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 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 3-6, 11-12, 14, 18 is 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 3-6, 11-12, 14, 19 the phrase “preferably” renders those claims indefinite because it is not clear whether the limitation following the phrase “preferably” is required of the claim.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 7-10, 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jin (US 2018/0104504), as cited in the applicant’s IDS.
Regarding claim 1, Jin discloses a magnetic-field applicator, comprising: a treatment surface adapted to receive at least one foot in an upright orientation (Fig. 1, element 106 shows the foot on the treatment surface in an upright orientation. paragraph [0046] “The person's foot (106) is placed on the treatment surface (102)”); and at least one stimulation coil (paragraph [0014] “the magnetic pulse generator is an electrical coil”).
Regarding claim 2, Jin discloses the magnetic-field applicator according to claim 1, wherein the at least one stimulation coil is positioned below the treatment surface (paragraph [0046] “FIG. 1 shows an exemplary device, in which the side of the enclosure (101) has been removed to show two coil-type magnetic pulse generators (103, 104)”).
Regarding claim 3, Jin discloses the magnetic-field applicator according to claim 1, wherein the applicator is adapted to be placed on the ground with the treatment surface pointing substantially upwards (figure 1, element 101, is placed on the ground and pointed substantially upwards. Paragraph [0001] “wherein the device is floor mounted”), and preferably such that the at least one stimulation coil is held at an elevated position with respect to the ground. (figure 1, elements 103 and 104 are at the top of the enclosure 101 and above the ground.)
Regarding claim 7, Jin discloses the magnetic-field applicator according to claim 1, and wherein the at least one stimulation coil is sized and/or shaped to correspond to the at least one foot. (paragraph [0049] “FIG. 4 shows an exemplary device, in which four coils (401, 402, 403, 404) are situated in the enclosure (408). This allows magnetic pulses to be delivered to two portions of both of a person's feet concurrently or alternating.”
Regarding claim 8, Jin discloses the magnetic-field applicator according to claim 1, and wherein the at least one stimulation coil comprises a round shape, a figure-of-eight shape or an oval shape. (Figure 4, element 401-404 show the coil comprises a round shape.)
Regarding claim 9, Jin discloses the magnetic-field applicator according to claim 1 wherein the treatment surface is adapted to receive two feet in an upright orientation. (paragraph [0046] “The person's foot (106) is placed on the treatment surface (102),” Figure 1, element 102 received the person foot 106 in an upright position. Paragraph [0020] “FIG. 4 shows an exemplary device in which four coils are positioned beneath the treatment surface, to allow magnetic pulses to be provided to two locations on both feet of the person”)
Regarding claim 10, Jin discloses the magnetic-field applicator according to claim 1, wherein the at least one stimulation coil comprises a first stimulation coil and a second stimulation coil placed side-by-side with respect to the treatment surface. (Figure 4, shows coils elements 401 and 403 placed side by side on the treatment surface.)
Regarding claim 13, Jin discloses the magnetic-field applicator according to claim 1, and further discloses wherein the at least one stimulation coil is air cooled and/or liquid cooled. (paragraph [0008] “the cooling mechanism comprises a fan mounted to the enclosure wherein the fan causes airflow around the heat sink.”)
Regarding claim 15, Jin discloses a magnetic-stimulation system, comprising:
At least one pulse generator (paragraph [0025] “The device incorporates one or more magnetic pulse generators in an enclosure that is preferably floor mounted.”)
and a magnetic-field applicator according to claim 1 (please see claim 1 rejection), wherein the applicator and/or the at least one stimulation coil is connectable to the at least one pulse generator. (paragraph [0026] “If the magnetic pulse generator is a coil, then an electric current pulse generator is required to create an electric current pulse in the coil, which generates a magnetic pulse through induction. The electric current pulse generator may connect to the device using a cable or connector, or the electric current pulse generator may be contained inside the enclosure.”)
