DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-35 are rejected under 35 U.S.C. 101 because it is drawn to non-statutory subject matter.
Applicant recites part of a human, i.e. "…a pair of electrodes disposed on a tongue surface (claim 18 line 2), “…at least one electrode being disposed on a midline of the tongue surface…” (Claim 18, line 3) "… and disposed on a skin surface…” (claim 18 line 6),
In claim 21, applicant recites part of a human, i.e. “… the electrode disposed on the skin surface is disposed around approximately an entire periphery of a neck”.
In claim 22, applicant recites part of a human, i.e. “…the pair of electrodes are respectively disposed at a tip of the tongue and a back of the tongue.”
In claim 23, applicant recites part of a human, i.e. “…wherein there are three electrodes respectively disposed at a tip of the tongue, a middle of the tongue, and a back of the tongue, and a pair is formed of the electrodes disposed at the middle and tip of the tongue and another pair is formed of the electrodes disposed at the middle and back of the tongue. “
In claim 25, applicant recites part of a human, i.e. “…the electrode disposed on the skin surface is disposed under a chin or on a front surface of a neck”.
In claim 26, applicant recites part of a human, i.e. “… the pair of electrodes are respectively disposed at a tip of the tongue and a back of the tongue.”
In claim 27, applicant recites part of a human, i.e. “…the electrode disposed on the skin surface is branched into at least two electrodes, and when there is an even number of branched electrodes, the electrodes are disposed in line symmetry with respect to a midline, or when there is an odd number of branched electrodes, one electrode is disposed on the midline and the rest of the electrodes is disposed in line symmetry with respect to the midline.
In claim 28, applicant recites part of a human, i.e. “…there are three electrodes respectively disposed at a tip of the tongue, a middle of the tongue, and a back of the tongue, and a pair is formed of the electrodes disposed at the middle and tip of the tongue and another pair is formed of the electrodes disposed at the middle and back of the tongue.
In claim 30, applicant recites part of a human, i.e. “…the electrode disposed on the skin surface is disposed a midline.”
In claim 31, applicant recites part of a human, i.e. “…the size of the electrode disposed on the skin surface is larger than the size of the electrode disposed in the oral cavity.”
In claim 32, applicant recites part of a human, i.e. “… a first pair of electrodes disposed on a tongue surface in an oral cavity, at least one electrode being disposed on a midline of the tongue surface; a first surface electrode branched from one electrode of the first pair of electrodes and disposed on a skin surface; … a second pair of electrodes disposed on a tongue surface in the oral cavity, at least one electrode being disposed on a midline of the tongue surface; a second surface electrode branched from one electrode of the second pair of electrodes and disposed on the skin surface;…”
In claim 33, applicant recites part of a human, i.e. “…the first and second surface electrodes are disposed under a chin or on a front surface of a neck.”
In claim 34, applicant recites part of a human, i.e. “…electrodes disposed in the oral cavity and the electrode disposed on the skin surface in the oral muscle training device according to claim 18”.
In claim 35, applicant recites part of a human, i.e. “…electrodes disposed in the oral cavity and the electrode disposed on the skin surface in the oral muscle training device according to claim 32”.
Thus, these claims include a human within the scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be disposed" when referring to the location of the electrodes in relation to patient’s body.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18, 25-30 and 32-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sama (U.S. Patent Application Publication Number: US 2020/0121924 A1, hereinafter “Sama”).
Regarding claim 18, Sama teaches an oral muscle training device (e.g. title, Abstract Figs.1, 3C-E) comprising:
a pair of electrodes disposed on a tongue surface in an oral cavity, at least one electrode being disposed on a midline of the tongue surface (e.g. 132 a, b, 133 a, b Fig. 1, Abstract, Note: the claims are directed to an apparatus and therefore the location of where the electrodes are positioned is intended use);
an electrode branched from one electrode of the pair of electrodes and disposed on a skin surface (e.g. 152a, b Figs. 3D, E, [0151]); and
an electric circuit (e.g. 150 Figs. 3D, E, [0151]-[0153]) configured to pass a medium frequency current between the electrodes (e.g. [0009],[0053]-[0059], Note: the claim does not recite any specific stimulation frequency parameters, Sama also teaches providing a Russian current stimulation).
