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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 7, in lines 6-7 each, recite the limitation “so that respiration is performed” with regard to the configuration of a ventilation hole formed in a center of the wing portion. This renders the claim indefinite as it is unclear how respiration is performed merely by the configuration of a “ventilation hole”. This renders the claim indefinite as it is unclear what the inventor regards as the invention for this limitation (the structure or the step or respiration). It appears the claim should read “so that respiration can be performed” by allowing ventilation through the wing portion. Examiner recommends amending the claim as such or removing the limitation as it is a functional limitation that does not add anything to the claim that is not already present from the structural limitation of “a ventilation hole”.
Claims 2-6 are reject by virtue of their dependency from claim 1.
Claim 4 recites the limitation “folded in two or more stages”. It is unclear what applicant is referring to as the “two or more stages” as there is no further description in the claim or specification to make it clear what applicant regards as the invention. The specification and claim, specifically drawings 5A and 5B appear to show the edge capable of folding, but it is unclear what applicant is referring to as a “stage”. For the sake of compact prosecution, the limitation is interpreted as the frenulum protection portions being formed in a way as to be foldable in a direction.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick et al. (US PGPub 20050217678), hereinafter referred to as McCormick, in view of Frank (US PGPub 20220139255).
With regard to claim 1, McCormick teaches a mouthpiece (Paragraph 0048; “intraoral mouthpiece”), the mouthpiece comprising:
a wing portion extending to both sides of cheeks, and configured to be flexibly bitten between teeth and lips (Paragraphs 0048, 0051; Figs 2, 3 teach the mouthpiece includes bowed sheets of flexible material on both sides of a central orifice and which is positioned between the teeth and lips of a person);
a front portion configured such that a ventilation hole is formed in a center of the wing portion so that respiration is performed (Paragraphs 0048, 0051; Figs 2, 3; “central orifice 16”); and
labial frenulum protection portions extending over and beneath the front portion, and protruding to come into contact with labial frenula (Paragraph 0055; Figs 2, 3 teach and show the mouthpiece include top and bottom edges which rest against the top and bottom of the inside of the lips (labial frenula) including central notches to prevent irritating frenula).
McCormick may not explicitly teach the mouthpiece being for vocalization and respiration training; and an extension portion extending from the ventilation hole and coupled to an air resistance regulator that adjusts air pressure according to exhalation. However, Frank teaches a voice therapy mask and method wherein a mask is connected to a positive end-expiratory pressure valve via a circular opening of the mask wherein the valve can be adjusted to change the pressure (air resistance) for the user while speaking/exhaling (Paragraphs 0031, 0034-0035, 0042).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McCormick to incorporate the teachings of Frank by attaching the PEEP valve of Frank to the opening/orifice of McCormick, as both references and the claimed invention are directed to respiratory system influencing devices using mouthpiece/mask interfaces. One of ordinary skill in the art would modify McCormick by attaching the PEEP valve to the orifice of the mouthpiece in order to improve the mouthpiece in the same way by allowing the mouthpiece to provide adjustable pressure/impedance and be used for vocalization and respiratory training/therapy. Upon such modification, the method and system of McCormick would include the mouthpiece being for vocalization and respiration training; and an extension portion extending from the ventilation hole and coupled to an air resistance regulator that adjusts air pressure according to exhalation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Frank with McCormick’s device in order to provide a comfortable fit mouthpiece with improved sealing and provide respiratory and vocalization therapy via adjustable pressure.
With regard to claim 2, McCormick further teaches wherein each of the labial frenulum protection portions is symmetrically inclined and also protrude from both sides thereof to a central area thereof (Paragraph 0055; Figs 2, 3 teach and show the mouthpiece include top and bottom edges which are symmetrical and surround both sides from the central notches (central area)).
With regard to claim 3, McCormick further teaches wherein the central area of each of the labial frenulum protection portions is cut out in a valley form (Paragraph 0055; Fig 2, Refs 46 and 48 show the top and bottom edges cut out in a valley form to form the central notches).
