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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 16, 2026 has been entered.
Response to Amendment
The amendment filed March 16, 2026 has been entered. Claims 1 and 15 have been amended. Currently, claims 1-15 are pending for examination.
Response to Arguments
Applicant's arguments filed March 16, 2026 regarding the 35 U.S.C. 101 rejection have been fully considered but they are not persuasive. Independent claims now require the implantable medical device (IMD) be configured to switch, via a wake-up device, between an off-state and an operational state, which the applicant argues allows the IMD to operate in an energy-efficient manner, allowing it to remain in the patient for prolonged periods of time ([0073] of the applicant’s published specification). The claimed limitations of essentially transitioning an IMD from an off state to an operational state is not sufficient to overcome the 35 U.S.C. 101 rejection to show that it is more than a generic computer functioning and an improvement in the functioning of a computer or to other technology, and transitioning an IMD from an off-state to an operational state before operational steps are performed is regarded as insignificant extra-solution activity. As an example, Maile et al. (US 2007/0250126) discloses an IMD 404 with a Hall Effect wake-up sensor 460 (fig. 8) adapted to sense a signal from a wake-up device 434, the principles of this operation being well known in the art ([0049]). If supported by the specification, the claims do not recite specifics claiming how the wake-up device switches the IMD from an off-state to an operational state, nor specifics claiming how the IMD switches from an operational state back to an off-state such that the claim describes a particular technological improvement that is more than the generic feature.
Applicant’s arguments, see pages 8-9, filed March 16, 2026, with respect to the rejection(s) of claim(s) 1-15 under 35 U.S.C. 102 or 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Stahmann et al. (US 2013/0178909).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-15 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to an apparatus.
In particular, claim 1 recites limitations directed to:
An implantable medical device configured to switch, via a wake-up device, between an off-state and an operational state, and when in the operational state measure at least one physiological parameter
A remote monitoring system configured to receive information from the implantable medical device
An information system configured to communicate with said remote monitoring device
Wherein at least one of the implantable medical device, the remote monitoring system, and the information system is configured to analyze information relating to said at least one physiological parameter to generate an alert signal for a systemic infection of the patient based on a state of the at least one physiological parameter
Wherein the at least one of the implantable medical device, the remote monitoring system and the information system is further configured to generate an alert message to be provided to a specific destination based on said alert signal
Wherein the information system is configured to transmit said alert message to said destination using a dedicated communication path
Wherein the information system is configured to provide information not related to said alert message on a default communication path different than said dedicated communication path.
Step 2A – Prong 1: Claim 1 recites limitations that are drawn to an abstract idea that, under its broadest reasonable interpretation, covers limitations that can be performed as a mental process or by a human with pen and paper. The underlined emphasized element is drawn to a judicial exception because it is a mere step that is capable of being performed in the mind or with pen and paper. For example, a skilled artisan is capable of using the mental process of observation to analyze information relating to a physiological parameter for further use.
Step 2A – Prong 2: Claim 1 recites the bolded emphasized limitations above that are beyond the judicial exception. These elements do not integrate the exception into a practical application of the exception because they either are: (1) directed to computer elements (e.g. implantable medical device, remote monitoring system, information system), recited at a high level of generality, that do not impose any meaningful limitations on practicing the abstract idea. See MPEP 2106.05(d)(II); (2) mere data gathering such as measuring data generating an alert signal or message using that data. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016); (3) receiving or transmitting data over a network such as transmitting an alert message or other information through communication paths. Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014). Transitioning an IMD from an off-state to an operational state before operational steps are performed is regarded as insignificant extra-solution activity performed before the abstract idea and is no more than a generic computer function.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Nothing in the claim amounts to significantly more than the judicial exception because the recited limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception. The recited implantable medical device, remote monitoring system and information system are generic computer components. See MPEP 2106.05(d)(II). Maile et al. (US 2007/0250126) discloses an IMD 404 with a Hall Effect wake-up sensor 460 (fig. 8) adapted to sense a signal from a wake-up device 434, the principles of this operation being well known in the art ([0049]), thus showing transitioning an IMD from an off-state to an operational state before operational steps are performed is well known in the art. Gathering and analyzing information using conventional techniques and outputting the result has been recognized by the courts as well-understood, routine, conventional insignificant extra-solution activity. TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48. Transmitting data over a network such as transmitting an alert message or other information through communication paths has been recognized by the courts as well-understood, routine, conventional insignificant extra-solution activity. Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
In view of the above, the additional elements do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the element taken individually. There is no indication that the element improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Claims 2-14 depend on claim 1 and recite the same abstract idea as the independent claim. These claims only contain recitations that either further limit the abstract idea, or recite additional elements beyond the judicial exception (i.e. communication device (claim 2)) that is recited at a high level of generality to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f) and do not integrate the abstract idea into a practical application because it does not impose any meaningful limitations on practicing the abstract idea. These additional elements are well-understood, routine and conventional activities previously known in the industry. See MPEP 2106.05(d)(II).
