Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claim(s)
Claims 1-19 have been examined
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1, 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17 of U.S. Patent No. 12,159,707. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite receiving first patient data obtained by one or more patient devices that are associated with and assigned to a first patient …; establishing, with at least one of the computing system or a management console, a first network transport link between the computing system and at least one healthcare data system that is accessible by or associated with one or more healthcare providers; sending, with at least one of the computing system or the management console, the first patient data over the first network transport link to the at least one healthcare data system.
Claims 1 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 of UP Patent No. 12,198,819. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite first code segment, a database coupled to the patient information collection system and storing credible healthcare information, wherein the first code segment associates each of the plurality of inputs with a unique identifier for uniquely identifying the patient, and stores the inputs with the unique identifier into the database; a second code segment, wherein the second code segment includes a pattern recognition algorithm configured to read the unique identifier and the plurality of received inputs from the database.
The claims differ in that claims 1, 8 of current application recite traversing a clinical decision tree, a patient clinical injury recovery plan generator coupled to the database, determine whether plurality of received inputs match to a patient clinical injury recovery plan and, upon the plurality of received inputs matching to a patient clinical injury recovery plan, assign the matched patient clinical injury recovery plan to the patient identifier and output the matched patient clinical injury recovery plan to at least one of the at least one output device, whereas claims 1, 9 of US Patent No. 12,198,819 recite a patient exercise string generator coupled to the database, determine whether the inputs match to a patient exercise string and, upon the inputs matching to a patient exercise string, assign the matched patient exercise string to the patient identifier.
Claims 1, 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 8 of UP Patent No. 11,587,687. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a patient clinical injury recovery plan generator coupled to the database, a second code segment, wherein the second code segment includes a pattern recognition algorithm configured to read the unique identifier and the plurality of received inputs from the database, determine whether plurality of received inputs match to a patient clinical injury recovery plan and, upon the plurality of received inputs matching to a patient clinical injury recovery plan, assign the matched patient clinical injury recovery plan to the patient identifier.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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(s) 8-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wund (US20140006045A1)
With respect to claim 8, Wund teaches a patient recovery plan generator system comprising:
a patient information collection system configured to receive patient inputs from an input device (‘045; Para 0038: FIGS. 5A-5C illustrate a workflow and graphical user interface (GUI) that may be displayed to a reporting party when creating an injury report. A home menu 502 in FIG. 5A provides a reporting party with an option to report an injury 504, which when selected leads to a process of collecting injury information, starting with an athlete identification menu 506 for identifying the athlete in FIG. 5B. In FIG. 5C, the reporting party is provided with an injury information menu 508 with the main categories of injury information that can be input, including selecting an injured area, selecting the injury, selecting symptoms and selecting treatments.);
a database coupled to the patient information collection system, wherein the patient information collection system is configured to receive and store patient inputs in the database (‘045; Para 0044: The application server 102 may include at least one processor and memory running software which analyzes the data from the injury reports, as well as one or more databases 104 that store the collected and classified information. The information may be stored in the local database 104 or a cloud database (not shown). The application server 102 may be running software which identifies information from a plurality of different fields and enters the information into a database based on the identified field);
a pattern recognition system coupled to the database, wherein the pattern recognition system is configured to categorize the patient inputs into injury patterns and generate corresponding recovery plans based on the categorized patterns (‘045; Para 0026: data on one or more of the categories can be correlated and displayed to a user to determine patterns of injuries, risk factors, preventative measures and other information relevant to preventing future injuries);
a patient clinical injury recovery plan generator coupled to the database, wherein the patient clinical injury recovery plan generator is configured to read patient inputs from the database and generate a patient clinical injury recovery plan based on the categorized patterns; and an output device configured to output the patient clinical injury recovery plan (‘045; Abstract: The injury reports are organized to generate a single injury event, and a notification of the injury is then automatically sent to one or more interested or authorized parties, such as a parent, guardian, coach, teacher, trainer, doctor or school administrator; Para 0019: IGS. 6A-61 illustrate a workflow and GUI for generating an injury report on a portable electronic device).
With respect to claim 9, Wund teaches the patient recovery plan generator system of claim 8, wherein the patient information collection system further comprises a biometric data collection device configured to collect biometric data from the patient (‘045; Para 0008).
