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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/05/2024 was considered by the examiner.
Claim Objections
Claims 1-15 are objected to because of the following informalities:
Claim 1, line 1: “Computer” should be replaced with “A computer”;
Claims 2-12, lines 1: “Computer” should be replaced with “The computer”;
Claim 7, line 1: in “the content”, the instance of “the” should be deleted;
Claim 13: “System” should be replaced with “A system”;
Claim 14, line 1: “Computer” should be replaced with “A computer”; and
Claim 15, line 1: “Computer” should be replaced with “A computer”.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because different reference characters have been used to designate the same element.
Reference characters S1, L, 10, and P have been used to designate an element in Fig. 1;
Reference characters S2a, 12, C, D1, D2, D3, 22, and 10a have been used to designate an element in Fig. 1;
Reference characters S2b, 14, 16, MP, C, D1, D2, D3, 15, and DB have been used to designate an element in Fig. 1;
Reference characters S3, MP, and 24 have been used to designate an element in Fig. 1;
Reference characters 10, L, and P have been used to designate an element in Fig. 2;
Reference characters 16, DB, 12, 14, 15, MP, and C have been used to designate an element in Fig. 2; and
Reference characters 18, DB have been used to designate an element in Fig. 2.
Additionally, the drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because the same reference character has been used to designate different elements.
C, D1, D2, and D3, have been used to designate different elements in Fig. 1; and
DB has been used to designate different elements in Fig. 2.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No limitations were interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-7 and 10-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “a patient device, in particular a handheld or wearable device, in particular preferably a smartphone, a smartwatch and/or a tablet computing device” in lines 2-4. First, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “a patient device” and the claim also recites “a handheld or wearable device” which is a narrower statement of the range/limitation. Claim 2 also recites “a smartphone, a smartwatch and/or a tablet computing device” which is a further narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Second, the phrases "in particular" and “preferably” render the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the narrower limitations will not be given patentable weight. Claims 3, 4, 6, 10, and 12 recite similar limitations, so the claims are rejected on similar grounds.
Claim 4 recites “high-risk” in lines 3, 5, and 6. The term is a relative term which renders the claim indefinite. The term “high-risk” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is unclear when something is classified as high-risk or low-risk. Claim 5 also recites the term, so it is rejected on similar grounds.
Claims 5-7 and 11 are rejected by virtue of their dependence from claim 4.
Claim 5 recites “a database hosted on the patient device, the implantable medical device and/or a remote server accessible by the patient device” in lines 4-6. Due to the grammatical structure, it is unclear whether (A) the database is hosted on the patient device, the implantable medical device, and/or a remote server or (B) the database is hosted on the patient device, wherein the implantable medical device and/or a remote server is accessible by the patient device. Clarification is required.
Claim 6 recites “the diagnostic function” in lines 1-2. Claim 1 recites “at least one diagnostic function” in line 5. If there are more than one diagnostic functions, it is unclear which of the plurality is being referred to by “the diagnostic function” in claim 6. The limitation in claim 6 will be interpreted to be “the at least one diagnostic function”.
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 14 and 15 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because (A) the computer program of claim 14 is a product that does not have a physical or tangible form and (B) the computer readable data carrier of claim 15 covers transitory forms of signal transmission. See MPEP 2106.03 (I). The Examiner suggests amending claim 15 to recite “A non-transitory computer readable data carrier”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 9, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0007354 A1 (Bulut).
