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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 20, 2026, has been entered.
As directed by the amendment: Claim 1 was amended. Claims 21-23 are newly added, and thus claims 1-23 are pending and currently under consideration for patentability under 37 CFR 1.104.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
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, 62/334,799 and 63/120,277 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, claim 1 recites “daily periods of about 8 hours of continuous vibratory stimulation for at least 12 weeks” and the prior-filed application(s) fail to provide support for the application of continuous vibration being for at least 12 weeks.
Therefore, claims 1-23 have an effective filing date of December 2, 2021, based upon the instant App. 17/541,154.
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 18-23 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) and Podrazhansky et al. (US 2008/0195007).
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 Tass does not specifically state the treatment regimen comprises daily periods of about 8 hours of continuous vibratory stimulation for at least 12 weeks.
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 daily periods of about 8 hours of continuous vibratory stimulation for at least 12 weeks. However, it is noted that there does not appear to be any particular criticality to the duration of “about 8 hours” (Note: this covers a relatively 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.
The modified Tass/Gerstenbrand method does not specifically state the treatment regimen comprises daily periods of the about 8 hours of continuous vibratory stimulation for at least 12 weeks. However, it is noted that Tass/Gerstenbrand do not suggest that a single vibratory session is a cure, and one of ordinary skill in the art would be motivated to repeat the stimulus over time (i.e., days, weeks, months) to continue to alleviate symptoms.
Furthermore, Podrazhansky teaches a related method for providing vibratory stimulation (with vibration unit 100, Fig. 1) to treat movement disorders (such as Essential Tremor, para. [0104], and Parkinson’s Disease, see para. [0093]). The vibratory stimulation regimen applies prolonged periods of vibration “daily or several times per day for as long as the therapeutic effect is desired, typically an extended period of weeks, months or years” (see the last sentence of [0108]).
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 provide the 8 hours of vibration on a daily basis for an extended period of time (i.e., a year) as taught by Podrazhansky to provide the therapeutic benefit for an extended period of time.
Regarding claim 2, the modified Tass/Gerstenbrand/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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. MPEP 2144.05.
Regarding claim 21, the modified Tass/Gerstenbrand/Podrazhansky method discloses the same method steps as recited in claim 21, and thus would be expected to reduce seizure frequency by about 25% (for at least some patients) after 12 weeks of the treatment regimen.
Regarding claim 22, the modified Tass/Gerstenbrand/Podrazhansky method discloses wherein the treatment regimen comprises daily periods of about 8 hours of continuous vibratory stimulation (see the claim 1 rejection statement above) for 24 weeks (“for as long as the therapeutic effect is desired, typically an extended period of weeks, months or years” see the last sentence of [0108] of Podrazhansky. Daily stimulation for a period such as a year would include 24 weeks of stimulation).
Regarding claim 23, the modified Tass/Gerstenbrand/Podrazhansky method discloses the same method steps as recited in claim 22, and thus would be expected to reduce seizure frequency by about 45% (for at least some patients) after 24 weeks of the treatment regimen.
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) and Podrazhansky et al. (US 2008/0195007) as applied to claim 1 above, and further in view of Lundqvist (US 2012/0245483)
Regarding claim 6, the modified Tass/Gerstenbrand/Podrazhansky 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/Podrazhansky 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) and Podrazhansky et al. (US 2008/0195007) as applied to claims 1-2 above, and further in view of Brandl (WO 2019/211488).
Regarding claim 8, the modified Tass/Gerstenbrand/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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) and Podrazhansky et al. (US 2008/0195007) 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/Podrazhansky 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 of Tass), 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/Podrazhansky 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) and Podrazhansky et al. (US 2008/0195007) as applied to claim 1 above, and further in view of Franceschetti (US 2016/0136383).
Regarding claim 11, the modified Tass/Gerstenbrand/Podrazhansky 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/Podrazhansky to occur at least partially 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) and Podrazhansky et al. (US 2008/0195007) as applied to claim 1 above, and further in view of Simkins (US 5,523,742).