With respect to claim 10, Wund teaches the patient recovery plan generator system of claim 8, wherein the database is further configured to store historical patient data and use it to enhance the accuracy of the recovery plans (‘045; Para 0008: athlete physical characteristics and medical history, etc).
With respect to claim 11, Wund teaches the patient recovery plan generator system of claim 8, wherein the pattern recognition system is further configured to update the categorized injury patterns based on new patient inputs and outcomes (‘045; Para 0026: data on one or more of the categories can be correlated and displayed to a user to determine patterns of injuries, risk factors, preventative measures and other information relevant to preventing future injuries).
With respect to claim 12, Wund teaches the patient recovery plan generator system of claim 8, wherein the patient clinical injury recovery plan generator is further configured to generate personalized exercise routines as part of the recovery plan.
With respect to claim 13, Wund teaches the patient recovery plan generator system of claim 8, wherein the output device is further configured to provide the recovery plan in multiple formats, including text, video, and audio (‘045; Abstract: using a variety of reporting platforms, such as desktop computers and smartphones, and with a variety of modalities, such as software, web-based applications, text message or e-mail. The injury reports are organized to generate a single injury event, and a notification of the injury is then automatically sent to one or more interested or authorized parties,).
With respect to claim 14, Wund teaches the patient recovery plan generator system of claim 8, wherein the patient information collection system is further configured to receive inputs from multiple input devices, including mobile devices and wearable technology (‘045; Abstract).
With respect to claim 15, Wund teaches the patient recovery plan generator system of claim 8, wherein the pattern recognition system is further configured to integrate with external medical databases to enhance the categorization of injury patterns (‘045; Para 0026).
With respect to claim 16, Wund teaches the patient recovery plan generator system of claim 8, wherein the patient clinical injury recovery plan generator is further configured to include dietary recommendations as part of the recovery plan (‘045; Para 0062).
With respect to claim 17, Wund teaches the patient recovery plan generator system of claim 8, wherein the output device is further configured to provide real-time feedback to the patient based on their progress (‘045; Para 0008).
With respect to claim 18, Wund teaches the patient recovery plan generator system of claim 8, wherein the system further comprises a clinician reporting system configured to generate reports for healthcare providers based on the patient inputs and recovery plans (‘045; Abstract; Para 0008).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, is/are rejected under 35 U.S.C. 103 as being unpatentable over Rolia et al. (WO2013184127A1 hereinafter Rolia) in view of Matt et al. (US 11901080B1 hereinafter Matt) and further in view of Wund (US.20140006045A1).
With respect to claim 1, Rolia teaches an evidence-based, clinical practice guideline-driven, patient communication system comprising:
a patient information collection system including:
a first code segment including instructions for traversing a clinical decision tree (‘127; page/lines 5/14-20: Medical guidelines are best practices for care that are typically established using evidence based methods and/or are based on regulatory requirements. Guidelines are published nationally and are typically adapted for use in particular healthcare settings. Medical guidelines have been modeled as decision trees that guide the care of a patient), wherein the first code segment is coupled to an input device to receive input from at least one user via the input device, and wherein the first code segment is coupled to one of at least one output device to provide output to at least one of the at least one user, wherein the instructions comprise:
initiating traversal at a first node of the clinical decision tree comprising a first prompt (‘127; Fig. 3; page/lines:17/11-25: A patient and/or a medical care provider can initiate a clinical pathway. For example, a patient may initiate a clinical pathway for shortness of breath, which can be used to initiate interactions that pre-ask questions of the patient in advance of their meeting with a medical care provider, e.g., regarding symptoms, etc. Once a starting guideline(s) is selected, or a new guideline is started or anticipated, or any other opportunity arises to pre-ask questions and inform the patient, this causes the engine 222 to direct the PIM Manager 242 to engage with the patient via the Conversation Manager 244. This engagement informs the patient and pre-asks questions whose responses are stored in the PIM 234 as PPP 240 and PHR 238. A question that is motivated by a guideline has its response annotated by the guideline's identifier when stored.);
providing a first output, via one of the at least one output device, prompting a user of the one output device to input a first input in response to the first prompt (‘127; page/lines25/17-26/7 : The process flow can proceed through each option in optionjist. If a treatment option is triggered by a rule, e.g., R4, R5, it can be output to an interaction, e.g., with patient and/or medical care provider, along with an associated SOE value, and/or patient preference value. Otherwise, if a rule is not triggered, the value for its SOE can be "N/A", indicating it is not applied. An output of the medical diagnosis decision tree can be summarized in a table 472, for example, where the advantages, side effects/risk, procedure, cost, SOE, and patient preference can be tabulated for presentation to the patient and/or medical care providers.);
receiving, via the input device, the first input in response to the first prompt (‘127; Fig. 3);
determining a next node of the clinical decision tree based on the first input (‘127; FIG. 3);
advancing to the determined next node (‘127; FIG. 3); and
repeating the steps of providing, receiving, determining, and advancing until an end of the clinical decision tree is reached (‘127; FIG. 3);
Rolia does not disclose a code segment.
