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 .
Claim Objections
Claim 6 objected to because of the following informalities:
Claim 6 reads “the coil is integrated into the fabric of the garment so as to not surround a portion of the garment through which a body part passes”. It is recommended that this claim be written to positively recite specifically which parts of the garment and/or body the coil will be surrounding for clarity. As currently written as long as the garment has an area through which a body part passes and does not have a coil at that location, the claim limitation is met. For example, although coil 104 in applicant’s figure 1E does surround a portion of the garment through which a body part passes, it also has a portion, around the chest and/or the lower part of the shirt, where the coil is integrated so as to not surround a portion of the garment through which a body part passes”.
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.
Claim 4 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4 and 21, the terms “optimize”, “quickly”, and “highest possible magnitude” in claim 4 are relative terms which renders the claim indefinite. The terms “optimize” and “quickly” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how “quick” or “fast” the time-varying drive signal should be in order to be considered “optimized”. Additionally, it is not clear what range or value is the “highest possible magnitude”. It is suggested this claim be amended to detail what time and magnitude is necessary for the waveform generator.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 5-6, 8-9, 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 2021/0251850), as cited in the applicant’s IDS, in view of Nunez (US 2022/0013869)
Regarding claim 1, Sharma teaches a device for administering therapy, comprising:
a wearable garment (Figures 2-6 show wearable garments. Paragraph [0055] “the coils are completely integrated inside a garment such as a bra, hat, shirt, bandage, etc.)” ),
the garment comprising a conductive coil (paragraph [0019] “at least one alternating polarity (AP) electromagnetic coil” The examiner notes that since the coils are electrical they are conductive.) integrated into a fabric of the garment (Paragraph [0055] “the coils are completely integrated inside a garment such as a bra, hat, shirt, bandage, etc.)”)
and a controller comprising:
a waveform generator (paragraph [0040] “The APMFG 110 may also cause the one or more AP electromagnetic coils 120 to generate AP magnetic fields having a variety of waveforms, e.g. sinusoidal, triangular, trapezoidal etc”) that produces a time-varying drive signal (the examiner notes that a sine wave is a time-varying signal.)
wherein: when the drive signal is communicably coupled to the conductive coil of the garment (paragraph [0033] “The MFT therapy system 100 includes an alternating polarity magnetic field generator (APMFG) 110 to generate an electrical signal to energize one or more alternating polarity (AP) electromagnetic coils 120 to produce an AP magnetic field having specified frequency and field strength characteristics.”), a non-targeted (paragraph [0020] “wherein the AP magnetic field selectively affects the cancer cells to achieve at least one of damaging the cancer cells, inhibiting the growth of the cancer cells, reducing tumor size, inhibiting angiogenesis, or preventing metastasis of the cancer cells, while leaving non-cancer cells substantially unharmed.” The examiner notes that by inhibiting growth, angiogenesis, and preventing metastasis the treatment is indirectly affecting the solid tumor and thus non-targeted.) induced electric field is generated (The examiner notes that an alternating magnetic field generates an electric field.)
However, Sharma fails to teach that the garment is washable and constructed using an insulated conductive thread that is integrated into a fabric of the garment.
Nunez teaches a system and method for a wearable circuit that is comprised of a washable material (paragraph [0020] “A soft substrate may include a washable material. A “washable material,”… A soft substrate may allow wearable circuit system 100 to be integrated into textiles and/or garments.“) and uses an insulated conductive thread (paragraph [0024] “flexible connecting device 120 may include but is not limited to a wire, a printed circuit board including, a flexible printed circuit board, a rigid printed circuit board, a flexible-rigid printed circuit board, a flat cable, a conductive thread, and the like.” Paragraph [0025] “With continued reference to FIG. 1A, a flexible connecting device 120 may include an electrically conductive core material, surrounded by an insulating outer layer.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the garment taught by Sharma to be washable and use a conductive thread integrated into a fabric as taught by Nunez. One of ordinary skill in the art would have been able to recognize that wearable devices require a way to be cleaned since they will be consistently used and comfortable for a user to wear. Therefore, it would have been obvious to integrate the insulated conductive thread into the garment so the user is not wearing multiple exposed wires.
