Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Amendment
In the amendment dated 03/04/2026, the following occurred: Claims 1, 3, 5-6, 12-15, 17 and 19 have been amended; and claim 20 has been canceled.
Claims 1-19 are pending and have been examined.
Priority
Acknowledgement is made of applicant’s claim to priority under 35 U.S.C. 120, 121, 365(c), or 386(c) and 37 CFR 1.78 for a continuing application, which claims priority to U.S. Application 16/989,749 filed 08/10/2020 (issued Patent No. 12,033,753), which claims priority to U.S. Provisional Patent Application No. 62/951,963 filed 12/20/2019.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS)(s) submitted on 12/03/2025 follow(s) the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ
644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(1)(1) -706.02(1)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321 (b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
Claims 1, 12 and 17 are rejected on the grounds of non-statutory double patenting over claims 1, 12 and 17 of Application No. 16/989,749 (reference Application ‘749) (issued Patent No. 12,033,753) in view of US 2016/0354039 A1 to Soto et al. and US 2018/0247712 A1 to Muhsin et al. Although the claims at issue are not identical, they are not patentably distinct from each other as set forth below.
Analogous Claims 1, 12 and 17 of the ‘749 application recite similar limitations to independent claims 1, 12 and 17 of the instant Application. Analogous claims 1, 12 and 17 are rejected as being obvious variations of the claims of the ‘749 application in view of US 2016/0354039 A1 to Soto et al. and US 2018/0247712 A1 to Muhsin et al.
The Examiner has bolded the claim language that is the same between the claims of the instant application and corresponding claims of the issued reference Application ‘749.
Claims of Instant Application ‘929
Claims of Application ‘749
1. A method, comprising: receiving, by a mobile device wirelessly coupled to a medical device implanted in a person, data from the implanted medical device including threshold homeostasis levels from the person that establish the person’s baseline dataset, wherein the baseline dataset includes identification data and location data associated with the medical device, and wherein the baseline dataset is related to an operation of the implanted medical device performed on the person, wherein the implanted medical device is an insulin pump; configuring the mobile device with the threshold homeostasis levels; receiving different data from the implanted medical device, wherein the different data is received from the implanted medical device as the different data is generated by the implanted medical device; analyzing the data from the implanted medical device and the different data generated by the implanted medical device; receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device; and initiating delivery, via a display of the mobile device, of an action at the mobile device or the implanted medical device, or both, based on the analyzed data from the implanted medical device and the different data generated by the implanted medical device; and the implanted medical device receiving the action and administering insulin to the person based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device.
1. A method, comprising:
receiving, by a mobile device comprising a smartwatch including a display and wirelessly coupled to a medical device implanted in a user, data from the implanted medical device, wherein the data is a part of a baseline dataset including threshold homeostasis levels from the user that establish the user’s baseline dataset and further including identification data about the medical device, user family history, medical device geographic location, a health of the user, and habits of the user, and wherein the baseline dataset is related to an operation of the implanted medical device performed on the user,
wherein the implanted medical device is an implantable cardioverter-defibrillator (ICD),
configuring the mobile device with the threshold homeostasis levels;
receiving different data from the implanted medical device, wherein the different data is received from the implanted medical device as the different data is generated by the implanted medical device;
analyzing, via comparison to the configured thresholds, the data from the implanted medical device and the different data generated by the implanted medical device in real time;
receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device;
establishing a trend specific to the user of the implanted medical device based on the analyzed data from the implanted medical device and the different data generated by the implanted medical device;
receiving an action;
displaying, via the display of the smartwatch, the established trend;
initiating, via the display of the smartwatch, at the mobile device and absent user interaction with a display of the mobile device, a delivery of an action comprising an electric shock by the implanted medical device;
the implanted medical device receiving the action and administering the electric shock to the user based on the established trend, the analyzed data from the implanted medical device, the configured thresholds, and the different data generated by the implanted medical device; and
monitoring additional trends in the different data generated by the implanted medical device, comparing the configured thresholds of the baseline dataset to the different data and updating the different data in response to the baseline dataset falling within one trend of a group of additional trends;
utilizing the different data to determine that an emergency contact for the user should be notified; and
sending, via the mobile device, a notification to the emergency contact.
12. A system, comprising: a mobile device coupled to a memory device; the memory device comprising instructions executable to cause the mobile device to: receive data from a medical device coupled to the memory device, wherein the data includes threshold homeostasis levels from the person that establish the person’s baseline dataset related to the medical device and includes identification data and location data associated with the medical device, and wherein the baseline dataset is related to an operation of the medical device performed on the person; receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device; analyze the data from the medical device and the different data generated by the medical device; receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device and initiate delivery of an action based on the analyzed data from the medical device and the different data generated by the medical device; and the medical device, comprising an insulin pump to: receive the action; and administer insulin to the person based on the established trend, the analyzed data from the medical device, the configured threshold homeostasis levels, and the different data generated by the medical device.
1. supra.
12. A system comprising:
a mobile device comprising a smartwatch including a display and coupled to a memory device, the memory device comprising instructions executable to cause the mobile device to: receive data from a medical device comprising an implantable cardioverter-defibrillator (ICD) coupled to the memory device, wherein the data is a baseline related to the medical device and includes threshold homeostasis levels from the user that establish the baseline user health dataset and further includes identification data about the medical device, user family history, medical device geographic location, a health of the user, and habits of the user;
configure with the threshold homeostasis levels;
receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device;
analyze the data from the medical device and the different data generated by the medical device via comparison to the configured thresholds;
establish a trend specific to a user of the medical device based on the analyzed data from the medical device and the different data generated by the medical device;
displaying, via [[a]] the display of the smartwatch, the established trend; and
initiate delivery of an action, via the smartwatch display, to the medical device comprising an electric shock by the ICD based on the established trend, the analyzed data from the medical device, the configured thresholds, and the different data generated by the medical device;
the medical device configured to:
receive the action; and
administer the electric shock to the user based on the established trend, the analyzed data from the medical device, and the different data generated by the medical device; and
the memory device configured to cause the mobile device to:
monitor additional trends in the different data generated by the implanted medical device, compare the configured thresholds of the baseline dataset to the different data and update the different data in response to the baseline dataset falling within one trend of a group of additional trends;
utilize the different data to determine that an emergency contact for the user should be notified; and
send a notification to the emergency contact.
