DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in response to the application filed 12/02/2024.
Claims 1-19 are currently pending and have been examined.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the memory" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the therapy device" in line 7. There is insufficient antecedent basis for this limitation in the claim.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-19 are drawn to a system, method and non-transitory computer readable storage medium which are statutory categories of invention (Step 1: YES).
Independent claims 1, 10 and 19 recite “integrated management of diagnostic and therapy data of a plurality of sleep disorder breathing patients, store a plurality of electronic patient records, wherein each electronic patient record is associated with a patient of the plurality of patients; and receive medical data store each of the received medical data in an electronic patient record of the plurality of electronic patient records; and accessing the plurality of electronic patient records presents device usage data and/or compliance data for each patient of the plurality of patients.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that “What is needed is an integrated electronic system which links the diagnostic provider and therapy provider to the same patient database, and allows for easy generation, management, and transfer of a patient's diagnostic information directly to the prescribed flow generator (which will also be referred to in herein as a therapy device).” (see: specification paragraph 44). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address “assigning a therapy provider to a patient that is ready for therapy; transferring diagnostic information for the patient to the assigned therapy provider; and electronically importing therapy settings from the diagnostic information onto the therapy device to be used by the patient.” (see: specification paragraph 62). This problem is addressed “The capability to send device settings data from a prescription issued by a sleep physician directly to the diagnostic patient record, where it can be accessed and downloaded by the therapy provider without the need of manual rewriting or electronic re-creating of the record. This contrasts with the current practice of the patient having to personally take their prescription to the therapy provider or, at best, the diagnostic provider faxing or otherwise transferring the prescription to the therapy provider who then has to read the prescription and manually input the settings into the device. The proposed system allows the diagnostic provider to save the prescription in the patient record from where it is directly accessed by the therapy provider. Those settings can also be automatically downloaded to a card or sent wirelessly to the device upon device setup.” (see: specification paragraph 192). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “electronic system”, “one or more memories”, “one or more processors”, “a plurality of medical devices”, “different medical device types”, “a user interface”, “one or more computing devices”, “non-transitory computer readable storage medium”, and “server system” are recited at a high level of generality (e.g., that the storing, receiving, and displaying is performed using generic computer components with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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 integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 4C, Figure 7, Figure 15 and
Paragraph 154, where “The system is compatible with, and processes data from, both diagnostic and therapy devices. As provided above, patient medical diagnostic device 101 may be any sleep testing device used in connection with diagnosis of the patient's sleep-related breathing disorder. Therapy device 105 may be any device used in connection with providing therapy for the patient's sleep-related breathing disorder. The diagnostic device 101 and therapy device 105 may each include the RPT device 4000, humidifier 5000, and patient interface 3000 described herein.”
Paragraph 159, where “As the patient uses medical diagnostic device 101, diagnostic data 111 may be recorded on a storage medium, also referred to as memory, 112. Diagnostic data 111 may include any data relating to the patient's sleep test, such as date, time and duration of test, as well as physiological data obtained during the test, such as recorded respiratory flow data, respiratory effort data, oximetry and pulse data, or other clinical information. Memory 112 may be of any non-transitory type capable of storing information accessible by a processor, including a computer-readable medium, or other medium that stores data that may be read with the aid of an electronic device, such as a hard-drive, memory card, ROM, RAM, DVD or other optical disks, as well as other write-capable and read-only memories.”
Paragraph 160, where “Server 201 includes a processor 210 and a memory 220 for storing data 230 and instructions 234. Memory 220 stores information accessible by processor 210, including instructions 234 that may be executed or otherwise used by the processor 21. The memory 220 may be of any non-transitory type capable of storing information accessible by the processor, including a computer-readable medium, or other medium that stores data that may be read with the aid of an electronic device, such as a hard-drive, memory card, ROM, RAM, DVD or other optical disks, as well as other write-capable and read-only memories. Systems and methods may include different combinations of the foregoing, whereby different portions of the instructions and data are stored on different types of media.”
Paragraph 166, where “The processor 210 may be any conventional processor, including commercially available processors. Alternatively, the processor may be a dedicated device such as an ASIC or FPGA. Although Fig. 2 functionally illustrates the processor, memory, and other elements of server 201 as being within the same block, it will be understood by those of ordinary skill in the art that the processor and memory may actually comprise multiple processors and memories that may or may not be stored within the same physical housing. For example, memory may be a hard drive or other storage media located in a housing different from that of server 201. Accordingly, references to a processor or computer will be understood to include references to a collection of processors or computers or memories that may or may not operate in parallel or even be located at the same site. Rather than using a single processor to perform the steps described herein some of the components such as steering components and deceleration components may each have their own processor that only performs calculations related to the component's specific function. Thus, server 201 may be referred to as both a system and an apparatus.”
