DETAILED ACTION
Status of Claims
This action is in reply to the amendment filed on 09/17/2025.
Claims 1-30 have been amended.
Claim 31 has been has been newly added.
Claims 1-31 are currently pending and have been examined.
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 .
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 1-31 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-7, 15-22, 24-25, 27-28 and 31 are directed to a system (i.e., a machine) and claims 8-14, 23, 26 and 29 are directed to a method (i.e., a process). Accordingly, claims 1-31 are all within at least one of the four statutory categories.
Step 2A - Prong One:
An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
Representative independent claims 1 and 15 includes limitations that recite an abstract idea. Note that independent claims 1, 15 and 31 are the system claims, while claim 8 covers a method claim.
Specifically, independent claim 1 recites:
A computerized system for generating an Electronic Data Document (EDD) employed for inserting at least one data value representative of a result of a clinical interaction between a clinical service provider and a patient and captured in an Electronic Medical Record (EMR) system into a data field associated with at least one question in an electronic Case Report Form (eCRF) provided by an electronic Case Report Form (eCRF) system in a clinical trial study, the system comprising:
a source document ingester for generating the EDD by associating at least a portion of an image taken from at least one patient source document stored within the EMR system the image of the at least one patient source document comprising a record of the at least one data value associated with a patient that is also enrolled in a clinical trial study, the at least one data value being captured during the clinical interaction between the clinical service provider and the patient outside of the clinical trial study; and
an input device for receiving input from a user indicative of a of the image of the at least one patient source document comprising the EDD to be associated with the at least one question in the clinical trial study presented in the eCRF in order to provide patient data into one or more fields at the eCRF.
Specifically, independent claim 15 recites:
A computerized clinical trial verification system including one or more computer programs stored in a non-transitory computer-readable medium for generating an Electronic Data Document (EDD) employed for inserting at least one data value representative of a result of a clinical interaction between a clinical service provider and a patient and captured in an Electronic Medical Record (EMR) system into a data field associated with at least one question in an electronic Case Report Form (eCRF) provided by an electronic Case Report Form (eCRF) system a clinical trial study, the one or more computer programs comprising:
a first computer program generating the EDD by associating at least a portion of an image taken from at least one patient source document stored within the (EMR) system by a source document ingester, the image of the at least one patient source document comprising a record of the at least one data value associated with a patient that is also enrolled in a clinical trial study, the at least one data value being captured during the clinical interaction between the clinical service provider and the patient outside of the clinical trial study; and
a second computer program receiving input from a user via an input device indicative of a portion of the image of the at least one patient source document comprising the EDD to be associated with the at least one question in the clinical trial study presented in the eCRF in order to provide patient data into one or more empty fields in the eCRF.
The Examiner submits that the foregoing underlined limitations constitute: (a) “certain methods of organizing human activity” because inserting data values representative of a result of a clinical interaction between a clinical service provider and a patient into a data field associated with one question and providing patient data into an empty fields or into case report form are a part of a clinical trial workflow and involve provider-patient interaction, which relate to managing human behavior/interactions between people. Furthermore, these limitations constitute (b) “a mental process” because associating a captured digital image, designated as being relevant and an answering a portion of the question on the case report form are observations/evaluations/analysis that can be performed in the human mind. The foregoing underlined limitations also relate to claim 8 (similarly to claims 1 and 15).
Accordingly, the claim describes at least one abstract idea.
In relation to claims 7, 14 and 21-22, these claims merely recite specific kinds of data, such as: claims 7, 14 and 21 - the redacted one or more portions of the image extraction include personally identifiable information and claim 22- the data that is input into the one or more empty fields associated with the at least one question of the eCRF system includes one or more text elements extracted from the captured digital image.
In relation to claims 2-6, 9-13, 16-20 and 23-30, these claims merely recite determining steps such as: claims 2, 9 & 16 - outputting the data value from the captured digital image representative of the result of the clinical interaction between the clinical service provider and the patient that is input into the one or more empty fields associated with the at least one question of the eCRF system without requiring a transcription process, and which data value is designated as being relevant to the answer of at least a portion of the at least one question of the eCRF, claims 3, 10 & 17 - redacting one or more portions of the captured digital image to allow one or more portions in the captured digital image to be redacted from the viewer to create a redacted captured digital image, claims 4, 11 & 18 - allowing an authorized person to view the full captured digital image or necessary parts thereof to confirm that the captured digital image comprises a graphical portion of information from the patient source document, claims 5, 12 & 19 - the redacted one or more portions of the captured digital image are no longer part of the redacted captured digital image, claims 6, 13 & 20 - the redacted one or more portions of the captured digital image are not retained by the computerized system, claim 23 - extracting one or more text elements from the selected graphical portion of the captured digital image wherein the data that is input into the one or more empty fields associated with the at least one question of the eCRF system includes the extracted one or more text elements, claim 24 – extracting one or more text elements from the selected graphical portion of the captured digital image, wherein the data that is input into the one or more empty fields associated with the at least one question of the eCRF system includes the extracted one or more text elements, claim 25 - patient source document displayed by the EMR system and the eCRF displayed by the eCRF system are displayed, claim 26 - displaying the at least one patient source document displayed by the EMR system and displaying the eCRF displayed, claim 27 – patient source document displayed by the EMR system and the eCRF displayed by the eCRF system are displayed on a single display and claims 28 & 30 - extracting the data value from the captured digital image captured from the EMR.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 8 and 15, as drafted is a process that, under its broadest reasonable interpretation, covers performance of the limitations done by humans and in the mind but for the recitation of generic computer components. That is, other than reciting a computerized system, at least one processor, a display screen, a first device, an Electronic Medical Record (EMR) system, an electronic Case Report Form (eCRF) system, computer screen capture software, a captured digital image viewing tool, a first computer program, a second computer program, a third computer program, computerized clinical trial verification system and non-transitory, and a non-transitory computer-readable medium to perform the limitations, nothing in the claim elements precludes the steps from practically being performed by humans and in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation within a health care professional environment in the mind but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” and “Mental Process” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the computerized system, at least one processor, display screen, first device, Electronic Medical Record (EMR) system, electronic Case Report Form (eCRF) system, computer screen capture software, captured digital image viewing tool, first computer program, second computer program, third computer program, computerized clinical trial verification system and non-transitory, and non-transitory computer-readable medium are recited at high levels of generality (i.e., as generic computer components performing generic computer functions of receiving data/inputs, determining and providing data) such that it amounts no more than mere instructions to apply the exception using the generic computer components.
