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 .
Notice to Applicant
This communication is in response to the amendment filed 5/27/2026. Claims 1-3 have been amended. Claims 4-20 have been added. Claims 1-20 remain pending and have been examined.
Response to Arguments
A. Applicant's remarks regarding the objection to claim 2 have been fully considered but they are not persuasive. While Applicant asserts that the grammatical errors have been corrected, Examiner notes that the asserted amendments are not reflected in the submitted claims.
B. Applicant's argument regarding the rejection of claims 1-3 under 35 USC 101 have been fully considered but are not persuasive.
Applicant asserts that the claims do not recite an abstract idea on the basis that they now recite "dynamically re-generating in real-time, by the database management system, the preview transformation of the outcome assessment for the given event based on the additional characteristics" and "displaying the preview transformation on a graphical user interface of a user computing device," and asserts that “[t]his real-time dynamic regeneration of preview transformations based on device type, aspect ratio, and language characteristics is inherently a computer-centric operation that cannot be practically performed by a human manually designing assessments.” Examiner respectfully disagrees.
The elements requiring that the re-generating be performed “dynamically” and “in real-time” do not limit the claim as a whole exclusively to performance in a computer with no manual analog. In the context of the claim limitations, “dynamically” encompasses performing the action using or in response to some criteria, while “in real-time” only requires that the action be performed without substantial delay until a later time. Examiner notes that the disclosure does not define or limit the construction of either of these terms.
Applicant further cites the decision in Ex parte Desjardins, arguing that “[i]n Desjardins, the ARP found that even though the claims recited a mathematical calculation (an abstract idea), the claims as a whole were not "directed to" an abstract idea because they reflected a technological improvement identified in the specification,” and that “here, claims 1-3 as amended reflect the specific technological improvement of dynamically re-generating in real-time preview transformations of clinical study outcome assessments based on device type, aspect ratio, and language-an improvement to how clinical study data is presented and previewed across different computing platforms.” Examiner respectfully disagrees.
The decision in Desjardins expressly addressed the improvements to machine learning models, and did not broadly hold that any asserted technological improvement integrates a recited abstract idea into a practical application. Furthermore, Examiner notes that the limitations reflecting “dynamically re-generating in real-time preview transformations of clinical study outcome assessments based on device type, aspect ratio, and language” all fall within the scope of the abstract idea itself, and do not constitute an improvement to the operating of a technology or technical field.
Applicant further argues with respect to Step 2A Prong 2 that claims 1-3 integrate any abstract idea into a practical application on the basis that “[t]he limitation "displaying the preview transformation on a graphical user interface of a user computing device" as recited by claims 1-3 as amended requires a specific technological output-visual display on a GUI of a computing device.” Examiner respectfully disagrees.
As cited by Applicant, the specification states that “"[t]he user computing devices 120a-120n may be any machine or system that is used by a user to access the content management system 110 via the network 150, and may be any commercially available computing devices including laptop computers, desktop computers, mobile phones, smart phones, tablet computers, netbooks, and personal digital assistants (PDAs)" (emphasis added). As addressed below, the use of a graphical user interface on a generic computing device to display generated information to a user only amounts to mere instructions to implement the function of providing the information using a generic graphical interface and computing device as a tool. Likewise, use of an interface element such as a button to present an interface containing generated information only amounts to the use of interface elements as tools to receive instructions from the user and provide corresponding information.
With respect to Applicant’s further citation to Desjardins and assertion that “the specification at paragraph [0034] identifies the improvement of "translating highly technical rules into readable prose and visual aids" and paragraph [0094] describes the dynamic real-time regeneration,” Examiner maintains that present claims are not analogous to those addressed in Desjardins, and do not satisfy the rationale set out therein regarding improvements to machine learning models.
Applicant lastly argues starting on page 5 that “[t]he requirement for "dynamically re-generating in real-time" the preview transformation as recited by claims 1-3 as amended imposes meaningful limitations on how the system operates, requiring specific computational capabilities for real-time processing” and that “[t]he requirement for "displaying the preview transformation on a graphical user interface of a user computing device" as recited by claims 1-3 as amended is not merely generic computer implementation but rather specifies a particular manner of outputting the transformed data through a GUI.” Examiner respectfully disagrees.
Initially, the elements reciting "dynamically re-generating in real-time" fall within the scope of the abstract idea and do not constitute additional elements. As addressed above, the broadest reasonable interpretation of the terms “dynamically” and “real-time” do not inherently require the use of computer hardware. Likewise, the use of a graphical user interface to output generated information only amounts to instructions to implement the outputting of information using a computer as a tool. Claims 1-3 only recite “displaying the preview transformation on a graphical user interface of a user computing device” at a high level of generality rather than “a particular manner” of outputting the information using a GUI. A broad description in the specification that "[a]n interactive user interface may allow the user to traverse the study build from various user perspectives" and that "[v]arious languages and platform displays are available" does not transform a high-level displaying of information into a specific technical solution, especially given that the described “interactive user interface” is not disclosed as having any specific relationship to the displayed preview transformation.
The rejection under 35 USC 101 is maintained.
C. Applicant's argument regarding the rejection of claims 1-3 under 35 USC 103 have been fully considered but are not persuasive.
Applicant argues starting on page 7 that Gassner does not disclose "wherein the definition object comprises study design configuration data including rules, casebooks, event groups, events, and forms stored in a repository." Examiner respectfully disagrees.