Regarding claim 25, Sama teaches that the electrode disposed on the skin surface is disposed under a chin or on a front surface of a neck (e.g. 152 a, b Figs. 3D, E, Note: position of the electrode is intended use since the claims are directed to an apparatus).
Regarding claim 26, Sama teaches a plurality of electrodes (e.g. 132 a, b and 133 a, b) as shown in Fig. 1 and therefore Sama teaches that the pair of electrodes are adapted to be respectively disposed at a tip of the tongue and a back of the tongue. (Note: the positioning of the electrodes on the tongue is intended use, since Sama teaches a plurality of electrodes that are capable of being place on or below the tongue, they are capable of being positioned at various parts of the tongue as claimed.
Regarding claim 27, Sama teaches the electrode disposed on the skin surface is branched into at least two electrodes, and when there is an even number of branched electrodes, the electrodes are disposed in line symmetry with respect to a midline (e.g. 152 a, b Figs. 3D, E), or when there is an odd number of branched electrodes, one electrode is disposed on the midline and the rest of the electrodes is disposed in line symmetry with respect to the midline.
Regarding claims 28 and 29, Sama teaches a plurality of electrodes (e.g. 132 a, b and 133 a, b) as shown in Fig. 1 and therefore Sama teaches there are three electrodes respectively disposed at a tip of the tongue, a middle of the tongue, and a back of the tongue, and a pair is formed of the electrodes disposed at the middle and tip of the tongue and another pair is formed of the electrodes disposed at the middle and back of the tongue and a plurality of pairs of electrodes are disposed as the pair of electrodes, in which adjacent electrodes are opposite poles to each other Note: the positioning of the electrodes is intended use, since Sama teaches a plurality of electrodes that are capable of being place on or below the tongue, they are capable of being positioned at the locations of the tongue as claimed. Furthermore, an electrode is a piece of metal and can be paired or configured as opposite poles as claimed).
Regarding claim 30, Sama teaches that the electrode disposed on the skin surface and is capable of being disposed on or about a midline (e.g. 152 a, b Figs. 3D, E e.g. Note: position of the electrode is intended use since the claims are directed to an apparatus.
Regarding claim 34, Sama teaches a set of the electrodes disposed in the oral cavity (e.g. 132 a, b, 133 a, b Fig. 1, Abstract, Note: the claims are directed to an apparatus and therefore the location of where the electrodes are positioned is intended use) and the electrode disposed on the skin surface (e.g. 152a, b Figs. 3D, E, [0151]) in the oral muscle training device according to claim 18.
Regarding claim 32, Sama teaches an oral muscle training device (e.g. title, Abstract Figs.1, 3C-E) comprising:
a first pair of electrodes (e.g. 132a Fig1) disposed on a tongue surface in an oral cavity, at least one electrode (e.g. 132b Fig.1) being disposed on a midline of the tongue surface (Note: the claims are directed to an apparatus, and the positioning of the electrodes is intended use);
a first surface electrode (e.g. 152a Fig. 3E) branched from one electrode of the first pair of electrodes and disposed on a skin surface;
an electric circuit (e.g. [0151]-[0153]) configured to pass a first medium frequency current between electrodes formed of the first pair of electrodes and the first surface electrode (e.g. [0188]-0191]);
a second pair of electrodes (e.g. 133a Fig1) disposed on a tongue surface in the oral cavity, at least one electrode (e.g. 133b Fig1) being disposed on a midline of the tongue surface;
a second surface electrode (e.g. 133a Fig1) branched from one electrode of the second pair of electrodes and disposed on the skin surface; and
an electric circuit (e.g. [0151]-[0153]) configured to pass a second medium frequency current between electrodes formed of the second pair of electrodes and the second surface electrode (e.g. [0188]-0191], [0009],[0053]-[0059], Note: the claim does not recite any specific stimulation frequency parameters, Sama also teaches providing a Russian current stimulation).
