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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 9-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The subject matter which was not described in the original disclosure is the use of a system, computer media, or method using three sensors, where the processing circuitry determines a first preliminary determination that the IMD has changed status based on a first sensor indication, determines a second preliminary determination that the IMD has changed status based on a second sensor indication, and responsive to the first preliminary determination indicating a status change for the IMD and the second preliminary determination indicating a change of status for the IMD, determine, based on the third indication, that the IMD changed status, in combination with the other elements or steps in the claim(s).
The original disclosure discussed determining 2 preliminary determinations to confirm the change in status for the IMD to change the communication mode (e.g. figures 6-11, etc.), but not then use the presently claimed third sensor to determine the IMD has changed status. The original disclosure also disclosed using three sensors, where two sensors are used in the first preliminary determination, and a third sensor is used for the second preliminary determination (e.g. para. 56), but did not disclose after the second preliminary determination to use the third sensor to determine the IMD has changed status.
The applicants in their response rely on paragraph 64 for adding the new limitations to the claims. However, paragraph 64 only states that the “processing circuitry 50 may determine the status of IMD 10 based on a specified sequence of sensed events. For example, processing circuitry may receive an indication that the light characteristics have changed, followed by detecting the magnetic field from the implant tool and later followed by an indication that the temperature of IMD 10 is within a specified range.”.
This paragraph states that the sequence of events of three sensors are used to determine status change, but does not disclose the newly claimed intermediate steps or functions of the processing circuitry determining a first preliminary determination that the IMD has changed status based on a first sensor indication, determining a second preliminary determination that the IMD has changed status based on a second sensor indication, and responsive to the first preliminary determination indicating a status change for the IMD and the second preliminary determination indicating a change of status for the IMD, determine, based on the third indication, that the IMD changed status.
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 1-6 and 9-22 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.
In claim 1, line 24, “the third preliminary…” lacks antecedent basis. It is suggested to delete “preliminary”.
Similarly, claims 10 and 19 use this language and therefore lack antecedent basis.
In claim 19, line 4, “the plurality of sensors” lacks antecedent basis. It is suggested in line 3 after “(IMD)” to add “having a plurality of sensors”. In line 15, “the third preliminary indication” is vague as no third sensor has been set forth. It is suggested after line 12 to add “receive a third indication from a third sensor of the plurality of sensors”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 10-17 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Weinberg et al. (5476485) in view of Juran et al (6016447).
Weinberg teaches the use of a sequence of at least 3 events using a temperature sensor for sensing temperature to compare the temperature to temperature criterion to make a first determination (e.g. figures 1, 3, 4, block 116/118, which is an indication of implantation, etc.) and an impedance biosensor for sensing impedance between electrodes (e.g. figures 1, 3, 4, blocks 122/136, the biosensor is controlled to sense the impedance by the IMD/method/programming and activated based on the temperature measurement meeting a first criterion, etc.) to determine if the IMD is implanted based on the impedance satisfying a second criterion (e.g. blocks 124/130/134) to switch from a low power mode to a higher power mode (e.g. block 134 or block 150, etc.) to constantly monitor/sense cardiac events for the pacemaker, where the system uses a programmable microprocessor and memory and therefore contains a non-transitory computer readable storage medium to perform the method and store the first and second criteria.
Weinberg discloses the claimed invention having wireless telemetry and being in a powered down low power first mode and then a powered mode when implanted, but does not disclose specifically the telemetry being activated from a first inactive/low power mode to send messages to advertise the establishment of a wireless connection with a computing device in the second mode/based on a determination that the IMD is implanted, and using three sensors with a determination from each to determine a status change for the IMD. Juran discloses using three sensors with a determination from each to determine a status change for the IMD (e.g. col. 14, lines 17-23; col. 11, lines 14-67, etc.) and discloses that the telemetry circuit is deactivated in the first mode (e.g. figure 5, col. 15, lines 44-56, etc.) and then activated in the second mode (e.g. figure 5, etc.) after detecting implantation and to provide an indication by telemetry to an external device of different device statuses (e.g. claims 17 and 19 of Juran, figure 8, etc.) and therefore necessarily meets the functional use recitations provided in the claim of providing messages/advertisement to a computing device since the device is telemetering to an external device, to allow the system and method to not waste power when not implanted and to notify the physician when the device is considered implanted. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Weinberg, with using three sensors with a determination from each to determine a status change for the IMD and the telemetry being activated to send messages to advertise the establishment of a wireless connection with a computing device in the second mode/based on a determination that the IMD is implanted, as taught by Juran, since it would provide the predictable results of allowing the system and method to reconfirm the status change with multiple sensors to ensure the device is implanted, and just in case one sensor is not working properly, and not waste power when the IMD is not implanted and to notify the physician when the device is considered implanted.