Regarding claim 5, Sharma and Nunez teach the device of claim 1, and Sharma further teaches the coil is integrated into the fabric ( paragraph [0055] “the AP electromagnetic coils 120 are completely integrated within the retaining element during manufacturing”) wherein: the coil is integrated into the fabric of the garment so as to surround at least one of a human torso (Figures 2 and 4, shows the garment that would surround a human torso when worn by an individual.), limb, neck (figure 5 shows a garment for the neck), head (figure 3 shows a garment for the head), digit (figure 6 shows the garment for the digit), or appendage
Regarding claim 6, Sharma and Nunez teach the device of claim 1, Sharma further teaches the coil, when driven by the controller, produces over a time interval, a heterogeneous and asymmetric B field (paragraph [0040] “The APMFG 110 may also cause the one or more AP electromagnetic coils 120 to generate AP magnetic fields having a variety of waveforms, e.g. sinusoidal, triangular, trapezoidal etc.” The examiner notes that a B field is a magnetic field, and that the listed waveforms above are heterogeneous and asymmetric. Paragraph [0050] “MFT therapy may be applied according to a defined treatment duty cycle of on-time and off-time periods”) and wherein: the coil is integrated into the fabric of the garment so as to not surround a portion of the garment through which a body part passes when the garment is worn by an individual (the examiner notes that in Sharma figures 3 and 5 that the coil does not surround the area of the fabric through which the body part (head in figure 3, neck in figure 5) would pass through when the garment is worn by an individual.
Regarding claim 8, Sharma and Nunez teach the device of claim 1, Nunez further teaches wherein the conductive thread comprises a plurality of wire strands braided. (paragraph [0025] Filament conductors may be braided together, containing wires that are braided into one larger conductive element. An electrically conductive core may be surrounded by an insulating outer layer.”)
It would have been obvious to one of ordinary skill in the art to modify the system taught by Sharma and Nunez to have a plurality of wire strands braided. One of ordinary skill in the art would have been able to recognize that braided threads would provide stronger tensile strength within the garment to allow for repetitive use without the circuit breaking down.
Regarding claim 9, Sharma and Nunez teach the device of claim 8, Nunez further teaches that the conductive thread can be partially insulated. (Paragraph [0025] “An electrically conductive core may be surrounded by an insulating outer layer. An “insulating outer layer,” as used in this material, is any material that surrounds and/or encompass an electrically conductive core. An insulating outer lay may include a material that has low electrical connectivity. An insulating outer layer may be composed of one or more materials such as plastic, including for example, polyethylene, and/or polyurethane.”)
It would have been obvious to one of ordinary skill in the art to modify the system taught by Sharma and Nunez to have the conductive thread at least partially insulated. One of ordinary skill in the art would have been able to recognize that if the garment were to be worn then the user must be protected from exposed wires for safety.
Regarding claim 14, Sharma and Nunez teach the system of claim 1, and Sharma further teaches wherein the drive signal is communicably coupled to the conductive coil of the garment so as to generate the electric field as a non-targeted induced electric field that does not cause current to flow in tissue of the individual wearing the garment, hence delivering no power to the tissue of the individual wearing the garment. (paragraph [0075] “The use of coils instead of electrodes results in only a de minimis induced electrical current during MFT therapies, and thus the risk of electrical shorting and consequent uncontrolled hearing of patient body tissue is negligible” The examiner notes that the drive signal is communicably coupled to the conductive coil to produce a non-targeted induced electric field is taught in claim 1 rejection.)
Regarding claim 15, Sharma and Nunez teach the device of claim 1, Sharma further teaches wherein the device only generates an alternating magnetic field. (paragraph [0031] “the invention provides apparatus and methods for treating a patient having cancer or other rapidly dividing cells (e.g., bacterial infection) in a target body area using alternating polarity (AP) magnetic fields”)
Regarding claim 16, Sharma and Nunez teach the device of claim 1, and Sharma further teaches wherein a field strength of the magnetic induction is in the range of a select one of: 1 pT – 0.199 mT, 1 fT – 0.199 mT, or greater than 5 mT. (paragraph [0045] “Preferably, MFT therapy fields in systems 100 of the present invention have field strengths of less than 5 milliTesla (i.e., 5,000 μT), such as field strengths within the range of 0.05-5 mT. ” The examiner notes that there is an embodiment that has the magnetic induction field range taught by the applicant form 0.05 mT to 0.199 mT.)
