DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgement is made of applicant’s claim for foreign priority to 14 January 2022 under 35 U.S.C. 119(a)-(d).
Status of Claims
Amended claims 1-15 received on 28 June 2024 are currently pending and being considered by Examiner in this Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 June 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner in this Office Action.
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.
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), because the claim limitations use 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 in claim 1 are:
“the first control unit being configured to…”;
“a communication interface simulation unit configured to…”;
“a programmer app unit configured to…”;
“a second control unit configured to…”
Such claim limitations in claim 3 are:
“the dispatch unit is configured to…”.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f), they 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 these limitations interpreted under 35 U.S.C. 112(f), Applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
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.
Claims 1-13 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 the following limitations are recited “the first control unit being configured to…”; “a communication interface simulation unit configured to…”; “a programmer app unit configured to…”; “a second control unit configured to…”, thereby invoking 35 U.S.C. 112(f) interpretation of these various “units”. However, Applicant’s Specification and/or drawings do not provide support and/or written description for the associated structure for the “units” recited and therefore do not comply with the written description requirement of 35 U.S.C. 112(a);
Regarding claim 3, the following limitation is recited “the dispatch unit is configured to…”, thereby invoking 35 U.S.C. 112(f) interpretation of these various “units”. However, Applicant’s Specification and/or drawings do not provide support and/or written description for the associated structure for the “units” recited, and therefore do not comply with the written description requirement of 35 U.S.C. 112(a);
Regarding claims 2-13, these claims are dependent from independent claim 1 and thereby inherit the deficiencies thereof by virtue of dependency.
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.
Claim limitations found in claim 1 reciting “the first control unit being configured to…”; “a communication interface simulation unit configured to…”; “a programmer app unit configured to…”; “a second control unit configured to…”, and claim 3 reciting “the dispatch unit is configured to…” invoke 35 U.S.C. 112(f). 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. Furthermore, claims 2-13 are dependent from independent claim 1 and thereby inherit the deficiencies thereof by virtue of dependency. Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b).
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.
As such, for examination purposes, the various “units configured to…” recited throughout claims 1-13 will be hereinafter interpreted as processing components with associated software for performing/executing computerized functions.
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.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter (Subject Matter Eligibility (SME) Test Step 1: No) because the claim recites a “computer program with program code”, which under broadest reasonable interpretation includes a computer program. The claim appears to be claiming a computer product. The claim needs to store the program on non-transitory computer readable media if this is the case, otherwise it is claiming a signal which is not one of the statutory categories. For examination purposes this is interpreted as a product claim.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims recite subject matter within a statutory category as a process (claim 14), machine (claims 1-13), and manufacture (claim 15) (Subject Matter Eligibility (SME) Test Step 1: Yes) which recite steps of:
transferring the data read out by the communication interface to a back-end communication unit by means of the first control unit;
receiving the data transferred by the first control unit by means of a communication interface simulation unit comprised by the back-end communication unit;
simulating the communication interface by means of the communication interface simulation unit;
reading out data from the communication interface simulation unit by means of a programmer app unit comprised by the back-end communication unit; and
controlling the communication interface simulation unit and the programmer app unit by means of a second control unit comprised by the back-end communication unit in such a way that the data is saved, in particular as a report, in a storage unit communicatively connected to the second control unit and/or the back-end communication unit, said data being accessible by a health care provider.
These steps of transferring the data read out, receiving the data transferred, reading out data, saving the data as a report, and storing said report/making the report accessible by a healthcare provider, as drafted, under the broadest reasonable interpretation, includes performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting steps as performed by the generic computer components, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the transferring data and receiving the transferred data language, receiving transferred data in the context of this claim encompasses a mental process of a user receiving data via a computerized tool or some other digital means. Similarly, the limitation of reading out said received data, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, such as a user either presenting or outputting, such as via vocalization or other means, said received data. For example, but for the saving the data as a report and storing said report/data language, saving and/or storing the data/report in the context of this claim encompasses a mental process of a user either archiving the report and/or filing a report, e.g. a medical report, and could even include storing said data/report in a generic computerized system. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-13, reciting particular aspects of how creating reports, receiving/transferring data, encrypting data, and performing data analysis may be performed in the mind but for recitation of generic computer components) (SME Test Step 2A, Prong 1: Yes).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of a front-end communication unit/interface, an implantable medical device, one or more control units, a back-end communication unit, an interface stimulation unit, a programmer app unit, a storage unit, and a computer amounts to invoking computers as a tool to perform the abstract idea, see Applicant’s Spec p. 3, ll. 17-21 for a front-end communication unit/interface; Spec p. 4, ll. 21-23 for an implantable medical device; Spec p. 9, ll. 1-7 for one or more control units; Spec p. 3, ll. 7-15 for a back-end communication unit; Spec p. 6, ll. 25-32 for an interface simulation unit; Spec p. 3, ll. 9-15 for a programmer app unit; Spec p. 5, ll. 7-16 for a storage unit; and Spec p. 2, ll. 27-29 for a computer, see MPEP 2106.05(f); the various “units configured to…” recited throughout claim 1 are interpreted as processing components with associated software for performing/executing computerized functions in accordance with the 35 U.S.C. 112(b) interpretation established above);
add insignificant extra-solution activity to the abstract idea (such as recitation of transferring the data read out by the communication interface to a back-end communication unit; receiving the data transferred by the first control unit, amounts to mere data gathering; recitation of saving the data in the form of a report amounts to selecting a particular data source or type of data to be manipulated; recitation of saving the data in the form of a report in a storage unit amounts to insignificant application, see MPEP 2106.05(g); recitation of reading out, i.e. understood to constitute reading out data by means of a communication interface, simulating the communication interface, making data accessible by a health care provider, such as via a user interface mounts to gathering and analyzing information using conventional techniques and displaying the result, see TLI Communications and MPEP 2106.05(a)(II)(iii));