Applicant asserts that “while Gassner discloses these components in the context of collecting and managing trial data, Gassner does not disclose or teach the specific combination of definition objects comprising study design configuration data including rules, casebooks, event groups, events, and forms stored in a repository in the context of generating a preview transformation that translates a technical study build configuration into a patient-facing visual representation.” However, as Applicant cites, Gassner explicitly discloses definition objects comprising study design configuration data including rules, casebooks, event groups, events, and forms stored in a repository. Examiner additionally notes that the claims do not specifically recite “generating a preview transformation that translates a technical study build configuration into a patient-facing visual representation.” Examiner maintains that Gassner discloses translating the definition objects into a study schedule matrix and generating a preview transformation of an outcome assessment for a given event based on a characteristic of the patient as cited below.
Applicant further argues that Gassner does not disclose translating "a technical study build configuration" of definition objects into a study schedule matrix comprising "a patient-facing visual representation showing which outcome assessments are collected at each patient visit" as recited by claims 1-3. Examiner respectfully disagrees. Examiner notes that the claim does not limit or define what constitutes “a technical study build configuration of definition objects” or what constitutes a “patient-facing visual representation,” and additionally that these embodiments are not present in the disclosure as-filed. The cited portions of Gassner show a table of elements setting out portions of a study schedule obtained from a build configuration, including outcome assessments which are collected at different patient visits. Whether the event forms may be displayed for information gathering purposes does not impact Gassner’s disclosure of the limitations at issue.
Applicant additionally asserts starting on page 10 that Gassner does not disclose “dynamically re-generating in real-time, by the database management system, the preview transformation of the outcome assessment for the given event based on the additional characteristics; and displaying the preview transformation on a graphical user interface of a user computing device" as recited in claims 1-3. Examiner respectfully disagrees.
Applicant asserts that “Gassner's versioning system describes that "the second version of content 2408 may also include references aligned to or pointing to multiple objects" and "may include specific references to modifications of objects that are referenced by the first version of content"” is “fundamentally different from dynamically re-generating in real-time a preview transformation of an outcome assessment based on device type, aspect ratio, and language characteristics.” However, Examiner notes that Gassner is not relied on to teach the additional characteristics including device type, aspect ratio, and language characteristics.
As cited in the rejection below, Figure 24 elements 2408, 2422, and 2428, Figure 25 elements 2514 and 2538, and Column 34 line 48 – Column 35 line 29 of Gassner describe generating a new version of the content based on modifications and new objects, which Examiner maintains falls within the broadest reasonable interpretation of dynamically regenerating the preview in real-time. Applicant does not provide further argument addressing why the full cited portions of Gassner are “fundamentally different” as asserted.
Applicant lastly argues on page 11 that the provided rationale for combining the cited Gassner, Chung, and Hsu references is insufficient “because the amended claims recite a specific technical solution for clinical trial study design preview that is not taught or suggested by any of the cited references.” Examiner respectfully disagrees.
Applicant asserts that “the combination of (1) definition objects comprising study design configuration data including rules, casebooks, event groups, events, and forms stored in a repository, (2) translating a technical study build configuration into a patient-facing visual representation showing which outcome assessments are collected at each patient visit, and (3) dynamically re-generating in real-time the preview transformation based on device type, aspect ratio, and language, followed by displaying the preview transformation on a graphical user interface… represents a specific technical solution that is not disclosed or suggested by Gassner, Chung, or Hsu whether considered individually or in combination.” However, Applicant does not provide further explanation of this “specific technical solution” beyond listing the above elements from claim 1, or why the combination of elements would not have performed the same function in combination as separately. Examiner additionally notes that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejection under 35 USC 103 is maintained.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 contains grammatical errors in the first word of each of lines 6, 9, 13, 14, 16, 18, 19, 21, and 24 when read in combination with line 4. For example, the recitation in lines 4-6 of “the processing circuit configured to: obtaining…” appears to contain a grammatical error.
Appropriate correction is required.
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 1-20 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 4-20 are drawn to a method, claim 2 is drawn to a system, and claim 3 is drawn to a non-transitory computer readable medium, each of which is within the four statutory categories.
Step 2A(1)
Claim 1 recites, in part, performing the steps of:
obtaining the definition object including data to be translated, wherein the definition object comprises study design configuration data including rules, casebooks, event groups, events, and forms;
translating a technical study build configuration of the definition objects into a study schedule matrix comprising a patient-facing visual representation outlining events, outcome assessments, and respondent type, the patient-facing visual representation showing which outcome assessments are collected at each patient visit;
obtaining a characteristic of a patient;
generating a preview transformation of an outcome assessment for a given event based on the characteristic of the patient;
obtaining additional characteristics defining a device type, aspect ratio, and language;
translating text of the outcome assessment to the obtained language;
transforming the outcome assessment based on the obtained device type and aspect ratio; and
dynamically re-generating in real-time the preview transformation of the outcome assessment for the given event based on the additional characteristics, and
displaying the preview transformation.
These steps amount to a type of managing personal behavior and therefore fall within the scope of an abstract idea in the form of a method of organizing human activity. Fundamentally the process is that of using study design information to create a schedule containing events, outcome assessments, and respondent types, as well as using a characteristic of a patient, language, and information about how an outcome assessment will be presented in order to generate outcome assessments. These steps could all be performed by an individual as part of manually designing and creating assessments for patients to use during a study.
Examiner notes that the recited “device type” and “aspect ratio” are not recited in a manner which limits them exclusively to computer hardware, and does not recite the “device” as computer hardware performing a function.
