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 .
DETAILED ACTION
Status of the Application
1. The following is a Final Office Action in response to communication received on 12/5/2025. Claims 1-21 are pending in this office action.
Response to Amendment
2. Applicant’s amendments to claims 1-2,6, 8-9, and 16-18 are acknowledged. Applicant’s addition of new claim 21 is acknowledged.
Response to Arguments
3. Based on Applicant’s response (see Remarks page 8) and amendments, the previous 112 second/b rejections have been withdrawn.
4. On Remarks pages 9-10, with respect to the 101 rejection Applicant argues preemption. The Examiner understands Applicant’s arguments here, however the Examiner respectfully disagrees. While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility, preemption is inherent in and resolved in the two part framework from Alice Corp and Mayo (which is found in the 101 rejection below), and while a preemptive claim may be ineligible, absence of complete preemption does not demonstrate that a claim is eligible.
See MPEP 2106.04 cited herein:
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible. Diamond v. Diehr, 450 U.S. 175, 191-92 n.14, 209 USPQ 1, 10-11 n.14 (1981) ("We rejected in Flook the argument that because all possible uses of the mathematical formula were not pre-empted, the claim should be eligible for patent protection"). See also Synopsys v. Mentor Graphics, 839 F.3d at 1150, 120 USPQ2d at 1483; FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1098, 120 USPQ2d 1293, 1299 (Fed. Cir. 2016); Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1320-21, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); Sequenom, 788 F.3d at 1379, 115 USPQ2d at 1158. Several Federal Circuit decisions, however, have noted the absence of preemption when finding claims eligible under the Alice/Mayo test. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016); BASCOM Global Internet v. AT&T Mobility, LLC, 827 F.3d 1341, 1350-52, 119 USPQ2d 1236, 1243-44 (Fed. Cir. 2016)
5. On Remarks pages 10-11, Applicant argues Finjan. Finjan was concerning virus scanning and found to be an improvement in computer technology and not directed to an abstract idea (see MPEP 2106. 04(d)). The fact patterns are not the same here. The present application is not directed towards virus scanning and improvements in the virus scanning computer technology. Further Applicant does not argue the claims recite an improvement in a computer technology as in Finjan, rather Applicant argues a specific way of achieving a result and not monopolizing the field, therefore the Examiner finds the argument not persuasive with respect to Finjan.
6. On remarks pages 11-12, applicant argues a practical application. Here Applicant argues not monopolizing the exception, which is not persuasive as detailed in section 4 above. Further the Examiner provided reasonings as detailed in the 101 rejection as to why the additional elements beyond the abstract idea in each claim did not amount to a practical application, specifically that the additional elements beyond the abstract amount to no more than mere instructions to apply an exception (see MPEP 2106.05(f) or generally linking it to the field of use of technological environment (see MPEP 2106.05(h)). Limitations that the courts have found to qualify as “significantly more when recited in a claim with a judicial exception include those discussed in MPEP 2106.05 (cited herein):
A. Relevant Considerations For Evaluating Whether Additional Elements Amount To An Inventive Concept
The Supreme Court has identified a number of considerations as relevant to the evaluation of whether the claimed additional elements amount to an inventive concept. The list of considerations here is not intended to be exclusive or limiting. Additional elements can often be analyzed based on more than one type of consideration and the type of consideration is of no import to the eligibility analysis. Additional discussion of these considerations, and how they were applied in particular judicial decisions, is provided in in MPEP § 2106.05(a) through (h).
Limitations that the courts have found to qualify as "significantly more" when recited in a claim with a judicial exception include:
i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).
Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include:
i. Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
iii. Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
iv. Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2B. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception is not in itself an inventive concept and does not guarantee eligibility:
7. On remarks pages 12-13, Applicant argues the non-conventional and non generic arrangement of parts as in BASCOM with respect to significantly more.
Specifically Applicant argues the limitation of:
a medical device configured to[] couple with the accessoryl] access the unique identifier associated with the accessory[ and] while in operation and coupled with the accessory, determine use data for the accessory when coupled with the accessory, the use data indicating a usage history of the accessory," as well as "an asset manager communicably coupled with the medical device[] configured to receive the use data and the unique identifier associated with the accessory from the medical devicel] determine a lifespan associated with the accessory based on the unique identifier[ and] determine an expected expiration of the accessory by analyzing at least the use data, the
lifespan, and previous use data received from at least one additional medical device."
It is noted that first this recites certain methods of organizing human activity steps as broadly recited in the claims. Specifically, access a unique identifier associated with an accessory while in operation and coupled to the accessory, determine use data for the accessory when coupled to the accessory, the use data indicating a usage history of the accessory. This can be done merely by looking at an identifier on a device and accessing records of the device to determine usage as broadly claimed. This is part of the abstract idea. Further it is certain methods of organizing human activity steps to receive the use data and the unique identifier, determine a lifespan associated with the accessory based on the unique identifier, determine an expected expiration of the accessory by analyzing at least the use data, the lifespan, and previous use data received from at least one additional medical device. This can be done merely by comparing identifiers with records (which can be paper or otherwise), as broadly recited in the claims. This is part of the abstract idea. The additional elements that this human activity steps are instead being performed by a “medical device” and “an asset manager community coupled with the medical device” merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. Further here the claim recites only the idea of a solution or outcome, in that the claim fails to recite details of how a solution to a problem is accomplished. As here the additional limitations provide only a result oriented solution and lack details as to how the computer performs the modifications, which was equivalent to the words apply it (see MPEP 2106.05(f).
Further these method of organizing human activity steps that merely recite instead being performed by a medical device coupled to the accessory and an asset manager coupled to the medical device (note under the 112 sixth/f interpretation this is software running on a computer) merely results in generally linking it to the field of computers (see MPEP 2106.05(h)).
Therefore this does not recite non-conventional and non-generic arrangement of parts here as broadly recited, instead the claims merely recite performing certain methods of organizing human activities by computers.