17. A system, comprising: a memory device coupled to a mobile device; a medical device comprising an insulin pump coupled to the mobile device, the medical device to provide information about the medical device to the mobile device, wherein the medical device is implantable; and a different memory device coupled to the mobile device to receive the information about the medical device from the mobile device; the mobile device configured to: receive data from the medical device, wherein the data includes threshold homeostasis levels from a person implanted with the medical device, is stored in the memory device as a baseline dataset related to the medical device and wherein the baseline data includes identification data and location data associated with the medical device; configure the mobile device with the threshold homeostasis levels; transmit the data from the medical device to the different memory device; receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device; transmit the different data from the medical device to the different memory device; receive analyzed data from the different memory device responsive to the different memory device performing an analysis on the data from the medical device and the different data generated by the medical device; initiate an action based on the analyzed data from the different memory device; and update the baseline dataset based on the analyzed data, the action, or both; and the medical devices to: receiving the action; and administering insulin to the person based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device.
12. A system comprising:
a mobile device comprising a smartwatch including a display and coupled to a memory device, the memory device comprising instructions executable to cause the mobile device to: receive data from a medical device comprising an implantable cardioverter-defibrillator (ICD) coupled to the memory device, wherein the data is a baseline related to the medical device and includes threshold homeostasis levels from the user that establish the baseline user health dataset and further includes identification data about the medical device, user family history, medical device geographic location, a health of the user, and habits of the user;
configure with the threshold homeostasis levels;
receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device;
analyze the data from the medical device and the different data generated by the medical device via comparison to the configured thresholds;
establish a trend specific to a user of the medical device based on the analyzed data from the medical device and the different data generated by the medical device;
displaying, via [[a]] the display of the smartwatch, the established trend; and
initiate delivery of an action, via the smartwatch display, to the medical device comprising an electric shock by the ICD based on the established trend, the analyzed data from the medical device, the configured thresholds, and the different data generated by the medical device;
the medical device configured to:
receive the action; and
administer the electric shock to the user based on the established trend, the analyzed data from the medical device, and the different data generated by the medical device; and
the memory device configured to cause the mobile device to:
monitor additional trends in the different data generated by the implanted medical device, compare the configured thresholds of the baseline dataset to the different data and update the different data in response to the baseline dataset falling within one trend of a group of additional trends;
utilize the different data to determine that an emergency contact for the user should be notified; and
send a notification to the emergency contact.
Soto et al. teaches a system causing an insulin pump to vary the amount of insulin the patient receives (para. 0055).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of the reference claims of the instant application ‘929 to include a process by which a system varies the amount of insulin administered by an insulin pump and to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0168).
Muhsin et al. teaches a different memory device (para. 0076 teaches the hub may include a large memory for storing some or all of the data it receives, processes, and/or associates with the patient, and/or communications it has with other devices and systems) and update the baseline dataset (para. 0006 teaches the settings user interface can be user-selectable to cause… to receive an updated setting… comprise adjusting a limit of an alarm. See Applicant’s disclosure at para. 0048).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of the reference claims of the instant application ‘929 to adjust alarm limits and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Dependent claims 2-11, 13-16 and 18-19 recite similar limitations to dependent claims 2, 4-11, 13-16 and 18-20 of the ‘749 application and are also rejected as being obvious variations of the claims of the ‘749 application in view of Muhsin et al.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 12-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Appropriate correction is required.
Claim 12 recites “receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device” (emphasis added), which lacks antecedent basis. Claim 12 also recites “based on…the configured threshold homeostasis levels”, which lacks antecedent basis. Unlike claim 1, claim 12 does not recite the limitation of “configuring the mobile device with the threshold homeostasis levels”. The rejections applied to independent claim 12 also apply to its dependents.
Claim 17 recites “the medical devices to: receiving the action…” (emphasis added), which lacks antecedent basis. The rejection of claim 17 also applies to its dependents. Note: The verb tense of “receiving” is not consistent with the verb tense of the claim.
Subject Matter Eligibility - 35 U.S.C. § 101
Re. rejection of claim 14, the Applicant has amended claim 14 to recite “the action is a signal transmitted to the medical device; and the medical device administers insulin responsive to the receipt of the signal”. The mobile device of parent claim 12 initiates delivery of an action, which is received by the medical device of the parent claim. The action transmitted by the mobile device is narrowed by claim 14 to be an action that causes the medical device to administer insulin to the patient, thus providing a practical application under subject matter eligibility analysis Step 2A2. That is, the mobile device controls the medical device operation of administering insulin, thereby improving another technology or technological field. As such, claim 14 is subject matter eligible. The 101 rejection of claim 14 is hereby withdrawn.
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 1-19 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.
Claims 1, 12 and 17 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 (YES)
Claims 1, 12 and 17 fall into at least one of the statutory categories (i.e., process or machine).
Step 2A1 (YES)
Claim 1 recites the limitations of receiving data including threshold homeostasis levels from the person that establish the person’s baseline dataset, wherein the baseline dataset includes identification data and location data associated with the (implanted) medical device, and wherein the baseline dataset is related to an operation performed on the person; configuring… the threshold homeostasis levels; receiving different data, wherein the different data is received as the different data is generated; analyzing the data from the (implanted) medical device and the different data generated by the (implanted) medical device; receiving… and responsive to the analysis, the analyzed data…; and initiating delivery,…, of an action based on the analyzed data from the (implanted) medical device and the different data generated by the (implanted) medical device; and… receiving the action and… based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device.
Claim 12 recites the limitations of receive data, wherein the data includes threshold homeostasis levels from the person that establish the person’s baseline dataset related to the medical device and includes identification data and location data associated with the medical device, and wherein the baseline dataset is related to an operation of the medical device performed on the person; receive different data, wherein the different data is received as the different data is generated; analyze the data from the medical device and the different data generated by the medical device; receiving, …, and responsive to the analysis, the analyzed data… and initiate delivery of an action based on the analyzed data from the medical device and the different data generated by the medical device; and … receive the action; and… based on the established trend, the analyzed data from the medical device, the configured threshold homeostasis levels, and the different data generated by the medical device.
Claim 17 recites the limitations of receive data, wherein the data includes threshold homeostasis levels from a person implanted with the medical device, is stored as a baseline dataset related to the (implantable) medical device and wherein the baseline data includes identification data and location data associated with the (implantable) medical device; configure… the threshold homeostasis levels; transmit the data; receive different data, wherein the different data is received as the different data is generated; transmit the different data; receive analyzed data responsive to performing an analysis on the data from the (implantable) medical device and the different data generated by the (implantable) medical device; initiate an action based on the analyzed data from the different memory device; and update the baseline dataset based on the analyzed data, the action, or both; and … receiving the action; and… based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device.
