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 .
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Highsmith (US 20220370121 A1) in view of Kennedy (US 20200159906 A1), Rager (US 20070050622 A1), Poeppelmann (DE 102020201768 A1), and Kwik (EP 3861951 A1).
Regarding claim 1, Highsmith teaches an electrosurgical puncture device ([0007] A system and method are disclosed herein for transseptal puncture which include steering a microcatheter with a guidewire therein to a target puncture site then puncturing the target puncture site with the guidewire), the electrosurgical puncture device configured for use with an electrosurgical generator in an electrosurgical puncture procedure ([0008] The generator can be configured to provide electrical energy to the distal end of the guidewire sufficient to puncture tissue so that the tissue is punctured without requiring a sharp end of a needle), the electrosurgical puncture device comprising: a connector configured to mechanically and electrically couple the electrosurgical puncture device to the electrosurgical generator ([0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114), the connector including a radiofrequency (RF) conductor to receive an RF puncture signal provided by the electrosurgical generator ([0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114 of the guidewire that are sufficient to puncture tissue, using RF energy, without requiring a needle or sharp end. The generator 180 can provide RF signals to the distal end 114 of the guidewire 110 that spread from the distal end 114 through a body of a patient to the return pad 198).
Highsmith fails to teach a tangible storage medium electrically coupled to the connector, the storage medium comprising: data configured for use with the electrosurgical generator in the electrosurgical puncture procedure; an asymmetric signature mechanism including a digital signature generated from a hash value of the data signed with a private key, the electrosurgical generator including a public key of the asymmetric signature mechanism to verify the hash value having an associated generator code field and a timestamp field in a write protectable region of the storage medium, the usage stamp mechanism configured to provide an input to the electrosurgical generator that ties the electrosurgical puncture device to the electrosurgical generator with a time expiration of the electrosurgical puncture device; and a challenge-response mechanism including a secret in an unreadable region of the storage medium and a challenge engine, the challenge engine configured to calculate a response with the secret and a challenge received from the electrosurgical generator.
However, Kennedy teaches a tangible storage medium electrically coupled to the connector ([0026] An interior of the connector 150 can include a printed circuit board assembly (PCBA) 154. The PCBA 154 can include one or more electronic components, such as a processing component 160, a memory component 170, and/or a charge storage component 180, to execute the method steps described herein), the storage medium comprising: data configured for use with the electrosurgical generator in the electrosurgical puncture procedure ([0026] The connector 156 can include a pin assembly 156 that directly engages the PIM 250 and/or the clinical system 200) ([0033] The memory component 170 can be any suitable storage device, including volatile or non-volatile memory. For example, the memory component 170 can include flash memory, erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), radio-frequency identification (RFID) chip, etc…The memory component 170 can have sufficient capacity to store intravascular data, including a unique serial number, configuration information, calibration information, initial parameters, a manufacture date, performance parameters, a version number, an expiration date, system configuration settings, and other data about the intravascular device 110) ([0047] the clinical system 200 can access the memory component 170 to retrieve operating parameters); a usage stamp mechanism including a usage stamp ([0034] The parameter can include an elapsed time since commencement of communication with any clinical system 200, whether the intravascular device 110 has been in communication with any clinical system 200, the number of times the intravascular device 100 has been in communication with any clinical system 200, the number of times the intravascular device 110 has collected data and/or provided therapy, etc.); and a timestamp field ([0046] the threshold value can be representative of a period of time after being connected to a clinical system 200 during which the integrity of data collected the intravascular device 100 is guaranteed by the manufacturer. The parameter value can be representative of an actual elapsed time since the intravascular device 110 and the clinical system 200 have been in communication…The parameter value can be representative of the actual number of times the intravascular device 110 has been connected/disconnected from any clinical system 200) in a write protectable region of the storage medium ([0037] For example, the processing component 160 can maintain an armed state and an unarmed state describing when parameter value of the intravascular device 110 (e.g., a use time) is ready to be tracked, being tracked, or not being tracked); a time expiration of the electrosurgical puncture device ([0037] The processing component 160 and/or the memory component 170 can maintain and/or change various operational states for the connector 150. For example, the operational states can include an unlocked state, a locked state, an armed state, an unarmed state…the processing component 160 can maintain an armed state and an unarmed state describing when parameter value of the intravascular device 110 (e.g., a use time) is ready to be tracked, being tracked, or not being tracked. During manufacturing and testing, the connector 150 can be in a disarmed state such that a parameter value will not be tracked when the connector 150 is connected to a PIM 250, a clinical system 200). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include a tangible storage medium electrically coupled to the connector, the storage medium comprising: data configured for use with the electrosurgical generator in the electrosurgical puncture procedure; a usage stamp mechanism including a usage stamp and a timestamp field in a write protectable region of the storage medium, with a time expiration of the electrosurgical puncture device. Doing so allows for the recorded use of the device during a procedure to monitor the value within a threshold to prevent overuse the device.
