), and the trial data database; computing devices (14a), (14b), and (14c) for use by trial participants and trial investigators; computing device (15); computer devices (16a), (16b), and (16c) for use by trial monitors; computing devices (18a), (18b), and (18c) for use by laboratories to connect via the network (20); Paragraph 29, The present invention allows the clinical trial to be conducted over a network, e.g., the Internet or a telephone grid. The participants use computing devices connected to the network to perform transactions of the clinical trial. Each of the tests comprises one or more periods of execution or intervals, test elements, and a plurality of exception limits. All the trial participants are listed in a database and are assigned access and validation levels. The clinical trial is performed according to the procedural guidelines by carrying out all of the transactions of the clinical trial. The executed transactions are stored in a database):
an acquisition processing unit configured to acquire clinical trial protocol information including a plurality of survey items defined for each clinical trial in advance from the information processing apparatus via the network (see at least Paragraph 11, A trial protocol will be formulated to achieve the desired goals of the trial, and the protocol will be presented for review and approval before an Institutional Review Board (IRB); Paragraph 38, The trial administrator selects the trial monitors, persons responsible with assuring the veracity of the study, and the trial investigators, persons such as nurses and doctors who will actually administer the study or trial. The trial administrator will further define procedural guidelines for the performance of the clinical trial; Paragraph 39, The present invention allows the clinical trial to be conducted over a network, e.g., the Internet or a telephone grid. The participants use computing devices connected to the network to perform transactions of the clinical trial. The clinical trial is performed according to the procedural guidelines by carrying out all of the transactions of the clinical trial; Paragraph 41, The trial participants and the trial investigators are asked to reply to a plurality of questions or enter information corresponding to various elements of the test. Each of the entered values is immediately evaluated to determine if values entered are outside of the exception limits. The exception limits may be default or custom set by the trial administrator; Paragraph 62, Computing device 12 maintains and utilizes databases 11 which include an application database 11a for defining trials, i.e., scopes of studies, a personnel database 11b for defining persons authorized to access the inventive system residing on computing device 12, and a trial database 11c for saving and maintaining information collected with reference to the trials of the applications database 11a; Paragraph 66, Before clinical trials are carried out they are defined by values that may be placed into the application database 11a (FIG. 1). The entity, person, or persons creating, authoring, or instigating the trial driven by the inquiry into the hypothesis under study in a particular clinical trial is (or are) called the trial administrator. The trial administrator defines every aspect of any clinical trial, which may be administered by the inventive system; Paragraph 67);
a generation processing unit configured to generate survey form information used to survey a prognosis of the patient by converting the plurality of survey items included in the acquired clinical trial protocol information based on a conversion rule stored in advance (see at least Paragraph 98, the clinical trial management program of the present invention, shown in FIG. 5, may read in the parameters of the trial established in the application data database 11a (FIG. 1) and automatically generate the appropriate questionnaires and forms to allow the trial participants of the trial to fill in the results of tests 77 (FIG. 4f));
a patient reported outcome acquisition processing unit configured to distribute the generated survey form information to the terminal apparatus via the network and acquire patient reported outcome information indicating an answer result of the patient to the survey form information from the terminal apparatus via the network (see at least Paragraph 41, The trial participants and the trial investigators are asked to reply to a plurality of questions or enter information corresponding to various elements of the test. Each of the entered values is immediately evaluated to determine if values entered are outside of the exception limits. The exception limits may be default or custom set by the trial administrator; Paragraph 73, The tests table 76 (FIG. 3b), in turn, is defined in step 176 by listing the tests, e.g., the blood; the urine; the weight; and a quality of life questionnaire, to be performed and replied to. Elements of each test 76 may be further defined in step 178 in the elements table 78 (FIG. 3b), which may comprise test parameters; Paragraph 98, shown in FIG. 5, may read in the parameters of the trial established in the application data database 11a (FIG. 1) and automatically generate the appropriate questionnaires and forms to allow the trial participants of the trial to fill in the results of tests 77 (FIG. 4f); Paragraph 118, s set forth in FIG. 5, the trial participants start to enter test result data in step 212. The test screens 76a-c (FIGS. 4d-4f) are dynamically generated by the clinical trial management program 200. In step 210 the actions required, i.e., defined in the application data database 11a (FIG. 1), are evaluated and only these required are presented. Furthermore, data entered in response may lead to additional options to be displayed); and
a transfer processing unit configured to transfer the acquired patient reported outcome information to the information processing apparatus used by the clinical trial operator via the network (see at least Paragraph 29, The present invention allows the clinical trial to be conducted over a network, e.g., the Internet or a telephone grid. The participants use computing devices connected to the network to perform transactions of the clinical trial. Each of the tests comprises one or more periods of execution or intervals, test elements, and a plurality of exception limits. All the trial participants are listed in a database and are assigned access and validation levels. The clinical trial is performed according to the procedural guidelines by carrying out all of the transactions of the clinical trial. The executed transactions are stored in a database; Paragraph 149, Once the trial monitor is properly logged into the application running on the computing device 12 (FIG. 1), they will have access to the entries of the trial participant related data stored in the personnel databases 11b (FIG. 1) and in the trial data database 11c (FIG. 1) referenced according to specific trial investigators. In step 240, the trial monitors will be able to get complete reports of transactions performed by individual trial investigators, e.g., 84 (FIG. 4g), identified by data stamps including the following; Paragraph 170, Simultaneously, messages are routed to the trial administrator's computing devices 15 (FIG. 1), which can also be physically or wirelessly connected to the network 20 or an associated health care provider. For example, if the trial participant is unable to be reached, a message, which can be a beep, a voice message, an e-mail, etc., is sent to notify the trial administrator or the associated health care provider to initiate a search for the trial participant. Alternatively, the trial participant can immediately report any form of adverse event, in which case the trial administrator or the associated health care provider will also be notified ).
