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 .
Status of Claims
This Action is in response to the amendment filed on December 22, 2025.
As directed by the amendment: Claim 3 was amended. Claims 1-20 are pending and currently under consideration for patentability under 37 CFR 1.104.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application(s), such as Application No. 16/300,211, PCT/US17/32214, and 62/334,799 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, claims 7-9 recite the position of the vibration motor(s) being at the base of a 2nd metatarsal and/or a base of a 2nd digit of a palm of a hand and the prior-filed application(s) fail to provide support for these limitations, and claim 10 recites positioning the vibration motor(s) at an ulnar nerve, which the prior-filed application(s) fail to provide support for.
Therefore, claims 7-10 have an effective filing date of December 2, 2020, based upon App. 63/120,277.
Information Disclosure Statement
The information disclosure statement filed Marcy 17, 2025, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. For example, there is no explanation of the relevance of KR 200345457. It has been placed in the application file, but the information referred to therein has not been considered.
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.
Claims 1-5, 7, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1).
Regarding claim 1, Tass discloses a method for reducing epileptic seizures in a subject (an apparatus 100, see Fig. 1, uses a first stimulation unit 11, see Figs. 1 and 32, to provide vibratory stimulation, see para. [0050], to treat epilepsy, see para. [0046]) comprising:
providing a first vibration motor (first stimulation unit 11, see Fig. 32; the first stimulation unit 11 including stimulation elements 311-314 for providing vibratory stimulation, see para. [0212]. Merriam-Webster defines “motor” as “one that imparts motion” and thus the vibratory stimulation unit 11 reads on a vibration motor as it imparts vibratory motion) coupled to a controller (control unit 10, see Fig. 32) configured to control vibratory motion of the first vibration motor (the vibrator 11 being controlled by the controller 10, see para. [0211], to control the vibratory motion of the vibrator 11, see para. [0212]);
positioning the first vibration motor (11, Fig. 32) on a limb of the subject (the vibrator 11 is positioned on the skin of the arm, leg, hand and/or foot of the subject, see para. [0212]); and
generating, according to a treatment regimen (any vibration applied for a therapeutic purpose is being considered a treatment regimen), a vibratory stimulation signal configured to stimulate proprioceptive nerves in the limb (a vibratory stimulation signal is generated by the controller 11, see paras. [0211]-[0212], to apply the vibratory stimulation to the skin tissue to be “guided to different target regions via nerve lines”, see paras. [0212]-[0213]. The vibratory stimulation is received by receptors lying beneath the skin, in the muscles, the subcutaneous tissue, and/or tendons of the patient, and guided to the nerve system, including Merkel cells, Ruffini bodies, Meissner bodies, hair follicle receptors, and Vater-Pacini bodies, see para. [0050]) and trigger kinesthetic cues (the vibratory stimulation is “intentionally … perceptible by the patient”, see para. [0044], and the vibration is received by receptors lying beneath the skin, in the muscles, the subcutaneous tissue, and/or tendons of the patient, and guided to the nerve system, including Merkel cells, Ruffini bodies, Meissner bodies, hair follicle receptors, and Vater-Pacini bodies, see para. [0050]. Thus, the vibration provides kinesthetic cues because the body is sensing physical vibratory movement/touch and the body is aware, perceiving this vibration at the vibration motor location) that stimulate nerves (be “guided to different target regions via nerve lines, which e.g. lie in the spinal cord and/or in the brain”, see paras. [0212]-[0213]) to suppress seizure activity (Tass treats neurological diseases including Parkinson’s, essential tremor, epilepsy, diseases of the cerebellum, see para. [0046]).
Tass suggests applying the vibratory stimulation to the arm, leg, hand, and/or foot (see para. [0212]) and adjusting the vibration location to treat different target nerves (see para. [0212]-[0214]), but does not specifically state that the kinesthetic cues stimulate nerves in cerebellar and pontine areas of the brain, and does not specifically state the treatment regimen comprises at least one period of about 8 hours of continuous vibratory stimulation.