Further, Rager teaches an asymmetric signature mechanism including a digital signature generated from a hash value of the data signed with a private key ([0048] In this case, asymmetric encryption can be used for authentication to compute a hash digest over the data to be authenticated. The hash digest can be computed, for example, using the SHA-1, SHA-256, or MD5 algorithms. The resulting hash value can be encrypted using an asymmetric private key to form a digital signature), the electrosurgical generator including a public key of the asymmetric signature mechanism to verify the hash value ([0049] The authenticating device also computes the hash digest over the data to be authenticated and it utilizes an asymmetric public key to decrypt the digital signature). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include an asymmetric signature mechanism including a digital signature generated from a hash value of the data signed with a private key, the electrosurgical generator including a public key of the asymmetric signature mechanism to verify the hash value. Doing so allows for preventing tampering with existing data stored on the device.
Further, Poeppelmann teaches having an associated generator code field ([Pg 9, Para 9] The device computes a one-time binding signature via the host ID using a private binding key and stores the signature in the NVM and atomically deactivates the private binding key that is used to generate the one-time signature (e.g., by Deleting the same)); the usage stamp mechanism configured to provide an input to the electrosurgical generator that ties the electrosurgical puncture device to the electrosurgical generator ([Pg 10, Para 3] According to one embodiment, the binding signature is generated via the host ID. Alternatively or additionally, the binding signature can have information such as the following: • a device ID • a timestamp • a random number • a firmware version of the host • the firmware or hardware version of the device); and a challenge-response mechanism ([Pg 11, Para 4] a multiple challenge-response (or demand-response) method can be implemented for further authentication, e.g. B. using another or the known public key). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include having an associated generator code; the usage stamp mechanism configured to provide an input to the electrosurgical generator that ties the electrosurgical puncture device to the electrosurgical generator field; and a challenge-response mechanism. Doing so allows for preventing re-use of the device with other generators.
Further, Kwik teaches and a challenge-response mechanism ([Pg 6, Para 13] The controller 35 now checks whether the return value R corresponds to the random number Z. In this case, the electrosurgical instrument 11 has been successfully authenticated; otherwise, as described above, there is a partial or complete restriction of the scope of functions made available) including a secret in an unreadable region of the storage medium ([Pg 6, Para 10] a private key P1 is stored on the second storage element 40 of the electrosurgical instrument 11, whereas an associated public key Ö1 is stored on the third storage element 50) ([Pg 7, Para 4] In order to prevent access to the memory contents of the second memory elements 40, 41, these are combined with the associated controllers 42 and 43 to form a security module. This can be, for example, a “Trusted Platform Module” (TPM)) and a challenge engine, the challenge engine configured to calculate a response with the secret and a challenge received from the electrosurgical generator ([Pg 6, Para 11] In order to authenticate the electrosurgical instrument 11, the controller 35 first generates a random number Z again, encrypts this according to the function A = g (Z, Ö1) in order to obtain the query value A, and sends the query value A to the electrosurgical instrument 11). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include a challenge-response mechanism including a secret in an unreadable region of the storage medium and a challenge engine, the challenge engine configured to calculate a response with the secret and a challenge received from the electrosurgical generator. Doing so prevents the device from being cloned by another device and increases security.
Regarding claim 2, Highsmith teaches the electrosurgical puncture device of claim 1, comprising a transseptal puncture device ([abstract] A microcatheter with a guidewire therein can be steered to target tissue, then the target tissue can be punctured with the guidewire to create a transseptal puncture).
Regarding claim 3, Highsmith teaches the electrosurgical puncture device of claim 2, wherein the transseptal puncture device includes one of a transseptal puncture guidewire and a cable couplable to the transseptal puncture guidewire ([0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114 of the guidewire that are sufficient to puncture tissue, using RF energy).
Regarding claim 4, Highsmith teaches the electrosurgical puncture device of claim 1, but fails to teach wherein the tangible storage medium includes a secure erasable electronic programmable read only memory (EEPROM).
However, Kennedy teaches wherein the tangible storage medium includes a secure erasable electronic programmable read only memory (EEPROM) ([0033] the memory component 170 can include flash memory, erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include wherein the tangible storage medium includes a secure erasable electronic programmable read only memory (EEPROM). Doing so allows for the data to be stored on the device and erased for increased security of data.
Regarding claim 5, Highsmith teaches the electrosurgical puncture device of claim 1, but fails to teach wherein the data includes default settings for the electrosurgical generator.
However, Kennedy teaches wherein the data includes default settings for the electrosurgical generator ([0033] The memory component 170 can have sufficient capacity to store intravascular data, including a unique serial number, configuration information, calibration information, initial parameters, a manufacture date, performance parameters, a version number, an expiration date, system configuration settings, and other data about the intravascular device 110). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include wherein the data includes default settings for the electrosurgical generator. Doing so allows the setup of the device to be constant with the same default settings.
