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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 5 is objected to because of the following informalities:
“additional quality control test” should read --additional quality control tests--.
“the generator column the pressure” should read --the generator column, the pressure--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a device connected to the system” in lines 10-11 and 13-14. It is unclear whether each limitation is intended to reference the same or different “device” elements.
The same issue appears in claim 19.
Claim 1 recites “a malware scan” and “an unauthorized connection scan” while parent claim 1 recites “a malware scan” and “a connection scan”. It is unclear whether the malware scan is intended to be the same, and whether the connection scan is intended to be the same, as that of claim 1.
The same issue appears in claims 12 and 15.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6-9, 13, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2019/0307949 (Hidem et al.) in view of U.S. Patent Application Publication No. 2002/0166067 (Pritchard et al.).
Regarding claim 1, Hidem teaches a radiopharmaceutical infusion system (abstract) comprising a source of a radiopharmaceutical (generator 21 produces radiopharmaceutical, [0036]), a pump (33), an eluant in a reservoir (15) (saline, [0036]), a waste bottle (23), a tubing line (301-305), a sensor (25), a valve (35WP) and a controller (controller, [0038]) ([0036]-[0038]; Figure 1D), wherein the source of the radiopharmaceutical comprises a generator column (21) containing a parent radioisotope that decays into a daughter radioisotope ([0036]), wherein the pump is able to infuse an eluant through the generator column and provide a sample ([0036]; [0038]), wherein the controller is configured to perform quality control tests on the system comprising: a) a calibration of the sample to determine the daughter isotope activity; b) a breakthrough test that measures the parent radioisotope activity in the sample ([0043]; activity level quality control, [0062]; quality control breakthrough testing, [0073]).
Hidem does not teach the quality control tests include c) a connection scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of an unauthorized connection; and d) a malware scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of a malware.
However, Pritchard teaches an apparatus for protecting a computer system from virus and unauthorized intrusion (abstract), comprising: a controller (110) configured to perform a connection scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of an unauthorized connection ([0025]-[0026]; [0068]); and a malware scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of a malware (virus detection, [0068]). Since Hidem teaches the system includes a network connection for remote computers, such as a hospital information system ([0081]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quality control tests to include a connection scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of an unauthorized connection; and a malware scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of a malware as taught by Pritchard in order to protect the system from unauthorized access, sensitive data theft, and data corruption (Pritchard: [0002]-[0003]; [0068]).
Regarding claim 2, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem teaches the controller is configured to allow operation of the system after the breakthrough test is found to be acceptable ([0073]).
Regarding claim 3, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem teaches the controller is configured to allow operation of the system after quality control is found to be acceptable ([0077]).
Regarding claim 4, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem teaches the system is automated (“automatic infusion”, [0038]).
Regarding claim 6, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem teaches the quality control tests are performed automatically (“automated quality control tests”, [0045], [0076]).
Regarding claims 7 and 8, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem teaches the radiopharmaceutical and daughter isotope is 82Rb ([0036]; [0038]). Regarding claim 9, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem as modified teaches the malware comprises a virus ([0068]).
Regarding claim 13, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem as modified does not specify the system further includes an intrusion detection system, a firewall or sandboxing, wherein said instrusion detection system, firewall or sandboxing is embedded in the system or located remotely.
However, Pritchard further teaches the system includes an embedded intrusion detection system (VTS 100 includes an embedded personal computer 105, [0026]; claim 27). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hidem as modified to further include an embedded intrusion detection system as taught by Pritchard to provide an on-board system for protecting the system from unauthorized access, sensitive data theft, and data corruption (Pritchard: [0002]-[0003]; [0068]).
Regarding claim 14, Hidem in view of Pritchard teaches all the limitations of claim 13. Hidem as modified does not specify the intrusion detection system comprises a firewall, an anti-virus, an artificial intelligence based software, a learning machine or a deep learning based software or hardware.
However, Pritchard further teaches the intrusion detection system includes an anti-virus software (“EPC 105 operates all commercially available anti-virus software programs and may be programmed to automatically download anti-virus software program updates and virus signature updates”, [0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hidem as modified such that the intrusion detection system includes an anti-virus software as taught by Pritchard in order to keep system protections up to date to prevent intrusion ([0003]; [0035]).