Paragraph 168, where “The memory 112 may be internal to diagnostic device 101 which may be accessed by connecting an USB data cable to a separate computer. Accordingly, the term "medical device" in such a case may be interpreted broadly to include a personal computer, such as a desktop or mobile computer, which contains usage data, including diagnostic data 111 collected from a medical device, such as a home sleep testing device. In addition, while Fig. 2 illustrates server 201 and computers 101-104 as being connected via a network 150, each two or more devices within system 100 may be connected via a separate network or via the Internet.”
Paragraph 145, where “In one preferred form of the present technology, a data communication interface 4280 is provided, and is connected to central controller processor. Data communication interface 4280 is preferably connectable to remote external communication network 4282.”
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with route, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claims 2-9 and 11-18 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are directed to an abstract idea without significantly more. Claim 2-3, 5, 11-12, 14 recite transmitting, generating, receiving, and storing healthcare data from patient records on the generically recited computing devices as shown in the parent claims above.
Claims 4, 6, 13 and 15 further recite “therapy device” , which is recited at a high level of generality (e.g., that the transmitting and receiving of data are performed using generic computer components with instructions are executed to perform the claimed limitations) as shown in the specification paragraphs 154. Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Claims 7-9 and 16-18 further recite “diagnostic devices”, “therapy devices”, “home sleep testing device”, “flow generator for respiratory therapy” which are recited at a high level of generality (e.g., that the transmitting and receiving of data are performed using generic computer components with instructions are executed to perform the claimed limitations) as shown in the specification paragraphs 154, 40. Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
These claims fail to remedy the deficiencies of their parent claims above, and therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lynch (US 2012/0247472 A1) in view of Psynik (US 2008/0114689 A1).
CLAIM 1-
Lynch teaches the limitations of:
An electronic system for integrated management of diagnostic and therapy data of a plurality of sleep disorder breathing patients, the electronic system comprising: (Lynch teaches that the system uses diagnosis and treatment data for sleeping disorders (para [0052, 0032, 0047]))
one or more memories configured to store a plurality of electronic patient records, wherein each electronic patient record is associated with a patient of the plurality of patients; and (Lynch teaches the system has a memory that stores electornic patient records for a plurality of patients (para [0017, 0038, 0039, 0066], claim 6, Figure 2))
one or more processors in communication with the one or more memories, the one or more processors configured to: receive medical data from a plurality of medical devices (Lynch teaches that the processor is in communication with the memory and can receive patient data from a plurality of medical home devices (para [0017, 0028, 0038, 0042]))
the plurality of medical devices comprising different medical device types; (Lynch teaches that multiple device types such as glucose meters and blood pressure monitors and auto-titrators to collect data (para [0042, 0035]))
store each of the received medical data in an electronic patient record of the plurality of electronic patient records; and (Lynch teaches that the medical data is stored in the database that contains a plurality of patient records (para [0034-0035, 0067], claim 5))
Lynch does not explicitly teach, however Psynik teaches:
generate a user interface for accessing the plurality of electronic patient records, (Psynik teaches a patient data screen that shows a plurality of patients and patient data including the health device data (para [0051]))
wherein the user interface presents device usage data and/or compliance data for each patient of the plurality of patients (Psynik teaches that the patient information interface includes compliance pattern of usage data and be organized for a plurality of patients (para [0098, 0053,
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the health device monitoring system of Lynch to integrate the application of user interface patient data of Psynik with the motivation of improving secure transmission of data from a patient device to a provider of a patient management system (see: Psynik, abstract).
CLAIM 2-
Lynch teaches the limitations of claim 1. Regarding claim 2, Psynik further teaches:
store a list of therapy providers within a system of therapy providers; and (Psynik shows that the interface includes a list of insurance providers that provide specific therapeutic devices (Figure 55))
receive a request to display the list from a diagnostic provider (Psynik teaches that the administrator or health care provider (i.e.., diagnostic provider) can request to display lists of data (para [0123, 0148]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the health device monitoring system of Lynch to integrate the application of user interface patient data of Psynik with the motivation of improving secure transmission of data from a patient device to a provider of a patient management system (see: Psynik, abstract).