8. On Remarks pages 13-16, Applicant argues the prior art rejection in view of Applicant’s amendments. The arguments while considered are moot in view of the new grounds of rejection in view of Applicant’s amendments. See newly cited reference Lamego et al. (United States Patent Application Publication Number: US 2012/0330112).
Claim Rejections - 35 USC § 101
2. 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.
3. Claims 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-8 and 21 recite a machine as the claims recite a system including limitations interpreted under 112 sixth/f. Claims 9-15 recite a machine as the claims recite a device with a processor executing instructions. Claims 16-20 recite a process as the claims recite a method.
The claim(s) 1-21 recite(s) the idea of collecting data and making a determination of when a piece of medical equipment expires according to rules and if it expires disabling it from being used again.
The idea of collecting data and making a determination of when a piece of medical equipment expires according to rules and if it expires disabling it from being used again is subject matter relating to managing personal behavior or relationships or interactions between people (including following rules or instructions) which is a certain method of organizing human activities.
Certain methods of organizing human activity are in the groupings of enumerated abstracts ideas, and hence the claims recite an abstract idea.
This judicial exception is not integrated into a practical application because the claims merely recite limitations that are not indicative of integration into a practical application in that the claims merely recite:
(1) Adding the words “apply it” ( or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)), and (2) Generally linking the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)).
Specifically as recited the claims:
As per claim 1, the claims recite limitations a human or humans could perform specifically a human could collect usage data associated with an accessory where the accessory could have a unique identifier on the side of the accessory, determine an expired expiration of the accessory based on analyzing the usage data that could be stored in logs related to use with various products, and generate a notification of the expected expiration. The additional elements that these limitations that could be performed by a human or humans are instead being performed by a medical device coupled to the accessory and an asset manager coupled to the medical device (note under the 112 sixth/f interpretation this is software running on a computer) merely results in apply it.
Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. Further here the claim recites only the idea of a solution or outcome, in that the claim fails to recite details of how a solution to a problem is accomplished. As here the additional limitations provide only a result oriented solution and lack details as to how the computer performs the modifications, which was equivalent to the words apply it.
Further limitations that could be performed by a human or humans that instead recite being performed by a medical device coupled to the accessory and an asset manager coupled to the medical device (note under the 112 sixth/f interpretation this is software running on a computer) merely results in generally linking it to the field of computers.
As per claim 2, the claims recite limitations a human or humans could perform specifically a human could gather a unique identifier of an accessory by for example looking at the number on the side of an accessory and then providing it to another user or looking at some record that has the identifier stored in it (like a file cabinet) and then providing it to another user. The additional element that this performed by ““the medical device” results in no more than apply it or generally linking it to the field of computers as discussed above in claim 1.
As per claim 3, the claims recite limitations a human or humans could perform specifically a human could remove the connection of the expired accessory by for example throwing it away or unplugging it. The additional elements that this is performed by a “medical device” and the “asset manager” merely results in apply it or generally linking it to the field of computers as discussed above in claim 1. Specifically here Applicant recites a result oriented solution and lack details as to how the step is performed, which is equivalent to the words “apply it” (see MPEP 2106.05(f)).
As per claim 4, the claims recite limitations a human or humans could perform specifically a human could perform the same operations above on other medical devices or computing devices of a service provider. For example do the operations again for other devices in a medical or hospital setting. The additional elements that further defines the asset manager as “asset manager comprises a cloud based service” merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. For example here Applicant does not recite an improvement in the additional element of cloud based computing rather applicant is merely applying cloud based computing to perform the functions by further describing the asset manager, which is the equivalent to apply it.
Further limitations that could be performed by a human or humans that instead defines the asset manager as “asset manager comprises a cloud based service” merely results in generally linking it to the field of computers.
As per claim 5, the claims recite limitations a human or humans could perform specifically a human could generate a report indicating the expiration of different devices or accessories within the medical setting and transmit that report to other user like their supervisor or maintenance crew. The additional elements that these limitation that could be performed by a human or humans are instead being performed by “asset manager” and instead of being sent to a maintenance crew are sent to “a computing device among the computing device” of a service provider (which could be the maintenance crew) merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more.
Further limitations that could be performed by a human or humans that are instead being performed by an “asset manager” and instead of being sent to a maintenance crew are sent to “a computing device among the computing device” of a service provider (which could be the maintenance crew) merely results in generally linking it to the field of computers.
As per claim 6, the claims recite limitations a human or humans could perform specifically a human could generate a message that the medical device or accessory expired based on a determination. The additional elements that this limitation that could be performed by a human or humans are instead being performed by “asset manager” merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more.
Further limitations that could be performed by a human or humans that instead recited being performed by an “asset manager” merely results in generally linking it to the field of computers.
As per claim 7, the claims recite limitations a human or humans could perform specifically a human could store usage information in a data store and update the entry based on additional usage information of the device with other devices to reflect the used life or remaining life where the device could be connected to other devices. The additional elements that this limitation that could be performed by a human or humans are instead being performed by “asset manager” and the data is stored in a “database” instead of for example a pen and paper ledger merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more.
Further limitations that could be performed by a human or humans that are instead recited as being performed by an “asset manager” and the data is stored in a “database” instead of for example a pen and paper ledger merely results in generally linking it to the field of computers.
As per claim 8, the claims recite limitations a human or humans could perform specifically a human or humans could provide another human with instructions on how to determine use data for an accessory, where then this human could perform the determination of use data at the location they are at. The additional elements that this limitation that could be performed by a human of giving the instructions to another is being performed by “an asset manager”, and the other user who would perform the calculation based on the received instructions is being performed by a “a computing component on board the medical device, the computing component comprising a processor and a non-transitory computer-readable medium storing instructions thereon, that when executed by the processor, cause the processor to” merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more.