With regard to claim 6, McCormick further teaches wherein outer peripheral edges of the wing portion are formed by being bent toward an inside of lips (Paragraphs 0024-0025, 0048 teach the mouthpiece is made of a flexible material in order to create a better seal by molding (bending) to the users mouth including molding to the user’s lips/being in contact with the inside of the user’s lips).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick in view of Frank as applied to claim 1 above, and further in view of Robertson et al. (US PGPub 20030089371).
With regard to claim 4, McCormick in view of Frank may not explicitly teach wherein each of the labial frenulum protection portions is segmentally formed to be folded in two or more stages toward an inside of the front portion. However, Robertson teaches a mouthpiece for oral delivery of a treatment including a bead (formed segment) provided around the edge for user comfort (Paragraphs 0037-0038).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McCormick in view of Frank to incorporate the teachings of Robertson by including a beaded edge around the mouth piece thicker than the main portion as taught by Robertson to the mouthpiece edge of McCormick, as the references and the claimed invention are directed to respiratory system influencing devices using mouthpiece/mask interfaces. One of ordinary skill in the art would modify McCormick in view of Frank by manufacturing the edge of the mouthpiece which is in contact with the user’s frenulum/lips to include a bead wherein the difference in thickness between the main portion of the mouthpiece and the bead creates segments and, in combination with the flexible material taught by McCormick, would allow the edge (the frenulum protection) to bend/fold inward toward the orifice for user comfort. Upon such modification, the method and system of McCormick in view of Frank would include wherein each of the labial frenulum protection portions is segmentally formed to be folded in two or more stages toward an inside of the front portion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Robertson with McCormick in view of Frank’s device in order to improve user comfort.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick in view of Frank as applied to claim 1 above, and further in view of Emerson et al. (US PGPub 20210290974).
With regard to claim 5, McCormick in view of Frank may not explicitly teach further comprising cheek expansion portions extending from both sides of the extension portion to the wing portion and formed to come into contact with insides of the cheeks and keep the expansion of the cheeks. However, Emerson teaches an oral illumination device including a mouthpiece wherein the mouthpiece includes an outer surface capable of applying an outward force on a user’s cheeks to expand the user’s oral cavity (Figures 46, 488A-D; Paragraphs 0324-0325).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McCormick in view of Frank to incorporate the teachings of Emmerson by including an outer surface capable of expanding into a user’s cheeks in order to maintain contact with a user’s cheeks as taught by Emmerson to the mouthpiece surface of McCormick, as the references and the claimed invention are directed to oral influencing systems including mouthpieces. One of ordinary skill in the art would modify McCormick in view of Frank by manufacturing the surface to include surfaces for engaging a user’s oral cavity including applying an outward force/expanding into a user’s cheek in order to maintain contact with the user’s cheeks and provide an improved seal. Upon such modification, the method and system of McCormick in view of Frank would include further comprising cheek expansion portions extending from both sides of the extension portion to the wing portion and formed to come into contact with insides of the cheeks and keep the expansion of the cheeks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Emmerson with McCormick in view of Frank’s device in order to improve user comfort and improve the mouthpiece seal with the user’s oral cavity.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick in view of Emerson and Frank.