generally link the abstract idea to a particular technological environment or field of use (such as recitation of communication technology for medical devices, specifically an implantable medical device in particular, see MPEP 2106.05(h)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-13, which recite limitations relating to one or more control units, a cloud server, a cloud gateway, a dispatch unit, a back-end communication unit, report creators, a communication interface simulation unit, an implantable medical device, a virtual machine, a programmer app unit, a communication interface, a reading and/or programming head, a certificate and key management system, a communication logic, memory, and a front-end communication unit, additional limitations which amount to invoking computers as a tool to perform the abstract idea; See Applicant’s Specification p. 9, ll. 1-7 for one or more control units; Spec p. 5, ll. 8-16 for a cloud server; Spec p. 5, ll. 8-16 for a cloud gateway; Spec p. 5, ll. 21-24 for a dispatch unit; Spec p. 3, ll. 7-15 for a back-end communication unit; Spec p. 6, ll. 23-32 for report creators; Spec p. 6, ll. 25-32 for a communication interface simulation unit; Spec p. 4, ll. 21-23 for an implantable medical device; Spec p. 6, ll. 23-32 for a virtual machine; Spec p. 3, ll. 9-15 for a programmer app unit; Spec p. 3, ll. 17-21 for a front-end communication unit/interface; Spec p. 12, ll. 6-13 for a reading and/or programming head; Spec p. 7, ll. 16-22 for a certificate and key management system; Spec p. 9, ll. 1-7 for a communication logic; Spec p. 9, ll. 17-24 for a memory; Spec p. 3, ll. 17-21 for a front-end communication unit/interface, see MPEP 2106.05(f), the various “units configured to…” recited throughout claims 2-13 are interpreted as processing components with associated software for performing/executing computerized functions in accordance with the 35 U.S.C. 112(b) interpretation established above; claims 2-4 & 6-13, which recite limitations relating to data being transferred, fetching data from a server, receiving/sending metadata, making data available for retrieval, checking for new data in the cloud gateway and downloading said data, acquiring cardiac current curve data, wherein information generated from the data is available for retrieval, wherein the data is accessible by the healthcare provider, communicating with different implantable medical devices to query identification data, transmit information on said memory areas, distribute software updates, notifying the front-end communication unit about the update, additional limitations which add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering; claims 4, 6, & 9-10, which recite limitations relating to the metadata comprising certain types of metadata, the data acquired by the medical device including cardiac current curve data, the query identification data comprising a model and/or firmware version, the predetermined memory areas comprise a current programming of the implantable medical device, trend data of the last 24 hours, last measured values, long-term trend data, a list of stored episodes, episode details of the episodes within the last 24 hours, patient data, or a predetermined interval or live IEGM data, additional limitations which add insignificant extra-solution activity to the abstract idea by selecting a particular data source or type of data to be manipulated; claims 2-3, 7, 11, & 13, which recite limitations relating to storing data, processing said data and using metadata to determine which report creator the data is sent to, decrypting data via a key/certificate, determining which memory areas the front-end communication unit is to query, maintaining one or more distribution rules, additional limitations which amount to insignificant application; claims 2-13, which recite limitations relating to communication technology for medical devices, specifically an implantable medical device in particular additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application (SME Test Step 2A, Prong 2: No).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as transferring the data read out by the communication interface to a back-end communication unit; receiving the data transferred by the first control unit, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); simulating the communication interface, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); saving the data in the form of a report in a storage unit, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv); reading out data by means of a front-end communication interface, allowing data to be accessible by a health care provider, such as via a communication interface, e.g., a web browser’s back and forward button functionality, Internet Patent Corp., MPEP 2106.05(d)(II)(ii); See Diebold Par [0006] which discloses the generally well-known, understood, and/or conventional nature of recording data in regard to the medical device and in regard to its operation occur during operation of a personal medical device, i.e. implantable device, and typically being read out from the implant by a programming device and exchanged between the programming device and a hospital information system).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-13, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 2-4 & 6-13, which recite limitations relating to data being transferred, fetching data from a server, receiving/sending metadata, making data available for retrieval, checking for new data in the cloud gateway and downloading said data, establishing a connection to a device, acquiring cardiac current curve data, wherein information generated from the data is available for retrieval, wherein the data is accessible by the healthcare provider, communicating with different implantable medical devices to query identification data, transmit information on said memory areas, distribute software updates, notifying the front-end communication unit about the update, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); claims 3, 7, 11, & 13, which recite limitations relating to processing data and using metadata to determine which report creator the data is sent to, decrypting data via a certificate/key, determining which memory areas the front-end communication unit is to query, checking the request of the front-end communication unit to determine whether there is a distribution, e.g. a software update, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); claims 7 & 13, which recite limitations relating to maintaining one or more security certificates and/or keys, such as via a certificate and key management system, maintaining one or more distribution rules based on various data, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii); claims 2-13, which recite limitations relating to storing received data, storing metadata, storing report creator instructions/templates, storing application instructions/architecture, storing communication interface instructions/architecture, storing a certificate and key management system instructions, storing computerized instructions for performance of the steps recited by a processor and/or computing device, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv); See Diebold Par [0006] which discloses the generally well-known, understood, and/or conventional nature of recording data in regard to the medical device and in regard to its operation occur during operation of a personal medical device, i.e. implantable device, and typically being read out from the implant by a programming device and exchanged between the programming device and a hospital information system). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation (SME Test Step 2B: No).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Forsell et al. (U.S. Patent Publication No. 2023/0355994), hereinafter “Forsell”, in view of DeBates et al. (U.S. Patent Publication No. 2020/0402656), hereinafter “DeBates”.
