DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1, 4-5, and 8 are currently pending and under examination. Claims 2-3 and 6-7 are canceled. As per the amendments filed on 10/24/2025, claims 1 and 5 are amended.
Response to Arguments
Applicant’s arguments, see Remarks pages 5-9, (Claim Rejections Under 35 U.S. C §103), filed 10/24/2025, with respect to the rejections of claims 1, 4-5, and 8 under 35 U.S.C. § 103 have been fully considered. Regarding claims 1 and 5, Applicant argues:
Thus, the claimed invention is characterized by determining and providing information on the user's inherent muscle contraction type (Type I or Type II) based on actual muscle activation sequences collected during the user's swallowing motion. See paragraph [0056} of the instant application.
Ryu is directed to a device where the timing and duration of stimulation for each channel
are based on a pre-defined algorithm of normal muscle contraction. Ryu is configured to synchronize the movement of a patient's hyoid bone with that of a normal person, thereby correcting the patient's abnormal muscle contraction pattern to match a pre-set normal pattern. However, the claimed invention is fundamentally different. The claimed invention does not simply correct an "abnormal" pattern to a single "normal" standard. Instead, the claimed invention is configured to first determine the user's inherent muscle contraction type (Type I or Type II) based on data collected from the user's own swallowing action, and then provide information based on that specifically determined type. In summary, Ryu attempts to make the patient's pattern conform to a single, predetermined normal pattern, whereas the claimed invention first identifies which unique physiological pattern the user possesses and then provides information and subsequent stimulation accordingly. (10/24/2025 Remarks, Page 7)
This argument is not persuasive. The Examiner deems the following limitations from claim 1 (where these are mirrored in claim 5) particularly relevant to the discussion:
• an input unit configured to receive user information, the user information including a food type divided into a low-viscosity liquid and a high-viscosity liquid, and a muscle contraction type
• wherein the processor provides information on the muscle contraction type by determining whether a muscle contraction pattern of the user is a first type or a second type, based on a muscle activation sequence collected during a user's swallowing motion through the stimulation unit
Regarding the first limitation, Ryu discloses a wearer enters inputs related to stimulating a particular muscle or muscle group and for swallowing a particular substance ([0034], [0065]). The second limitation is interpreted as requiring that a muscle contraction type selection be based on a muscle activation sequence collected during a user’s swallowing motion. The muscle contraction type is interpreted as being the setting for the stimulation, which is selected based an analysis of current deficiencies in the swallowing patterns. This is particularly relevant given there is no structural sensor being claimed (claim 1) or mentioned (claim 5) beyond a generic input unit receiving information about muscle contraction type. Note Ryu contains sensor units 10 and 20, which monitor swallowing to determine the timing of muscle stimulation necessary to facilitate proper swallowing ([0055-0056]). Castel teaches a determination is made to apply either monophasic or biphasic stimulation based on being able to correct the swallowing motion ([0016-0017], [0058]). Therefore, the rejections of claims 1, 4-5, and 8 are maintained.
Applicant additionally argues:
Castel discloses improving dysphagia by providing pre-set electrical pulse patterns ( e.g.,
multi-cycle biphasic, triphasic, sequential/overlapping). Basically, Castel's electrical pulse patterns are programmed by determining the muscle firing sequence, frequency, and duration obtained from electromyography (EMG) recordings of "standardized healthy normal subjects" see paragraph [0076} of Castel.
That is, in Castel's method, a therapist would select one of several standardized patterns based on the patient's condition. This approach, like Ryu's, relies on a library of pre-set "normal" patterns. Castel does not teach or suggest the claimed invention's feature of determining a user's unique muscle contraction type (Type I or Type II) based on data collected from that specific user's actual swallowing motion.
