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
Claims 1-20 are pending in Instant Application.
Priority
Examiner acknowledges Applicant’s claim to priority benefits of 62847359 filed 05/14/2019.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the conflicting claims so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-5, 6, 8, 9 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 12-13 of U.S. Patent No. 11924645. Although the claims at issue are not identical, they are not patentably distinct from each other because.
Instant Application
U.S. patent 11924645
1. A method, comprising: receiving, by a medical device, a request to pair from an external device over a first wireless communication path; in response to receiving the request to pair: enabling, by the medical device, a window of exclusivity for pairing with the external device, and transmitting, by the medical device, an authorization instruction message to the external device over the first wireless communication path; during the window of exclusivity, receiving, via a second wireless communication path, an authorization pulse; and in response to receiving the authorization pulse, pairing with the external device.
2. The method of claim 1, wherein the authorization pulse is received from an authorization device.
5. The method of claim 1, wherein the authorization device is not the external device.
1. A method for ensuring secure pairing with a medical device, the method comprising: receiving, by the medical device, a request to pair from an external device over a first communication path; in response to receiving the request to pair, enable, by the medical device, a window of exclusivity for the external device such that the medical device refuses requests to pair from any other device during the window of exclusivity; in response to the request to pair, transmit, by the medical device, an authorization instruction message to the external device over the first communication path; while the request to pair is pending, receive, via a second communication path, an authorization pulse from an authorization device, wherein the authorization device is not the external device; and in response to receiving the authorization pulse, finalizing the pairing with the external device.
3. The method of claim 2, wherein the authorization device is a charging device for the medical device.
2. The method of claim 1, wherein the authorization device is a charging device for the medical device.
4. The method of claim 2, wherein the authorization pulse is an encoded command instructing the medical device to authorize the request to pair.
3. The method of claim 1, wherein the authorization pulse is an encoded command instructing the medical device to authorize the request to pair.
6. The method of claim 1, wherein the request to pair is a request to initiate a pairing relationship between the medical device and the external device using short-wavelength ultra-high frequency radio waves.
4. The method of claim 1, wherein the request to pair is a request to initiate a pairing relationship between the medical device and the external device using short-wavelength ultra-high frequency radio waves
8. The method of claim 1, wherein the medical device is implanted into a patient, and wherein the external device is configured with an interface for obtaining information from or setting parameters of the medical device.
5. The method of claim 1, wherein the medical device is implanted into a patient, and wherein the external device is configured with an interface for obtaining information from or setting parameters of the medical device.
9. The method of claim 1, wherein the second wireless communication path is an inductive communication path or a near-field communication path.
12. The method of claim 1, wherein the second communication path is an inductive communication path.
13. The method of claim 1, wherein the second communication path is a near-field communication path.
Response to Arguments
Applicant's arguments filed in the amendment filed 11/04/2025 have been fully considered but they are not persuasive. The reasons are set forth below.
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.
Claims 1-9, 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Newham et al., “hereinafter Newham” (U.S. Patent Application: 20170259072) in view of Berthelsdorf et al., “hereinafter Berthelsdorf” (U.S. Patent Application: 20080058900).
As per Claim 1, Newham discloses a method, comprising:
receiving, by a medical device, a request to pair from an external device over a first wireless communication path (Newham, Para.86, instructions are received from an external hospital interrogator device for configuring the implant device according to a treatment profile. Before the implant device can be paired with another electronic device to communicate the physiological data, and before the implant device can be configured, an external hospital interrogator device is authenticated and secure communication is established with the implant device.);
in response to receiving the request to pair:
transmitting, by the medical device, an authorization instruction message to the external device over the first wireless communication path (Newham, Para.65, a secure communication may be established between the hospital interrogator device 420a and the implant device 400 in communication pathway 402… authentication and key agreement may be performed using public/private key pairs of the implant device 400 and the hospital interrogator device 420a… Information may be transmitted securely while maintaining the appropriate security and privacy, Para.86, The external hospital interrogator device may be authenticated according to user credentials and protocols discussed above. Authentication limits configuring the implant device and limits providing identification data for pairing the implant device to authorized users of the external hospital interrogator device.);
receiving, via a second wireless communication path, an authorization pulse (Newham, Para.63, A doctor, healthcare professional, or other authorized user 490 may communicate directly with the hospital interrogator device 420a across a communication pathway 401, Para.64, the hospital interrogator device 420a may receive a request from a user to access the hospital interrogator device where the request includes authentication credentials, determine that the authentication credentials are valid, and establish secure communication between the implant device 400 and the hospital interrogator device 420a in communication pathway 402 after determining that the authentication credentials are valid.); and
in response to receiving the authorization pulse, pairing with the external device (Newham, Para.65, When authenticating a user for authorizing access to the hospital interrogator device 420a, a secure communication may be established between the hospital interrogator device 420a and the implant device 400 in communication pathway 402.).
