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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“a network module configured to obtain usage data”, “a learning module configured to determine…”, and “an analysis module configured to compare… and generate” in claim 1.
“a recommendation module configured to process and communicate” in claim 2.
“a first agent for monitoring a first medical device” and “a second agent for monitoring a second medical device” in claim 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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.
Claims 1-14 are 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 limitations “a network module configured to obtain usage data”, “a learning module configured to determine…”, “an analysis module configured to compare… and generate”, “a recommendation module configured to process and communicate”, “a first agent for monitoring a first medical device”, and “a second agent for monitoring a second medical device” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While the specification discloses the agent comprises a network module, a learning module, and an analysis module, and the agent is implemented in hardware and/or software (See specification pg. 11, lines 2-5), the specification fails to clearly associate each particular unit with a structure, material, or act to perform the claimed functions. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-14 recite various modules for performing different functions, however, the specification fails to provide sufficient description of the modules for performing the claimed functions. Therefore, the claims lack written description under 112(a).
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claims
Step 1 analysis:
Claim 1 is interpreted as a system based on the 112(f) interpretation above, and Claim 15 is drawn to a method (i.e., process), which are within the four statutory categories. (Step 1 – Yes, the claim falls into one of the statutory categories).
Step 2A analysis – Prong One:
Claim 15 recites:
A method for monitoring a medical device, the method comprising:
determining normal operation values of the medical device based on the usage data of the medical device, and the usage data of the at least one other medical device;
comparing the usage data of the medical device with the normal operation values of the medical device and a standard operation policy; and
generating, based on the comparison, an operation issue signal describing a detected discrepancy between the usage data of the medical device with the normal operation of the medical device.
The series of steps as recited above falls within the “mental processes” grouping of abstract ideas, and describes concepts that can be performed in the human mind through observation, evaluation, judgement, and opinion. Determining normal operation values of the medical device, and comparing the usage data with the normal operation values can all be performed in the human mind, with or without the use of a physical aid. Therefore, the claim recites an abstract idea of a mental process.
Claim 1 recites/describes nearly identical steps as claim 15 (and therefore also recites limitations that fall within this subject matter grouping of abstract ideas), and this claim is therefore determined to recite an abstract idea under the same analysis.
Step 2A analysis – Prong 2:
This judicial exception is not integrated into a practical application. Specifically, independent claims 1 and 15 recite the following additional elements beyond the abstract idea: an interface, network module, learning module, and an analysis module. These limitations are recited at a high level of generality and amount to no more than mere instructions to apply the exception using generic computer components. The limitations do not impose any meaningful limits on practicing the abstract idea, and therefore do not integrate the abstract idea into a practical application (see MPEP 2106.05(f)).
The limitations “an interface configured to obtain usage data”, “a network module configured to obtain usage data”, “obtaining usage data describing an operation of a medical device” and “obtaining usage data describing an operation of at least one other medical device” are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
The additional elements do not show an improvement to the functioning of a computer or to any other technology, rather the additional elements perform general computing functions and do not indicate how the particular combination improves any technology or provides a technical solution to a technical problem. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, Claims 1 and 15 are directed to an abstract idea without practical application. (Step 2A – Prong 2: No, the additional elements are not integrated into a practical application).
Step 2B analysis:
As discussed above in “Step 2A analysis – Prong 2”, the identified additional elements in Independent Claims 1 and 15 are equivalent to adding the words “apply it” on a generic computer, and/or generally link the use of the judicial exception to a particular technological environment or field of use. Therefore, the claims as a whole do not amount to significantly more than the judicial exception itself.
Additional elements of “an interface configured to obtain usage data”, “a network module configured to obtain usage data”, “obtaining usage data describing an operation of a medical device” and “obtaining usage data describing an operation of at least one other medical device” were found to be insignificant extra-solution activity in Step 2A, Prong Two, because they were determined to be insignificant limitations as necessary data gathering and outputting. However, a conclusion that an additional element is insignificant extra -solution activity in Step 2A, Prong Two should be re-evaluated in Step 2B. See MPEP 2106.05, subsection I.A. At Step 2B, the evaluation of the insignificant extra-solution activity consideration takes into account whether or not the extra-solution activity is well understood, routine, and conventional in the field. See MPEP 2106.05(g).
