DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on April 22, 2024. As directed by the amendment: no claims have been amended, claims 1-22 have been canceled, and new claims 23-39 have been added. Thus, claims 23-39 are presently pending in the application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 23-27, 29, and 31-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 12 of U.S. Patent No. 11,850,203, in view of Ludlow et al. (US 2009/0187124).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
As to instant claim 23, The ‘203 patent discloses a method of stimulating a thyroid cartilage (the patented claim 1 is a method of enhancing speech control by stimulating the thyroid cartilage), the method comprising: applying a first vibrotactile stimulator positioned over a left portion of the thyroid cartilage and a second vibrotactile stimulator positioned over a right portion of the thyroid cartilage; applying a vibrotactile stimulation having a first vibrating property or a second vibrating property different from the first vibrating property (see claim 1), but does not disclose that the stimulators are part of a collar applied around the neck of the subject or that the first and second vibrating properties are applied based on an input received from a control box.
However, Ludlow (‘124) teaches applying vibrotactile stimulation to a thyroid cartilage via a neck collar (Fig. 1 and paragraph [0044] discloses the collar/band 101 being wrapped around the subject’s neck with a contact portion 120 of vibrator 102 positioned over the larynx; Fig. 9 and paragraph [0067] discloses that multiple vibrators can be used and placed over the thyroid cartilage) and that the vibrating properties are applied based on input from a control box (paragraph [0045]: a control box (not shown) having appropriate switches, knobs, or dials can be provided to set a stimulus type, a stimulus rate (set or increasing) and/or a stimulus amplitude (set or increasing). Additionally, the control box can include features to determine stimulus duration).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patented claim 1 so that the stimulators are applied to the thyroid cartilage via a neck collar and that the vibrating properties are applied based on input from a control box, as taught by Ludlow (‘124) in order to provide a convenient wearable device for positioning and holding the stimulators over the thyroid cartilage in use, and to allow the vibrating properties to be selectively controlled by the subject/caregiver to suit a subjects desired therapy.
As to instant claim 24, Ludlow (‘124) teaches use of vibrotactile stimulators over the thyroid cartilage for inducing swallowing in addition to enhancing speech (see paragraphs [0069]-[0070]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patented claim 1 so that the method is used for inducing swallowing, as taught by Ludlow (‘124), in order to treat a wider variety of patients with loss of voluntary motor control functions.
As to instant claim 25, the limitation is disclosed in patented claim 1.
As to instant claim 26, overlapping frequency ranges are disclosed in patented claim 3. Thus, a prima facie case of obviousness exists.
As to instant claim 27, the limitation is disclosed in patented claim 12.
As to instant claim 29, the limitation is disclosed in Ludlow (‘124), paragraph [0050]: the collar is an adjustable band).
As to instant claim 31, Ludlow (‘124) teaches deactivating the vibrotactile stimulation after a predetermined duration of time ((paragraph [0045]: the control box can be configured to allow for stimulation for a specific duration of time upon activation of actuator 103). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patented claim 1 to include deactivating the stimulation after a predetermined period of time, as taught by Ludlow (‘124), to prevent the subject from having to time the end of stimulation each time.
As to instant claim 32, Ludlow (‘124) teaches manually deactivating vibrotactile stimulation via actuator button 103 (paragraphs [0045]-[0046]: the control box can be configured to allow for stimulation…as long as actuator 103 is depressed, see also paragraph [0051]: when the ON switch is deactivated, the vibration is terminated). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patented claim 1 to include manually deactivating the stimulation via an actuator button, as taught by Ludlow (‘124), to give the subject more control over the timing of the end of stimulation.
As to instant claim 33, the limitation is disclosed in patented claim 8.
As to instant claim 34, the modified method discloses that the first vibrotactile stimulator and the second vibrotactile stimulator are in wireless communication with the control box (see Ludlow (‘124) at paragraph [0046]).