However Newham does not disclose enabling, by the medical device, a window of exclusivity for pairing with the external device.
Berthelsdorf discloses enabling, by the medical device, a window of exclusivity for pairing with the external device and during the window of exclusivity, receive authorization pulse (Berthelsdorf, Para.14, a soft paired patient device will return to its unpaired state when no communication between the patient device and the implant the patient device is paired with takes place within a predetermined period of time (that is longer than the period of time for canceling tentative pairing), no such time limit is applicable to hard paired patient devices, Para.15, A patient device can be assigned to no implant or a single implant, but never simultaneously to multiple implants. Thus, the patient device can either be in an unpaired state where it is not assigned to any specific implant or in some paired state wherein the patient device is assigned to a single specific implant, Para.60, patient device 10 will wait for a predetermined first period of time for a response data packet from the specific implant patient device 10 is tentatively paired to. If during the predetermined period of time a response data packet is received from the implant the patient device is tentatively paired to, and the response data packet contains the patient device's own identification code, then patient device 10 will enter its soft paired state.)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the teachings as in Newham with the teachings as in Berthelsdorf. The motivation for doing so would have been for preventing the patient device from being fooled by data packets sent out by other patient devices, the control unit preferably is adapted to discriminate data packets originating from an implant from data packets originating from other devices. The control unit can be adapted to evaluate a predetermined bit or bits of an incoming data packet in order to determine whether the data originates from an implant or not. In a preferred embodiment, the control unit is adapted to reject pairing when determination of the incoming data packets origin indicates that the incoming data packet does not originate from an implant. Thus, automatic soft pairing can only be induced by an implant itself. (Berthelsdorf, Para.24).
With respect to Claim 11 is substantially similar to Claim 1 and is rejected in the same manner, the same art and reasoning applying.
As per Claim 2, Newham in view of Berthelsdorf discloses the method of claim 1, wherein the authorization pulse is received from an authorization device (Newham, Para.9, the implantable medical device further includes a wireless charger and a rechargeable battery coupled to the wireless charger, where the wireless charger is configured to receive signals to wirelessly charge the rechargeable battery in a mid-field frequency range between about 100 MHz and about 5 GHz or in a near-field frequency range, Para.65, When authenticating a user for authorizing access to the hospital interrogator device 420a, a secure communication may be established between the hospital interrogator device 420a and the implant device 400 in communication pathway 402)
With respect to Claim 12 is substantially similar to Claim 2 and is rejected in the same manner, the same art and reasoning applying.
As per Claim 3, Newham in view of Berthelsdorf discloses the method of claim 2, wherein the authorization device is a charging device for the medical device (Newham, Para.41, the power supply 260 may include a rechargeable battery, such as a rechargeable lithium ion battery. In some implementations, the rechargeable battery is recharged by converting a wireless signal into electrical current via a wireless charger. The wireless charger can include an antenna to receive wireless power from a wireless power source. An optimal frequency can be safely and effectively delivered to the antenna, where the frequency can be in the near-field range or in the mid-field range. In the near-field range, the frequency for power transfer can occur at less than about 10 MHz. In the mid-field range, the frequency for power transfer can occur at frequencies ranging from 100 MHz to 5 GHz.).
With respect to Claim 13 is substantially similar to Claim 3 and is rejected in the same manner, the same art and reasoning applying.
As per Claim 4, Newham in view of Berthelsdorf discloses the method of claim 2, wherein the authorization pulse is an encoded command instructing the medical device to authorize the request to pair (Newham, Para. 0065, When authenticating a user for authorizing access to the hospital interrogator device 420a, a secure communication may be established between the hospital interrogator device 420a and the implant device 400 in communication pathway 402. A handshake protocol may be performed between the hospital interrogator device 420a and the implant device 400. To ensure integrity protection and confidentiality of the communication pathway 402, integrity and confidentiality keys may be generated using a secret key to perform authentication and key agreement. 0075, An authorized user may be authenticated to access the data from the cellular device 480 if it is determined that his/her authentication credentials are valid. If authenticated, then the communication pathway 406 between the home interrogator device 420b and the cellular device 480 may be established, 0086, The external hospital interrogator device may be authenticated according to user credentials and protocols discussed above. Authentication limits configuring the implant device and limits providing identification data for pairing the implant device to authorized users of the external hospital interrogator device.).
With respect to Claim 14 is substantially similar to Claim 4 and is rejected in the same manner, the same art and reasoning applying.
As per Claim 5, Newham in view of Berthelsdorf discloses the method of claim 2, wherein the authorization device is not the external device (Newham, Para.9, the implantable medical device further includes a wireless charger and a rechargeable battery coupled to the wireless charger, where the wireless charger is configured to receive signals to wirelessly charge the rechargeable battery in a mid-field frequency range between about 100 MHz and about 5 GHz or in a near-field frequency range.)