It would be prima facie obvious to one of ordinary skill modify the field strength range taught in Sharma to be 1 fT -0.199 mT. One of ordinary skill would have been able to recognize that it is not inventive to discover the optimum or workable ranges by routine experimentation. Please see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and MPEP 2144.05, section II.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez further in view of Pilla (US 7758490), as cited in the applicant’s IDS.
Regarding claim 2, Sharma and Nunez teach the device of claim 1, but fail to teach wherein the controller is operative to generate the induced electric field has a so as to have a magnitude in the range of 1 microvolt per centimeter (µV/cm) to 100 millivolts per centimeter (mV/cm).
PIlla teaches a wearable magneto therapy system. (teach wherein the controller is operative to generate the induced electric field has a so as to have a magnitude in the range of 1 microvolt per centimeter (µV/cm) to 100 millivolts per centimeter (mV/cm). (column 4, line 53 “An induced electric field from about 0.001 mV/cm to about 100 mV/cm is generated.” The examiner notes that 0.001 mV/cm is equivalent to 1 microvolt/cm.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the system taught by Sharma and Nunez to generate an electric field in the range taught by Pilla. One of ordinary skill would have been able to recognize that lower electric field magnitudes can be applied safely over a longer period time allowing for continuous treatment for the user.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez further in view of Pilla further in view of Gleim (US 2010/0057146).
Regarding claim 3, Sharma and Nunez teach the device of claim 2, Pilla further teaches wherein the controller is further configured operative to generate the electric field via a magnetic field (The examiner notes that in claim 1, Pilla taught that electric coils induce a magnetic field that induces an electric field.) but fails to teach that the field is on the order of 10 nanotesla to 10 millitesla (10 nT - 10 mT).
Gleim teaches a device for generating an electromagnetic field as a therapy that generate magnetic field intensities on the scale of 10 nanotesla to 10 microtesla (Paragraph [0048] “Intensities ranging from nanotesla up to millitesla are possible, e.g. 50 nT to 800 mT,”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Sharma, Nunez, and PIlla to generate magnetic fields on the order of 10 nanotesla to 10 millitesla. One of ordinary skill in the art would have been able to recognize that generating lower electric fields would have minimal side effects and would not induce unwanted nerve stimulation on the user. Additionally, since the claimed range in the limitation overlaps with the range taught in the prior art, there is an embodiment in the prior art that has a generates an electric field in the claimed range limitation. One of ordinary skill would have been able to recognize that it is not inventive to discover the optimum or workable ranges by routine experimentation. Please see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and MPEP 2144.05, section II.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez in view of Jones et al (Jones et al.; Design and characterization of an electromagnetic probe for distinguishing morphological differences in soft tissues; Review of Scientific Instruments 89, 084302; 2018), as cited in the applicant’s IDS.
Regarding claim 4, Sharma and Nunez teach the device of claim 1 but fail to teach wherein the waveform generator is configured to optimize the time-varying drive signal based upon how quickly a magnetic induction can change with time to produce an induced electric field having the highest possible magnitude.
Jones teaches a design for a probe that uses a sawtooth waveform to optimize how quickly a magnetic induction can change with time. (page 2, column 2, paragraph 2 “The sawtooth excitation waveform is specifically chosen to exploit the sharp drop-off ( ~50 ns) in order to induce the largest possible eddy currents” page 2, column 1, paragraph 1 “[sawtooth waveform] has the benefit of a relatively large temporal variation of B (magnetic induction)”) therefore producing an induced electric field having the highest possible magnitude
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to use a sawtooth waveform in the system taught by Sharma and Nunez. One of ordinary skill in the art would have been able to recognize that a sawtooth waveform has the benefit of a relatively large temporal variation of B (magnetic induction). See page 2, column 1, paragraph 1 of Jones.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez further in view of Oskin (US 2012/0146797).
Regarding claim 7, Sharma and Nunez teach the device of claim 1 but fail to teach wherein the conductive thread that is sewn or woven into the garment using at least one of stitching, weaving, knitting, or crocheting.