Regarding claim 6, Highsmith teaches the electrosurgical puncture device of claim 1, but fails to teach wherein the digital signature and secret are generated at manufacture of the electrosurgical puncture device.
However, Poeppelmann teaches wherein the digital signature ([Pg 10, Para 4] each authentication device typically includes a unique public authentication public key and a private authentication private key that is generated during manufacture and introduced into a specially protected environment. The public part of this key can be digitally signed together with an authentication ID in order to form an authentication digital certificate) and secret are generated at manufacture of the electrosurgical puncture device ([Pg 10, Para 4] each authentication device typically includes a unique public authentication public key and a private authentication private key that is generated during manufacture and introduced into a specially protected environment). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include wherein the digital signature and secret are generated at manufacture of the electrosurgical puncture device. Doing so allows for a unique signature and secret that apple to a specific device.
Regarding claim 7, Highsmith teaches the electrosurgical puncture device of claim 1, but fails to teach wherein the tangible storage medium includes a plurality of at least three enforcement mechanisms including the asymmetric signature mechanism, the usage stamp mechanism, and the challenge-response mechanism.
However, Poeppelmann teaches wherein the tangible storage medium includes a plurality of at least three enforcement mechanisms including the asymmetric signature mechanism ([Pg 10, Para 4] some devices can implement an asymmetric authentication protocol), the usage stamp mechanism ([Pg 10, Para 3] According to one embodiment, the binding signature is generated via the host ID. Alternatively or additionally, the binding signature can have information such as the following: • a device ID • a timestamp), and the challenge-response mechanism ([Pg 11, Para 4] a multiple challenge-response (or demand-response) method can be implemented for further authentication, e.g. B. using another or the known public key). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include wherein the tangible storage medium includes a plurality of at least three enforcement mechanisms including the asymmetric signature mechanism, the usage stamp mechanism, and the challenge-response mechanism. Doing so allows for multi factor authentication for increased security.
Regarding claim 8, Highsmith teaches the electrosurgical device of claim 1, but fails to teach wherein the tangible storage medium includes three enforcement mechanisms.
However, Poeppelmann teaches wherein the tangible storage medium includes three enforcement mechanisms ([Pg 10, Para 4] some devices can implement an asymmetric authentication protocol) ([Pg 9, Para 9] The device computes a one-time binding signature via the host ID using a private binding key and stores the signature in the NVM and atomically deactivates the private binding key that is used to generate the one-time signature) ([0066] According to one embodiment, the binding signature is generated via the host ID. Alternatively or additionally, the binding signature can have information such as the following: • a device ID • a timestamp) ([Pg 11, Para 4] a multiple challenge-response (or demand-response) method can be implemented for further authentication, e.g. B. using another or the known public key). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include wherein the tangible storage medium includes three enforcement mechanisms. Doing so allows for multi factor authentication for increased security.
Regarding claim 9, Highsmith teaches the electrosurgical puncture device of claim 1, but fails to teach further comprising a usage count mechanism having a usage amount value in the write protectable region of the storage medium.
However, Kennedy teaches further comprising a usage count mechanism having a usage amount value in the write protectable region of the storage medium ([0046] the threshold value can be representative of a period of time after being connected to a clinical system 200 during which the integrity of data collected the intravascular device 100 is guaranteed by the manufacturer. The parameter value can be representative of an actual elapsed time since the intravascular device 110 and the clinical system 200 have been in communication. For example, the threshold value can be representative of the maximum number of times the intravascular device 110 can be connected to any clinical system 200. This can prevent the intravascular device 110 from being inappropriately used in multiple locations and/or with multiple patients, which presents risk of harm to patients). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include comprising a usage count mechanism having a usage amount value in the write protectable region of the storage medium. Doing so allows each usage to be recorded and monitored below a threshold for safety measures.
Regarding claim 10, Highsmith teaches the electrosurgical puncture device of claim 9, but fails to teach wherein the usage amount value is configured to be one of incremented and decremented with each electrosurgical puncture procedure.
However, Kennedy teaches wherein the usage amount value is configured to be one of incremented and decremented with each electrosurgical puncture procedure ([0046] the threshold value can be representative of the maximum number of times the intravascular device 110 can be connected to any clinical system 200. This can prevent the intravascular device 110 from being inappropriately used in multiple locations and/or with multiple patients, which presents risk of harm to patients. The parameter value can be representative of the actual number of times the intravascular device 110 has been connected/disconnected from any clinical system 200. For example, the threshold value can be representative a maximum number of times that the efficacy of data collection or therapy delivery is guaranteed by the manufacturer. The parameter value can be representative of the actual number of times the intravascular device 110 has collected data and/or provided therapy). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include wherein the usage amount value is configured to be one of incremented and decremented with each electrosurgical puncture procedure. Doing so allows for monitoring of usage to ensure the device has not been used with no authorization.
