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 12/17/2025 have been fully considered but they are not persuasive.
The Applicant argues that the first device is considered element 40 in Rondoni and the second device is considered element 60 and therefore does not meet the limitation of the transmission from the second device to the implant is carried out without routing or relay by the first device. The examiner respectfully disagrees as the first device, element 60, communicates with the second device, 40, which communicates the signal to the IMD 20. In order to advance prosecution, the examiner also notes Hoffman et al (US Publication 2019/0030349) which discloses a server device 1702 which communicates with a device 1302 or 114 which communicates the transmission from 1702 to the IMD 104.
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.
Claim 62 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 62 requires “wherein any communication between the implant and the second external device is relayed through the first external device”; this is unclear because claim 59 states “wherein the system is configured to carry out the transmission of the encrypted instruction from the second external device to the implant without routing through or relay by the first external device”. How does the communication between the implant and the second device relay through the first external device while the communication from the second external device and the implant is transmitted without relay by the first external device.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 62 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 62 requires “wherein any communication between the implant and the second external device is relayed through the first external device”; this appears to fail to include all the limitations of the claim from which it depends, particularly Claim 59 recitation of “wherein the system is configured to carry out the transmission of the encrypted instruction from the second external device to the implant without routing through or relay by the first external device”. Adding a relay through the first device between the IMD and second external device is prohibited by the independent claim and means claim 62 does not further limit the claim from which it depends and fails to include all the limitations of the claim upon which it depends Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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) 43-44, 48-50, 54-59, and 62-63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rondoni et al (US Publication 2020/0086128).
Referring to Claim 43, Rondoni et al teaches a method for transmitting an instruction from a first external device to an implant, comprising: transmitting an instruction for the implant from the first external device to a second external device, the instruction relating to a function of the implant (e.g. Figures 1A and 3, first device 60, user interface 1061 and Paragraph [0171] discloses which allow users (e.g. clinicians) to modify IMD parameters), encrypting, at the second external device and using a first encryption key, the instruction into an encrypted instruction (e.g. Figure 1A secure communication 70B and Figure 9 TA to IMD message 1210 and Paragraphs [0071] and [0077]), and transmitting the encrypted instruction from the second external device to the implant (e.g. Figure 1A secure communication 70A/70B and Figure 9 TA to IMD message 1210), decrypting, at the implant, the instructions using a second encryption key corresponding to the first encryption key (e.g. Paragraph [0074]).
Referring to Claim 44, Rondoni et al teaches the method according to claim 43, further comprising receiving, through a user interface at the first external device, an instruction to be transmitted to the implant (e.g. Figures 1A and 3, first device 60, user interface 1061 and Paragraph [0171] discloses which allow users (e.g. clinicians) to modify IMD parameters).
Referring to Claim 48, Rondoni et al teaches the method according to claim 43, further comprising, at the implant, running the instruction (e.g. Paragraphs [0054] and [0153] disclose controlling operations of the IMD).
Referring to Claim 49, Rondoni et al teaches the method according to claim 43, further comprising receiving, at the first external device, the instruction (e.g. Figure 1 and Paragraphs [0052], [0074-0075], and Paragraph [0171]).
Referring to Claim 50, Rondoni et al teaches the method according to claim 49, further comprising displaying, at the first external device, a user interface for receiving the instruction (e.g. Figure 3, Element 1061 and Paragraph [0171]).
Referring to Claim 54, Rondoni et al teaches the method according to claim 43, wherein the first external device and the implant are configured to communicate over a wireless connection (e.g. Paragraphs [0036] and [0071]).
Referring to Claim 55, Rondoni et al teaches the method according to claim 54, wherein the wireless connection comprises at least one of the following protocols: Radio Frequency type protocol RFID type protocol WLAN type protocol Bluetooth type protocol BLE type protocol NFC type protocol 3G/4G/5G type protocol GSM type protocol Bluetooth 5 (e.g. Paragraphs [0071] and [0077]).
Referring to Claim 56, Rondoni et al teaches the method according to claim 43, wherein the transmitting of data between the first external device and the second external device is performed a wireless connection (e.g. Paragraph [0053]).
Referring to Claim 57, Rondoni et al teaches the method according to claim 43, further comprising authenticating the connection between the first external device and the implant over which the encrypted instruction is to be transmitted (e.g. Paragraphs [0067] and [0071]).
Referring to Claim 58, Rondoni et al teaches the method according to claim 43, wherein the implant comprises an internal control unit for controlling a function of the implant, and wherein the internal control unit is configured to run the instruction (e.g. Paragraphs [0054] and [0171] disclose controlling operations of the IMD).
Referring to Claim 59, Rondoni et al teaches a system for transmitting an instruction from a first external device to an implant, comprising: an implant configured to be implanted in a human patient, the implant comprising an internal control unit configured to control a function of the implant (e.g. Figures 1A, first device 20 and/or Figure 9, Element 1020 and Paragraphs [0054] and [0171] disclose controlling operations of the IMD); a first external device configured to receive or determine an instruction to be transmitted to the implant, and to transmit the instruction to a second external device (e.g. Figures 1A and 3, first device 60, user interface 1061 and Paragraph [0171]); a second external device configured to receive the instruction transmitted from the first external device, to encrypt the instruction using a first encryption key to form an encrypted instruction, and to transmit the encrypted instruction to the implant (e.g. Figure 1A secure communication 70B and Figure 9 TA to IMD message 1210 and Paragraphs [0071], and [0077] which teaches communication with the IMD using Bluetooth encryption), wherein the implant is configured to received and decrypt the instruction using a second encryption key corresponding to the first encryption key (e.g. Paragraph [0071] and [0074]), and wherein the system is configured to carry out the transmission of the encrypted instruction from the second external device to the implant without routing through or relay by the first external device (e.g. Figure 1A, first external device 60 and second external device 40) .