Regarding claim 16, Jin discloses a method for magnetic stimulation of at least one foot of an individual, comprising: placing, in an upright orientation, the at least one foot on a treatment surface of a magnetic-field applicator according to claim 1 (Figure 6, shows at least one foot upright on the treatment surface 602. Please see claim 1 rejection); and applying one or more pulses by the applicator. (paragraph [0049] “FIG. 4 shows an exemplary device, in which four coils (401, 402, 403, 404) are situated in the enclosure (408). This allows magnetic pulses to be delivered to two portions of both of a person's feet concurrently or alternating.”)
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin.
Regarding claim 11, Jin teaches the applicator of claim 1 and further teaches wherein the first stimulation coil comprises a first orientation and the second stimulation coil comprises a second orientation, wherein the first stimulation coil and the second stimulation coil are arranged such that the first orientation and the second orientation enclose a second angle (Figure 5, element 501 and element 502. Paragraph [0049] “ four coils (401, 402, 403, 404) are situated in the enclosure” and paragraph [0050] “dotted lines (501, 502) are indicators showing where the person should place their feet to ensure optimal coil placement.” The examiner notes the line indicators are where the coils are in a first (501) and second (502) orientation with an undisclosed angle between the two positions.)
However, Jin does not disclose the specific angle between the first and second orientation.
It would be prima facie obvious to modify the orientations taught by Jin to be at specific angles. One of ordinary skill would have been able to recognize that every person would have different anatomical measurements that would need to be adjusted for to ensure proper placement of the feet and further that even though where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Please see MPEP 2144, section II, A; in re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and in re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Fischell (US 9849302).
Regarding claim 4, Jin teaches the magnetic-field applicator according to claim 1, and Jin further teaches when the applicator is placed on the ground, at least a portion of the treatment surface and/or at least a portion of the at least one stimulation coil encloses a first angle with respect to the ground, (Figure 1, shows element 102 at a first angle with respect to the ground) but fails to teach when the angle is preferably of at most 45°, more preferably of at most 15°, most preferably of 2° to 8°, wherein the first angle is optionally adjustable.
Fischell teaches the use of an adjustable angled platform with a magnetic stimulation system. (Figure 4, element 40. Column 7, line 33“The top platform 43 also has a hole 46 through which can slide a round, curved metal cylinder 45 which is used to adjust the angle “a” of the top platform 43 relative to the bottom platform 41. The knurled handled screw 47 can be loosened to adjust the angle “a” of the top platform 43 and can then be tightened to hold that angle fixed relative to the bottom platform 41.” The examiner is modifying the enclosure to be adjustable as taught by Fischell.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Jin in view of Fischell to have an adjustable angle. One of ordinary skill in the art would have been able to recognize that the platform should be adjusted for the optimum comfort of the patient as he/she undergoes a somewhat lengthy procedure for the treatment of foot and ankle pain. See column 7, line 40 of Fischell.
However, both Jin and Fischell fail to disclose a specific angle.
Both Jin (figure 1) and Fischell (figure 4) teach the platform at less than a 90-degree angle.
It would be prima facie obvious to modify the system taught by Jin and Fischell to have a 45-degree angle, 15, and 2 to 8. One of ordinary skill would have been able to recognize that even though where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Please see MPEP 2144, section II, A; in re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and in re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Fischell further in view of Chin (KR 20220007790)
Regarding claim 5, Jin teaches the applicator according to claim 1, but fails to teach wherein the treatment surface and/or the at least one stimulation coil are movable relative to each other, preferably by one or more motors.
Fischell teaches the use of an adjustable angled platform with a magnetic stimulation system. (Figure 4, element 40. Column 7, line 33“The top platform 43 also has a hole 46 through which can slide a round, curved metal cylinder 45 which is used to adjust the angle “a” of the top platform 43 relative to the bottom platform 41. The knurled handled screw 47 can be loosened to adjust the angle “a” of the top platform 43 and can then be tightened to hold that angle fixed relative to the bottom platform 41.” The examiner is modifying the enclosure to be adjustable as taught by Fischell.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Jin in view of Fischell to have an adjustable angle. One of ordinary skill in the art would have been able to recognize that the platform should be adjusted for the optimum comfort of the patient as he/she undergoes a somewhat lengthy procedure for the treatment of foot and ankle pain. See column 7, line 40 of Fischell.