However, Matt disclose a code segment (‘080; col/lines 58/23-41 : code segments to perform the necessary tasks may be stored in a machine readable medium such as a storage medium. A code segment or machine-executable instruction may represent a procedure, a function, a subprogram, a program, a routine, a subroutine, a module, a software package, a script, a class, or any combination of instructions, data structures, and/or program statements. A code segment may be coupled to another code segment or a hardware circuit by passing and/or receiving information, data, arguments, parameters, and/or memory content )
Matt further teaches
a database coupled to the patient information collection system, wherein the first code segment is configured to associate each of a plurality of received inputs with a unique identifier for uniquely identifying the patient, and stores each of the plurality of inputs with the unique identifier into the database (‘080; col/lines 14/34-49 : management engine 106 (e.g., collection engine 504 of management engine 106) may generate a unique identifier for the message in order to track that message as it moves throughout the interaction system. The unique identifier may be included in the header of the message such that when the next node (e.g., component, device, server, etc.) after transformative processing engine 108 receives the message, that node can report back to management engine 106 that it saw the message. In this manner, management engine 106 may track messages from end-to-end for the life of the message.); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the system of Rolia with the technique of predictive modeling for user condition prediction as taught by Matt and the motivation is to provide a code segment with unique identifier for traversing a clinical decision tree.
Wund teaches
a patient clinical injury recovery plan generator coupled to the database, wherein the patient clinical injury recovery plan generator comprises:
a second code segment, wherein the second code segment includes a pattern recognition algorithm configured to read the unique identifier and the plurality of received inputs from the database (‘045; Para 0008: clinical diagnosis and added injury recovery can be added by certified professionals to complete the process, adding a level of organizational closure to the report; Para 0059: he administrator could also be given a summary report of all injuries that have occurred at the school for a particular sport or for all sports over a particular period of time without being provided with the specific information about the injured parties, such as their symptoms or the treatments being given. The privacy of the injured party may be ensured by providing a code identifier for each injured party instead of the injured party's name.), determine whether plurality of received inputs match to a patient clinical injury recovery plan and, upon the plurality of received inputs matching to a patient clinical injury recovery plan, assign the matched patient clinical injury recovery plan to the patient identifier and output the matched patient clinical injury recovery plan to at least one of the at least one output device. (‘045; Para 0045: To identify duplicate injury reports, the various fields in different reports are compared to determine how many fields include matching data. Fields such as date of birth, gender, type of injury, date of injury will be clear indicators as to whether or not the report is a duplicate or not. The system may have a threshold requirement of matching entries, such that a particular number of matching entries must be the same before the report is deemed to be matching).
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the system of Rolia/Matt with the technique of reporting and notifying parties of injuries as taught by Wund and the motivation is to provide a code segment with unique identifier for notifying party of injury.
With respect to claim 2, the combined art teaches the evidence-based, clinical practice guideline-driven, patient communication system of claim 1, wherein: said matched patient clinical injury recovery plan comprises at least one of a string of exercises, healthcare educational information, and healthcare information promoting recovery from a particular type of injury (‘045; Para 0064: Study the conditions affecting their peers participating in sports).
With respect to claim 3, the combined art teaches the evidence-based, clinical practice guideline-driven, patient communication system of claim 2, wherein: said matched patient clinical injury recovery plan comprises a string of exercises (‘045; Para 0064: Study the conditions affecting their peers participating in sports).
With respect to claim 4, the combined art teaches the evidence-based, clinical practice guideline-driven, patient communication system of claim 3, wherein: the clinical decision tree includes at least one advancement prompt, and the matched patient clinical injury recovery plan includes progressing the user to more advanced exercises, maintaining previously output exercises, or outputting less advanced exercises (‘127; FIG. 3).
