DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation of US Application no. 16/805,515, now US Patent no. 11,759,644 filed 28 February 2020 which is a continuation of US Application no. 15//220,667, now US Patent no. 10,576,290 filed 27 July 2016.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is not directly related to an article of manufacture. The claim recites “a computer-readable medium” which has been held as ineligible and is recommended to be amended to recite “a non-transitory computer-readable medium.”
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 1-20 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.
Claims 1, 12, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the claims recite (e.g., claim 1) “send, via the first communication circuitry, the session information according to the first telemetry communication protocol” wherein it is not clear as to where the session information is being sent rendering the claim unclear if the session information is to be sent to “a second communication circuitry” or to “a second device”. It is assumed that the claims intend to recite that the session information is being sent to a second communication circuitry, but this is not clear or obvious based on the claims. Clarification is respectfully requested.
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.
Claim(s) 1-3, 6-10, 12-14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arx et al. (US Publication no. 2004/0260363 – disclosed by Applicant) in view of Roberts et al. (US Publication no. 2012/0271380 – disclosed by Applicant).
In regard to claims 1, 12, and 20, Arx et al. discloses system and method for securing telemetry sessions between an implantable medical device and an external device comprising (using claim 1 as the exemplary claim as it recites structural features in a functional manner that is suggestive of process claims):
a first device comprising (IMD 1, figure 1): first communication circuitry configured to communicate according to a first telemetry communication protocol (para 31, transmitter/receiver circuit (T/R) associated with coils C1 and C3 for short range telemetry using inductive link);
second communication circuitry configured to communicate according to a second telemetry communication protocol (para 31, transmitter/receiver circuit (T/R) associated with antenna A1 and A2 for long range telemetry using radio link), wherein the second communication circuitry is separate from the first communication circuitry (para 31, short range telemetry is explicitly described as inductive which is separate from long range telemetry explicitly described as radio link and explicitly shown in figure 1 to comprise separate circuits).
Arx et al. describes an architecture that permits establishment of telemetry sessions using first communication circuitry that is associated with a first telemetry communication protocol and second communication circuitry that is associated with a second telemetry communication protocol. Arx et al. fails to teach that the processing circuitry (e.g., microprocessor 10) is configured to perform the steps of receiving, generating, sensing, activating, and establishing as further claimed.
Roberts et al. is directed to a system and method for initiating a communication link between an implantable medical device and an external device and teaches that initiating communication in this manner includes:
receive, via first communication circuitry, a request according to the first telemetry communication protocol (para 29-30, a communication session is initialized with a request over a short range inductive link in order to limit what devices may communicate with IMD; para 50);
generate, based on receiving the request, session information (para 29, once an inductive link is formed a session key or other code comprising the claimed session information is generated (para 34 and 39, session key is generated by a device); also see para 50-52);
send, via the first communication circuitry, the session information according to the first telemetry communication protocol (para 29, once the inductive link is formed the session key is sent to the IMD; para 46, Near-field transmission of a session key can minimize the chance that a third (unauthorized or otherwise unintended) device will be close enough to receive the session key; also see para 50-52);
activate, based on sending the session information according to the first telemetry communication protocol, the second communication circuitry (para 29, the session key may later facilitate secure radio frequency communication (e.g., using Bluetooth) between the same device, which can permit a much longer distance between the devices (e.g., up to 30 feet in some implementations); para 46, a secure communication session can only be initiated by near-field communication (e.g., inductance signals) but after initiation will be conducted via far-field communication (e.g., radiofrequency signals) as the communications modules switch between near-field and far-field communication); and
establish, using the session information, a telemetry session between the first device and a second device according to the second telemetry communication protocol via the second communication circuitry (para 46, a session key will only be passed between two devices establishing a secure communication session by near-field communication, and a secure communication session can only be initiated by near-field communication (e.g., inductance signals) but after initiation will be conducted via far-field communication (e.g., radiofrequency signals) as the communications modules switch between near-field and far-field communication; para 50, the communication session is secure because the session key is shared between the devices, and each transmission can be coded by the session key (e.g., by a unique number of the session key) so that the receiving device knows any transmission appropriately coded is from a trusted source and that any data transmitted can only be recognized by another device having the same key).