Further limitations that could be performed by a human of giving the instructions to another is being performed by “an asset manager”, and the other user who would perform the calculation based on the received instructions is being performed by a “a computing component on board the medical device, the computing component comprising a processor and a non-transitory computer-readable medium storing instructions thereon, that when executed by the processor, cause the processor to” merely results in generally linking it to the field of computers.
As per claim 9, the claims recite limitations a human or humans could perform specifically a human could collect usage data associated with an accessory where the accessory could have a unique identifier on the side of the accessory, determine an expired expiration of the accessory based on analyzing the usage data where usage data related to the devices use across devices could be stored in logs, and generate a notification of the expected expiration. Further a human could interface with other humans or devices to send and receive information, for example by looking at a screen on a device to capture information or looking at the side of a device to capture the model number. The additional elements that these limitations that could be performed by a human or humans are instead being performed by a medical device comprising a processor running instructions (a processor; and a non-transitory computer-readable medium having instructions stored thereon, that when executed by the processor, cause the processor to:), the medical device includes interfaces to connect with other devices (like an accessory and a cloud based management system), and this is being performed in a “cloud-based management system” merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. Further here the claim recites only the idea of a solution or outcome, in that the claim fails to recite details of how a solution to a problem is accomplished. As here the additional limitations provide only a result oriented solution and lack details as to how the computer performs the modifications, which was equivalent to the words apply it.
Further limitations that could be performed by a human or humans that instead recite being performed by a medical device comprising a processor running instructions (a processor; and a non-transitory computer-readable medium having instructions stored thereon, that when executed by the processor, cause the processor to:), the medical device includes interfaces to connect with other devices (like an accessory and a cloud based management system), and this is being performed in a “cloud-based management system” merely results in generally linking it to the field of computers.
As per claim 10, the claims recite limitations a human or humans could perform specifically a human could gather a unique identifier of an accessory by for example looking at the number on the side of an accessory or looking at some record that has the identifier stored in it (like a file cabinet). The additionally element that this performed by “instructions” results in no more than apply it or generally linking it to the field of computers as discussed above in claim 9.
As per claim 11, the claims recite limitations a human or humans could perform specifically a human could look at an identifier on the side of an accessory to determine the identity of the visual identifier by for example looking up the code 12356 in a data store like a list on a piece of paper. The additional elements that these limitations that could be performed by a human or humans are instead being performed by a camera merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. Further here the claim recites only the idea of a solution or outcome, in that the claim fails to recite details of how a solution to a problem is accomplished. As here the additional limitations provide only a result oriented solution and lack details as to how the computer performs the modifications, which was equivalent to the words apply it.
Further limitations that could be performed by a human or humans that instead recite being performed by a camera merely results in generally linking it to the field of computers.
As per claim 12, the claims recite limitations a human or humans could perform specifically a human could look at an identifier tag on the side of an accessory to determine the identity of the visual identifier by for example looking up the code 12356 in a data store like a list on a piece of paper. The additional elements that these limitations that could be performed by a human or humans are instead being performed by RFID merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. Further here the claim recites only the idea of a solution or outcome, in that the claim fails to recite details of how a solution to a problem is accomplished. As here the additional limitations provide only a result oriented solution and lack details as to how the computer performs the modifications, which was equivalent to the words apply it. Specifically here Applicant does not disclose an improvement in RFID, rather applicant is merely reciting using RFID to perform the abstract idea.
Further limitations that could be performed by a human or humans that instead recite being performed by a RFID merely results in generally linking it to the field of computers.
As per claim 13, the claims recite limitations a human or humans could perform specifically a human could remove the connection of the expired accessory by for example throwing it away or unplugging it. The additional elements that the connection is in “first communication interface” and “the fused connection is configured to disconnect” merely results in apply it as discussed above. Specifically here Applicant recites a result oriented solution and lack details as to how the step is performed or the mechanism for accomplishing the result, which is equivalent to the words “apply it” (see MPEP 2106.05(f)).
As per claim 14, the claims recite limitations a human or humans could perform a human could collect the usage information in claim 13 as broadly recited in the claims. There are no additional elements beyond those previously discussed above.
As per claim 15, the claims recite limitations a human or humans could perform specifically a human could perform generate a report of medical devices and accessories for a service provider including expirations of medical devices or accessories. The additional elements that this limitation a human or humans could perform are instead being performed by “The cloud based management system” merely result in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more.
Further limitations that could be performed by a human or humans that instead recite being performed by “The cloud based management system” merely results in generally linking it to the field of computers.
As per claim 16, the claims recite limitations a human or humans could perform specifically a human could collect usage data associated with an accessory where the accessory could have a unique identifier on the side of the accessory, determine an expired expiration of the accessory based on analyzing the usage data where usage information may be stored in logs related to its use across devices, and generate a notification of the expected expiration. The additional elements that these limitations that could be performed by a human or humans are instead being performed by a medical device and providing information to a “cloud based asset manager” merely results in apply it. Specifically here the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to receive, store or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not integrate a judicial exception into a practical application or provide significantly more. Further here the claim recites only the idea of a solution or outcome, in that the claim fails to recite details of how a solution to a problem is accomplished. As here the additional limitations provide only a result oriented solution and lack details as to how the computer performs the modifications, which was equivalent to the words apply it.
Further limitations that could be performed by a human or humans that instead recite being performed by a medical device and providing information to a “cloud based asset manager” merely results in generally linking it to the field of computers.
As per claim 17, the claims recite limitations a human or humans could perform specifically a human could store updates and use information for the accessory. The fact that the limitations that could be performed by a human or humans are instead being performed by the additional elements of “the medical device” and “the cloud based asset manager” merely result in apply it or generally linking it to the field of computers as discussed above.
As per claim 18, the claims recite limitations a human or humans could perform specifically a human could determine the expected expiration using lifetime use data stored in storage where the lifetime use data comprises aggregated use data for the accessory over a lifespan of the accessory. The fact that the limitations that could be performed by a human or humans are instead being performed by the additional elements “the medical device” and “the cloud based asset manager” merely result in apply it or generally linking it to the field of computers as discussed above.