Claims 1-6, 10-17 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Weinberg et al. (5476485) in view of Juran (6016447) and Cinbis et al (2017/0100036).
Weinberg teaches the use of a sequence of at least 3 events using a temperature sensor for sensing temperature to compare the temperature to temperature criterion to make a first determination (e.g. figures 1, 3, 4, block 116/118, which is an indication of implantation, etc.) and an impedance biosensor for sensing impedance between electrodes (e.g. figures 1, 3, 4, blocks 122/136, the biosensor is controlled to sense the impedance by the IMD/method/programming and activated based on the temperature measurement meeting a first criterion, etc.) to determine if the IMD is implanted based on the impedance satisfying a second criterion (e.g. blocks 124/130/134) to switch from a low power mode to a higher power mode (e.g. block 134 or block 150, etc.) to constantly monitor/sense cardiac events for the pacemaker, where the system uses a programmable microprocessor and memory and therefore contains a non-transitory computer readable storage medium to perform the method and store the first and second criteria.
Weinberg discloses the claimed invention having wireless telemetry and being in a powered down low power first mode and then a powered mode when implanted, but does not disclose specifically using three sensors with a determination from each to determine a status change for the IMD, and the telemetry being activated from a first inactive/low power mode to send messages to advertise the establishment of a wireless connection with a computing device in the second mode/based on a determination that the IMD is implanted. Juran discloses using three sensors with a determination from each to determine a status change for the IMD (e.g. col. 14, lines 17-23; col. 11, lines 14-67, etc.). Cinbis discloses that the telemetry circuit is deactivated in the first mode (e.g. para. 20, etc.) and then activated in the second mode (e.g. figures 3-7, paras. 24-31, etc.) after implantation and to provide a plurality of indications by telemetry to a computing device (e.g. paras. 51-53, figures 5, 6, etc.) and therefore necessarily meets the functional use recitations provided in the claim of providing messages/advertisements to a computing device since the device is telemetering to an external device, and allowing the device to be activated to receive a wakeup signal from a computing device in response to the first preliminary determination being made (e.g. figures 3-7, paras. 21-31, 52-53, 60-68, etc.), to allow the system and method to not waste power when not implanted, to notify the physician when the device is considered implanted, and allow an external/computing device to communicate with the IMD to check the status of the implantation or device. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Weinberg, with using three sensors with a determination from each to determine a status change for the IMD, as taught by Juran, and the telemetry being activated to send messages to advertise the establishment of a wireless connection with a computing device in the second mode/based on a determination that the IMD is implanted, as taught by Cinbis, since it would provide the predictable results of allowing the system and method to reconfirm the status change with multiple sensors to ensure the device is implanted, and just in case one sensor is not working properly, and allowing the system and method to not waste power when the IMD is not implanted, to notify the physician when the device is considered implanted, and allow an external/computing device to communicate with the IMD to check the status of the implantation or device.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Weinberg et al. (5476485) in view of Juran, or over Weinberg in view of Juran and Cinbis (i.e. “modified Weinberg” used below for either rejection). Modified Weinberg discloses the claimed invention for monitoring the heart and having a housing containing the processing circuitry, telemetry, sensors, and a housing electrode, but does not disclose a plurality of electrodes on the housing. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by modified Weinberg, to have additional electrodes on the housing or being a leadless cardiac device containing the circuitry and having multiple electrodes on the housing, as is well known and common knowledge in the art (mpep 2144I, 2144.03), to provide the predictable results of an implantable cardiac monitor that can sense the ecg, or stimulate the body, from different directions/planes in the heart to better sense the patient’s cardiac condition and apply appropriate therapy, and/or provide a leadless cardiac monitor and stimulator that does not require leads to be implanted or can be implanted directly in the heart.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/Primary Examiner, Art Unit 3792 12/24/25
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