The limitations of claims 1, 12 and 17, as drafted, is a process that under the broadest reasonable interpretation (BRI) covers a method of organizing human activity (i.e., managing personal behavior or relationships or interactions between people including following rules or instructions) but for the recitation of generic computer component language (discussed below in 2A2). That is, other than reciting the generic computer component language, the claimed invention amounts to managing personal behavior or relationships or interactions between people. For example, but for the generic computer component language, the claims encompass a person generating data, transmitting data, receiving data, configuring data, analyzing data, initiating an action, receiving the action, and updating data as above-described. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP § 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people but for the recitation of generic computer component language, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. See additionally MPEP § 2106. Accordingly, the claims recite an abstract idea.
Step 2A2 (NO)
The judicial exception, the above-identified abstract idea, is not integrated into a practical application. In particular, the claims recite the additional elements of a mobile device including a memory device and a display; and a different memory device that implement the identified abstract idea. The additional elements aforementioned are not described by the applicant and are recited at a high-level of generality (i.e., a generic computer or computer component performing a generic computer or computer component function that facilitates the identified abstract idea) such that these amount no more than mere instructions to apply the exception using a generic computer component (see Specification e.g., at Fig. 1 and para. 0025-0026, 0028 and 0040). See MPEP § 2106.04(d)(I). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claims further recite the additional element of a medical device (implanted, implantable or otherwise), i.e., an insulin pump, as collecting, transmitting or outputting data. The additional element is recited at a high-level of generality (i.e., a general means of collecting, transmitting or outputting data) and amounts to a location from which data is received or to which data is transmitted or outputted, each of which represents an extra-solution activity (e.g., mere data gathering and data output). MPEP § 2106.04(d)(I) indicates that extra-solution data gathering and data output activity cannot provide a practical application. Accordingly, even in combination, the additional element does not integrate the abstract idea into a practical application. The claims are directed to an abstract idea.
The claims further recite the additional element of an operation of the medical device (implanted, implantable or otherwise), i.e., the insulin pump, performed on the person, e.g., administering insulin to the person. The claim limitation, which is considered an additional element, is merely reciting the words “apply it” (or an equivalent) with the judicial exception, which is insufficient to provide a practical application. See MPEP § 2106.04(d)(I). Accordingly, the additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B (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 integration of the abstract idea into a practical application, the additional elements of a mobile device including a memory device and a display; and a different memory device to perform the method amount no more than mere instructions to apply the exception using a generic computer or generic computer component. Mere instructions to apply an exception using generic computer(s) and/or generic computer component(s) cannot provide an inventive concept (“significantly more”). See MPEP § 2106.05(f).
Also discussed above with respect to integration of the abstract idea into a practical application, the additional element of a medical device (implanted, implantable, or otherwise), i.e., an insulin pump (i.e., a device that collects, transmits or outputs data) is considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2106.05(d)(II) indicates that receiving, transmitting or outputting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing TLI Communications, Symantec, OIP Techs., and buySAFE). See also MPEP 2106.05(g) (citing Cybersource, Mayo, OIP Techs.) Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such, the claims are not patent eligible.
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of an operation of the medical device (implanted, implantable or otherwise), i.e., an insulin pump, performed on the person, e.g., administering insulin to the person to perform the method amounts no more than merely reciting the words “apply it” (or an equivalent) with the judicial exception, which is insufficient to provide a practical application. See MPEP §§ 2106.05(a) and (f). Merely reciting the words “apply it” (or an equivalent) with the judicial exception cannot provide an inventive concept (“significantly more”).
Dependent claims 2-11, 13, 15-16 and 18-19, when analyzed as a whole, are similarly rejected under 35 U.S.C. §101 because the additional limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. The claims, when considered alone or as an ordered combination, either (1) merely further define the abstract idea, (2) do not further limit the claim to a practical application, or (3) do not provide an inventive concept such that the claims are subject matter eligible.
Claim(s) 2 merely further describe(s) the additional element(s) of the memory device and the mobile device (receiving data, storing data, updating data). See analysis, supra.
Claim(s) 3 merely further describe(s) the abstract idea (e.g., receiving patient-related information). See analysis, supra.
Claims 4-5 recite the additional elements of a computing device and another mobile device that implement the identified abstract idea. The additional elements are not described by the applicant and are recited at a high-level of generality, such that these amount no more than merely using a computer as a tool to perform an abstract idea (see specification at para. 0026, 0028). See analysis, supra.
Claim 6 merely further describes the additional element of the implanted medical device (e.g., initiating an operation), which amounts no more than merely reciting the words "apply it" (or an equivalent) with the judicial exception. See analysis, supra.
Claim 7 merely further describes the additional elements of the mobile device and the different memory device (e.g., transmitting data, receiving data, performing an action). See analysis, supra.
Claim 8 merely further describes the different memory device is located on a private cloud and communicatively coupled to the mobile device and a computing device of a medical facility. The additional element is not described by the applicant and are recited at a high-level of generality (i.e., a generic computing environment or a generic computer network), such that this amounts no more than merely using computer(s) as tool(s) to perform an abstract idea, such that these amount no more than mere instructions to apply the exception using a computer (see specification at para. 0020 and 0040). See analysis, supra.
Claim 9 merely further describes the additional element of the different memory device (e.g., performing an analysis / comparing data). See analysis, supra.
Claims 10-11 merely further describe the abstract idea (e.g., updating data, refraining from updating data). See analysis, supra.
Claim 13 merely further describes the additional element of the (implantable) medical device and the abstract idea (e.g., the data from the implantable medical device). See analysis, supra.
Claim 15 merely further describes an additional elements of the medical device (e.g., receiving an alarm) and the mobile device (e.g., generating an alarm action in the form of providing an audible signal or a vibration or an electronic communication or any combination thereof) at a high-level of generality, each of which amounts to a location from which data is received and to which data is outputted, each of which represents an extra-solution activity or insignificant computer implementation (e.g., mere data gathering and data output) and additionally representing mere instructions to apply the judicial exception on a generic computer. See analyses, supra.
Claim 16 merely further describes the additional element of a computing device (e.g., receiving a notification action including information about the medical device). See analysis, supra.
Claim 18 merely further describes the additional element of the mobile device as a smartwatch including a display (e.g., initiating the action) (see specification again at para. 0026, 0028). See analysis, supra.
Claim 19 merely further describes the additional element of the medical device as an implanted medical device and the abstract idea (e.g., the action is an alarm). See analysis, supra.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1, 3-9 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Houben et al. (US 2011/0105860 A1; “Houben” herein) in view of Soto et al. (US 2016/0354039 A1; “Soto” herein).