Regarding claim 11, Highsmith teaches the electrosurgical puncture device of claim 1, but fails to teach wherein the electrosurgical generator is configured to apply the asymmetric signature mechanism, the usage stamp mechanism, and the challenge-response mechanism, and permit the electrosurgical puncture procedure to proceed if the electrosurgical puncture device is valid.
However, Poeppelmann teaches wherein the electrosurgical generator is configured to apply the asymmetric signature mechanism ([Pg 10, Para 4] some devices can implement an asymmetric authentication protocol), the usage stamp mechanism ([Pg 10, Para 3] According to one embodiment, the binding signature is generated via the host ID. Alternatively or additionally, the binding signature can have information such as the following: • a device ID • a timestamp), and the challenge-response mechanism ([Pg 11, Para 4] a multiple challenge-response (or demand-response) method can be implemented for further authentication, e.g. B. using another or the known public key), and permit the electrosurgical puncture procedure to proceed if the electrosurgical puncture device is valid ([Pg 9, Para 3] In the event of a match, the device can 50 consider the communication partner as an authorized communication partner, e.g. B. as a valid consumable). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include wherein the electrosurgical generator is configured to apply the asymmetric signature mechanism, the usage stamp mechanism, and the challenge-response mechanism, and permit the electrosurgical puncture procedure to proceed if the electrosurgical puncture device is valid. Doing so allows for authentication steps before the device can be used to increase security.
Regarding claim 12, Highsmith teaches the electrosurgical puncture device of claim 11, but fails to teach wherein the electrosurgical generator applies two or more of the asymmetric signature mechanism, the usage stamp mechanism, and the challenge-response mechanism concurrently.
However, Poeppelmann teaches wherein the electrosurgical generator applies two or more of the asymmetric signature mechanism ([Pg 10, Para 4] some devices can implement an asymmetric authentication protocol), the usage stamp mechanism ([Pg 10, Para 3] According to one embodiment, the binding signature is generated via the host ID. Alternatively or additionally, the binding signature can have information such as the following: • a device ID • a timestamp), and the challenge-response mechanism concurrently ([Pg 9, Para 3] In the event of a match, the device can 50 consider the communication partner as an authorized communication partner, e.g. B. as a valid consumable). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include teach wherein the electrosurgical generator applies two or more of the asymmetric signature mechanism, the usage stamp mechanism, and the challenge-response mechanism concurrently. Doing so allows for multiple authentication steps before the device can be used to increase security.
Regarding claim 13, Highsmith teaches the electrosurgical puncture device of claim 11, but fails to teach wherein the electrosurgical generator is configured to apply additional enforcement mechanisms.
However, Poeppelmann teaches, wherein the electrosurgical generator is configured to apply additional enforcement mechanisms ([Pg 10, Para 9] a hash of the authentication digital certificate can be used instead of the authentication ID in order to bind the binding signature to further information in the device. Alternatively or additionally, countermeasures can be used to prevent the binding signature from being simply read out. This could be scrambling of the information or the use of cryptographic protocols, e.g. B. when the host must first authenticate to the device in order to be able to read the binding signature). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include wherein the electrosurgical generator is configured to apply additional enforcement mechanisms. Doing so allows for multiple authentication steps before the device can be used to increase security.
Regarding claim 14, Highsmith teaches the electrosurgical puncture device of claim 1, wherein the electrosurgical puncture device is included in an electrosurgical puncture assembly including a delivery component associated with the electrosurgical puncture device (Fig 1; [0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114 of the guidewire that are sufficient to puncture tissue, using RF energy).
Regarding claim 15, Highsmith teaches an electrosurgical system configured for use in an electrosurgical puncture procedure ([0007] A system and method are disclosed herein for transseptal puncture which include steering a microcatheter with a guidewire therein to a target puncture site then puncturing the target puncture site with the guidewire), the electrosurgical system comprising: an electrosurgical generator ([0008] The generator can be configured to provide electrical energy to the distal end of the guidewire sufficient to puncture tissue so that the tissue is punctured without requiring a sharp end of a needle) configured to provide a radiofrequency (RF) puncture signal ([0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114 of the guidewire that are sufficient to puncture tissue, using RF energy, without requiring a needle or sharp end. The generator 180 can provide RF signals to the distal end 114 of the guidewire 110 that spread from the distal end 114 through a body of a patient to the return pad 198); and an electrosurgical puncture device, the electrosurgical puncture device configured for use with the electrosurgical generator in the electrosurgical puncture procedure (([0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114 of the guidewire that are sufficient to puncture tissue, using RF energy, without requiring a needle or sharp end), the electrosurgical puncture device comprising: a connector configured to mechanically and electrically couple the electrosurgical puncture device to the electrosurgical generator ([0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114), the connector including an RF conductor to receive the RF puncture signal ([0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114 of the guidewire that are sufficient to puncture tissue, using RF energy, without requiring a needle or sharp end. The generator 180 can provide RF signals to the distal end 114 of the guidewire 110 that spread from the distal end 114 through a body of a patient to the return pad 198).