With regards to claim 1, Bulut teaches a computer implemented method for controlling an implantable medical device (¶ [0077] and Fig. 8 depict a computer-implemented, proximity triggered sampling method which includes causing a change in data collection function characteristics; ¶ [0019] discloses that the wearable device 12 for collecting data may be an implantable device including biocompatible sensors); comprising the steps of: detecting a geographic location of the implantable medical device and/or a proximity of the implantable medical device to an object and/or person (Fig. 8 and ¶ [0077] discloses receiving data corresponding to an interaction with a user at step 102; ¶ [0029] discloses the proximity data includes the social interaction characteristics; ¶ [0019] discloses either wearable device 12 or electronics device 14 include a global navigation satellite system (GNSS) receiver which tracks and provides location coordinates and may comprise indoor location or proximity sensing technology, including beacons, RFID or other coded light technologies; ¶ [0028] discloses determining proximity between people; ¶ [0037] discloses determination of proximity in relation to other devices equipped with beacon or proximity sensing technology); and at least temporarily activating and/or deactivating at least one diagnostic function of the implantable medical device and/or at least temporarily changing a transmission frequency and/or a selection of at least one medical parameter of a patient detected by the implantable medical device if the detected geographic location of the implantable medical device and/or the proximity of the implantable medical device to the object and/or person meets a predetermined condition (Fig. 8 and ¶¶ [0029], [0077] depict based on received data, predicting a moment in time when a state of the user is likely to change at step 104 and causing a change in data collection function characteristics at the moment in time at step 106, wherein data collection function characteristics include whether the data collection is activated or not, a start and stop time of the data collection, a frequency of the data collection, the type of measurement function, a delivery time of the data collection function, among other characteristics; also see ¶ [0032] regarding the prediction module).
With regards to claim 2, Bulut further teaches the geographic location of the implantable medical device is detected by a patient device, in particular a handheld or wearable device, in particular preferably a smartphone, a smartwatch and/or a tablet computing device, wirelessly communicating with the implantable medical device (¶¶ [0019], [0037] depict electronics device 14 may perform GNSS functionality; ¶ [0021] depict electronics device 14 may be embodied as a smartphone, etc.; Fig. 1 and ¶ [0020] depict electronics device 14 is configured for wirelessly communicating with wearable device 12), wherein the patient device determines the geographic location of the implantable medical device using GNSS and/or mobile data (¶¶ [0019], [0037] depict electronics device 14 may perform GNSS functionality).
With regards to claim 3, Bulut further teaches wherein if the predetermined condition is met, the patient device controls the implantable medical device, in particular by wireless communication, in particular preferably by Bluetooth low energy and/or Mics-Band communication, to at least temporarily activate and/or deactivate the at least one diagnostic function of the implantable medical device and/or to at least temporarily change the transmission frequency and/or the selection of the at least one medical parameter of a patient detected by the implantable medical device (¶ [0034] depicts a communications module 38 of wearable device 12 that is configured to, in cooperation with communications circuit 40, receive any messages (or instructions to activate and/or increase/decrease data collection function characteristics) from the electronics device 14 or the computing system 20, wherein the communication technologies include NFC, Bluetooth, Zigbee, etc.).
With regards to claim 9, Bulut further teaches the diagnostic function of the implantable medical device is a temperature, impedance, respiratory function, sound, posture and/or movement measurement and/or tracking by sensors of the implantable medical device (¶ [0019] of Bulut teaches the wearable device is configured to sense/measure or derive physiological parameters (e.g., heart rate, respiration, skin temperature, etc.) and physical activity; also see ¶ [0037] regarding the sensors)
With regards to claim 13, Bulut teaches a system for controlling an implantable medical device (Fig. 1 and ¶ [0019] depict an environment 10 for controlling a wearable device 12; ¶ [0019] discloses the wearable device 12 may be implantable) comprising: a patient device configured to detect a geographic location of the implantable medical device and/or a proximity of the implantable medical device to an object and/or person (¶¶ [0019], [0037] depict electronics device 14 may perform GNSS functionality; ¶ [0021] depict electronics device 14 may be embodied as a smartphone, etc.; Fig. 1 and ¶ [0020] depict electronics device 14 is configured for wirelessly communicating with wearable device 12); and the implantable medical device (Fig. 1 and ¶ [0019] depict a wearable device 12 which may be implantable), wherein the patient device is further configured to at least temporarily activate and/or deactivate at least one diagnostic function of the implantable medical device and/or at least temporarily change a transmission frequency and/or a selection of at least one medical parameter of a patient detected by the implantable medical device if the detected geographic location of the implantable medical device and/or the proximity of the implantable medical device to the object and/or person meets a predetermined condition (Fig. 8 and ¶¶ [0029], [0077] depict based on received data, predicting a moment in time when a state of the user is likely to change at step 104 and causing a change in data collection function characteristics at the moment in time at step 106, wherein data collection function characteristics include whether the data collection is activated or not, a start and stop time of the data collection, a frequency of the data collection, the type of measurement function, a delivery time of the data collection function, among other characteristics; also see ¶ [0032] regarding the prediction module).
