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 .
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive. Applicant argues that Hoffman teaches communication between an external device and implant and no instruction from a second external device are relayed by the communication device. Hoffman discloses in Figure 17 server device (1702) which transmits instructions to the external device 114. The instructions are then to be transmitted by the external device 114 to the implantable device 104 in association with authorizing a telemetry session with the implantable device 104, see paragraphs [0255] and [0260]-[0262].
Drawings/Specification
The amendment to the drawings/specification are sufficient to overcome the previous objection.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 43-63 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Applicant recites part of a human, i.e. "…implant implanted in a patient…”(Claim 43, line 2). Thus, these claims include a human within the scope and are non-statutory. The examiner suggests using the phrase "adapted to be implanted" when referring to the location of the implant in relation to a patient.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 43-56, 59, and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al (US Publication 2019/0030349) in view of Rondoni et al (US Publication 2020/0086128).
Referring to Claim 43, Hoffman et al teaches a system (e.g. Figures 2 and 17) an implant adapted to be implanted in the patient (e.g. Figure 17, Element 104), an external device (e.g. Figure 17, Element 114), a second external device (e.g. Figure 17, Element 1702), wherein the external device is configured to relay communication between the second external device and an implant implanted in a patient (e.g. Fig. 17 and Paragraphs [0260]-[0262], the external device comprising: a wireless transceiver configured for wireless communication with the second external device and the implant, the wireless transceiver being configured to receive an instruction from the second external device, wherein the wireless transceiver is configured to transmit the instruction to the implant (e.g. Figure 17, Element 214 and Paragraphs [0116], [0255] and [0260]-[0262]), and a relay verification unit configured to receive authentication input from a user, for authenticating a relaying functionality of the external device (e.g. Figure 17, Element 208), wherein the wireless transceiver is configured to: upon authentication of the relaying functionality of the external device, cause the wireless transceiver to transmit the instruction to the implant; upon non-authentication or failed authentication of the relaying functionality of the external device, cause the external device to hold the instructions (e.g. Paragraphs [0210], [0212], [0255] and [0260]-[0262] and Figure 8). However, Hoffman et al does not disclose wherein the instruction received at the external device is encrypted, and wherein the external device is configured to transmit the instruction to the implant without decrypting the instruction.
Rondoni et al teaches that it is known to use encrypted data sent to the communication platform (external device) is encrypted and the communication platform transmits the encrypted data to the implantable medical device and does not have access to decrypt the secure communication as set forth in Figure 1A, Element 70A and 70 B and Paragraphs [0052], [0074-0075] to provide improved security to reduce the risk of medical data being leaked or compromising the control and/function of the medical device. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoffman et al, with the instruction received at the external device is encrypted, and wherein the external device is configured to transmit the instruction to the implant without decrypting the instruction as taught by Rondoni et al, since such a modification would provide the predictable results of improved security to reduce the risk of medical data being leaked or compromising the control and/function of the medical device.
Referring to Claim 44, Hoffman et al in view of Rondoni et al teaches the system according to claim 43, wherein the user is the patient in which the implant is implanted (e.g. Paragraph [0095] discloses using sound).
Referring to Claim 45, Hoffman et al in view of Rondoni et al teaches the system according to claim 44, wherein the authentication input is a parameter of the patient (e.g. Paragraph [0095] discloses using sound and Paragraph [0210] discloses using a fingerprint).
Referring to Claim 46, Hoffman et al in view of Rondoni et al teaches the system according to claim 44, wherein the authentication input is a code (e.g. Paragraph [0215] discloses using a code).
Referring to Claim 47, Hoffman et al in view of Rondoni et al teaches the system according to claim 43, wherein the user is a caregiver (e.g. Paragraph [0095] discloses using sound).
Referring to Claim 48, Hoffman et al in view of Rondoni et al teaches the system according to claim 47, wherein the authentication input is a parameter of the caregiver (e.g. Paragraph [0095] discloses using sound).
Referring to Claim 49, Hoffman et al in view of Rondoni et al teaches the system according to claim 47, wherein the authentication input is a code (e.g. Paragraph [0215]).
Referring to Claim 50, Hoffman et al in view of Rondoni et al teaches the system according to claim 43, wherein the wireless transceiver is configured to receive the instruction from the second external device communicated using a first network protocol (e.g. Paragraph [0117] discloses using Bluetooth to communicate with another device and Figure 17 illustrates the device communicating with server 1702 or second external device 1302).
Referring to Claim 51, Hoffman et al in view of Rondoni et al teaches the system according to any one of claim 43, wherein the wireless transceiver is configured to transmit the instruction to the implant communicated using a second network protocol (e.g. Paragraph [0117] discloses the communication device communicates with the implant using a proprietary network protocol).
Referring to Claim 52, Hoffman et al in view of Rondoni et al teaches the system according to claim 50, wherein the first network protocol is a standard network protocol from the list of: Radio-frequency type protocol, RFID type protocol, WLAN, Bluetooth, BLE, NFC, 3G/4G/5G, and GSM (e.g. Paragraph [0117]).
Referring to Claim 53, Hoffman et al in view of Rondoni et al teaches the system according to claim 51, wherein the second network protocol is a proprietary network protocol (e.g. Paragraph [0117]).
Referring to Claim 54, Hoffman et al in view of Rondoni et al teaches the system according to claim 43, wherein the second external device comprises an instruction module adapted to receive instructions from a caregiver generating at least one component of the instruction (e.g. Paragraph [0215]).
Referring to Claim 55, Hoffman et al in view of Rondoni et al teaches the system according to claim 43, being further adapted to receive authentication input from the caregiver, comprising at least one of a code and a parameter of the caregiver (e.g. Paragraph [0215]).
