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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The amendment to the specification filed on 03/30/2026 with the preliminary amendment is acknowledged.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: upper fixing portion in claim 1; lower fixing portion in claim 2.
Claim limitation “fixing portion” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “portion” as a substitute for means coupled with functional language “fixing” without reciting sufficient structure to achieve the function. Furthermore, the generic place holder is not preceded by a structural modifier.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the corresponding structure of the 35 U.S.C. 112(f) or pre-AIA U.S.C. 112, sixth paragraph limitation “upper fixing portion” and “lower fixing portion” described in the specification includes a tooth indentation (Fig. 1, Fig. 2, respectively), tooth mold {0041]; and a cover (Applicant’s specification, [0015]);
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 5 objected to because of the following informalities: Claim 1 and 5 each recite “an upper fixing portion that covers and is fixed to a tooth of an upper jaw of the user from a tooth mold of the upper jaw of the user”. It is not clear from the claim whether an upper fixing portion is from a tooth mold or if a tooth is from a tooth mold. It appears that each claim should be clarified by indicting -- an upper fixing portion that covers and is fixed to a tooth of an upper jaw of the user, the upper fixing portion from a tooth mold of the upper jaw of the user--.
Claims 6 is objected to because of the following informalities: Claim 6 recites “the upper side fixing portion” in line 7. For clarity, it should recite “the upper side portion” which was previously introduced in claim 5.
Appropriate correction is required.
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.
Claim 6 is 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.
Claim 6 recites the limitation "an upper fixing portion that covers and is fixed to a tooth of an upper jaw of the user from a tooth mold of the upper jaw of the user from a tooth mold" in lines 3-5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as –the upper fixing portion that covers and is fixed to the tooth of the upper jaw of the user from the tooth mold--.
Claim 6 recites the limitation "a tongue suction portion facing a tongue of the user on a back surface side of the recess in the upper side fixing portion”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted --the tongue suction portion facing the tongue of the user attached to the back surface side of the recess in the upper side fixing portion--.
Claim 6 recites the limitation "a lower fixing portion that covers and is fixed to a tooth of the lower jaw of the user on a lower jaw side of the upper fixing portion”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as --the lower fixing portion that covers and is fixed to the tooth of the lower jaw of the user on the lower jaw side of the upper fixing portion--.
Claim 6 recites the limitation "a suction hole communicating with the tongue suction portion from the recess, and a suction portion communicating with the recess and applying a negative pressure to the closed pace from an outside”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as -- the suction hole communicating from the recess to the tongue section portion, and the suction portion communicating with the recess and applying the negative pressure to the closed space from the outside”
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 5-6 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 5, lines 2-3 recite, “an upper fixing portion material for forming an upper fixing portion that covers and is fixed to a tooth of an upper jaw of a user” which positively claims the human body. Language such as “configured to” or “adapted for” is recommended to avoid positively claiming human body parts. For example, the claim could be amended to recite -- an upper fixing portion material for forming an upper fixing portion that is configured to cover and is configured to be fixed to a tooth of an upper jaw of a user --.
Claim 5, lines 4-6 recite, “forming an annular abutment portion that abuts a hard palate of the user, and a recess that forms a closed space with the hard palate at an inner side of the abutment portion in a state in which an entire circumference of the abutment portion abuts the hard palate” which positively claims the human body. Language such as “configured to” or “adapted for” is recommended to avoid positively claiming human body parts. For example, the claim could be amended to recite --forming an annular abutment portion that is configured to abut a hard palate of the user, and a recess that is configured to form a closed space with the hard palate at an inner side of the abutment portion when in a state in which an entire circumference of the abutment portion abuts the hard palate--.
Claim 5, lines 7-8 recite, “a tongue suction portion material that is attached to a back surface side of the recess and that forms a tongue suction portion facing a tongue of the user” which positively claims the human body. Language such as “configured to” or “adapted for” is recommended to avoid positively claiming human body parts. For example, the claim could be amended to recite -- a tongue suction portion material that is attached to a back surface side of the recess and that forms a tongue suction portion configured to face a tongue of the user--.