With regards to claim 14, Bulut further teaches a computer program with program code to perform the method of claim 1 when the computer program is executed on a computer (¶ [0077] depicts the proximity triggered sampling method is computer-implemented; also see ¶¶ [0064] and [0081]).
With regards to claim 15, Bulut further teaches a computer readable data carrier with program code of a computer program to perform the method of claim 1 when the computer program is executed on a computer(¶ [0077] depicts the proximity triggered sampling method is computer-implemented; also see ¶¶ [0064] and [0081]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0007354 A1 (Bulut), as applied to the rejection of claim 1 above, and in view of US 2023/0125123 A1 (Vialle)
With regards to claim 4, Bulut teaches the computer implemented method of claim 1. See the above rejection of claim 1 under 35 U.S.C. §102. Bulut is silent regarding whether the predetermined condition is met if the detected geographic location of the implantable medical device is classified as a high-risk area or poses a patient specific risk, in particular dependent on a specified patient condition and/or if a proximity of the implantable medical device to a high-risk object and/or a high-risk person is detected.
In a system relevant to the problem of determining risks to patients based on social interactions, Vialle teaches determining if the detected geographic location of a device is classified as a high-risk area or poses a patient specific risk, in particular dependent on a specified patient condition and/or if a proximity of the device to a high-risk object and/or a high-risk person is detected (Fig. 1 and ¶¶ [0086]-[0087] discloses detecting regions at risk of infection based on data from terminal T1; Fig. 2 and ¶¶ [0088]-[0090] depict determining whether geographical positions occupied by terminal T2 stored in step S20 are included in the region of risk). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the predetermined condition of Bulut to incorporate that it is met if the detected geographic location of a device is classified as a high-risk area or poses a patient specific risk, in particular dependent on a specified patient condition and/or if a proximity of the device to a high-risk object and/or a high-risk person is detected as taught by Vialle. The motivation would have been to assist with limiting the spread of a contagious disease (¶ [0002] of Vialle) and/or to improve the prediction of when the state of the user is likely to change by detecting whether a user is at risk of infection.
With regards to claim 5, the above combination teaches or suggests a database hosted on the patient device, the implantable medical device and/or a remote server accessible by the patient device via a network in order to determine if the predetermined condition is met (¶ [0025] of Bulut discloses a computing system coupled to a wide area network 18 which serve as a cloud computing environment for the electronics device 14 and/or wearable device 12, performing processing and data storage on behalf of the electronics device 14; ¶ [0027] of Bulut discloses the computing system 20 determines a user state)
The above combination is silent regarding whether geographic location data of the implantable medical device and/or proximity data of the implantable medical device to the object and/or person detected by the patient device is compared to data on high-risk areas and/or patient specific risks stored in a database hosted on the patient device.
In a system relevant to the problem of determining risks to patients based on social interactions, Vialle teaches geographic location data of a device and/or proximity data of the device to the object and/or person detected by the patient device is compared to data on high-risk areas and/or patient specific risks stored in a database hosted on the patient device (Fig. 1 and ¶¶ [0086]-[0087] discloses detecting regions at risk of infection based on data from terminal T1; Fig. 2 and ¶¶ [0088]-[0090] depict determining whether geographical positions occupied by terminal T2 stored in step S20 are included in the region of risk, wherein the determination is made at the terminal T2). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate geographic location data of the implantable medical device and/or proximity data of the implantable medical device to the object and/or person detected by the patient device is compared to data on high-risk areas and/or patient specific risks stored in a database hosted on the patient device as taught by Vialle. The motivation would have been to further assist with limiting the spread of a contagious disease (¶ [0002] of Vialle) and/or to further improve the prediction of when the state of the user is likely to change by detecting whether a user is at risk of infection.