For the role of a computer in a computer implemented invention to be deemed meaningful in the context of this analysis, it must involve more than performance of “well- understood, routine, [and] conventional activities previously known to the industry.” Further, “the mere recitation of a generic computer cannot transform a patent ineligible abstract idea into a patent-eligible invention.”
The applicant’s specification discloses: the network module establishes a communication channel between the agent and at least one other agent to be able to gather information from a large number of networked agents (see Applicant’s specification Pg. 3, lines 29-34). The interface is configured to obtain usage data describing an operation of a medical device (see Applicant’s specification pg. 11, lines 13-14).
Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. Here, the claim limitations of “an interface configured to obtain usage data” and “a network module configured to obtain usage data” are similar to receiving and sending information over a network (Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OJP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); See MPEP 2106.05(d)(ll)(i)).
The claims 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 of the abstract idea into a practical application, using the additional elements to perform the steps monitoring medical devices amount to no more than using computer related devices to implement the abstract idea.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing. Therefore, the claims are not patent eligible. The Examiner has therefore determined that no additional element, or combination of additional claims elements is/are sufficient to ensure the claims amount to significantly more than the abstract idea identified above (Step 2B: Independent claims - NO).
Dependent Claims
Dependent Claims 2-14 are directed towards elements used to describe processing of the data and communicating recommendations and actions to a user. These elements fall within the same “mental processes” grouping of abstract ideas as independent claims 1 and 15, and describe concepts that can be performed in the human mind through observation, evaluation, judgement, and opinion. Generating a best practice recommendation, determining a correction action describing a change, executing the correction action, identifying the correction action, determining the correction action would alter operation parameters, determining normal operation, identifying a typical operation, and generating operation advice are all tasks that can be performed in the human mind. Therefore, the dependent claims recite an abstract idea of a mental process.
This judicial exception is not integrated into a practical application. Specifically, the dependent
claims recite the following additional elements beyond the abstract idea: sensors of the medical device, a reinforcement learning model, a first agent, a second agent, establish a communication channel, receive usage data, a rectification machine learning module, alerting a user, and communicate to a user device.
The sensors of the medical device, a reinforcement learning model, a first agent, a second agent, establish a communication channel, and a rectification machine learning module are recited at a high level of generality and amount to no more than mere instructions to apply the exception using generic computer components. The limitations do not impose any meaningful limits on practicing the abstract idea, and therefore do not integrate the abstract idea into a practical application (see MPEP 2106.05(f)).
The limitations receive usage data, alerting a user, and communicate to a user device are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”).
The additional elements do not show an improvement to the functioning of a computer or to
any other technology, rather the additional elements perform general computing functions and do not
indicate how the particular combination improves any technology or provides a technical solution to a
technical problem. Accordingly, these additional elements, when considered separately and as an
ordered combination, do not integrate the abstract idea into a practical application because they do not
impose any meaningful limits on practicing the abstract idea. Therefore, the dependent claims are
directed to an abstract idea without practical application.
The Examiner has therefore determined that no additional element, or combination of
additional claims elements is/are sufficient to ensure the claims amount to significantly more than the
abstract idea identified above.
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.
Claims 1-4, 6-11, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Page et al. (WO 2020/014169) (hereinafter Page).
Regarding Claim 1, Page teaches the following:
An agent for monitoring a medical device (Page [0004] and [0017] discloses a medical device data (MDD) processing system implemented in a variety of hardware and/or software for monitoring a plurality of medical devices), the agent comprising:
an interface configured to obtain usage data describing an operation of a medical device ([0014], [0015], [0024], and [0025] discloses a gateway device which facilitates a secure communications link between the medical devices at the hospital network with the servers, processors, and computer readable media implementing the MDD processing system. The gateway receives the medical device data as time series data for any of the medical device data available from the medical devices, including operational data);
a network module configured to obtain usage data describing an operation of at least one other medical device related to the medical device ([0020]-[0022], [0026] The MDD processing system is connected to at least one hospital network that allows the system or portions thereof to communicate with one or more computing devices. A high speed ingestion module of the MDD processing system can receive concurrent data streams from multiple connected devices across multiple connected devices.);
a learning module configured to determine normal operation values of the medical device based on the usage data of the medical device, and the usage data of the at least one other medical device ([0055] and [0057] The clinical cases and the associated medical device data are used by the deep learning network to train deep learning algorithms. Medical device data from normal and outlier cases are classified, and the identified normal cases are submitted to the learning network. Relative values and/or changes in any of those metrics may also be used to identify between procedure phases), and
an analysis module ([0045]-[0048] streaming analytics algorithms for analyzing the device data) configured to: compare the usage data of the medical device with the normal operation values of the medical device and a standard operation policy ([0014], [0047] to detect deviations from standard practice, the data, including operational data from the medical devices, may be compared to normal or expected operation); and
generate, based on the comparison, an operation issue signal describing a detected discrepancy between the usage data of the medical device with the normal operation values of the medical device ([0053] Events detected by the streaming analytics at are provided to an event router which routes the identified events into predetermined groups or topics in an event notifier).