The analysis of claim 15 is as follows:
Step 1: Claim 15 is drawn to a process.
In particular, claim 15 recites limitations:
Waking up an implantable medical device to place it in an operational state
When in an operational state measuring, using an implantable medical device, at least one physiological parameter
Receiving, by a remote monitoring system, information from the implantable medical device
Communicating, by an information system, with said remote monitoring device
Analyzing, by at least one of the implantable medical device, the remote monitoring system, and the information system, information relating to said at least one physiological parameter to generate an alert signal for a systemic infection of the patient based on a state of the at least one physiological parameter
Generating, by at least one of the implantable medical device, the remote monitoring system and the information system, an alert message to be provided to a specific destination based on said alert signal
Wherein the information system transmits said alert message to said destination using a dedicated communication path
Wherein the information system provides information not related to said alert message on a default communication path different than said dedicated communication path.
Step 2A – Prong 1: Claim 15 recites limitations that are drawn to an abstract idea in the form of a process that, under its broadest reasonable interpretation, covers limitations that can be performed as a mental process or by a human with pen and paper. The underlined emphasized element is drawn to a judicial exception because it is a mere step that is capable of being performed in the mind or with pen and paper. For example, a skilled artisan is capable of using the mental process of observation to analyze information relating to a physiological parameter for further use.
Step 2A – Prong 2: Claim 15 recites the bolded emphasized limitations above that are beyond the judicial exception. These elements do not integrate the exception into a practical application of the exception because they either are: (1) directed to computer elements (e.g. implantable medical device, remote monitoring system, information system), recited at a high level of generality, that do not impose any meaningful limitations on practicing the abstract idea. See MPEP 2106.05(d)(II); (2) mere data gathering such as measuring data generating an alert signal or message using that data. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016); (3) receiving or transmitting data over a network such as transmitting an alert message or other information through communication paths. Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014). Waking up an IMD to place it in an operational state before operational steps are performed is regarded as insignificant extra-solution activity performed before the abstract idea and is no more than a generic computer function.
Step 2B: Claim 15 does not recite additional elements that amount to significantly more than the judicial exception itself. Nothing in the claim amounts to significantly more than the judicial exception because the recited limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception. The recited implantable medical device, remote monitoring system and information system are generic computer components. See MPEP 2106.05(d)(II). Maile et al. (US 2007/0250126) discloses an IMD 404 with a Hall Effect wake-up sensor 460 (fig. 8) adapted to sense a signal from a wake-up device 434, the principles of this operation being well known in the art ([0049]), thus showing waking up an IMD to place it in an operational state before operational steps are performed is well known in the art. Gathering and analyzing information using conventional techniques and outputting the result has been recognized by the courts as well-understood, routine, conventional insignificant extra-solution activity. TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48. Transmitting data over a network such as transmitting an alert message or other information through communication paths has been recognized by the courts as well-understood, routine, conventional insignificant extra-solution activity. Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
In view of the above, the additional elements do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the element taken individually. There is no indication that the element improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 4-10, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braganza et al. (US 2021/0228160) in view of Stahmann et al. (US 2013/0178909).