With respect to Claim 15 is substantially similar to Claim 5 and is rejected in the same manner, the same art and reasoning applying.
As per Claim 6, Newham in view of Berthelsdorf discloses the method of claim 1, wherein the request to pair is a request to initiate a pairing relationship between the medical device and the external device using short-wavelength ultra-high frequency radio waves (Newham, Para.0099, 0011; “Bluetooth,” 100 MHz to 5 GHz or in a near field frequency range).
With respect to Claim 16 is substantially similar to Claim 6 and is rejected in the same manner, the same art and reasoning applying.
As per Claim 7, Newham in view of Berthelsdorf discloses the method of claim 1, wherein engaging the window of exclusivity comprises declining all other pairing requests over a communication protocol of the first wireless communication path while the window of exclusivity is active (Berthelsdorf, Para.14, a soft paired patient device will return to its unpaired state when no communication between the patient device and the implant the patient device is paired with takes place within a predetermined period of time (that is longer than the period of time for canceling tentative pairing), no such time limit is applicable to hard paired patient devices, Para.15, A patient device can be assigned to no implant or a single implant, but never simultaneously to multiple implants. Thus, the patient device can either be in an unpaired state where it is not assigned to any specific implant or in some paired state wherein the patient device is assigned to a single specific implant, Para.60, patient device 10 will wait for a predetermined first period of time for a response data packet from the specific implant patient device 10 is tentatively paired to. If during the predetermined period of time a response data packet is received from the implant the patient device is tentatively paired to, and the response data packet contains the patient device's own identification code, then patient device 10 will enter its soft paired state.).
The same motivation that was utilized for combining Newham, Berthelsdorf as set forth in claim 1 is equally applicable to claim 7.
With respect to Claim 17 is substantially similar to Claim 7 and is rejected in the same manner, the same art and reasoning applying.
As per Claim 8, Newham in view of Berthelsdorf discloses the method of claim 1, wherein the medical device is implanted into a patient, and wherein the external device is configured with an interface for obtaining information from or setting parameters of the medical device (Newham, Para, 89, The implant device may be equipped with one or more sensors to measure and/or collect physiological data regarding a patient. The one or more sensors can include but is not limited to temperature sensors, chemical sensors (e.g., blood glucose sensors), pressure sensors, pulse sensors, piezoelectric sensors, electric field sensors, electromyographic sensors, respiration sensors, moisture sensors, optical sensors, and other biomedical sensors. The physiological data may include physiological signals, biometric information, conditions, or parameters associated with the patient as treatment is being delivered to the patient. Examples of physiological data can include but is not limited to blood pressure, heart rate, pulse rate, EEG, EKG, ECG, skin conduction, body or skin temperature, weight, body fat, respiration rate, blood flow, oxygen level, CO2 level, and glucose level, among others, Para.83, one or more operations of the implant device is configured using the external hospital interrogator device. The one or more operations of the implant device may be controlled by a control system of the implant device. In some implementations, the one or more operations include changing a therapy or treatment profile of the implant device.).
With respect to Claim 18 is substantially similar to Claim 8 and is rejected in the same manner, the same art and reasoning applying.
As per Claim 9, Newham in view of Berthelsdorf discloses the method of claim 1, wherein the second wireless communication path is an inductive communication path or a near-field communication path (Newham, Para, 0044, “near-field magnetic induction”).
With respect to Claim 19 is substantially similar to Claim 0 and is rejected in the same manner, the same art and reasoning applying.
Claims 10, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Newham et al., “hereinafter Newham” (U.S. Patent Application: 20170259072) in view of Berthelsdorf et al., “hereinafter Berthelsdorf” (U.S. Patent Application: 20080058900) and further in view of Wu et al., “hereinafter WU” (U.S. Patent Application: 20180078777).
As per Claim 10, Newham in view of Berthelsdorf discloses the method of claim 1,
However Newham in view of Berthelsdorf do not disclose broadcasting an advertisement packet; and stop broadcasting the advertisement packet during the window of exclusivity.