Regarding Claim 2, Page further discloses:
The agent of claim 1, further comprising a recommendation module configured to:
process the usage data of the medical device and the usage data of the at least one other medical device in order to generate a best practice recommendation describing an operation mode for the medical device ([00104] based upon an analysis of the machine data, a recommendation can be identified for changing medical device settings and/or parameters. This may include adjustments to any of the values in the received machine data or other identified medical device settings, including alarm parameters); and
communicate the best practice recommendation to a user associated with the medical device ([00104] the recommendation for medical device setting changes can be sent in a notification to a responsible clinician).
Regarding Claim 3, Page further discloses:
The agent of claim 1, wherein the network module is configured to:
establish a communication channel between the agent and at least one other agent, each other agent configured to obtain usage data of the at least one other medical device ([0024] a gateway may exemplarily be an internet of things (IOT) gateway which facilitates a secure communications link between the medical devices at the hospital network with the servers, processors, and computer readable media implementing the MDD processing system); and
receive, via the communication channel, the usage data from the at least one other agent ([0025] The gateway receives the medical device data as time series data for any of the medical device data available from the medical devices. The data streams of machine data are available in time series format as acquired from the medical devices and may include, but are not limited to time series information of alarms, device status, device settings, messages, and measured data. In embodiments, the medical devices may be equipped with sensors that improve the self-awareness of the medical device, e.g. sensors that monitor the function, inputs and/or outputs of various components of the medical device itself).
Regarding Claim 4, Page further discloses:
The agent of claim 1, wherein the analysis module is further configured to:
determine, based on the operation issue signal, a correction action describing a change to the medical device to reduce the discrepancy ([00104] particular events may be identified, these events being recommended changes to medical device settings or parameters. This may include adjustments to any of the values in the received machine data or other identified medical device settings, including alarm parameters. In one exemplary embodiment, these events result in notifications to a responsible clinician with recommendations for such medical device setting changes); and
execute the correction action on the medical device ([00104] medical device data processing system communicates back to the medical devices, for example through the gateway to provide operational instructions and/or medical device setting adjustments directly to the medical device).
Regarding Claim 6, Page further discloses:
The agent of claim 4, wherein the analysis module is configured to determine the correction action based on the operation issue signal and the usage data of the at least one other medical device ([00102], [00104], [00105] analysis of machine operational status (e.g. in use, standby status, and offline) may further provide information and insights not only to a hospital to assist in efficient management of medical device assets, but may further provide generalized information regarding specific use case and use trends to provide insight into field use of medical devices, in still further exemplary embodiments, maintenance, use, or other schedules may be based upon utilization reports specific to particular devices. Medical device data processing system communicates back to the medical devices, for example through the gateway to provide operational instructions and/or medical device setting adjustments directly to the medical device. The machine data is produced by a plurality of medical devices for use in the streaming analytics.).
Regarding Claim 7, Page further discloses:
The agent of claim 4, wherein the analysis module is configured to input the operation issue signal to a rectification machine learning module adapted to identify the correction action based on the operation issue signal ([0046], [0048], [00104] Streaming analytics algorithms detect a medical device needing maintenance. The streaming analytics may classify events (deviations from standard practice) detected in the time series medical device data. Deep learning algorithms may further classify the events with more specificity than the above noted reactive, predictive, and prescriptive. Based upon an analysis of the machine data, a recommendation can be identified for changing medical device settings and/or parameters. This may include adjustments to any of the values in the received machine data or other identified medical device settings, including alarm parameters).