Re. Claim 1, Houben teaches a method, comprising:
receiving, by a mobile device (24) wirelessly coupled to a medical device implanted in a person (16), data from the implanted medical device including threshold homeostasis levels from the person that establish the person’s baseline dataset, wherein the baseline dataset includes […] associated with the medical device, and wherein the baseline dataset is related to an operation of the implanted medical device performed on the person ([0036]-[0037] teach the programmer, which may be a hand-held computing device, retrieves physiological or diagnostic information from the IMD 16 via wireless communication (see [0041]). See also [0038]. Fig. 6, step 202 and [0108]-[0110] teach the IMD measures and records baseline heart rates and baseline respiration rates (threshold homeostasis levels), e.g., for a person at rest (see also [0116], [0124]), which are used to calculate a predetermined threshold zone 272 for the person at rest (see Figs. 7B, 9B).), […]; configuring the mobile device with the threshold homeostasis levels (claim 7 teaches the IMD is configured to compare the heart rate, respiration rate, and activity level to the predetermined threshold zone (necessarily configured). See also Fig. 6 step 210. [0123] teaches the functionalities may be provided by the programmer 24.); receiving different data from the implanted medical device, wherein the different data is received from the implanted medical device as the different data is generated by the implanted medical device (see again [0036]-[0038] (receiving). Fig. 6 step 208 and [0113]-[0114] teach the IMD 16 begins monitoring short term averages of heart rate, respiration rate and activity level for the patient (different data) … system 10 continues to monitor… unless and until one or more measurements are outside of the predetermined threshold zone… system 10 may continue to monitor… even after issuing an alert.); analyzing the data from the implanted medical device and the different data generated by the implanted medical device (Fig. 6 and [0113] teach, after reviewing or imputing the predetermined TZ stored in memory of system 10, the clinician may program the IMD 16 to begin monitoring at step 208… and comparing the monitored heart rate, respiration rate and activity level to the TZ (analyzing the data and the different data) at step 210.); receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device (See again [0123] (the mobile device). Fig. 6, [0114] teach, in the event that one or more measurements of heart rate, respiration rate, and activity level of the patient are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert (necessitates receiving the analyzed data). See also Fig. 9B and [0126].); and initiating delivery, via a display on the mobile device, of an action at the mobile device or the implanted medical device, or both, based on the analyzed data from the implanted medical device and the different data generated by the implanted medical device (Fig. 6, step 212 and [0114] teach in the event that one or more measurements are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert to the patient (initiating delivery of an action) … in some examples, the alert may be… transmitted to another device associated with a clinician. [0036] teaches the programmer 24 may be a handheld computing device, including a keypad and a display, that receives input from a user.); and […] based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device (see previous citations. E.g., [0126] teaches exemplary data points 477 outside the predetermined TZ indicate that the patient is experiencing worsening heart failure and that a heart failure event, such as decompensation, may occur.)
Houben does not teach
the baseline dataset including identification data and location data associated with the medical device;
wherein the implanted medical device is an insulin pump; or
the implanted medical device receiving the action and administering the insulin to the person.
Soto teaches
baseline dataset including identification data and location data associated with the medical device (Fig. 1B and [0075] teach registering sensors… the registration information may include a unique sensor identifier, a unique patient identifier for the patient associated with the sensor, a sensor IP address (which may also serve as the unique sensor identifier), the sensor type and/or the data-type and units of measurements for the data provided by the sensor.);
wherein the implanted medical device is an insulin pump ([0055], [0057] teach an implanted insulin pump.); and
the implanted medical device receiving the action and administering the insulin to the person ([0055], [0057] teach if the model execution indicates a patient is at a significantly heightened risk, e.g., of heart failure exacerbation, the system may generate an electronic notification and transmit the notification to one or more destinations, e.g., patient’s phone… the action may include altering the operation of a medical device (necessarily receiving the action) to rectify an adverse medical condition identified via the model execution… if the model execution predicts that a patient’s glucose levels will result in hypoglycemia, the system can cause an implanted insulin pump to vary the amount of insulin the patient receives (administering).)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of Houben to include a system performing glucose monitoring, insulin delivery, and a sensor registration process and to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0168).
Re. Claim 3, Houben/Soto teaches the method of claim 1, further comprising receiving information related to the person, wherein the information is related to one of family history, a health of the person, habits of the person, or any combination thereof (Houben Figs. 7A-7D, [0039] teaches using programmer 24 to program parameters associated with the predetermined threshold zone for a given patient activity level (habits)… and furthermore, to (2) enter clinical information, such as patient history, medication history, history of heart failure hospitalizations, or other historical or current observations of patient condition (health). Houben [0119] teaches these factors of patient medical history, family history, etc. may also be used as inputs to calculate the predetermined threshold zone.)
Re. Claim 4, Houben/Soto teaches the method of claim 1, further comprising transmitting the analyzed data to a computing device, wherein the computing device is within a medical center (Houben Fig. 6, [0114] teaches in the event that one or more measurements are outside the predetermined threshold zone (the analyzed data), either IMD 16 or programmer 24 issues an alert… the alert may be transmitted to another device associated with a clinician or other user (a computing device). See additionally Houben [0120], [0123], computing devices 316.)
Re. Claim 5, Houben/Soto teaches the method of claim 1, further comprising transmitting the analyzed data to another mobile device corresponding to the person (Houben Fig. 6, [0114] teaches in the event that one or more measurements are outside the predetermined threshold zone (the analyzed data), either IMD 16 or programmer 24 issues an alert to the patient (mobile device)… the alert may be transmitted to another device (another mobile device) associated with a clinician or other user, i.e., the patient. See additionally Houben [0036], [0089].)
Re. Claim 6, Houben/Soto teaches the method of claim 1, further comprising: assessing a health of the person responsive to the analyzed data (Houben Fig. 6, [0113] teaches comparing monitored data to the predetermined threshold zone based on the measured baselines; an issuing an alert when the monitored data is not within the threshold zone (necessarily assessed)); and initiating an operation of the implanted medical device based on the assessment (Houben Fig. 6, [0114] teaches the IMD 16 or programmer 24 issues the alert to the patient.)
