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 12 is objected to because of the following informalities: The phrase “method of claim 10 1” should be “method of claim 10”. Appropriate correction is required.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 20 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 20 recites the limitation “stimulators overlays at least one of patient’s hip, waist, thigh, calf, shin, and/or buttocks”. Thus, it is claiming that the stimulators are attached to the patient. “overlays” should be amended to “configured to overlay” to overcome this 101 rejection.
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)(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) 1-8, 15-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Robison et al. (Pub. No.: US 2023/0039154 A1); hereinafter referred to as “Robison”.
Regarding claim 1, Robison discloses a garment for treating restless leg syndrome (e.g. see [0047]. Note: The RLS limitation adds no structure. It is an intended use limitation of a system claim. The structural limitations are met by the prior art and therefore the system of Robison is capable of being used for the treatment of RLS) comprising: an article of clothing (e.g. see [0047]); at least one electrode (e.g. see figure 2 element 201, [0043]-[0048]), the at least one electrode attached to the article of clothing (e.g. see [0047]); and a pulse generator (e.g. see figure 2 element 204, [0055]) the pulse generator connected to the at least one electrode.
Regarding claim 2, Robison discloses the at least one electrode produces electric pulses at a frequency between 0-120 Hz (e.g. see figure 5, element 520).
Regarding claim 3, Robison discloses the at least one electrode produces electric pulses, the electric pulses having a pulse width of between 0-500 μs (e.g. see figure 5, element 520).
Regarding claim 4, Robison discloses the at least one electrode produces electric pulses having a varying intensity (e.g. see figure 5, element 520).
Regarding claim 5, Robison discloses a remote control, wherein the remote control is configured to control frequency, pulse width, and/or intensity of pulses delivered through the at least one electrode (e.g. see figures 5 and 6, elements 500a, 500b, 600a, 600b, figure 1 element 150, [0106]-[01112]).
Regarding claim 6, Robison discloses a power source (e.g. see figure 2 element 205).
Regarding claim 7, Robison discloses a mechanical stimulator (e.g. see [0055], [0097]).
Regarding claim 8, Robison discloses the article of clothing is a pair of leggings (e.g. see [0047]).
Regarding claim 15, Robison discloses a system for treating one or more symptoms of restless leg syndrome (RLS) (e.g. see [0047]. Note: The RLS limitation adds no structure. It is an intended use limitation of a system claim. The structural limitations are met by the prior art and therefore the system of Robison is capable of being used for the treatment of RLS), comprising: a pair of leggings (e.g. see [0047]) comprising one or more electrical stimulators (e.g. see [0055], [0097]) and one or more mechanical stimulators (e.g. see [0055], [0097]) arranged on an inner surface thereof; one or more pulse generators (e.g. see figure 2 element 204, [0055]) in electrical communication with the one or more electrical stimulators and the one or more mechanical stimulators; a power source (e.g. see figure 2 element 205) in electrical communication with the one or more pulse generators; and a mobile device in communication with the pulse generator and comprising at least one processor programmed and/or configured to control one or more characteristics of pulses generated by the pulse generator (e.g. see figures 5 and 6, elements 500a, 500b, 600a, 600b, figure 1 element 150).
Regarding claim 16, Robison discloses the power source is removably coupleable with the pair of leggings (e.g. see [0047], [0066], [0104]).
Regarding claim 18, Robison discloses the at least one processor is programmed and/or configured to generate a user interface on the mobile device configured to allow a patient to control the one or more characteristics of the pulses (e.g. see figures 5 and 6, elements 500a, 500b, 600a, 600b, figure 1 element 150, [0106]-[01112]).
Regarding claim 19, Robison discloses the user interface allows the patient to control one or more of pulse frequency, pulse width, pulse duration, interstimulus interval, and duration of stimulation (e.g. see figures 5 and 6, elements 500a, 500b, 600a, 600b, figure 1 element 150, [0106]-[01112]).
Regarding claim 20, Robison discloses the one or more electrical stimulators and one or more mechanical stimulators are arranged such that one or more of the stimulators overlays at least one of a patient's hip, waist, thigh, calf, shin, and/or buttocks (e.g. see [0047], [0066], [0104]. Robison teaches calf).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robison in view of Wolfe et al. (Pub. No.: US 2010/0286545 A1); hereinafter referred to as “Wolfe”.
Regarding claim 9, Robison discloses in [0047] that “any wearable form factor suitable for targeting a particular muscle group on a user's body, or a combination thereof” but is silent as to the article of clothing is a shirt or jacket. Wolfe teaches it is known to use a shirt in an RLS treatment device as set forth in [0048] and [0080] to provide upper body sensing capabilities. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a shirt in an RLS treatment device as taught by Wolfe in the device of Robison, since said modification would provide the predictable results of upper body sensing capabilities.
Claim(s) 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robison in view of Kent (Pub. No.: US 2016/0354604 A1).
Regarding claim 10, Robison discloses the device (see the rejection for claim 1 above) and discloses movement augmentation (e.g. see [0027]-[0030]) but is silent as to specifically treating RLS. Kent teaches that it is known to use a lower body garment to treat RLS as set forth in the abstract, figure 6, [0063] to provide more effective treatment of the RLS without the undesirable side effects of drugs currently used for RLS treatment (e.g. see [0008]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to treat a patient suffering from RLS as taught by Kent in the method of Robison, since said modification would provide the predictable results of more effective treatment of the RLS without the undesirable side effects of drugs currently used for RLS treatment.
Regarding claim 11, Robison discloses varying a frequency of the electric pulse between 0-120 Hz (e.g. see figure 5, element 520).
Regarding claim 12, Robison discloses varying a pulse width of the electric pulse between 0-500 us (e.g. see figure 5, element 520).
Regarding claim 13, Robison discloses varying an intensity of the electric pulse (e.g. see figure 5, element 520).
Regarding claim 14, Robison discloses placing at least one mechanical stimulator on the patient and providing at least one vibrational pulse through the at least one mechanical stimulator (e.g. see [0055], [0097]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robison in view of Moaddeb et al. (Pub. No.: US 2021/0330547 A1); hereinafter referred to as “Moaddeb”.
Regarding claim 17, Robison teaches the power source is a battery (e.g. [0097]) but does not disclose whether the battery is rechargeable. Moaddeb teaches that it is known to use such a modification as set forth in [0049], [0063] to provide means to repower the device after the power has been discharged. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a rechargeable battery in a RLS treatment device as taught by Moaddeb in the system/method of Robison, since said modification would provide the predictable results of means to repower the device after the power has been discharged.
Conclusion
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/PHILIP C EDWARDS/Examiner, Art Unit 3792
/JAMES M KISH/Supervisory Patent Examiner, Art Unit 3792