With regards to claim 6, the above combination teaches or suggests the diagnostic function of the implantable medical device is selected by a health care provider, in particular a physician, or by an algorithm using medical data of the patient stored in the patient device (¶ [0077] of Bulut discloses an example of the method (i.e., algorithm) of Fig. 8 in which data collection function characteristic may involve increased sampling of a heart rate measurement), the implantable medical device and/or the remote server accessible by the patient device via the network (¶ [0025] of Bulut discloses a computing system 20 coupled to a wide area network 18 which serve as a cloud computing environment for the electronics device 14 and/or wearable device 12, performing processing and data storage on behalf of the electronics device 14; ¶ [0027] of Bulut discloses the computing system 20 determines a user state).
With regards to claim 7, the above combination is silent regarding whether the content of the database is synchronized between the remote server and the implantable medical device and/or the patient device at predetermined intervals and/or when the database is updated.
In a system relevant to the problem of determining risks to patients based on social interactions, Vialle teaches content of a database is synchronized between a remote server and the implantable medical device and/or the patient device at predetermined intervals and/or when the database is updated (¶ [0089] of Vialle discloses the server SER sending a notification to terminal T2, comparing a list of geographical positions stored in S20 at T2 with the region of risk determined at T1, wherein the notification is presented when the region at risk specific to terminal T1 is estimated). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the database of the above combination to incorporate, based on the teachings of Vialle, that the content of the database is synchronized between the remote server and the implantable medical device and/or the patient device at predetermined intervals and/or when the database is updated. The motivation would have been to provide a more immediate update of the database, which allows for a prompter response to the identification of the risk.
With regards to claim 12, Bulut teaches the computer implemented method of claim 1. See the above rejection of claim 1 under 35 U.S.C. §102. Bulut is silent regarding if a proximity of the implantable medical device within a predefined range, in particular within 1.5m, to an infected person is detected, by means of proximity tracing using Bluetooth, GNSS and/or mobile data, the predetermined condition is met and/or an alert is sent from the patient device to the remote server accessible by the health care provider.
In a system relevant to the problem of determining risks to patients based on social interactions, Vialle teaches if a proximity of the implantable medical device within a predefined range, in particular within 1.5m, to an infected person is detected, by means of proximity tracing using Bluetooth, GNSS and/or mobile data (¶ [0090] discloses determining if T2 has a same radiofrequency beacon as terminal T1 at the same timestamp using Bluetooth, which is indicative of the terminals being within a predetermined range), the predetermined condition is met (¶ [0092] discloses that risk of infection of the user of terminal T2 is established and the user is alerted using a human-machine interface of terminal T2). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that if a proximity of the implantable medical device within a predefined range, in particular within 1.5m, to an infected person is detected, by means of proximity tracing using Bluetooth, GNSS and/or mobile data, the predetermined condition is met as taught by Vialle. The motivation would have been to provide a more accurate diagnosis of whether the user is at risk of changing state.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0007354 A1 (Bulut), as applied to the rejection of claim 1 above, and in view of US 2020/0146552 A1 (Nyquist)(Cited by Applicant)
With regards to claim 8, Bulut teaches the computer implemented method of claim 1. See the above rejection of claim 1 under 35 U.S.C. §102. Bulut further teaches if the predetermined condition is met, the diagnostic function of the implantable medical device is activated and/or deactivated and/or the transmission frequency and/or the selection of the at least one medical parameter of the patient detected by the implantable medical device is changed (Fig. 8 and ¶¶ [0029], [0077] depict based on received data, predicting a moment in time when a state of the user is likely to change at step 104 and causing a change in data collection function characteristics at the moment in time at step 106, wherein data collection function characteristics include whether the data collection is activated or not, a start and stop time of the data collection, a frequency of the data collection, the type of measurement function, a delivery time of the data collection function, among other characteristics; also see ¶ [0032] regarding the prediction module).