As to instant claim 35, the modified method discloses manually selecting either the first vibrating property of the second vibrating property (a control box (not shown) having appropriate switches, knobs, or dials can be provided to set a stimulus type, a stimulus rate (set or increasing) and/or a stimulus amplitude (set or increasing). Additionally, the control box can include features to determine stimulus duration. Thus, the subject manually selects the first or second vibrating property, such as stimulus rate, amplitude, etc. via the switches, knobs, dials, etc.)
As to instant claim 37, the modified method discloses delaying the vibrotactile stimulation based on an input received from a sensor (see Ludlow (‘124), paragraph [0046]: a movement feedback signal 107 from piezoelectric or pressure sensor 108 can be displayed on a display screen 106 when the swallowing movement begins; the subject/trainer can observe when the actuator 103 was activated in relation to the onset of swallowing movement in the neck. In this manner, the subject can learn to optimize the timing of the sensory switch to occur about 600 ms to about 200 ms prior to the onset of their motor act of swallowing. Thus, upon viewing that the button was pressed too early previously, the subject can decide to delay actuation of actuator 103 in order to time the swallowing act with a desired onset of swallowing).
As to instant claim 38, the modified method discloses that the sensor is a physiological sensor (see Ludlow (‘124), paragraph [0046]: piezoelectric or pressure sensor 108 measuring swallowing movements of the subject’s neck).
As to instant claim 39, the modified method discloses monitoring compliance by recording usage data on the control box (see Ludlow (‘124), paragraph [0068]: records swallowing events).
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,850,203, in view of Ludlow et al. (US 2009/0187124), as applied to claim 23 above, and further in view of Juto (US 2010/0274164).
As to instant claim 28, the modified patented claim 1 discloses the claimed invention except that a pressure applied by the vibrotactile stimulation is between 2 kPa and 6 kPa. However, Juto teaches applying vibrating stimulation to body tissue at a pressure of between 3.9-7.8 kPa (40-80 cm water), which overlaps the claimed range (see Juto, paragraph [0156] and Juto’s claim 40). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify the method so that the pressure applied by the vibration stimulation is within the claimed range, as taught by Juto, in order to provide a suitable pressure range to stimulate body tissue and which is tolerable for a subject to receive vibration.
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,850,203, in view of Ludlow et al. (US 2009/0187124), as applied to claim 23 above, and further in view of Goren (US 2007/0073361).
As to instant claim 30, the modified patented claim 1 discloses the claimed invention except for recharging the collar. However, Goren teaches a stimulating neck collar having a battery that is rechargeable (see Figs. 1-3, paragraph [0027]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to further modify the method so that collar is rechargeable, as taught by Goren, in order to avoid having to buy and replace the batteries when they run empty.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 23-27, 29, 31-39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ludlow et al. (US 2009/0187124), in view of Dunlay et al. (US 2007/0293926).
As to claim 23, Ludlow discloses a method of stimulating a thyroid cartilage (paragraph [0043],[0067]), the method comprising:
applying a collar 101 around a neck of a subject 105 (Fig. 1) such that a first vibrotactile stimulator 102 and a second vibrotactile stimulator 102 is positioned over the thyroid cartilage (Fig. 1 and paragraph [0044] discloses the collar/band 101 being wrapped around the subject’s neck with a contact portion 120 of vibrator 102 positioned over the larynx; Fig. 9 and paragraph [0067] discloses that multiple vibrators can be used and placed over the thyroid cartilage);
applying a vibrotactile stimulation having a first vibrating property or a second vibrating property different from the first vibrating property based on an input received from a control box (paragraph [0045]: a control box (not shown) having appropriate switches, knobs, or dials can be provided to set a stimulus type, a stimulus rate (set or increasing) and/or a stimulus amplitude (set or increasing). Additionally, the control box can include features to determine stimulus duration).
Ludow lacks detailed description as to the limitation that the first vibrotactile stimulator is positioned over a left portion of the thyroid cartilage and the second vibrotactile stimulator is positioned over a right portion of the thyroid cartilage.