With regard to claim 7, McCormick teaches the mouthpiece including:
a wing portion extending to both sides of cheeks, and configured to be flexibly bitten between teeth and lips (Paragraphs 0048, 0051; Figs 2, 3 teach the mouthpiece includes bowed sheets of flexible material on both sides of a central orifice and which is positioned between the teeth and lips of a person);
a front portion configured such that a ventilation hole is formed in a center of the wing portion so that respiration is performed (Paragraphs 0048, 0051; Figs 2, 3; “central orifice 16”); and
labial frenulum protection portions extending over and beneath the front portion, and protruding to come into contact with labial frenula (Paragraph 0055; Figs 2, 3 teach and show the mouthpiece include top and bottom edges which rest against the top and bottom of the inside of the lips (labial frenula) including central notches to prevent irritating frenula); and
a first step of wearing the mouthpiece (Fig 2 shows a user wearing the mouthpiece);
McCormick may not explicitly teach cheek expansion portions extending from both sides of the extension portion to the wing portion, and formed to come into contact with insides of the cheeks and keep the cheeks expanded. However, Emerson teaches an oral illumination device including a mouthpiece wherein the mouthpiece includes an outer surface capable of applying an outward force on a user’s cheeks to expand the user’s oral cavity (Figures 46, 488A-D; Paragraphs 0324-0325).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McCormick to incorporate the teachings of Emmerson by including an outer surface capable of expanding into a user’s cheeks in order to maintain contact with a user’s cheeks as taught by Emmerson to the mouthpiece surface of McCormick, as the references and the claimed invention are directed to oral influencing systems including mouthpieces. One of ordinary skill in the art would modify McCormick by manufacturing the surface to include surfaces for engaging a user’s oral cavity including applying an outward force/expanding into a user’s cheek in order to maintain contact with the user’s cheeks and provide an improved seal. Upon such modification, the method and system of McCormick would include cheek expansion portions extending from both sides of the extension portion to the wing portion, and formed to come into contact with insides of the cheeks and keep the cheeks expanded. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Emmerson with McCormick’s device in order to improve user comfort and improve the mouthpiece seal with the user’s oral cavity.
McCormick in view of Emmerson may not explicitly teach a vocalization training method using a mouthpiece for vocalization and respiration training, the vocalization training method comprising: a first step of wearing the mouthpiece for vocalization and expiration training to which the air resistance regulator is coupled; a second step of controlling air resistance according to exhalation by adjusting the air resistance regulator according to a user's lung capacity while wearing the mouthpiece for vocalization and respiration training; a third step of filling an oral cavity with air and keeping the cheeks expanded while allowing a specific amount of air to be discharged through the air resistance regulator when the user exhales; and a fourth step of practicing vocal-cord and vowel sound vocalization. However, Frank teaches a voice therapy mask and method wherein a mask is connected to a positive end-expiratory pressure valve via a circular opening of the mask wherein the valve can be adjusted to change the pressure (air resistance) for the user while speaking/exhaling wherein a user wears the mask/mouthpiece during vocalization training including exhaling air wherein the impedance/air resistance may be adjusted creating pressure back to the user such that when a user vocalizes or exhales the pressure will push back on the user’s breathing causing their cheeks to expand while air travels through the valve at a set level based on the impedance level (Paragraphs 0019, 0031, 0034-0035, 0039-0042, 0047).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McCormick in view of Emmerson to incorporate the teachings of Frank by attaching the PEEP valve of Frank to the opening/orifice of McCormick, as both references and the claimed invention are directed to respiratory system influencing devices using mouthpiece/mask interfaces. One of ordinary skill in the art would modify McCormick in view of Emmerson by attaching the PEEP valve to the orifice of the mouthpiece in order to improve the mouthpiece in the same way by allowing the mouthpiece to provide adjustable pressure/impedance and be used for vocalization and respiratory training/therapy including having a user exhale and vocalize through the mouthpiece and valve wherein pressure/impedance is set by adjusting the valve as a user practices vocalization. Upon such modification, the method and system of McCormick in view of Emmerson would include a vocalization training method using a mouthpiece for vocalization and respiration training, the vocalization training method comprising: a first step of wearing the mouthpiece for vocalization and expiration training to which the air resistance regulator is coupled; a second step of controlling air resistance according to exhalation by adjusting the air resistance regulator according to a user's lung capacity while wearing the mouthpiece for vocalization and respiration training; a third step of filling an oral cavity with air and keeping the cheeks expanded while allowing a specific amount of air to be discharged through the air resistance regulator when the user exhales; and a fourth step of practicing vocal-cord and vowel sound vocalization. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Frank with McCormick in view of Emmerson’s device in order to provide a comfortable fit mouthpiece with improved sealing and provide respiratory and vocalization therapy via adjustable pressure.
Conclusion
Accordingly, claims 1-7 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached at (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CORRELL T FRENCH/Examiner, Art Unit 3715