Claim 1 –
Regarding Claim 1, Forsell discloses implant communication system comprising:
a front-end communication unit comprising a communication interface configured to read out data from an implantable medical device (See Forsell Par [1500] which discloses the external device being configured to transmit data pertaining to the sensed parameter, such that the external device can be configured to add information to the data pertaining to the sensed parameter, such as those described in Forsell Par [1505]-[1513], i.e. implantable medical device data; See Forsell Par [3742] which discloses a computing unit deriving information related to the functional status of an operation device of the implant, i.e. also can be considered implantable medical device data; See Forsell Par [3407] which discloses a communication unit comprising means for communication, such that an external device, i.e. front-end communication unit, can have a display, i.e. front-end, on which information regarding the sensed parameters can be presented, albeit not a “read out” per se), and
a first control unit communicatively connected to the communication interface (See Forsell Par [3407] which discloses a communication unit comprising means for communication, such that an external device, i.e. front-end communication unit, can have a display, i.e. front-end, on which information regarding the sensed parameters can be presented),
the first control unit being configured to transfer the data read out by the communication interface to a back-end communication unit (See Forsell Par [1500] which discloses the external device being configured to transmit data pertaining to the sensed parameter, such that the external device can be configured to add information to the data pertaining to the sensed parameter, such as those described in Forsell Par [1505]-[1513], i.e. implantable medical device data; See Forsell Par [3742] which discloses a computing unit deriving information related to the functional status of an operation device of the implant, i.e. also can be considered implantable medical device data; See Forsell Par [3227] & [3742] which discloses storing authentication data, measured parameters of the patient, and/or functional status of an operation device of the implant in memory of the implant, i.e. back-end storage/communication units, albeit not a “read out” per se); and
the back-end communication unit comprising a communication interface simulation unit configured to receive the data transferred by the first control unit and to simulate the communication interface (“simulating” is understood to merely constitute making use of a communication interface, therefore see Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant; See Forsell Par [3227] which discloses storing authentication data and/or measured parameters of the patient in memory of the implant, i.e. back-end storage/communication units; See Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit),
the back-end communication unit further comprising a programmer app unit configured to read out data from the communication interface simulation unit (See Forsell Par [3227] which discloses storing authentication data and/or measured parameters of the patient in memory of the implant, i.e. back-end storage/communication units; See Forsell Par [3742] which discloses a computing unit deriving information related to the functional status of an operation device of the implant, i.e. also can be considered implantable medical device data, albeit not a “read out” per se),
the back-end communication unit further comprising a second control unit configured to control the communication interface simulation unit and the programmer app unit in such a way that the data is saved, in particular as a report (See Forsell Par [3227] which discloses storing authentication data and/or measured parameters of the patient in memory of the implant, i.e. back-end storage/communication units; See Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit, albeit not recited for the data being saved, in particular, as a “report” per se), in a storage unit communicatively connected to the second control unit and/or the back-end communication unit, said data being accessible by a health care provider (See Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit, albeit not recited for the data being saved, in particular, as a “report” per se; See Forsell Par [1017] which discloses that the second external device is operated by a healthcare provider of the patient, thereby rendering accessible the data by the healthcare provider).
While Forsell generally discloses transmitting data pertaining to sensed parameters, such that the external device can be configured to add information to the data pertaining to the sensed parameter and/or implant device itself, and a communication unit comprising means for communication, such that an external device, i.e. front-end communication unit, can have a display, i.e. front-end, on which information regarding the sensed parameters can be presented, Forsell does not explicitly mention a “read out” or “read out data” per se and/or the data being saved “as a report” per se.