Gerstenbrand teaches a related device for applying vibratory stimulation to the foot (via massage parts 7, Fig. 2), such as in the metatarsal area (“toe ball area” see page 4, the 4th-5th paragraphs of the English translation and see Fig. 2). Gerstenbrand states that vibration on the sole of the foot provides stimulation to the cerebellum (see page 2, the last seven lines of the second paragraph of the English translation) to provide improved motor performance and improved performance of the human body’s entire balance and coordination system and thus should be used to treat neurological diseases with damage to the postural system (the postural system includes the cerebellum) for stroke or Parkinson’s patients, and the massage is useful to simulate a proprioceptive and epicritic input to the brain (see page 2, the fourth paragraph of the English translation).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the positioning of the first vibration motor(s) of Tass to be positioned to vibrate the sole of the foot in the metatarsal area as taught by Gerstenbrand because this will stimulate the postural system including the cerebellum and provide improved motor performance, balance, and coordination, to treat neurological diseases associated with motor control.
The modified Tass/Gerstenbrand method thus applies vibration to the metatarsal area of the foot to stimulate the cerebellum as a treatment of neurological diseases relating to motor control and the postural system (as taught by Gerstenbrand) and thus would be expected to stimulate nerves in the pontine area because this is the same location of vibration as the instant invention (see Fig. 52A, for example) and Applicant states that prior art demonstrates that cerebellar and pontine processes are activated by stimulation of the foot (see par. [0008] of the publication). Furthermore, it is known that the pontine area of the brain contributes to coordination of balance and posture.
However, even assuming the modified Tass/Gerstenbrand method was considered silent regarding stimulating nerves in the pontine area, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjust the vibration location on the foot to treat different target nerves in the pontine area, since it has been held that where the general conditions of a claim are disclosed in the prior art (applying vibration to the metatarsal area of the foot to stimulate nerves associated with the cerebellum and postural system to treat motor control and balance disorders as taught by Gerstenbrand), discovering the optimum or workable ranges (applying the vibration at the second metatarsal to target the pontine area, which is also involved in the coordination of balance and posture) involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05.
The modified Tass/Gerstenbrand does not specifically state the treatment regimen comprises at least one period of about 8 hours of continuous vibratory stimulation. However, it is noted that there does not appear to be any particular criticality to the duration of “about 8 hours” (this covers a broad range of 6.4 hours to 9.6 hours as Applicant’s specification defines “about” to encompass variations of +/- 20%, see para. [0072]) and 8 hours was only stated to have beneficial effects compared to a control group of no vibrations. Furthermore, Tass discloses providing continuous vibratory stimulation for periods (such as Δt1, Fig. 2A-2B) “between 30 minutes and 6 hours [and] can, however, also lie outside of this range” (emphasis added, see the first sentence of [0057] and Fig. 2A). This clearly suggests to one of ordinary skill in the art that stimulation periods greater than 6 hours would have a reasonable expectation of success.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment regimen of Tass/Gerstenbrand to comprise at least one period of about 8 hours of continuous vibratory stimulation as part of routine experimentation of testing different durations to see which duration is best suited for particular patients, since it has been held that where the general conditions of a claim are disclosed in the prior art (applying vibration for 6 hours or more as generally taught by Tass), discovering the optimum or workable ranges (applying continuous vibration for “about” 8 hours) involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05.
Regarding claim 2, the modified Tass/Gerstenbrand method discloses providing a second vibration motor (see the plurality of stimulation elements 311-314, Fig. 32 of Tass. One of these vibrators may be considered a second vibration motor. Alternatively, Tass discloses providing a second stimulation unit 12, Fig. 10, which may be considered a second vibration motor), and wherein the step of positioning comprises positioning at least one of the first and second vibration motor on a foot or a hand of the subject (at least the first vibration motor has been positioned on a foot of the subject, at the metatarsal area as taught by Gerstenbrand).
Regarding claim 3, the modified Tass/Gerstenbrand method discloses positioning the first and second vibration motors on opposing ends of the foot (Gerstenbrand discloses providing vibration at the front end of the foot at the metatarsal area, and at the rear, heel end of the foot as seen in Fig. 2. In the modified method, a first vibration motor will be in the metatarsal area and a second vibration motor will be in the heel area).
Regarding claim 4, the modified Tass/Gerstenbrand method discloses positioning the first vibration motor on a foot of the subject (the first vibration motor has been positioned on a foot of the subject, at the metatarsal area as taught by Gerstenbrand), but the method as currently combined is silent regarding the second vibration motor being positioned on the hand of the subject.