Regarding the additional limitation “receiving input from a user indicative of a of the image of the at least one patient source document comprising the EDD to be associated with the at least one question in the clinical trial study presented in the eCRF in order to provide patient data into one or more fields at the eCRF,” the Examiner submits that this additional limitation merely adds insignificant pre-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea (see MPEP § 2106.05(g)).
Regarding the additional limitations “an electronic Case Report Form”, “source document”, and “patient source document” the Examiner submits that this additional limitation amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)). Regarding the additional limitation “capturing a digital image” the Examiner submits that this additional limitation merely adds insignificant pre-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea (see MPEP § 2106.05(g)).
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination add nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvements in the functioning of a computer or an improvement to another technology or technical field, apply or us the above-noted implement/use to above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see MPEP §2106.05). Their collective functions merely provide conventional computer implementation.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer component provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, in representative independent claims 1, 8, 15 and 31, regarding the additional limitations of the computerized system, at least one processor, display screen, first device, Electronic Medical Record (EMR) system, electronic Case Report Form (eCRF) system, computer screen capture software, captured digital image viewing tool, first computer program, second computer program, third computer program, computerized clinical trial verification system and non-transitory, and non-transitory computer-readable medium, the Examiner submits that these limitations amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Thus, representative independent claim 1 and analogous independent claims 8, 15 and 31 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The dependent claims no not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reason discussed above with respect to determining that the dependent claims do not integrate the at least abstract idea into a practical application.
Therefore, claims 1-31 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 102
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.
Claim 31 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Francois (US 2016/0110523 A1).
Claim 31:
Francois discloses An electronic data document (EDD) for use in a computerized system for inserting at least one data value representative of a result of a clinical interaction between a clinical service provider and a patient and captured m an Electronic Medical Record (EMR) system into a data field associated with at least one question in an electronic Case Report Form (eCRF) provided by an electronic Case Report Form (eCRF) system in a clinical trial study (See [P0254-P0256] EDC systems allow study personnel, e.g., investigators and CRCs, to enter data at a site, typically into an electronic document referred to as an electronic case report form (eCRF), where the “Electronic data capture” (EDC) serves as another form of EDD, P0100 template to be completed by answering questions, P0173, P0194, P0441, P0444 patient questionnaires and symptom diary app entry.), the EDD comprising:
an image of at least a portion of an image of at least one patient source document stored within the EMR system, the image of the at least one patient source document comprising visual evidence of the at least one data value associated with a patient that is also enrolled in a clinical trial study (Taught in P0189 as entry of test results (e.g., lab test results, images, etc.). Also, see P0100.), the at least one data value from the image of the at least one patient source document having been captured during the clinical interaction between the clinical service provider and the patient outside of the clinical trial study (See health care organizations outside of the clinical trial study setting such as hospitals, clinics, centers and skilled nursing facilities in P0093.), the visual evidence of the at least one data value from the image of the at least one patient source document being designated as relevant to the answer of at least a portion of the at least one question including the data field in the eCRF (See [P0100] a template may contain at least some fields that are to be completed by (a) making a selection from a set of predetermined options (whether presented visually, orally, or otherwise); (b) entering a numerical value; (c) answering questions.).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, 8-9, 11, 15-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Udani (US 8,655,796 B2) in view of Francois (US 2016/0110523 A1)
Claim 1:
Udani discloses A computerized system for generating an Electronic Data Document (EDD) employed for inserting at least one data value representative of a result of a clinical interaction between a clinical service provider and a patient and captured in an Electronic Medical Record (EMR) system into a data field associated with at least one question in an electronic Case Report Form (eCRF) provided by an electronic Case Report Form (eCRF) system in a clinical trial study (See [column 29, line 26-37] proposed procedures for a study from the beginning of design to final report submission and may include ... the procedure steps, editable and suggested electronic formats may be provided. In one, interactive applications, programs, and instructions may be provided for the procedures”, column 34 line 1-8 discloses captured interaction by viewing the video recording of that portion of the clinical visit such as a video and audio recording of the entire encounter between the doctor(s), the nurse(s), the clinic research coordinator(s), research assistant(s), and the patient, which can be captured using a combination of electronic devices. Notice the input data can be also provided from EMR as described in column 10, line 14-24. Also, see Fig. 5C, column 16, lines 3-23 importation of medical data by scanning in a paper report, which may involve optical character recognition or manual capture of data fields, column 31, line 66 to column 32, line 