Oskin teaches a wearable therapeutic device that stitches conductive thread (paragraph [0012] “the conductive thread forms a stitched pattern in the garment.”)
It would have been obvious to one of ordinary skill in the art to modify the system taught by Sharma and Nunez to stitch the conductive thread. One of ordinary skill in the art would have been able to recognize that this technique is well-known in the art of sewing and garment making and it would be simple substitution of how the thread is integrated into the garment.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez further in view of Longinotti-Buiton (WO 2016/009277).
Regarding claim 10, Sharma and Nunez teach the device of claim 1 but fail to teach wherein the coil is integrated into the fabric by using at least one of felting, lacing, boding, fusing, printing or laminating.
Longinotti-Buiton teaches a printing process using bonding. (Paragraph [000475] “For example, a conductive thread may be sewn on a band made on the same fabric of the garment and then transferred by a thermal process to the garment, e.g., using a layer of adhesive.” The examiner notes that using adhesive is a form of bonding.)
It would have been obvious to one of ordinary skill in the art to modify the system taught by Sharma and Nunez to use printing to integrate the coil into the garment. One of ordinary skill in the art would have been able to recognize that using bonding is an accessible and less time consuming way to manufacture the garment compared to sewing.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez in view of Ahirwar (Ahirwar, D., Nasser, M., Jones, T. et al. Non-contact method for directing electrotaxis. Sci Rep 5, 11005 (2015).) further in view of Jones et al (Jones et al.; Design and characterization of an electromagnetic probe for distinguishing morphological differences in soft tissues; Review of Scientific Instruments 89, 084302; 2018), as cited in the applicant’s IDS.
Regarding claim 11, Sharma and Nunez teach the device of claim 1 but fail to teach wherein the waveform generator produces the time-varying drive signal as an asymmetric, periodic sawtooth waveform having a rise time of 10 milliseconds or less, and a fall time of 50 nanoseconds or less, or a sawtooth waveform having a fall time of 10 milliseconds or less, and a rise time of 50 nanoseconds or less.
Ahirwar teaches a method to direct cancer cell migration using electromagnetic fields with an asymmetric, periodic sawtooth waveform having a rise time of 10 milliseconds or less. (Figure 2A shows a asymmetric, periodic sawtooth wave form with a rise time of less than 10 milliseconds (~5 microseconds)).
Jones teaches a design for an electromagnetic probe to distinguish different tissues using a sawtooth waveform, with a fall time of 50 nanoseconds or less. (Page 2, column 2, paragraph 2 “The sawtooth excitation waveform is specifically chosen to exploit the sharp drop-off ( ~50 ns) in order to induce the largest possible eddy currents”).
It would be prima facie obvious to use a sawtooth waveform with a rise time of 10 milliseconds or less and a fall time of 50 nanoseconds or less as taught by both Ahirwar and Jones instead of the sinusoidal, triangular, trapezoidal, etc taught by Sharma and Nunez. One of ordinary skill would have been able to recognize that this would be a simple substitution of the waveforms used to generate changing magnetic fields.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez further in view of Kaib (US 2017/0143977).
Regarding claim 12, Sharma and Nunez teach the device of claim 1, but fails to teach the device further comprises at least one washable connector integrated into the garment that detachably couples power from an external device to the controller.