However, DeBates explicitly discloses providing “read out” or “read out data” from an implant by a programming device (See DeBates Par [0060] which specifically discloses a request for information may be generated to (implantable medical device) IMD, which may include a request for the IMD's serial number, time/date of when the IMD is implanted in the patient (e.g., a timestamp indicative of first implantation and/or subsequent (re)implantations if performed), a measurement or read-out of any device, and more) and data being saved “as a report” per se (See DeBates Par [0075] which discloses a historical record of all such interactions, modifications, reconfigurations, etc., being generated with respect to the IMD and patient device may be maintained and transmitted to server, and a clinician may not only be able to monitor and evaluate the patient based on a number of real-time variables, but also access the historical record of all such interactions, modifications, reconfigurations, etc., and is thereby understood to constitute a “report”). The disclosure of DeBates is directly applicable to the disclosure of Forsell, because both disclosures share limitations and capabilities, such as being directed towards maintenance of one or more implantable medical devices and software, firmware, etc., associated therewith.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Forsell, which already discloses transmitting data pertaining to sensed parameters, such that the external device can be configured to add information to the data pertaining to the sensed parameter and/or implant device itself, to further specifically include a “read out” or “read out data” per se, as disclosed by DeBates, because this allows for tracking operations of a personal medical device, such as an implantable device, over time, and maintenance of said personal medical device, and ensuring a trusted associative relationship between the clinician programmer/device and a patient controller/device, and this being mediated via the corresponding IMD (See Debates Par [0060]). It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Forsell, which already discloses storing data pertaining to sensed parameter and/or operating parameters of an implantable device, to further include data being saved “as a report” per se, as disclosed by DeBates, because this allows for future access of said report/record, e.g. by a clinician, for utilizing information in providing appropriate therapy and IMD operative settings (See DeBates Par [0075]).
Claim 2 –
Regarding Claim 2, Forsell and DeBates disclose the system of claim 1 in its entirety. Forsell further discloses a system, wherein:
the data is transferred from the first control unit to a cloud server, wherein a cloud gateway is configured to fetch the data from the cloud server and store it (See Forsell Par [2734] which discloses the external device having processing power to perform methods and functions needed to provide safe operation of the implant, and may be cloud based or a virtual machine; See Forsell Par [1361]-[1362] which discloses updating a control program adapted to run in a computing unit of an implant when implanted in a patient, such as receiving data by the computing unit, and updating the control program on the basis of the received data), wherein
the cloud gateway is further configured to make the data available for retrieval by a dispatch unit of the back-end communication unit (See Forsell Par [2734] which discloses the external device having processing power to perform methods and functions needed to provide safe operation of the implant, and may be cloud based or a virtual machine; See Forsell Par [2735]-[2736] which discloses updating or amending software of the implant, such that the supplier or producer of the implant may be connected to a database, and the database may be regularly update to provide new or improved functionality of the implant, and said update can be transmitted from the database to the device, i.e. data made available by a dispatch unit to update the implant, such that as in Forsell Par [3685]-[3691] the update may be verified via transmission of logging data and confirming the most recent update; See Forsell Par [1361]-[1362] which discloses updating a control program adapted to run in a computing unit of an implant when implanted in a patient, such as receiving data by the computing unit, and updating the control program on the basis of the received data).
Claim 3 –
Regarding Claim 3, Forsell and DeBates disclose the system of claim 2 in its entirety. Forsell and DeBates further discloses a system, wherein:
the back-end communication unit comprises a plurality of report creators, each report creator comprising a version of the communication interface simulation unit, the programmer app unit and the second control unit (While not “report creator” per se, see Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit, albeit not recited for the data being saved, in particular, as a “report” per se; See DeBates Par [0075] which discloses a historical record of all such interactions, modifications, reconfigurations, etc., being generated with respect to the IMD and patient device may be maintained and transmitted to server, and a clinician may not only be able to monitor and evaluate the patient based on a number of real-time variables, but also access the historical record of all such interactions, modifications, reconfigurations, etc., and is thereby understood to constitute a “report”), wherein
the dispatch unit is configured to check at predetermined intervals for new data in the cloud gateway (See Forsell Par [2735]-[2736] which discloses updating or amending software of the implant, such that the supplier or producer of the implant may be connected to a database, and the database may be regularly update to provide new or improved functionality of the implant, and said update can be transmitted from the database to the device, such that as in Forsell Par [3685]-[3691] the update may be verified via transmission of logging data and confirming the most recent update; See Forsell Par [2734] which discloses the external device having processing power to perform methods and functions needed to provide safe operation of the implant, and may be cloud based or a virtual machine), and is further configured to download and process said data and during processing, to use metadata to determine to which report creator the data is sent to (While not “report creator” per se, see Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit, albeit not recited for the data being saved, in particular, as a “report” per se; See Forsell Par [2382]-[2398] which discloses updating a control program and logging data relating to an installation of the update, such as relating to the receipt of the update or configuration, i.e. firmware version, of one or more devices; See DeBates Par [0075] which discloses a historical record of all such interactions, modifications, reconfigurations, etc., being generated with respect to the IMD and patient device may be maintained and transmitted to server, and a clinician may not only be able to monitor and evaluate the patient based on a number of real-time variables, but also access the historical record of all such interactions, modifications, reconfigurations, etc., and is thereby understood to constitute a “report”).