Referring to Claim 62, Rondoni et al teaches the system according to claim 59, wherein the second external device is an encryption device communicatively coupled to the first external device, and wherein any communication between the implant and the second external device is relayed through the first external device (e.g. Figure 9).
Referring to Claim 63, Rondoni et al teaches the system according to claim 59, wherein the internal control unit is configured to run the decrypted instruction for controlling a function of the implant (e.g. Paragraphs [0054] and [0153] disclose controlling operations of the IMD).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al (US Publication 2020/0086128) in view of Goetz et al (US Publication 2008/0140162).
Referring to Claim 45, Rondoni et al teaches the method according to claim 43, except further comprising verifying, at the second external device, that the instruction is correct, before transmitting the encrypted instruction. Goetz et al teaches that it is known to use the intermediate device that verifies and validates the content of programming instructions being transmitted from the clinician programmer to intermediate device, the intermediate device will recognize invalid parameters and will not send the programming instructions to IMD as set forth in Paragraphs [0065]-[0066] to provide improved patient safety by distinguishing valid and invalid programming information. 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 method as taught by Rondoni et al, with verifying, at the second external device, that the instruction is correct, before transmitting the encrypted instruction as taught by Goetz et al, since such a modification would provide the predictable results of improved patient safety by distinguishing valid and invalid programming information.
Claim(s) 47, and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al (US Publication 2020/0086128) in view of Hoffman et al (US Publication 2019/0030349).
Referring to Claim 47, Rondoni et al teaches the method according to claim 43, except wherein the transmitting of the encrypted instruction from the second external device to the implant comprises: transmitting the encrypted instruction from the second external device to a third external device, and transmitting the encrypted instruction from the third external device to the implant.
Hoffman et al teaches that it is known to use a first device (1702) which communicates with a second device (1302) which communicates that information to a third device (114) which communicates with the IMD (104) as set forth in Figure 17 to provide communicating information over greater distances therefore allowing the user to have more movement. 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 method as taught by Rondoni et al, with transmitting the encrypted instruction from the second external device to a third external device, and transmitting the encrypted instruction from the third external device to the implant as taught by Hoffman et al, since such a modification would provide the predictable results of communicating information over greater distances therefore allowing the user to have more movement.
Referring to Claim 61, Rondoni et al teaches the system according to claim 59, except wherein the second external device is configured to transmit the encrypted instruction by transmitting the encrypted instruction to a third external device, and wherein the third external device is configured to transmit the encrypted instruction to the implant.
Hoffman et al teaches that it is known to use a first device (1702) which communicates with a second device (1302) which communicates that information to a third device (114) which communicates with the IMD (104) as set forth in Figure 17 to provide communicating information over greater distances therefore allowing the user to have more movement. 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 Rondoni et al, with transmitting the encrypted instruction from the second external device to a third external device, and transmitting the encrypted instruction from the third external device to the implant as taught by Hoffman et al, since such a modification would provide the predictable results of communicating information over greater distances therefore allowing the user to have more movement.
Claim(s) 51-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al (US Publication 2020/0086128).
Referring to Claims 51-53, Rondoni et al teaches the method according to claim 50, except wherein the implant comprises a set of a predefined program steps, and wherein the method further comprises verifying, by the implant, that the received instruction is comprised in the predefined program steps; wherein the verifying comprises rejecting the instruction in response to the instruction not being comprised in the set of predefined program steps; wherein the verifying comprises allowing the instruction in response to the instruction being comprised in the set of predefined program steps.
Rondoni et al teaches that it is a performance manager known to use verifying that the implemented parameters are within constraints set by the manufacturer of the IMD and are also within constraints determined and/or approved within a medical regulatory framework as set forth in Paragraph [0155] to provide operations that run on the IMD are within safe guidelines for the operation of the device and for the safety of the patient. 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 Rondoni et al, with a performance manager in the implant which comprises a set of a predefined program steps, and wherein the method further comprises verifying, by the implant, that the received instruction is comprised in the predefined program steps; wherein the verifying comprises rejecting the instruction in response to the instruction not being comprised in the set of predefined program steps; wherein the verifying comprises allowing the instruction in response to the instruction being comprised in the set of predefined program steps as taught by Rondoni et al, since such a modification would provide the predictable results of ensuring that instructions on the IMD are within safe guidelines for the operation of the device and for the safety of the patient.
Claim(s) 64-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al (US Publication 2020/0086128) in view of Maus et al (US Publication 2009/0282192).
Referring to Claims 64-65, Rondoni et al teaches the system according to claim 43, except wherein the first encryption key comprises a hardware key or a software key; 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/method as taught by Rondoni 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.
Claim(s) 45 and 66-67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al (US Publication 2020/0086128) in view of Cohen et al (US Publication 2014/0188398).
Referring to Claim 45, Rondoni et al teaches the method according to claim 43, except further comprising verifying, at the second external device, that the instruction is correct, before transmitting the encrypted instruction.
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 is a length of the data, a timestamp, or other data 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/method as taught by Rondoni 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 is a length of the data, a timestamp, or other data 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.
Referring to Claims 66-67, Rondoni et al teaches the system according to claim 43, except wherein the second external device is further configured to: transmit a cryptographic hash or metadata corresponding to the instruction to the implant, and, wherein the implant is further configured to verify the integrity of the instruction based on the cryptographic hash or metadata; and 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 is a length of the data, a timestamp, or other data 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/method as taught by Rondoni 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 is a length of the data, a timestamp, or other data 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.
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