Highsmith fails to teach a tangible storage medium electrically coupled to the connector, the storage medium comprising: data configured for use with the electrosurgical generator in the electrosurgical puncture procedure; an asymmetric signature mechanism including a digital signature generated from a hash value of the data signed with a private key, the electrosurgical generator including a public key of the asymmetric signature mechanism to verify the hash value; a usage stamp mechanism including a usage stamp having an associated generator code field and a timestamp field in a write protectable region of the storage medium, the usage stamp mechanism configured to provide an input to the electrosurgical generator that ties the electrosurgical puncture device to the electrosurgical generator with a time expiration of the electrosurgical puncture device; and a challenge-response mechanism including a secret in an unreadable region of the storage medium and a challenge engine, the challenge engine configured to calculate a response with the secret and a challenge received from the electrosurgical generator.
However, Kennedy teaches a tangible storage medium electrically coupled to the connector ([0026] An interior of the connector 150 can include a printed circuit board assembly (PCBA) 154. The PCBA 154 can include one or more electronic components, such as a processing component 160, a memory component 170, and/or a charge storage component 180, to execute the method steps described herein), the storage medium comprising: data configured for use with the electrosurgical generator in the electrosurgical puncture procedure ([0026] The connector 156 can include a pin assembly 156 that directly engages the PIM 250 and/or the clinical system 200) ([0033] The memory component 170 can be any suitable storage device, including volatile or non-volatile memory. For example, the memory component 170 can include flash memory, erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), radio-frequency identification (RFID) chip, etc…The memory component 170 can have sufficient capacity to store intravascular data, including a unique serial number, configuration information, calibration information, initial parameters, a manufacture date, performance parameters, a version number, an expiration date, system configuration settings, and other data about the intravascular device 110) ([0047] the clinical system 200 can access the memory component 170 to retrieve operating parameters); a usage stamp mechanism including a usage stamp ([0034] The parameter can include an elapsed time since commencement of communication with any clinical system 200, whether the intravascular device 110 has been in communication with any clinical system 200, the number of times the intravascular device 100 has been in communication with any clinical system 200, the number of times the intravascular device 110 has collected data and/or provided therapy, etc.); a timestamp field in a write protectable region of the storage medium ([0046] the threshold value can be representative of a period of time after being connected to a clinical system 200 during which the integrity of data collected the intravascular device 100 is guaranteed by the manufacturer. The parameter value can be representative of an actual elapsed time since the intravascular device 110 and the clinical system 200 have been in communication…The parameter value can be representative of the actual number of times the intravascular device 110 has been connected/disconnected from any clinical system 200) ([0037] For example, the processing component 160 can maintain an armed state and an unarmed state describing when parameter value of the intravascular device 110 (e.g., a use time) is ready to be tracked, being tracked, or not being tracked), with a time expiration of the electrosurgical puncture device ([0037] The processing component 160 and/or the memory component 170 can maintain and/or change various operational states for the connector 150. For example, the operational states can include an unlocked state, a locked state, an armed state, an unarmed state…the processing component 160 can maintain an armed state and an unarmed state describing when parameter value of the intravascular device 110 (e.g., a use time) is ready to be tracked, being tracked, or not being tracked. During manufacturing and testing, the connector 150 can be in a disarmed state such that a parameter value will not be tracked when the connector 150 is connected to a PIM 250, a clinical system 200). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include a tangible storage medium electrically coupled to the connector, the storage medium comprising: data configured for use with the electrosurgical generator in the electrosurgical puncture procedure; a usage stamp mechanism including a usage stamp and a timestamp field in a write protectable region of the storage medium, with a time expiration of the electrosurgical puncture device. Doing so allows for the recorded use of the device during a procedure to monitor the value within a threshold to prevent overuse the device.
Further, Rager teaches an asymmetric signature mechanism including a digital signature generated from a hash value of the data signed with a private key ([0048] In this case, asymmetric encryption can be used for authentication to compute a hash digest over the data to be authenticated. The hash digest can be computed, for example, using the SHA-1, SHA-256, or MD5 algorithms. The resulting hash value can be encrypted using an asymmetric private key to form a digital signature), the electrosurgical generator including a public key of the asymmetric signature mechanism to verify the hash value ([0049] The authenticating device also computes the hash digest over the data to be authenticated and it utilizes an asymmetric public key to decrypt the digital signature). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include an asymmetric signature mechanism including a digital signature generated from a hash value of the data signed with a private key, the electrosurgical generator including a public key of the asymmetric signature mechanism to verify the hash value. Doing so allows for preventing tampering with existing data stored on the device.