Re. Claim 7, Houben/Soto teaches the method of claim 1, further comprising: transmitting, from the mobile device, the data from the implanted medical device to a different memory device wirelessly coupled to the mobile device; transmitting, from the mobile device, the different data from the implanted medical device to the different memory device wirelessly coupled to the mobile device (Fig. 8 and [0121] teach the server 314 may monitor respiration rate, heart rate and activity level of the patient based on signals or information received from IMD 16 and/or programmer 24 via network 312 and compare the monitored levels to predetermined levels to detect worsening heart failure (transmitting the data and the different data). [0041] teaches wireless communication. See additionally [0123].); receiving, by the mobile device, analyzed data from the different memory device wirelessly coupled to the mobile device and responsive to the different memory device wirelessly coupled to the mobile device performing an analysis on the data from the implanted medical device (Fig. 6, step 204 and [0109]-[0111] teach calculate a predetermined threshold zone (TZ) as a function of the measured baselines (performing an analysis on the data). Fig. 6 and [0113] teach once calculated, store the predetermined TZ in memory… after reviewing or imputing the predetermined TZ stored in memory of system 10, the clinician may program the IMD 16 to begin monitoring… and comparing the monitored heart rate, respiration rate and activity level to the TZ (also performing an analysis on the data). Referring to teachings of [0121] and [0123], the Examiner interprets the server 314 as performing the comparison functionality. Fig. 1 and [0036]-[0037], [0121], [0123] teach the programmer retrieves the physiological or diagnostic information from the server 314.); and performing the action at the mobile device or the implanted medical device, or both, based on the analyzed data from the implanted medical device and the different data generated by the implanted medical device (Fig. 6, step 212 and [0114] teach in the event that one or more measurements are outside of the predetermined TZ (based on the analyzed data and different data), either IMD 16 or programmer 24 issues an alert to the patient (performs an action).)
Re. Claim 8, Houben/Soto teaches the method of claim 7, wherein the different memory device (314) wirelessly coupled to the mobile device (24) is located on a private cloud (312) and communicatively coupled to at least one of the implanted medical device (16), a computing device of a medical facility (316), or both (see claim 1 prior art rejection. Houben Fig. 8, [0041], [0120], [0123] teach an example system that includes elements coupled via a network 312 (cloud)… and communicating wirelessly. See also Houben [0122]. Soto [0009] teaches establishing a virtual private network. See also Soto [0190].)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of Houben to include a sensor registration process and establishment of a virtual private network to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving communication security, resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0061, 0168).
Re. Claim 9, Houben/Soto teaches the method of claim 7, wherein the different memory device wirelessly coupled to the mobile device performs the analysis on the data by comparing the baseline dataset to the different data generated by the implanted medical device (see claims 1 and 7 prior art rejectons. Houben Fig. 6 and [0111], [0113] teach monitoring data and comparing the monitored data (the different data) to the threshold zone (performs the analysis), which is a function of the measured baselines (the baseline dataset). Houben [0120]-[0121], [0123] teaches the server 314 may be wirelessly coupled to the other elements of Fig. 8; and the server 314 may provide the functionalities, for example, monitor respiration rate, heart rate and activity level of the patient based on signals or information received from the IMD 16 and/or programmer 24 via network 312; and compare the monitored levels to predetermined levels to detect worsening heart failure of the patient.)
Re. Claim 12, Houben teaches a system, comprising:
a mobile device coupled to a memory device ([0036], [0089] teach a programmer 24, which may be a hand-held computing device, includes a memory 102); the memory device comprising instructions executable to cause the mobile device to (see [0091]): receive data from a medical device (16) coupled to the memory device, wherein the data includes threshold homeostasis levels from the person that establish the person’s baseline dataset related to the medical device and includes […] associated with the medical device, and wherein the baseline dataset is related to an operation of the medical device performed on the person (Fig. 1 and [0036]-[0037] teach a system 10, wherein the programmer includes a memory; and retrieves physiological or diagnostic information from the IMD 16. See also [0038] and [0113]. Fig. 6, step 202 and [0108]-[0110] teach the IMD measures and records baseline heart rates and baseline respiration rates (threshold homeostasis levels), e.g., for a person at rest (see also [0116], [0124]), which are used to calculate a predetermined threshold zone 272 for the person at rest (see Figs. 7B, 9B).); receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device (see again [0036]-[0038] (receiving). Fig. 6 step 208 and [0113]-[0114] teach the IMD 16 begins monitoring short term averages of heart rate, respiration rate and activity level for the patient (different data) … system 10 continues to monitor… unless and until one or more measurements are outside of the predetermined threshold zone… system 10 may continue to monitor… even after issuing an alert.); analyze the data from the medical device and the different data generated by the medical device (Fig. 6 and [0113] teach, after reviewing or imputing the predetermined TZ stored in memory, the clinician may program the IMD 16 to begin monitoring… and comparing the monitored heart rate, respiration rate and activity level to the TZ (analyzing the different data). [0123] teaches the functionalities may be provided by the programmer 24.); receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device (See again [0123] (the mobile device). Fig. 6, [0114] teach, in the event that one or more measurements of heart rate, respiration rate, and activity level of the patient are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert (necessitates receiving the analyzed data). See also Fig. 9B and [0126].) and initiate delivery of an action based on the analyzed data from the medical device and the different data generated by the medical device (Fig. 6, step 212 and [0114] teach in the event that one or more measurements are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert to the patient (initiating delivery of an action) … in some examples, the alert may be… transmitted to another device associated with a clinician.); and […] based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device (see previous citations. E.g., [0126] teaches exemplary data points 477 outside the predetermined TZ indicate that the patient is experiencing worsening heart failure and that a heart failure event, such as decompensation, may occur.)
Houben does not teach
the baseline dataset including identification data and location data associated with the medical device; or
the medical device, comprising an insulin pump, to: receive the action; and administer insulin to the person.
Soto teaches
baseline dataset including identification data and location data associated with the medical device (Fig. 1B and [0075] teach registering sensors… the registration information may include a unique sensor identifier, a unique patient identifier for the patient associated with the sensor, a sensor IP address (which may also serve as the unique sensor identifier), the sensor type and/or the data-type and units of measurements for the data provided by the sensor.);
the medical device, comprising an insulin pump, to: receive the action; and administer the insulin to the person ([0055], [0057] teach an implanted insulin pump; and also teach if the model execution indicates a patient is at a significantly heightened risk, e.g., of heart failure exacerbation, the system may generate an electronic notification and transmit the notification to one or more destinations, e.g., patient’s phone… the action may include altering the operation of a medical device (necessarily receiving the action) to rectify an adverse medical condition identified via the model execution… if the model execution predicts that a patient’s glucose levels will result in hypoglycemia, the system can cause an implanted insulin pump to vary the amount of insulin the patient receives (administering).);
and additionally teaches analyze monitored data (Abstract teaches the models may be automatically executed in response to receiving certain types and/or amount of data, such as data received from one or more physiological remote sensors.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of Houben to include a system performing glucose monitoring, insulin delivery, a sensor registration process, and additionally remote data analysis and to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0168).