With respect to claim 5, the combined art teaches the evidence-based, clinical practice guideline-driven, patient communication system of claim 1, wherein: the second code segment is further configured to determine a likely injury based on the plurality of the received inputs and output the likely injury to at least one of the at least one output device (‘045; Para 0063: he summary reports may also provide direct and immediate advice and recommendations to treat an injury, how to prevent similar injuries, and likely causes of the injury based on empirical data collected by the system).
With respect to claim 6, the combined art teaches the evidence-based, clinical practice guideline-driven, patient communication system of claim 1, wherein: the second code segment is further configured to generate a clinician referral in response to determining that the plurality of received inputs match to the patient clinical injury recovery plan (‘045; Para 0059).
With respect to claim 7, the combined art teaches the evidence-based, clinical practice guideline-driven, patient communication system of claim 1, wherein :the patient information collection system further comprises a biometric data collection device configured to collect biometric data from the user of the one output device (‘045; Para 0008: physical characteristics and medical history, etc).
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wund (US.20140006045A1) in view of Rolia et al. (WO2013184127A1 hereinafter Rolia).
With respect to claim 19, Wund does not teach the patient recovery plan generator system of claim 8, said patient information collection system further comprising : a first code segment including instructions for traversing a clinical decision tree, wherein the first code segment is coupled to an input device to receive input from at least one user via the input device; and wherein the first code segment is coupled to one of at least one output device to provide output to at least one of the at least one user, wherein the instructions comprise: initiating traversal at a first node of the clinical decision tree comprising a first prompt; providing a first output, via one of the at least one output device, prompting a user of the one output device to input a first input in response to the first prompt; receiving, via the input device, the first input in response to the first prompt; determining a next node of the clinical decision tree based on the first input; advancing to the determined next node; and repeating the steps of providing, receiving, determining, and advancing until an end of the clinical decision tree is reached.
Rolia teaches
a first code segment including instructions for traversing a clinical decision tree, wherein the first code segment is coupled to an input device to receive input from at least one user via the input device (‘127; page/lines 5/14-20: Medical guidelines are best practices for care that are typically established using evidence based methods and/or are based on regulatory requirements. Guidelines are published nationally and are typically adapted for use in particular healthcare settings. Medical guidelines have been modeled as decision trees that guide the care of a patient, and wherein the first code segment is coupled to one of at least one output device to provide output to at least one of the at least one user, wherein the instructions comprise:
initiating traversal at a first node of the clinical decision tree comprising a first prompt (‘127; Fig. 3; page/lines:17/11-25: A patient and/or a medical care provider can initiate a clinical pathway. For example, a patient may initiate a clinical pathway for shortness of breath, which can be used to initiate interactions that pre-ask questions of the patient in advance of their meeting with a medical care provider, e.g., regarding symptoms, etc. Once a starting guideline(s) is selected, or a new guideline is started or anticipated, or any other opportunity arises to pre-ask questions and inform the patient, this causes the engine 222 to direct the PIM Manager 242 to engage with the patient via the Conversation Manager 244. This engagement informs the patient and pre-asks questions whose responses are stored in the PIM 234 as PPP 240 and PHR 238. A question that is motivated by a guideline has its response annotated by the guideline's identifier when stored.);
providing a first output, via one of the at least one output device, prompting a user of the one output device to input a first input in response to the first prompt (‘127; page/lines 25/17-26/7: The process flow can proceed through each option in optionjist. If a treatment option is triggered by a rule, e.g., R4, R5, it can be output to an interaction, e.g., with patient and/or medical care provider, along with an associated SOE value, and/or patient preference value. Otherwise, if a rule is not triggered, the value for its SOE can be "N/A", indicating it is not applied. An output of the medical diagnosis decision tree can be summarized in a table 472, for example, where the advantages, side effects/risk, procedure, cost, SOE, and patient preference can be tabulated for presentation to the patient and/or medical care providers.);
receiving, via the input device, the first input in response to the first prompt (‘127; FIG. 3);
determining a next node of the clinical decision tree based on the first input;
advancing to the determined next node; and repeating the steps of providing, receiving, determining, and advancing until an end of the clinical decision tree is reached (‘127; FIG. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the system of Wund with the technique of patient information interface as taught by Rolia and the motivation is to provide a code for traversing a clinical decision tree.
Conclusion
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686