Wu discloses an advertisement packet; and stop broadcasting the advertisement packet (Wu, Para.152, in response to the start connection request notification from the IMD application 824, the RF circuit 802 enters a scanning state during which a transceiver of the RF circuit 802 scans for an advertisement notice during scanning windows. By way of example, the connect request may be a BLE connection request sent by the IMD application 824, Para.156, The IMD application 824 identifies that the scan timer 866 expires before the advertising notice is detected during one of the scanning windows. In response to the identifying operation, when in the foreground state, the IMD application 824 automatically restarts the scan timer 866, cancels the scanning state and enters a new scanning state defined by the base scanning schedule. The cancelling and entering operations comprise cancelling a first connection request to the RF circuit 802 and sending a second connection request to the RF circuit 802.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the teachings as in Newham, Berthelsdorf with the teachings as in Wu. The motivation for doing so would have been for managing establishment of a communications link between an external instrument (EI) and an implantable medical device (IMD). The method comprises storing, in memory in at least one of the IMD or the EI, an advertising schedule that defines a pattern for advertisement notices. The advertisement notices are distributed un-evenly and separated by unequal advertisement intervals. The method transmits, from a transmitter in at least one of the IMD or the EI, the advertisement notices distributed as defined by the advertising schedule. The method includes determining, at the IMD, when a connection request is received from the EI in connection with one of the advertisement notices. The method establishes a communications session between the IMD and the EI. (Wu, Para.8).
With respect to Claim 20 is substantially similar to Claim 10 and is rejected in the same manner, the same art and reasoning applying.
The applicant Argue:
Argument 1:
Applicant argues that the reference Newham in view of Berthelsdorf fails to teach or suggest “transmitting, by the medical device, an authorization instruction message to the external device over the first wireless communication path” as recited in claim 1.
In response, Examiner would like to point out that the reference Newham does teach in Para.65, “secure communication may be established between the hospital interrogator device 420a and the implant device 400 in communication pathway 402… authentication and key agreement may be performed using public/private key pairs of the implant device 400 and the hospital interrogator device 420a… Information transmitted across the communication pathway 402 may be encrypted (e.g., via AES 128) and integrity protected via a message authentication code using keys generated during the authentication and key agreement process. Information may be transmitted securely while maintaining the appropriate security and privacy required under government regulations (e.g., HIPAA).” and Para.31., “The remote device 300 may be configured to wirelessly communicate with the implant device via a secure communication pathway 50. The remote device 300 can be configured to transmit wireless signals via communication pathway 50 and the implant device 200 can be configured to receive the wireless signals.”.
The communication path 402 could be interpreted as first wireless communication path.
Argument 2:
Applicant argues that the reference Newham in view of Berthelsdorf fails to teach or suggest “receiving, via a second wireless communication path, an authorization pulse” as recited in claim 1.
In response, Examiner would like to point out that the reference Newham does teach in Para.67, “A doctor, healthcare professional, or other authorized user 490 may communicate directly with the hospital interrogator device 420a across a communication pathway 401, Para.64, the hospital interrogator device 420a may receive a request from a user to access the hospital interrogator device where the request includes authentication credentials, determine that the authentication credentials are valid, and establish secure communication between the implant device 400 and the hospital interrogator device 420a in communication pathway 402 after determining that the authentication credentials are valid” and in Para.71, “only authorized doctors, authorized healthcare professionals, or authorized users 490 may access the implant device 400 through the hospital interrogator device 420a.”
The communication pathway 401 could be interpreted as second wireless communication path.
Argument 3:
Applicant argues that the reference Newham in view of Berthelsdorf fails to teach or suggest “enabling, by the medical device, a window of exclusivity for pairing with the external device and during the window of exclusivity, receive authorization pulse”
In response, Examiner would like to point out that the reference Berthelsdorf in in Para.60, “patient device 10 will wait for a predetermined first period of time for a response data packet from the specific implant patient device 10 is tentatively paired to. If during the predetermined period of time a response data packet is received from the implant the patient device is tentatively paired to, and the response data packet contains the patient device's own identification code, then patient device 10 will enter its soft paired state.” And in Para.23, “Wait for an incoming data packet in response to the outgoing data packet that contains the patient device's identification code (EID) and an implant identification code (IID).” And in Para.56, “As long as patient device 10 is paired to its specific implant, patient device 10 may be either in a wait mode as long as no data communication is going on with the implant patient device 10 is assigned (paired) to, or in a communication mode during data communication between patient device 10 and the implant patient device 10 is paired to.”.
The reference Newham discloses medical device (implantable medical devices) and the external device (an interrogator device) and receiving an authorization pulse in Para.63. the refence Berthelsdorf discloses “a window of exclusivity for pairing and during the window of exclusivity” in Para.60, 23, 56.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the teachings as in Newham with the teachings as in Berthelsdorf. The motivation for doing so would have been for preventing the patient device from being fooled by data packets sent out by other patient devices, the control unit preferably is adapted to discriminate data packets originating from an implant from data packets originating from other devices. The control unit can be adapted to evaluate a predetermined bit or bits of an incoming data packet in order to determine whether the data originates from an implant or not. In a preferred embodiment, the control unit is adapted to reject pairing when determination of the incoming data packets origin indicates that the incoming data packet does not originate from an implant. Thus, automatic soft pairing can only be induced by an implant itself. (Berthelsdorf, Para.24).
Conclusion
THIS ACTION IS MADE FINAL. 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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/NORMIN ABEDIN/Primary Examiner, Art Unit 2449