Prosecution Insights
Last updated: April 19, 2026
Application No. 18/270,286

ELECTROMAGNETIC IMPLANT FOR TREATMENT OF SOLID CANCERS

Non-Final OA §103
Filed
Jun 29, 2023
Examiner
CASLER, BRIAN L
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Ohio State Innovation Foundation
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
4y 2m
To Grant
95%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
21 granted / 29 resolved
+2.4% vs TC avg
Strong +23% interview lift
Without
With
+22.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 2m
Avg Prosecution
32 currently pending
Career history
61
Total Applications
across all art units

Statute-Specific Performance

§101
9.5%
-30.5% vs TC avg
§103
36.3%
-3.7% vs TC avg
§102
25.3%
-14.7% vs TC avg
§112
23.1%
-16.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 29 resolved cases

Office Action

§103
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 § 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 ( 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. 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. Claim (s) 1 -7, 10-15, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulman et al.(5193539) hereinafter Schulman et al. in view of Kroll et al.(US20050222646) hereinafter Kroll et al. Schulman et al. teaches an implantable microstimulator is substantially encapsulated within a hermetically-sealed housing inert to body fluids, and of a size and shape capable of implantation in a living body, Power and information for operating the microstimulator is received through a modulated, alternating magnetic field in which a coil is adapted to function as the secondary winding of a transformer. Electrical energy is stored in capacitor means and is released into the living body by controlled, stimulating pulses which pass through body fluids and tissue between the exposed electrodes of the microstimulator. Detection and decoding means within the microstimulator are provided for controlling the stimulating pulses in accordance with the modulation of the received, alternating magnetic field. Means for controllably recharging the capacitor is provided. The invention teaches the electrical elements of an implantable, microstimulator useful in a wide variety of applications . The microstimulators, may be planted in or near any part of the body, in the brain, a muscle, nerve, organ or other body area. Regarding claim s 1 -3 , 10 , 12-14, 17 and 19, Schulman et al. teaches placing the hermetically-sealed housing of the implant near or within an organ within the body, generating a magnetic field near the implant and inducing an electric field in the implant device and to correspondingly treat the desired area of the body. Note Fig. 2 and 12, and paragraph 8, a modulated, power source on the left, the skin and two implanted microstimulators on the right. Coil 1 is driven by a modulated oscillator 6 which, in turn, is driven by a stimulation controller 7. Underneath (shown to the right of) skin 8 are implanted microstimulators such as 9 and 10. Microstimulator 9 is shown in greater detail. Secondary coil 11, within microstimulator 9 receives energy and control information from the modulated, alternating magnetic field ( generating a changing magnetic field) provided by coil 1 and passes such energy and information to electronic control means which comprises power supply and data detector 12 which, in turn, provides power to an electrode recharge current controller 13 and stimulating electrodes 14 and 15 . Schulman et al. teaches microstimulators, may be planted in or near any part of the body, in the brain, a muscle, nerve, organ or other body area , does not specifically teach that the energy applied to the localized area in the body or organ is an electric field or that the applied energy is specifically to treat cancer. Kroll et al. teaches in the same field of endeavor of implantable devices for treating the body a method of treating cancer including a device, either partially or totally implanted, consisting of a generator and one or more wires (or leads) containing one or more electrodes. The electrodes are implanted in or near the tumor and the generator may be implanted subcutaneously as close to the tumor as practical. The device is powered either by an implantable generator or via an external electrical source . Paragraph [0112] sets forth Many variations of lead configurations are possible and, likewise, possibilities of electrode placement are equally numerous. The above are but a few examples of the types of lead configurations and electrode placements possible. As shown above, the leads of the present embodiment may be multipolar and unipolar and of various lengths, sizes, and shapes. Furthermore, the leads may terminate with electrodes that are anode and/or cathode, and be implanted into, adjacent to, and/or in the internal periphery of a tumor. In any event, the electrodes and leads of the preferred embodiment should be configured so that an electric field encompasses as much of the tumor as possible (or alternatively a target portion of the tumor) while excluding the majority of the surrounding tissue. Note also, paragraphs [0070] specifically sets forth a wide variety of types of cancers the device treats including prostate, liver and pancreatic cancers, [0112], [0114], [0124], and [0148]. Paragraph [0125], As the size, shape, density, and other characteristics of the tumor 6 change during application of electrical therapy, the central vector of current flow can be altered through selectively activating multiple electrodes. The system can also pulse for more energy efficiency, such as by delivering one or more pulses of current between one or more pairs (or more) of the electrodes 48. In some cases it is more energy efficient to pulse at a low duty cycle than to maintain a steady current, even when the pulses may be at a higher voltage. Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Schulman et al. to specifically generate an electric field within the electrodes to treat cancerous tumors as taught by Kroll et al. to provide a more localized and effective treatment for cancer. Regarding claim 4 and 18, Schulman et al. teaches a biocompatible casing and a coil with a number of windings. Note Fig. 2 and 12, and paragraph 4, (4) FIG. 1 shows, figuratively, how a primary coil 1, which produces an alternating magnetic field, at a frequency, say, of 2 mHz , is disposed with respect to a number of microstimulators such as 2, 3, and 4, implanted, say, in an arm 5. The microstimulators, of course, may be planted in or near any part of the body, in the brain, a muscle, nerve, organ or other body area. The system operates as an air-gap transformer in which coil 1 is the primary winding, exterior to the body, and the microstimulators such as 2, 3 and 4 each have coils within them which act as secondary windings of the transformer. Regarding claim 5 and 20, Schulman et al. teaches where the device further includes a capacitor. Note Figures 2, and 12 and paragraph (13) , The microstimulator of this invention receives both energy and control information from a modulated, alternating magnetic field. A coil, acting as a secondary winding of a transformer, receives the alternating magnetic field energy which is rectified and stored on a capacitor. Regulation of the charge on the capacitor is provided. Electronic control means detects and decodes the modulating information to provide the desired control. Such control includes validating the received information, providing the stimulation signal, (its duration, amplitude and shape), and controlling the recharge of the capacitor for the stimulating charge. Paragraph (64), the electrodes are each connected in series with an axial capacitor, such as axial capacitor 82. Regarding claim s 6 -7 and 15, Schulman et al. teaches the small size, the microstimulator must be capable of receiving and storing sufficient energy to provide the desired stimulating pulses , but also, may be required to respond to received control information as to pulse duration, current amplitude and shape . Further, stimulators should achieve a "charge balancing", that is, a balancing of current flow through the body tissue in both directions to prevent damage to the tissue which results from continued, preponderance of current flow in one direction. It is operable to provide stimulation pulses of desired duration, desired current amplitude and desired shape . The stimulation pulses are delivered to the body through electrodes exposed on the outer surface of the microstimulator. Within the microstimulator, an induction coil receives energy from outside the body and a capacitor is used to store electrical energy which is released to the microstimulator's exposed electrodes under the control of electronic control circuitry means. The stimulating pulse duration, pulse amplitude and pulse shape are controlled by a received alternating magnetic field . (67) The embodiment shown in FIGS. 12 and 13 allows the provision of a single large stimulating pulse, or quick, successive pulses, or spaced pulses at rates and magnitudes not otherwise achievable. Such wire electrodes may be longer than the proportions shown in the drawings . (59) FIG. 9 is a top view of a microstimulator with only the housing 72 shown in cross-section. Coil 11 is illustrated as being numerous turns of a fine wire and is included within the microstimulator housing 72 which is only approximately 10 mm long. The coil 11 and ferrite core 50 occupy a large part of the housing 72. Coil 11 may be approximately 200 turns or more of a fine, copper wire. The coil 11 acts as the secondary of a transformer and receives energy by induction from outside the body. (60) A preferred embodiment in the construction of coil 11, is 250 turns of 0.00102" D, or finer, insulated, copper wire on a ferrite core having a diameter of approximately, 0.050". Due to the stray, or distributed capacitance of such windings, the coil would be resonant at approximately 2 mHz. Schulman et al. teaches the number of windings of the coil and the coil may have different number of windings and Kroll et al. teaches the electrodes and leads of the preferred embodiment should be configured so that an electric field encompasses as much of the tumor as possible (or alternatively a target portion of the tumor) while excluding the majority of the surrounding tissue. The electrodes 31, 32, 33, 34, and 35 comprise an electrode array 310 that can be used to increase the effectiveness of electrical therapy by establishing an electric field pattern that encompasses all of the tumor volume. Typically a set of electrode pairings having a greater interelectrode distance, such as between the electrodes 40 and 42, in comparison to electrodes 40 and 41, or 41 and 42, are used in electrical therapy to create the maximum electric field for encompassing large portions of a tumor . However, Schulman et al. as modified by Kroll et al. do not specifically teach changing the number of windings or the size of the capacitor or the parameters of the magnetic field to alter the electric filed output. It is noted that there are a limited number of choices available to a person of ordinary skill in the art to generate and modify a corresponding magnetically induced electric field. Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to vary the windings, or change the capacitor size or vary the magnetic field parameters to adjust the corresponding electric field output with a reasonable expectation of successfully generating the varying magnetic field and ultimately the electric field to ensure that the electric field encompasses as much of the tumor as possible (or alternatively a target portion of the tumor) while excluding the majority of the surrounding tissue. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct . 1727, 1742, 82 USPQ2d 1385, 1396 (2007). Regarding claim s 11, Schulman et al. teaches the small size, the microstimulator must be capable of receiving and storing sufficient energy to provide the desired stimulating pulses, but also, may be required to respond to received control information as to pulse duration, current amplitude and shape. However, Schulman et al. does not specifically teach determining a change in a voltage or a current in the implant device; and determining a change in a size of the tumor based on the determined change in the voltage or current. Kroll et al. teaches in paragraph [0081] a lthough electrical therapy examples described hereinbelow may be expressed in voltage (i.e. volts) and/or current (i.e. amperes), it should be understood that by applying Ohm's law, which states that voltage and current are proportional (i.e. V=IR), the equivalent voltage to current or current to voltage may be calculated. The proportionality constant is the resistance (R) in the electrode/tissue system. Resistance is measured in Ohms (.OMEGA.) and is equal to one volt per ampere. Resistance is the property of a material to resist current flow. In the electrical therapy system described herein, resistance may be caused by any number of factors including tumor density, tumor consistency, tumor volume, tumor location, pharmaceuticals utilized, wire(s) (or lead) utilized, electrode(s) utilized, and patient characteristics such as weight, age, gender, and diet. Each of the three leads 45, 46, and 47, which have a plurality of spaced apart electrodes 48 along a portion of their distal ends are implanted into a tumor 6 orthogonally and intersect near the center of the tumor 6. As the size, shape, density, and other characteristics of the tumor 6 change during application of electrical therapy, the central vector of current flow can be altered through selectively activating multiple electrodes 48 on the x, y, and z coordinates. In this way, the system can target the center of the tumor's mass. Additionally the system can selectively designate electrodes 48 as anodes or cathodes, or both anodes and cathodes in any sequence (such as using the hex bridge 300, such as shown in FIG. 2e-2f) and alter the 3-dimensional distribution of currents. Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Shuman et al. to determine a change in a parameter( current or voltage) of the device as the tumor changes as taught by Kroll et al. to be able to adjust the volume treated or ensure the tumor’s center of mass is maintained during treatment . Claim (s) 8,9, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulman et al.(5193539) hereinafter Schulman et al. in view of Kroll et al.(US20050222646) hereinafter Kroll et al. and further in view of CHEN et al.( WO 9939769 ) hereinafter Chen et al. Regarding claim s 8-9 and 16 Schulman et al. teaches p ower and information for operating the microstimulator is received through a modulated, alternating magnetic field in which a coil is adapted to function as the secondary winding of a transformer. Electrical energy is stored in capacitor means and is released into the living body by controlled, stimulating pulses which pass through body fluids and tissue between the exposed electrodes of the microstimulator. (13) The microstimulator of this invention receives both energy and control information from a modulated, alternating magnetic field . A coil, acting as a secondary winding of a transformer, receives the alternating magnetic field energy which is rectified and stored on a capacitor. Regulation of the charge on the capacitor is provided. Electronic control means detects and decodes the modulating information to provide the desired control. Such control includes validating the received information, providing the stimulation signal, (its duration, amplitude and shape), and controlling the recharge of the capacitor for the stimulating charge. However, Schulman et al. as modified by Kroll et al. do not