Re. Claim 13, Houben/Soto teaches the system of claim 12, wherein the medical device is an implantable medical device (see Houben [0017]), and the data from the medical device is an identifier of the medical device, an identifier of the person, a medical facility associated with the medical device, family history of the person, or any combination thereof (see claim 12 prior art rejection. Soto Fig. 1B and [0075] teaches registering sensors… the registration information may include a unique sensor identifier, a unique patient identifier for the patient associated with the sensor, a sensor IP address (which may also serve as the unique sensor identifier), the sensor type and/or the data-type and units of measurements for the data provided by the sensor. Houben [0118]-[0119] teaches the IMD 16 can calculate the predetermined threshold zone using additional factors including family history.)
Re. Claim 14, Houben/Soto teaches the system of claim 12, wherein: the action is a signal transmitted to the medical device; and the medical device administers insulin responsive to the receipt of the signal (Houben [0106] teaches the IMD 16 provides an alert by communicating with an external device, e.g., the programmer 24; and similarly, if the alert module is implemented in the programmer, the alert module 128 may cause the programmer to send a telemetry signal to the IMD 16 that causes the IMD 16 to generate an alert. Houben [0025]-[0026] teaches system 10 may alter patient therapy in response to detecting worsening heart failure, e.g., system 10 may alter drug therapy; and IMD 16 may additionally operate as an implanted drug delivery device. Soto [0055], [0057] teaches the system can cause the insulin pump to vary the amount of insulin the patient receives.)
Re. Claim 15, Houben/Soto teaches the system of claim 12, wherein: the action is an alarm; and the alarm is generated by the mobile device in the form of providing an audible signal, providing a vibration, providing an electronic communication, administering of insulin, or any combination thereof (Houben [0106], [0114] teaches the IMD 16 provides an alert by communicating with an external device, e.g., the programmer 24; and similarly, if the alert module is implemented in the programmer, the alert module 128 may cause the programmer to send a telemetry signal to the IMD 16 that causes the IMD 16 to generate an alert (alarm) … in response to communication from alert module 128, the programmer may emit a beeping sound, display a text prompt, vibrate, or cause buttons and/or screens to flash. See also Soto [0055], notification.)
Claims 2, 10-11 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Houben in view of Soto and Muhsin et al. (US 2018/0247712 A1; “Muhsin” herein).
Re. Claim 2, Houben/Soto teaches the method of claim 1, further comprising: receiving, at a memory device (102) coupled to the mobile device (24), the baseline dataset; storing the baseline dataset including the part of the baseline dataset in the memory device coupled to the mobile device (Houben [0036]-[0037] teach the programmer retrieves the physiological or diagnostic information from the IMD 16. See also Houben [0038], [0113]. Houben Fig. 6 and [0108]-[0110] teach the IMD measures and records the baselines. See additionally Houben Figs. 9A-9B. Houben [0091] teaches the memory 102 stores… information (the baseline dataset) used by processor 100 and/or diagnostic 110 to provide the functionality ascribed to programmer 24.); and […] based at least in part on the different data received from the implanted medical device (the monitored data), the action (the issuing of an alarm), or both (see claim 1 prior art rejection).
Houben/Soto may not teach updating the baseline dataset.
Muhsin teaches
updating the baseline dataset ([0006] teaches the settings user interface can be user-selectable to cause… to receive an updated setting (baseline)… which may comprise adjusting a limit of an alarm (updating). See Applicant’s disclosure at para. 0048.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto to update settings and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Re. Claim 10, Houben/Soto teaches the method of claim 9, further comprising […] responsive to the comparison of the baseline dataset to the different data generated by the implanted medical device (see claim 9 prior art rejection).
Houbin/Solo may not teach updating the baseline dataset.
Muhsin teaches
update the baseline dataset ([0006] teaches the settings user interface can be user-selectable to cause… to receive an updated setting (baseline)… which may comprise adjusting a limit of an alarm. See Applicant’s disclosure at para. 0048.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto to update settings and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Re. Claim 11, Houben/Soto teaches the method of claim 9, further comprising […] responsive to the comparison of the baseline dataset to the different data generated by the implanted medical device (see claim 9 prior art rejection).
Houben/Soto may not teach refraining from updating the baseline dataset.
Muhsin teaches
refraining from updating the baseline dataset ([0006] teaches the settings user interface can be user-selectable to cause… to receive an updated setting (baseline)… which may comprise adjusting a limit of an alarm (updating). See Applicant’s disclosure at para. 0048. Fig. 73C, [0308]-[0310] teach refraining from changing a setting (step 7354 = NO).)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto to update settings or to not update settings associated with an external device based on received medical data and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Re. Claim 17, Houben teaches a system, comprising:
a memory device coupled to a mobile device ([0036], [0089] teach a programmer 24, which may be a hand-held computing device, includes a memory 102); a medical device […] coupled to the mobile device (see Fig. 8 and [0041]), the medical device to provide information about the medical device to the mobile device (see below), wherein the medical device is implantable ([0017], “implantable medical device (IMD)”); and a different memory device (314) coupled to the mobile device (see Fig. 8) to receive the information about the medical device from the mobile device (see below); the mobile device configured to: receive data from the medical device (16), wherein the data includes threshold homeostasis levels from a person implanted with the medical device, is stored in the memory device as a baseline dataset related to the medical device, and wherein the baseline data includes […] associated with the medical device (Fig. 6, step 202 and [0108]-[0110] teach the IMD measures and records baseline heart rates and baseline respiration rates (threshold homeostasis levels), e.g., for a person at rest (see also [0116], [0124]), which are used to calculate a predetermined threshold zone 272 for the person at rest (see Figs. 7B, 9B). Fig. 1 and [0036]-[0037] teach the programmer retrieves physiological or diagnostic information from the IMD 16. See also [0038], [0113]. [0091] teaches the memory 102 stores… information (a baseline dataset) used by processor 100 and/or diagnostic unit 110 to provide the functionality ascribed to programmer 24.); configure the mobile device with the threshold homeostasis levels (claim 7 teaches the IMD is configured to compare the heart rate, respiration rate, and activity level to the predetermined threshold zone (necessarily configured). See also Fig. 6 step 210. [0123] teaches the functionalities may be provided by the programmer 24.); transmit the data from the medical device to the different memory device (Fig. 8 and [0121] teach the server 314 may monitor respiration rate, heart rate and activity level of the patient based on signals or information