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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 19 May 2026 is acknowledged. Thus, claims 1 – 10 are being considered on the merits.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8, lines 1 - 2, "providing PEMF treatment" should read -providing the PEMF treatment--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 – 10 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, line 5, "a PEMF treatment" is the same or different as the previously recited in lines 1 - 2 of claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 - 10 are directed to steps of detecting an electrical signal, determining that the electrical signal corresponds to a PEMF treatment applied to the treatment site; and transmitting, to a second device, data, which is an abstract idea.
Claims 1 - 10 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 20 is as follows:
Step 1: Claim 1 is drawn to an method.
Step 2A – Prong One: Claim 20 recites an abstract idea. In particular, claim 20 recites the following limitations:
detecting, with a PEMF sensor that is held or worn at a detection site on the patient that is distal from the treatment site, an electrical signal;
determining that the electrical signal corresponds to a PEMF treatment applied to the treatment site; and
transmitting, to a second device, data characterizing the PEMF treatment in response to determining that the electrical signal corresponds to a PEMF treatment level.
These elements detect, determine and transmit of claim 1 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper; and/or (3) they involve methods of organizing human activity such as managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). In particular, the “detecting, with a PEMF sensor that is held or worn at a detection site on the patient that is distal from the treatment site, an electrical signal; determining that the electrical signal corresponds to a PEMF treatment applied to the treatment site; and transmitting, to a second device, data characterizing the PEMF treatment in response to determining that the electrical signal corresponds to a PEMF treatment level” steps can be performed by a practitioner visually detecting the PEMF sensor being worn, determining that the electrical signal corresponds to a PEMF treatment applied to the treatment site, then based on that determination, transmitting the data characterizing the PEMF treatment. Accordingly, the “detect”, “determine”, and “transmit” limitations fall within the “Mental Processes” grouping of abstract ideas. Alternatively the detect and transmit step may be classified as insignificant extra solution activity.
Step 2A – Prong Two: Claim 20 recites the following limitations that are beyond the judicial exception: sensor and processor.
These element sensor of claim 1 does not integrate the exception into a practical application of the exception. In particular, the element sensor is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 20 does not recite additional elements that amount to significantly more than the judicial exception itself. The recitation “detecting, with a PEMF sensor that is held or worn at a detection site on the patient that is distal from the treatment site, an electrical signal”, as noted above, amounts to insignificant extrasolution activity, e.g., mere data gathering employed in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. Such sensors are conventional as evidenced by:
Fisher (US 20170113059 A1) discloses “FIG. 1 is a preferred embodiment with a wristband comprising an ulna ergonomic cutout and PPG sensor linked to a microprocessor and PEMF generator for sending a PEMF through a coil in the wristband.” ([0017]).
Ryaby (US 20180104484 A1) discloses “A PEMF device includes sensors that detect attributes indicating whether the PEMF device is in use.” (abstract).
Franco-Obregon (US 20190126036 A1) discloses “a pulsed electromagnetic field (PEMF) to a cell, comprising: a sensor” (abstract).
Blackwell (US 5951459 A) discloses “PEMF field induces a current into the wire sensor 202” (column 3, line 59 - 60).
Claims 9 - 10 are dependent on claim 1.
Claim Rejections - 35 USC § 102
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 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.
Claims 1 and 3 – 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryaby et al (US 20190217090 A1, hereinafter “Ryaby”).