Independent claims 2 and 3 recite similar limitations and also recite an abstract idea under the same analysis.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claim 1 recites the additional elements of a) a database management system recited as performing each of the obtaining, translating, and generating steps, b) a repository used to store the study design configuration data, and c) a graphical user interface of a user computing device used to display the preview transformation.
Claim 2 recites the additional elements of a) a processing circuit comprising a processor and memory, b) a database management system recited as performing each of the obtaining, translating, and generating steps, c) a repository used to store the study design configuration data, and d) a graphical user interface of a user computing device used to display the preview transformation.
Claim 3 recites the additional elements of a) a non-transitory computer readable medium recited as including instructions, b) one or more processors recited as executing the instructions to perform the subsequent steps, and c) a database management system recited as performing each of the obtaining, translating, and generating steps, d) a repository used to store the study design configuration data, and e) a graphical user interface of a user computing device used to display the preview transformation.
Paragraphs 35, 82-84, and 89 of Applicant’s specification as originally filed describe the database management system as comprising a data management server, which may be a computing device including a processing unit such as a CPU, system memory including non-volatile media, and a stored data management controller. Paragraph 94 describes the data management controller performing functions such as translating the study schedule definition objects and generating graphical user interfaces. Paragraphs 109-111 provide further description of generic computing elements such as various types of processors and computer readable media storing executable instructions. The database management system, processing circuit comprising a processor and memory, non-transitory computer readable medium, and one or more processors are each therefore construed as encompassing generic computing elements.
Figures 1A and 1B, and paragraphs 51, 56, 64, and 65 describe data and content repositories as part of a database management system. The repository is construed accordingly as encompassing generic computer storage devices.
Paragraph 94 describes a data management controller generating a graphical user interface, while paragraphs 36, 82, 86, and 87 describe the user computing devices as any of a personal computer, a PC, a smart phone, “or any other media consumption or transmission device.” The graphical user interface of a user computing device is construed accordingly as encompassing generic computer display devices and interface elements.
The above elements only amount to instructions to implement functions within the abstract idea using computing elements as tools. For example, the database management system and repository are only recited at a high level of generality in relation to each of the recited data processing and storage functions, and is similarly disclosed as encompassing a broad array of generic computing elements, while the recited processors and memory elements are likewise only recited at a high level of generality and disclosed broadly as encompassing generic computer hardware. These elements are not sufficient to integrate the recited abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1-3 only recite the database management system, processors, memory, non-transitory computer readable medium, repository, and graphical user interface of the user device as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f)
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claim 4 recites wherein the translating of the definition objects into the study schedule matrix comprises translating the study schedule design into a patient perspective. These limitations fall within the scope of the abstract idea set out above.
Claim 5 recites generating a dynamic, linguistic summary of a study configuration by translating technical rules into readable prose and visual aids. These limitations fall within the scope of the abstract idea set out above.
Claim 6 recites wherein the linguistic summary is tailored for different user roles. These limitations fall within the scope of the abstract idea set out above.
Claim 7 recites wherein the study schedule matrix organizes the outcome assessments based on survey type and respondent. These limitations fall within the scope of the abstract idea set out above.
Claim 8 recites in response to a selection of an outcome assessment for a given event from the study schedule matrix, displaying details of the selected outcome assessment. These limitations fall within the scope of the abstract idea set out above.
Claim 8 further recites the additional element of a generated overlay window used to display the details of the outcome assessment.
As cited above, paragraph 94 describes a data management controller generating a graphical user interface while paragraphs 82, 86, and 87 describe the user computing devices as any of a personal computer, a PC, a smart phone, “or any other media consumption or transmission device.” Paragraph 94 further describes the system generating an overlay window upon selection of surveys, but does not provide further definition beyond simply generating the interface window. Figures 12 and 13 similarly show an “overlay window” as a graphical user interface displaying information about corresponding assessments. The generation of an overlay window to display the details of the selected outcome assessment is construed accordingly as generating computer interface elements.
The generation of an overlay window only amounts to instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the generated overlay window is only recited at a high level of generality as performing the function of displaying the outcome assessment details, and is disclosed broadly as a generated interface. This element is not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 9 recites generating the preview transformation of the outcome assessment. These limitations fall within the scope of the abstract idea set out above.
Claim 9 further recites the additional element of a preview survey button in the overlay window as causing the generation of the preview upon selection.
Paragraph 94 states “[w]hen the Preview Survey button is selected, the data management controller 130 generates graphical user interface 1400 depicted in FIG. 14.” No further description of the “preview survey” button is provided. The preview survey button is construed accordingly as broadly encompassing selectable graphical interface elements.
The recited preview survey button only amounts to instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the preview survey button is only recited at a high level of generality as performing the function of triggering the generating of the preview transformation when selected, and is not disclosed beyond a selectable interface element. This element is not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 10 recites wherein the characteristic of the patient comprises an age characteristic, and wherein the study has different outcome assessments depending on the age characteristic. These limitations fall within the scope of the abstract idea set out above.
Claim 11 recites interpreting and translating technical study build configuration files to generate the linguistic representation. These limitations fall within the scope of the abstract idea set out above.
Claim 12 recites the additional element of providing an interactive user interface that allows a user to traverse the study build from various user perspectives.
Paragraph 101 provides the only disclosure of the above element, reflecting the language of the claim in stating that “[a]n interactive user interface may allow the user to traverse the study build from various user perspectives.” No further description of the interactive user interface is provided or what constitutes “allow[ing] the user to traverse the study build from various user perspectives.”