However, Tass discloses positioning the vibration motors at the hand of the subject (see the second sentence of [0212] and the second sentence of [0232]), and states that the vibration motors) enable stimulating different receptive regions of the skin to target different nerve lines in the spinal cord and/or brain, and that different target regions can be stimulated in the spinal cord and/or brain during the same stimulation period (see para. [0213], see the first two sentences of [0229], and para. [0232]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the positioning of the second vibration motor of Tass/Gerstenbrand to be positioned on the hand of the subject as taught by Tass so the treatment can provide a combined stimulation to different nerve lines in the spinal cord and brain, which may be desired for certain patients depending on their illnesses (see para. [0212]).
Regarding claim 5, the modified Tass/Gerstenbrand method discloses positioning the first vibration motor on a sole of a foot of the subject (the first vibration motor has been positioned on a foot of the subject, at the metatarsal area as taught by Gerstenbrand).
Regarding claim 7, the modified Tass/Gerstenbrand method discloses positioning the first vibration motor on a sole of a foot at a base of a 2nd metatarsal (the first vibration motor has been positioned on a foot of the subject, at the metatarsal area as taught by Gerstenbrand, and specifically at the base of the 2nd metatarsal as modified based on In re Aller in the claim 1 rejection statement above).
Regarding claims 18-20, the modified Tass/Gerstenbrand method discloses the step of generating the vibratory stimulation signal (see paras. [0211]-[0212] of Tass), but does not specifically disclose that the vibratory stimulation signal comprises a 128Hz sine wave.
However, Tass discloses that the perceptible vibratory stimulation signals are in the range of 10 to 160 Hz (see para. [0078]) which encompasses the claimed value of 128 Hz, and the vibratory stimulation signals are sinusoidal (see para. [0217]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the vibratory stimulation signal of Tass/Gerstenbrand to be a 128 Hz sine wave to provide a sensory perceptible vibratory stimulus for treating epilepsy in the subject (see para. [0078] and [0046] of Tass), and since it has been held that where the general conditions of a claim are disclosed in the prior art (applying sinusoidal vibration signals between 10-160 Hz for treatment of epilepsy), discovering the optimum or workable ranges (i.e., 128 Hz) involves only routine skill in the art.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1) as applied to claim 1 above, and further in view of Lundqvist (US 2012/0245483)
Regarding claim 6, the modified Tass/Gerstenbrand method discloses positioning a vibration motor on the hand of the subject (see para. [0212] of Tass), but does not specifically state positioning the first vibration motor on a palm of the hand.
Lundqvist teaches a method for providing vibration to a subject (a vibration motor 12, see Fig. 1 and para. [0061]) for relaxation of a spastic muscle of disease states including neuromuscular dysfunction (see abstract and para. [0019]), and includes positioning at least one vibration motor on a palm of the hand (Ulnocarpeal ligament VF17, Radiocarpeal ligament VF18, Radiocarpeum ligament VF19, Collateral radial ligament in the radiocarpeal joint VF20, see Fig. 9). One of ordinary skill in the art would recognize that epileptic patients may also experience muscle spasms such as myoclonic seizures, and thus there would be a desire for relaxation of spastic muscle(s).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the positioning of at least one of the vibration motor(s) of Tass/Gerstenbrand to include a vibration motor at the palm of the hand as taught by Lundqvist for the purpose of providing the proprioceptive stimulation to relax spastic muscles along the hand, which would be beneficial for at least some patients experiencing muscle spasms. Additionally, it is noted that claim 1 does not require the vibratory stimulation to be associated with the first vibration motor. Thus, the modified method will still have a “first vibration motor” on the palm as taught by Lundqvist, and other vibration motor(s) on the sole of the foot to suppress seizure activity as taught by Gerstenbrand.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1) as applied to claims 1-2 above, and further in view of Brandl (WO 2019/211488).
Regarding claim 8, the modified Tass/Gerstenbrand method discloses positioning a vibration motor on the hand of the subject (see para. [0212] of Tass), but does not specifically state positioning the first vibration motor on a base of a 2nd digit of a palm of the hand.
Brandl teaches a related wearable vibratory device for reducing tremors (Fig. 13) wherein at least a first vibration motor is positioned on a base of a 2nd digit of a palm of the hand (vibration-damping device 18, Fig. 13 is shown to be at the base of a 2nd digit, “which is designed to generate at least one vibration with at least one vibration amplitude which can reduce the amplitude of the tremors” see the Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the first vibration motor of Tass/Gerstenbrand to be positioned on a base of a 2nd digit of a palm of the hand as taught by Brandl to help reduce the amplitude of any tremors of the patient. Additionally, it is noted that claim 1 does not require the vibratory stimulation to be associated with the first vibration motor. Thus, the modified method will still have a “first vibration motor” on the base of the 2nd digit as taught by Brandl, and other vibration motor(s) on the sole of the foot to suppress seizure activity as taught by Gerstenbrand.