Regarding claim 1, Ryaby teaches a method for detecting a pulsed electromagnetic field (PEMF) treatment provided to a treatment site on a patient (method 600 for tissue treatment and monitoring. In particular, the method 600 illustrates the operation of the system including the tissue engineering device 102, UE 104, server 108, server 110, and access device 114, Fig. 6, Para. [0105]; The tissue engineering device 102 may be a PEMF device. The tissue engineering device 102 provides therapeutic treatment [e.g., PEMF or ultrasound, a combination, etc.] to musculoskeletal tissues of a patient; Fig. 1, Para. [0024],, the method comprising:
detecting, with a PEMF sensor that is held or worn at a detection site on the patient that is distal from the treatment site, an electrical signal (The tissue engineering device 102 may include multiple sensors, Para. [0024]; the UE 104 may periodically pair with one or more tissue engineering devices 102 to receive treatment data [also referred to as sensor data, usage data, or monitored data herein]. Para. [0026]; as an alternative to the impedance monitor sensor, more generally the impedance monitor sensor may be a type of sensor to monitor healing. Alternatively, it may include a sensor such as x-rays [e.g., low-energy x-rays], ultrasound, electrical impedance tomography, or other approaches to measure healing or density such as measuring electrical and/or electroacoustic properties of healing tissue, etc., Para. [0048]);
determining that the electrical signal corresponds to a PEMF treatment applied to the treatment site (sensors 210.a through 210.n that may be included with the tissue engineering device 102, and which may be used to output data [historical and/or current] that assists in determining an amount of progress for a current application period as well as multiple application periods over time, Para. [0049]); and
transmitting, to a second device, data characterizing the PEMF treatment in response to determining that the electrical signal corresponds to a PEMF treatment level At block 606, the tissue engineering device 102 transfers monitoring data to the UE 104. This may be a real-time transfer of monitoring data as it is obtained, Para. [0108]), data characterizing the PEMF treatment in response to determining that the electrical signal corresponds to a PEMF treatment level (the UE 104 may periodically pair with one or more tissue engineering devices 102 to receive treatment data [also referred to as sensor data, usage data, or monitored data herein]. Para. [0026]; as an alternative to the impedance monitor sensor, more generally the impedance monitor sensor may be a type of sensor to monitor healing. Alternatively, it may include a sensor such as x-rays [e.g., low-energy x-rays], ultrasound, electrical impedance tomography, or other approaches to measure healing or density such as measuring electrical and/or electroacoustic properties of healing tissue, etc., Para. [0048]; the processor 202 may access the treatment regimen stored in the memory 204 that causes current to pass through the coil 208, including according to a set rise and/or fall time, duty cycle, amplitude, frequency, etc. for the current so as to generate electromagnetic frequency pulses of a desired duration, size, shape, and frequency, Para. [0040]).
Regarding claim 3, Orthofix teaches all limitations of claim 1. Orthofix teaches determining the electrical signal corresponds to the PEMF treatment applied to the treatment site (sensors 210.a through 210.n that may be included with the tissue engineering device 102, and which may be used to output data [historical and/or current] that assists in determining an amount of progress for a current application period as well as multiple application periods over time, Para. [0049]) comprises determining that the electrical signal has a frequency within a predefined range (the processor 202 may access the treatment regimen stored in the memory 204 that causes current to pass through the coil 208, including according to a set rise and/or fall time, duty cycle, amplitude, frequency, etc. for the current so as to generate electromagnetic frequency pulses of a desired duration, size, shape, and frequency, Para. [0040]).
Regarding claim 4, Orthofix teaches all limitations of claim 1. Orthofix teaches transmitting data characterizing the PEMF treatment comprises transmitting one or both of: a PEMF treatment level and a PEMF treatment duration (the UE 104 may periodically pair with one or more tissue engineering devices 102 to receive treatment data [also referred to as sensor data, usage data, or monitored data herein], Para. [0026]; the processor 202 may access the treatment regimen stored in the memory 204 that causes current to pass through the coil 208, including according to a set rise and/or fall time, duty cycle, amplitude, frequency, etc. for the current so as to generate electromagnetic frequency pulses of a desired duration, size, shape, and frequency, Para. [0040]).
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.
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ryaby in view of Benedikt et al (WO 2020222020 A1, see attached, hereinafter “Benedikt”).
Regarding claim 2, Orthofix teaches all limitations of claim 1. Orthofix does not teach determining the electrical signal corresponds to the PEMF treatment applied to the treatment site comprises determining that the electrical signal is greater than a threshold.
However, Benedikt discloses a “a medical device (100) for inducing cell death in cancer cells” (abstract) and teaches determining an electrical signal corresponds to a PEMF treatment applied to a treatment site comprises determining that the electrical signal is greater than a threshold (the device 100 is configured to instruct the signal generator 102 to temporarily stop generating the pulsed electrical signal if it is determined that the rate at which energy is absorbed and/or the amount of absorbed energy exceeds a threshold, Para. [0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Orthofix to incorporate determining the electrical signal corresponds to the PEMF treatment applied to the treatment site comprises determining that the electrical signal is greater than a threshold, as taught by Benedikt, for the benefit of temporarily stopping the generating the pulsed electrical signal (Benedikt: Para. [0130]).
Regarding claim 5, Orthofix teaches all limitations of claim 1. Orthofix does not teach the PEMF treatment level is proportional to pulsed electromagnetic fields provided by a PEMF applicator.
However, Benedikt discloses a “a medical device (100) for inducing cell death in cancer cells” (abstract) and teaches a PEMF treatment level is proportional to pulsed electromagnetic fields provided by a PEMF applicator (The energy deposited into the treatment volume may be proportional to the power of the electrical signal that is used to generate the electric field, Para. [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Orthofix to incorporate the PEMF treatment level is proportional to pulsed electromagnetic fields provided by a PEMF applicator, as taught by Benedikt, for the benefit of monitoring the ratio of the delivered and reflected powers and thereby obtain an indication of the energy deposited into the treatment volume (Benedikt: Para. [0053]).