Claim 4 –
Regarding Claim 4, Forsell and DeBates disclose the system of claim 3 in its entirety. Forsell and DeBates further disclose a system, wherein:
the metadata comprises an implant serial number, an implant type and/or an implant firmware version (The broadest reasonable interpretation of “and/or” is “or”, therefore only one of the alternatives elected above needs to be met, therefore see Forsell Par [2974] & [3359] which discloses conductive communication may comprise feedback parameters relating to the functionality of the implant including version number of the implant and/or version of the control program, i.e. firmware/software version; While not relied upon, because Forsell discloses one of the alternatives elected, for purposes of furthering prosecution, see DeBates Par [0056] which specifically discloses additional device information associated with CP/CD and/or the remote care application may be included in the relayed/proxied request, such as, device identity, i.e. implant type, application version data, i.e. firmware version, and/or any hard-coded device data, etc. RCSM 306 may be provided as part of a cloud-based service architecture and Debates Par [0060] discloses a request for information may be generated to (implantable medical device) IMD, which may include a request for the IMD's serial number)), wherein
the respective report creator is configured to process data (D) having a predetermined format matching the firmware version of the implantable medical device (see Forsell Par [2974] & [3359] which discloses conductive communication may comprise feedback parameters relating to the functionality of the implant including version number of the implant and/or version of the control program, i.e. firmware/software version; See Forsell Par [2382]-[2398] which discloses updating a control program and logging data, i.e. understood to constitute a report since the data is logged over time, relating to an installation of the update, such as relating to the receipt and confirmation of the update or configuration, i.e. firmware version, of one or more devices being correct).
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Forsell, which already discloses storing data pertaining to sensed parameter and/or operating parameters of an implantable device, to further include data being saved “as a report” per se, as disclosed by DeBates, because this allows for future access of said report/record, e.g. by a clinician, for utilizing information in providing appropriate therapy and IMD operative settings (See DeBates Par [0075]).
Claim 5 –
Regarding Claim 5, Forsell and DeBates disclose the system of claim 3 in its entirety. Forsell and DeBates further discloses a system, wherein:
each report creator is a virtual machine (While not “report creator” per se, see Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit, albeit not recited for the data being saved, in particular, as a “report” per se; See DeBates Par [0075] which discloses a historical record of all such interactions, modifications, reconfigurations, etc., being generated with respect to the IMD and patient device, such as by the system, and may be maintained and transmitted to server, and a clinician may not only be able to monitor and evaluate the patient based on a number of real-time variables, but also access the historical record of all such interactions, modifications, reconfigurations, etc., and is thereby understood to constitute a “report”; See Forsell Par [2734] which discloses the external device being cloud-based or a virtual machine; See Forsell Par [2382]-[2398] which discloses updating a control program and logging data, i.e. understood to constitute a report being created since the data is logged over time, relating to an installation of the update, such as relating to the receipt and confirmation of the update or configuration, i.e. firmware version, of one or more devices being correct), and wherein
the communication interface simulation unit, the programmer app unit and the second control unit are applications installed in the virtual machine (See Forsell Par [2382]-[2398] which discloses updating a control program and logging data, i.e. understood to constitute a report since the data is logged over time, relating to an installation of the update, such as relating to the receipt and confirmation of the update or configuration, i.e. firmware version, of one or more devices being correct; See Forsell Par [2385] & [2756] which discloses internal and/or external computing units and/or functional units, such that certain components or all components may be implemented as software executed by a processor or as an application specific integrated circuit; See Forsell Par [2734] which discloses the external device being cloud-based or a virtual machine).
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Forsell, which already discloses storing data pertaining to sensed parameter and/or operating parameters of an implantable device, to further include data being saved “as a report” per se, as disclosed by DeBates, because this allows for future access of said report/record, e.g. by a clinician, for utilizing information in providing appropriate therapy and IMD operative settings (See DeBates Par [0075]).
Claim 6 –
Regarding Claim 6, Forsell and DeBates disclose the system of claim 1 in its entirety. Forsell further discloses a system, wherein:
the communication interface is a reading and/or programming head configured to establish a connection to the implantable medical device (The broadest reasonable interpretation of “and/or” is “or”, therefore only one of the alternatives elected above needs to be met, therefore see Forsell Par [2963] which discloses a conductive member configured to be in connection (electrical/conductive or wireless or otherwise) with the external device, and thereby creating increased security for communication between the external device and the implant, for example, when a sensitive update of a control program of the implant is t be made, or if sensitive data regarding physical parameters of the patient is to be sent to the externa device (or otherwise), the conductive member may ensure that the patient is aware of such communication and actively participate in validating that the communication may take place), and wherein
the data acquired by an implantable medical device is cardiac current curve data (See Forsell Par [01473]-[01474] which discloses the implant comprising a cardiac portion that is configured to sense at least one cardiac/heart parameter of the patient, and Forsell Par [1514] discloses the implant being an implantable cardioverter defibrillator, which is understood by Examiner to collect cardiac current curve data).
Claim 7 –
Regarding Claim 7, Forsell and DeBates disclose the system of claim 1 in its entirety. Forsell further discloses a system, wherein:
the data is encrypted by the first control unit (See Forsell Par [2739] & [2748] which discloses communication between external devices and the implant may be encrypted, including symmetric or asymmetric encryption, single or multi-key encryption, etc.), and wherein
the data fetched from the cloud gateway is decrypted using a certificate and key management system located in the back-end communication system (See Forsell Par [2734] which discloses the external device having processing power to perform methods and functions needed to provide safe operation of the implant, and may be cloud based or a virtual machine; See Forsell Par [2739] which discloses communication between external devices and the implant may be encrypted, including symmetric or asymmetric encryption, single or multi-key encryption, etc.; See Forsell Par [03213] which discloses the implant comprising a computing unit configured to update the control program running in the implant using the decrypted data, such that the computing unit may be configured to derive a combined key from the first part of the key and the second part of the key and decrypt the encrypted data using the combined key; ).