Regarding claim 9, the modified Tass/Gerstenbrand method discloses positioning the first vibration motor on a sole of a foot at a base of a 2nd metatarsal (the first vibration motor has been positioned on a foot of the subject, at the metatarsal area as taught by Gerstenbrand, and specifically at the base of the 2nd metatarsal as modified based on In re Aller in the claim 1 rejection statement above), and further discloses positioning a vibration motor on the hand of the subject (see para. [0212] of Tass), but does not specifically state positioning the second vibration motor on a base of a 2nd digit of a palm of the hand.
Brandl teaches a related wearable vibratory device for reducing tremors (Fig. 13) wherein at least a second vibration motor is positioned on a base of a 2nd digit of a palm of the hand (vibration-damping device 18, Fig. 13 is shown to be at the base of a 2nd digit, “which is designed to generate at least one vibration with at least one vibration amplitude which can reduce the amplitude of the tremors” see the Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the second vibration motor of Tass/Gerstenbrand to be positioned on a base of a 2nd digit of a palm of the hand as taught by Brandl to help reduce the amplitude of any tremors of the patient.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1) as applied to claim 1 above, and further in view of Rosenbluth et al. (US 9,452,287).
Regarding claim 10, the modified Tass/Gerstenbrand method discloses positioning at least one vibration motor on a wrist or arm of a subject (see para. [0212] and see stimulation unit 12 on the wrist, Fig. 10), but does not specifically disclose positioning the first vibration motor adjacent to an ulnar nerve of an arm of the subject.
Rosenbluth teaches a related nerve stimulation device to treat tremor (Fig. 1, see abstract) in which the stimulation is applied adjacent to an ulnar nerve of an arm of the subject (see wrist 530, Fig. 5, which shows “access points” for stimulating nerves such as the ulnar nerve 630, Fig. 6A, see col. 10, line 63 through col. 11, line 9; see also col. 13, lines 55-58). Rosenbluth states that the stimulation may be provided by a vibration motor (see col. 17, lines 20-33).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the first vibration motor of Tass/Gerstenbrand to be positioned adjacent to an ulnar nerve of an arm of the subject as taught by Rosenbluth to help treat tremor of a patient. Additionally, it is noted that claim 1 does not require the vibratory stimulation to be associated with the first vibration motor. Thus, the modified method will have a first vibration motor adjacent to the ulnar nerve as taught by Rosenbluth and it will still have other vibration motor(s) on the sole of the foot to suppress seizure activity as taught by Gerstenbrand.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1) as applied to claim 1 above, and further in view of Franceschetti (US 2016/0136383).
Regarding claim 11, the modified Tass/Gerstenbrand method discloses the step of generating the vibratory stimulation signal (see paras. [0212]-[0213] of Tass), but does not specifically disclose that the step of generating a vibratory stimulation signal is performed while the subject is sleeping.
However, Franceschetti teaches that a system for providing vibration to the subject to treat epileptic seizures (see para. [0084]) includes providing a vibratory stimulation signal is performed while the subject is sleeping (a vibrating pillow strip 240, see Fig. 2, is controlled to provide vibration while the subject is sleeping, see para. [0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the step of generating a vibratory stimulation signal of Tass/Gerstenbrand to occur when the subject is sleeping, as taught by Franceschetti, to prevent the subject from injury, due to an onset of a seizure, while the subject is sleeping (see para. [0084] of Franceschetti).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1) as applied to claim 1 above, and further in view of Simkins (US 5,523,742).
Regarding claim 12, the modified Tass/Gerstenbrand method discloses the subject has epilepsy (see para. [0046] of Tass), but does not specifically disclose that the subject has a condition selected from a group consisting of temporal lobe epilepsy, generalized tonic-clonic epilepsy and focal epilepsy.
However, Simkins teaches that, of several types of seizures associated with epilepsy, the most common of are generalized as tonic-clonic (see lines 29-41 of col. 1).
