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 .
Preliminary Amendment
In the preliminary amendment filed 01/30/2025, the following has occurred: claims 3-4, 6-7, 10-11, 13-15, 17, and 19 have been amended and claims 21-24 have been canceled. Now, claims 1-20 are pending.
Priority
The instant application is a National Stage Application of PCT/US2023/029366, claiming priority to provisional application 63/395,294.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A Prong One
Claims 1, 8, and 20 (claim 1 representative) monitoring a plurality of medical devices for adjustments to the medical devices during a period of time; identifying, based on the monitoring, the adjustments to the plurality of medical devices during the period of time; building a therapy profile associated with a patient and the medical devices based on the identified adjustments; identifying an adverse event pertaining the patient or a respective medical device of the plurality of medical devices; and after identifying the adverse event: generating, based on the therapy profile, a plurality of corrective…to correct the adverse event, each being associated with a different one of the medical devices or a different user.
These limitations, as drafted, given the broadest reasonable interpretation, encompass managing personal behavior, which is a subgrouping of Certain Methods of Organizing Human Activity. For example, the claims encompass an individual, such as a care provider, to monitor medical devices for adjustments, identifying an adjustment, building a therapy profile associated with a patient and a medical device from the adjustments, identifying an adverse event pertaining the patient or medical device, and correcting the adverse event. Such manual steps could be carried out by a care provider in a healthcare environment to correct averse events and encompass Certain Methods of Organizing Human Activity.
Claims 2-7 and 9-19 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 3 and 10 further expand on monitoring the devices, which is part of the abstract idea identified above. Claims 4-5 and 11-12 further recite displaying a message, which could be carried out by the user identified as carrying out the abstract idea. Claim 14 further recites receiving user roles and providing different information corresponding to the rules, which is also managing personal behavior. Claims 15-19 further recite steps related to protocol information and therapy selection. These could similarly be carried out manually, encompassing managing personal behavior. As explained above, these manual steps encompass Certain Methods of Organizing Human Activity.
Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with insignificant, extra-solution data gathering and transmitting activity.
Claims 1-20, directly or indirectly, recite the following additional elements at a high level of generality and merely utilized as tools to implement the abstract idea:
Claim 1:
under control of one or more processing devices.
generating control signals.
Claim 8:
a communication interface configured to exchange information with a plurality of medical devices, and to exchange information with at least one of a plurality of user devices; a processor; and a non-transitory computer readable medium including instructions that, when executed by the processor, cause the medical device resource management system to.
generate control signals.
Claim 20:
A machine-implemented method.
generating control signals
Note that the various recitations of “control signals” are generated and/or sent to medical devices. While claims recite descriptions of how the recited “control signals” would cause operations at the medical devices, none of the claims recite the medical devices carrying out certain operations according to the control signals. The written description discloses that the recited computer components encompass generic components including “personal computers, personal data assistants, mobile devices such as laptops, tablet computers, augmented reality devices, or smartphones, configured with software for communications with information system server” (see paragraph 0026). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Claims 1-20, directly or indirectly, recite the following additional elements at a high level of generality, involving no more that extra-solution data gathering and transmitting activity:
Claims 2 and 9:
sending each of a plurality of the consecutive control signals to a different device associated with a different user.
Claims 5 and 12:
The second control signal is sent to a device outside of an area associated with a procedure being performed during the period time.
These additional elements are recited at a high degree of generality and are merely involved in insignificant extra solution data gathering and transmitting of data over a generic computer network. Note that the various recitations of “control signals” are generated and/or sent to medical devices. While claims recite descriptions of how the recited “control signals” would cause operations at the medical devices, none of the claims recite the medical devices carrying out certain operations according to the control signals. As set forth in MPEP 2106.05(g) insignificant, extra-solution activity, such as insignificant acquisition and data transmission, is an example of when an abstract idea has not been integrated into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Insignificant, extra solution, data gathering activity (e.g. transmitting and receiving data over a computer network) has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)).
Additionally, the aforementioned additional elements, considered in combination, do not provide an improvement to a technical field or provide a technical improvement to a technical problem. Additionally, that the various recitations of “control signals” are generated and/or sent to medical devices. While claims recite descriptions of how the recited “control signals” would cause operations at the medical devices, none of the claims recite the medical devices carrying out certain operations according to the control signals. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-13, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kaib, US Patent Application Publication No. 2003/0095648.
