Prosecution Insights
Last updated: April 19, 2026
Application No. 17/777,104

TISSUE TREATMENT SYSTEMS, DEVICES, AND METHODS

Final Rejection §102§103
Filed
May 16, 2022
Examiner
RHODES, NORA W
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Enchannel Medical Ltd.
OA Round
2 (Final)
52%
Grant Probability
Moderate
3-4
OA Rounds
4y 2m
To Grant
82%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allow Rate
47 granted / 91 resolved
-18.4% vs TC avg
Strong +30% interview lift
Without
With
+30.3%
Interview Lift
resolved cases with interview
Typical timeline
4y 2m
Avg Prosecution
62 currently pending
Career history
153
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
60.4%
+20.4% vs TC avg
§102
23.1%
-16.9% vs TC avg
§112
14.6%
-25.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 91 resolved cases

Office Action

§102 §103
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 Amendment Acknowledgment is made to the amendment received 12/2/2025. Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action. Response to Arguments Applicant’s arguments with respect to claim 55 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claim 55 was rejected under 35 U.S.C. 102(a)(1) as being anticipated by Long. Now, based on amendments to the claim language, claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Zarins. Applicant's arguments filed 12/2/2/2025 regarding claim 73 have been fully considered but they are not persuasive. Applicant argues that Nicolaescu does not disclose delivering a second dose of energy to tissue because the ultrasonic energy drives a vibrating blade which cuts the tissue. However, the vibration of the blade is a form of energy that is being applied to the tissue in a “dose”. This vibration due to the ultrasonic energy is a different type of energy than the RF energy that Nicolaescu also applies to tissue. Thus, Nicolaescu does disclose the claim language “wherein the first dose of energy and the second dose of energy comprise different forms of energy”. Therefore, applicant’s arguments regarding claim 73 have been fully considered but they are not persuasive so the previous rejection stands. Claim Rejections - 35 USC § 103 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. 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 55, 57-60, 65, 68-72, 74-77, 79-80, and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Long et al., US 20120220998, herein referred to as “Long”, in view of Zarins et al., US 20190175268, herein referred to as “Zarins”. Regarding claim 55, Long discloses a system for treating tissue of a patient (Figure 1), the system comprising: an energy delivery console (Figure 1: energy source 14) for providing a first dose of energy and a second dose of energy ([0034]); and an energy delivery device (Figure 1: electrical ablation device) comprising a first energy delivery element configured to deliver the first dose of energy to target tissue (Figures 1-2: first electrode 24a), and a second energy delivery element configured to deliver the second dose of energy to the target tissue (Figures 1-2: second electrodes 24b), wherein the first dose of energy comprises a delivery of energy that reversibly alters the target tissue ([0093]: “Once the electrodes 24a,b are located into or proximate the undesirable tissue 48, the electrodes 24a,b may be energized with a first sequence of electrical pulses to deliver a first energy dose that is less than the necrotic threshold to induce thermal heating in the tissue surrounding the electrode/tissue interface.” And [0034]); wherein the second dose of energy comprises a delivery of energy that irreversibly alters the target tissue ([0093]: “Once the temperature and/or pressure of the undesirable tissue 48 achieves a predetermined threshold, the electrodes 24a,b may be energized with a second sequence of electrical pulses to deliver a second energy dose equal to or greater than the necrotic threshold to induce cell necrosis in the tissue by irreversible electroporation to create a necrotic zone 65.”); wherein the first dose of energy is delivered to enhance an effect of a therapy provided by the second dose of energy ([0094] and [0069]: “The first energy dose may reduce the necrotic threshold by 0-500 mV, such as, for example, 50-400 mV, 100-300 mV, and 150-250 mV. The first energy dose may reduce the necrotic threshold by 0-50%, such as, for example, 10%, 20%, 30%, and 40%.”). Long does not explicitly disclose a system comprising a processor configured to monitor tissue impedance during delivery of the second dose of energy and to automatically terminate delivery of the second dose of energy upon confirmation of irreversible electroporation. However, Zarins teaches a system (Figure 4) comprising a processor configured to monitor tissue impedance during delivery of the second dose of energy ([0056]) and to automatically terminate delivery of the second dose of energy upon confirmation of irreversible electroporation ([0048]: “This may be achieved, for example, via irreversible electroporation, electrofusion and/or inducement of apoptosis in the nerve cells.” And [0056] and [0019]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that it includes a processor configured to monitor tissue impedance during delivery of the second dose of energy and to automatically terminate delivery of the second dose of