25 where clinician or doctor is instructed to ask a patient questions about diabetes and blood pressure in a telemedicine videoconference and imports supportive blood pressure reading taken from a wireless sphygmomanometer (Item 569) as inserting a data value representative of a result of a clinical interaction between a clinical service provider (Items 564, 565 and Fig. 5E) and a patient into a data field. Also, see clinical encounter, clinical trial, clinic and hospital settings mentioned in column 8, lines 22-27, column 8, line 62 to column 9, line 5 and the electronic Case Report Form (eCRF) is established in column 10, lines 30-30-37 then taught in [column 28, lines 1-13 ] The details, instructions, guidance, requirements, outcomes, and recommendations for performing all of these areas of the clinical trial in accordance with the requirements set forth in the electronic protocol guide the execution and management of the clinical trial by the creation of documentation, in electronic or paper format, utilized in various stages of execution of the clinical trial. As shown in FIG. 4A, such documentation may contain sets of structured information configured for use by one or more units such as eSource, eCRF, eConsent, eCompliance, ePRO, eInventory, eStudy Product, eSponsor, eMonitor, eRegulatory, eFinance, eRecruitment, eData, eStatistics, eInvestigator, eLaboratory, eProcedure, ePatient, eDocument.), the system comprising:
a source document ingester for generating the EDD by associating at least a portion of an image taken from at least one patient source document stored within the EMR system (See [column 41, line 10-14] advance to the page or section of the eCompliance record in question and instantly view the video recording of that portion of the clinic visit as the video recording will be tagged to associate the portion of the video recording with the data record or input. Also, see Fig. 5C include Medical History portion of the display screen, column 31, line 66 to column 32, line 25 where importing supportive blood pressure reading taken from a wireless sphygmomanometer (Item 569) construe capturing the data value is done during the clinical interaction between the clinician or doctor and the patient.) the image of the at least one patient source document comprising a cord of the at least one data value associated with a patient that is also enrolled in a clinical trial study, the at least one data value being captured during the clinical interaction between the clinical service provider and the patient (Besides captured interaction disclosed in column 34 line 1-8, see [column 16, line 16-29] the Health Level 7 (HL7) standard for healthcare informatics interoperability can be utilized for secure data transfer between these laboratory and medical assessments (250) and the system (200). Collection of data or assessments from the external laboratories and medical facilities can be by direct data importation or indirectly by scanning in a paper report. See [column 32, lines 10-25] [Additionally, the display (560) can include sub-screens configured to display the next required procedure (568). The display (560) can also comprise a data import button (569) with which the user may initiate the importation of the data directly from a mHealth device (220 in FIG. 2)]. See documenting device (column 2, line 58 to column 3, line 8), source document terminology established (column 6, lines 4-11, column 10, lines 15-29) and Fig. 5A-5G flow charts and displays of exemplary eSource unit display screens.) outside of the clinical trial study (See column 7, lines 22-24, [column 8, line 62 to column 9, line 5] where performing a physical examination, in medical setting such as ambulatory care facilities such as medical offices, clinics, ambulatory surgery facilities, hemodialysis facilities, rehabilitation facilities, drug abuse treatment facilities, family planning centers, hospitals, home health agencies, hospices, clinical trials clinics, oncology clinics, pharmacies, adult day healthcare centers, assisted living facilities, nursing homes, residential health care facilities, disease management programs, wellness management programs, and others serve as settings outside of the clinical trial study.); and
an input device for receiving input from a user indicative of a portion of the image of the fields at the eCRF (See [column 4, line 11-26], [col. 10, line 15-20] indicating input for portion of the fields of the electronic report and as in Fig 5C. Also, besides capturing a digital signature (column 2, lines 45-57), hologram, videos recording, still image, using a camera (column 7, lines 51-64) and exemplary radiology procedures and EKG test to acquire medical images (column 7, lines 22-38), see electronic record in digital form mentioned in column 10, lines 25-42. Also, see screen image shown as Fig. 5C include questions posed to the patient about diabetes, blood pressure and the empty field for inserting and importing the actual Systolic and Diastolic blood pressure readings, mentioned in column 31, line 49 to column 32, line 15.).
Although Udani discloses the computerized system for a user to input the image of the fields at the eCRF in a setting outside the clinical trial study as mentioned above, Udani does not explicitly teach generating an Electronic Data Document (EDD) and a patient source document used for answering clinical trial questions to provide patient data into empty fields in the eCRF. Francois teaches:
generating an Electronic Data Document (EDD) employed (See P0254-P0256 where the “Electronic data capture” (EDC) serves as another form of EDD.) for
at least one patient source document comprising the EDD to be associated with the at least one question in the clinical trial study presented in the eCRF in order to provide patient data into one or more empty fields in the eCRF (See P0100 template to be completed by answering questions, P0173, P0194, P0441, P0444 patient questionnaires and symptom diary app entry.).
Therefore, it would have been obvious to one of ordinary skill in the art of EMR and patient app management at the time of the invention to modify the method, software and system of Udani to have generating an Electronic Data Document (EDD) and a patient source document used for answering clinical trial questions to provide patient data into empty fields in the eCRF, as taught by Francois, to reduce the burden, offering accurate and comprehensive when entering patient information mention in Francois’s P0001.