The above element only amounts to instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the interactive user interface is only recited at a high level of generality as an interface “that allows a user to traverse the study build from various user perspectives” without further limitation on the actual content or functionality beyond the intended use, and is not disclosed beyond the specific language of the claim. The above element is not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 13 recites the additional element of generating preview links for users not associated with the study.
However, this element only amounts to insignificant extra-solution activity. The only disclosure of “generating preview links” is in paragraph 101, which merely states that “[p]review links may also be generated for users not associated with the study.” The claim does not further limit what constitutes a “preview link” or its generation. This element is only nominally or tangentially related to the invention given the high level of generality at which it is recited and the lack of further disclosure.
Generating preview links for users not associated with the study additionally only amounts to well-understood routine and conventional activity. As noted above, this element is only recited at a high level of generality and as insignificant extra-solution activity, and further only amounts to a form of receiving or transmitting data over a network.
The above element is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 14 recites wherein the study schedule matrix differs based on an event modality, and wherein the outcome assessments collected at each event differ depending on whether the patient is in-clinic or remote. These limitations fall within the scope of the abstract idea set out above.
Claim 15 recites wherein the device type comprises a smartphone. These limitations fall within the scope of the abstract idea set out above. Examiner notes that the “device type” constitutes data, and the device type comprising a smartphone does not recite a physical smartphone device.
Claim 15 recites the additional element of wherein the transforming comprises generating a smartphone preview of the outcome assessment.
Paragraph 94 states that “the user device, scale and/or aspect ratio may be previewed and adjusted,” and “FIG. 15 depicts a user interface 1500 when a smartphone preview is selected.” The “smartphone preview” and its generation are therefore construed as encompassing a user interface. Examiner notes that labeling the preview as a “smartphone” preview only constitutes a non-functional descriptor.
The above element only amounts to instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the generation of a “smartphone” preview is only recited at a high level of generality without limitation on the actual content or functionality of the interface, and is not disclosed beyond the specific language of the claim. The above element is not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 16 recites wherein the outcome assessment comprises a clinical outcome assessment that collects data on at least one of patient reported outcomes, clinician reported outcomes, observer reported outcomes, or performance outcomes. These limitations fall within the scope of the abstract idea set out above.
Claim 17 recites wherein the definition objects are stored by a sponsor, and wherein a first study design stored as the definition objects specifies what is required to happen on each site during the study. These limitations fall within the scope of the abstract idea set out above.
Claim 17 further recites the additional element of a first repository used to store the definition objects.
Figures 1A and 1B, and paragraphs 51, 56, 64, and 65 describe data and content repositories as part of a database management system. Paragraphs 55 and 59 describe the first repository as “used by a sponsor,” but do not further define the first repository. The first repository is construed accordingly as encompassing generic computer storage devices.
The first repository therefore only amounts to instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the first repository is only recited at a high level of generality as used “by a sponsor” and to perform the function of storing the definition objects, and is disclosed broadly as encompassing generic computing elements. The recited first repository is not sufficient to integrate the recited abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 18 recites wherein a patient perspective transforms configuration data into a timeline and interaction diagram. These limitations fall within the scope of the abstract idea set out above.
Claim 19 recites displaying a listing of outcome assessments for the study, the listing including for each outcome assessment at least a source, a survey label, a display label, a type, a respondent, and a schedule. These limitations fall within the scope of the abstract idea set out above.
Claim 20 recites displaying a listing of studies, the listing including for each study a version, a status, an approval datetime, a number of outcome assessments, a number of study schedules, patient languages, site languages, and a summary of changes. These limitations fall within the scope of the abstract idea set out above.
Claims 1-20 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112(a)
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 1-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
With regard to claims 1-3, the newly added recitation of the study schedule matrix "comprising a patient-facing visual representation" and “the patient-facing visual representation showing which outcome assessments are collected at each patient visit” appears to constitute new matter. Examiner was unable to find support for this newly added language in the indicated paragraphs of the specification or elsewhere within the disclosure as originally filed. While paragraph 94 states that “[t]he data management controller 130 translates the study schedule definition objects stored in the data management system and generates a study schedule table depicted in FIG. 11,” and “[e]vents 1101 (e.g., patient visits) are listed with the various associated outcome assessments 1104 that are collected in each visit,” no disclosure is provided in the specification or associated drawings of the study schedule table, i.e. the study schedule matrix, "comprising a patient-facing visual representation" with “the patient-facing visual representation showing which outcome assessments are collected at each patient visit” (emphasis added).
Claims 4-20 inherit the deficiencies of claim 1 through dependency and are likewise rejected.
Claim Rejections - 35 USC § 112(b)
The previous rejection of claims 1-3 under 35 USC 112(b) is withdrawn based on the amendment submitted 5/27/2026.
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, 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.
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 1-5, 10-13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gassner et al (US 10,902,081) in view of Chung et al (US Patent Application Publication 2024/0203545) and Hsu et al (US Patent Application Publication 2022/0350962).
