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 07/06/2026 regarding the 35 U.S.C. § 101 rejection have been fully considered and are persuasive. The 35 U.S.C. § 101 rejection is hereby withdrawn.
Applicant’s arguments filed 07/06/2026 regarding the 35 U.S.C. § 102(a)(1) rejection have been fully considered but are not persuasive.
Applicant argues, “Soykan does not disclose such an IMD and instead in the Background provides IMDs can store physiological data in a memory. Para. [0003]. Soykan also discloses that to avoid overwriting data and loss of data that the IMD can transmit the data to an external device before the memory is filled with data. Id. However, Soykan does not describe how this transfer occurs, nor if such transfer occurs during a collection session, after a collection session is completed, if during such a collection session the memory exceeds its capacity, or otherwise….Soykan does not disclose or suggest one or more processors configured to continuously store physiological data in the buffer memory for a duration of a collection session, the amount of data stored in the buffer memory during the collection session, including the physiological data, exceeding a capacity of the buffer memory and transmit at least a portion of the physiological data stored in the buffer memory with the transceiver circuit to the external device, wherein the connect with the external device and transmit at least a portion of the physiological data are performed at a periodic communication interval during the collection session.”
Examiner respectfully disagrees. Soykan discloses
one or more processors (43), that when executing program instructions [0047], is configured to: responsive to receiving a trigger ([0028]: initial programming that causes physiological signal to be continuously monitored, recorded, and analyzed):
enable a continuous data collection mode (CDCM) [0115] comprising a predetermined sampling rate [0115];
continuously generate the physiological data [0028, 0082];
continuously store the physiological data in the buffer memory at the predetermined sampling rate for a duration of a collection session associated with the CDCM ([0115]: continuously stores data until a capacity is reached [0003]),
the amount of data stored in the buffer memory during the collection session, including the physiological data, exceeding a capacity of the buffer memory ([0003]: when a predetermined capacity of the SRAM memory is met, data is transmitted to an external device);
connect with the external device [0003]; and
transmit at least a portion of the physiological data stored in the buffer memory with the transceiver circuit ([0003]: portion of the transceiver circuit that wireless transmits data radio frequency; [0056]) to the external device [0003],
wherein the connect with the external device and transmit at least a portion of the physiological data are performed at a periodic communication interval during the collection session
([0029]: data may be periodically transmitted to external device; [0082]: physiological sensor data recorded by an implantable device and saved to the memory is transmitted periodically to an external device; [0118]: physiological signal may be sensed continuously over a period of time and transmitted via radio frequency to the external device; [0141]: features from embodiment may be combined).
Specifically, regarding the limitations, “wherein the connect with the external device and transmit at least a portion of the physiological data are performed at a periodic communication interval during the collection session”, Soykan teaches wherein psychological data is recorded and stored continuously within an implantable medical device [0029], and periodically transmitted to an external device over a period of time [0029, 0118, 0082].
Additionally, Soykan teaches that physiological data sensed and captured over a period of at least 4 hours [0120] may be stored in both the memory of the implantable device and may be transmitted to the external device [0120].
Thus, Soykan discloses the above recited limitations.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soykan et al. (US 2020/0352441).
In re claim 1, Soykan discloses an implantable medical device (IMD) (fig. 4A: 50; [0041]), comprising:
one or more sensing circuits (fig. 5: 40) configured
to sense one or more physiological characteristics (48, 49, 53) and
to generate physiological data indicative of the one or more physiological characteristics [0045-0047];
an input configured to receive a trigger ([0028]: trigger is program received to record physiological signals continuously; [0063-0064]: determination and selection done at beginning of communications session);
a transceiver circuit (55) configured to communicate with an external device ([0056]: long-range telemetry module 55 communicates with external devices; fig. 4A: external device 80);
a memory (fig. 5: combination of 44 and 45; [0048]) configured to store program instructions [0030],
the memory comprising a buffer memory (static random access memory 44; [0039, 0048]); and
one or more processors (43), that when executing the program instructions [0047], is configured to: responsive to receiving the trigger ([0028]: initial programming that causes physiological signal to be continuously monitored, recorded, and analyzed):
enable a continuous data collection mode (CDCM) [0115] comprising a predetermined sampling rate [0115];
continuously generate the physiological data [0028, 0082];
continuously store the physiological data in the buffer memory at the predetermined sampling rate for a duration of a collection session associated with the CDCM ([0115]: continuously stores data until a capacity is reached [0003]),
the amount of data stored in the buffer memory during the collection session, including the physiological data, exceeding a capacity of the buffer memory ([0003]: when a predetermined capacity of the SRAM memory is met, data is transmitted to an external device);
connect with the external device [0003]; and
transmit at least a portion of the physiological data stored in the buffer memory with the transceiver circuit ([0003]: portion of the transceiver circuit that wireless transmits data radio frequency; [0056]) to the external device [0003],
wherein the connect with the external device and transmit at least a portion of the physiological data are performed at a periodic communication interval during the collection session
([0029]: data may be periodically transmitted to external device; [0082]: physiological sensor data recorded by an implantable device and saved to the memory is transmitted periodically to an external device; [0118]: physiological signal may be sensed continuously over a period of time and transmitted via radio frequency to the external device; [0141]: features from embodiment may be combined).
In re claim 2, Soykan discloses wherein the CDCM is further configured to store the physiological data at the predetermined sampling rate for a predetermined duration ([0115]: continuous sampling and recording is stored in memory based on a sampling rate that is adjusted for a predetermined duration).