Chin teaches a device for stimulating feet with a movable platform using a motor (Page 3, paragraph 2 “In addition, according to an embodiment, the plate 110 may move in the vertical direction, that is, in the direction 111 on one side of the plate or the direction 112 on the other side of the plate by an actuator.”)
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 Jin to have a motor to adjust the treatment surface as taught by Chin. One of ordinary skill in the art would have been able to recognize that it would be more comfortable for the user to have an automated mechanism to adjust the platform for comfort.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Sotiriou (US 2009/0105520).
Regarding claim 6, Jin teaches the applicator according to claim 1, but fails to teach wherein a magnetic core is placed inside and/or around the at least one stimulation coil, wherein the magnetic core is optionally movable relative to the treatment surface and/or the at least one stimulation coil, preferably by one or more motors.
Sotiriou teaches a magnetic therapy device with a core inside a stimulation coil movable by a motor. (paragraph [0037] “The secondary coil 252 may, for example, include a wire such as a copper wire wrapped around a pot core.” paragraph [0052] “The motor 104 may spin a disk (shown in FIG. 6D) upon which a plurality of magnets are mounted, according to an example embodiment.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the coils taught by Jin in view of Sotirou. One of ordinary skill in the art would have been able to recognize that a coil with a core would produce stronger electric fields and reduce unwanted heat generation compared to a coil without a core.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Sumners (US 2013/0331907) further in view of Bove (US 2008/0243197), as cited in the applicant’s IDS.
Regarding claim 12, Jin teaches the magnetic-field applicator according to claim 1, but fails to teach wherein the treatment surface comprises: at least one bulge adapted to receive at least a part of the at least one foot, preferably a medial part of a forefoot region of the at least one foot, wherein optionally a shape of the at least one bulge is adjustable, and/or a shape that forms a footbed for the at least one foot, and/or a biocompatible material.
Sumners teaches a foot platform with a contact surface adapted to receive a foot. (paragraph [0056] “Each contact surface 16a, 16b is generally elongate and is shaped to resemble the general outline of a foot. The contact surfaces 16a, 16b are of a size to accommodate the entire plantar surface of a foot of the subject.” paragraph [0057] “Each contact surface 16a, 16b is provided with a plurality of arcuate ridges 18 thereon.” Paragraph [0025] “The contact surface may have any suitable shape, so as to provide a sufficient contact with the plantar surface of the foot of the subject.” The examiner notes that the contact surfaces are the bulges, the plantar surface includes the forefoot and midfoot, and that a footbed is formed in figure 1, elements 14a and 14b.)
It would be prima facie obvious to modify the dotted outlines taught by Jin to have a bulge as taught by Sumners. One of ordinary skill in the art would have been able to recognize that the contact surfaces would allow the feet to not slide off during treatment and stay in place.
However, both Jin and Sumners fail to teach the bulge is made of a biocompatible material.
Bove teaches a magnetic therapy applicator for the foot (Figure 8, element 300. Paragraph [0023] “The applicator surface may be made from a medical grade silicon flexible resin, to better facilitate the transmission of all the energy waves and frequencies desired to be applied. Silicone is generally used for both comfort reasons and functionality reasons and may also in and of itself further facilitate the generation or transmission of energy to static ions.”)
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 Jin and Sumners in view of Bove. One of ordinary skill in the art would have been able to recognize that silicone would allow transmission of energy waves and frequences while still being comfortable for a user. See paragraph [0023] of Bove.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Fischell further in view of Rajguru (US 2017/0266443) (as cited in the applicant’s IDS) further in view of Sotiriou.
Regarding claim 14, Jin teaches the magnetic-field applicator of claim 1, wherein the at least one stimulation coil is adapted to generate a magnetic field at the treatment surface: With an intensity of 0.1 to 5T, preferably with an intensity of 0.5 to 3T (paragraph [0043] “the strength of the magnetic field is from about 10 Gauss to about 4 Tesla.”
But Jin fails to teach with an intensity of 0.1 to 5 T, preferably with an intensity of 0.5 to 3 T and and/or upon receiving a current of 500 to 10,000 A, preferably upon receiving a current of 3,000 A to 5,000 A.