Therefore, it would be an obvious matter of design choice to modify the Tass/Gerstenbrand method to treat a subject experiencing tonic-clonic epilepsy, as taught by Simkins, since a doctor would expect that a therapy method, for treating epilepsy, would be beneficial for treating a subject with the most common type of seizures, tonic-clonic epilepsy.
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1) as applied to claim 1 above, and further in view of Lorberbaum (US 9,463,287).
Regarding claim 13, the modified Tass/Gerstenbrand method discloses the step of generating a vibratory stimulation signal comprises delivery of the vibration in pulses (see Fig. 34C and para. [0219] of Tass), but is silent with regard to the step of generating a vibratory stimulation signal comprises a delivery of pulses at a rate of about 50-150 pulses per minute.
However, Lorberbaum teaches that a step of generating a vibratory stimulation signal, for a vibration motor (motor 24 and cam 26, see Fig. 1), comprises a delivery of pulses at a rate of about 50-150 pulses per minute (a controller, PCB 28, see Fig. 1, generates a vibratory stimulation signal to control the vibration motor 24/26 to deliver pulses every second, with a tenth of a second delay, such that the vibratory stimulation signal is delivered at 54 seconds per minute, see lines 58-63 of col. 17).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Tass/Gerstenbrand to deliver pulses of the vibratory stimulation signal at a rate of about 54 pulses per minute, as taught by Lorberbaum, for the purpose of restimulating the nerves of the subject (see lines 61-63 of col. 17 of Lorberbaum), to provide constant perceptible stimulation to the subject.
Regarding claim 15, the modified Tass/Gerstenbrand method discloses the step of generating a vibratory stimulation signal includes providing a pulse train of vibration stimuli (see Fig. 34C of Tass), but is silent with regard to the step comprising pulsing in a variable-amplitude sequence.
However, Lorberbaum teaches that the controller (28, see Fig. 1) delivers the pulses of vibratory stimulation in a variable-amplitude sequence a vibrator (the controller 28 provides the sequence of variable-amplitude pulses of vibratory stimulation, see lines 58-63 of col. 17, to provide effective stimulation based on the subject’s physiology, see lines 5-10 of col. 18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of the modified Tass/Gerstenbrand method to control the vibratory stimulation signal to pulse in a variable-amplitude sequence, as taught by Lorberbaum, for the purpose of improving the effectiveness of the vibratory stimulation by varying the stimulation in accordance with the subject’s physiology (see lines 5-10 of col. 18 of Lorberbaum).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1) as applied to claim 1 above, and further in view of Amblard (US 2016/0158091).
Regarding claim 14, the modified Tass/Gerstenbrand method discloses the controller (see Fig. 32 and paras. [0211]-[0212] of Tass), and that the controller sets a pulse rate, pulse duration and pulse amplitude (the delivery of the vibration in pulses is shown to include a rate of the pulses, a duration of the pulses over time and an amplitude of the pulses, see Fig. 34C and para. [0219] of Tass, and the controller varies an interpulse duration, see Fig. 40 and paras. [0243]-[0244] of Tass, where the controller 10 controls the generation of the pulses, see paras. [0216] and [0248] of Tass).
The modified Tass/Gerstenbrand method is silent with regard to the controller being configured to set a burst duration and an interburst duration.
However, Amblard teaches that a controller (generator housing 18, see Fig. 1) is configured to set a burst duration and an interburst duration (the controller 18 controls pulse bursts at a frequency of 250 Hz, see para. [0046], at a burst duration, as the duration of the pulses as recited in para. [0047], and interburst duration of pulses, as a spacing between pulses as recited in para. [0064], of a vibrator, defined by effector 20 shown in Fig. 1, for providing optimal kinesthetic stimulation to the skin of the subject, see paras. [0036] and [0046]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of the modified Tass/Gerstenbrand method to control the burst duration and interburst duration of the vibratory stimulation signal, as taught by Amblard, for the purpose of providing optimal kinesthetic stimulation to the subject (see para. [0046] of Amblard).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1) as applied to claim 1 above, and further in view of Corbishley (US 7,318,811).
Regarding claim 16, the modified Tass/Gerstenbrand method discloses the vibration motors are a small vibrating motor (the stimulation elements such as 311, 312, 313, 314, are relatively small wearable units as shown in Fig. 51 of Tass), but is silent with regard to the first vibration motor being between 2 mm and 15 mm in diameter.