Further, Poeppelmann teaches having an associated generator code field ([Pg 9, Para 9] The device computes a one-time binding signature via the host ID using a private binding key and stores the signature in the NVM and atomically deactivates the private binding key that is used to generate the one-time signature (e.g., by Deleting the same)); the usage stamp mechanism configured to provide an input to the electrosurgical generator that ties the electrosurgical puncture device to the electrosurgical generator ([Pg 10 para 3] According to one embodiment, the binding signature is generated via the host ID. Alternatively or additionally, the binding signature can have information such as the following: • a device ID • a timestamp • a random number • a firmware version of the host • the firmware or hardware version of the device); and a challenge-response mechanism ([Pg 11, Para 4] a multiple challenge-response (or demand-response) method can be implemented for further authentication, e.g. B. using another or the known public key). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include having an associated generator code; the usage stamp mechanism configured to provide an input to the electrosurgical generator that ties the electrosurgical puncture device to the electrosurgical generator field; and a challenge-response mechanism. Doing so allows for preventing re-use of the device with other generators.
Further, Kwik teaches a challenge-response mechanism ([Pg 6, Para 13] The controller 35 now checks whether the return value R corresponds to the random number Z. In this case, the electrosurgical instrument 11 has been successfully authenticated; otherwise, as described above, there is a partial or complete restriction of the scope of functions made available) including a secret in an unreadable region of the storage medium ([Pg 6, Para 10] a private key P1 is stored on the second storage element 40 of the electrosurgical instrument 11, whereas an associated public key Ö1 is stored on the third storage element 50) ([Pg 7, Para 4] In order to prevent access to the memory contents of the second memory elements 40, 41, these are combined with the associated controllers 42 and 43 to form a security module. This can be, for example, a “Trusted Platform Module” (TPM)) and a challenge engine, the challenge engine configured to calculate a response with the secret and a challenge received from the electrosurgical generator ([Pg 6, Para 11] In order to authenticate the electrosurgical instrument 11, the controller 35 first generates a random number Z again, encrypts this according to the function A = g (Z, Ö1) in order to obtain the query value A, and sends the query value A to the electrosurgical instrument 11). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include a challenge-response mechanism including a secret in an unreadable region of the storage medium and a challenge engine, the challenge engine configured to calculate a response with the secret and a challenge received from the electrosurgical generator. Doing so prevents the device from being cloned by another device and increases security.
Regarding claim 16, Highsmith teaches the electrosurgical system of claim 15, wherein the electrosurgical puncture device is a transseptal puncture device including one of a transseptal puncture guidewire and a cable couplable to the transseptal puncture guidewire (Fig 1; [0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114 of the guidewire that are sufficient to puncture tissue, using RF energy).
Regarding claim 17, Highsmith teaches the electrosurgical puncture system of claim 16, wherein the transseptal puncture device is included in a transseptal puncture assembly including a delivery component associated with the transseptal puncture device (Fig 1; [0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114 of the guidewire that are sufficient to puncture tissue, using RF energy).
Regarding claim 18, Highsmith teaches an electrosurgical puncture device ([0007] A system and method are disclosed herein for transseptal puncture which include steering a microcatheter with a guidewire therein to a target puncture site then puncturing the target puncture site with the guidewire), the electrosurgical puncture device configured for use with an electrosurgical generator in an electrosurgical puncture procedure ([0008] The generator can be configured to provide electrical energy to the distal end of the guidewire sufficient to puncture tissue so that the tissue is punctured without requiring a sharp end of a needle), the electrosurgical puncture device comprising: a connector (150) configured to mechanically and electrically couple the electrosurgical puncture device to the electrosurgical generator ([0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114), the connector including a radiofrequency (RF) conductor to receive an RF puncture signal provided by the electrosurgical generator ([0052] The generator 180 can be electrically connected to the proximal end 112 of the guidewire 110 through an easily attachable connector/cable and can provide electrical signals through the core 116 of the guidewire 110 to the distal end 114 of the guidewire that are sufficient to puncture tissue, using RF energy, without requiring a needle or sharp end. The generator 180 can provide RF signals to the distal end 114 of the guidewire 110 that spread from the distal end 114 through a body of a patient to the return pad 198).
Highsmith fails to teach a tangible storage medium electrically coupled to the connector, the storage medium comprising: data configured for use with the electrosurgical generator in the electrosurgical puncture procedure; an asymmetric signature mechanism including a digital signature generated from a hash value of the data signed with a private key, the electrosurgical generator including a public key of the asymmetric signature mechanism to verify the hash value; a usage stamp mechanism including a usage stamp having an associated generator code field and a timestamp field in a write protectable region of the storage medium, the usage stamp mechanism configured to provide an input to the electrosurgical generator that ties the electrosurgical puncture device to the electrosurgical generator with a time expiration of the electrosurgical puncture device; a challenge-response mechanism including a secret in an unreadable region of the storage medium and a challenge engine, the challenge engine configured to calculate a response with the secret and a challenge received from the electrosurgical generator; and a usage count mechanism having a usage amount value in the write protectable region of the storage medium.