Kaib teaches a washable garment for medical devices with a detachable power unit. (Paragraph [0164] “the energy storage module 402 may include a battery 420 to charge the capacitors.” Paragraph [189] “ the patient can disconnect the energy storage modules 402 and/or the therapy control modules 404 and remove the modules from the assembly 400C.” Paragraph [0224] “Thereby, the garment maybe washed without damaging the electrical components that are permanently disposed into the garment”)
It would be prima facie obvious to use a washable connector to detach a power unit from the system as taught in Kaib in the system taught by Sharma and Nunez. One of ordinary skill would have been able to recognize that the device would need to be cleaned while protecting the circuitry used to power the device, therefore a connector is needed to safely connect and disconnect the power source from the device.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez in view of Sharma further in view of Hu (WO 2022169404)
Regarding claim 13, Sharma and Nunez teach the device of claim 1, and Sharma further teaches wherein the controller communicably couples the drive signal to the conductive coil by induction (paragraph [0040] “the APMFG 110 may provide an electrical signal to cause each of the one or more AP electromagnetic coils 120 to generate magnetic fields having one or more fixed or variable AP frequencies.”), wherein the controller comprises a secondary coil (figure 2, element 220) and the garment comprises at least one of a user-accessible pocket (paragraph [0055] “Because the magnetic coils do not need to be in direct contact with the skin of the patent, the retaining elements may include pouches or pockets for securely retaining the coils in position”) that aligns the secondary coil of the controller to an external power module. (paragraph [0055] “In various embodiments, the retaining element may include a lead wire for coupling each of the one or more coils 120 to the AP magnetic field generator 110 and/or controller. In alternative embodiments, a direct electrical coupling (e.g., a snap fit) may be used between an electronics package and the AP electromagnetic coil(s) 120. The electronics package may include one or more of the power supply 150”)
However, Sharma and Nunez fail to teach that the coils are the conductive coil is integrated into a fabric of the garment so as to form a continuous coil with no coil ends.
Hu teaches a system for wireless power transfer with continuous coils with no ends. (paragraph [0060] “the wireless power transmitter 1320 connected to the power source 1324, the time-varying current from the power source 1324 for generating a magnetic field 1332 to perform wireless power transfer with a receiver coupler 1360 over an air gap 1352 based on magnetic induction;” paragraph [0063] “For example, a coil (a continuous winding) may be laid onto a substrate (e.g., mould or housing) that is made of non-conductive materials.” The examiner notes that since the power transfer occurs wirelessly the coil is a continuous coil with no ends.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to use a continuous coil design as taught in Edwards. One of ordinary skill would have been able to recognize that a continuous coil design can provide more efficient magnetic therapy by minimizing resistance and leakage of power.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez further in view of Errico (US 2019/0111255).
Regarding claim 17, Sharma and Nunez teach the system of claim 1, but fail to teach wherein the controller generates the electric field as a non-targeted induced electric field that operates so as to stimulate a vagus or other nerve triggering a host immune system to respond to attack a tumor somewhere else, away from the neck, in the body.
Errico teaches a therapeutic nerve stimulation device. (paragraph [0280] “For example, the medical device 108 can be configured to prevent, diagnose, monitor, ameliorate, or treat a cancer, such as bladder cancer, breast cancer, prostate cancer, lung cancer, colon or rectal cancer, skin cancer, thyroid cancer, brain cancer, leukemia, liver cancer, lymphoma, pancreatic cancer, or others, as understood to skilled artisans and which are only omitted here for brevity.” Paragraph [0324] “For example, the stimulation may be at a side of a neck of a patient. For example, the nerve can be a vagus nerve” paragraph [0258] “VNS has the robust ability to reduce inflammatory cytokine production, and to shift immune cells into an active but anti-inflammatory state.” The examiner notes that since this device can be used to treat other cancers located outside the neck, therefore the device can trigger an immune response away from the neck in the body.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Sharma and Nunez to stimulate the nervous system to attack cancer cells as taught in Errico. One of ordinary skill would be able to recognize that stimulating the vagus nerve or other nervous system pathways is an additional way of performing indirect (non-targeted) electromagnetic therapy and could attenuate other ways cancer can spread through the body (ex angiogenesis, cell growth, and metastasis).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez further in view of Jones further in view Collins (US 2013/0023867).
Regarding claim 18, Sharma and Nunez teach the device of claim 1 but fail to teach detecting changes in a mass within a patient wearing the garment by detecting variations in current flowing in a circuit with the conductive coil caused by changes in electrical characteristics in the mass within the patient that cause an applied B field to change, thus affecting the current flow in the coil.