It is considered to have been obvious to one of ordinary skill in the art at the time of the invention to modify Arx et al. to establish secure communication between the implantable and external devices by utilizing the inductive link and radio links provided therein since Roberts et al. explicitly teaches that communication establishment between such devices is more secured when initiated over short range telemetry first before switching to long range telemetry in order to limit the range which the IMD may initially communicate in order to minimize unauthorized devices from gaining access to the implant. This modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
In regard to claims 2 and 13, Arx et al. explicitly teaches that the first telemetry communication protocol is associated with first wireless data communication over a first distance (para 31, transmitter/receiver circuit (T/R) associated with coils C1 and C3 for short range telemetry using inductive link), and wherein the second telemetry communication protocol is associated with second wireless data communication over a second distance greater than the first distance (para 31, transmitter/receiver circuit (T/R) associated with antenna A1 and A2 for long range telemetry using radio link). Roberts et al. is explicit of this as well.
In regard to claims 3 and 14, Arx et al. teach that the request is a first request, wherein the first request comprises a device identifier associated with the second device (para 20, external device (ED) transmits a first message to the IMD over the telemetry channel and receives in response a message derived from the first message which is encrypted by a secret key expected to be possessed by the IMD), and wherein the processing circuitry is further configured to:
receive, via the second communication circuitry, a second request according to the second telemetry communication protocol, wherein the second request comprises the device identifier (para 20, IMD transmits a second message to the ED over the telemetry channel and receives in response a message derived from the second message which is encrypted by a secret key expected to be possessed by the ED); and
establish, using the session information based on receiving the second request comprising the device identifier, the telemetry session between the first device and a second device (para 28, Once authentication and release of the telemetry interlock have occurred, the IMD and the ED can proceed to communicate data over the long-range telemetry link with each device.)/
In regard to claim 6, Arx et al. teach that the first telemetry communication protocol comprises an induction-based telemetry communication protocol para 31, transmitter/receiver circuit (T/R) associated with coils C1 and C3 for short range telemetry using inductive link), and wherein the second telemetry communication protocol comprises a radio link protocol, but does not teach a Bluetooth ® low energy (BLE) telemetry communication protocol. Roberts et al. explicitly teach that the second telemetry protocol may be Bluetooth which is a form of radio communication (para 29, the session key may later facilitate secure radio frequency communication (e.g., using Bluetooth) between the same device, which can permit a much longer distance between the devices (e.g., up to 30 feet in some implementations) which allows a patient to move around the room during communication). Modification of Arx et al. to enable Bluetooth communication as the long range communication protocol is considered to have been obvious to one of ordinary skill since Bluetooth is recognized as an suitable alternative for radio links in the art and is explicitly taught by Roberts et al.
In regard to claims 7 and 16, Arx et al. teaches the session information includes a session identifier and a session key (para 11-17) and wherein the processing circuitry is further configured to:
encrypt, using the session key (encryption key), a first set of data (para 21);
transmit, via the second communication circuitry, the encrypted first set of data to the second device during the telemetry session (para 21);
receive, via the second communication circuitry, an encrypted second set of data from the second device during the telemetry session (para 21); and
decrypt, using the session key, the encrypted second set of data to generate a decrypted second set of data (para 21).
Arx et al. teaches that it is desirable to encrypt some or all communications between the IMD and external device, particularly once data is communicated over the long-range telemetry link (para 28).
In regard to claims 8 and 17, Arx et al. does not teach that the security information further comprises a second session key. Roberts et al. teaches the use of two session keys, therefore a first and a second session key (para 73). Roberts et al. teaches that the communication component is further configured to: encrypt second transmitted data transmitted by the implantable device and decrypt second received data received by the implantable device using the second session key in association with the performance of the clinician telemetry session with the clinician device (para 73, this would take place in the situation where a second clinician programmer is used with the IMD, and it would be in association with the performance of the clinician telemetry session with the clinician device because the use of a second clinician device would disable the session key established by the first clinician device and replace it with a new session).