Claims 6 and 7 recite substantially similar method and non-transitory computer-readable storage medium limitations to those of apparatus claim 1 and, as such, are rejected for similar reasons as given above.
Claim 5:
De Vries discloses the limitations as shown in the rejection above. De Vries further discloses the following limitations:
a transmission processing unit configured to determine whether the acquired patient reported outcome information includes an answer result indicating a suspicious harmful phenomenon by the medicine, and if the answer result indicating the suspicious harmful phenomenon is included, transmit the patient reported outcome information to the information processing apparatus used by a medical institution via the network (see at least Paragraph 17, The parameters studied in a clinical trial may include subjective findings such as trial participants' complaints, satisfaction, or symptoms. Objective parameters may also be studied, which parameters include physical examination, laboratory or radiological tests, and other measured findings. Finally, a separate parameter followed in almost all trials is incidence of adverse events or complications from the treatment; Paragraph 156, This may allow the trial monitor to address each specific issue with the trial investigator and to reconcile the problem in the trial data. Separate reports may further be generated for every adverse event reported by the trial investigator. Each report may list the adverse event and the follow-up necessary to be performed by the trial investigator in order to document the ultimate consequences to the trial participant).
Claim Rejections - 35 USC § 103
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 of this title, if the differences between the claimed invention and the prior art axe 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication US 20040006553 A1 to De Vries et al. in view of WIPO Application Publication WO 2022/060949 A1 to Das et al.
Claim 2:
De Vries discloses the limitations as shown in the rejection above.
wherein the acquisition processing unit further acquires information indicating a clinical trial condition from the information processing apparatus, and the patient reported outcome collection support apparatus further comprises (see at least Paragraph 8, Typically, a clinical trial is carried out in the following manner: At the initiation of a clinical trial, the company sponsoring the trial or the CRO contracted for the trial (the "sponsor") will select a number of trial investigators. These trial investigators are usually doctors who specialize in the area of medicine relevant to the new medical technology under study. The trial investigators are chosen based upon several criteria; Paragraphs 9, 10; Paragraph 11, A trial protocol will be formulated to achieve the desired goals of the trial; Paragraph 165, One of the major components of clinical research is the participation of the patients in performing the chore of replying to subjective questionnaires. These questionnaires typically pertain to issues of quality of life, pain scales, and symptom diaries, to name just a few. In addition, subjects involved in clinical research are often asked to take medications that may require strict doses and regimens for route of administration and frequency of consumption; Paragraph 167, The present invention trains the trial participants to use handheld devices and other electronic data entry clients, such as wireless telephones, to answer questions and to report adverse events. In a fashion described above where the questionnaires are formatted electronically to enable entry of subjective data directly from the trial participants' computing devices 14 (FIG. 1) over the network 20, the same can be accomplished with the use of wireless technologies where the computing device 14 is connected to the network 20 or even to the computing device 12 itself via wireless means)
a clinical trial object person selection processing unit configured to select a clinical trial target patient satisfying the acquired clinical trial condition from the plurality of patients by referring to information of the plurality of patients (see at least Paragraph 12, Begin recruiting trial participants that fit the inclusion/exclusion criteria of the protocol; Paragraph 17, These reports generally serve as the data collection vehicle with various parameters studied as outlined in the particular protocol. The parameters studied in a clinical trial may include subjective findings such as trial participants' complaints, satisfaction, or symptoms. Objective parameters may also be studied, which parameters include physical examination, laboratory or radiological tests, and other measured findings. Finally, a separate parameter followed in almost all trials is incidence of adverse events or complications from the treatment).