Jones teaches detecting differences between cancerous tissue and non-cancerous tissue by measuring electrical characteristics. (page 13, column 1, paragraph 2 “Measurements on fresh tissue excised from a human patient undergoing surgical treatment for a liver metastasis from colorectal cancer further showed the feasibility of using the EM probe and the method presented in this paper to distinguish between the tumor and surrounding normal tissue.” page 2, column 1, paragraph 3 “The primary coil subjected to a time-varying voltage generates eddy currents in the conducting specimen whose magnetic fields alter the voltage induced in the (secondary) detector coil.” page 9, col 1, paragraph 3 “When the EM probe is brought in the proximity of a specimen, the EM probe becomes mutually inductively and capacitively coupled with the sample…This coupling results in a change in the magnitude and phase of the induced current and voltage in the detector coil”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Sharma and Nunez to be able to detect changes in the cancerous tissue via the electrical characteristics. One of ordinary skill would have been able to recognize that this method would not require blood testing or imaging to detect the effectiveness of the therapy and would provide results quickly.
However, Sharma, Nunez, and Jones fails to teach wherein the controller comprises a feedback mechanism.
Collins teaches a feedback mechanism for detecting electrical characteristics in living tissue. (Paragraph [0031] “measurement components 120 and 122 for measuring a variety of tissue and energy properties (e.g., voltage, a current, a duty cycle, a frequency, a power level, an energy efficiency, a reflectance, a wattage, a total power delivered, a power factor, an instantaneous power delivery and a S-parameter etc.) and to provide feedback to the control component 114 based on the measured properties.” The examiner is modifying the system taught by Sharma, Nunez, and Jones to detect any changes in the induced current and voltage of the circuit in a feedback loop, to have consistent monitoring of the therapy.)
It would be prima facie obvious to modify the system taught by Sharma, Nunez, and Jones to use a feedback mechanism to monitor changes in current flowing to detect changes in cancer tissue. One of ordinary skill would have been able to recognize that this would allow the user to get continuous feedback on the therapy received and make adjustments accordingly.
Regarding claim 19, Sharma, Nunez, Jones and Collins teach the device of claim 18, and Collins further teaches wherein the feedback comprises a matching network, wherein the controller monitors the matching network to detect changes in current through the coil indicative of the changes in the electrical characteristics of the mass. (paragraph [0011] “The impedance matching network is interposed along a path of the energy and matches an input impedance of the source of the energy to an output impedance (or thereabouts). “) The examiner notes that by modifying the system taught by Sharma, Nunez, and jones to use the impedance matching network taught by Collins thus matching the inductance between the conductive and secondary coil. Then the system would read the output impedance of the mass which would or would not match the input of energy which would thus identifying the changes in mass of the tissue.
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Sharma and Nunez to be able to detect changes in the cancerous tissue via the electrical characteristics. One of ordinary skill would have been able to recognize that this method would not require blood testing or imaging to detect the effectiveness of the therapy and would provide results quickly.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez in view of Jones.
Regarding claim 20, Sharma teaches a device for administering therapy, comprising:
wearable garment (Figures 2-6 show wearable garments. Paragraph [0055] “the coils are completely integrated inside a garment such as a bra, hat, shirt, bandage, etc.)” ),
the garment comprising a conductive coil stitched into a fabric of the garment (paragraph [0055] “ the coils are completely integrated inside a garment such as a bra, hat, shirt, bandage, etc.”) so as to surround at least one of a human torso (Figures 2 and 4, shows the garment that would surround a human torso when worn by an individual.), limb, neck (figure 5 shows a garment for the neck), head (figure 3 shows a garment for the head), digit (figure 6 shows the garment for the digit), or appendage when the garment is worn
wherein: when the drive signal is communicably coupled to the conductive coil (paragraph [0033] “The MFT therapy system 100 includes an alternating polarity magnetic field generator (APMFG) 110 to generate an electrical signal to energize one or more alternating polarity (AP) electromagnetic coils 120 to produce an AP magnetic field having specified frequency and field strength characteristics.”) of the garment, a non-targeted (paragraph [0020] “wherein the AP magnetic field selectively affects the cancer cells to achieve at least one of damaging the cancer cells, inhibiting the growth of the cancer cells, reducing tumor size, inhibiting angiogenesis, or preventing metastasis of the cancer cells, while leaving non-cancer cells substantially unharmed.” The examiner notes that by inhibiting growth, angiogenesis, and preventing metastasis the treatment is indirectly affecting the solid tumor.) induced electric field is generated (The examiner notes that an alternating magnetic field generates an electric field.)