As per claim 19, the claims recite limitations a human or humans could perform specifically a human could determine conditions for expirations using categories of use data, where the categories describe metrics of use for the accessory and further determining the expiration is performed using the conditions for expiration. There are no additional elements beyond those previously discussed.
As per claim 20, the claims recite limitations a human or humans could perform specifically a human could estimate an expiration or failure based on a model that has been determined using data for past expiration of data for labeled accessories. The additional elements that this model is instead a “trained machine learned model” merely results in apply it. Here there are no details about the particular machine learning model or how it operates to derive the information other than it being trained. The machine learning model is used to generally apply the abstract idea without placing any limitation on how the machine learning operates to derive the information other than it being “trained”. The limitation recites only the idea of determining expiration using a trained machine learning model without details on how this is accomplished. The claim omits any details as to how the machine learning model solves a technical problem, and instead recites only the idea of a solution or outcome. Also the claim invokes a generic trained machine learning model merely as a tool to making the calculation rather than purporting to improve the computer or technology (See additionally USPTO Examples 47-48)
As per claim 21, the claims recite certain methods of organizing human activities of gathering usage data comparing a connection count, time in use, or volume of delivered product associated with the accessory as broadly recited in the claims. This is part of the abstract idea. There are no additional elements beyond those previously discussed above.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims merely recite limitations that are not indicative of an inventive concept (“significantly more”) in that the claims merely recite:
(1) Adding the words “apply it” ( or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)), and (2) Generally linking the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)), as detailed above under the practical application step.
Claim Interpretation
6. 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.
7. 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.
8. 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 limitation(s) is/are:
- a medical device configured to: couple with the accessory; access the unique identifier associated with the accessory; and while in operation and coupled with the accessory, determine use data for the accessory, the use data indicating a usage history of the accessory; (see claim 1)
-and an asset manager communicably coupled with the medical device, the asset manager being configured to: receive the use data and the unique identifier associated with the accessory from the medical device; determine a lifespan associated with the accessory based on the unique identifier; determine an expected expiration of the accessory by analyzing at least the use data, the lifespan, and previous use data received from at least one additional medical device; and generate a notification indicating the expected expiration. (see claim 1)
- wherein the medical device is configured to access the unique identifier from a memory device coupled to the accessory when the accessory is coupled to the medical device (see claim 2)
- wherein the accessory is coupled to the medical device via a fused connection (see claim 3)
- wherein the asset manager is configured to output the notification to the medical device, the notification indicating that the expected expiration has elapsed, (see claim 3)
-and wherein the medical device is configured to disrupt the fused connection in response to receiving the notification. (See claim 3)
- wherein the asset manager comprises a cloud- based service configured to communicate with additional medical devices and computing devices of a service provider. (see claim 4)
-wherein the asset manager is further configured to: generate a report indicating the additional medical devices or additional accessories that have been coupled with the additional medical devices, the report comprising expected expirations of the additional medical devices or additional accessories; and transmit the report to a computing device among the computing devices of the service provider. (see claim 5)
-wherein the asset manager is configured to generate, in response to the expected expiration having elapsed, a message for an account associated with the medical device, the message comprising the expected expiration. (see claim 6)
-wherein the accessory is coupleable to additional medical devices, (see claim 7)
-and wherein the asset manager is further configured to: store the use data and the unique identifier in an entry of a database; receive, from the additional medical devices, additional use data associated with the unique identifier, the additional use data indicating usage of the accessory with the additional medical devices; and update the entry to reflect the additional use data. (see claim 7)
-the cloud-based management system to cause the cloud-based management system to determine, by analyzing the use data and previous use data received from at least one additional medical device, an expected expiration of the connected accessory (see claim 9)
-wherein the cloud-based management system is configured to generate a report of medical devices and accessories for a service provider, the report comprising expected expirations for the medical device or accessories (see claim 15)
-determining, by the medical device, use data for the accessory when the accessory is coupled to the medical device, wherein the use data comprises indications of use for the accessory; (see claim 16)
-conveying, by the medical device and to a cloud-based asset manager, the use data for the accessory and the unique identifier; (see claim 16)
-wherein the cloud-based asset manager stores and updates use data for the accessory in response to receiving the use data from the medical device. (see claim 17)
-wherein determining the expected expiration comprises the medical device determining the expected expiration using lifetime use data stored at the cloud-based asset manager, the lifetime use data comprising at least he aggregated use data for the accessory over a lifespan of the accessory. (see claim 18)
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.
From review of the specification the following appears to be the corresponding structure and equivalents thereof:
Accessory: Paragraph 0018, In some examples, the accessory 104 may include leads for a defibrillator, tubes, passages, valves, end-effectors, or other components for providing a therapy to the patient 102 from a medical device 108.
Medical device: Paragraph 0018, The medical device 108 may, in some examples include a defibrillator (e.g., an Automated External Defibrillator (AED) or a monitor-defibrillator), a mechanical chest compression device, a ventilation device, a capnography device, or other such treatment device.
Asset Manager: Paragraph 0022, In some examples, the medical device 108 is configured to communicate over a network 116, which includes wired and/or wireless connections, to an external device 106, such as a computing device having a processor and processor executable instructions to perform various actions, and a computing device 110, which may include an asset manager 112. The asset manager 112 may be a cloud-based service for managing and tracking indications of use for the accessory 104 based on data uploaded from the medical device 108. In some examples, the external device 106, which may include a client device, such as a system of a service provider associated with the medical device 108. The asset manager 112 may be embodied on the computing device 110 and/or the external device 106.
Cloud based asset manager Paragraph 0022, In some examples, the medical device 108 is configured to communicate over a network 116, which includes wired and/or wireless connections, to an external device 106, such as a computing device having a processor and processor executable instructions to perform various actions, and a computing device 110, which may include an asset manager 112. The asset manager 112 may be a cloud-based service for managing and tracking indications of use for the accessory 104 based on data uploaded from the medical device 108.