Claims 6 - 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ryaby in view of Babico et al (US 20190388676 A1, see attached, hereinafter “Babico”).
Regarding claim 6, Orthofix teaches all limitations of claim 1. Orthofix does not teach the PEMF sensor is held or worn at the detection site on the patient's arm, hand or wrist, or on a garment worn by the patient.
However, Babico discloses “high-power pulsed electromagnetic field (PEMF) applicator apparatuses” (abstract) and teaches a PEMF sensor is held or worn at the detection site on the patient's arm, hand or wrist, or on a garment worn by the patient (the one or more applicators can be configured to be hand-held or wearable, Para. [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Orthofix such that the PEMF sensor is held or worn at the detection site on the patient's arm, hand or wrist, or on a garment worn by the patient, as taught by Babico, for the benefit of being convenient for treatment (Babico: [0072]).
Regarding claim 7, Orthofix teaches all limitations of claim 1. Orthofix does not teach the PEMF sensor is one of: an armband, a ring, a belt, a wrist band, a necklace, a strap, a band, an anklet, a disposable patch, a smart watch adaptor, a watch adaptor, or a combination thereof.
However, Babico discloses “high-power pulsed electromagnetic field (PEMF) applicator apparatuses” (abstract) and teaches a PEMF sensor is one of: an armband, a ring, a belt, a wrist band, a necklace, a strap, a band, an anklet, a disposable patch, a smart watch adaptor, a watch adaptor, or a combination thereof (the applicator may be configured to be applied specifically to a foot, hand, head, neck, arm, wrist, leg, torso, knee, etc., Para. [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Orthofix such that teach the PEMF sensor is one of: an armband, a ring, a belt, a wrist band, a necklace, a strap, a band, an anklet, a disposable patch, a smart watch adaptor, a watch adaptor, or a combination thereof, as taught by Babico, for the benefit of being convenient for treatment (Babico: [0072]).
Regarding claim 8, Orthofix teaches all limitations of claim 1. Orthofix does not teach the method comprising concurrently providing PEMF treatment by the second device.
However, Babico discloses “high-power pulsed electromagnetic field (PEMF) applicator apparatuses” (abstract) and teaches a method comprising concurrently providing PEMF treatment by a second device (the base housing 10 and/or the applicators 20, 20b, 20c, 20d can be wearable, especially after reducing the size and weight of the base housing by removing the display and reducing the size of the rechargeable battery. The base housing can include a strap, clip or other fastening mechanism to reversibly attach the base housing to the user, Para. [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Orthofix such that the method comprising concurrently providing PEMF treatment by the second device, as taught by Babico, for the benefit of being convenient for treatment (Babico: [0072]).
Regarding claim 9, Orthofix teaches all limitations of claim 1. Orthofix does not teach the second device is a PEMF therapy device coupled to a PEMF applicator.
However, Babico discloses “high-power pulsed electromagnetic field (PEMF) applicator apparatuses” (abstract) and teaches a second device is a PEMF therapy device coupled to a PEMF applicator (the applicator may be configured to be applied specifically to a foot, hand, head, neck, arm, wrist, leg, torso, knee, etc., Para. (0055]; in some embodiments, the base housing 10 and/or the applicators 20, 20b, 20c, 20d can be wearable, especially after reducing the size and weight of the base housing by removing the display and reducing the size of the rechargeable battery. The base housing can include a strap, clip or other fastening mechanism to reversibly attach the base housing to the user. The applicators can be fastened to the body part using an adhesive, strap, or other fastening mechanism, Para. [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Orthofix such that the second device is a PEMF therapy device coupled to a PEMF applicator, as taught by Babico, for the benefit of being convenient for treatment (Babico: [0072]).
Regarding claim 10, Orthofix teaches all limitations of claim 1. Orthofix does not teach the second device is at least one of a smart phone, a tablet computer, a laptop computer, a smart watch, or a server computer.
However, Babico discloses “high-power pulsed electromagnetic field (PEMF) applicator apparatuses” (abstract) and teaches the second device is at least one of a smart phone, a tablet computer, a laptop computer, a smart watch, or a server computer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Orthofix such that the second device is at least one of a smart phone, a tablet computer, a laptop computer, a smart watch, or a server computer, as taught by Babico, for the benefit of being convenient for treatment (Babico: [0072]) and alternating high-energy PEMF between the left, then right applicators (Babico: Para. [0061]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
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/JULIE THI TRAN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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