Claim 8:
Udani discloses A method for inserting at least one data value representative of a result of a clinical interaction between a clinical service provider and a patient and captured in an Electronic Medical Record (EMR) system into a data field associated with at least one question in an electronic Case Report Form (eCRF) provided by an electronic case Report Form (eCRF) system in a clinical trial study (See Fig. 5C, column 16, lines 3-23 importation of medical data by scanning in a paper report, which may involve optical character recognition or manual capture of data fields, column 31, line 66 to column 32, line 25 where clinician or doctor is instructed to ask a patient questions about diabetes and blood pressure in a telemedicine videoconference and imports supportive blood pressure reading taken from a wireless sphygmomanometer (Item 569) as inserting a data value representative of a result of a clinical interaction between a clinical service provider (Items 564, 565 and Fig. 5E) and a patient into a data field. Also, see clinical encounter, clinical trial, clinic and hospital settings mentioned in column 8, lines 22-27, column 8, line 62 to column 9, line 5 and the electronic Case Report Form (eCRF) is established in column 10, lines 30-30-37 then taught in [column 28, lines 1-13 ] As shown in FIG. 4A, such documentation may contain sets of structured information configured for use by one or more units such as eSource, eCRF, eConsent, eCompliance…eDocument.), the system comprising:
generating the EDD by associating at least a portion of an image taken from at least one patient source document stored within the (EMR) system by a source document ingester, the image of the at least one patient source document comprising a record of the at least one data value associated with a patient that is also enrolled in a clinical trial study, the at least one data value being captured during the clinical interaction between the clinical service provider and the patient (See Fig. 5C include Medical History portion of the display screen, column 31, line 66 to column 32, line 25 where importing supportive blood pressure reading taken from a wireless sphygmomanometer (Item 569) construe capturing the data value is done during the clinical interaction between the clinician or doctor and the patient. See [column 32, lines 10-25] [Additionally, the display (560) can include sub-screens configured to display the next required procedure (568). The display (560) can also comprise a data import button (569) with which the user may initiate the importation of the data directly from a mHealth device (220 in FIG. 2)]. Also, see documenting device (column 2, line 58 to column 3, line 8), source document terminology established (column 6, lines 4-11, column 10, lines 15-29) and Fig. 5A-5G flow charts and displays of exemplary eSource unit display screens.) outside of the clinical trial study (See column 7, lines 22-24, [column 8, line 62 to column 9, line 5] where performing a physical examination, in medical setting such as ambulatory care facilities such as medical offices, clinics, ambulatory surgery facilities, hemodialysis facilities, rehabilitation facilities, drug abuse treatment facilities, family planning centers, hospitals, home health agencies, hospices, clinical trials clinics, oncology clinics, pharmacies, adult day healthcare centers, assisted living facilities, nursing homes, residential health care facilities, disease management programs, wellness management programs, and others serve as settings outside of the clinical trial study.).
Although Udani discloses the computerized system for a user to input the image of the fields at the eCRF in a setting outside the clinical trial study as mentioned above, Udani does not explicitly teach generating an Electronic Data Document (EDD) and a patient source document used for answering clinical trial questions to provide patient data into empty fields in the eCRF. Francois teaches:
generating an Electronic Data Document (EDD) employed (See P0254-P0256 where the “Electronic data capture” (EDC) serves as another form of EDD.) for
receiving input from a user via an input device indicative of a portion of the image of the at least one patient source document comprising the EDD to be associated with the at least one question in the clinical trial study presented in the eCRF in order to provide patient data into one or more empty fields in the eCRF (See P0100 template to be completed by answering questions, P0173, P0194, P0441, P0444 patient questionnaires and symptom diary app entry.).
Therefore, it would have been obvious to one of ordinary skill in the art of EMR and patient app management at the time of the invention to modify the method, software and system of Udani to have generating an Electronic Data Document (EDD) and a patient source document used for answering clinical trial questions to provide patient data into empty fields in the eCRF, as taught by Francois, to reduce the burden, offering accurate and comprehensive when entering patient information mention in Francois’s P0001.
Claim 15:
Udani discloses computerized clinical trial verification system including one or more computer programs stored in a non-transitory computer-readable medium for inserting at least one data value representative of a result of a clinical interaction between a clinical service provider and a patient and captured in an Electronic Medical Record (EMR) system into a data field associated with at least one question in an electronic Case Report Form(eCRF) system in a clinical trial study (See Fig. 5C, See Fig. 5C, column 16, lines 3-23 importation of medical data by scanning in a paper report, which may involve optical character recognition or manual capture of data fields, column 31, line 66 to column 32, line 25 where clinician or doctor is instructed to ask a patient questions about diabetes and blood pressure in a telemedicine videoconference and imports supportive blood pressure reading taken from a wireless sphygmomanometer (Item 569) as inserting a data value representative of a result of a clinical interaction between a clinical service provider (Items 564, 565 and Fig. 5E) and a patient into a data field. Also, see clinical encounter, clinical trial, clinic and hospital settings mentioned in column 8, lines 22-27, column 8, line 62 to column 9, line 5 and the electronic Case Report Form (eCRF) is established in column 10, lines 30-30-37 then taught in [column 28, lines 1-13 ] As shown in FIG. 4A, such documentation may contain sets of structured information configured for use by one or more units such as eSource, eCRF, eConsent, eCompliance…eDocument.), the one or more computer programs comprising:
a first computer program generating the EDD by associating at least a portion of an image taken from at least one patient source document stored within the (EMR) system by a source document ingester, the image of the at least one patient source document comprising a record of the at least one data value associated with a patient that is also enrolled in a clinical trial study, the at least one data value being captured during the clinical interaction between the clinical service provider and the patient (See Fig. 5C include Medical History portion of the display screen, column 31, line 66 to column 32, line 25 where importing supportive blood pressure reading taken from a wireless sphygmomanometer (Item 569) construe capturing the data value is done during the clinical interaction between the clinician or doctor and the patient. See [column 32, lines 10-25] [Additionally, the display (560) can include sub-screens configured to display the next required procedure (568). The display (560) can also comprise a data import button (569) with which the user may initiate the importation of the data directly from a mHealth device (220 in FIG. 2)]. Also, see documenting device (column 2, line 58 to column 3, line 8), source document terminology established (column 6, lines 4-11, column 10, lines 15-29) and Fig. 5A-5G flow charts and displays of exemplary eSource unit display screens.) outside of the clinical trial study (See column 7, lines 22-24, [column 8, line 62 to column 9, line 5] where performing a physical examination, in medical setting such as ambulatory care facilities such as medical offices, clinics, ambulatory surgery facilities, hemodialysis facilities, rehabilitation facilities, drug abuse treatment facilities, family planning centers, hospitals, home health agencies, hospices, clinical trials clinics, oncology clinics, pharmacies, adult day healthcare centers, assisted living facilities, nursing homes, residential health care facilities, disease management programs, wellness management programs, and others serve as settings outside of the clinical trial study.).