It would have been obvious to one having ordinary skill in the art to use two session keys in order to allow the system to communicate with more than one external programmers without compromising security. It would further have been obvious to one having ordinary skill in the art to encrypt a third set of data transmitted by the device using the second session key during the first type of telemetry session with the second device, because such a system only describes sending another set of data, possibly different sensor or programming data, to the second device, using the same session keys as before, when a link has already previously been established. It would have been obvious to one having ordinary skill in the art that in this the second session key wherein the first set of data represents a first data type, and wherein the third set of data represents a second data type (they comprise different programming data, or different sensor data from sensors in the body), and to decrypt a fourth set of data received by the device using the second session key during the first type of telemetry session with the second device, because this fourth set of data may comprise yet more sensing or programming data being transmitted, and it makes sense to use the same communication protocols for short-range links transmitting any number of different data types back and forth between the internal and external devices, encrypting and decrypting them as necessary.
In regard to claims 9 and 18, Arx et al. teaches that after establishing the first type of telemetry session, the processing circuitry is configured to communicate data with the second device using the security information in association with performance of the first type of telemetry session with the second device (Arx et al., 2-way secure communication between the clinician device and the IMD, para 5). Arx et al. does not teach rendering the security information unusable. Roberts et al. teaches that after establishment of the telemetry session with an external programmer, the security component may be configured to render the security information unusable to establish or perform another telemetry session between the implantable device and the external programmer device or another device at a later time to communicate the data or other data based on closing of the clinician telemetry session (para 6 and 60). It would have been obvious to one having ordinary skill in the art to render the security information unusable when a session has ended, because if an attempt is made later to resume same session, the security may be compromised.
In regard to claims 10 and 19, Arx et al. teaches that the processing circuitry is further configured to communicate data with the second device using the security information in association with performance of the first telemetry session with the second device (Arx et al., 2-way secure communication between the external programming device and the IMD, para 5). Arx et al. does not teach rendering the security information unusable. Roberts et al. teaches that the security component is further configured to: render the security information unusable to establish or conduct the clinician telemetry session or another telemetry session between the implantable device and the clinician device or another device at a later time based on failure of the implantable device to re-establish the first type of telemetry session with the second device using the security information within a defined period of time after loss of the first type of telemetry session (para 6, after a close event, a time period is counted, and the session key is disabled at the conclusion of this count). It would have been obvious to one having ordinary skill in the art to render the security information unusable when a session has ended, because if an attempt is made later to resume same session, the security may be compromised.
Claim(s) 4 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arx et al. (US Publication no. 2004/0260363 – disclosed by Applicant) in view of Roberts et al. (US Publication no. 2012/0271380 – disclosed by Applicant), further in view of Young et al. (US Publication no. 2015/0341785 – disclosed by Applicant).
In regard to claims 4 and 15, Arx et al. in view of Roberts et al. fails to teach the feature to transmit, via the second communication circuitry to the second device, a set of advertisement data packets according to the second telemetry communication protocol based on activating the second communication circuitry; and receive, via the second communication circuitry from the second device, the second request based on transmitting the set of advertisement data packets. transmission of advertisement data packets comprising the session identifier. Young et al. teaches a secure telemetry system for use with an IMD, wherein the communication component is configured to: transmit one or more advertisement data packets comprising the session identifier using the second telemetry communication protocol in association with activation of the telemetry communication by the implantable device via the second telemetry communication protocol (para 5 and 51). It would have been obvious to one having ordinary skill in the art to apply the teachings of Young et al. to the invention described by Arx et al. and Roberts et al. so that other peripheral devices to recognize the presence of the IMD and to interact with it in order to provide useful information for other devices in close proximity to an implantable device, while maintaining the security of the system. The modification is considered to comprise the application of a known technique to known device to yield a predictable result.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arx et al. (US Publication no. 2004/0260363 – disclosed by Applicant) in view of Roberts et al. (US Publication no. 2012/0271380 – disclosed by Applicant), further in view of Reihman et al. (US Publication no. 2015/0119667).
In regard to claim 5, Arx et al. in view of Roberts et al. substantially describes the invention as claimed, however does not teach the first telemetry communication protocol comprises a proprietary telemetry communication protocol, and wherein the second telemetry communication protocol comprises a non-proprietary telemetry communication protocol. Reihman et al. describes wireless protocols that includes a first wireless protocol is a proprietary wireless protocol, and the second wireless protocol is a standardized wireless protocol (para 58-59). It would have been obvious to one having ordinary skill in the art to use a proprietary telemetry communication protocol and a non-proprietary telemetry communication protocol since it is explicitly taught by Reihman et al. and in order to reduce risk of interference from unauthorized sources, and to use a proprietary protocol in order to enable a much wider variety of devices, such as commercial consumer products, to communicate with the implantable device, once a secure session has been established.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arx et al. (US Publication no. 2004/0260363 – disclosed by Applicant) in view of Roberts et al. (US Publication no. 2012/0271380 – disclosed by Applicant), further in view of Masoud et al. (US Publication no. 2016/0330573 – disclosed by Applicant).