As above, both Ryu and Castel are based on the same technical principle: attempting to
fit a patient's swallowing pattern into a pre-defined "normal" category. Ryu uses a single
"normal" algorithm to correct an abnormal pattern, while Castel provides a selection of
standardized "normal" patterns for a therapist to choose from. Applicant therefore respectfully submits that there is no reason and motivation, for a of ordinary skill in the art, but not knowing the claimed invention, to be tempted to combine Ryu and Castel to arrive at the claimed invention. (10/24/2025 Remarks, Page 8)
This argument is not persuasive. This is interpreted as a recapitulation of the same arguments discussed in paragraphs 4-5 of this action while including a discussion of Castel. As previously discussed, Ryu contains sensors units 10 and 20, which monitor swallowing to determine the timing of muscle stimulation necessary to facilitate proper swallowing ([0055-0056]). Castel teaches a determination is made to apply either monophasic or biphasic stimulation based on being able to correct the swallowing motion ([0016-0017], [0058]). Both Ryu and Castel are devices used to correct the abnormal muscle patterns which characterize dysphagia. Castel provides another level of stimulation by accounting for monophasic and biphasic stimulation patterns and would be an obvious incorporation into Ryu’s device to further specialize the stimulation provided (see full obviousness rationale in “Claim Rejections - 35 USC § 103”). Therefore, the rejections of claims 1, 4-5, and 8 are maintained.
Applicant additionally argues:
Even if Ryu and Castel are combined, their combination would, at most, suggest a system where a patient's swallowing motion is sensed (as in Ryu) and then one of several pre-set normal patterns (as in Castel) is selected to "correct" the patient's motion. That is, such a combination would still not lead to the above-discussed claimed features: first analyzing and determining the user's own inherent muscle contraction type based on data collected from their actual swallowing motion. Ryu and Castel, either alone or in combination, provides no teaching or motivation to diagnose and classify the user's intrinsic physiological pattern before providing stimulation.
The claimed invention achieves a significant benefit. As described in the description of the instant application (e.g., paragraphs [0054] and [0056] thereof), the user, with electrodes attached, swallows a substance a predetermined number of times. The processor (130) collects and records the muscle activation sequence, determines whether the pattern for each muscle is monophasic or biphasic (Type I or Type II), and provides this user-specific information. The system can then sequentially stimulate all swallowing muscles according to the muscle activation sequence that corresponds to the user's unique, determined muscle contraction type. This enables a highly personalized and adaptive therapy. These benefits cannot be achieved by Ryu and Castel, either alone or in combination. (10/24/2025 Remarks, Pages 8-9 )
This argument is not persuasive. The Examiner does not see the level of specificity in the claim language necessary to support the argued personalization of the waveform. Ryu contains sensors units 10 and 20, which monitor swallowing to determine the timing of muscle stimulation necessary to facilitate proper swallowing ([0055-0056]). From the Examiner’s perspective, the instant application is interpreted as having a “sensed abnormal muscle pattern -> determination of corrective stimulation waveform -> application of corrective stimulation waveform” cycle. Given Ryu similarly applies a corrective waveform based on sensed muscle contractions, Ryu appears to disclose the current claim language (particularly without more specific claim language in the instant application regarding how the sensed data is acquired or how the determination of a corrective stimulus is determined in order to differentiate for prior art). Castel teaches monophasic and biphasic as a variable to be applied to the corrective stimulation waveform based on the specific swallowing abnormality ([0016-0017], [0058]). Therefore, the rejections of claims 1, 4-5, and 8 are maintained.
Summary: The 35 U.S.C. § 103 rejections for claims 1, 4-5, and 8 are maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu (KR 101798365 B1, disclosed in IDS filed on 07/19/2022) in view of Evans (US PG Pub 2018/0122265 A1, see previously cited) and Castel (US PG Pub 2007/0156182 A1, see previously cited). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Ryu (KR 101798365 B1 - see previously attached for copy of the Description translation).