As per claim 1, Kaib teaches a method for medical device resource management, the method comprising, under control of one or more processing devices: monitoring a plurality of medical devices for adjustments to the medical devices during a period of time (see paragraph 0032; remote data collection of patient-worn medical devices; paragraph 0035 describes monitored medical devices includes wear-time of devices); identifying, based on the monitoring, the adjustments to the plurality of medical devices during the period of time (see paragraphs 0035-0036; example of adjustments being parameter changes); building a therapy profile associated with a patient and the medical devices based on the identified adjustments (see paragraph 0035; complete medical profile represents patient and medical device usage); identifying an adverse event pertaining the patient or a respective medical device of the plurality of medical devices (see paragraph 0038; analysis of equipment performance data may indicate the need for service or repair and/or a need to adjust treatment or therapies of the patient); and after identifying the adverse event: generating, based on the therapy profile, a plurality of consecutive control signals to correct the adverse event, each being associated with a different one of the medical devices or a different user (see paragraph 0038; the adverse event may be corrected through updating the operation of the device by changing the software via the Internet or by prescribing different medicines and notifying the patient. Additionally, the analysis of the collected data and corrective actions may be performed for any and all devices in use in the field).
As per claim 2, Kaib teaches the method of claim 1 as described above. Kaib further teaches sending each of the plurality of consecutive control signals to a different device associated with a different user (see paragraph 0038; the analysis of the collected data and corrective actions may be performed for any and all devices in use in the field).
As per claim 3, Kaib teaches the method of claim 1 as described above. Kaib further teaches the monitoring the plurality of medical devices comprises monitoring medical devices that are associated with a procedure being performed during the period of time (see paragraph 0038; analysis of patient data allows adjustment to treatment or therapies through updating the operation of the device, which is encompassed by monitoring the devices associated with a procedure during the period of time).
As per claim 4, Kaib teaches the method of claim 1 as described above. Kaib further teaches a first control signal of the plurality of consecutive control signals causes a first message to be displayed on a first device (see paragraph 0046; a message display regarding patient/ECG), and a second control signal of the plurality of consecutive control signals causes a second message to be displayed on a second device at a different time than when the first message is displayed on the first device (see paragraph 0034; patient message to correct nonconformities).
As per claim 5, Kaib teaches the method of claim 4 as described above. Kaib further teaches the second control signal is sent to a device outside of an area associated with a procedure being performed during the period of time (see paragraph 0034; message is sent to a device that is outside of an area associated with a procedure because procedures may be performed in other areas).
As per claim 6, Kaib teaches the method of claim 1 as described above. Kaib further teaches the adverse event comprises a sensor failure, wherein one of the consecutive control signals comprises a message for adjusting one of the medical devices (see paragraph 0035; message is sent advising adjustment to garment or device for proper placement of electrodes).
Claims 8-13 recite substantially similar system limitations to method claims 1-6 and, as such, are rejected for similar reasons as given above.
As per claim 15, Kaib teaches the system of claim 8 as described above. Kaib further teaches the plurality of consecutive control signals causes display of protocol information after receiving a user selection of a therapy (see paragraph 0043; describes selection of therapy (such as arrhythmia evens) resulting in display of protocol information (such as actions to be taken)).
As per claim 19, Kaib teaches the system of claim 8 as described above. Kaib further teaches the medical device resource management system is configured to update, delete, or download emergency protocol information via the communication interface (see paragraph 0013; updating and downloading software).
Claim 20 recites substantially similar method limitations to method claim 1 and, as such, is rejected for similar reasons as given above.
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) 7 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib, US Patent Application Publication No. 2003/0095648 in view of Hresko, US Patent Application Publication No. 2017/0296056.
As per claim 7, Kaib teaches the method of claim 1 as described above. Kaib does not explicitly teach a first control signal of the plurality of consecutive control signals comprises a reset command configured to cause a restart an operation of a medical device. Hresko teaches resolving a problem with a medical device with a first control signal comprises a reset command configured to cause a restart an operation of a medical device (see paragraph 0099; initiating a remote reboot of a specific functionality a medical device). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to include remotely restarting a device with a problem in the system of Kaib with the motivation of further facilitating corrections of problems with medical devices being used outside of access by a technician (see paragraph 0005 of Hresko).