Regarding Claim 8, Page further discloses:
The agent of claim 4, wherein the analysis module is further configured to:
determine whether the correction action would alter manually set operational parameters of the medical device ([0014], [00104] Machine data may further include settings and values that represent specific actions taken with the medical device for example, in response to clinician inputs. For example, a clinician may make changes to oxygen and/or anesthetic agent concentrations (i.e., parameters). Adjustments to any of the values in the machine data can be made.); and
responsive to determining that the correction action would alter the manually set operation parameters, alerting a user associated with medical device of the correction action ([00104] adjustments to any of the values in the received machine data or other identified medical device settings, including alarm parameters. In one exemplary embodiment, these events result in notifications to a responsible clinician with recommendations for such medical device setting changes.).
Regarding Claim 9, Page further discloses:
The agent of claim 1, wherein the interface is configured to obtain the usage data from sensor logs of the medical device ([0044], [0055] The medical device data includes data measured from device sensors), and system parameter logs of the medical device ([0090] the MDD can include operation or keystroke data which can be stored in a log at the MDD processing system. This data can be analyzed to provide information regarding the interaction between a clinician and the machine just prior to the alarm, event, or notification to be corrected).
Regarding Claim 10, Page further discloses:
The agent of claim 1, wherein the usage data comprises at least one of: medical device usage patterns, medical device parameters, medical device behavior, and medical device best practices ([0055] the medical device data includes, but is not limited to data streams in time series format of machine data, for example alarms, device statuses, settings, messages, and data measured from device sensors).
Regarding Claim 11, Page further discloses:
The agent of claim 10, wherein the usage data further comprises contextual data, including at least one of: physical parameters, and environmental parameters, and wherein the interface is configured to obtain the contextual data from sensors of the medical device ([0025] the medical devices may be equipped with sensors that improve the self-awareness of the medical device, e.g. sensors that monitor the function, inputs and/or outputs of various components of the medical device itself. Many such sensors are already incorporated into medical devices such as to measure compressor speeds and/or cycle times, internal pressures, voltages, clock speeds, or temperatures, or other sensors).
Regarding Claim 13, Page further discloses:
The agent of claim 1, wherein the analysis module is further configured to:
generate, based on the operation issue signal, operation advice related to an operation mode of the medical device ([00104] based upon an analysis of the machine data, a recommendation can be identified for changing medical device settings and/or parameters. This may include adjustments to any of the values in the received machine data or other identified medical device settings, including alarm parameters); and
communicate the operation advice to a user associated with the medical device ([00104] the recommendation for medical device setting changes can be sent in a notification to a responsible clinician).
Regarding Claim 14, Page further discloses:
A system for monitoring a medical device (Page Abstract discloses systems and methods of managing maintenance for a plurality of monitored medical devices), the system comprising:
a first agent for monitoring a first medical device according to claim 1 (Page [0004] and [0017] discloses a medical device data (MDD) processing system implemented in a variety of hardware and/or software for monitoring a medical device);
a second agent for monitoring a second medical device ([0045], [0055] different streaming analytics algorithms may relate the analysis of multiple streams of data, for example streams of data originating from the same medical device and/or streams of data originating from different medical devices but from the same location), and
wherein the network module of the first agent is configured to obtain usage data describing an operation of the second medical device from the second agent ([0055] The medical devices 16 may be located all within the same unit within a hospital, within the same hospital, or across a plurality of different hospitals and locations. The method begins by continuously acquiring the streaming time series of medical device data at from all of the medical devices.).