Regarding claim 33, Sama teaches the first and second surface electrodes are disposed under a chin or on a front surface of a neck (e.g. 152 a, b Figs. 3D, E, Note: position of the electrode is intended use since the claims are directed to an apparatus).
Regarding claim 35, Sama teaches a set of the electrodes (e.g. 132 a, b, 133 a, b Fig. 1, Abstract, Note: the claims are directed to an apparatus and therefore the location of where the electrodes are positioned is intended use) disposed in the oral cavity and the electrode (e.g. 152a, b Figs. 3D, E, [0151]) disposed on the skin surface in the oral muscle training device according to claim 32.
Regarding claim 36, Sama teaches an oral muscle training method (e.g. title, Abstract Figs.1, 3C-E) comprising:
disposing a pair of electrodes on a tongue surface in an oral cavity, and disposing at least one of the pair of electrodes on the midline of the tongue surface (e.g. 132a,b, 133a,b Fig 1,[0012], [0059],[0189]: electrical stimulation is directed at the dilatory palate muscles in the midline, such as the uvular muscle 77);
disposing an electrode branched from one electrode of the pair of electrodes under a chin, on a skin surface of a front surface of a neck (e.g.152a,b Figs.3D, 3E), or on a skin surface of an entire circumference surface of a neck ; and
passing a medium frequency current between the electrodes (e.g. [0009],[0053]-[0059], Note: the claim does not recite any specific stimulation frequency parameters, Sama also teaches providing a Russian current stimulation which is a medium frequency stimulation at 2400 to 2500 Hz provided in bursts).
Claim Rejections - 35 USC § 102/ 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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 21-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sama (U.S. Patent Application Publication Number: US 2020/0121924 A1, hereinafter “Sama”) or in the alternative as being obvious over Sama (U.S. Patent Application Publication Number: US 2020/0121924 A1, hereinafter “Sama”) in view of Honour (U.S. Patent Application Publication Number: US 2011/0230702 A1, hereinafter “Honour”)
Regarding claim 21, Sama teaches the electrode disposed on the skin surface is disposed around approximately an entire periphery of a neck (e.g. Fig.3E shows electrodes located around both sides of the neck). In the alternative, Sama teaches two electrodes positioned on two locations on the neck but does not specifically teach an electrode collar disposed around approximately an entire periphery of a neck.
Honour teaches an electrode collar used to position electrodes on a user so current travelling between the electrodes can stimulate the tissue (e.g. Abstract, Fig. 2). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Sama with a collar as taught by Honour in order to provide the predictable results of ensuring that the electrodes are in position to stimulate the underlying tissue.
Regarding claims 22-24, Sama in view of Honour teaches the claimed invention as discussed above and Sama teaches a plurality of electrodes (e.g. 132a,b and 133a,b) as shown in Fig. 1 and therefore Sama teaches that the pair of electrodes are respectively disposed at a tip of the tongue and a back of the tongue (as claimed in claim 22) and that there are three electrodes respectively disposed at a tip of the tongue, a middle of the tongue, and a back of the tongue, and a pair is formed of the electrodes disposed at the middle and tip of the tongue and another pair is formed of the electrodes disposed at the middle and back of the tongue and that a plurality of pairs of electrodes are disposed as the pair of electrodes, in which adjacent electrodes are opposite poles to each other (as claimed in claim 24) (Note: the positioning of the electrodes is intended use, since Sama teaches a plurality of electrodes that are capable of being place on or below the tongue, they are capable of being positioned at the locations of the tongue as claimed. Furthermore, an electrode is a piece of metal and can be configured as opposite poles as claimed).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sama (U.S. Patent Application Publication Number: US 2020/0121924 A1, hereinafter “Sama”) in view of Taylor (U.S. Patent Application Publication Number: US 2011/022126 A1, hereinafter “Taylor”) OR Papay (U.S. Patent Application Publication Number: US 2015/0142120 A1, hereinafter “Papay”).