Bulut is silent regarding whether the change is for a predetermined period of time after which the previous setting is automatically resumed or until receipt of a user generated cancellation request.
In the same field of endeavor of location/proximity based monitoring, Nyquist teaches a change of a functioning of a medical device is kept until receipt of a user generated cancellation request (¶ [0060] teaches the medical device determines when the patient is no longer at the medical care facility using information (e.g., patient or user confirmation such as a patient) and altering or changing operation using the information). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate the change in the functioning of the device is kept until receipt of a user generated cancellation request as taught by Nyquist. The motivation would have been to allow for a more appropriate diagnostic analysis based on the user’s input.
With regards to claim 10, Bulut teaches the computer implemented method of claim 1. See the above rejection of claim 1 under 35 U.S.C. §102. Bulut further teaches if the predetermined condition is met, the diagnostic function of the implantable medical device is activated and/or deactivated and/or the transmission frequency and/or the selection of the at least one medical parameter of the patient detected by the implantable medical device is changed (Fig. 8 and ¶¶ [0029], [0077] depict based on received data, predicting a moment in time when a state of the user is likely to change at step 104 and causing a change in data collection function characteristics at the moment in time at step 106, wherein data collection function characteristics include whether the data collection is activated or not, a start and stop time of the data collection, a frequency of the data collection, the type of measurement function, a delivery time of the data collection function, among other characteristics; also see ¶ [0032] regarding the prediction module).
Bulut is silent regarding whether the change is for a period of time defined by the patient and/or the health care provider, in particular a travel time period and/or a quarantine duration and/or for a time period automatically set by the implantable medical device or the patient device, in particular an incubation time.
In light of the rejection under 35 U.S.C. §112(b) above, the recitation of “in particular a travel time period and/or a quarantine duration and/or for a time period automatically set by the implantable medical device or the patient device, in particular an incubation time” is not being given patentable weight.
In the same field of endeavor of location/proximity based monitoring, Nyquist teaches a change of a functioning of a medical device is for a period of time defined by the patient and/or the health care provider (¶ [0060] teaches the medical device determines when the patient is no longer at the medical care facility using information (e.g., patient or user confirmation such as a patient) and altering or changing operation using the information). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate the change in the functioning of the device is for a period of time defined by the patient and/or the health care provider as taught by Nyquist. The motivation would have been to allow for a more appropriate diagnostic analysis based on the user’s input.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0007354 A1 (Bulut) in view of US 2023/0125123 A1 (Vialle), as applied to the rejection of claim 6 above, and further in view of US 2005/0096703 A1 (Sanders).
With regards to claim 11, Bulut in view of Vialle teaches the computer implemented method of claim 6.
The above combination is silent regarding whether the at least one medical parameter of the patient is surveilled for a predetermined period of time, wherein if the at least one medical parameter of the patient is outside a predefined range a message is sent from the patient device to the remote server accessible by the health care provider and/or a therapeutic function of the implantable medical device is activated.
In the same field of endeavor of implantable medical devices, Sanders teaches at least one medical parameter of the patient is surveilled for a predetermined period of time, wherein if the at least one medical parameter of the patient is outside a predefined range a message is sent from the patient device to the remote server accessible by the health care provider and/or a therapeutic function of the implantable medical device is activated (¶ [0006] teaches an implantable medical device for delivering therapy when the an activity level above a specified threshold value is measured). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that at least one medical parameter of the patient is surveilled for a predetermined period of time, wherein if the at least one medical parameter of the patient is outside a predefined range a message is sent from the patient device to the remote server accessible by the health care provider and/or a therapeutic function of the implantable medical device is activated as taught by Sanders. The motivation would have been to provide the patient with therapy based on the sensed parameters.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791