Claim 8 –
Regarding Claim 8, Forsell and DeBates disclose the system of claim 1 in its entirety. Forsell further discloses a system, wherein:
information generated from the data stored in the data stored in the storage unit is available for retrieval via a web application (See Forsell Par [2728] which discloses communications occurring via wireless communications, including through IP (internet protocol); See Forsell Par [2942] & [4111] which discloses that the encrypted data may be received from the external device or the second external device or another external device via the internet) wherein
the data is accessible by the health care provider and/or by an intermediary security entity (The broadest reasonable interpretation of “and/or” is “or”, therefore only one of the alternatives elected above needs to be met, therefore see Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit, albeit not recited for the data being saved, in particular, as a “report” per se; See Forsell Par [1017] which discloses that the second external device is operated by a healthcare provider of the patient, thereby rendering accessible the data by the healthcare provider; See Forsell Par [2745]-[2746] which discloses a verification unit for two-part authentication, and would therefore constitute the data being accessible by an intermediary security entity that performs said two-part authentication).
Claim 9 –
Regarding Claim 9, Forsell and DeBates disclose the system of claim 1 in its entirety. Forsell further discloses a system, wherein:
the first control unit contains a communication logic configured to communicate with different implantable medical devices in order to query identification data of the implantable medical device, in particular a model and/or firmware version (The broadest reasonable interpretation of “and/or” is “or”, therefore only one of the alternatives elected above needs to be met, therefore see Forsell Par [0758] which discloses a computing unit adapted to communicate with the implant using a network protocol, i.e. “communication logic” under BRI; see Forsell Par [1500] which discloses the external device being configured to transmit data pertaining to the sensed parameter, such that the external device can be configured to add information to the data pertaining to the sensed parameter, such as those described in Forsell Par [1505]-[1513], i.e. implantable medical device data; See Forsell Par [3742] which discloses a computing unit deriving information related to the functional status of an operation device of the implant, i.e. also can be considered implantable medical device data; See Forsell Par [3407] which discloses a communication unit comprising means for communication; see Forsell Par [2974] & [3359] which discloses conductive communication may comprise feedback parameters relating to the functionality of the implant including version number of the implant and/or version of the control program, i.e. firmware/software version; See DeBates Par [0056] which specifically discloses additional device information associated with CP/CD and/or the remote care application may be included in the relayed/proxied request, such as, device identity, i.e. implant type/model version, application version data, i.e. firmware version, and/or any hard-coded device data, etc. RCSM 306 may be provided as part of a cloud-based service architecture and Debates Par [0060] discloses a request for information may be generated to (implantable medical device) IMD, which may include a request for the IMD's serial number)), wherein
the first control unit is further configured, based on the identification data, to read predetermined memory areas of the implantable medical device (see Forsell Par [0758] which discloses a computing unit adapted to communicate with the implant using a network protocol, i.e. “communication logic” under BRI; see Forsell Par [1500] which discloses the external device being configured to transmit data pertaining to the sensed parameter, such that the external device can be configured to add information to the data pertaining to the sensed parameter, such as those described in Forsell Par [1505]-[1513], i.e. implantable medical device data; See Forsell Par [3742] which discloses a computing unit deriving information related to the functional status of an operation device of the implant, i.e. also can be considered implantable medical device data; See Forsell Par [3407] which discloses a communication unit comprising means for communication; see Forsell Par [2974] & [3359] which discloses conductive communication may comprise feedback parameters relating to the functionality of the implant including version number of the implant and/or version of the control program, i.e. firmware/software version, and by accessing said data, would thereby be compatible with the version of the control program when said data established above and throughout Forsell is received).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Forsell, which already discloses transmitting data pertaining to the implant device and/or functional parameters thereof, to further specifically include querying identification data of the implantable device, including a serial number, as disclosed by DeBates, because this allows for tracking operations of a personal medical device, such as an implantable device, over time, and maintenance of said personal medical device, and ensuring a trusted associative relationship between the clinician programmer/device and a patient controller/device, and this being mediated via the corresponding IMD (See Debates Par [0060]).
Claim 10 –
Regarding Claim 10, Forsell and Debates disclose the system of claim 9 in its entirety. Forsell further discloses a system, wherein:
information contained in the predetermined memory areas of the implantable medical device comprises a current programming of the implantable medical device, trend data of the last 24 hours, last measured values from automatic tests, long-term trend data, a list of stored episodes, episode details of the episodes within the last 24 hours, patient data stored in the implant, and/or a predetermined interval of live IEGM data (The broadest reasonable interpretation of “and/or” is “or”, therefore only one of the alternatives elected above needs to be met, therefore see Forsell Par [2974] & [3359] which discloses conductive communication may comprise feedback parameters relating to the functionality of the implant including version number of the implant and/or version of the control program, i.e. current programming of the implantable medical device; See Forsell Par [2974] which discloses physiological parameters being stored in the memory of the implant or sensed in prior to transmitting the conductive communication, i.e. last measured values from automatic tests conducted by the implant, patient data stored in the implant, etc.; See Forsell Par [3455] which discloses measurements comprising recording a parameter event, i.e. episode, such as a movement detected by the sensors, and/or strength/power of a parameter measured exceeding a threshold, and the associated value of the event, constituting stored episodes and/or episode detail; while not IEGM data per se, see Forsell Par [01473]-[01474] which discloses the implant comprising a cardiac portion that is configured to sense at least one cardiac/heart parameter of the patient, and Forsell Par [1514] discloses the implant being an implantable cardioverter defibrillators, which is understood by Examiner to collect IEGM data).