Although Udani discloses the computerized system for a user to input the image of the fields at the eCRF in a setting outside the clinical trial study as mentioned above, Udani does not explicitly teach generating an Electronic Data Document (EDD) and a patient source document used for answering clinical trial questions to provide patient data into empty fields in the eCRF. Francois teaches:
gererating an Electronic Data Document (EDD) employed (See P0254-P0256 where the “Electronic data capture” (EDC) serves as another form of EDD.) for
a second computer program receiving input from a user via an input device indicative of a portion of the image of the at least one patient source document comprising the EDD to be associated with the at least one question in the clinical trial study presented in the eCRF in order to provide patient data into one or more empty fields in the eCRF (See P0100 template to be completed by answering questions, P0173, P0194, P0441, P0444 patient questionnaires and symptom diary app entry.).
Therefore, it would have been obvious to one of ordinary skill in the art of EMR and patient app management at the time of the invention to modify the method, software and system of Udani to have generating an Electronic Data Document (EDD) and a patient source document used for answering clinical trial questions to provide patient data into empty fields in the eCRF, as taught by Francois, to reduce the burden, offering accurate and comprehensive when entering patient information mention in Francois’s P0001.
Regarding claim 2, Udani discloses the computerized system of clam 1, wherein the source document ingester includes computer screen capture software that outputs the data value from the portion of the image of the at least one patient source document representative of the result of the clinical interaction between the clinical service provider and the patient that is input into the one or more empty fields associated with the at least one question of the eCRF system without requiring a transcription process and which data value is designated as being relevant to the answer of at least a portion of the at least one question of the eCRF (See Fig. 5C, column 31, line 66 to column 32, line 25 where clinician or doctor is instructed to ask a patient questions about diabetes and blood pressure in a telemedicine videoconference and imports supportive blood pressure reading taken from a wireless sphygmomanometer (Item 569) as inserting a data value representative of a result of a clinical interaction between a clinical service provider (Items 564, 565 and Fig. 5E) and a patient into a data field. Also, see clinical encounter, clinical trial, clinic and hospital settings mentioned in column 8, lines 22-27, column 8, line 62 to column 9, line 5 and the electronic Case Report Form (eCRF) is established in column 10, lines 30-30-37 then taught in [column 28, lines 1-13 ] As shown in FIG. 4A, such documentation may contain sets of structured information configured for use by one or more units such as eSource, eCRF, eConsent, eCompliance…eDocument.). Francois further teaches comprising the EDD (See P0254-P0256 where the “Electronic data capture” (EDC) serves as another form of EDD.).
Therefore, it would have been obvious to one of ordinary skill in the art of EMR and patient app management at the time of the invention to modify the method, software and system of Udani to have generating an Electronic Data Document (EDD), as taught by Francois, to reduce the burden, offering accurate and comprehensive when entering patient information mention in Francois’s P0001.
Regarding claim 4, Udani discloses wherein the at least one processor comprises a captured digital image viewing tool allowing an authorized person to view the full captured digital image or necessary parts thereof to confirm that the captured digital image comprises a graphical portion of information from the patient source document (See authenticating authorized user with biometrics (column 9, lines 29-45, column 12, lines 15-26) for accessing eLaboratory and medical eProcedure data.).
Regarding claim 9, Udani discloses the method as recited in claim 8, further comprising wherein outputting the data value from the captured digital mage representative of the result of the clinical interaction between the clinical service provider and the patient that is input into the one or more empty fields associated with the at least one question of the eCRF system (See Fig. 5C, column 31, line 66 to column 32, line 25 where clinician or doctor is instructed to ask a patient questions about diabetes and blood pressure in a telemedicine videoconference and imports supportive blood pressure reading taken from a wireless sphygmomanometer (Item 569) as inserting a data value representative of a result of a clinical interaction between a clinical service provider (Items 564, 565 and Fig. 5E) and a patient into a data field. Also, see clinical encounter, clinical trial, clinic and hospital settings mentioned in column 8, lines 22-27, column 8, line 62 to column 9, line 5 and the electronic Case Report Form (eCRF) is established in column 10, lines 30-30-37 then taught in [column 28, lines 1-13 ] As shown in FIG. 4A, such documentation may contain sets of structured information configured for use by one or more units such as eSource, eCRF, eConsent, eCompliance…eDocument.).
Regarding claim 11, Udani discloses further comprising allowing an authorized person to view the full captured digital image or necessary parts thereof to confirm that the captured digital image comprises a graphical portion of information from the patient source document (See authenticating authorized user with biometrics (column 9, lines 29-45, column 12, lines 15-26) for accessing eLaboratory and medical eProcedure data.).
Regarding claim 16, Udani discloses system as recited m claim 15, wherein the one or more computer instructions further comprise: outputting the data value from the captured digital image representative of the result of the clinical interaction between the clinical service provider and the patient that is input into the one or more empty fields associated with the at least one question of the eCRF system without requiring a transcription process, and which data value is designated as being relevant to the answer of at least a portion of the at least one question of the eCRF (See Fig. 5C, column 31, line 66 to column 32, line 25 where clinician or doctor is instructed to ask a patient questions about diabetes and blood pressure in a telemedicine videoconference and imports supportive blood pressure reading taken from a wireless sphygmomanometer (Item 569) as inserting a data value representative of a result of a clinical interaction between a clinical service provider (Items 564, 565 and Fig. 5E) and a patient into a data field. Also, see clinical encounter, clinical trial, clinic and hospital settings mentioned in column 8, lines 22-27, column 8, line 62 to column 9, line 5 and the electronic Case Report Form (eCRF) is established in column 10, lines 30-30-37 then taught in [column 28, lines 1-13 ] As shown in FIG. 4A, such documentation may contain sets of structured information configured for use by one or more units such as eSource, eCRF, eConsent, eCompliance…eDocument.).