However, Corbishley teaches that a vibration motor (vibratory mechanism 34, see Fig. 1), placed on a body of a subject has a diameter of 10 mm (the vibration motor 34 is a coin type vibration DC motor having a diameter of 10 mm, see lines 48-56 of col. 10, and is positioned on the body of the subject, see the abstract)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameter of the modified Tass/Gerstenbrand vibration motors to be 10 mm, as taught by Corbishley, for the purpose of providing a low-profile wearable vibration motor (see lines 45-59 of col. 14 of Corbishley), to increase portability and comfort of the vibration motor.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tass (US 2013/0090519) in view of Gerstenbrand et al. (WO 2009/152544 A1) as applied to claim 1 above, and further in view of Poepperling (US 2013/0204169).
Regarding claim 17, the modified Tass/Gerstenbrand method discloses the first vibration motor placed against a skin surface of a foot or palm of the hand of the subject (see para. [0212] of Tass), but does not specifically disclose that the first vibration motor is covered by a material attached to the subject's skin.
However, Poepperling teaches that a vibrating device 10 (see Fig. 3C) having a vibration motor 14 (see Fig. 3C), for providing vibration to a subject (see para. [0056]), includes a material (base 12 and adhesive material 20, see Fig. 3C) for attaching to the skin of the subject (see para. [0056]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the vibration motors of the modified Tass/Gerstenbrand method with the addition of a material, as taught by Poepperling, for the purpose of maintaining a stable connection between the vibration motor and skin of the subject (see para. [0056] of Poepperling).
Response to Arguments
Applicant's arguments filed December 22, 2025, have been fully considered but they are not persuasive.
Regarding the argument that there is 112(a) support for the at least one period of about 8 hours of continuous vibratory stimulation based on para. [0194] of the published application (see the first two paragraphs of page 7 of the Remarks), this argument is persuasive and the 112(a) rejection(s) are withdrawn.
Regarding the argument that the cited references, alone or in combination do not suggest a treatment regimen that comprises at least one period of about 8 hours of continuous vibratory stimulation, as Tass only teaches “between 30 minutes and 6 hours and can, however, also lie outside of this range” but does not suggest what values outside the range are optimal or workable (see the last paragraph of page 8 of the Remarks), this argument is not persuasive.
Tass alone does not need to suggest what values outside of the range are workable. Based upon MPEP 2144.05, one of ordinary skill in the art would be able to determine the workable range through routine experimentation based upon Tass’s disclosure. Tass discloses the stimulation duration can be “between 30 minutes and 6 hours [and] can, however, also lie outside of this range” (emphasis added, see the first sentence of [0057]). Thus, Tass clearly suggests to one of ordinary skill in the art that stimulation periods greater than 6 hours would have a reasonable expectation of success.
Additionally, it is noted that claim 1 recites “about 8 hours” which means durations of 6.4 hours to 9.6 hours (“about” meaning +/- 20%, see para. [0072] of Applicant’s Specification). Thus, Tass disclosing 6 hours (or more) is closely approaching the recited range. Lastly, it has been held that where the general conditions of a claim are disclosed in the prior art (applying vibration for 6 hours or more as generally taught by Tass), discovering the optimum or workable ranges (applying continuous vibration for “about” 8 hours) involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05.
Regarding the argument that Tass “claiming any duration of time (ranging from microseconds to days, or even weeks or years) does not specifically teach or suggest a treatment regimen that comprises at least one period of about 8 hours of continuous vibratory stimulation” (see the last paragraph of page 8 of the Remarks, through the first paragraph of page 9), this argument is not persuasive. Tass does not claim “any duration of time,” “microseconds to days, or even weeks or years.” Instead, Tass discloses vibratory stimulation periods (Δt1, Fig. 2A) of “between 30 minutes and 6 hours [and] can, however, also lie outside of this range” (emphasis added, see the first sentence of [0057]). A disclosure of up to 6 hours (or more) of continuous vibration clearly suggests to one of ordinary skill in the art that stimulation periods greater than 6 hours would have a reasonable expectation of success. Claim 1 recites “about 8 hours” which means 6.4 hours (6 hours and 24 minutes) to 9.6 hours (9 hours and 36 minutes). Thus, Tass discloses a vibratory duration (6 hours) that is only 24 minutes from the recited claim range. Since Tass specifically states that durations outside of the range (i.e., more than 6 hours) can be used, one of ordinary skill in the art would be able to determine an optimum or workable range of 6.5 hours, for example, as part of routine experimentation of testing different durations to see which duration is best suited for particular patients.