Regarding Claim 15, Page teaches the following:
A method for monitoring a medical device (Page Abstract discloses systems and methods of managing maintenance for a plurality of monitored medical devices), the method comprising:
obtaining usage data describing an operation of a medical device ([0014], [0015], [0024], and [0025] discloses a gateway device which facilitates a secure communications link between the medical devices at the hospital network with the servers, processors, and computer readable media implementing the MDD processing system. The gateway receives the medical device data as time series data for any of the medical device data available from the medical devices, including operational data);
obtaining usage data describing an operation of at least one other medical device related to the medical device ([0020]-[0022], [0026] The MDD processing system is connected to at least one hospital network that allows the system or portions thereof to communicate with one or more computing devices. A high speed ingestion module of the MDD processing system can receive concurrent data streams from multiple connected devices across multiple connected devices.);
determining normal operation values of the medical device based on the usage data of the medical device, and the usage data of the at least one other medical device ([0055] and [0057] The clinical cases and the associated medical device data are used by the deep learning network to train deep learning algorithms. Medical device data from normal and outlier cases are classified, and the identified normal cases are submitted to the learning network.);
comparing the usage data of the medical device with the normal operation values of the medical device and a standard operation policy ([0014], [0047] to detect deviations from standard practice, the data, including operational data from the medical devices, may be compared to normal or expected operation); and
generating, based on the comparison, an operation issue signal describing a detected discrepancy between the usage data of the medical device with the normal operation of the medical device ([0053] Events detected by the streaming analytics at are provided to an event router which routes the identified events into predetermined groups or topics in an event notifier).
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 (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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Page et al. (WO 2020/014169) (hereinafter Page) in view of Junker et al. (US 2021/0193305) (Hereinafter Junker).
Regarding Claim 5, Page further discloses:
The agent of claim 4, wherein the correction action comprises at least one of a medical device parameter change ([00104] particular events may be identified, these events being recommended changes to medical device settings or parameters. This may include adjustments to any of the values in the received machine data or other identified medical device settings, including alarm parameters. In one exemplary embodiment, these events result in notifications to a responsible clinician with recommendations for such medical device setting changes),
However, Page does not teach the following that is met by Junker:
and a medical device operation order change ([0026] the medical device data management system and/or the portable electronic device may determine a prioritized order in which the information received by the portable electronic device is displayed).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to have combined the medical device parameter change correction action, as taught by Page, with the medical device operation order change, as taught by Junker, because by using an optimized sequential order, the integrity of the samples which are being analyzed by the medical device will be ensured (See Junker para. [0041]).
Regarding Claim 12, Page further teaches the following:
The agent of claim 1, wherein the learning module is configured to determine the normal operation of the medical device by inputting the usage data of the medical device and the usage data of the at least one other medical device to a reinforcement learning model ([0057] The clinical cases and the associated medical device data (i.e., usage data from a plurality of medical devices) are used by the deep learning network to train deep learning algorithms. In embodiments, the deep learning network may additionally incorporate curated data from a wide variety of clinical research institutions that have joined into a shared learning and discovering community)
However, Page does not teach the following that is met by Junker:
adapted to identify a typical operation of a medical device ([0047], [0053] The medical device data management system may thus determine a typical workload of the various medical devices. The medical device data management system may compute the expected future work-load from historic usage data (indicating a typical workload e.g. for a given time of day)) based on operational parameters of a plurality of related medical devices ([0021] Examples of parameters indicative of an operational status that may be presented by a medical device data management system include one or more of the following: error indicators, calibration information, information indicative of required QC procedures, information about required maintenance, and/or the like. The medical device data management system may compute an estimated current global workload for all medical devices or weigh the estimated workload for different medical devices based on other parameters).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to have combined inputting usage data into a reinforcement learning module with the ability to identify a typical operation of a medical device based on operation parameters, as taught by Junker, because by utilizing the information from a plurality of medical devices, the availability prediction (i.e., the operation status prediction) will be improved and more accurate (See Junker para. [0053] and [0058]).
Relevant Prior Art of Record Not Currently Being Applied
The relevant art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Yatim et al. (US 2022/0148717) discloses a medical device reporting system which identifies adverse events by utilizing known defects, recalls and expirations, as well as usage of similar or related devices.
Vinograd et al. (US 2021/0196576) discloses a system which gathers usage data of medical devices and calculated an adherence score based on usage and device status data using machine learning.
Gur et al. (TR 2021/006205 A2) discloses a system that detects malfunctions and problems that may occur in an electronic device, and takes necessary actions by obtaining usage data and analyzing it using machine learning techniques.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXIS K VAN DUZER whose telephone number is (571)270-5832. The examiner can normally be reached Monday thru Thursday 8-5 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.K.V./Examiner, Art Unit 3682
/EVANGELINE BARR/Primary Examiner, Art Unit 3682