Regarding claim 18, Udani discloses wherein the computer instructions further comprise fourth instructions that allow an authorized person to view the full captured digital image or necessary parts thereof to confirm that the captured digital image comprises a graphical portion of information from the source document (See authenticating authorized user with biometrics (column 9, lines 29-45, column 12, lines 15-26) for accessing eLaboratory and medical eProcedure data.).
Claims 3, 5-7, 10, 12-14, 17, 19-21 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Udani (US 8,655,796 B2) in view of Francois (US 2016/0110523 A1) further in view of Salagado (US 2008/0239365 A1).
Regarding claim 3, although Udani and Francois teach the computerized system of claim 1 as mention above, Udani and Francois do not explicitly teach a tool for redacting. Salgado teaches further comprising a redaction tool configured to allow one or more portions of the portion of the image of the at least one patient source document comprising the EDD to be redacted from the viewer to create a redacted portion of the image of the at least one patient source document comprising the EDD (See P0016 digital copy of document, Fig. 2, P0021, 50 rectangular opaque strips.).
Therefore, it would have been obvious to one of ordinary skill in the art of masking medical documentation at the time of the invention to modify the method, software and system of Udani and Francois to have a tool for redacting, as taught by Salgado, to ensure that the original document remains unaltered and that sensitive information cannot be identified.
Regarding claims 5 and 12, although Udani and Francois teach the computerized system and method as mention above, Udani and Francois do not explicitly teach extracting portions no longer a part of the document. Salgado teaches wherein the redacted one or more portions of the image of the at least one patient source document comprising the EDD are no longer part of the redacted portion of the image of the at least one patient source document comprising the EDD image (See Fig. 2, P0021, where the rectangular opaque strips indicate extractions that are not a part of the document such as an exemplary diagnosis.).
Therefore, it would have been obvious to one of ordinary skill in the art of masking medical documentation at the time of the invention to modify the method, software and system of Udani and Francois to have extracting portions no longer a part of the document, as taught by Salgado, for masking sensitive information when medical records are made available to researchers mentioned in Salgado’s P0004.
Regarding claims 6 and 13, although Udani and Francois teach the computerized system and method as mention above, Udani and Francois do not explicitly teach extracting portions not retained. Salgado teaches wherein the redacted one or more portions of the at least one patient source document comprising the EDD are not retained by the computerized system (See Fig. 2, P0021, where the rectangular opaque strips indicate data that are not retained from the document, in electronic form (P0017, P0041).).
Therefore, it would have been obvious to one of ordinary skill in the art of masking medical documentation at the time of the invention to modify the method, software and system of Udani and Francois to have extracting portions not retained, as taught by Salgado, for masking sensitive information when medical records are made available to researchers mentioned in Salgado’s P0004.
Regarding claims 7 and 14, although Udani and Francois teach the computerized system and method as mention above, Udani and Francois do not explicitly teach redacting personally identifiable information. Salgado teaches wherein the redacted one or more portions of the at least one patient source document comprising the EDD comprise personally identifiable information (See Fig. 2, P0021, where the rectangular opaque strips indicate personally identifiable information such as name and address.).
Therefore, it would have been obvious to one of ordinary skill in the art of masking medical documentation at the time of the invention to modify the method, software and system of Udani and Francois to have redacting personally identifiable information, as taught by Salgado, for masking sensitive information when medical records are made available to researchers mentioned in Salgado’s P0004.
Regarding claim 10, although Udani and Francois teach the method as recited in claim 8 as mention above, Udani and Francois do not explicitly teach redacting the captured digital image to be redacted from the viewer. Salgado teaches further comprising redacting one or more portions of the captured digital image to allow one or more portions in the at least one patient source document comprising the EDD to be redacted from the viewer to create a redacted at least one patient source document comprising the EDD (See P0016 digital copy of document, Fig. 2, P0021, 50 rectangular opaque strips.).
Therefore, it would have been obvious to one of ordinary skill in the art of masking medical documentation at the time of the invention to modify the method, software and system of Udani and Francois to have redacting the captured digital image to be redacted from the viewer, as taught by Salgado, to ensure that the original document remains unaltered and that sensitive information cannot be identified.
Regarding claim 17, although Udani and Francois teach the system as recited in claim 16 as mention above, Udani and Francois do not explicitly teach redacting the captured digital image to be redacted from the viewer. Salgado teaches wherein the computer instructions further comprise third instructions for redacting one or more portions of the portion of the image of the at least one patient source document comprising the EDD via redaction tool to allow one or more portions in the portion of the image of the at least one patient source document comprising the EDD via redaction tool to be redacted from the viewer to create a redacted portion of the image of the at least one patient source document comprising the EDD via redaction tool (See P0016 digital copy of document, Fig. 2, P0021, 50 rectangular opaque strips.).
Therefore, it would have been obvious to one of ordinary skill in the art of masking medical documentation at the time of the invention to modify the method, software and system of Udani and Francois to have redacting the captured digital image to be redacted from the viewer, as taught by Salgado, to ensure that the original document remains unaltered and that sensitive information cannot be identified.
Regarding claim 19, although Udani and Francois teach the system as recited in claim 17 as mention above, Udani and Francois do not explicitly teach a tool for redacting. Salgado teaches wherein the redacted one or more portions of the image of the at least one patient source document comprising the EDD are no longer part of the redacted portion of the image of the at least one patient source document comprising the EDD (See P0016 digital copy of document, Fig. 2, P0021, 50 rectangular opaque strips.).
Therefore, it would have been obvious to one of ordinary skill in the art of masking medical documentation at the time of the invention to modify the method, software and system of Udani and Francois to have a tool for redacting, as taught by Salgado, to ensure that the original document remains unaltered and that sensitive information cannot be identified.