energy upon confirmation of irreversible electroporation as taught by Zarins to quantify the efficacy, extent, or cell selectivity of the therapy (Zarins [0056]). Regarding claim 57, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the target tissue comprises tissue selected from the group consisting of: cardiac tissue; nerve tissue; vessel wall tissue; organ tissue; brain tissue; lung tissue; kidney tissue; liver tissue; stomach tissue; muscle tissue; and combinations thereof ([0041]). Regarding claim 58, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the energy delivery device comprises a catheter (Figure 1: flexible shaft 22 and sheath 26 form a catheter). Regarding claim 59, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the first energy delivery element and the second energy delivery element comprise the same component ([0067]: “applying a first sequence of electrical pulses to the first electrode less than the necrotic threshold to induce thermal heating, applying a second sequence of electrical pulses to the first electrode to induce cell necrosis by irreversible electroporation,”). Regarding claim 60, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the first energy delivery element and the second energy delivery element comprise different components ([0067]: “In bipolar mode, the first electrode 24a may be electrically connected to a prescribed voltage of one polarity and the second electrode 24b may be electrically connected to a prescribed voltage of the opposite polarity. When more than two electrodes are used, the polarity of the electrodes may be alternated so that any two adjacent electrodes may have either the same or opposite polarities.”). Regarding claim 65, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the first dose of energy is insufficient to ablate, cause necrosis of, and/or otherwise permanently alter the target tissue ([0034]: “wherein the first sequence of electrical pulses delivers a first energy dose that is less than the necrotic threshold to induce thermal heating in the tissue”), and the second dose of energy is sufficient to ablate, cause necrosis of, and/or otherwise permanently alter the target tissue ([0034]: “the second sequence of electrical pulses delivers a second energy dose equal to or greater than the necrotic threshold to induce cell necrosis in the tissue by irreversible electroporation.”). Regarding claim 68, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the system is configured to deliver the second dose of energy after the first dose of energy has been delivered ([0067] and Figures 7 and 9). Regarding claim 69, Long in view of Zarins discloses the system as in claim 68, and Long further discloses a system wherein the second dose of energy is configured to irreversibly electroporate the target tissue ([0069]: “applying a second sequence of electrical pulses to undesirable tissue to induce cell necrosis by irreversible electroporation.”). Regarding claim 70, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the first dose of energy comprises radiofrequency (RF) energy delivered at a level insufficient to ablate the target tissue ([0061]: “In one embodiment, the energy source 14 may be configured to produce RF waveforms at predetermined frequencies, amplitudes, pulse widths, and/or polarities suitable for thermal heating and/or electrical ablation of cells in the tissue treatment region.” ). Regarding claim 71, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the first dose of energy comprises a form of energy selected from the group consisting of: thermal energy; heat energy; cryogenic energy; electromagnetic energy; radiofrequency (RF) energy; microwave energy; light energy; laser light energy; sound energy; subsonic energy; ultrasonic energy; chemical energy; and combinations thereof ([0057] and [0034]). Regarding claim 72, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the second dose of energy comprises a form of energy selected from the group consisting of: thermal energy; heat energy; cryogenic energy; electromagnetic energy; radiofrequency (RF) energy; microwave energy; light energy; laser light energy; sound energy; subsonic energy; ultrasonic energy; chemical energy; and combinations thereof ([0057] and [0034]). Regarding claim 74, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the second dose of energy comprises an irreversible electroporation pulse of energy ([0069]: “applying a second sequence of electrical pulses to undesirable tissue to induce cell necrosis by irreversible electroporation.”). Regarding claim 75, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the second dose of energy comprises a parameter selected from the group consisting of: a dose delivered by an electrode with a length of at least 1.46mm, and/or a length of no more than 8mm; a dose delivered by a pair of electrodes that are separated by at least 1mm, and/or separated by no more than 11mm; a dose based on a provided voltage of at least 500V and/or no more than 5000V; a dose comprising a field strength of at least 200V/cm and/or no more than 1000V/cm ([0081]); a dose comprising a pulse width of at least 0.1 psec and/or no more than 200psec; a dose comprising a series of pulses with a pulse repetition interval of at least 1 psec; and combinations thereof. Regarding claim 76, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the