With respect to claim 1, Gassner discloses the claimed computer-implemented method for digitally translating definition objects into a linguistic representation to generate a preview transformation of a study, the method comprising:
obtaining, by a database management system, the definition object including data to be translated, wherein the definition object comprises study design configuration data including rules, casebooks, event groups, events, and forms stored in a repository (Column 18 line 47- Column 19 line 1, and Column 20 lines 48-55 describe a study design being stored as definition objects, including events and forms having items and fields to be filled out; Column 18 lines 47-59 specifies that “[a] first repository (e.g., 1711a) may be used by a first sponsor (e.g., a pharmaceutical company) to store a first study design” which “may comprise rules (e.g., for queries, derived values, notifications and displaying events, forms and items), a casebook (i.e., a doctor's binder), event groups, events (e.g., subject visits), forms which comprise segregate sections and fields”; Figures 20B and 20C, Column 22, and Column 34 lines 48-59 describe user interfaces for creating new events and forms for the study);
translating, by the database management system, a technical study build configuration of the definition objects into a study schedule matrix comprising a patient-facing visual representation outlining events, outcome assessments, and respondent type, the patient-facing visual representation showing which outcome assessments are collected at each patient visit (Figures 31 and 36 and Column 47 lines 1-10 describe a screen displaying information on event visits, which outcome assessments are administered to a patient at each visit, i.e. patient-facing, and the type of respondent for the forms, i.e. a subject patient);
obtaining, by the database management system, a characteristic of a patient (Figure 20C and Column 28 describe various definition elements associated with forms, including patient demographic information);
generating, by the database management system, a preview transformation of an outcome assessment for a given event based on the characteristic of the patient (Column 34 lines 48-52 describe ‘content’ versions as referring to versions of forms including the various objects while Column 30 lines 8-25 also describes the forms including the various patient data objects for collection; Figure 24 elements 2406, 2420 and 2426, Figure 25 elements 2504 and 2528, and Column 34 lines 3-14 describe generating a first version of the content, i.e. a previous transformation of an assessment form, based on information to be included in the form such as the demographic information);
obtaining, by the database management system, additional characteristics (Column 35 lines 8-29 describe creating a new version of the content and modifying objects and other aspects of the content, i.e. obtaining new characteristics associated with new content or modifications);
dynamically re-generating in real-time, by the database management system, the preview transformation of the outcome assessment for the given event based on the additional characteristics (Figure 24 elements 2408, 2422, and 2428, Figure 25 elements 2514 and 2538, and Column 34 line 48 – Column 35 line 29 describe generating the new version based on the modifications and new objects, i.e. dynamically regenerating them in real-time); and
displaying the preview transformation on a graphical user interface of a user computing device (Column 35 lines 8-29 describe displaying the new content to the user on a user device for review and comparison),
but does not expressly disclose:
the additional characteristics defining a device type, aspect ratio, and language;
translating text of the outcome assessment to the obtained language;
transforming the outcome assessment based on the obtained device type and aspect ratio; and
re-generating, by the database management system, the preview transformation of the outcome assessment for the given event based on the device type, aspect ratio, and language.
However, Chung teaches that it was old and well known in the art of medical assessment generation before the effective filing date of the claimed invention to obtain additional characteristics defining a language ([12], [15], and [51] describe the system receiving the patient’s used language), translate text of an outcome assessment to the obtained language ([12], [17], [23], and [54]-[55] describe translating the text from the examination scenario into an output understandable by the patient using the received language), and re-generate a preview transformation of the outcome assessment for a given event based on the additional characteristics ([12], [23], [55], and [66] describe providing the re-generated medical examination to the patient).
Therefore it would have been obvious to one of ordinary skill in the art of medical assessment generation before the effective filing date of the claimed invention to modify the system of Gassner to obtain additional characteristics defining a language, translate text of an outcome assessment to the obtained language, and re-generate a preview transformation of the outcome assessment for a given event based on the additional characteristics as taught by Chung since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gassner already discloses generating and regenerating patient medical assessments, and doing so by translating the text of an assessment into the patient’s language as taught by Chung would serve that same function in Gassner, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Hsu further teaches that it was old and well known in the art of user interface generation before the effective filing date of the claimed invention to obtain additional characteristics defining a device type and aspect ratio (Figures 2 and 4B, Figure 5 element 501, Figure 12, [40], [42], [43], [48], and [117] describe receiving an input of an aspect ratio and type of display device), transform user interface elements based on the obtained device type and aspect ratio (Figure 5, [52]-[56], and [117] describe transforming the interface based on the device and aspect ratio), and re-generate a preview transformation of the user interface based on the additional characteristics (Figure 5 elements 503-505, [56], [62], and [76] describe displaying the interface as modified by the device and aspect ratio).