Regarding Claim 1, Ryu discloses an electrical stimulation therapy apparatus for dysphagia ([0001-0002]), the apparatus comprising:
• an input unit configured to receive user information, the user information including a food type ([0065]) and a muscle contraction type ([0119] – different types of muscles are contracted with four channels);
• a stimulation unit including a plurality of channels and configured to stimulate swallowing muscles of a user ([0001]); and
• a processor configured to generate a control command for driving the stimulation unit ([0009]),
wherein the processor sequentially stimulates the swallowing muscles including a bilateral suprahyoid muscle (SH), a thyrohyoid muscle (TH), and a sternothyroid muscle (StH) of the user according to a preset muscle activation sequence based on the user information) and the muscle contraction type determined for the user ([0010] – muscle types, Fig 6, [0064] – muscles shown to contract in particular order for swallowing);
wherein the processor provides information on the muscle contraction type ([0119] – different types of muscles are contracted with four channels) by determining whether a muscle contraction pattern is a first type or second type (the term “type” could generically apply to any muscle input in Ryu) based on a muscle activation sequence collected during a user's swallowing motion through the stimulation unit ([0093] – the muscle stimulation timing is determined by the contraction time of normal, desired muscle contraction: “The contraction start time and contraction duration for each channel of the electrical stimulator are based on the contraction algorithm of normal muscles, and are based on an algorithm that is designed to induce normal movements based on normal muscle contraction”, see Figure 6 for a representation of normal timing; [0055-0056] - The current contraction pattern, which is intended to be corrected, is monitored via sensors to determine the timing of muscle stimulation necessary to facilitate swallowing).
wherein the muscle contraction type includes the first type in which each of the swallowing muscles has a phasic pattern, and the second type in which at least one of the swallowing muscles has a phasic pattern and the other swallowing muscles have a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes),
wherein the first type includes a first pattern in which each of the SH, the TH, and the StH has a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes, [0093] - stimulation location, in [0024] “the subhyoid muscles are the muscles connected to the hyoid bone and may include the sternohyoid muscle, sternothyroid muscle, and thyrohyoid muscle”), and
wherein the second type includes:
a second pattern in which the TH and StH have a phasic pattern and the SH has a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes, [0093] - stimulation location),
a third pattern in which the StH has a phasic pattern and the SH and the TH have a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes, [0093] - stimulation location), and
a fourth pattern in which each of the SH, the TH, and the StH has a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes, [0093] - stimulation location).
Ryu discloses: “The electrical stimulation therapy device can determine the wearer's willingness to swallow in order to operate. For example, the wearer may input into the electrical stimulation treatment device (100) such that the first stimulation unit contracts the suprasellar muscle only when the wearer has the intention to swallow a certain food. The wearer can activate the electrical stimulation therapy device by pressing a button or inputting a swallowing intention into an external server” ([0065]). Ryu does not disclose receiving user information including a food type divided into a low-viscosity liquid and a high-viscosity liquid from a user through an input unit.
Evans, in the same field of endeavor of treating dysphagia ([0002]), teaches a method for quantifying food type (including liquids [0024]) for dysphagia patients using a viscometer ([0065, 0123]). Evans discloses: “Furthermore, an aspect of the present invention is to provide an inexpensive and durable apparatus that accurately measures a quantifiable characteristic of liquid foods that enables the diagnosing professional to prescribe a customized dysphagia diet that addresses the needs for the specific type and severity of a patient's dysphagia, and then even further, enables a treating professional, caregiver, or the patient to accurately reproduce foods consistent with the parameters of the prescribed customized dysphagia diet for that particular patient” ([0024]).
It would have been obvious to a person of ordinary skill in the art to combine the electrical stimulator in Ryu with food property quantification in Evans because proper delineation of food properties allows the user to adjust swallowing (via stimulation) for the type of food involved. Ryu allows for control of the stimulation pattern to be adjusted by the user for different foods ([0065]). Evans is specifically concerned with liquids ([0024]) and provides for the quantification of viscosity into categories ([0065, 0123]). A person of ordinary skill in the art would have been motivated to combine Ryu’s known element (electrical stimulator for dysphagia) with Evans’ known element (a viscometer measurement for dysphagia) and the results would have been predictable.
Ryu discloses “as another example, in the case of the first stimulation unit (30) that stimulates the suprahyoid muscle, one electrode (negative or positive) may be attached to the gastrocnemius muscle, which is one of the muscles that constitute the suprahyoid muscle, and another electrode may be attached to the outer surface of the skin covering the mylohyoid muscle” ([0043]). Ryu does not disclose monophasic or biphasic patterns.