However, Sharma fails to teach the garment is washable.
Nunez teaches a system and method for a wearable circuit that is comprised of a washable material (paragraph [0020] “A soft substrate may include a washable material. A “washable material,”… A soft substrate may allow wearable circuit system 100 to be integrated into textiles and/or garments.“)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the garment taught by Sharma to be washable as taught by Nunez. One of ordinary skill in the art would have been able to recognize that wearable devices require a way to be cleaned since they will be consistently used and comfortable for a user to wear. Therefore, it would have been obvious to integrate the conductive thread into the garment so the user is not wearing multiple exposed wires.
However, both Sharma and Nunez fail to teach and a controller comprising: a waveform generator that produces a sawtooth drive signal.
Jones teaches a design for a probe that uses a sawtooth waveform to optimize how quickly a magnetic induction can change with time. (page 2, column 2, paragraph 2 “The sawtooth excitation waveform is specifically chosen to exploit the sharp drop-off ( ~50 ns) in order to induce the largest possible eddy currents” page 2, column 1, paragraph 1 “[sawtooth waveform] has the benefit of a relatively large temporal variation of B (magnetic induction)”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to use a sawtooth waveform in the system taught by Sharma and Nunez. One of ordinary skill in the art would have been able to recognize that a sawtooth waveform has the benefit of a relatively large temporal variation of B (magnetic induction). See page 2, column 1, paragraph 1 of Jones.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Nunez in view of Jones in view of Collins.
Regarding claim 21, Sharma teaches a device for administering therapy, comprising:
a wearable garment (Figures 2-6 show wearable garments. Paragraph [0055] “the coils are completely integrated inside a garment such as a bra, hat, shirt, bandage, etc.)” ),
the garment comprising a conductive coil (paragraph [0019] “at least one alternating polarity (AP) electromagnetic coil” The examiner notes that since the coils are electrical they are conductive. )
and a controller comprising:
a waveform generator (paragraph [0040] “The APMFG 110 may also cause the one or more AP electromagnetic coils 120 to generate AP magnetic fields having a variety of waveforms, e.g. sinusoidal, triangular, trapezoidal etc”) that produces a time-varying drive signal (the examiner notes that a sine wave is a time-varying signal.)
wherein: when the drive signal is communicably coupled to the conductive coil (paragraph [0033] “The MFT therapy system 100 includes an alternating polarity magnetic field generator (APMFG) 110 to generate an electrical signal to energize one or more alternating polarity (AP) electromagnetic coils 120 to produce an AP magnetic field having specified frequency and field strength characteristics.”) of the garment, a non-targeted (paragraph [0020] “wherein the AP magnetic field selectively affects the cancer cells to achieve at least one of damaging the cancer cells, inhibiting the growth of the cancer cells, reducing tumor size, inhibiting angiogenesis, or preventing metastasis of the cancer cells, while leaving non-cancer cells substantially unharmed.” The examiner notes that by inhibiting growth, angiogenesis, and preventing metastasis the treatment is indirectly affecting the solid tumor and therefore non-targeted.) induced electric field is generated (The examiner notes that an alternating magnetic field generates an electric field.)
However, Sharma fails to teach that the garment is washable and constructed using an insulated conductive thread that is integrated into a fabric of the garment.
Nunez teaches a system and method for a wearable circuit that is comprised of a washable material (paragraph [0020] “A soft substrate may include a washable material. A “washable material,”… A soft substrate may allow wearable circuit system 100 to be integrated into textiles and/or garments.“) and uses an insulated conductive thread (paragraph [0024] “flexible connecting device 120 may include but is not limited to a wire, a printed circuit board including, a flexible printed circuit board, a rigid printed circuit board, a flexible-rigid printed circuit board, a flat cable, a conductive thread, and the like.” Paragraph [0025] “With continued reference to FIG. 1A, a flexible connecting device 120 may include an electrically conductive core material, surrounded by an insulating outer layer.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the garment taught by Sharma to be washable and use a conductive thread integrated into a fabric as taught by Nunez. One of ordinary skill in the art would have been able to recognize that wearable devices require a way to be cleaned since they will be consistently used and comfortable for a user to wear. Therefore, it would have been obvious to integrate the conductive thread into the garment so the user is not wearing multiple exposed wires.