However, Kennedy teaches a tangible storage medium electrically coupled to the connector ([0026] An interior of the connector 150 can include a printed circuit board assembly (PCBA) 154. The PCBA 154 can include one or more electronic components, such as a processing component 160, a memory component 170, and/or a charge storage component 180, to execute the method steps described herein), the storage medium comprising: data configured for use with the electrosurgical generator in the electrosurgical puncture procedure ([0026] The connector 156 can include a pin assembly 156 that directly engages the PIM 250 and/or the clinical system 200) ([0033] The memory component 170 can be any suitable storage device, including volatile or non-volatile memory. For example, the memory component 170 can include flash memory, erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), radio-frequency identification (RFID) chip, etc…The memory component 170 can have sufficient capacity to store intravascular data, including a unique serial number, configuration information, calibration information, initial parameters, a manufacture date, performance parameters, a version number, an expiration date, system configuration settings, and other data about the intravascular device 110) ([0047] the clinical system 200 can access the memory component 170 to retrieve operating parameters); a usage stamp mechanism including a usage stamp ([0034] The parameter can include an elapsed time since commencement of communication with any clinical system 200, whether the intravascular device 110 has been in communication with any clinical system 200, the number of times the intravascular device 100 has been in communication with any clinical system 200, the number of times the intravascular device 110 has collected data and/or provided therapy, etc.); a timestamp field in a write protectable region of the storage medium ([0046] the threshold value can be representative of a period of time after being connected to a clinical system 200 during which the integrity of data collected the intravascular device 100 is guaranteed by the manufacturer. The parameter value can be representative of an actual elapsed time since the intravascular device 110 and the clinical system 200 have been in communication…The parameter value can be representative of the actual number of times the intravascular device 110 has been connected/disconnected from any clinical system 200) ([0037] For example, the processing component 160 can maintain an armed state and an unarmed state describing when parameter value of the intravascular device 110 (e.g., a use time) is ready to be tracked, being tracked, or not being tracked), with a time expiration of the electrosurgical puncture device ([0037] The processing component 160 and/or the memory component 170 can maintain and/or change various operational states for the connector 150. For example, the operational states can include an unlocked state, a locked state, an armed state, an unarmed state…the processing component 160 can maintain an armed state and an unarmed state describing when parameter value of the intravascular device 110 (e.g., a use time) is ready to be tracked, being tracked, or not being tracked. During manufacturing and testing, the connector 150 can be in a disarmed state such that a parameter value will not be tracked when the connector 150 is connected to a PIM 250, a clinical system 200); and a usage count mechanism having a usage amount value in the write protectable region of the storage medium ([0046] the threshold value can be representative of a period of time after being connected to a clinical system 200 during which the integrity of data collected the intravascular device 100 is guaranteed by the manufacturer. The parameter value can be representative of an actual elapsed time since the intravascular device 110 and the clinical system 200 have been in communication. For example, the threshold value can be representative of the maximum number of times the intravascular device 110 can be connected to any clinical system 200. This can prevent the intravascular device 110 from being inappropriately used in multiple locations and/or with multiple patients, which presents risk of harm to patients). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include a tangible storage medium electrically coupled to the connector, the storage medium comprising: data configured for use with the electrosurgical generator in the electrosurgical puncture procedure; a usage stamp mechanism including a usage stamp and a timestamp field in a write protectable region of the storage medium, with a time expiration of the electrosurgical puncture device, and a usage count mechanism having a usage amount value in the write protectable region of the storage medium. Doing so allows for the recorded use of the device during a procedure to monitor the value within a threshold to prevent overuse of the device and ensure use only with correct authentication.
Further, Rager teaches an asymmetric signature mechanism including a digital signature generated from a hash value of the data signed with a private key ([0048] In this case, asymmetric encryption can be used for authentication to compute a hash digest over the data to be authenticated. The hash digest can be computed, for example, using the SHA-1, SHA-256, or MD5 algorithms. The resulting hash value can be encrypted using an asymmetric private key to form a digital signature), the electrosurgical generator including a public key of the asymmetric signature mechanism to verify the hash value ([0049] The authenticating device also computes the hash digest over the data to be authenticated and it utilizes an asymmetric public key to decrypt the digital signature). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include an asymmetric signature mechanism including a digital signature generated from a hash value of the data signed with a private key, the electrosurgical generator including a public key of the asymmetric signature mechanism to verify the hash value. Doing so allows for preventing tampering with existing data stored on the device.