Regarding claims 1 and 15, Braganza et al. discloses a system and method for generating an alert for a systemic infection of a patient ([0001]), the system comprising: an implantable medical device 10 configured to, in an operational state, measure at least one physiological parameter (“temperature” [0009]), a remote monitoring system 94 configured to receive information from the implantable medical device (“IMD 10 may use communication circuitry 54 to communicate… communicate with an access point 90 via a second wireless connection.” [0080], “Access point 90 may then communicate the retrieved data to server 94 via network 92.” [0081]), and an information system 100 configured to communicate with said remote monitoring system (“server 94 may… provide alerts to one or more clinicians via computing devices 100” [0083]; fig. 5), wherein at least one of the implantable medical device, the remote monitoring system and the information system is configured to analyze information relating to said at least one physiological parameter to generate an alert signal ([0043], [0066]) for a systemic infection of the patient based on a state of the at least one physiological parameter (“server 94 may receive an alert from IMD 10” [0083]), wherein at least one of the implantable medical device, the remote monitoring system and the information system is further configured to generate an alert message to be provided to a specified destination 4 (“patient”, “one or more clinicians”) based on said alert signal (“server 94 may receive an alert from IMD 10… via network 92, and provide alerts to one or more clinicians via computing devices 100.” [0083]; “a computing device 100 may generate an alert to patient 4” [0084]), wherein the information system is configured to transmit said alert message to said destination using a dedicated communication path (“provide alerts to one or more clinicians via computing devices 100” [0083]), wherein the information system is configured to provide information not related to said alert message on a default communication path different than said dedicated communication path (“Device 100 then may transmit the instructions for medical intervention to another of computing devices 100 located with patient 4 or a caregiver of patient 4” [0084]). Braganza et al. does not expressly disclose the implantable medical device configured to switch, via a wake-up device, between an off-state and the operational state as required by claim 1, or waking up the implantable medical device to place it in an operational state as required by claim 15. Stahmann et al. teaches an external device 12 to generate a signal 44 for waking up an IMD 16 from “an initial, low-power state to an active state to take one or more sensor readings within the body and then transmit those readings” ([0022]), therefore teaching it is known in the art for an implantable medical device to switch, via a wake-up device, between an off-state (“initial, low-power state”) to an operational state (“active state”), the operational state allowing for measurement of at least one physiological parameter such as that disclosed by Braganza et al. above. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Braganza et al. such that the implantable medical device comprised a low-power off state and an active operational state, and to switch via a wake-up device between the off state and the operational state to measure at least one physiological parameter as taught by Stahmann et al. in order to allow the implantable medical device to idle in a low-power sleep state ([0022], [0031]) thus conserving power of the implantable medical device when not in active use.
Regarding claim 2, Braganza et al. discloses the implantable medical device 10 comprises a communication device 90 for communicating with the remote monitoring system using a pre-defined communication protocol for transmitting information related to said at least one physiological parameter to the remote monitoring system (“IMD 10 may use communication circuitry 54 to communicate… communicate with an access point 90 via a second wireless connection.” [0080], “Access point 90 may then communicate the retrieved data to server 94 via network 92.” [0081]).
Regarding claim 4, Braganza et al. discloses wherein said at least one physiological parameter includes at least one of a body temperature, a heart rate, a heart rate at rest, a respiration rate, and a body activity parameter (“temperature” [0009]).
Regarding claim 5, Braganza et al. discloses wherein the implantable medical device 10 is configured to generate said alert signal based on said at least one physiological parameter ([0043], [0066]) and to transmit information relating to said alert signal to the remote monitoring system 92 (“server 94 may receive an alert from IMD 10… via network 92” [0083]; “a computing device 100 may generate an alert to patient 4” [0084]).