Referring to Claim 56, Hoffman et al in view of Rondoni et al teaches the system according to claim 54, wherein a code is generated by the instruction module (e.g. Paragraph [0215] and Rondoni et al Figure 1A, Element 70A and 70 B and Paragraphs [0052], [0074-0075).
Referring to Claim 59, Hoffman et al in view of Rondoni et al teaches the system according to claim 43, wherein the implant comprises at least one of: a pacemaker unit, or an implantable cardioverter defibrillators, an external heart compression device, an apparatus assisting the pump function of a heart of the patient, an operable artificial heart valve, an implantable drug delivery device, a hydraulic, mechanic, and/or electric constriction implant, an operable volume filling device, an operable gastric band, an operable implant for stretching the stomach wall of the patient, an operable cosmetic implant, an implant controlling the emptying of a urinary bladder, an implant hindering urinary leakage, an implant hindering anal incontinence, an implant controlling the emptying of fecal matter, an implant monitoring an aneurysm, an implant lubricating a joint, an implant with a reservoir for holding bodily fluids an implant storing and/or emptying a bodily reservoir or a surgically created reservoir, an implant communicating with a database outside the body, an implant able to be programmed from outside the body, an implant able to be programmed from outside the body with a wireless signal, an implant treating impotence, an implant controlling the flow of eggs in the uterine tube, an implant controlling the flow of sperms, an implant treating osteoarthritis, an implant performing a test of parameters inside the body, an implant controlling specific treatment parameters from inside the body, an implant controlling bodily parameters from inside the body, an implant controlling the blood pressure, an implant controlling a drug treatment parameter, an implant controlling a parameter in the blood, an implant for adjusting or replacing any bone part of a body of the patient, an implant replacing an organ of the patient or part of an organ of the patient or the function thereof, a vascular treatment device, and an implant adapted to move fluid inside the body of the patient (e.g. Paragraph [0046] discloses a cardiac pacemaker).
Referring to Claim 60, Hoffman et al in view of Rondoni et al teaches the system according to claim 43, wherein the instruction is encrypted using a first encryption key, wherein the first encryption key comprises a hardware key or a software key (e.g. Paragraph [0210] discloses a key).
Claim(s) 57 and 62-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al (US Publication 2019/0030349) in view of Rondoni et al (US Publication 2020/0086128) as applied above, and further in view of Cohen et al (US Publication 2014/0188398).
Referring to Claim 57, Hoffman et al in view of Rondoni et al teaches the system according to claim 55, except wherein the authentication input comprises a single use code. Cohen et al teaches that it is known to use the authentication input comprises a single use code as set forth in Paragraph [0168] to provide improved validation by having a code that cannot be reused by someone watching the user enter the code. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoffman et al, with the authentication input comprises a single use code as taught by Cohen et al, since such a modification would provide the predictable results of a code that cannot be reused by someone watching the user enter the code.
Referring to Claim 62-63, Hoffman et al in view of Rondoni et al teaches the system according to claim 43, except further comprising: transmitting, from the second external device, a cryptographic hash or metadata corresponding to the instruction to the implant, and, verifying, at the implant, the integrity of the instruction based on the cryptographic hash or metadata; wherein the metadata comprises at least one of a length of the data, and a timestamp, for verifying the integrity of the received measurement data. Cohen et al teaches that it is known to use transmitting a cryptographic hash or metadata corresponding to the sent data and verifying, at the receiving device, the integrity of the data based on the cryptographic hash or metadata; wherein the metadata comprises at least one of a length of the data, and a timestamp, for verifying the integrity of the received measurement data as set forth in Paragraph [0140] to provide validating and verifying the integrity of the received data. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoffman et al, with transmitting a cryptographic hash or metadata corresponding to the sent data and verifying, at the receiving device, the integrity of the data based on the cryptographic hash or metadata; wherein the metadata comprises at least one of a length of the data, and a timestamp, for verifying the integrity of the received measurement data as taught by Cohen et al, since such a modification would provide the predictable results of validating and verifying the integrity of the received data.
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al (US Publication 2019/0030349) in view of Rondoni et al (US Publication 2020/0086128) as applied above, and further in view of Klimovitch et al (US Publication 2018/0236249).
Referring to Claim 58, Hoffman et al in view of Rondoni et al teaches the system according claim 43, except wherein the external device is configured to be placed in electrical connection with a conductive member, for conductive communication with the implant.
Klimovitch et al teaches that it is known to use the external device is configured to be placed in electrical connection with a conductive member, for conductive communication with the implant as set forth in Figure 4A and Paragraph [0093] to provide reduced power consumption for communication. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoffman et al, with the external device is configured to be placed in electrical connection with a conductive member, for conductive communication with the implant as taught by Klimovitch et al, since such a modification would provide the predictable results of reduced power consumption for communication.
Claim(s) 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al (US Publication 2019/0030349) in view of Rondoni et al (US Publication 2020/0086128) as applied above, and further in view of Maus et al (US Publication 2009/0282192).
Referring to Claim 61, Hoffman et al in view of Rondoni et al teaches the system according to claim 60, except wherein when the first encryption key comprises a hardware key, the hardware key comprises a smartcard, or when the encryption key comprises a software key, the software key comprises an e-ID.
Maus et al teaches that it is known to use the encryption key comprises a hardware key, the hardware key comprises a smartcard as set forth in Paragraph [0168] to provide improved security by having the key on a physical object that is assigned to the individual. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoffman et al, with the encryption key comprises a hardware key, the hardware key comprises a smartcard as taught by Maus et al, since such a modification would provide the predictable results of improved security by having the key on a physical object that is assigned to the individual.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796