DETAILED ACTION
1. This office action is in response to the communicated dated 17 April 2026 concerning application number 18/386,895 effectively filed on 03 November 2023.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of Claims
3. Claims 1-7, 9-19, and 21-34 are pending, of which claims 1 and 9-10 have been amended; claims 21-34 have been added; claims 8 and 20 have been canceled; and claims 1-7, 9-19, and 21-34 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 17 April 2026, referred to herein as “the Arguments”, have been fully considered and are persuasive. Therefore, the Examiner has withdrawn the rejections of claims 1-7 and 11-18 are under 35 U.S.C. 103.
However, claims 1, 18, and 21 have been rejected under 35 U.S.C. 112 (b) within the updated text below.
Claim Objections
5. Claims 22-34 are objected to because of the following informalities.
The Examiner respectfully submits that claims 22-34 have been recently added, but are currently presented as “original”. Specifically, claims 22-34 depends upon claim 21 which is currently presented as a “new” claim. The Examiner suggests that Applicant updates the status of the claims within the next response.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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, 18, and 21 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 the limitation "tissue temperatures and time stamps of the same" in lines 13-14. There is insufficient antecedent basis for this limitation in the claim. The Examiner respectfully submits this limitation is indefinite, as “the same” is not defined.
Claim 18 recites the limitation “modulate a therapy parameter based on the same” in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner respectfully submits this limitation is indefinite, as “the same” is not defined. However, Applicant’s specification states that modulating a therapy parameter based on the same includes modulating therapy parameter based on estimated physical activity in advance of measured temperature changes (page 8, lines 5-10). Based on the specification, the Examiner has interpreted “the same” as the “estimated physical activity”. Furthermore, the Examiner suggests that Applicant changes “the same” to “the estimated physical activity”.
Claim 21 recites the limitation “modulate a therapy parameter based on the same in advance of measured temperature changes” in lines 9-10. As stated previously above, Applicant’s specification states that modulating a therapy parameter based on the same includes modulating therapy parameter based on estimated physical activity in advance of measured temperature changes (page 8, lines 5-10). Based on the specification, the Examiner has interpreted “the same” as the “estimated physical activity”. Furthermore, the Examiner suggests that Applicant changes “the same” to “the estimated physical activity”.
Allowable Subject Matter
7. Claims 1-7, 9-19, and 21-34 are not in condition for allowance, as claims 1, 18 and 21 have been rejected under 35 U.S.C. 112(b). Furthermore, claims 2-7 and 9-19 are objected, as claims 2-7 and 9-19 depends upon claim 1. Meanwhile, claims 22-34 are objected, as claims 22-34 depends upon claim 21.
8. The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided an explanation below that describes how the prior art of record fails to suggest the corresponding claims.
Regarding claim 1, Schmidt (US 2020/0338346 A1) teaches an implantable system for cancer treatment (the implanted medical device 500 is configured to treat a cancerous tumor [0044, 0057, 0059, FIG. 5]) comprising:
a therapy output circuit (the implanted medical device 500 comprises an electric field generating circuit [abstract, 0057]), wherein the therapy output circuit is configured to generate an electrical output for one or more electrodes to create one or more electric fields (the electric field generating circuit is configured to generate an electrical output for the electrodes 108 to create one or more electric fields [abstract, 0051, 0057, 0059]);
control circuitry (the implanted medical device 500 comprises a control circuitry [abstract, 0057, 0059]), wherein the control circuitry causes the therapy output circuit to generate the one or more electric fields at frequencies selected from a range of between 10 kHz to 1 MHz within a bodily tissue ([abstract, 0057, 0101]), wherein the one or more electric fields are effective to prevent and/or disrupt cellular mitosis in a cell ([0102]); and
a therapy zone temperature sensor (the implanted medical device 500 may comprise one or more temperature sensors 518 that are configured to measure the temperature of tissue at the site of the tumor 110 which is treated by the electric field [abstract, 0060-0062]);
wherein the implantable system is configured to measure temperature and/or record temperature data of a patient over time (the one or more temperature sensors 518 are configured to monitor the temperature of the tissue [0060-0062]. Furthermore, the one or more temperature sensors 518 may monitor the changes in temperature of the tissue throughout the duration of the treatment [0060-0062]);
track that the tissue is exposed to temperatures above a threshold level ([0044]); and
the temperature data comprises tissue temperatures (the temperature sensors 518 are configured to record the changes in the temperature of the tissue throughout the duration of the treatment [0060-0061, 0072]).