Claim 5, lines 9-11 recite, “a lower fixing portion material for forming a lower fixing portion that is attached to a lower jaw side of the upper fixing portion and that covers and is fixed to a tooth of a lower jaw of the user”. Language such as “configured to” or “adapted for” is recommended to avoid positively claiming human body parts. For example, the claim could be amended to recite --a lower fixing portion material for forming a lower fixing portion that is attached to a lower jaw side of the upper fixing portion and that is configured to cover and configured to be fixed to a tooth of a lower jaw of the user--.
As claim 6 depends from claim 5, it is rejected for at least the same reasons as claim 5.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masakatsu (JP 2008183388A, English Translation Provided as NPL).
Regarding claim 1, Masakatsu discloses a tongue suction restrainer (1A) ([0001]; [0005]; capable of intended use), comprising: an upper fixing portion (11a, 11c) (annotated Fig. 3 below; per 112f analysis above an upper fixing portion includes an indentation for a tooth and Fig. 1 of the Masakatsu includes an indentation for a tooth thus the limitation is met)
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that is fixable to an upper jaw of a user when the tongue suction restrainer is attached to an oral cavity of the user ([0008]; [0014]; capable of intended use; Fig. 3); an annular abutment portion (12) ([0020]; Fig. 2; annotated Fig. 3; NOTE: a rim of the suction portion 12 is annular as seen in Fig. 2 which abuts a hard palate as seen in Fig. 3) that abuts a hard palate of the user (Fig. 3 shows the rim of 12 abutting a hard palate of the user; [0014]) when the tongue suction restrainer is attached to the oral cavity (Fig. 3; [0021]); a recess (Fig. 3; space and walls inside suction cup that is indented/recessed relative to the outer annular rim/abutment portion that is abutting the hard palate space) that is formed at an inner side of the abutment portion (Fig. 3 shows the abutment portion/rim having a recess at an inner side) to form a closed space (Fig. 3 shows a closed space formed with a suction cup 12 in the region of the hard palate) with the hard palate (Fig. 3 shows the abutment portion/rim attached to a hard palate; [0019], capable of intended use) in a state in which an entire circumference of the abutment portion abuts the hard palate (Fig. 3; [0021]; [0014]; FIG. 3 shows that in all embodiments of the tongue locking device of the present invention, the tongue locking device 1 and the other tongue locking devices 1A and 1B are locked to the tongue 2 and the palate portion 3); a suction portion (22) ([0021], The outside air (air), saliva, etc. staying in the entire area of the opening 22a through the air passage 22 are exhausted (see FIG. 2), and the adsorbing portion 12 and the base 11 are applied to the tongue portion 2 and the palate portion 3, respectively. By locking through the tongue locking device, the movement of the tongue 2 is prevented and the fall in the direction of the airway 5 is prevented; [0022], The air passage 22 also becomes the air passage 22 and is provided with a forced discharger 24 at the extension destination. The suction portion 12 and the suction portion 12 are maintained in the suction state, or the forced discharger 24 is operated in the reverse direction) that communicates with the recess to apply a negative pressure to the closed space from an outside ([0021]; [0022]; NOTE: exhausting the air provides negative pressure to the opening of 12 and the closed space); and a tongue suction portion (12) ([0021]; [0022]; [0014]; NOTE: lower cup 12 in annotated Fig. 3 is a suction portion) that is formed at a position facing a tongue of the user (annotated Fig. 3) when the tongue suction restrainer is attached to the oral cavity (Fig. 3), that has a suction hole (22a) provided to communicate with the recess (capable of intended use, [0020], One of the passages 22 is connected to the opening 22a of the suction portion so as to allow ventilation, and the other is connected to the ventilation opening / closing portion 22b. As a result, the outside air (air), saliva, etc. staying in the entire area of the opening 22a can be discharged and the adsorbing part can be adsorbed to the tongue 2 or palate part 3; [0021], [0022]) and that sucks the tongue by the negative pressure (Fig. 3; [0020], air in the area of the opening can be discharged and the adsorbing part can be adsorbed to the tongue; capable of intended use) by applying the negative pressure in the closed space to the suction hole ([0020], [0022]; forced air discharger provides discharge of air/negative pressure in the closed space to the suction hole).