Castel, in the same field of endeavor of treating dysphagia vis stimulation ([0004]), teaches an electrical stimulation device and method where the stimulation pattern can be monophasic or biphasic ([0058]). Castel teaches “the relative positive and negative electrodes contain both phases of the current and, thus, the electrode placement is generally determined by the sensitivity of the neural structures and the proximity of the nerve to the superficial tissue” ([0018]). Castel then provides examples of how biphasic stimulation with positive and negative electrodes applied to the back of the neck can improve the acts of lip/tongue motions during the oral phase ([0019]), chewing during the oral phase ([0020]), tongue motions during the oropharyngeal phases ([0021]), swallowing during the oropharyngeal phases ([0022-0024]), and swallowing during the esophageal phases ([0022-0024]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Ryu’s electrical stimulator by incorporating the phasic stimulation (monophasic or biphasic) in Castel. This would have been obvious because both Ryu and Castel discuss stimulation devices for treating dysphagia and Castel provides a solution/improvement by adding different phasic stimulation patterns to better tailor stimulation to produce specific muscle responses.
Therefore, a person of ordinary skill in the art would be motivated to improve the system of Ryu by incorporating the phasic stimulation (monophasic or biphasic) in Castel.
Therefore, Claim 1 is obvious over Ryu in view of Evans and Castel.
Regarding Claim 5, Ryu discloses an electrical stimulation therapy method performed by an
electrical stimulation therapy apparatus for dysphagia ([0001-0002]), the electrical stimulation therapy method comprising:
• receiving user information from a user through an input unit, the user information including a food type ([0065]), and a muscle contraction ([0119] – different types of muscles are contracted with four channels); and
• sequentially stimulating, by using a stimulation unit, a bilateral suprahyoid muscle (SH), a thyrohyoid muscle (TH), and a sternothyroid muscle (StH) of the user according to a preset muscle activation sequence based on the user information and the muscle contraction type determined for the user ([0010] – muscle types, Fig 6, [0064] – muscles shown to contract in particular order for swallowing during stimulation);
wherein prior to the receiving of the user information, information on the muscle contraction type ([0119] – different types of muscles are contracted with four channels) is provided by determining whether a muscle contraction pattern of the user is a first or second type (the term “type” could generically apply to any muscle input in Ryu), based on a muscle activation sequence collected during a user's swallowing action through the stimulation unit ([0093] – the muscle stimulation timing is determined by the contraction time of normal, desired muscle contraction: “The contraction start time and contraction duration for each channel of the electrical stimulator are based on the contraction algorithm of normal muscles, and are based on an algorithm that is designed to induce normal movements based on normal muscle contraction”, see Figure 6 for a representation of normal timing; [0055-0056] - The current contraction pattern, which is intended to be corrected, is monitored via sensors to determine the timing of muscle stimulation necessary to facilitate swallowing).
wherein the muscle contraction type includes the first type in which each of the SH, the TH, and the StH has a phasic pattern, and the second type in which at least one of the SH, the TH, and the StH has a phasic pattern and the other swallowing muscles have a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes),
wherein the first type includes a first pattern in which each of the SH, the TH, and the StH has a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes, [0093] - stimulation location, in [0024] “the subhyoid muscles are the muscles connected to the hyoid bone and may include the sternohyoid muscle, sternothyroid muscle, and thyrohyoid muscle”), and
wherein the second type includes:
a second pattern in which the TH and the StH have a phasic pattern and the SH has a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes, [0093] - stimulation location),
a third pattern in which the StH has a phasic pattern and the SH and the TH have a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes, [0093] - stimulation location), and
a fourth pattern in which each of the SH, the TH, and the StH has a phasic pattern ([0043] - introduces phasic stimulation with the use of positive and negative electrodes, [0093] - stimulation location).
Ryu discloses “The electrical stimulation therapy device can determine the wearer's willingness to swallow in order to operate. For example, the wearer may input into the electrical stimulation treatment device (100) such that the first stimulation unit contracts the suprasellar muscle only when the wearer has the intention to swallow a certain food. The wearer can activate the electrical stimulation therapy device by pressing a button or inputting a swallowing intention into an external server” ([0065]). Ryu does not disclose receiving user information including a food type divided into a low-viscosity liquid and a high-viscosity liquid from a user through an input unit.