As per claim 16, Kaib teaches the system of claim 15 as described above. Kaib does not explicitly teach the user selection of the therapy comprises a therapy for one of asystole, bradycardia, ventricular tachycardia, or ventricular fibrillation. Hresko teaches the user selection of the therapy comprises a therapy for one of asystole, bradycardia, ventricular tachycardia, or ventricular fibrillation (see paragraph 0048; remote interactions set thresholds for different therapies including ventricular tachycardia and ventricular fibrillation). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to include these types of therapies for selection in the system of Kaib because monitors arrhythmia further improving the addressing of problems with similar medical devices (see paragraph 0004 of Hresko).
As per claim 17, Kaib teaches the system of claim 15 as described above. Kaib does not explicitly teach the medical device resource management system is further configured to: receive verifications of one or more actions performed in response to the user selection of the therapy; and cause dynamic protocol information to be displayed based on the verifications of the one or more actions. Hresko teaches a medical device resource management system is configured to: receive verifications of one or more actions performed in response to user selection of a therapy (see paragraph 0100; verifies a problem with an action with a device corresponding to selected therapy); and cause dynamic protocol information to be displayed based on the verifications of the one or more actions (see 0100; in response to verification informing the patient that the device needs to be replaced). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to include verification of a device with a problem in the system of Kaib with the motivation of further facilitating corrections of problems with medical devices being used outside of access by a technician (see paragraph 0005 of Hresko).
As per claim 18, Kaib teaches the system of claim 15 as described above. Kaib does not explicitly teach the protocol information comprises emergency protocol information, and wherein the emergency protocol information is provided in accordance with a determination by the medical device resource management system that a close-loop control algorithm of the medical devices fails to correct an anomaly detected during the period of time. Hresko teaches the protocol information comprises emergency protocol information, and wherein the emergency protocol information is provided in accordance with a determination by the medical device resource management system that a close-loop control algorithm of the medical devices fails to correct an anomaly detected during the period of time (see paragraph 0100; critical fault provides emergency protocol where immediate contact with a technician is initiated). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to include emergency protocol for a problem in the system of Kaib with the motivation of further facilitating corrections of problems with medical devices being used outside of access by a technician (see paragraph 0005 of Hresko).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib, US Patent Application Publication No. 2003/0095648 in view of Kehr, US Patent Application Publication No. 2003/0036683.
As per claim 14, Kaib teaches the system of claim 8 as described above. Kaib does not explicitly teach the medical device resource management system is configured to: receive, from a plurality of user devices, information about roles of respective users associated with corresponding user devices; and display, based on the plurality of consecutive control signals, different protocol information at the corresponding user devices based on the roles of respective users. Kehr teaches a medical device resource management system is configured to: receive, from a plurality of user devices, information about roles of respective users associated with corresponding user devices; and display, based on a plurality of consecutive control signals, different protocol information at the corresponding user devices based on the roles of respective users (see paragraph 0083; user authentication determines user roles for accessing data, such as a designated healthcare providers being able to review patient treatment information). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to provide role-based access to data in the system of Kaib with the motivation of improving the access to data by permitting different levels of access and modification to patient data in the system of Kaib (see abstract of Kehr).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Baudet, International Publication No. WO 2016/044125 A2, discloses a system that monitors a variety of medical equipment and identifies errors with an error message.
Knight, US Patent Application Publication No. 2022/0157445, discloses automatically programming a medical device used for treating a patient.
Avraham, US Patent No. 10,658,079, discloses managing updates to medical monitoring devices.
Patel, US Patent Application Publication No. 2018/0351987, discloses managing deployment of patches to medical devices to solve device problems.
Mruthyunjaya, US Patent Application Publication No. 2013/0132109, discloses updating medical device software.
Chen et al., Medical Cyber–Physical Systems: A Solution to Smart Health and the State of the Art, discusses remote medical device usage, including error detection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to C. Luke Gilligan whose telephone number is (571)272-6770. The examiner can normally be reached Monday through Friday 9:00 - 5:00.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683