Claim 11 –
Regarding Claim 11, Forsell and Debates disclose the system of claim 1 in its entirety. Forsell further discloses a system, wherein:
the front-end communication unit is configured to send metadata from the implantable medical device to the back-end communication unit (See Forsell Par [1500] which discloses the external device, front-end communication unit, being configured to transmit data pertaining to the sensed parameter before transmitting to the second external device, back-end communication unit, such that the external device can be configured to add information to the data pertaining to the sensed parameter, such as those described in Forsell Par [1505]-[1513] & [2169], i.e. metadata), wherein
the back-end communication unit is configured to determine which memory areas the front-end communication unit is to query (See Forsell Par [3061]-[3066] which discloses including metadata identifying data relating to the previously transmitted set of instructions, including upon determining that the extracted previously transmitted set of instructions equals the previously received instructions stored in the implant, the authenticity of the received first combined set of instructions may be determined as valid, thereby determining which memory areas to query and transmit instructions to), and wherein
the back-end communication unit is configured to transmit information on said memory areas to the front-end communication unit (See Forsell Par [3061]-[3066] which discloses including metadata identifying data relating to the previously transmitted set of instructions, including upon determining that the extracted previously transmitted set of instructions equals the previously received instructions stored in the implant, the authenticity of the received first combined set of instructions may be determined as valid, thereby determining which memory areas to query and transmit instructions to).
Claim 12 –
Regarding Claim 12, Forsell and Debates disclose the system of claim 1 in its entirety. Forsell further discloses a system, wherein:
the cloud gateway is configured to distribute software updates to the cloud server (See Forsell Par [2736] which discloses external device being able to provide and control program updates and/or instructions, such that a database may be regularly updated to provide new or improved functionality of the implant or to mitigate previously undetected flaws, wherein the updated control program may be transmitted from the database in a push mode and optionally routed via one or more further external devices before received by the implant, such that as described in Forsell Par [2734], the external device may be cloud based or a virtual machine), wherein
the front-end communication unit is configured to query the cloud server for software updates (See Forsell Par [2736] which discloses external device being able to provide and control program updates and/or instructions, such that a database may be regularly updated to provide new or improved functionality of the implant or to mitigate previously undetected flaws, wherein the updated control program may be transmitted from the database in a push mode and optionally routed via one or more further external devices before received by the implant, such that as described in Forsell Par [2734], the external device may be cloud based or a virtual machine).
Claim 13 –
Regarding Claim 13, Forsell and Debates discloses the system of claim 12 in its entirety. Forsell further discloses a system, wherein:
the cloud server is configured to check on request of the front-end communication unit whether there is a distribution rule for the front-end communication unit, in particular based on a serial number and/or country/region of the front-end communication unit (The broadest reasonable interpretation of “and/or” is “or”, therefore only one of the alternatives elected above needs to be met, therefore see Forsell Par [2735]-[2736] which discloses updating or amending software of the implant, such that the supplier or producer of the implant may be connected to a database, and the database may be regularly update to provide new or improved functionality of the implant, and said update can be transmitted from the database to the device, and is understood to thereby include a serial number of the particular implant for updating, such that as in Forsell Par [3685]-[3691] the update may be verified via transmission of logging data and confirming the most recent update; See Forsell Par [2734] which discloses the external device having processing power to perform methods and functions needed to provide safe operation of the implant, and may be cloud based or a virtual machine; See Forsell Par [2974] & [3359] which discloses conductive communication may comprise feedback parameters relating to the functionality of the implant including version number of the implant and/or version of the control program, i.e. firmware/software version; While not relied upon, because Forsell discloses one of the alternatives elected, for purposes of furthering prosecution, see DeBates Par [0056] which specifically discloses additional device information associated with CP/CD and/or the remote care application may be included in the relayed/proxied request, such as, device identity, i.e. implant type/model version, application version data, i.e. firmware version, and/or any hard-coded device data, etc. RCSM 306 may be provided as part of a cloud-based service architecture and Debates Par [0060] discloses a request for information may be generated to (implantable medical device) IMD, which may include a request for the IMD's serial number)), wherein
if a software update is available, the cloud server is configured to notify the front-end communication unit about the update (See Forsell Par [2819] which discloses a communication unit of the implant including a feedback unit representing information relating to when the update of the software has started and when the update has finished, i.e. notifying about the update).