specifically teach where the magnetic field is generated with a magnet or that the magnet is rotating. CHEN et al. teaches in the same field of endeavor an external power head (20) is energized by a motor (22) causing movement of an element (26) that produces a varying magnetic field, thereby inducing power in an implanted receiver coil (30) within a patient's body. The external power head (20) includes either one or more moving permanent magnets (42), or one or more moving elements that vary the magnetic flux coupled to the implanted receiver coil (30). As a result of the varying magnetic field experienced by the implanted receiver coil (30), an electric current flows from the implanted receiver coil (30) to energize an implanted medical device (34). It is noted that there are a limited number of choices available to a person of ordinary skill in the art to generate and modify a corresponding magnetically induced electric field. Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to try to utilize an electromagnet or a permanent magnet with rotation to generate the desired magnetic field as taught by Chen et al. with a reasonable expectation of successfully generating the magnetic field and ultimately the electric field to ensure that the electric field encompasses as much of the tumor as possible (or alternatively a target portion of the tumor) while excluding the majority of the surrounding tissue. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct . 1727, 1742, 82 USPQ2d 1385, 1396 (2007). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. GLEICH ( WO 2014076666 ) teaches an energy application system for applying energy to an object, particularly to a low dose rate brachytherapy system. The system includes an energy application device (6), which is preferentially a seed to be introduced into the object and which comprises a radioactive unit (10) for applying the energy and a switching unit (8, 1, 12) for modifying the energy applied to the object, wherein the switching unit is adapted 5 to be switchable by a field like a magnetic or ultrasound field generated outside of the object. PARSAI ( WO 2010051322 ) teaches a system combines hyperthermia and radiation treatments in a single treatment modality by using a radioactive seed having magnetic properties. Faltys ( 10583304 ) teaches an implantable microstimulators for treating chronic inflammation. These devices can include a static magnetic field detector (e.g., non-Hall effect sensors/detectors, including those based on a Wiegand effect or generating pulses at a predetermined frequency range and using a detection circuit to determine the decay rate of the pulses), to trigger an emergency shut off of the microstimulator. Also described are methods and apparatuses for regulating the temperature of an implant based applied power from a charger (e.g., voltage across the charger when unloaded and when loaded by the implant) to yield a power control loop correlated with the power drawn by the implant to determine temperature of the implant. A negotiation protocol can exchange data between the charger and the implant (e.g., type of charger, type of implant, nature of the coupling between the two, etc.) to set target power control loop parameters to estimate and regulate implant temperature. CHENG ( CN 109363826 ) teaches a tumor thermotherapy device based on embedded coil and the parameter optimization method. in the traditional magnetic-mediated tumor thermal therapy to human body injecting magnetic particles generate heat, and along with the diffusion of particles, the effect of heat treatment is reduced. The invention claims a based on implantable coil magnetic-mediated tumor thermal therapy device, comprising an internal coil and external coil. KOZUKA ( JP 2003038548 ) teaches an implant in which a resonance circuit is constituted of a coil 1 and a capacitor 2 and coil electric current is efficiently energized by magnetic field irradiation of a definite frequency and heat is highly efficiently generated by optimization of cross-sectional diameter of a coil wire material is constituted. Schroeppel ( US 20040254618 ) teaches an implantable electrical method and apparatus for the treatment of cancer tumors based on the usage of various levels of electrical fields and current to assist in specific ways to reduce tumor size. The appropriate voltage, currents, and time duration as well as the usage of adjunctive pharmacological therapy are taught. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT BRIAN L CASLER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-4956 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-Th 6:30 to 4:30 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Charles Marmor can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-4730 . 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. /BRIAN L CASLER/ Primary Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Jun 29, 2023
Application Filed
Mar 08, 2026
Non-Final Rejection — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
72%
Grant Probability
95%
With Interview (+22.9%)
4y 2m
Median Time to Grant
Low
PTA Risk
Based on 29 resolved cases by this examiner. Grant probability derived from career allow rate.

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