Regarding claim 19, Hidem teaches a radiopharmaceutical infusion system (abstract) comprising a source of a radiopharmaceutical (generator 21 produces radiopharmaceutical, [0036]), a pump (33), an eluant in a reservoir (15) (saline, [0036]), a waste bottle (23), a tubing line (301-305), a sensor (25), a valve (35WP) and a controller (controller, [0038]) ([0036]-[0038]; Figure 1D), wherein the source of the radiopharmaceutical comprises a generator column (21) containing a parent radioisotope that decays into a daughter radioisotope ([0036]), wherein the pump is able to infuse an eluant through the generator column and provide a sample ([0036]; [0038]), wherein the controller is configured to perform quality control tests on the system comprising: a) a calibration of the sample to determine the daughter isotope activity; b) a breakthrough test that measures the parent radioisotope activity in the sample ([0043]; activity level quality control, [0062]; quality control breakthrough testing, [0073]). Hidem does not teach wherein the controller is configured to perform: a) a connection scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of an unauthorized connection; and b) a malware scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of a malware; wherein the controller is configured to allow system operation once the absence of malware and/or an unauthorized connection is confirmed.
However, Pritchard teaches an apparatus for protecting a computer system from virus and unauthorized intrusion (abstract), comprising: a controller (110) configured to perform a connection scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of an unauthorized connection ([0025]-[0026]; [0068]); and a malware scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of a malware (virus detection, [0068]). Since Hidem teaches the system includes a network connection for remote computers, such as a hospital information system ([0081]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the quality control tests to include a connection scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of an unauthorized connection; and a malware scan on the system, on a network connected to the system or on a device connected to the system in order to confirm absence of a malware as taught by Pritchard in order to protect the system from unauthorized access, sensitive data theft, and data corruption (Pritchard: [0002]-[0003]; [0068]). Since Hidem teaches quality control tests are performed “each day, prior to “any patient infusions”, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the battery of quality control tests performed prior to patient infusions in the system of Hidem as modified to allow system operation once the absence of malware and/or an unauthorized connection is confirmed in order to prevent system failure or damage, or loss of sensitive data prior to use.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2019/0307949 (Hidem et al.) in view of U.S. Patent Application Publication No. 2002/0166067 (Pritchard et al.) as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2015/0228368 (Lefort et al.).
Regarding claim 5, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem teaches the system comprises additional quality control tests comprising verifications of the status of the generator column (“ by tracking activity of eluate over a life of the generator”, [0085]), a flow rate of the eluant (“flow rate”, [0062]), a pump speed ([0038]; [0079]), leakage of the eluant ([0037]), the type of the eluant (saline known, [0065]), a volume in the waste bottle (“tracks a volume of the eluate which is discharged from generator 21 into waste bottle”, [0067]), the volume of eluant in the reservoir (“tracking the volume of eluant in reservoir”, [0067]), the volume of the eluant that has passed through the generator column (“tracks a volume of the eluate which is discharged from generator”, [0067]), the pressure in the tubing line (“pressure”, [0039]; “pressure and/or flow through circuit”, [0041]), the activity of the parent isotope and the daughter isotope (“activity level”, [0062]; “dose rate”, [0071]). Hidem as modified does not specify quality control tests include sensor functioning and valve functioning.
However, Lefort teaches a radiopharmaceutical infusion system comprising: a controller configured to perform quality control tests including determining sensor and valve functioning (detects pressure sensor malfunction or pinch valve malfunction, [0083]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the controller of Hidem as modified such that the quality control tests include detection of sensor and valve malfunctioning as taught by Lefort to ensure the infusion system may be stopped upon detection of sensor and valve malfunctions.
Claims 10-12, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2019/0307949 (Hidem et al.) in view of U.S. Patent Application Publication No. 2002/0166067 (Pritchard et al.) as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2011/0247071 (Hooks et al.).
Regarding claim 10, Hidem in view of Pritchard teaches all the limitations in claim 1. Hidem as modified does not specify the controller is configured to perform a malware scan and/or an unauthorized connection scan continuously.
However, Hooks teaches a system for protecting a computer system from malware (abstract; [0026]), comprising: a controller configured to perform a malware scan continuously ([0026]; “operate in the near real time”, [0058]; “Agent 202 scans all the time”, [0073]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Hidem as modified to perform a malware scan continuously as taught by Hooks in order to improve protection of the system.
Regarding claims 11 and 12, Hidem in view of Pritchard teaches all the limitations in claim 1. Hidem teaches breakthrough and calibration tests are performed at a predetermined interval of time, or at the start of each day prior to any patient infusions ([0068]). Hidem as modified does not specify the malware and connection scan is performed overnight and results are displayed prior to the breakthrough and calibration testing.
However, Hooks teaches a system for protecting a computer system from malware (abstract; [0026]), comprising: a controller configured to perform a malware scan, wherein the malware scan is “performed periodically, e.g., daily, during a time when the user may not be using the client machine” ([0040]), and results are displayed ([0047]; [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Hidem as modified such that the malware and connection scan is performed at a time when the practitioner may not be using the system, such as overnight, and displaying results prior to the breakthrough and calibration testing performed by a practitioner in light of the teachings of Hook, in order to ensure the sensitive data and software operations on the system are not compromised prior to each day’s use.