However, Dunlay teaches a method of stimulating a thyroid cartilage via a first stimulator and a second stimulator (electrodes 222a, 222b, Figs. 3-4), the first stimulator 222b being positioned over a left portion of the thyroid cartilage and the second stimulator 222a being positioned over a right portion of the thyroid cartilage (see Fig. 3, paragraph [0046] for the specific location of electrodes on the skin above the thyroid cartilage on each side, and Fig. 7-7E, paragraph [0055] which describes several arrangements of electrode pairs 701/702,703/704 that can be placed on a patient’s neck in any suitable site within the pharyngeal region 200 and whose placement can be changed several times in an effort to obtain the strongest and most effective treatment for swallowing).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method of Ludlow so that the first and second vibrotactile stimulators are positioned on respective left and right sides of the thyroid cartilage, as taught by Dunlay, in order to provide a suitable location for stimulation that is likely to improve swallowing ability for the patient.
As to claim 24, modified Ludlow discloses the method of Claim 22, further comprising applying the vibrotactile stimulation to induce swallowing (see Ludlow, paragraph [0014]).
As to claim 25, modified Ludlow discloses the method of Claim 22, further comprising the vibrotactile stimulation to induce speech (see Ludlow, paragraph [0013]).
As to claim 26, modified Ludlow discloses the method of Claim 22, wherein the first vibrating property is a first vibrating rate between 50 Hz and 90 Hz, and the second vibrating property is a second vibrating rate between 90 Hz and 130 Hz (see Ludlow, paragraph [0045],[0052]: the subject or caregiver can select/program the vibrating frequency via knobs, dials, buttons, etc. on the control box; paragraph [0078]: vibratory stimulation is applied at a frequency of about 1 to about 100 Hz, thus the subject or caregiver can adjust from a frequency between 50 Hz and 90 Hz and then adjust to a higher frequency between 90-130 Hz based on individual preference and effectiveness, see also paragraph [0012] describing other frequency ranges for the vibration signal and Fig. 5, paragraph [0054] describing an external adjustable potentiometer 520 for adjusting the vibrator motor 515 vibrational frequency).
As to claim 27, modified Ludlow discloses the method of Claim 22, wherein the first vibrating property is a first vibrating amplitude and the second vibrating property is a second vibrating amplitude (see Ludlow, paragraph [0045]: control box having appropriate switches, knobs, or dials can be provided to set a…stimulus amplitude; paragraph [0052]: the automatic stimulation module 410 enables the subject or caregiver to programmably define vibrator motor 405 operating parameters such as duration, vibrational frequency, and amplitude), and wherein the first vibrating amplitude and the second vibrating amplitude are between 100 micron and 1 mm (see Ludlow, paragraph [0078]: Amplitudes of about 100 micron to about 1 mm are useful).
As to claim 29, modified Ludlow discloses the method of Claim 22, further comprising adjusting a band 101 on the collar to tailor a position of the first vibrotactile stimulator and the second vibrotactile stimulator (see Ludlow Fig. 1, paragraph [0044]: position can be adjusted via adjustment mechanism 125).
As to claim 31, modified Ludlow discloses the method of Claim 22, further comprising deactivating the vibrotactile stimulation after a pre-determined duration of time (paragraph [0045]: the control box can be configured to allow for stimulation for a specific duration of time upon activation of actuator 103).
As to claim 32, modified Ludlow discloses the method of Claim 22, further comprising manually deactivating the vibrotactile stimulation (see Ludlow, paragraphs [0045]-[0046], the control box can be configured to allow for stimulation…as long as actuator 103 is depressed, see also paragraph [0051]: when the ON switch is deactivated, the vibration is terminated).
As to claim 33, modified Ludlow discloses the method of Claim 22, further comprising manually activating the vibrotactile stimulation (see Ludlow, paragraphs [0045]-[0046], manual button allows user to control the start and stop of vibration, see also paragraph [0051]: the actuator is a pushbutton ON switch that when pressed, or activated, energizes a vibrator motor 405).
As to claim 34, modified Ludlow discloses the method of Claim 22, wherein the first vibrotactile stimulator and the second vibrotactile stimulator are in wireless communication with the control box (see Ludlow, Fig. 1, paragraph [0046], actuation of the vibrator 102 via the actuator 103 may be accomplished via…wireless telemetry).