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 § 103
13. 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.
14. 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.
12. Claim(s) 1-2, 4-6, 8-10, 14-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen World Intellectual Property Organization (WIPO)(WO 2013/151713) further in view of Lamego et al. (United States Patent Application Publication Number: US 2012/0330112).
As per claim 1, Jensen teaches A system for managing lifespans of medical device accessories, the system comprising: (see paragraph 0002, Examiner’s note: system for maintaining medical devices).
an accessory storing a unique identifier associated with the accessory; a medical device configured to: couple with the accessory; (see paragraph 0034, 0037, 0083, and Figure 10, Examiner’s note: components that attach to and reside outside the medical device (see paragraphs 0034 and 0037). Further teaches in paragraph 0083 and corresponding Figure 10 reference character 632 that accessories can have serial numbers, names, hardware versions, etc.).
access the unique identifier associated with the accessory, and while in operation and coupled with the accessory (see paragraphs 0053, 0063, 0051, and Figures 9-10, Examiner’s note: teaches reporting serial numbers and the associated devices it is connected to, where this information comes from medical devices).
determine use data for the accessory when coupled with the accessory, the use data indicating a usage history of the accessory; (see Figure 12 and paragraphs 0028-0029, 0053, 0078-0079, 0081-0083, 0086, Examiner’s note: teaches receiving components and medical device maintenance information).
and an asset manager communicably coupled with the medical device, the asset manager being configured to: receive the use data and the unique identifier associated with the accessory from the medical device; (see paragraphs 0053, 0063, 0051, and Figures 9-10, Examiner’s note: teaches reporting serial numbers and the associated devices it is connected to, where this information comes from medical devices).
determine an expected expiration of the accessory by analyzing the use data, the life span; (see paragraphs 0029-0030, 0053-0054, 0067 Examiner’s note: various server configurations and the servers providing maintenance information to the technicians. Further teaches providing expected life, average usage per day, and estimated replacement date (see paragraph 0081)).
and generate a notification indicating the expected expiration (see Figures 4-11, Examiner’s note: show generate reports with required maintenance information).
While Jensen as shown above clearly teaches determining remaining life of an accessory of a medical device (see Figures 9-10), Jensen does not expressly teach how this information is acquired. Specifically Jensen merely discloses receiving this information from the medical device (See paragraphs 0053, 0063, and 0051). Therefore Jensen does not expressly teach as amended determining the lifespan of the accessory based on the unique identifier and based on data from another medical device or more specifically as recited in the claims of determine a lifespan associated with the accessory based on the unique identifier; determine an expected expiration of the accessory by analyzing at least the use data, the lifespan, and previous use data received from at least one additional medical device.
However, Lamego et al. is a patient medical system that uses reusable and disposable parts (see paragraph 0020) and teaches determining the lifespan of the accessory based on the unique identifier and based on data from another medical device or more specifically as recited in the claims of determine a lifespan associated with the accessory based on the unique identifier; determine an expected expiration of the accessory by analyzing at least the use data, the lifespan, and previous use data received from at least one additional medical device (see paragraphs 0049-0054, Examiner’s note: here teaches the canisters can be used across one or more monitors, and that information can be stored in memory as to the usage information when it is being used by a monitor. Further teaches an alert is generated once it is determined that a canister should be replaced, in that it will run out of gas or the remaining number of uses).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen with the aforementioned teachings from Lamego et al. with the motivation of providing a known way to reuse medical products for substantiality purposes as well as provide a way to track usage of those reusable products so that accurate remaining life information can be reported (see Lamego et al. paragraph 0020 and 0049-0054), when tracking and providing remaining life of individual accessories of a medical device as well as those accessory have serial numbers for tracking purposes is known (see Jensen paragraphs Figures 9-10).
As per claim 2, Jensen teaches
and wherein the medical device is configured to access the unique identifier from a memory device coupled to the accessory when the accessory is coupled to the medical device. (see paragraphs 0053, 0067, 0086, and 0098, Examiner’s note: teaches the medical device providing information on parts needing maintenance).
As per claim 4, Jensen teaches
wherein the asset manager comprises a cloud- based service configured to communicate with additional medical devices and computing devices of a service provider (see paragraph 0021, 0030, and Figures 4-11, Examiner’s note: teaches the server is in the cloud, Figures 4-11 teach providing reports on many different devices, where they can be in one or more different facilities (see paragraph 0021)).
As per claim 5, Jensen teaches
wherein the asset manager is further configured to: generate a report indicating the additional medical devices or additional accessories that have been coupled with the additional medical devices, the report comprising expected expirations of the additional medical devices or additional accessories; and transmit the report to a computing device among the computing devices of the service provider. (see paragraphs 0019, 0021, and Figures 4-11, Examiner’s note: Figures 4-11 teach providing reports on many different devices, where they can be in one or more different facilities (see paragraph 0021). Further teaches providing information to a technician to allow a technician to make decisions on the maintenance of the medical devices (see paragraph 0019)).
As per claim 6, Jensen teaches
wherein the asset manager is configured to generate, in response to the expected expiration having elapsed, a message for an account associated with the medical device, the message comprising the expected expiration (see Figure 4 and 9-10, Examiner’s note: teaches a component has expired. Further teaches providing future calibration due).
As per claim 8, Jensen teaches
wherein the asset manager comprises a computing component on-board the medical device, the computing component comprising a processor and a non-transitory computer-readable medium storing instructions thereon that, when executed by the processor, cause the processor to determine information (see paragraphs 0030, 0053, 0094-0096, Examiner’s note: determining information from software running on a computer).