Evans, in the same field of endeavor of treating dysphagia ([0002]), teaches a method for quantifying food type (including liquids [0024]) for dysphagia patients using a viscometer ([0065, 0123]). Evans discloses “Furthermore, an aspect of the present invention is to provide an inexpensive and durable apparatus that accurately measures a quantifiable characteristic of liquid foods that enables the diagnosing professional to prescribe a customized dysphagia diet that addresses the needs for the specific type and severity of a patient's dysphagia, and then even further, enables a treating professional, caregiver, or the patient to accurately reproduce foods consistent with the parameters of the prescribed customized dysphagia diet for that particular patient” ([0024]).
It would have been obvious to a person of ordinary skill in the art to combine the electrical stimulator method in Ryu with food property quantification in Evans because proper delineation of food properties allows the user to adjust swallowing (via stimulation) for the type of food involved. Ryu allows for control of the stimulation pattern to be adjusted by the user for different foods ([0065]). Evans is specifically concerned with liquids ([0024]) and provides for the quantification of viscosity into categories ([0065, 0123]). A person of ordinary skill in the art would have been motivated to combine Ryu’s known element (electrical stimulator method for dysphagia) with Evans’ known element (a viscometer measurement for dysphagia) and the results would have been predictable.
Ryu discloses “as another example, in the case of the first stimulation unit (30) that stimulates the suprahyoid muscle, one electrode (negative or positive) may be attached to the gastrocnemius muscle, which is one of the muscles that constitute the suprahyoid muscle, and another electrode may be attached to the outer surface of the skin covering the mylohyoid muscle” ([0043]). Ryu does not disclose monophasic or biphasic patterns.
Castel, in the same field of endeavor of treating dysphagia vis stimulation ([0004]), teaches an electrical stimulation device and method where the stimulation pattern can be monophasic or biphasic ([0058]). Castel teaches “the relative positive and negative electrodes contain both phases of the current and, thus, the electrode placement is generally determined by the sensitivity of the neural structures and the proximity of the nerve to the superficial tissue” ([0018]). Castel then provides examples of how biphasic stimulation with positive and negative electrodes applied to the back of the neck can improve the acts of lip/tongue motions during the oral phase ([0019]), chewing during the oral phase ([0020]), tongue motions during the oropharyngeal phases ([0021]), swallowing during the oropharyngeal phases ([0022-0024]), and swallowing during the esophageal phases ([0022-0024]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Ryu’s electrical stimulator method by incorporating the phasic stimulation (monophasic or biphasic) in Castel. This would have been obvious because both Ryu and Castel discuss stimulation methods for treating dysphagia and Castel provides a solution/improvement by adding different phasic stimulation patterns to better tailor stimulation to produce specific muscle responses. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Ryu by incorporating the phasic stimulation (monophasic or biphasic) in Castel.
Therefore, Claim 5 is obvious over Ryu in view of Evans and Castel.
Claims 4 and 8 are rejected under U.S.C 103 as being unpatentable over Ryu (KR 101798365 B1, disclosed in IDS filed on 07/19/2022) in view of Evans (US PG Pub 2018/0122265 A1, see previously cited), Castel (US PG Pub 2007/0156182 A1, see previously cited), and Ludlow (US PG Pub 2009/0187124 A1, see previously cited). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Ryu (KR 101798365 B1 - see previously attached for copy of the Description translation).
Regarding Claim 4, the apparatus for delivering electrical stimulation in Claim 1 is obvious over Ryu in view of Evans and Castel, as indicated hereinabove. Ryu further teaches the stimulation unit includes:
-a first stimulation unit attached to digastric and mylohyoid muscles to stimulate the SH ([0043], [0085] – stimulation unit for suprahyoid muscles highlighting digastric and mylohyoid)
-a second stimulation unit attached onto both sides of thyroid cartilage to stimulate the TH ([0093] – stimulation channel for thyroid cartilage muscles), and
-a third stimulation unit attached to stimulate the StH ([0081]).
Ryu discloses “In order for the second stimulation unit (40) to stimulate at least one of the sternohyoid muscle, the sternothyroid muscle and the thyrohyoid muscle, the second stimulation unit (40) may be attached to the outer surface of the skin covering a position corresponding to at least one of the sternohyoid muscle, the sternothyroid muscle and the thyrohyoid muscle” ([0081]). Ryu does not teach a stimulation unit is attached to an inner side of sternocleidomastoid muscle and to a lower portion of the thyroid cartilage to stimulate a sternohyoid muscle.