As to claim 35, modified Ludlow discloses the method of Claim 22, further comprising manually selecting the first vibrating property or the second vibrating property ((see Ludlow, paragraph [0045]: control box having appropriate switches, knobs, or dials can be provided to set a stimulus type, a stimulus rate (set or increasing) and/or a stimulus amplitude (set or increasing). Additionally, the control box can include features to determine stimulus duration; paragraph [0052]: the automatic stimulation module 410 enables the subject or caregiver to programmably define vibrator motor 405 operating parameters such as duration, vibrational frequency, and amplitude).
As to claim 36, modified Ludlow discloses the method of Claim 22, further comprising automatically activating the vibrotactile stimulation after a predetermined duration of time (see Ludlow, paragraph [0052]: automatic module automatically energizes the vibrator motor 405 at regular intervals such as one every 3 minutes to one every 30 minutes).
As to claim 37, modified Ludlow discloses the method of Claim 22, further comprising delaying the vibrotactile stimulation based on an input received from a sensor (see Ludlow, paragraph [0046]: a movement feedback signal 107 from piezoelectric or pressure sensor 108 can be displayed on a display screen 106 when the swallowing movement begins; the subject/trainer can observe when the actuator 103 was activated in relation to the onset of swallowing movement in the neck. In this manner, the subject can learn to optimize the timing of the sensory switch to occur about 600 ms to about 200 ms prior to the onset of their motor act of swallowing. Thus, upon viewing that the button was pressed too early previously, the subject can decide to delay actuation of actuator 103 in order to time the swallowing act with a desired onset of swallowing).
As to claim 38, modified Ludlow discloses the method of Claim 37, wherein the sensor is a physiological sensor (paragraph [0046]: piezoelectric or pressure sensor 108 measuring swallowing movements of the subject’s neck).
As to claim 39, modified Ludlow discloses the method of Claim 22, further comprising monitoring compliance by recording usage data on the control box (paragraph [0068]: records swallowing events).
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ludlow et al. (US 2009/0187124), in view of Dunlay et al. (US 2007/0293926), as applied to claim 22, and further in view of Juto (US 2010/0274164).
As to claim 28, modified Ludlow discloses the method of Claim 22, but does not disclose that a pressure applied by the vibrotactile stimulation is between 2 kPa and 6 kPa. However, Juto teaches applying vibrating stimulation to body tissue at a pressure of between 3.9-7.8 kPa (40-80 cm water), which overlaps the claimed range (see Juto, paragraph [0156] and Juto’s claim 40). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method of Ludlow so that the pressure applied by the vibration stimulation is within the claimed range, as taught by Juto, in order to provide a suitable pressure range to stimulate body tissue and which is tolerable for a subject to receive vibration.
Claim 30 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ludlow et al. (US 2009/0187124), in view of Dunlay et al. (US 2007/0293926), as applied to claim 22, and further in view of Goren (US 2007/0073361).
As to claim 30, modified Ludlow discloses the method of Claim 22, and further discloses that the collar includes a battery 505 (see Ludlow, Fig. 5, paragraph [0054]), but lacks detailed description as to the step of recharging the collar. However, Goren teaches a stimulating neck collar having a battery pack that is rechargeable (see Figs. 1-3, paragraph [0027]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method of Ludlow so that the collar is recharged via a rechargeable battery, as taught by Goren, in order to avoid having to buy and replace the batteries when they run empty.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hanna (US 2005/0267388) discloses a vibration system for relieving headaches comprising a headband and multiple vibration generators 12a-12c.
Burgess (US 2005/0059909) discloses a neck collar for providing vibration and heat to the neck and spine.
Castel (US 7,660,636) discloses a method for the treatment of dysphagia by applying electrical stimulation to the posterior region of the neck for treatment of dysphagia.
Ludlow et al. (US 2009/0054980 and US 20100049103) discloses a method for stimulating thyroid cartilage via vibration stimulator(s) on a neck band.
Snow (US 2012/0253236) discloses a collar that provides vibrational to a user’s neck.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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