Jensen does not expressly teach performing the determination of the expiration on medical device or more specifically the recited limitation of determine the expected use data of the accessory
Lamego et al. is a patient medical system that uses reusable and disposable parts (see paragraph 0020) teaches performing the determination of the expiration on medical device or more specifically the recited limitation of determine the use data of the accessory (see paragraphs 0049-0054, Examiner’s note: here teaches the canisters can be used across one or more monitors, and that information can be stored in memory as to the usage information when it is being used by a monitor. Further teaches an alert is generated once it is determined that a canister should be replaced, in that it will run out of gas or the remaining number of uses).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen in view of Lamego et al. with the aforementioned teachings from Lamego et al. with the motivation of providing a way to perform a determination locally on a device (see Lamego et al. paragraphs 0049-0054), when a device providing information used in a determination is known (see Jensen paragraphs 0067 and 0070).
As per claim 9, Jensen teaches A medical device, comprising: (see paragraph 0034, 0037, 0083, and Figure 10, Examiner’s note: components that attach to and reside outside the medical device (see paragraphs 0034 and 0037). Further teaches in paragraph 0083 and corresponding Figure 10 reference character 632 that accessories can have serial numbers, names, hardware versions, etc.).
a first communication interface configured to connect with an accessory; (see paragraph 0034, 0037, 0083, and Figure 10, Examiner’s note: components that attach to and reside outside the medical device (see paragraphs 0034 and 0037). Further teaches in paragraph 0083 and corresponding Figure 10 reference character 632 that accessories can have serial numbers, names, hardware versions, etc.).
a second communication interface configured to connect with a cloud-based management system; (see paragraphs 0029-0030, Examiner’s note: cloud server device).
a processor; and a non-transitory computer-readable medium having instructions stored thereon that, when executed by the processor, cause the processor to: (see paragraphs 0094-0096, Examiner’s note: software running on a computer to perform operations).
in response to the first communication interface connecting with the accessory, determine an identity associated with the accessory; determine use data indicating a usage of the accessory; (see Figure 12 and paragraphs 0028-0029, 0053, 0078-0079, 0081-0083, 0086, Examiner’s note: teaches receiving components and medical device maintenance information).
Provide the use data to the cloud-based management system to cause the cloud-based management system to determine, by analyzing the use data, (see paragraphs 0053, 0063, 0051, and Figures 9-10, Examiner’s note: teaches reporting serial numbers and the associated devices it is connected to, where this information comes from medical devices).
an expected expiration of the connected accessory; (see paragraph 0081 and Figures 9-10, Examiner’s note: module provides information about the cycle counts, expected life average usage (per day) and estimated replacement date (see paragraph 0081), it is noted that this is shown in Figures 9-10)
Receive the expected expiration from the cloud-based management system. (see paragraph 0081 and Figures 9-10, Examiners’ note: shows replacement date estimated and remaining cycle counts).
While Jensen as shown above clearly teaches determining remaining life of an accessory of a medical device (see Figures 9-10), Jensen does not expressly teach how this information is acquired. Specifically Jensen merely discloses receiving this information from the medical device (See paragraphs 0053, 0063, and 0051). Jensen does not expressly teach as amended determining based on data from another medical device or more specifically as recited in the claims of and previous use data received from at least one additional medical device.
However, Lamego et al. is a patient medical system that uses reusable and disposable parts (see paragraph 0020) and teaches determining based on data from another medical device or more specifically as recited in the claims of and previous use data received from at least one additional medical device (see paragraphs 0049-0054, Examiner’s note: here teaches the canisters can be used across one or more monitors, and that information can be stored in memory as to the usage information when it is being used by a monitor. Further teaches an alert is generated once it is determined that a canister should be replaced, in that it will run out of gas or the remaining number of uses).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen with the aforementioned teachings from Lamego et al. with the motivation of providing a known way to reuse medical products for substantiality purposes as well as provide a way to track usage of those reusable products so that accurate remaining life information can be reported (see Lamego et al. paragraph 0020 and 0049-0054), when tracking and providing remaining life of individual accessories of a medical device as well as those accessory have serial numbers for tracking purposes is known (see Jensen paragraphs Figures 9-10).
As per claim 10, Jensen teaches
wherein the instructions to determine the identity of the accessory comprise instructions to read a memory device coupled to the accessory. (see paragraphs 0067, 0070, 0086, and 0098, Examiner’s note: teaches the medical device providing information on parts needing maintenance).
As per claim 14, Jensen teaches
wherein the use data is determined using: a use time for the accessory; a temperature of the accessory; a volume of fluid conveyed by the accessory; a number of use cycles completed by the accessory; a number of inflations completed by the accessory; a number of connections between the accessory and other medical devices; a type of the medical device; or an amount of delivered charges of the accessory (see paragraphs 0065 and Figure 9, Examiner’s note: only one required by the claims like expires after a given number of uses like 6000. Also teaches replacement estimate based on average counts per day).
As per claim 15, Jensen teaches
wherein the cloud-based management system is configured to generate a report of medical devices and accessories for a service provider, the report comprising expected expirations for the medical device or accessories. (see paragraphs 0019, 0021, and Figures 4-11, Examiner’s note: Figures 4-11 teach providing reports on many different devices, where they can be in one or more different facilities (see paragraph 0021). Further teaches providing information to a technician to allow a technician to make decisions on the maintenance of the medical devices (see paragraph 0019)).
As per claim 16, Jensen teaches A method comprising: (see paragraph 0003, Examiner’s note: method for providing maintenance information for a plurality of medical devices).
determining a unique identifier associated with an accessory coupled to a medical device; (see paragraph 0034, 0037, 0083, and Figure 10, Examiner’s note: components that attach to and reside outside the medical device (see paragraphs 0034 and 0037). Further teaches in paragraph 0083 and corresponding Figure 10 reference character 632 that accessories can have serial numbers, names, hardware versions, etc.).
determining, by the medical device, use data for the accessory when the accessory is coupled to the medical device, wherein the use data comprises indications of use for the accessory; (see Figure 12 and paragraphs 0028-0029, 0053, 0078-0079, 0081-0083, 0086, Examiner’s note: teaches receiving components and medical device maintenance information).
conveying, by the medical device and to a cloud-based asset manager, the use data for the accessory and the unique identifier; (see paragraphs 0029-0030, 0053-0054, 0067 Examiner’s note: various server configurations and the servers providing maintenance information to the technicians).
determining, using the use data, an expected expiration for the accessory; and generating, in response to determining the expected expiration, a report comprising the unique identifier and the expected expiration for the accessory. (see Figures 4-11, Examiner’s note: show generate reports with required maintenance information).