Regarding claim 6, Braganza et al. discloses wherein the remote monitoring system 92 is configured to generate said alert signal based on information relating to said at least one physiological parameter and to transmit information relating to said alert signal to the information system 100 (“server 94 may monitor temperature, e.g., based on measured temperature information received from IMD 10… to identify an infection status of patient... Server 94 may provide alerts relating to an infection status of patient 4… to one or more clinicians via computing devices 100” [0083]).
Regarding claim 7, Braganza et al. discloses wherein the information system 100 is configured to generate said alert signal based on information relating to said at least one physiological parameter (“a computing device 100 may generate an alert to patient 4 based on a status of a medical condition of patient 4” [0084]).
Regarding claim 8, Braganza et al. discloses wherein the information system is an automated information system delivering patient information to the patient (“a computing device 100 may generate an alert to patient 4 based on a status of a medical condition of patient 4” [0084]).
Regarding claim 9, Braganza et al. discloses wherein the specified destination is a person (“patient”, “one or more clinicians” [0083-0084]) familiar with the patient or a specified communication terminal associated with a person familiar with the patient.
Regarding claim 10, Braganza et al. discloses wherein at least one of the implantable medical device 10, the remote monitoring system 92, and the information system 100 is configured, for analyzing said at least one physiological parameter, to compare the at least one physiological parameter or a parameter value derived from the at least one physiological parameter to a threshold ([0106-0107], [0120], [0125], [0128], [0140]) and to generate said alert signal based on said comparison ([0043], [0063], [0077], [0153]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braganza et al. (US 2021/0228160) in view of Stahmann et al. (US 2013/0178909) and further in view of Gerber et al. (US 2008/0262323).
Regarding claim 3, Braganza et al. does not expressly disclose the pre-defined communication protocol is MICS, BLE or Zigbee. Gerber et al. teaches Medical Implant Communication Service (MICS) is a known wireless communication technique between an implantable device 1 and an external device 40 ([0053]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Braganza et al. to try using MICS as a communication protocol between the implantable device and the remote monitoring system as taught by Gerber et al. as it is a known format for communication between implantable and external devices, such a modification being relatively predictable and would not alter the overall operation of the system.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braganza et al. (US 2021/0228160) in view of Stahmann et al. (US 2013/0178909) and further in view of Lee et al. (US 2008/0064980).
Regarding claim 11, Braganza et al. does not expressly disclose wherein the at least one physiological parameter includes a mean value of a heart rate or a heart rate at rest but does teach that the described techniques can be implemented in a wide variety of devices or apparatuses ([0164]). Lee et al. teaches detection of an infection (“sepsis”) can be determined by measuring the temperature ([0057]) or the mean heart rate of a patient (“average heart rate” [0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try detecting an elevated heart rate as a physiological parameter to detect an infection as taught by Lee et al. as it is also a known parameter associated with infections that can be measured in a similar manner, the results of such a modification being relatively predictable.
Regarding claim 12, Braganza et al. in view of Lee et al. discloses said mean value is compared to a threshold (“90 beats per minute”) to generate an alert signal (“indication of sepsis”), wherein the threshold is pre-defined or determined based on a group of prior values of a heart rate or a heart rate at rest (“trend showing an increased heart rate” [0056]).
Regarding claim 13, Braganza et al. in view of Lee et al. disclose wherein said threshold is a range between 90 bpm and 120 bpm (“90 beats per minute” [0056]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braganza et al. (US 2021/0228160) in view of Stahmann et al. (US 2013/0178909) and Lee et al. (US 2008/0064980) and as further evidenced by Patek (US 2019/0125241).
Regarding claim 14, Braganza et al. in view of Lee et al. does not expressly disclose wherein said threshold is a range between 110% and 150% of an average of the heart rate or the heart rate at rest over a predefined time period. Patek teaches the average resting heart rate is 60-100 bpm ([0069]). Given Lee et al. teaches a threshold of 90 bpm, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the threshold 90 bpm would be in a range of between 110% and 150% of the heart rate at rest over a predefined time period as evidenced by the teachings of Patek.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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