Therefore it would have been obvious to one of ordinary skill in the art of user interface generation before the effective filing date of the claimed invention to modify the combination of Gassner and Chung to obtain additional characteristics defining a device type and aspect ratio, transform user interface elements based on the obtained device type and aspect ratio, and re-generate a preview transformation of the user interface based on the additional characteristics as taught by Hsu since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gassner and Chung already teach generating and regenerating interfaces in the form of outcome assessments based on additional characteristics, and performing the regeneration based on additional characteristics including device type and aspect ratio as taught by Hsu would perform that same function in Gassner and Chung making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 2, Gassner discloses the claimed data management system for digitally translating definition objects into a linguistic representation to generate a preview transformation of a study, the data management system comprising: a processing circuit comprising a processor and a memory (Figure 18, Column 19 line 60 – Column 20 line 17, and Column 38 lines 13-38), the processing circuit configured to:
obtaining, by a database management system, the definition object including data to be translated, wherein the definition object comprises study design configuration data including rules, casebooks, event groups, events, and forms stored in a repository (Column 18 line 47- Column 19 line 1, and Column 20 lines 48-55 describe a study design being stored as definition objects, including events and forms having items and fields to be filled out; Column 18 lines 47-59 specifies that “[a] first repository (e.g., 1711a) may be used by a first sponsor (e.g., a pharmaceutical company) to store a first study design” which “may comprise rules (e.g., for queries, derived values, notifications and displaying events, forms and items), a casebook (i.e., a doctor's binder), event groups, events (e.g., subject visits), forms which comprise segregate sections and fields”; Figures 20B and 20C, Column 22, and Column 34 lines 48-59 describe user interfaces for creating new events and forms for the study);
translating, by the database management system, a technical study build configuration of the definition objects into a study schedule matrix comprising a patient-facing visual representation outlining events, outcome assessments, and respondent type, the patient-facing visual representation showing which outcome assessments are collected at each patient visit (Figures 31 and 36 and Column 47 lines 1-10 describe a screen displaying information on event visits, which outcome assessments are administered to a patient at each visit, i.e. patient-facing, and the type of respondent for the forms, i.e. a subject patient);
obtaining, by the database management system, a characteristic of a patient (Figure 20C and Column 28 describe various definition elements associated with forms, including patient demographic information);
generating, by the database management system, a preview transformation of an outcome assessment for a given event based on the characteristic of the patient (Column 34 lines 48-52 describe ‘content’ versions as referring to versions of forms including the various objects while Column 30 lines 8-25 also describes the forms including the various patient data objects for collection; Figure 24 elements 2406, 2420 and 2426, Figure 25 elements 2504 and 2528, and Column 34 lines 3-14 describe generating a first version of the content, i.e. a previous transformation of an assessment form, based on information to be included in the form such as the demographic information);
obtaining, by the database management system, additional characteristics (Column 35 lines 8-29 describe creating a new version of the content and modifying objects and other aspects of the content, i.e. obtaining new characteristics associated with new content or modifications);
dynamically re-generating in real-time, by the database management system, the preview transformation of the outcome assessment for the given event based on the additional characteristics (Figure 24 elements 2408, 2422, and 2428, Figure 25 elements 2514 and 2538, and Column 34 line 48 – Column 35 line 29 describe generating the new version based on the modifications and new objects, i.e. dynamically regenerating them in real-time); and
displaying the preview transformation on a graphical user interface of a user computing device (Column 35 lines 8-29 describe displaying the new content to the user on a user device for review and comparison),
but does not expressly disclose:
the additional characteristics defining a device type, aspect ratio, and language;
translating text of the outcome assessment to the obtained language;
transforming the outcome assessment based on the obtained device type and aspect ratio; and
re-generating, by the database management system, the preview transformation of the outcome assessment for the given event based on the device type, aspect ratio, and language.
However, Chung teaches that it was old and well known in the art of medical assessment generation before the effective filing date of the claimed invention to obtain additional characteristics defining a language ([12], [15], and [51] describe the system receiving the patient’s used language), translate text of an outcome assessment to the obtained language ([12], [17], [23], and [54]-[55] describe translating the text from the examination scenario into an output understandable by the patient using the received language), and re-generate a preview transformation of the outcome assessment for a given event based on the additional characteristics ([12], [23], [55], and [66] describe providing the re-generated medical examination to the patient).
Therefore it would have been obvious to one of ordinary skill in the art of medical assessment generation before the effective filing date of the claimed invention to modify the system of Gassner to obtain additional characteristics defining a language, translate text of an outcome assessment to the obtained language, and re-generate a preview transformation of the outcome assessment for a given event based on the additional characteristics as taught by Chung since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gassner already discloses generating and regenerating patient medical assessments, and doing so by translating the text of an assessment into the patient’s language as taught by Chung would serve that same function in Gassner, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Hsu further teaches that it was old and well known in the art of user interface generation before the effective filing date of the claimed invention to obtain additional characteristics defining a device type and aspect ratio (Figures 2 and 4B, Figure 5 element 501, Figure 12, [40], [42], [43], [48], and [117] describe receiving an input of an aspect ratio and type of display device), transform user interface elements based on the obtained device type and aspect ratio (Figure 5, [52]-[56], and [117] describe transforming the interface based on the device and aspect ratio), and re-generate a preview transformation of the user interface based on the additional characteristics (Figure 5 elements 503-505, [56], [62], and [76] describe displaying the interface as modified by the device and aspect ratio).