Fischell teaches a magnetic treatment device with an intensity of 0.1 – 5 T (column 3, line 55 “an optimum magnetic pulse strength at the skin being between 0.8 and 3.0 Tesla” The examiner notes this range overlaps with the claimed limitation.) that receives a current of about 500 to 10,000 Amperes (column 3, line 61 “500 Amperes or as strong as 10,000 Amperes”) and has a duration between 10 – 500 microseconds (column 3, line 46 “The waveform for treatment would be a magnetic pulse with a rise time between 10 and 500 microseconds.” The examiner notes this range overlaps with the claimed range in the limitation.)
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 Jin in view of Fischell. One of ordinary skill in the art would have been able to recognize that these treatment parameters have been used previously in the art to treat the foot and would yield the predictable results of providing magnetic stimulation treatment for foot pain. See column 2, line 43 of Fischell.
But Jin and Fischell fail to teach at least one stimulation coil comprises a diameter of 15 cm to 40 cm, preferably of 20 cm to 35 cm.
Rajguru teaches a magnetic stimulation device for the feet with a coil diameter of about 4.5 cm. (paragraph [0236] The diameter of the coil body may vary. For example, the diameter may range from about 3.0 to about 7 inches or from about 4 to about 5 inches or the diameter may about 4.5 inches.)
It would be prima facie obvious to one of ordinary skill to modify the system of Jin and Fischell to the coil size taught by Rajguru. One of ordinary skill in the art would have been able to recognize that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Please see MPEP 2144.04, section IV, A; Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
However, Jin, Fischell, and Rajguru fail to teach at least one simulation coil comprises an inductance of 0.1 to 10,000 µH, preferably of 1 to 500 µH.
Sotiriou teaches a magnetic therapy device with an the at least one simulation coil comprises an inductance of 0.1 to 10,000 µH, preferably of 1 to 500 µH. (Paragraph [0026] “The inductor 214 may, for example, have an inductance of approximately one milliHenry.” The examiner notes one millihenry is 1000 microhenry, and this range is overlapping with the claimed limitation.)
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 Jin and Fischell in view of Sotiriou. One of ordinary skill in the art would have been able to recognize that these treatment parameters have been used previously in the art to provide magnetic therapy.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Rajguru.
Regarding claim 17, Jin teaches the method according to claim 16, but fails to teach wherein the one or more pulses are applied by the applicator while the individual is sitting, preferably on a chair.
Rajguru teaches a method for magnetic stimulation while the patient is sitting. (paragraph [0404] “Place the patient in a comfortable position, supine or sitting, for easy access to the placement site.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify Jin in view of Rajguru. One of ordinary skill in the art would have been able to recognize that a user must be comfortable for treatment. See paragraph [0404] for Rajguru.
Regarding claims 18 and 19, Jin teaches the method according to claim 16 (of claim 18) and the use of a magnetic-field applicator according to claim 1 (please see claim 1 rejection) (of claim 19), Jin fails to teach applying one or more additional pulses, by one or more additional applicators, to a pelvic or pelvic floor region of the individual and/or to a leg of the individual, preferably below a knee of the leg (of claim 18) and an urge incontinence treatment (of claim 19).
Rajguru teaches a method of treating the pelvic region and an incontinence treatment. (paragraph [0209] “In certain variations, methods of treating a subject with urinary incontinence or various pelvic floor disorders utilizing the energy emitting systems described herein are contemplated.” Paragraph [0210] “A current is then passed through the energy generator to produce, generate or deliver energy, e.g., a magnetic or electromagnetic field or electrical or magnetic energy or stimulus, focused on the tibial or posterior tibial nerve or branches thereof. This in turn may cause the stimulation of a pudendal nerve, sacral plexus, or other nerves in the pelvic floor.” The examiner notes that the treatment is going through the feet or legs since the energy is focused on the tibial or posterior nerve.)
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 Jin in view of Rajguru. One of ordinary skill in the art would have been able to recognize that various nerves affecting the urinary tract and bladder can be stimulated through the tibial nerve. See paragraph [0210] of Rajguru.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kagaya (US 20210244959) teaches a magnetic stimulation device for feet.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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