energy delivery device is configured to deliver the first dose of energy for a fixed time period ([0075]: “In one embodiment, the series of first pulses 70 may comprises a single pulse 70a or multiple pulses having a first amplitude v.sub.1 of 500 VDC, a first pulse width t.sub.w1 of 10 .mu.s to 15 .mu.s, and a period t.sub.1 of about 100 ms (f.sub.1=10 Hz) sufficient to induce thermal heating in the tissue proximate the electrode-tissue-interface immediately surrounding the respective electrodes 24a,b.”). Regarding claim 77, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the system is configured to monitor the heart cycle of the patient ([0108]), and wherein the energy delivery device is configured to initiate the second dose of energy when the heart cycle reaches a desired heart cycle point ([0069]: “The first energy dose and/or second energy dose may be synchronized with the patient's cardiac cycle to prevent ventricular arrhythmia.”). Regarding claim 79, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the system is configured to monitor the patient's heart cycle during the delivery of the first dose and/or during the delivery of the second dose ([0108] and ([0069]: “The first energy dose and/or second energy dose may be synchronized with the patient's cardiac cycle to prevent ventricular arrhythmia.”). Regarding claim 80, Long in view of Zarins discloses the system as in claim 79, and Long further discloses a system wherein the system is configured to monitor the patient's heart cycle during both the delivery of the first dose and the delivery of the second dose ([0108] and ([0069]: “The first energy dose and/or second energy dose may be synchronized with the patient's cardiac cycle to prevent ventricular arrhythmia.”). Regarding claim 87, Long in view of Zarins discloses the system as in claim 55, and Long further discloses a system wherein the first dose of energy is configured to cause at least a 2°C increase in temperature of the target tissue ([0090]). Claims 56, 61-64, 66-67, and 81-86 are rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Zarins, further in view of Stewart et al., US 20190216525, herein referred to as “Stewart”. Regarding claim 56, Long in view of Zarins discloses the system as in claim 55, but does not explicitly disclose a system wherein the target tissue comprises cardiac tissue. However, Stewart teaches a system (Figure 1) wherein the target tissue comprises cardiac tissue ([0009]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the target tissue comprises cardiac tissue as taught by Stewart so that the system can treat cardiac arrhythmia (Stewart [0003]). Regarding claim 61, Long in view of Zarins discloses the system as in claim 55, but does not explicitly disclose a system wherein the first energy delivery element comprises multiple energy delivery elements. However, Stewart teaches a system wherein the first energy delivery element comprises multiple energy delivery elements (Figure 2: electrodes e1, e3, e5, and e7 and [0029]: “energy may be delivered between odd-numbered electrodes in a first delivery”). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the first energy delivery element comprises multiple energy delivery elements as taught by Stewart so that the device can form a contiguous lesion without the need to move the catheter (Stewart [0029]). Regarding claim 62, Long in view of Zarins and Stewart discloses the system as in claim 61, and Stewart further teaches a system wherein the second energy delivery element comprises multiple energy delivery elements (Figure 2: electrodes e2, e4, e6, and e8 and [0029]: “energy may be delivered between odd-numbered electrodes in a first delivery and may be delivered between even-numbered electrodes in a second delivery”). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the second energy delivery element comprises multiple energy delivery elements as taught by Stewart so that the device can form a contiguous lesion without the need to move the catheter (Stewart [0029]). Regarding claim 63, Long in view of Zarins and Stewart discloses the system as in claim 62, and Stewart further teaches a system wherein the energy delivery device comprises a first energy delivery device and a second energy delivery device (Figures 4A-B: delivery devices 12A and 12B), wherein the multiple energy delivery elements of the first energy delivery device comprises a first device element (Figures 4A: electrodes 18) and the multiple energy delivery elements of the second energy delivery device comprises a second device element ([0030]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the multiple energy delivery elements of the first energy delivery device comprises a first device element and the multiple energy delivery elements of the second energy delivery device comprises a second device element as taught by Stewart so that the device can form a contiguous lesion without the need to move the catheter (Stewart [0029]). Regarding claim 64, Long in view of Zarins and Stewart discloses the system as in claim 63, and Stewart further teaches a system wherein during the delivery of the second dose, the first device element is configured to be positioned on an endocardial surface of the patient's heart ([0018]: “The system 10 may be used to treat endocardial surfaces” and [0030]: “ the first delivery device 12A may be located inside a heart chamber and the second delivery device 12B may be located in another area of the heart but proximate the location of the first delivery device 12A”) and the second device element is configured to be positioned on an epicardial surface of the patient's heart ([0018]: “the system may be used to treat other areas, including epicardial tissue” and [0030]: “ the first delivery device 12A may be located inside a heart chamber and the second delivery device 12B may be located in another area of the heart but proximate the location of the first delivery device 12A”). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that during the delivery of the second dose, the first device element is configured to be positioned on an endocardial surface of the patient's heart and the second device element is configured to be positioned on an epicardial surface of the patient's heart as taught by Stewart so that the device can ablate an area of cardiac tissue between two devices (Stewart [0030]. Regarding claim 66, Long in view of Zarins discloses the system as in claim 55, but does not explicitly disclose a system wherein the system is configured to deliver the first dose of energy and/or the second dose of energy to an endocardial tissue surface. However, Stewart teaches a system wherein the system is configured to deliver the first dose of energy and/or the second dose of energy to an endocardial tissue surface ([0018]: “The system 10 may be used to treat endocardial surfaces”). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the system is configured to deliver the first dose of energy and/or the second dose of energy to an endocardial tissue surface as taught by Stewart because endocardial tissue is affected by cardiac motion, respiratory motion, random patient movements, and/or other factors that may affect electrode-tissue contact (Stewart [0018]). Regarding claim 67, Long in view of Zarins discloses the system as in claim 55, but does not explicitly disclose a system wherein the system is configured to deliver the first dose of energy and/or the second dose of energy to an epicardial tissue surface. However, Stewart teaches a system wherein the system is configured to deliver the first dose of energy and/or the second dose of energy to an epicardial tissue surface ([0018]: “the system may be used to treat other areas, including epicardial tissue”). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the system is configured to deliver the first dose of energy and/or the second dose of energy to an epicardial tissue surface as taught by Stewart because endocardial tissue is affected by cardiac motion, respiratory motion, random patient movements, and/or other factors that may affect electrode-tissue contact (Stewart [0018]). Regarding claim 81, Long in view of Zarins discloses the system as in claim 79, but does not explicitly disclose a system wherein the energy delivery device is configured to deliver the first dose until the patient's heart cycle reaches a desired heart cycle point or until a timeout is reached. However, Stewart teaches a system wherein the energy delivery device is configured to deliver the first dose until the patient's heart cycle reaches a desired heart cycle point or until a timeout is reached (Figure 8 and [0036]: “An exemplary energy delivery timing may be at approximately 60-120 milliseconds after detection of the R wave so that the energy is delivered during at least a portion the ST segment. Energy delivery may be terminated before the onset of the T wave, regardless of what point during the ST segment at which energy delivery is initiated. ”). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the system is configured to deliver the first dose until the patient's heart cycle reaches a desired heart cycle point or until a timeout is reached as taught by Stewart to ensure that the timing of energy delivery occurs after depolarization of the ventricles and before repolarization (Stewart [0033]). Regarding claim 82, Long in view of Zarins discloses the system as in claim 55, but does not explicitly disclose a system wherein the system is configured to monitor the patient's heart prior to the delivery of the first dose of energy. However, Stewart teaches a system wherein the system is configured to monitor the patient's heart prior to the delivery of the first dose of energy (Figure 6: step 70 occurs before step 78). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the system is configured to monitor the patient's heart prior to the delivery of the first dose of energy as taught by Stewart to ensure that the timing of energy delivery occurs after depolarization of the ventricles and before repolarization (Stewart [0033]). Regarding claim 83, Long in view of Zarins and Stewart discloses the system as in claim 82, and Stewart further discloses a system wherein the system is configured to predict a time T1 of a next desired heart cycle point after receiving an energy delivery signal (Figure 6: step 72 and [0034]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the system is configured to predict a time T1 of a next desired heart cycle point after receiving an energy delivery signal as taught by Stewart so that the energy deliveries can be timed to interrupt the aberrant cardiac conduction circuit (Stewart [0034]). Regarding