De Vries may not specifically disclose the following limitations, but Das as shown does:
attribute information, medical treatment information, and prescription information of the plurality of patients (see at least Paragraph 2, Clinical trials in medicine are research studies that are used to test and evaluate various medical treatments, drugs, or devices under development. Typically, clinical trials define certain candidate patient “eligibility criteria” (or “inclusion criteria”) specifying the characteristics of candidate patients who may be eligible to participate in a specified trial, and “disqualifying criteria” (or “’exclusion criteria”) specifying the characteristics of patients who are not eligible for participation in the trial. For example, the inclusion criteria may include the age of the candidate patient, the gender of the candidate patient, the candidate patient may be required to have been diagnosed with the medical condition that the experimental therapy is seeking to address, a stage of medical treatment that patients should be at, the state of disease or condition progression the candidate patient should be at, what previous treatments a patient may have received prior to entering the clinical trial, and the like. The disqualifying criteria defining the characteristics of patients who are not eligible to participate in a specified trial may include, for example, a stage of a disease beyond which a patient would be ineligible for inclusion in the trial, previous or current treatments that disqualify a patient from participating in the trial, and the like)
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of the system and method of patient information collection of de Vries with the various information of Das with the motivation of providing the benefit and convenience “… to automatically identify or select a candidate patient who satisfies clinical trial inclusion criteria and is statistically likely to meet one or more clinical trial endpoints” (Das, see at least the Abstract).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication US 20040006553 A1 to De Vries et al. in view of US Patent Application Publication US 2018/0060539 A1 to Lin et al.
Claim 3:
De Vries discloses the limitations as shown in the rejection above. De Vries may not specifically disclose the following limitations, but Lin as shown does:
wherein the generation processing unit converts, in accordance with the conversion rule, data of the survey item created by a first application into data that can be handled by a second application (see at least Paragraph 7, It is better to use the standard forms to collect data from the beginning of a trial. However, few people design case report form based on CDISC standards), and
the second application generates the survey form information (see at least Fig. 4; Paragraph 8, The present invention provides a system to generate the standard-compliant electronic case report form (eCRF). This system comprises a standard-compliant eCRF designer module and a standard rules validator. The standard-compliant eCRF designer module further comprises a standard specification analyzer, a standard-compliant question generator and a standard-compliant CRF design interface; Paragraph 10, The standard-compliant question generator connected to the standard specification analyzer, is used to transform the standard-compliant question information to a standard-compliant electronic question object; Paragraph 47, User selects different categories of the standard-compliant case report form database 216 based on label 514 switch in the standard-compliant case report form design interface 500 to generate the standard-compliant eCRF. Clinical questions in each standard-compliant eCRF is generated based on different standards and classification 516, 524 displayed to users)
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of the system and method of patient information collection of de Vries with the feature of Lin with the motivation of providing the convenience and benefit to “… simplify the design process” (Lin, see at least Paragraph 7).
Claim 4:
The combination of De Vries/Lin discloses the limitations as shown in the rejection above. De Vries may not specifically disclose the following limitations, but Lin as shown does:
wherein the generation processing unit converts the data of the survey item created in a table format by the first application into data of a document format that can be handled by the second application (see at least Paragraph 7, It is better to use the standard forms to collect data from the beginning of a trial. However, few people design case report form based on CDISC standards), and
the second application generates the survey form information of the document format including question information corresponding to the survey item and answer candidate information therefor (see at least Fig. 4; Paragraph 8, The present invention provides a system to generate the standard-compliant electronic case report form (eCRF). This system comprises a standard-compliant eCRF designer module and a standard rules validator. The standard-compliant eCRF designer module further comprises a standard specification analyzer, a standard-compliant question generator and a standard-compliant CRF design interface; Paragraph 10, The standard-compliant question generator connected to the standard specification analyzer, is used to transform the standard-compliant question information to a standard-compliant electronic question object; Paragraph 47, User selects different categories of the standard-compliant case report form database 216 based on label 514 switch in the standard-compliant case report form design interface 500 to generate the standard-compliant eCRF. Clinical questions in each standard-compliant eCRF is generated based on different standards and classification 516, 524 displayed to users; Paragraph 48, Each wording of clinical question complies with standard document suggestion 520. The menu follows controlled term specification 522 in the standard book. For example, the standard-compliant eCRF is generated by the system of standard-compliant electronic case report, which further provides wording options accepted by the regulatory authority, for example, man, woman and intersex not male, female or other synonyms).
At the time of the filing of the application it would have been obvious to one of ordinary skill in the art to combine the teaching of the system and method of patient information collection of de Vries with the feature of Lin for at least the same reasons given for claim 3 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joy Chng whose telephone number is 571.270.7897. The examiner can normally be reached on Monday-Friday, 9:00am-5:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, JASON DUNHAM can be reached on 571.272.8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOY CHNG/
Primary Examiner, Art Unit 3686