Regarding the argument that the Office “is dismissing the surprising and unexpected results presented in the present application in Experimental Example 2 (paragraphs [0189] to [0203]) not because the results are insignificant, but rather because the importance of the experimentally demonstrated conditions to achieve the surprising and unexpected results is not readily apparent” (see the third paragraph of page 9 of the Remarks), this argument is not persuasive. It is entirely unclear what Applicant is suggesting by arguing that the Office dismissed unexpected results because the importance of the demonstrated conditions were not readily apparent. Which conditions are not readily apparent? Which conditions are important? What was the unexpected or surprising result? Why is it considered unexpected? Conclusory statements that results are “unexpected”, unsupported by objective factual evidence, are not of substantial evidentiary value (see MPEP 716.01(c)(III)).
To be of probative value, objective evidence of unexpected results “must be factually supported by an appropriate affidavit or declaration” (emphasis added, see MPEP 716.01(c)(I)). The burden is on Applicant to establish that the results are in fact unexpected and unobvious and of both statistical and practical significance, such as through direct and indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims (see MPEP 716.02(b)) “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected” … and “a difference of degree is not as persuasive as a difference in kind – i.e., if the range produces ‘"a new property dissimilar to the known property,’" rather than producing a predictable result but to an unexpected extent” (MPEP 716.02).
Here, Applicant has not submitted any affidavit or declaration to demonstrate what the expected result would be, has not clearly defined what the “result” is, and has not compared the results to the closest prior art. Is the alleged unexpected result just that vibration of “about 8 hours” provided better outcomes than no vibration? How do the results compare to the prior art? Even if the results were “really unexpected,” were they producing a difference in degree, or a difference in kind? It is reiterated that the burden is on Applicant to establish that the results are both unexpected and significant.
Regarding the argument that “this is the definition of results being surprising and unexpected, and this is why the Applicant has made the claims commensurate in scope to those conditions” (see the third paragraph of page 9 of the Remarks), this argument is not persuasive. First, it is entirely unclear what Applicant is suggesting as “the definition” of results being surprising and unexpected. The Examiner suggests following the guidance in MPEP 716. Second, the claims are not commensurate in scope with the experimental conditions that allegedly produce “unexpected” results. The Example 2 protocol specifically uses “cutaneous 128 Hz vibration through 12 mm disc motors delivered to the sole of the foot for 8-h nightly” (see para. [0193] of the published application) … with a “vibration force: 2.00 G” (see para. [0194] of the published application). Claim 1 is completely silent as to the vibration being on the sole of the foot, the 128 Hz vibration frequency, and the vibration force of 2.00 G.
Regarding the argument that there is nothing in the cited references that would provide one of ordinary skill in the art with a reasonable expectation of success (see the penultimate paragraph of page 10 of the Remarks), this argument is not persuasive. The combination of Tass and Gerstenbrand provide a clear expectation of success because Gerstenbrand teaches that vibration on the sole of the foot provides stimulation to the cerebellum (see page 2, the last seven lines of the second paragraph of the English translation) to provide improved motor performance and improved performance of the human body’s entire balance and coordination system and thus should be used to treat neurological diseases with damage to the postural system (the postural system includes the cerebellum) for stroke or Parkinson’s patients, and the massage is useful to simulate a proprioceptive and epicritic input to the brain (see page 2, the fourth paragraph of the English translation). Furthermore, Tass discloses the stimulation duration can be “between 30 minutes and 6 hours [and] can, however, also lie outside of this range” (emphasis added, see the first sentence of [0057]). Thus, Tass clearly suggests to one of ordinary skill in the art that stimulation periods greater than 6 hours would have a reasonable expectation of success.
Regarding the argument that if one cannot predict the likely outcome for an experiment, one cannot have a reasonable expectation of success in achieving a given outcome (see the last paragraph of page 10 of the Remarks), this argument is not persuasive. When the prior art specifically suggests applying vibration stimulation for periods of 6 hours (or more), this provides a reasonable expectation of success for one of ordinary skill in the art to determine a workable range such as the claimed range of 6.4 hours to 9.6 hours (“about 8 hours”) through routine experimentation due to the close proximity of the disclosed range and the claimed range.
