CTNF 18/847,424 CTNF 88743 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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 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. 12-151 AIA 26-51 12-51 Status of Claims Claims 1-12 are pending and under consideration for patentability. Information Disclosure Statement The Information Disclosure Statement submitted on 07 March 2025 has been acknowledged and considered by the Examiner. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1, 3, 5-8, and 10 are rejected under 35 U.S.C. 102( a)(1) and 35 U.S.C. 102(a)(2 ) as being anticipated by Subramanian et al. (WO 2021/011588 A1) . Regarding claim 1, Subramanian describes an intraoperative patient monitoring system ([0054]), the system comprising one or more sensors configured to measure electroencephalogram ([0071], scenarios presented) and electrodermal signals of a patient ([0015], [0054]) subject to at least one anesthetic agent and at least one analgesic agent during an operative medical procedure ([0006], [0064] - [0065]) a processor, operably coupled to the one or more sensors ([0054] - [0055]), configured to receive the EEG and electrodermal signals ([0054] - [0055]) using the EEG or electrodermal signals, monitor a nociceptive state of the patient in real-time during the operative medical procedure ([0015], [0054]) generate a post-operative pain management plan using at least one of the nociceptive state of the patient during the operative medical procedure or the at least one analgesic agent administered to the patient for the operative medical procedure ([0065]) Regarding claim 3, Subramanian describes wherein the at least one analgesic agent includes an opioid ([0065], the anesthesiologist may administer a combination of drugs instead of simply increasing the quantity of propofol or opioid, indicating that opioids are administered during the surgery). Regarding claim 5, Subramanian describes wherein the post-operative pain management plan includes a plurality of post-operative outcomes ([0065]). Regarding claim 6, Subramanian describes wherein the plurality of outcomes includes post-operative pain or opioid requirements ([0065]). Regarding claim 7, Subramanian describes wherein the processor is further configured to achieve a desired post-operative outcome including reduced post-operative pain or opioid requirements based on the nociceptive state of the patient in real-time during the operative medical procedure ([0054], [0065]). Regarding claim 8, Subramanian describes an intraoperative patient monitoring system ([0054]), the system comprising one or more sensors configured to measure electroencephalogram ([0071], scenarios presented) and electrodermal signals of a patient ([0015], [0054]) subject to at least one anesthetic agent and at least one analgesic agent during an operative medical procedure ([0006], [0064] - [0065]) a processor, operably coupled to the one or more sensors ([0054] - [0055]), configured to receive the EEG and electrodermal signals ([0054] - [0055]) using the EEG or electrodermal signals, generate a report indicating the nociceptive state of the patient in real-time during the operative medical procedure while the patient is subject to the at least one anesthetic ([0015], [0054]) Regarding claim 10, Subramanian describes wherein the at least one analgesic agent includes an opioid ([0065], the anesthesiologist may administer a combination of drugs instead of simply increasing the quantity of propofol or opioid, indicating that opioids are administered during the surgery) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 2, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Subramanian in view of Brown et al. (US 2018/0146876 A1) . Regarding claims 2 and 9, Subramanian describes the systems of claim 1 and claim 9, but Subramanian does not explicitly disclose wherein the processor is further configured to identify from the EEG signal a signature highly correlated with an effective site concentration in the patient of the at least one analgesic agent. However, Brown also describes a patient monitoring system ([0100]), including wherein the system is configured to identify from an EEG signal a signature highly correlated with an effective site concentration in a patient of an analgesic agent (figures 6A-6B and their corresponding descriptions in [0172] - [0174]). As Brown is also directed towards patient monitoring systems, including the use of EEG, and is in a similar form of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to identify an effective site concentration of an analgesic agent in a patient, as described by Brown, when using the system described by Subramanian, as doing so advantageously allows the resulting system to better monitor the state of consciousness of the patient. Regarding claim 12, Subramanian describes generating the report indicating the nociceptive state of the patient in real-time during the operative medical procedure ([0054]), and Brown describes including an instruction to titrate at least one of the dose of the at least one anesthetic agent or at least one analgesic agent administered to the patient ([0172]) . 07-21-aia AIA Claim s 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Subramanian in view of Addison et al. (US 2022/0015696 A1) . Regarding claims 4 and 11, Subramanian describes the systems of claim 3 and claim 10, but Subramanian does not explicitly disclose wherein the opioid includes fentanyl. However, Addison also describes an intraoperative patient monitoring system ([0015]), including wherein the opioid used as an analgesic includes fentanyl ([0079]). As Addison is also directed towards an intraoperative patient monitoring system and is in a similar form of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use fentanyl, as described by Addison, as the analgesic agent in the system described by Subramanian, as doing so advantageously allows the resulting system to use a known opioid to induce the analgesia during a surgical procedure. Statement on Communication via Internet Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant: “Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.” Please refer to MPEP 502.03 for guidance on Communications via Internet. Conclusion Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 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. /Ankit D Tejani/ Primary Examiner, Art Unit 3796 Application/Control Number: 18/847,424 Page 2 Art Unit: 3796 Application/Control Number: 18/847,424 Page 3 Art Unit: 3796 Application/Control Number: 18/847,424 Page 4 Art Unit: 3796 Application/Control Number: 18/847,424 Page 5 Art Unit: 3796 Application/Control Number: 18/847,424 Page 6 Art Unit: 3796 Application/Control Number: 18/847,424 Page 7 Art Unit: 3796 Application/Control Number: 18/847,424 Page 8 Art Unit: 3796
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