Regarding claim 15, Hidem in view of Pritchard teaches all the limitations in claim 1. Hidem teaches the generator column is recharged following an elution (quality control tests including breakthrough and calibration testing performed daily, which requires producing a radioactive eluate and subsequently recharging the column for the next elution, [0068]). Hidem as modified does not specify the controller is configured to perform a malware scan and/or an unauthorized connection scan after an elution and the generator column is recharging.
However, Hook teaches a system for protecting a computer system from malware (abstract; [0026]), comprising: a controller configured to perform a malware scan, wherein the malware scan is “performed periodically, e.g., daily, during a time when the user may not be using the client machine” ([0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the controller of Hidem as modified is configured to perform a malware and/or connection scan daily when the system is not in use, such as overnight, in light of the teaching of Hook, in order to ensure the sensitive data and software operations on the system are not compromised prior to each day’s use. Consequently, the malware and/or connection scan would be performed at night when the system is not in use, following the patient elution(s) and column recharging done earlier in the day.
Regarding claim 20, Hidem in view of Pritchard teaches all the limitations of claim 19. Hidem as modified does not specify the malware and connection scan is performed overnight.
However, However, Hook teaches a system for protecting a computer system from malware (abstract; [0026]), comprising: a controller configured to perform a malware scan, wherein the malware scan is “performed periodically, e.g., daily, during a time when the user may not be using the client machine” ([0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the controller of Hidem as modified is configured to perform a malware and/or connection scan daily when the system is not in use, such as overnight, in light of the teaching of Hook, in order to ensure the sensitive data and software operations on the system are not compromised prior to each day’s use.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2019/0307949 (Hidem et al.) in view of U.S. Patent Application Publication No. 2002/0166067 (Pritchard et al.) as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2011/0023115 (Wright).
Regarding claim 16, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem as modified does not specify that upon detection of an attempt to connect the system, the controller is configured to: a) provide an alert to a user about said attempt that requests confirmation of the authenticity of said attempt; and b) stop the system from operating in case the user fails to authenticate the detected attempt to connect the system.
However, Wright teaches a system for detecting malware or unauthorized connection (abstract; [0027]; [0030]), comprising: a controller configured to detect an unauthorized attempt to connect to a computer system and a malware scan ([0030]; [0047]; [0056]; [0061]); wherein upon detection of an attempt to connect to the system, the controller is configured to: a) provide an alert to a user about said attempt that requests confirmation of the authenticity of said attempt (personal firewall controls network traffic by “permitting or denying communications based on a security policy”, and “providing prompts each time a connection is attempted and adapting security policy accordingly”, [0056]; authentication, [0058]; login, [0081]); and b) stop the system from operating in case the user fails to authenticate the detected attempt to connect the system (“[p]ersonal firewalls…provide some level of intrusion detection, which may allow the software to terminate or block connectivity where it suspects an intrusion is being attempted”, wherein “stop the system…fails to authenticate…” is construed as terminating or blocking connectivity when an intrusion is being attempted, [0056]; authentication, [0058]; quarantine or limit to a restricted environment/sandbox, [0077]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the controller of Hidem as modified to include providing an alert to a user about said attempt that requests confirmation of the authenticity of said attempt; and stopping the system from operating in case the user fails to authenticate the detected attempt to connect the system as taught by Wright in order to limit or prevent unauthorized access to the system to protect sensitive data.
Regarding claim 17, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem as modified does not specify the controller is configured to stop the system from operating in case a malware is detected by the malware scan until the malware is neutralized.
However, Wright teaches a system for detecting malware or unauthorized connection (abstract; [0027]; [0030]), comprising: a controller configured to detect an unauthorized attempt to connect to a computer system and a malware scan ([0030]; [0047]; [0056]; [0061]); wherein the controller is configured to stop the system from operating in case a malware is detected by the malware scan until the malware is neutralized (“terminating the application”, [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the controller of Hidem as modified to stop the system from operating in case a malware is detected by the malware scan until the malware is neutralized as taught by Wright in order to prevent damage to the system.
Regarding claim 18, Hidem in view of Pritchard teaches all the limitations of claim 1. Hidem as modified does not teach the controller is configured to repeat the quality control tests in case a malware and/or an unauthorized connection is detected on the system.
However, Wright teaches a system for detecting malware or unauthorized connection (abstract; [0027]; [0030]), comprising: a controller configured to detect an unauthorized attempt to connect to a computer system and a malware scan ([0030]; [0047]; [0056]; [0061]); and notifying a user when an unauthorized connection is attempted (personal firewall controls network traffic by “permitting or denying communications based on a security policy”, and “providing prompts each time a connection is attempted and adapting security policy accordingly”, [0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the controller of Hidem as modified such that the controller is configured to repeat the quality control tests in case a malware and/or an unauthorized connection is detected on the system in light of the teachings of Wright, in order to ensure the system is properly operational upon detection of malware and/or unauthorized connection to prevent harm to a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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