Claim 14 –
Regarding Claim 14, Forsell discloses the computer implemented method for communicating with an implantable medical device comprising the steps of:
reading out data from the implantable medical device by means of a front-end communication unit comprising a communication interface and a first control unit communicatively connected to the communication interface (See Forsell Par [1500] which discloses the external device being configured to transmit data pertaining to the sensed parameter, such that the external device can be configured to add information to the data pertaining to the sensed parameter, such as those described in Forsell Par [1505]-[1513]; See Forsell Par [3407] which discloses a communication unit comprising means for communication, such that an external device, i.e. front-end communication unit, can have a display, i.e. front-end, on which information regarding the sensed parameters can be presented);
transferring the data read out by the communication interface to a back-end communication unit by means of the first control unit (See Forsell Par [3227] which discloses storing authentication data and/or measured parameters of the patient in memory of the implant, i.e. back-end storage/communication units);
receiving the data transferred by the first control unit by means of a communication interface simulation unit comprised by the back-end communication unit (See Forsell Par [3227] which discloses storing authentication data and/or measured parameters of the patient in memory of the implant, i.e. back-end storage/communication units; See Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit);
simulating the communication interface by means of the communication interface simulation unit (“simulating” is understood to merely constitute making use of a communication interface, therefore see Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant);
reading out data from the communication interface simulation unit by means of a programmer app unit comprised by the back-end communication unit (See Forsell Par [3233]-[03237] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit, albeit not a “read out” per se); and
controlling the communication interface simulation unit and the programmer app unit by means of a second control unit comprised by the back-end communication unit in such a way that the data is saved, in particular as a report (See Forsell Par [3227] which discloses storing authentication data and/or measured parameters of the patient in memory of the implant, i.e. back-end storage/communication units; See Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit, albeit not recited for the data being saved, in particular, as a “report” per se), in a storage unit communicatively connected to the second control unit and/or the back-end communication unit, said data being accessible by a health care provider (See Forsell Par [3227] which discloses storing authentication data and/or measured parameters of the patient in memory of the implant, i.e. back-end storage/communication units; See Forsell Par [3233]-[03234] which discloses the system comprising the implant, the external device, and an optional second external device, such that the external device may be configured for receiving the encrypted data from the second external device and relaying the encrypted data to the implant, i.e. back-end communication/read out of data by a back-end communication unit, albeit not recited for the data being saved, in particular, as a “report” per se; See Forsell Par [1017] which discloses that the second external device is operated by a healthcare provider of the patient, thereby rendering accessible the data by the healthcare provider).
While Forsell generally discloses transmitting data pertaining to sensed parameters, such that the external device can be configured to add information to the data pertaining to the sensed parameter and/or implant device itself, and a communication unit comprising means for communication, such that an external device, i.e. front-end communication unit, can have a display, i.e. front-end, on which information regarding the sensed parameters can be presented, Forsell does not explicitly mention a “read out” or “read out data” per se and/or the data being saved “as a report” per se.
However, DeBates explicitly discloses providing “read out” or “read out data” from an implant by a programming device (See DeBates Par [0060] which specifically discloses a request for information may be generated to (implantable medical device) IMD, which may include a request for the IMD's serial number, time/date of when the IMD is implanted in the patient (e.g., a timestamp indicative of first implantation and/or subsequent (re)implantations if performed), a measurement or read-out of any device, and more) and data being saved “as a report” per se (See DeBates Par [0075] which discloses a historical record of all such interactions, modifications, reconfigurations, etc., being generated with respect to the IMD and patient device may be maintained and transmitted to server, and a clinician may not only be able to monitor and evaluate the patient based on a number of real-time variables, but also access the historical record of all such interactions, modifications, reconfigurations, etc., and is thereby understood to constitute a “report”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Forsell, which already discloses transmitting data pertaining to sensed parameters, such that the external device can be configured to add information to the data pertaining to the sensed parameter and/or implant device itself, to further specifically include a “read out” or “read out data” per se, as disclosed by DeBates, because this allows for tracking operations of a personal medical device, such as an implantable device, over time, and maintenance of said personal medical device, and ensuring a trusted associative relationship between the clinician programmer/device and a patient controller/device, and this being mediated via the corresponding IMD (See Debates Par [0060]). It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Forsell, which already discloses storing data pertaining to sensed parameter and/or operating parameters of an implantable device, to further include data being saved “as a report” per se, as disclosed by DeBates, because this allows for future access of said report/record, e.g. by a clinician, for utilizing information in providing appropriate therapy and IMD operative settings (See DeBates Par [0075]).
Claim 15 –
Regarding Claim 15, Forsell and DeBates disclose a computer program with program code to perform the method of claim 14 when the computer program is executed on a computer (See Forsell Par [2756] which discloses non-transitory media for storing computerized instructions for performance of the methods recited throughout Forsell; See analysis of claim 14 above which is met by Forsell and DeBates).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure:
Snell et al. (U.S. Patent No. 6,249,705) discloses a system for performing functions directed to programming an implantable medical device and having a transceiver for communicating with the implantable medical device in response to those functions;
Katra et al. (U.S. Patent Publication No. 2020/0357513) discloses a system for remote monitoring of a patient and a corresponding implantable medical device, and determining an abnormality associated therewith, and automatically outputting/generating a post-implant report of the interactive session;
Doerr et al. (U.S. Patent Publication No. 2023/0019155) discloses an implantable medical device with a communication component for establishing communication connection with an external communication arrangement outside of a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HUNTER J RASNIC whose telephone number is (571)270-5801. The examiner can normally be reached M-F 8am-5:30pm.
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, Shahid Merchant can be reached at (571) 270-1360. 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.
/H.R./Examiner, Art Unit 3684
/KENNETH BARTLEY/Primary Examiner, Art Unit 3684
Prosecution Insights