Regarding claim 12, the modified Tass/Gerstenbrand/Podrazhansky 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/Podrazhansky 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) and Podrazhansky et al. (US 2008/0195007) as applied to claim 1 above, and further in view of Lorberbaum (US 9,463,287).
Regarding claim 13, the modified Tass/Gerstenbrand/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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) and Podrazhansky et al. (US 2008/0195007) as applied to claim 1 above, and further in view of Amblard (US 2016/0158091).
Regarding claim 14, the modified Tass/Gerstenbrand/Podrazhansky 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/Podrazhansky 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/Podrazhansky 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) and Podrazhansky et al. (US 2008/0195007) as applied to claim 1 above, and further in view of Corbishley (US 7,318,811).
Regarding claim 16, the modified Tass/Gerstenbrand/Podrazhansky 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/Podrazhansky 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) and Podrazhansky et al. (US 2008/0195007) as applied to claim 1 above, and further in view of Poepperling (US 2013/0204169).
Regarding claim 17, the modified Tass/Gerstenbrand/Podrazhansky 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/Podrazhansky 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 April 20, 2026, have been fully considered but they are not persuasive.
Regarding the argument that Tass does not specifically suggest the treatment regimen comprises daily periods of about 8 hours of continuous vibratory stimulation for at least 12 weeks (see the first paragraph of page 7 of the Remarks), this argument has been considered, but it is moot because Podrazhansky has now been relied upon to teach the feature of the vibratory treatment regimen being “daily” for a period of at least 12 weeks.
Regarding the argument that Gerstenbrand is non-analogous art because it is a plantar massage device intended to stimulate mechanoreceptors on the sole of the foot in order to improve posture, balance, coordination, alertness, and general wellness and is described for use in contacts including Parkinson’s disease but does not address epilepsy or suppression of seizure activity and thus would not have logically commended itself to the inventor’s attention seeking to reduce epileptic seizures … and Gerstenbrand is not reasonably pertinent to the problem (see the last two paragraphs of page 7 of the Remarks), this argument is not persuasive. One of the inventor’s concerns was reducing epileptic seizures by positioning at least one vibration motor on a limb of the subject, and generating a vibratory stimulation signal configured to stimulate proprioceptive nerves in the limb to trigger kinesthetic cues that stimulate nerves in cerebellar and pontine areas of the brain (see para. [0004]). “Central targets for vibration include the cerebellum and doral pons” (para. [0058]), “The intervention described here uses the principle of activation of cerebellar areas to reduce seizure incidence” (para. [0078]).
Gerstenbrand is at least reasonably pertinent to the problem faced by the inventor because it 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). Since Gerstenbrand specifically states that its vibration to the sole of the foot targets the cerebellum to treat neurological diseases, including related movement disorders like Parkinson’s Disease, it is at least reasonably pertinent to the problem faced by the inventor which involves primarily targeting the cerebellum with vibration.
Regarding the argument that the claimed method produces surprising and unexpected results as seizure activity was reduced following prolonged treatment regimens of daily stimulation of about 8 hours of continuous vibratory stimulation for 12 weeks (see the second paragraph of page 8 of the Remarks), this argument is not persuasive.
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 unexpected results.
Regarding the argument that an extended treatment regimen in month-long periods of daily stimulation for reduction of seizure activity is both surprising and unexpected, that 12 weeks from the measured decrease in seizure activity, additional treatment can further decrease seizure activity (see the second paragraph of page 8 of the Remarks), this argument is not persuasive. 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)).
Regarding the argument that Paragraphs [0197]-[0200] and Figs. 53A-53B describe the surprising and unexpected results (see the last paragraph of page 8 of the Remarks, through page 9 of the Remarks), this argument is not persuasive. These do describe “results” but there is no explanation of why they are unexpected. Additionally, it is reiterated that 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)).
Regarding the argument that the disclosed finding of a specific duration for treatment regimen relative to efficacy in seizure suppression points to an unforeseen role of “learning” of brain structures, which is missing in previous disclosures of vibration stimulus to overcome neurological disorders (see the first full paragraph of page 9 of the Remarks), this argument is not persuasive.