While Jensen as shown above clearly teaches determining remaining life of an accessory of a medical device (see Figures 9-10), Jensen does not expressly teach how this information is acquired. Specifically Jensen merely discloses receiving this information from the medical device (See paragraphs 0053, 0063, and 0051). Jensen does not expressly teach as amended determining based on data from another medical device or more specifically as recited in the claims of and aggregated use data that includes previous use data received from at least one additional medical device.
However, Lamego et al. is a patient medical system that uses reusable and disposable parts (see paragraph 0020) and teaches determining based on data from another medical device or more specifically as recited in the claims of and aggregated use data that includes previous use data received from at least one additional medical device (see paragraphs 0049-0054, Examiner’s note: here teaches the canisters can be used across one or more monitors, and that information can be stored in memory as to the usage information when it is being used by a monitor. Further teaches an alert is generated once it is determined that a canister should be replaced, in that it will run out of gas or the remaining number of uses).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen with the aforementioned teachings from Lamego et al. with the motivation of providing a known way to reuse medical products for substantiality purposes as well as provide a way to track usage of those reusable products so that accurate remaining life information can be reported (see Lamego et al. paragraph 0020 and 0049-0054), when tracking and providing remaining life of individual accessories of a medical device as well as those accessory have serial numbers for tracking purposes is known (see Jensen paragraphs Figures 9-10).
As per claim 17, Jensen teaches
wherein the cloud-based asset manager stores and updates use data for the accessory in response to the use data from the medical device. (see paragraph 0021, 0030, and Figures 4-11, Examiner’s note: teaches the server is in the cloud, Figures 4-11 teach providing reports on many different devices, where they can be in one or more different facilities (see paragraph 0021)).
As per claim 18, Jensen teaches
wherein determining the expected expiration comprises the medical device determining the expected expiration using lifetime use data stored at the cloud-based asset manager, the lifetime use data comprising aggregated use data for the accessory over a lifespan of the accessory (see Figure 9 and paragraphs 0029, 0065, 0067, 0070, Examiner’s note: calibration information, replacement data, updates available).
As per claim 19, Jensen teaches
further comprising determining conditions for expiration using categories of use data, the categories of use data describing metrics for use of the accessory, and wherein determining the expected expiration is further performed using the conditions for expiration. (see Figure 9 and paragraphs 0029, 0065, 0067, 0070, Examiner’s note: calibration information, replacement data, updates available).
As per claim 21, Jensen teaches
Wherein the use data comprises at least one of a connection count, time in use, charge, or volume of delivered product associated with the accessory (see Figures 9-10, Examiner’s note: only one of the alternatives is required by the claims. Things like total used cycle counts, average cycle counts per day could relate to charge (battery or time in use, or connection count)).
14. Claim(s) 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen World Intellectual Property Organization (WIPO)(WO 2013/151713) further in view of Lamego et al. (United States Patent Application Publication Number: US 2012/0330112) further in view of Brown et al. (United States Patent Application Publication Number: US 2014/0032232).
As per claim 3, Jensen teaches
wherein the accessory is coupled to the medical device via a fused connection, (see paragraphs 0034 and 0037-0038, Examiner’s note: accessory attached to the device).
Jensen in view of Lamego et al. does not expressly teach wherein the asset manager is configured to output the notification to the medical device, the notification indicating that the expected expiration has elapsed, and wherein the medical device is configured to disrupt the fused connection in response to receiving the notification
However, Brown which is in the art of medical devices (see abstract) teaches wherein the asset manager is configured to output the notification to the medical device, the notification indicating that the expected expiration has elapsed, and wherein the medical device is configured to disrupt the fused connection in response to receiving the notification (see paragraphs 0019 and 0026-0028, Examiner’s note: locking a medical device when it has been used a predetermined number of times without maintenance).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen in view of Lamego et al. with the aforementioned teachings from Brown with the motivation of providing a way to lock a device so it can’t be used when it needs to have maintained performed on it (see Brown paragraphs 0019 and 0026-0028), when determining maintenance needs to be performed on a device and it requires additional attention is known (see Jensen Figures 4-11).
As per claim 13, Jensen teaches
wherein the first communication interface comprises a fused connection, (see paragraphs 0034 and 0037-0038, Examiner’s note: accessory attached to the device).
Jensen in view of Lamego et al. does not expressly teach wherein the instructions further comprise determining the expected expiration has expired, and wherein the fused connection is configured to disconnect from the accessory in response to determining the expected expiration has elapsed.
However, Brown which is in the art of medical devices (see abstract) teaches wherein the instructions further comprise determining the expected expiration has expired, and wherein the fused connection is configured to disconnect from the accessory in response to determining the expected expiration has elapsed (see paragraphs 0019 and 0026-0028, Examiner’s note: locking a medical device when it has been used a predetermined number of times without maintenance).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen in view of Lamego et al. with the aforementioned teachings from Brown with the motivation of providing a way to lock a device so it can’t be used when it needs to have maintained performed on it (see Brown paragraphs 0019 and 0026-0028), when determining maintenance needs to be performed on a device and it requires additional attention is known (see Jensen Figures 4-11).
15. Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen World Intellectual Property Organization (WIPO)(WO 2013/151713) further in view of Lamego et al. (United States Patent Application Publication Number: US 2012/0330112) further in view of Kumar (United States Patent Application Publication Number: US 2023/0307117).
As per claim 7, Jensen does not expressly teach wherein the accessory is coupleable to additional medical devices, and wherein the asset manager is further configured to: store the use data and the unique identifier in an entry of a database; receive, from the additional medical devices, additional use data associated with the unique identifier, the additional use data indicating usage of the accessory with the additional medical devices; and update the entry to reflect the additional use data.