claim 84, Long in view of Zarins and Stewart discloses the system as in claim 83, and Stewart further discloses a system wherein the first dose of energy comprises energy delivery parameters based on a target amount of energy to be delivered and a time period to reach T1 ([0040]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the first dose of energy comprises energy delivery parameters based on a target amount of energy to be delivered and a time period to reach T1 as taught by Stewart so that the energy deliveries can be timed to interrupt the aberrant cardiac conduction circuit (Stewart [0034]). Regarding claim 85, Long in view of Zarins and Stewart discloses the system as in claim 84, and Stewart further discloses a system wherein the energy delivery device is configured to deliver the second dose of energy if the patient's heart cycle is determined by the system to be equal to the desired heart cycle point at time T1 ([0036]: “Energy may be delivered once during this time or it may be delivered multiple times, such as delivering energy a first time at approximately 80 milliseconds after detection of the R wave and delivering energy a second time at approximately 120 milliseconds after detection of the R wave. In this manner, energy may be delivered multiple times based, optionally, only during the ST segment and contact would not have to be evaluated after the initial contact assessment because energy delivery during this time may not induce arrhythmia.” And [0040]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the energy delivery device is configured to deliver the second dose of energy if the patient's heart cycle is determined by the system to be equal to the desired heart cycle point at time T1 as taught by Stewart so that the energy deliveries can be timed to interrupt the aberrant cardiac conduction circuit (Stewart [0034]). Regarding claim 86, Long in view of Zarins and Stewart discloses the system as in claim 84, and Stewart further discloses a system wherein the energy delivery device is configured to withhold delivery of the second dose of energy if the patient's heart cycle is determined to be different than the desired heart cycle point at time T1 (Figure 8 and [0035]: “Such deliveries may also be blanked or prevented from occurring during vulnerable periods of repolarization of the atrial or ventricular myocardium.”). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the energy delivery device is configured to withhold delivery of the second dose of energy if the patient's heart cycle is determined to be different than the desired heart cycle point at time T1 as taught by Stewart so that the energy deliveries can be timed to interrupt the aberrant cardiac conduction circuit (Stewart [0034]). Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Zarins, further in view of Yates et al., US 20180036065, herein referred to as “Yates”. Regarding claim 73, Long in view of Zarins discloses the system as in claim 55, but does not explicitly disclose a system wherein the first dose of energy and the second dose of energy comprise different forms of energy. However, Nicolaescu teaches a system (Figure 1) wherein the first dose of energy and the second dose of energy comprise different forms of energy (Figure 11 and Table 1 example 5). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the first dose of energy and the second dose of energy comprise different forms of energy as taught by Nicolaescu so that the system can achieve any combination of diagnostic or therapeutic effects (Nicolaescu [0035]). Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Zarins, further in view of Monson et al., US 20130103024, herein referred to as “Monson”. Regarding claim 78, Long in view of Zarins discloses the system as in claim 55, but does not explicitly disclose a system wherein the system is configured to enter an alert mode if the first dose is delivered and a timeout period is reached prior to the second dose being delivered. However, Monson teaches a system (Figure 1) wherein the system is configured to enter an alert mode if the first dose is delivered and a timeout period is reached prior to the second dose being delivered (Table 3: Device Status – Activation cycle timeout occurs after 25 sec od power activation without reaching Cycle Complete). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Long so that the system is configured to enter an alert mode if the first dose is delivered and a timeout period is reached prior to the second dose being delivered as taught by Monson so that a user is alerted that the treatment cycle is not complete (Monson Table 3). 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 Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm 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, Joanne Rodden can be reached on 3032974276. 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. /NORA W RHODES/Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Read full office action

Prosecution Timeline

May 16, 2022
Application Filed
Jun 24, 2025
Non-Final Rejection — §102, §103
Dec 02, 2025
Response Filed
Mar 04, 2026
Final Rejection — §102, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
52%
Grant Probability
82%
With Interview (+30.3%)
4y 2m
Median Time to Grant
Moderate
PTA Risk
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