received from IMD 16 and/or programmer 24 via network 312. See additionally [0123].); receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device (see again [0036]-[0038] (receiving). Fig. 6 step 208 and [0113]-[0114] teach the IMD 16 begins monitoring short term averages of heart rate, respiration rate and activity level for the patient (different data) … system 10 continues to monitor… unless and until one or more measurements are outside of the predetermined threshold zone… system 10 may continue to monitor… even after issuing an alert.); transmit the different data from the medical device to the different memory device (Fig. 8 and [0121] teach the server 314 may monitor respiration rate, heart rate and activity level of the patient based on signals or information received from IMD 16 and/or programmer 24 via network 312. See additionally [0123].); receive analyzed data from the different memory device responsive to the different memory device performing an analysis on the data from the medical device and the different data generated by the medical device (Fig. 6, step 204 and [0109]-[0111] teach calculate a predetermined threshold zone (TZ) as a function of the measured baselines (performing an analysis on the data). Fig. 6 and [0113] teach once calculated, store the predetermined TZ in memory… after reviewing or imputing the predetermined TZ stored in memory of system 10, the clinician may program the IMD 16 to begin monitoring… and comparing the monitored heart rate, respiration rate and activity level to the TZ (also analyzing the different data). Referring to teachings of [0121] and [0123], the Examiner interprets the server 314 as performing the comparison functionality. Fig. 1 and [0036]-[0037], [0121], [0123] teach the programmer retrieves the physiological or diagnostic information from the server 314.); initiate an action based on the analyzed data from the different memory device (Fig. 6, step 212 and [0114] teach in the event that one or more measurements are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert to the patient.); and […] based on the analyzed data, the action, or both (see previous citations); and […] based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device (see previous citations. E.g., [0126] teaches exemplary data points 477 outside the predetermined TZ indicate that the patient is experiencing worsening heart failure and that a heart failure event, such as decompensation, may occur.)
Houben does not teach
the baseline dataset including identification data and location data associated with the medical device;
the medical device comprising an insulin pump; or
the medical devices to: receiving the action; and administer insulin to the person.
Soto teaches
baseline dataset including identification data and location data associated with the medical device (Fig. 1B and [0075] teach registering sensors… the registration information may include a unique sensor identifier, a unique patient identifier for the patient associated with the sensor, a sensor IP address (which may also serve as the unique sensor identifier), the sensor type and/or the data-type and units of measurements for the data provided by the sensor.)
the medical device comprising an insulin pump ([0055], [0057] teach an implanted insulin pump.); and
the medical devices to: receiving the action and administer the insulin to the person ([0055], [0057] teach if the model execution indicates a patient is at a significantly heightened risk, e.g., of heart failure exacerbation, the system may generate an electronic notification and transmit the notification to one or more destinations, e.g., patient’s phone… the action may include altering the operation of a medical device (necessarily receiving the action) to rectify an adverse medical condition identified via the model execution… if the model execution predicts that a patient’s glucose levels will result in hypoglycemia, the system can cause an implanted insulin pump to vary the amount of insulin the patient receives (administering).)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of Houben to include a system performing glucose monitoring, insulin delivery, and a sensor registration process and to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0168).
Houben/Soto may not teach update the baseline dataset.
Muhsin teaches
update the baseline dataset ([0006] teaches the settings user interface can be user-selectable to cause… to receive an updated setting (baseline)… which may comprise adjusting a limit of an alarm. See Applicant’s disclosure at para. 0048.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto to update settings and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Re. Claim 18, Houben/Soto/Muhsin teaches the system of claim 17, wherein: the mobile device is a smartwatch including a display; and the action is initiated via the display (Soto [0058], [0246] teaches the user terminals described herein may be in the form of a networked watch / a smartwatch… The user terminals may optionally include displays, etc. Houben [0090], [0098], [0106] teaches providing the alert via user interface 104, which may include a display.)
Re. Claim 19, Houben/Soto/Muhsin teaches the system of claim 18, wherein the medical device is implanted in a person (Houben [0026] teaches IMD 16 may be implanted) and the action is an alarm of the smartwatch worn by the person (Houben [0090], [0098], [0106] teaches providing the alert (alarm action) via the programmer 24 user interface 104. Soto [0058], [0246] teaches the user terminals described herein may be in the form of a networked watch / a smartwatch.)
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Houben in view of Soto and Degen et al. (US 2018/0060520 A1; “Degen” herein).
Re. Claim 16, Houben/Soto teaches the system of claim 12, wherein: the action is a notification; and the notification is transmitted to a computing device and includes […] (Houben [0106] teaches IMD 16 or programmer 24 provides an alert by communicating with an external device, sends a telemetry signal to the receiving device, causes the receiving device to generate the alert (notification). Houben Fig. 8, [0033], [0121] teaches the alert may be… transmitted to another device associated with a clinician or other user, such as an alert transmitted to a server 314 and relayed to a physician via a computing device 316.)
Houben/Soto does not explicitly teach information about the medical device.
Degen teaches information about the medical device (Fig. 9, [0073] teach a clinician graphical user interface 71 may communicate various messages such as warnings 79 to the physician; and operational data box 74 may display operational data such as operational measurements 77, which may include measurements related to performance of the implantable device 15.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto to include information about the implantable device and to use this information as part of systems and methods for managing and analyzing data generated by an implantable device as taught by Degen, with the motivation of improving patient care and outcomes (see Degen at para. 0004, 0034 and 0048).
Response to Arguments
Double Patenting Rejection
The rejection of canceled claim 20 is rendered moot. The rejection of pending claims 1-19 is updated as necessitated by amendment and respectfully maintained for the pending claims.
Claim Objections
Re. the objection(s), the Applicant has cancelled claim 20, rendering objection moot for claim 20. Regarding the remaining claim 17, the Applicant has amended claim 17 to overcome the basis of objection, hereby withdrawn.
Rejections under 35 U.S.C. §112(b)
Re. the rejection of claim 15, the Applicant has amended claim 15 to overcome the previous issue of indefiniteness; however, some claim amendments cause new issues.