Regarding claim 19, Sama teaches the claimed invention as discussed above and while they teach a continuous wave current having a medium stimulation frequency (e.g. [0053], [0057] Russian stimulation as well as the stimulation of 150Hz considered as a medium frequency current), they do not specifically teach that the medium frequency current is equal to or more than 3 kHz and less than 8 kHz.
In a similar field of endeavor, Taylor teaches that it is well known to provide an oral stimulation of a low-amperage frequency in the range of 2,000 Hz (2 KHz) to 15,000 Hz (15 KHz) to the intra-oral cavity or areas of the head and neck and that these frequencies increase the myo-fascicular function of all the skeletal muscles and usually increases the overall strength of the user by 20% to 25% (e.g. [0048]). Papay is another teaching that shows that it is well known to provide a stimulation of 0.5hz to 4KHz (e.g. [0065]), to a target tissue associated with control of a posterior base of the tongue of the subject (e.g. Abstract, [0037]) Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Sama with the medium frequency current as taught by Taylor OR Papay in order to provide the predictable results of a more targeted stimulation to increase the overall muscle strength.
In the alternative, Sama in view of Taylor OR Papay teaches the low frequency stimulation current with an overlapping frequency with the claimed range but do not exactly teach that the medium frequency current is equal to or more than 3 kHz and less than 8 kHz. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Sama in view of Taylor OR Papay with the medium frequency current being equal to or more than 3 kHz and less than 8 kHz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Regarding claim 20, Sama teaches the claimed invention as discussed above and while they teach a continuous wave current having a medium stimulation frequency (e.g.[0053], [0057] Russian current stimulation which is a medium frequency stimulation at 2400 to 2500 Hz provided in bursts and thus an intermittent wave in which a current flows continuously for a predetermined period of time and then does not flow for a predetermined period of time and as well as the stimulation of 150Hz considered as a medium frequency currents), they do not specifically teach the medium frequency intermitted provided is more than 3 kHz and less than 8 kHz.
In a similar field of endeavor, Taylor teaches that it is well known to provide an oral stimulation of a low-amperage frequency in the range of 2,000 Hz (2 KHz) to 15,000 Hz (15 KHz) to the intra-oral cavity or areas of the head and neck abd that these frequencies increase the myo-fascicular function of all the skeletal muscles and usually increases the overall strength of the user by 20% to 25% (e.g. [0048]). Papay is another teaching that shows that it is well known to provide a stimulation of 0.5hz to 4KHz (e.g. [0065]), to a target tissue associated with control of a posterior base of the tongue of the subject (e.g. Abstract, [0037]) Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Sama with the medium frequency current as taught by Taylor OR Papay in order to provide the predictable results of a more targeted stimulation to increase the overall muscle strength.
In the alternative, Sama in view of Taylor OR Papay teaches the low frequency stimulation current with an overlapping frequency with the claimed range but do not exactly teach that the medium frequency current is equal to or more than 3 kHz and less than 8 kHz. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Sama in view of Taylor OR Papay with the medium frequency current being equal to or more than 3 kHz and less than 8 kHz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Sama (U.S. Patent Application Publication Number: US 2020/0121924 A1, hereinafter “Sama”).
Regarding claim 31, Sama discloses the claimed invention except for the size of the electrode disposed on the skin surface being larger than the size of the electrode disposed in the oral cavity. It would have been an obvious matter of design choice to modify the size of the electrode disposed on the skin surface to be larger than the size of the electrode disposed in the oral cavity, since such a modification would have involved a mere change in the size/ proportion of a component. A change in size/ proportion is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sama (U.S. Patent Application Publication Number: US 2016/0317803 A1, hereinafter “Sama’803”) teaches an oral muscle training device comprising a plurality of electrodes (e.g. Figs 1-3) adapted to be placed on a tongue surface and an electric circuit to provide stimulation to increase resting muscle tone and/or muscle tone during sleep (e.g. abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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