Ludlow, in the same field of endeavor of treating dysphagia ([0007]), teaches a set of electrodes placed over the thyroid cartilage and a sternocleidomastoid muscle ([0109]) to stimulate a sternohyoid muscle ([0105]). Ludlow discloses “two sets of electrodes were used; the top set was placed horizontally in the submental region over the region of the mylohyoid muscle above the hyoid bone (FIG.16). The bottom set was placed on the skin over the thyroid cartilage on either side of the midline over the region of the thyrohyoid muscle medial to the sternocleidomastoid muscle. This electrode array was recommended as effective during certification training of the first two authors” ([0109]) and “current activates either the sternohyoid or stenothyroid muscle” ([0105]).
It would have been obvious to a person of ordinary skill in the art to combine the electrical stimulator in Ryu with the stimulation electrode placement in Ludlow to better stimulate the sternohyoid muscle (a goal of the stimulation in Ryu – [0081]). Ludlow suggests the sternohyoid muscle can be stimulated from electrodes attached to the sternocleidomastoid muscles and a lower portion of the thyroid cartilage ([0105, 0109]). One of ordinary skill in the art would have been motivated to combine Ryu’s known element (an electrical stimulator for dysphagia) with Ludlow’s known element (stimulator electrode placement for dysphagia) and the results would have been predictable.
Therefore, Claim 4 is obvious over Ryu in view of Evans, Castel, and Ludlow.
Regarding Claim 8, the electrical stimulation therapy method in Claim 5 is obvious over Ryu in view of Evans and Castel, as indicated hereinabove. Ryu further teaches the stimulation unit includes:
-a first stimulation unit attached to digastric and mylohyoid muscles to stimulate the SH ([0043], [0085] –stimulation unit for suprahyoid muscles highlighting digastric and mylohyoid)
-a second stimulation unit attached onto both sides of thyroid cartilage to stimulate the TH ([0093] – stimulation channel for thyroid cartilage muscles), and
-a third stimulation unit attached to stimulate the StH ([0081]).
Ryu discloses “In order for the second stimulation unit (40) to stimulate at least one of the sternohyoid muscle, the sternothyroid muscle and the thyrohyoid muscle, the second stimulation unit (40) may be attached to the outer surface of the skin covering a position corresponding to at least one of the sternohyoid muscle, the sternothyroid muscle and the thyrohyoid muscle” ([0081]). Ryu does not teach a stimulation unit is attached to an inner side of sternocleidomastoid muscle and to a lower portion of the thyroid cartilage to stimulate a sternohyoid muscle.
Ludlow, in the same field of endeavor of treating dysphagia ([0007]), teaches a set of electrodes placed over the thyroid cartilage and a sternocleidomastoid muscle ([0109]) to stimulate a sternohyoid muscle ([0105]). Ludlow discloses “two sets of electrodes were used; the top set was placed horizontally in the submental region over the region of the mylohyoid muscle above the hyoid bone (FIG.16). The bottom set was placed on the skin over the thyroid cartilage on either side of the midline over the region of the thyrohyoid muscle medial to the sternocleidomastoid muscle. This electrode array was recommended as effective during certification training of the first two authors” ([0109]) and “current activates either the sternohyoid or sternothyroid muscle” ([0105]).
It would have been obvious to a person of ordinary skill in the art to combine the electrical stimulator method in Ryu with the stimulation electrode placement in Ludlow to better stimulate the sternohyoid muscle (a goal of the stimulation in Ryu – [0081]). Ludlow suggests the sternohyoid muscle can be stimulated from electrodes attached to the sternocleidomastoid muscles and a lower portion of the thyroid cartilage ([0105, 0109]). A person of ordinary skill in the art would have been motivated to combine Ryu’s known element (electrical stimulator method for dysphagia) with Ludlow’s known element (stimulator electrode placement for dysphagia) and the results would have been predictable.
Therefore, Claim 8 is obvious over Ryu in view of Evans, Castel, and Ludlow.
Conclusions
THIS ACTION IS MADE FINAL. 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 8:30 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796