Although teaches the use of time stamps ([0093]) Schmidt does not explicitly teach the temperature data to include time stamps.
The prior art by Shamir (US 2022/0305277 A1) is analogous to Schmidt, as they both teach the application of electric fields to region of interest (e.g., tumor) within the patient’s body [0070, 0074-0075]).
Shamir teaches the temperature data to include time stamps (the patient’s vital or physiological parameters (e.g., temperature) are recorded during a treatment session of inducing an electric field (e.g., tumor treating field) in the subject’s body [0074-0075]. Specifically, the patient’s vital or physiological parameters (e.g., temperature) are recorded over time and stored with time stamps [0032, 0040, 0074-0075]. Furthermore, the patient’s vital or physiological parameters (e.g., temperature) may be collected at regular time intervals (e.g., every second, five seconds, thirty seconds, one minute, five minutes, ten minutes, thirty minutes, an hour, two hours, four hours, etc.) [0074-0075]).
However, Schmidt and Shamir do not explicitly teach wherein the implantable system is configured to track the amount of time that tissue is exposed to temperatures above the threshold level.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 2-7 and 9-19 are considered to contain allowable subject matter, as claims 2-7 and 9-19 depends upon claim 1.
Regarding claim 21, Schmidt teaches an implantable system for cancer treatment (the implanted medical device 500 is configured to treat a cancerous tumor [0044, 0057, 0059, FIG. 5]) comprising:
a therapy output circuit (the implanted medical device 500 comprises an electric field generating circuit [abstract, 0057]), wherein the therapy output circuit is configured to generate one or more electric fields (the electric field generating circuit is configured to generate an electrical output for the electrodes 108 to create one or more electric fields [abstract, 0051, 0057, 0059]);
a control circuitry (the implanted medical device 500 comprises a control circuitry [abstract, 0057, 0059]), wherein the control circuitry causes the therapy output circuit to generate the one or more electric fields at frequencies selected from a range of between 10 kHz to 1 MHz within a bodily tissue ([abstract, 0057, 0101]), wherein the one or more electric fields are effective to prevent and/or disrupt cellular mitosis in a cell ([0102]);
a therapy zone temperature sensor (the implanted medical device 500 may comprise one or more temperature sensors 518 that are configured to measure the temperature of tissue at the site of the tumor 110 which is treated by the electric field [abstract, 0060-0062]);
wherein the implantable system is configured to measure temperature and/or record temperature data of a patient over time (the one or more temperature sensors 518 are configured to monitor the temperature of the tissue [0060-0062]. Furthermore, the one or more temperature sensors 518 may monitor the changes in temperature of the tissue throughout the duration of the treatment [0060-0062]); and
the temperature data comprising tissue temperatures (the temperature sensors 518 are configured to record the changes in the temperature of the tissue throughout the duration of the treatment [0060-0061, 0072]).
Schmidt does not explicitly teach an accelerometer, wherein the implantable system is configured to estimate physical activity based on a signal from the accelerometer and to modulate a therapy parameter based on the same in advance of measured temperature changes.
The prior art by Hendrick (WO 2023/039091 A1, with citations to corresponding US Publication No. 2024/0399154 A1) is analogous to Schmidt, as they both teach an implantable system that is configured to deliver electrical fields to treat a cancerous tissue ([0069]).
Hendrick teaches an accelerometer, wherein the implantable system is configured to estimate physical activity based on a signal from the accelerometer and modulate a therapy parameter based on the estimated physical activity (the IMD 106 is configured to receive and utilize the movement signals from the accelerometer as feedback to control or modulate the delivery of electric field therapy [0123]).
However, Schmidt and Hendrick do not explicitly teach modulating the therapy parameter based on the same in advance of measured temperature changes. As stated previously in the 112(b) rejection above, Applicant defines “the same” is defined as “the estimated physical activity” within the specification ([page 8, lines 5-10]). In this case, the Schmidt and Hendrick do not teach the estimated physical activity measured by the accelerometer to be used to modulate the therapy parameter in advance of measured temperature changes.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 22-34 are considered to contain allowable subject matter, as claims 22-34 depends upon claim 21.
Conclusion
9. Due to the new grounds of rejection included in this office action, which were not necessitated by the Applicant’s amendments to the claims, this action has been made NON-FINAL.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
Prosecution Insights