Further, Poeppelmann teaches having an associated generator code field ([Pg 9, Para 9] The device computes a one-time binding signature via the host ID using a private binding key and stores the signature in the NVM and atomically deactivates the private binding key that is used to generate the one-time signature (e.g., by Deleting the same)); the usage stamp mechanism configured to provide an input to the electrosurgical generator that ties the electrosurgical puncture device to the electrosurgical generator ([Pg 10, Para 3] According to one embodiment, the binding signature is generated via the host ID. Alternatively or additionally, the binding signature can have information such as the following: • a device ID • a timestamp • a random number • a firmware version of the host • the firmware or hardware version of the device); and a challenge-response mechanism ([Pg 11, Para 4] a multiple challenge-response (or demand-response) method can be implemented for further authentication, e.g. B. using another or the known public key). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include having an associated generator code; the usage stamp mechanism configured to provide an input to the electrosurgical generator that ties the electrosurgical puncture device to the electrosurgical generator field; and a challenge-response mechanism. Doing so allows for preventing re-use of the device with other generators.
Further, Kwik teaches a challenge-response mechanism ([Pg 6, Para 13] The controller 35 now checks whether the return value R corresponds to the random number Z. In this case, the electrosurgical instrument 11 has been successfully authenticated; otherwise, as described above, there is a partial or complete restriction of the scope of functions made available) including a secret in an unreadable region of the storage medium ([Pg 6, Para 10] a private key P1 is stored on the second storage element 40 of the electrosurgical instrument 11, whereas an associated public key Ö1 is stored on the third storage element 50) ([Pg 7, Para 4] In order to prevent access to the memory contents of the second memory elements 40, 41, these are combined with the associated controllers 42 and 43 to form a security module. This can be, for example, a “Trusted Platform Module” (TPM)) and a challenge engine, the challenge engine configured to calculate a response with the secret and a challenge received from the electrosurgical generator ([Pg 6, Para 11] In order to authenticate the electrosurgical instrument 11, the controller 35 first generates a random number Z again, encrypts this according to the function A = g (Z, Ö1) in order to obtain the query value A, and sends the query value A to the electrosurgical instrument 11). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include a challenge-response mechanism including a secret in an unreadable region of the storage medium and a challenge engine, the challenge engine configured to calculate a response with the secret and a challenge received from the electrosurgical generator. Doing so prevents the device from being cloned by another device and increases security.
Regarding claim 19, Highsmith teaches the electrosurgical puncture device of claim 18, wherein the electrosurgical generator is configured to apply the asymmetric signature mechanism, the usage stamp mechanism, the challenge-response mechanism, and the usage count mechanism and permit the electrosurgical puncture procedure to proceed if the electrosurgical puncture device is valid.
However, Kennedy teaches the usage count mechanism ([0046] the threshold value can be representative of a period of time after being connected to a clinical system 200 during which the integrity of data collected the intravascular device 100 is guaranteed by the manufacturer. The parameter value can be representative of an actual elapsed time since the intravascular device 110 and the clinical system 200 have been in communication. For example, the threshold value can be representative of the maximum number of times the intravascular device 110 can be connected to any clinical system 200. This can prevent the intravascular device 110 from being inappropriately used in multiple locations and/or with multiple patients, which presents risk of harm to patients). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include the usage count mechanism. Doing so allows for the use to be recorded and monitored for only use with correct authentication.
Further, Poeppelmann teaches wherein the electrosurgical generator is configured to apply the asymmetric signature mechanism ([Pg 10, Para 4] some devices can implement an asymmetric authentication protocol), the usage stamp mechanism ([Pg 10, Para 3] According to one embodiment, the binding signature is generated via the host ID. Alternatively or additionally, the binding signature can have information such as the following: • a device ID • a timestamp), the challenge-response mechanism ([Pg 11, Para 4] a multiple challenge-response (or demand-response) method can be implemented for further authentication, e.g. B. using another or the known public key), and permit the electrosurgical puncture procedure to proceed if the electrosurgical puncture device is valid ([Pg 9, Para 3] In the event of a match, the device can 50 consider the communication partner as an authorized communication partner, e.g. B. as a valid consumable). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Highsmith to include wherein the electrosurgical generator is configured to apply the asymmetric signature mechanism, the usage stamp mechanism, the challenge-response mechanism, and the usage count mechanism and permit the electrosurgical puncture procedure to proceed if the electrosurgical puncture device is valid. Doing so allows for multi-step authentication and to record device use to ensure it was only operated with correct authentication.
Regarding claim 20, Highsmith teaches the electrosurgical puncture device of claim 18, wherein the electrosurgical puncture device is included in an electrosurgical puncture system including the electrosurgical generator ([0007] A system and method are disclosed herein for transseptal puncture which include steering a microcatheter with a guidewire therein to a target puncture site then puncturing the target puncture site with the guidewire) ([0008] The generator can be configured to provide electrical energy to the distal end of the guidewire sufficient to puncture tissue so that the tissue is punctured without requiring a sharp end of a needle).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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