First, it is reiterated that 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)).
Second, prior art already discloses “learning” of brain structures through neuroplasticity in response to stimulation. For example, Rosenbluth et al. (2019/0001129) teaches a related method for providing stimulation (“wearable device for treating tremor … first stimulation comprises electrical stimulation or vibratory stimulation” see para. [0071] and Fig. 1) to a limb to treat movement disorders (such as Essential tremor or Parkinson’s Disease, see para. [0016]). Rosenbluth states that “Burst stimulation of peripheral nerves, including afferent nerves, can in some cases deliver a more efficacious therapy by remotely accelerating plasticity of one or more central nervous system (e.g., brain and/or spinal cord) circuits, in other words creating plasticity in neural circuits for a period of time that is far longer than the duration of the stimulation session, such as, for example, about or at least about 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, or even longer” (see para. [0283]).
Additionally, Gilner (7,236,830) applies neural stimulation for treating movement disorders, with a focus on creating “lasting or long term neuroplastic change” (col. 4, lines 4-7; see also col. 12, lines 19-27). Gilner states “Neuroplastic changes can include adaptive structural changes or reorganizations in particular brain regions, which may result in enhancement or restoration of one or more functional abilities (i.e., physical, sensory, and/or cognitive functions) associated with such brain regions, possibly on a long term or lasting basis. Application of neural stimulation to a patient in accordance with the principles described herein may increase the likelihood that neuroplastic changes can occur to facilitate at least partial recovery of diminished or lost functionality associated with or giving rise to one or more patient symptoms” (see col. 4, lines 40-51). Gilner states different symptoms may respond to neural stimulation in different manners, and/or across different time scales such that one symptom may see relatively immediate effects while another symptom may have greatly delayed effects (see col. 4, lines 22-36). Thus, it was recognized that neural stimulation may have a delayed effect, and that neuroplastic changes (brain “learning”) will result.
Regarding the argument that the cited art does not provide any reasonable expectation of success, and that MPEP 2143E articulates how to determine if a claim can be rejected on an “obvious-to-try” rationale (see page 10 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 does not provide a suggestion that prolonged stimulation would reduce epileptic seizure frequency, with no guidance regarding stimulation on the scale of hours per day, or month-long treatment regimens (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.
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 on a daily basis for at least 12 weeks. 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 based on Tass, a skilled artisan would have had no basis to predict that applying vibratory stimulation about 8 hours per day over multiple weeks or months would produce a therapy resulting in seizure reduction and thus cannot provide a reasonable expectation of success (see the second paragraph of page 11 of the Remarks), this argument is not persuasive. Although Tass does not specify that the treatment would be repeated on a daily basis for at least 12 weeks, determining a treatment or dosage frequency involves only routine skill in the art. Tass does not suggest that a single vibratory session is a cure, and one of ordinary skill in the art would be motivated to repeat the stimulus over time (i.e., days, weeks, months) to continue to alleviate symptoms. Podrazhansky is relied upon to further demonstrate this, as the stimulation regimen applies prolonged periods of vibration “daily or several times per day for as long as the therapeutic effect is desired, typically an extended period of weeks, months or years” (see the last sentence of [0108]).
Regarding the argument that the Applicant submits that application of daily periods of continuous vibratory stimulation for about 8 hours for at least 12 weeks produced unexpected success in treating epileptic seizures (see the penultimate paragraph of page 11 of the Remarks), this argument is not persuasive. 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)).
Regarding the argument that it is not logical or expected that a treatment that does not appear to work on a short scale will suddenly show results after continuous, daily periods on month-long scales (see the last paragraph of page 11 of the Remarks), this argument is not persuasive. What evidence is there that the treatment does not work on a short scale?
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ross et al. (2021/0402172) discloses a wearable vibratory stimulation device for treating neurological movement disorders, showing that patients improve over time from 1 day to 1 week to 1 month of treatment. Rosenbluth et al. (9,452,287) discloses a related wearable vibratory stimulation device for treating neurological movement disorders, and states that the length of time the user may use the device before having an effect on the user’s tremor may be one day to one month.
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
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