Therefore it would have been obvious to one of ordinary skill in the art of user interface generation before the effective filing date of the claimed invention to modify the combination of Gassner and Chung to obtain additional characteristics defining a device type and aspect ratio, transform user interface elements based on the obtained device type and aspect ratio, and re-generate a preview transformation of the user interface based on the additional characteristics as taught by Hsu since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gassner and Chung already teach generating and regenerating interfaces in the form of outcome assessments based on additional characteristics, and performing the regeneration based on additional characteristics including device type and aspect ratio as taught by Hsu would perform that same function in Gassner and Chung making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 3, Gassner discloses the claimed non-transitory computer-readable medium including instructions that, when executed by one or more processors (Figure 18, Column 19 line 60 – Column 20 line 17, and Column 46 lines 8-11), cause the one or more processors to perform the steps of:
obtaining, by a database management system, the definition object including data to be translated, wherein the definition object comprises study design configuration data including rules, casebooks, event groups, events, and forms stored in a repository (Column 18 line 47- Column 19 line 1, and Column 20 lines 48-55 describe a study design being stored as definition objects, including events and forms having items and fields to be filled out; Column 18 lines 47-59 specifies that “[a] first repository (e.g., 1711a) may be used by a first sponsor (e.g., a pharmaceutical company) to store a first study design” which “may comprise rules (e.g., for queries, derived values, notifications and displaying events, forms and items), a casebook (i.e., a doctor's binder), event groups, events (e.g., subject visits), forms which comprise segregate sections and fields”; Figures 20B and 20C, Column 22, and Column 34 lines 48-59 describe user interfaces for creating new events and forms for the study);
translating, by the database management system, a technical study build configuration of the definition objects into a study schedule matrix comprising a patient-facing visual representation outlining events, outcome assessments, and respondent type, the patient-facing visual representation showing which outcome assessments are collected at each patient visit (Figures 31 and 36 and Column 47 lines 1-10 describe a screen displaying information on event visits, which outcome assessments are administered to a patient at each visit, i.e. patient-facing, and the type of respondent for the forms, i.e. a subject patient);
obtaining, by the database management system, a characteristic of a patient (Figure 20C and Column 28 describe various definition elements associated with forms, including patient demographic information);
generating, by the database management system, a preview transformation of an outcome assessment for a given event based on the characteristic of the patient (Column 34 lines 48-52 describe ‘content’ versions as referring to versions of forms including the various objects while Column 30 lines 8-25 also describes the forms including the various patient data objects for collection; Figure 24 elements 2406, 2420 and 2426, Figure 25 elements 2504 and 2528, and Column 34 lines 3-14 describe generating a first version of the content, i.e. a previous transformation of an assessment form, based on information to be included in the form such as the demographic information);
obtaining, by the database management system, additional characteristics (Column 35 lines 8-29 describe creating a new version of the content and modifying objects and other aspects of the content, i.e. obtaining new characteristics associated with new content or modifications);
dynamically re-generating in real-time, by the database management system, the preview transformation of the outcome assessment for the given event based on the additional characteristics (Figure 24 elements 2408, 2422, and 2428, Figure 25 elements 2514 and 2538, and Column 34 line 48 – Column 35 line 29 describe generating the new version based on the modifications and new objects, i.e. dynamically regenerating them in real-time); and
displaying the preview transformation on a graphical user interface of a user computing device (Column 35 lines 8-29 describe displaying the new content to the user on a user device for review and comparison),
but does not expressly disclose:
the additional characteristics defining a device type, aspect ratio, and language;
translating text of the outcome assessment to the obtained language;
transforming the outcome assessment based on the obtained device type and aspect ratio; and
re-generating, by the database management system, the preview transformation of the outcome assessment for the given event based on the device type, aspect ratio, and language.
However, Chung teaches that it was old and well known in the art of medical assessment generation before the effective filing date of the claimed invention to obtain additional characteristics defining a language ([12], [15], and [51] describe the system receiving the patient’s used language), translate text of an outcome assessment to the obtained language ([12], [17], [23], and [54]-[55] describe translating the text from the examination scenario into an output understandable by the patient using the received language), and re-generate a preview transformation of the outcome assessment for a given event based on the additional characteristics ([12], [23], [55], and [66] describe providing the re-generated medical examination to the patient).
Therefore it would have been obvious to one of ordinary skill in the art of medical assessment generation before the effective filing date of the claimed invention to modify the system of Gassner to obtain additional characteristics defining a language, translate text of an outcome assessment to the obtained language, and re-generate a preview transformation of the outcome assessment for a given event based on the additional characteristics as taught by Chung since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gassner already discloses generating and regenerating patient medical assessments, and doing so by translating the text of an assessment into the patient’s language as taught by Chung would serve that same function in Gassner, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Hsu further teaches that it was old and well known in the art of user interface generation before the effective filing date of the claimed invention to obtain additional characteristics defining a device type and aspect ratio (Figures 2 and 4B, Figure 5 element 501, Figure 12, [40], [42], [43], [48], and [117] describe receiving an input of an aspect ratio and type of display device), transform user interface elements based on the obtained device type and aspect ratio (Figure 5, [52]-[56], and [117] describe transforming the interface based on the device and aspect ratio), and re-generate a preview transformation of the user interface based on the additional characteristics (Figure 5 elements 503-505, [56], [62], and [76] describe displaying the interface as modified by the device and aspect ratio).
Therefore it would have been obvious to one of ordinary skill in the art of user interface generation before the effective filing date of the claimed invention to modify the combination of Gassner and Chung to obtain additional characteristics defining a device type and aspect ratio, transform user interface elements based on the obtained device type and aspect ratio, and re-generate a preview transformation of the user interface based on the additional characteristics as taught by Hsu since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gassner and Chung already teach generating and regenerating interfaces in the form of outcome assessments based on additional characteristics, and performing the regeneration based on additional characteristics including device type and aspect ratio as taught by Hsu would perform that same function in Gassner and Chung making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 4, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
wherein the translating of the definition objects into the study schedule matrix comprises translating the study schedule design into a patient perspective (Column 18 line 47- Column 19 line 1, and Column 20 lines 48-55 describe a study design being stored as definition objects, including events and forms having items and fields to be filled out; Figures 31 and 36 and Column 47 lines 1-10 describe displaying information on event visits, and outcome assessments administered to a patient at each visit, i.e. a patient-facing perspective).