CLAIM 3-
Lynch teaches the limitations of claim 1. Regarding claim 3, Lynch further teaches:
receive diagnostic data from at least one of the plurality of medical devices; (Lynch teaches that multiple device types such as glucose meters and blood pressure monitors and auto-titrators to collect diagnostic data (para [0042, 0035, 0052]))
generate summary statistics by processing the diagnostic data using a set of predetermined analysis criteria; (Lynch teaches based on parameters (i.e., predetermined analysis criteria) daily data reports are exported based on the data received from the medical devices and include statistical data (para [0038, 0051, 0040, 0045], Table 1))
Lynch does not explicitly teach, however Psynik teaches:
receive a request generated by a diagnostic provider; and transmit, in response to the request, a diagnostic report comprising the summary statistics. (Psynik teaches that the user (which may be healthcare provider) can request summary reports and statistics of the data that is generated from the medical device (para [0159, 0142, 0161,0163]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the health device monitoring system of Lynch to integrate the application of user interface patient data of Psynik with the motivation of improving secure transmission of data from a patient device to a provider of a patient management system (see: Psynik, abstract).
CLAIM 4-
Lynch teaches the limitations of claim 1. Regarding claim 4, Lynch further teaches:
store a diagnostic report; (Lynch teaches storing the electronic medical record for the patient (para [0066], claim 5))
store a prescription comprising a selection of at least a therapy device and therapy device settings; (Lynch teaches that the settings can be adjusted remotely of the therapy device and can implement remote prescription changes that are monitored by the system (para [0039]))
Lynch does not explicitly teach, however Psynik teaches:
store a note generated by a diagnostic provider; and (Psynik teaches that the physician can create notes associated with the patients that are stored on the system (para [0155, 0110]))
transmit the diagnostic report, the prescription, and the note to a selected therapy provider (Psynik teaches that the report, prescription and notes can all be sent to a different healthcare providers that are providing therapy to the patient (para [0108-0110, 0072, 0155, 0159-0160]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the health device monitoring system of Lynch to integrate the application of user interface patient data of Psynik with the motivation of improving secure transmission of data from a patient device to a provider of a patient management system (see: Psynik, abstract).
CLAIM 5-
Lynch teaches the limitations of claim 1. Regarding claim 5, Psynik further teaches:
allow access to diagnostic and/or prescription data of an electronic patient record to the selected therapy provider; (Psynik teaches that based on the type of user, the user has access to diagnostic data of the patient record (para [0148, 0159, 0032, 0071]))
dynamically update a list of patients available to the therapy provider with at least one new patient record; and display the new patient record in the list of patients (Psynik teaches that the system updates the listing of patients and their records of the user who logs in (i.e., the therapy provider) and includes adding new patients to the list (para [0050-51, 0053, 0056]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the health device monitoring system of Lynch to integrate the application of user interface patient data of Psynik with the motivation of improving secure transmission of data from a patient device to a provider of a patient management system (see: Psynik, abstract).
CLAIM 6-
Lynch teaches the limitations of claim 1. Regarding claim 6, Psynik further teaches:
display patient information and a prescription for therapy as selected by a therapy provider; (Psynik teaches that the report, prescription and notes can all be selected and sent to a different healthcare providers that are providing therapy to the patient (para [0108-0110, 0072, 0155, 0159-0160], Figure 48A, 48B))
receive a request to assign a patient with a therapy device ID that corresponds to the prescription; and (Psynik teaches assigning patients based on their validation numbers that correspond to their assigned prescription and devices and received requests for authentication (para [0182-0184]))
automatically transfer clinical settings information from the prescription into the memory of the therapy device (Psynik teaches that the devices’ settings information is on the device (para [0175, 0070], Figure 15))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the health device monitoring system of Lynch to integrate the application of user interface patient data of Psynik with the motivation of improving secure transmission of data from a patient device to a provider of a patient management system (see: Psynik, abstract).
CLAIM 7-
Lynch teaches the limitations of claim 1. Regarding claim 7, Lynch further teaches:
wherein the plurality of medical devices comprise diagnostic devices and therapy devices (Lynch teaches that multiple device types such as glucose meters and blood pressure monitors to collect data and auto-titrators to provide therapy (para [0042, 0035]))
CLAIM 8-
Lynch teaches the limitations of claim 7. Regarding claim 8, Lynch further teaches:
wherein the diagnostic devices comprise a home sleep testing device (Lynch teaches home sleep therapy equipment being used by the system (para [0036, 0038]))
CLAIM 9-
Lynch teaches the limitations of claim 7. Regarding claim 9, Lynch further teaches:
wherein the therapy devices comprise a flow generator for respiratory therapy (Lynch teaches a CPAP (i.e., flow generator for respiratory therapy) being used by the system (para [0036]))
CLAIMS 10-18-
Claims 10-18 are significantly similar to claims 1-9 and are rejected upon the same prior art as claims 1-9 respectively.
CLAIM 19-
Claim 19 is significantly similar to claim 1 and is rejected upon the same prior art as claim 1.
Conclusion
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/KIMBERLY A. SASS/Examiner, Art Unit 3686
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