Regarding the argument that MPEP 2143E articulates how to determine if a claim can be rejected on an “obvious-to-try” rationale (see the last paragraph of page 10 of the Remarks, through the first paragraph of page 11 of the Remarks), this argument is not persuasive. None of the rejections relied on the “obvious-to-try” rationale. Instead, the Office Action articulated why it would have been routine optimization to arrive at the claimed invention and why there would have been a reasonable expectation of success (see the claim rejections above).
Regarding the argument that Tass does not provide a skilled artisan with any predictability or expectation of success at arriving at the claimed method because Tass merely suggests a general method of suppressing pathologically synchronous activity of neurons with no teaching regarding the specific treatment of epileptic seizures via a vibratory stimulation signal configured to stimulate proprioceptive nerves and trigger kinesthetic cues that stimulate nerves in cerebellar and pontine areas of the brain (see the third paragraph of page 11 of the Remarks), this argument is not persuasive. First, the method recited in claim 1 is rather broad, as it merely positions one vibration motor coupled to a controller on “a limb” and generates a vibratory stimulation signal that stimulates nerves, and the treatment regimen comprises at least one period of “about 8” hours of stimulation. Claim 1 does not specify where exactly on the limb the vibration motor is positioned, whether there is a second vibration motor, the position of the second motor, the vibration frequency of the motor(s), the vibration force of the motor(s), etc.
Tass has at least one vibration motor positioned on a limb to apply vibration from 10-160 Hz which is stated to activate a variety of nerves, can be used to treat epilepsy, and suppresses pathologically synchronous activity of neurons (see the claim rejection statement(s) above). Furthermore, the combination of Tass and Gerstenbrand provide a clear expectation of success because Gerstenbrand teaches that vibration on the sole of the foot provides stimulation to the cerebellum (see page 2, the last seven lines of the second paragraph of the English translation) to provide improved motor performance and improved performance of the human body’s entire balance and coordination system and thus should be used to treat neurological diseases with damage to the postural system (the postural system includes the cerebellum) for stroke or Parkinson’s patients, and the massage is useful to simulate a proprioceptive and epicritic input to the brain (see page 2, the fourth paragraph of the English translation).
Furthermore, Tass discloses the stimulation duration can be “between 30 minutes and 6 hours [and] can, however, also lie outside of this range” (emphasis added, see the first sentence of [0057]). Thus, Tass clearly suggests to one of ordinary skill in the art that stimulation periods greater than 6 hours would have a reasonable expectation of success.
Regarding the argument that Tass merely 1) lists epilepsy in a laundry list of exemplary types of neurological or psychiatric diseases, 2) lists vibration as one of numerous types of theoretically deliverable stimuli to treat the diseases, and 3) lists virtually any body surface on which to deliver stimuli, so a skilled artisan could not possibly predict how to effectively reduce epileptic seizures without undergoing undue experimentation (see the penultimate paragraph of page 11 of the Remarks), this argument is not persuasive. Tass listing other diseases and other forms of stimulation does not make Tass’ disclosure require undue experimentation. Furthermore, the combination of references provide a clear expectation of success because Gerstenbrand teaches that vibration on the sole of the foot provides stimulation to the cerebellum (see page 2, the last seven lines of the second paragraph of the English translation) to provide improved motor performance and improved performance of the human body’s entire balance and coordination system and thus should be used to treat neurological diseases with damage to the postural system (the postural system includes the cerebellum) for stroke or Parkinson’s patients, and the massage is useful to simulate a proprioceptive and epicritic input to the brain (see page 2, the fourth paragraph of the English translation).
Regarding the argument that the present application reduces the total number of seizures and provides related benefits and that Exhibit A demonstrates that application of continuous vibratory stimulation for 8 hours resulted in reduced seizure frequency, thus a skilled artisan cannot predict the unexpected success of treating epileptic seizures using the specific recited vibratory stimulation treatment regimen (see the last paragraph of page 11 of the Remarks through the first paragraph of page 12), this argument is not persuasive. It is unclear what the effectiveness of Applicant’s invention has to do with the “Reasonable expectation of success” based upon the prior art. The prior art does not necessarily need to perform equally as well in order to read on the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kitchens (2015/0272815) discloses a method of applying constant vibration to the lower limb while the user sleeps, to alleviate restless leg syndrome. Ben-David et al. (2019/0001117) discloses a method of treating Parkinson’s and tremor by providing nerve stimulation during sleep.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
/TIMOTHY A STANIS/ Supervisory Patent Examiner, Art Unit 3785