However, both Sharma and Nunez fail to teach and a controller comprising: a waveform generator that produces a sawtooth drive signal.
Jones teaches a design for a probe that uses a sawtooth waveform to optimize how quickly a magnetic induction can change with time. (page 2, column 2, paragraph 2 “The sawtooth excitation waveform is specifically chosen to exploit the sharp drop-off ( ~50 ns) in order to induce the largest possible eddy currents” page 2, column 1, paragraph 1 “[sawtooth waveform] has the benefit of a relatively large temporal variation of B (magnetic induction)”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to use a sawtooth waveform in the system taught by Sharma and Nunez. One of ordinary skill in the art would have been able to recognize that a sawtooth waveform has the benefit of a relatively large temporal variation of B (magnetic induction). See page 2, column 1, paragraph 1 of Jones.
Sharma and Nunez teach the device of claim 1 but fail to teach detecting changes in a mass within a patient wearing the garment by detecting variations in current flowing in a circuit with the conductive coil caused by changes in electrical characteristics in the mass within the patient that cause an applied B field to change, thus affecting the current flow in the coil.
Jones teaches detecting differences between cancerous tissue and non-cancerous tissue by measuring electrical characteristics. (page 13, column 1, paragraph 2 “Measurements on fresh tissue excised from a human patient undergoing surgical treatment for a liver metastasis from colorectal cancer further showed the feasibility of using the EM probe and the method presented in this paper to distinguish between the tumor and surrounding normal tissue.” page 2, column 1, paragraph 3 “The primary coil subjected to a time-varying voltage generates eddy currents in the conducting specimen whose magnetic fields alter the voltage induced in the (secondary) detector coil.” page 9, col 1, paragraph 3 “When the EM probe is brought in the proximity of a specimen, the EM probe becomes mutually inductively and capacitively coupled with the sample…This coupling results in a change in the magnitude and phase of the induced current and voltage in the detector coil”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Sharma and Nunez to be able to detect changes in the cancerous tissue via the electrical characteristics. One of ordinary skill would have been able to recognize that this method would not require blood testing or imaging to detect the effectiveness of the therapy and would provide results quickly.
However, Sharma, Nunez, and Jones fails to teach wherein the controller comprises a feedback mechanism.
Collins teaches a feedback mechanism for detecting electrical characteristics in living tissue. (Paragraph [0031] “measurement components 120 and 122 for measuring a variety of tissue and energy properties (e.g., voltage, a current, a duty cycle, a frequency, a power level, an energy efficiency, a reflectance, a wattage, a total power delivered, a power factor, an instantaneous power delivery and a S-parameter etc.) and to provide feedback to the control component 114 based on the measured properties.” The examiner is modifying the system taught by Sharma, Nunez, and Jones to detect any changes in impedance of the circuit in a feedback loop, to have consistent monitoring of the therapy.)
It would be prima facie obvious to modify the system taught by Sharma, Nunez, and Jones to use a feedback mechanism to monitor changes in current flowing to detect changes in cancer tissue. One of ordinary skill would have been able to recognize that this would allow the user to get continuous feedback on the therapy received and make adjustments accordingly.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 and 15 - 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12496455. Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons described below.
Regarding claim 1, this claim is rejected as being unpatentable over patent reference claim 1, although the claims at issue are not identical, they are not patentably distinct from each other because the language of claim 1 is found in reference claim 1.
Regrading claims 2-13, all the limitations are recited verbatim in patent reference claims 2-13.
Regarding claim 15, all the limitations are recited verbatim in patent reference claim 14.
Regarding claim 16, all the limitations are recited verbatim in patent reference claim 15.
Regarding claim 17, all limitations are recited in patent reference claim 16.
Regarding claims 18-19, these claims are not patentably distinct from patent reference claims 17-18, as the limitations are encompassed in those claims.
Regarding claims 20 – 21, these claims are not patentably distinct from patent reference claims 17-18, as the limitations are encompassed in those claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nicocacio discloses a method and apparatus for inhibiting growth of cells using alternating magnetic therapy (US 2021/0228895).
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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