Regarding claim 20, although Udani and Francois teach the system as recited in claim 17 mentioned above, Udani and Francois do not explicitly teach the present combination fail to teach extracting portions not retained. Salgado teaches wherein the redacted one or more portions at least one patient source document comprising the EDD are not retained by the computerized system (See Fig. 2, P0021, where the rectangular opaque strips indicate data that are not retained from the document, in electronic form (P0017, P0041).).
Therefore, it would have been obvious to one of ordinary skill in the art of masking medical documentation at the time of the invention to modify the method, software and system of Udani and Francois to have extracting portions not retained, as taught by Salgado, for masking sensitive information when medical records are made available to researchers mentioned in Salgado’s P0004.
Regarding claim 21, although Udani and Francois teach the system as recited in claim 17 as mention above, Udani and Francois do not explicitly teach redacting personally identifiable information. Salgado teaches wherein the redacted one or more portions of the at least one patient source document comprising the EDD include personally identifiable information (See Fig. 2, P0021, where the rectangular opaque strips indicate personally identifiable information such as name and address.).
Therefore, it would have been obvious to one of ordinary skill in the art of masking medical documentation at the time of the invention to modify the method, software and system of Udani and Francois to have redacting personally identifiable information, as taught by Salgado, for masking sensitive information when medical records are made available to researchers mentioned in Salgado’s P0004.
Regarding claim 23, although Udani and Francois teach the method of claim 9 mentioned above, Udani and Francois do not explicitly teach extracting text elements from the selected graphical portion of the captured image, where the SD extraction consists of a selected graphical portion of the ingested SD. Salagado teaches:
further comprising the step of extracting one or more text elements from the at least one patient source document comprising the EDD, wherein the data that is input into the one or more empty fields associated with the at least one question of the eCRF system includes the extracted one or more text elements (See Fig. 3, S102, P0041, inputting original document serves as collecting for the purpose off masking portions of the original document (P0011, P0053) in the preparation of a digital copy or hardcopy of the document and converting back to native form S118. The source data retrieved (page 10, lines 5-13) construe ingesting source document extractions. See extracting pertinent text mentioned in P0024, P0032. See Fig. 2 and exemplary snippet markup tool for highlighting marks in a report in P0028. In [P0032] The mask module 30 may also be configured to extract and load the masking rules.).
Therefore, it would have been obvious to one of ordinary skill in the art of computer-assisted medical documentation at the time of the invention to modify the method of Udani and Francois to have extracting text elements from the selected graphical portion of the captured image, where the SD extraction consists of a selected graphical portion of the ingested SD, as taught by Salagado, to have the capability of leaving access to sensitive but otherwise interesting documents (whether printed or scanned) to readers by removing the sensitive information on the document itself mention in Salagado’s P0061.
Regarding claim 24, although Udani and Francois teach the system of claim 16 mentioned above, Udani and Francois do not explicitly teach extracting text elements from the selected graphical portion of the captured image, where the SD extraction consists of a selected graphical portion of the ingested SD. Salagado teaches:
wherein the computer instructions further comprise fourth instructions for extracting one or more text elements from the at least one patient source document comprising the EDD, wherein the data that is input into the one or more empty fields associated with the at least one question of the eCRF system includes the extracted one or more text elements (See Fig. 3, S102, P0041, inputting original document serves as collecting for the purpose off masking portions of the original document (P0011, P0053) in the preparation of a digital copy or hardcopy of the document and converting back to native form S118. The source data retrieved (page 10, lines 5-13) construe ingesting source document extractions. See extracting pertinent text mentioned in P0024, P0032. See Fig. 2 and exemplary snippet markup tool for highlighting marks in a report in P0028. In [P0032] The mask module 30 may also be configured to extract and load the masking rules.).
Therefore, it would have been obvious to one of ordinary skill in the art of computer-assisted medical documentation at the time of the invention to modify the method of Udani and Francois to have extracting text elements from the selected graphical portion of the captured image, where the SD extraction consists of a selected graphical portion of the ingested SD, as taught by Salagado, to have the capability of leaving access to sensitive but otherwise interesting documents (whether printed or scanned) to readers by removing the sensitive information on the document itself mention in Salagado’s P0061.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Udani (US 8,655,796 B2) in view of Francois (US 2016/0110523 A1) further in view of Lyon (US 2016/0283676 A1).
Regarding claim 22, although Udani and Francois teach the computerized system of clam 2 collecting data from the at least one patient source document comprising the EDD as mentioned above, Udani and Francois do not explicitly teach input into empty fields associated with a question or elements extracted. Lyon teaches wherein the data that is input into the one or more empty fields associated with the at least one question of the eCRF system includes one or more text elements extracted (See participating a clinical trial in P0071 and in [P0009] if a patient response is incomplete or left blank, the survey itself may identify this deficiency and require the patient to properly complete the question before allowing the survey to be completed.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare digital data management at the time of the invention to modify the method, software and system of Udani and Francois to have input into empty fields associated with a question or elements extracted, as taught by Lyon, to reduce clinician workload and improve clinical efficiency by providing an easily-navigable and simple interface for collecting patient data and providing clinical reports mention in Lyon’s P0002.
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Udani (US 8,655,796 B2) in view of Francois (US 2016/0110523 A1) further in view of Pierce (US 2008/0256128 A1).