In regard to claim 11, Arx teaches that the security information comprises first security information and that the device’s security keys may be programmed into a home monitor (para 43), but Arx et al. does not expressly teach the use of a separate monitoring device, which is a third device, together with the previously recited second device, which is an external programmer, receiving second security information from a remote server device. Masoud teaches that the security component is further configured to receive second security information from a remote server device for establishing a second type of telemetry session with a third device; and employ the second security information to establish a trusted relationship with the third device and store information associating a monitoring device identifier for the third device in the memory (para 27, 28, and 63), and establish the second type of telemetry session with the third device using the second telemetry communication protocol (para 22, Bluetooth may be the second telemetry communication protocol) based on determining that the monitoring session request, received via the second telemetry communication protocol, was transmitted by the third device based on inclusion of the monitoring device identifier in the monitoring session request (para 57). It would have been obvious to one having ordinary skill in the art to modify the invention described by Arx et al. in view of Roberts et al. in order to allow the user to monitor basic aspects of the IMD at home, using a consumer electronics device such as a smartphone.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4-13 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,759,644. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘644 patent recite and every feature of the present invention and therefore anticipate the present invention.
For instance, claims 1, 14, and 19 of the ‘644 patent respectfully recite a device, method, and non-transitory computer readable medium that is configured as the present invention with first communication circuitry configured to communicate with a first telemetry communication protocol and second communication circuitry configured to communicate with a second telemetry communication protocol with processing circuitry configured to perform the claimed steps for receiving, generating, sending, activating, and establishing in the same functional manner as claimed. The session identifier and session key of the ‘644 comprising the presently claimed session information. While the claims of the ‘644 are narrower than the present invention, they recite limitations with sufficient specificity to anticipate the present invention.
Additionally, it has been found that claims 1, 14, and 19 of the ‘644 substantially recite the features of present claims 2 and 13 regarding the telemetry ranges of the first communication protocol and the second communication protocol. Similar overlap in features is exhibited by claim 2 of the ‘644 patent over present claim 5, claim 3 of the ‘644 patent over present claim 6, claims 4, 5, and 15 of the ‘644 patent over present claims 4 and 14, claims 6 and 7 of the ‘644 patent over present claims 4 and 17, claims 8, 9, and 17 of the ‘644 patent over present claims 9, 10, 18, and 19, claims 10 and 18 of the ‘644 patent over present claim 11.
For these reasons, the present invention is not patentably distinct over the ‘644 patent.
Claims 1, 2, and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-26 of U.S. Patent No. 10,576,290. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘290 patent recite and every feature of the present invention and therefore anticipate the present invention.
For instance, claim 24 of the ‘290 patent respectfully recite a system that is configured as the present invention with first communication circuitry (i.e., a first telemetry component ‘290 patent) configured to communicate with a first telemetry communication protocol and second communication circuitry (i.e., a second telemetry component ‘290 patent) configured to communicate with a second telemetry communication protocol with processing circuitry configured to perform the claimed steps for receiving, generating, sending, activating, and establishing in the same functional manner as claimed. A session identifier and session keys of the ‘290 patent comprising the presently claimed session identifier. While the claims of the ‘290 patent are narrower than the present invention (i.e., recites narrowly an implantable medical device and clinician device which are interpreted to be the broader first device and second device as claimed), they recite limitations with sufficient specificity to anticipate the present invention.
Additionally, it has been found that claim 25 of the ‘290 patent substantially recite the features of present claim 2 regarding the telemetry ranges of the first communication protocol and the second communication protocol. Similar overlap in features is exhibited by claim 26 of the ‘290 patent over present claim 4 regarding advertisement transmission.
For these reasons, the present invention is not patentably distinct over claims 24-26 of the ‘290 patent.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 24 October 2025
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