With respect to claim 5, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
generating a dynamic, linguistic summary of a study configuration by translating technical rules into readable prose and visual aids (Column 18 line 47- Column 19 line 1, and Column 20 lines 48-55 describe a study design being stored as definition objects, including events and forms having items and fields to be filled out; Figures 20a-20e, Column 21 line 12 – Column 22 line 10, and Column 34 line 48 – Column 35 line 29 translating the study design and rules into text and graphics, i.e. readable prose and visual aids).
With respect to claim 10, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
wherein the characteristic of the patient comprises an age characteristic (Column 34 lines 48-52 describe ‘content’ versions as referring to versions of forms including the various objects while Column 30 lines 8-25 also describes the forms including the various patient data objects for collection; Figure 28 shows age as an item of collected demographic data),
but does not expressly disclose:
wherein the study has different outcome assessments depending on the age characteristic.
However, Chung teaches that it was old and well known in the art of medical assessment generation before the effective filing date of the claimed invention to obtain a patient’s age ([15] describes the patient data including age) and provide different assessments depending on the patient’s age ([15], [23], and [30] describe altering the content of patient assessments based on the patient’s age).
Therefore it would have been obvious to one of ordinary skill in the art of medical assessment generation before the effective filing date of the claimed invention to modify the combination of Gassner, Chung, and Hsu to obtain a patient’s age and provide different assessments depending on the patient’s age as taught by Chung since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gassner, Chung, and Hsu already teach collecting a patient’s age and providing assessments as part of a clinical study, and having different assessments depending on the age as taught by Chung would serve that same function in Gassner, Chung, and Hsu, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 11, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
interpreting and translating technical study build configuration files to generate the linguistic representation (Column 18 line 47- Column 19 line 1, and Column 20 lines 48-55 describe a study design being stored as definition objects, including events and forms having items and fields to be filled out; Figures 20a-20e, Column 21 line 12 – Column 22 line 10, and Column 34 line 48 – Column 35 line 29 translating the study design and rules into text).
With respect to claim 12, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
providing an interactive user interface that allows a user to traverse the study build from various user perspectives (Figures 31-39 and Column 47 line 1 – Column 48 line 13 describe various interactive interfaces which allow a user to navigate to different elements of a study, where “traverse the study build from various user perspectives” is construed as navigating between sets of information for the study provided in different views).
With respect to claim 13, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
generating preview links for users not associated with the study (Figure 11a and Column 13 lines 36-50 describe creating preview hyperlinks for individuals not associated with a particular study).
With respect to claim 15, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
wherein the device type comprises a smartphone (Column 18 lines 9-14 describe the user devices as including smart phones), and
wherein the transforming comprises generating a smartphone preview of the outcome assessment (Column 35 lines 8-29 describe displaying the new content to the user on a user device for review and comparison, where display on a smart phone is construed as a “smartphone preview”).
With respect to claim 16, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
wherein the outcome assessment comprises a clinical outcome assessment that collects data on at least one of patient reported outcomes, clinician reported outcomes, observer reported outcomes, or performance outcomes (Figure 47 shows clinical visit forms, i.e. outcome assessments, having vitals and testing data, i.e. patient and/or clinician reported outcomes).
With respect to claim 17, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
wherein the definition objects are stored in a first repository used by a sponsor, and wherein a first study design stored as the definition objects specifies what is required to happen on each site during the study (Column 18 lines 47-59 specifies that “[a] first repository (e.g., 1711a) may be used by a first sponsor (e.g., a pharmaceutical company) to store a first study design” which “may comprise rules (e.g., for queries, derived values, notifications and displaying events, forms and items), a casebook (i.e., a doctor's binder), event groups, events (e.g., subject visits), forms which comprise segregate sections and fields”; Column 19 line 65 – Column 20 line 1 states that “the first study design may be stored as definition objects in the first repository 1711a, specifying what is required to happen on each site during the study”).
With respect to claim 18, Gassner/Chung/Hsu teach the method of claim 1. Gassner further discloses:
wherein a patient perspective transforms configuration data into a timeline and interaction diagram (Figure 36 shows an interactive timeline view corresponding to a patient, i.e. a patient perspective).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gassner et al (US 10,902,081) in view of Chung et al (US Patent Application Publication 2024/0203545) and Hsu et al (US Patent Application Publication 2022/0350962) as applied to claim 5, and further in view of Shah (US Patent Application Publication 2004/0093240).
With respect to claim 6, Gassner/Chung/Hsu teach the method of claim 5. Gassner does not expressly disclose wherein the linguistic summary is tailored for different user roles.
However, Shah teaches that it was old and well known in the art of clinical trials to generate a linguistic summary tailored for different user roles ([37], [44], [89], [168], and [172] describe a clinical trial system which provides different information summaries to different stakeholders depending on role).
Therefore it would have been obvious to one of ordinary skill in the art of medical assessment generation before the effective filing date of the claimed invention to modify the combination of Gassner, Chung, and Hsu to generate a linguistic summary tailored for different user roles as taught by Shah since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Gassner, Chung, and Hsu already teach generating a linguistic summary, and doing so in a manner tailored for different roles as taught by Shah would serve that same function in Gassner, Chung, and Hsu, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claims not Rejected Under 35 USC 102/103
Claims 7-9, 14, 19, and 20 are not presently rejected under the closest prior art of record listed herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Olek et al (US Patent Application Publication 2023/0377697);
Garty et al (US 11,082,407);
Hompesch et al (US Patent Application Publication 2024/0339183);
Longo et al (US Patent Application Publication 2018/0101662).
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.
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/Gregory Lultschik/Examiner, Art Unit 3682
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