Regarding claim 25, although Udani and Francois teach the computerized system of claim 1 mentioned above and Udani discloses wherein the result of a clinical interaction between a clinical service provider and a patient and captures (See Fig 8A, column 44, lines 8-34.), Udani and Francois do not explicitly teach source document for the EMR system and the eCRF displayed on a single display. Pierce teaches in the EMR system and the eCRF displayed by the eCRF system are displayed on a single display (See Fig. 1 eCRF database 118, an electronic case report form (eCRF) Interface and used for third party solutions mentioned in P0024, P0035 and P0075 for creating source documents, audits and clinical trial transactions shown in Fig. 9, 11-12 regarding Consent, Adverse Events and Concomitant Medications. Notice in Fig. 10 how a section for Concomitant Meds, Medical History and Medical Records are displayed on the same screen.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical study source systems at the time of the invention to modify the system of Udani and Francois to have source document for the EMR system and the eCRF displayed on a single display, as taught by Pierce, to rule out accidental or deliberate tampering with electronic data about drugs which could be difficult to monitor mention in Pierce’s P0103.
Regarding claim 26, although Udani and Francois teach the method of claim 8 mentioned above, Udani and Francois do not explicitly teach source document for the EMR system and the eCRF displayed on a single display. Pierce teaches further comprising the step of displaying the at least one patient source document displayed by the EMR system and displaying the eCRF displayed by the eCRF system on a single display (See Fig. 1 eCRF database 118, an electronic case report form (eCRF) Interface and used for third party solutions mentioned in P0024, P0035 and P0075 for creating source documents, audits and clinical trial transactions shown in Fig. 9, 11-12 regarding Consent, Adverse Events and Concomitant Medications. Notice in Fig. 10 how a section for Concomitant Meds, Medical History and Medical Records are displayed on the same screen.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical study source method at the time of the invention to modify the method of Udani and Francois to have source document for the EMR system and the eCRF displayed on a single display, as taught by Pierce, to rule out accidental or deliberate tampering with electronic data about drugs which could be difficult to monitor mention in Pierce’s P0103.
Regarding claim 27, although Udani and Francois teach the system of claim 15 mentioned above, and Udani discloses the at least one question in the clinical trial study presented in (See Fig 8A, column 44, lines 8-34.), Udani and Francois do not explicitly teach source document for the EMR system and the eCRF displayed on a single display. Pierce teaches wherein the at least one patient source document displayed by the EMR system and the eCRF system are displayed on a single display (See Fig. 1 eCRF database 118, an electronic case report form (eCRF) Interface and used for third party solutions mentioned in P0024, P0035 and P0075 for creating source documents, audits and clinical trial transactions shown in Fig. 9, 11-12 regarding Consent, Adverse Events and Concomitant Medications. Notice in Fig. 10 how a section for Concomitant Meds, Medical History and Medical Records are displayed on the same screen).
Therefore, it would have been obvious to one of ordinary skill in the art of medical study source system at the time of the invention to modify the system of Udani and Francois to have source document for the EMR system and the eCRF displayed on a single display, as taught by Pierce, to rule out accidental or deliberate tampering with electronic data about drugs which could be difficult to monitor mention in Pierce’s P0103.
Claims 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Udani (US 8,655,796 B2) in view of Francois (US 2016/0110523 A1) further in view of Sumino (US 2007/0271214 A1).
Regarding claims 28 and 30, although Udani and Francois teach the system of claims 1 and 15 with a data value captured as mentioned above, Udani and Francois do not explicitly teach extracting the data value from the captured digital image. Sumino teaches wherein the at least one data value is extracted from the at least one patient source document comprising the EDD captured from the EMR (See extracting features in P0099-P0101, extracted from image processing result mentioned in P0135-P0137, Fig. 29.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical imaging support of clinical trials at the time of the invention to modify the system of Udani and Francois to have extracting the data value from the captured digital image, as taught by Sumino, to facilitate clinical trial efficiency and analysis as mentioned in Sumino’s P0010-P0011.
Regarding claim 29, although Udani and Francois teach the method of claim 8 with a data value captured as mentioned above, Udani and Francois do not explicitly teach extracting the data value from the captured digital image. Sumino teaches further comprising extracting the at least one data value from the at least one patient source document comprising the EDD captured from the EMR (See extracting features in P0099-P0101, extracted from image processing result mentioned in P0135-P0137, Fig. 29.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical imaging support of clinical trials at the time of the invention to modify the method of Udani and Francois to have extracting the data value from the captured digital image, as taught by Sumino, to facilitate clinical trial efficiency and analysis as mentioned in Sumino’s P0010-P0011.
Response to Arguments
Applicant’s arguments, see page 12, filed 09/17/2025, with respect to the 112 rejection have been fully considered and are persuasive. The 112 rejection of claims 1-30 has been withdrawn.
Applicant argues that the claims have been amended to recite an Electronic Data Document, which is no longer a business method, an automated process, an error-free eCRF answer to a question. g. see pgs. 12-14 of Remarks – Examiner disagrees.
The recited limitation, “receiving input from a user indicative of a of the image of the at least one patient source document comprising the EDD to be associated with the at least one question in the clinical trial study presented in the eCRF in order to provide patient data into one or more fields at the eCRF”, is mere data gathering equivalent to using a computer for answering questions or entering patient data in an electronic form with entry fields. This is not a part of an automated process, but rather relies on humans to perform manually and mentally.
Applicant argues that the claimed invention presents patentable subject matter, and provides a sufficient technical innovation over and above the outdated, error-prone manual process. g. see pgs. 12-14 of Remarks – Examiner disagrees.
Besides no technological implementations or improvements being explained or claimed, the instant case is a problem that has already been solved. Also, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the computer as recited is a generic computer component that performs functions.
Applicant’s arguments have been fully considered, but are now moot in view of the new grounds of rejection. The Examiner has entered a new rejection under 35 USC § 102 (a)(1) and 103 and applied new art and art already of record.
Conclusion
THIS ACTION IS MADE FINAL. 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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/T.S.W./Examiner, Art Unit 3687 01/03/2026
/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687