In re claim 3, Soykan discloses wherein the periodic communication interval is determined based on
i) a capacity of the buffer memory ([0003]: depends on a threshold of data in the SRAM before it is full),
ii) a number of sensing channels configured to sense cardiac activity (CA) signals during the collection session,
iii) the predetermined sampling rate ([0115]: sampling rate would determine how fast the memory gets full),
iv) a capacity of a memory space of the external device,
v) data transfer speed between the IMD and the external device, or
vi) time to establish connection between the IMD and the external device.
In re claim 4, Soykan discloses wherein the physiological data comprises
heart sounds [0054],
ii) blood glucose data ,
iii) pulse oximetry,
iv) CA signals,
v) temperature [0040],
vi) heart rate [0047],
vii) impedance [0040],
viii) blood pressure [0040],
ix) blood oxygen saturation,
x) activity [0046],
xi) posture [0040],
xii) nerve activity,
xiii) blood sugar level, or
xiv) cholesterol level.
In re claim 10, Soykan discloses
wherein the connect operation further comprises connecting with the external device [0029] at least
a first time ([0029]: frequency of transmitting data to the external device may be adjusted) and
a second time ([0029]: second time that the external device receives data),
wherein the transmit operation further comprises
transmitting a first set of data during the first time [0029] and
transmitting a second set of data during the second time [0029]
that is different from the first set of data ([0082]: data is continuously recorded which means the second set of data would be different from the first; [0029]).
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 5-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Soykan et al. (US 2020/0352441) in view of Morris et al. (US 2018/0168463).
In re claim 5, Soykan fails to disclose wherein the trigger is
a communication from the external device,
ii) a physiological trigger from a physiological sensor located within the IMD or external to the IMD, or
iii) generated in response to a physiological condition.
Morris teaches an implantable medical device (fig. 1A: 8A which includes 10A and 15A; [0047]: may be a pacemaker; [0033-0045]) comprising sensing circuit (12A; [0045]) configured to receive a trigger [0004, 0045],
wherein the trigger is
a communication from an external device [0004] or
a physiological trigger from a physiological sensor [0044] located external to the IMD ([0044-0045]: physiological parameters are sensed to determine whether to trigger continuous sensing of pulmonary blood pressure; [0004]);
wherein one or more processors is configured to disable a CDCM ([0045]: CDCM occurs during a trigger because pulmonary blood pressure is sensed continuously) based on a physiological feature ([0045]: pulmonary blood pressure being sensed is a physiological feature) exceeding a threshold ([0045-0046]: time window is a threshold) of a predetermined duration ([0046]: upon completion of sensing during a time window, the sensing device transitions back to a low-power mode; [0075]);
wherein, in response to receiving a disabling message [0046], the one or more processors is further configured to disable the CDCM ([0045-0046]: once the time window of sensing has passed, the pressure sensing device returns to the low-power mode).
Morris teaches that automatically triggering collection of pulmonary blood pressure measurements based on sensed data [0041] provides convenience to a user [0041], since they don’t have to manually input the trigger [0041]. Morris further teaches that transitioning in and out of a lower-power mode [0040] based on the trigger conserves on-board power [0040].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the implantable medical device taught by Soykan, to provide wherein the trigger is a communication from the external device or a physiological trigger from a physiological sensor located within the IMD or external to the IMD, as taught by Morris, because automatically triggering collection of measurements based on sensed data provides convenience to a user, since they don’t have to manually input the trigger, and also because transitioning in and out of a lower-power mode based on the trigger conserves on-board power.
The proposed combination would also yield wherein the one or more processors of the proposed combination is configured to disable a CDCM based on a physiological feature exceeding a threshold of a predetermined duration, and wherein, in response to receiving a disabling message, the one or more processors is further configured to disable the CDCM.
In re claim 6, regarding the limitations, “wherein the one or more processors is further configured to disable the CDCM based on
a predetermined end time,
ii) a predetermined duration,
iii) a predetermined number of transmissions, or
iv) receipt of a disabling message from a sensor or the external device”,
see the proposed combination yielded in re claim 5 above.
In re claim 7, regarding the limitations,
“wherein the one or more processors is further configured to determine a physiological feature,
wherein in response to the physiological feature exceeding a threshold, the one or more processors are further configured to disable the CDCM”,
see the proposed combination yielded in re claim 5 above.
In re claim 9, regarding the limitations, “wherein, in response to receiving a disabling message, the one or more processors is further configured to disable the CDCM”, see the proposed combination yielded in re claim 5 above.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Soykan et al. (US 2020/0352441) in view of Morris et al. (US 2018/0168463) in view of Koninklike (WO 2017148881).
In re claim 8, the proposed combination fails to yield wherein the physiological feature is a heart rate.
Koninklike teaches assessing reliability of a fetal heart rate measurement (pg. 2, lines19-25), wherein a physiological feature is a heart rate (pg. 2, lines 26-28) and is used to stop recording measurements when the heart rate is above a maximum value (pg. 12, lines 13-22).
Koninklike further teaches stopping measurement recording due to apparat non-reliability of the heart rate (pg. 12, lines 19-27).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the implantable medical device yielded by the proposed combination, to provide wherein the physiological feature is a heart rate, as taught by Koninklike, because measurement recording can be stopped due to apparat non-reliability of the heart rate when it exceeds a threshold.
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUMAISA RASHID BAIG/Examiner, Art Unit 3796 /William J Levicky/ Primary Examiner, Art Unit 3796