However, Lamego et al. is a patient medical system that uses reusable and disposable parts (see paragraph 0020) and teaches wherein the accessory is coupleable to additional medical devices, and wherein the asset manager is further configured to: store the use data and the unique identifier in an entry of a data store; receive, from the additional medical devices, additional use data associated with the unique identifier, the additional use data indicating usage of the accessory with the additional medical devices; and update the entry to reflect the additional use data. (see paragraphs 0049-0054, Examiner’s note: here teaches the canisters can be used across one or more monitors, and that information can be stored in memory as to the usage information when it is being used by a monitor. Further teaches an alert is generated once it is determined that a canister should be replaced, in that it will run out of gas or the remaining number of uses).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen in view of Lamego et al. with the aforementioned teachings from Lamego et al. with the motivation of providing a known way to reuse medical products for substantiality purposes as well as provide a way to track usage of those reusable products so that accurate remaining life information can be reported (see Lamego et al. paragraph 0020 and 0049-0054), when tracking and providing remaining life of individual accessories of a medical device as well as those accessory have serial numbers for tracking purposes is known (see Jensen paragraphs Figures 9-10).
Jensen in view of Lamego et al do not expressly teach storing medical device reuse information in a specific type of storage of a database.
However, Kumar which is in the art of recycling medical devices (see abstract) teaches storing medical device reuse information in a specific type of storage of a database (see paragraphs 0059-0060, Examiner’s note: storing remaining life based on ID in a database and using that determine the life of the new medical device).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen in view of Lamego et al dwith the aforementioned teachings from Kumar with the motivation of using a specific type of data storage to store medical device usage information (see Kumar paragraphs 0001-0004), when storing device usage information in various locations is known (see Lamego et al. paragraph 0050 and Jensen paragraph 0054) (see Jensen Figures 4-11).
16. Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen World Intellectual Property Organization (WIPO)(WO 2013/151713) further in view of Lamego et al. (United States Patent Application Publication Number: US 2012/0330112) further in view of Souffrou (United States Patent Application Publication Number: US 2022/0254482).
As per claim 11, Jensen in view of Lamego et al. does not expressly teach further comprising: a camera configured to capture an image depicting a visual identifier displayed on the accessory, wherein the instructions to determine the identity of the accessory comprise analyzing the visual identifier.
However, Souffrou which is in the art of medical device inventory management (see abstract) teaches further comprising: a camera configured to capture an image depicting a visual identifier displayed on the accessory, wherein the instructions to determine the identity of the accessory comprise analyzing the visual identifier (see paragraphs 0030, 0040, and Figure 5, Examiner’s note: scanner scans a barcode to determine information on the medical device where the system may generate an alert if the device is past is expiration date).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen in view of Lamego et al. with the aforementioned teachings from Souffrou with the motivation of using a known way to gather information related to a device by scanning a code attached to the device (see Souffrou paragraphs 0030, 0040, and Figure 5), when determining information related to a device is known (see Jensen paragraphs 0067,0070, and Figures 4-11).
As per claim 12, Jensen in view of Lamego et al. does not expressly teach further comprising: a radio frequency identification (RFID) sensor, wherein the instructions to determine the identity of the accessory comprise instructions to read a code detected by the RFID sensor from an RFID tag associated with the accessory.
However, Souffrou which is in the art of medical device inventory management (see abstract) teaches further comprising: a radio frequency identification (RFID) sensor, wherein the instructions to determine the identity of the accessory comprise instructions to read a code detected by the RFID sensor from an RFID tag associated with the accessory. (see paragraphs 0030, 0040, and Figure 5, Examiner’s note: scanner scans a barcode to determine information on the medical device where the system may generate an alert if the device is past is expiration date, this may include RFID).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen in view of Lamego et al. with the aforementioned teachings from Souffrou with the motivation of using a known way to gather information related to a device by scanning a code attached to the device (see Souffrou paragraphs 0030, 0040, and Figure 5), when determining information related to a device is known (see Jensen paragraphs 0067,0070, and Figures 4-11).
17. Claim(s) 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen World Intellectual Property Organization (WIPO)(WO 2013/151713) further in view of Lamego et al. (United States Patent Application Publication Number: US 2012/0330112) further in view of Liao Machine Learning To Predict Medical Devices Repair and Maintenance Needs August 17-19, 2021.
As per claim 20, Jensen teaches
wherein determining the expected expiration comprises inputting the use data from the medical device and aggregated use data associated with the accessory from the cloud-based asset manager to a model using compiled use data for accessories labeled with expiration data for the accessories. (see Figure 9 and paragraphs 0029, 0065, 0067, 0070, Examiner’s note: calibration information, replacement data, updates available).
Jensen in view of Lamego et al. does not expressly teach machine learned model trained to determine expiration for the medical accessory.
However, Liao which is in the art of machine learning to forecast failure types of medical devices and to help the maintenance team decide on repair strategies (see abstract) teaches machine learned model trained to determine expiration for the medical accessory (see abstract, 3. Method, and 2.2 data analysis, Examiner’s note: machine learning to forecast failure types of medical devices and to help the maintenance team decide on repair strategies (see abstract). Further teaches it is trained to forecast the next failure, time (see 3. method and 2.2 data analysis).
Before the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to have modified Jensen in view of Lamego et al. with the aforementioned teachings from Liao with the motivation of providing a way to handle waste by determining when a medical device can be recycled (see Liao 1. Introduction), when determining expiration and replacement information in Jensen (see Figure 9 and paragraphs 0029, 0065, 0067, 0070) is known.
Conclusion
18. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
19. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Taub et al. (United States Patent Application Publication Number: US 2014/0200426) teaches a device that provides interfaces on expired medical sensors (see abstract and Figure 4)
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/KIERSTEN V SUMMERS/Primary Examiner, Art Unit 3626