Rejections under 35 U.S.C. §101
Re. the rejection of claims 1-20, the Applicant has cancelled claim 20, rendering the rejection of claim 20 moot; and the Examiner has pulled the rejection of claim 14 for reasons above-specified. Regarding the remaining claims 1-13 and 15-19, the Examiner has considered the Applicant’s arguments but does not find them persuasive for at least the following reasons. Applicant argues:
Note: Assuming the Applicant has alleged that the claims do not recite an abstract idea: The Examiner respectfully submits the basis of rejection as necessitated by amendment. The identified claim elements under broadest reasonable interpretation (BRI) cover a method of organizing human activity wherein a person follows a series of rules or steps to implement the identified abstract idea by interacting with a computer system. Given the broadest reasonable interpretation, the claims recite Certain Methods of Organizing Human Activity (managing personal behavior and/or interactions between people, which includes one or more persons following a series of steps or rules, and which includes interaction of a person with a computer) (see 2019 PEG at pg. 5 and as now incorporated into the most recent version of MPEP 2106).
A1. The Applicant argues that the claims are not merely directed to an abstract idea. “The independent claims, for example, recite initiating an action and a medical device performing the action. Examples of the action performed are noted in the application as filed and can include administering insulin to a user of the medical device (e.g., Paragraphs [0037], [0047], [0054]). As a result, the claims recite more than merely an abstract idea.” (Remarks, pg. 9-10).
Re. argument A1: The Examiner respectfully submits that initiating delivery of an action at one location and receiving the action at that same location (i.e., claim 1 recitation of “initiating delivery” at one location “of an action at” the same location) is part of the abstract idea. Even if the action of claim 1 were claimed as the action of claim 14, the action is not controlling another technology if the initiating location receives the action (as recited in claim 1); this would be mere instructions to apply the judicial exception on a generic computer.
Additionally, even if the action initiates at one location and is received at another location (as in claims 12 and 17), the independent claims do not positively recite the additional element of “administering insulin to the person” being responsive to the receipt of the action by the medical device. (This distinction is made by dependent claim 14, which has been found subject matter eligible.)
Given the BRI, the action of the independent claims may be an alert message generated and received at one location (claim 1) or generated and sent from one location to a second location (claims 12 and 17), such that the additional elements amount no more than mere instructions to apply the abstract idea on a generic computer or mere data gathering and data output.
Also given the BRI, without reciting control of the medical device operation (e.g., administering insulin to the person), the additional element of “an operation of the medical device… administering insulin to the person” amounts no more than mere instructions to “apply it” (or an equivalent) with the judicial exception. See MPEP 2106.04(d)(I).
A2. “First, the improvement in the technological field is explained in Applicant's specification. Paragraph [0019] describes an example improvement provided by the present invention…”
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(See Remarks, pg. 10-11).
Re. argument A2: The Examiner respectfully submits that the specification describes at most improvement to the monitoring of user-specific trends in the data collected and updated in real-time and data reporting (mere data gathering and data output). While the abstract idea may be improved, an improved abstract idea is still an abstract idea. Only additional elements may provide a practical application or significantly more. Looking at the combination of elements (the abstract idea and the additional elements), the MPEP 2106.04(d)(I) indicates that extra-solution data gathering and data output activity cannot provide a practical application. The MPEP 2106.05(d)(II) indicates that mere data gathering and data output is well-understood, routine, conventional activity that cannot provide significantly more. See also MPEP 2106.05(g). Also, in accordance with MPEP 2106.05(f), the use of the mobile device components, even in combination, to implement the abstract idea cannot provide significantly more.
A3. “Claims 1, 12, and 17 have been amended to claim the performance of the action by the medical device, which is an additional element rather than generic computer components. For instance, Applicant has added administering insulin to the independent claims. The additional element considered individually and in combination with the other claim elements reflect an improvement to the technological field of inventory management” (Remarks, pg. 11).
Re. argument A3: See response to argument A1. The additional element related to the medical device administering the insulin is not tied to the action received by the medical device. This affects the claim as a whole and renders the claim as a whole subject matter ineligible. The BRI of the claims is the receipt of an action (such as an alert) by the medical device, and a user may decide to operate the medical device based on the alert action received. To tie the two steps, the Examiner suggests amending to incorporate the features of claim 14 into the independent claims. The Examiner also suggests amending claim 1 to clarify that the action is initiated by the mobile device prior to being received by the medical device.
Re. the rejection of Claims 2-11, 13, 15-16 and 18-19, the Applicant has not offered any arguments with respect to these claims other than to reiterate the argument(s) present for the claim(s) from which they depend. As such, the rejection of these claims is also respectfully maintained.
Rejection under 35 U.S.C. §103
Re. the rejection of claims 1-20, the Applicant has cancelled claim 20, rendering the rejection of claim 20 moot.
Re. the remaining claims 1-19, the Examiner has considered the Applicant’s arguments but does not find them persuasive for at least the following reasons. Applicant argues:
B1. “Applicant has amended independent claim I to recite… Independent claim 12 has been amended similarly… the Houben, Soto, and Muhsin references, alone or in combination, do not teach or suggest… as recited in independent claim 17, as amended” (Remarks, pg. 12-14).
Re. argument B1: The Examiner respectfully submits the basis of rejection as necessitated by amendment. Given the BRI, claims 1, 12, 17 are rejected as being obvious in view of Houben, Soto, and/or Muhsin.
Regarding the rejection of 2-11, 13-16 and 18-19, the Applicant has not offered any arguments with respect to these claims other than to reiterate the argument(s) present for the claim(s) from which they depend. As such, the rejection of these claims is also maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Palti (US 5,474,552) for teaching an implanted sensor of living cells produces a detectable electrical signal which varies with the concentration of glucose. A controller detects the electrical signal produced by the sensor and determines if the concentration of glucose is within the predetermined range. If the glucose is too low or too high, the controller activates a pump causing either glucose or glucagon, or insulin to be delivered to the person until the glucose level is within the predetermined range. This reference would be used to reject claim 20 (1) if claim 20 recited the medical device receiving the initiated action and (2) if the action initiated via the display could be more than a notification telling the user to initiate delivery of glucose. Motivation to combine: It would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto/Muhsin to deliver glucose and to use this information as part of the implanted drug delivery pump as taught by Palti, with the motivation of improving patient care by improving sensor-controlled delivery systems (see Palti at Abstract and col. 1, lines 45-55).
Kaib et al. (US 2016/0278652 A1) for teaching systems and methods of determining location using a medical device.
Finch et al. (US 2019/0030350 A1) for teaching wearable cardioverter defibrillator system outputting human-visible indication and proximate programming device with screen producing the human-visible indication in real time.
Saha et al. (US 2019/0343415 A1) for teaching systems and methods for detecting arrhythmias.
Mazlish et al. (US 2018/0200437 A1) for teaching a system and method for adjusting insulin delivery.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.M.W./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
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