Regarding claim 2, Masakatsu discloses the invention as described above with regard to claim 1.
Masakatsu further discloses wherein the upper fixing portion is fixable to a tooth of the upper jaw of the user (Fig. 1; capable of intended use; [0028], wherein the upper fixing portion is fixable to a tooth of the upper jaw of the user; [0030]).
Regarding claim 3, Masakatsu discloses the invention as described above with regard to claim 1.
Masakatsu further discloses a lower fixing portion (Fig. 2; [0032]; per 112f analysis above a lower fixing portion includes an indentation for a tooth Masakatsu discloses an indentation for a tooth thus the limitation is met) that is fixable to a tooth of a lower jaw of the user ([0032], the accidental ingestion preventing portions 11a and 11c are all illustrated so as to face upward, but these elevation directions may be directed downward as well as upward. It can be moored on the lips or both lips and / or teeth or gingival area to prevent accidental ingestion; capable of intended use).
Masakatsu further discloses a protrusion that protrudes from an inner peripheral portion of the lower fixing portion to form a pocket for allowing a part of the tongue to enter between the protrusion and the tongue suction portion, wherein the suction hole is provided in a portion of the lower fixing portion which forms the pocket.
Regarding claim 5, Masakatsu discloses a tongue suction restrainer manufacturing kit (1A) ([0001]; [0005]; capable of intended use), comprising: an upper fixing portion material for forming an upper fixing portion (11a, 11c) (annotated Fig. 3 below; per 112f analysis above an upper fixing portion includes an indentation for a tooth and Fig. 1 of the Masakatsu includes an indentation for a tooth thus the limitation is met)
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that covers and is fixed to a tooth of an upper jaw of a user (Fig. 3; [0028]; [0008]; [00014]) from a tooth mold of the upper jaw of the user (As to claim 5, the limitation, “an upper fixing portion that covers and is fixed to a tooth of an upper jaw of a user from a tooth mold” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Masakatsu is silent as to the process used to form the upper fixing portion, the apparatus discloses is the same as claimed. Accordingly, the limitation is met), and forming an annular abutment portion (12) ([0020]; Fig. 2; annotated Fig. 3 with regard to claim 1; NOTE: a rim of the suction portion 12 is annular as seen in Fig. 2 which abuts a hard palate as seen in Fig. 3) that abuts a hard palate of the user(Fig. 3 shows the rim of 12 abutting a hard palate of the user), and a recess (Fig. 3; space and walls inside suction cup that is indented/recessed relative to the outer annular rim/abutment portion that is abutting the hard palate; [0014]) that forms a closed space (Fig. 3 shows a closed space formed with a suction cup 12 in the region of the hard palate) with the hard palate at an inner side of the abutment portion (Fig. 3 shows the abutment portion/rim attached to a hard palate; [0019], capable of intended use) in a state in which an entire circumference of the abutment portion abuts the hard palate (Fig. 3; [0014]; [0021]; FIG. 3 shows that in all embodiments of the tongue locking device of the present invention, the tongue locking device 1 and the other tongue locking devices 1A and 1B are locked to the tongue 2 and the palate portion 3); a suction portion (22) ([0021], The outside air (air), saliva, etc. staying in the entire area of the opening 22a through the air passage 22 are exhausted (see FIG. 2), and the adsorbing portion 12 and the base 11 are applied to the tongue portion 2 and the palate portion 3, respectively. By locking through the tongue locking device, the movement of the tongue 2 is prevented and the fall in the direction of the airway 5 is prevented; [0022], The air passage 22 also becomes the air passage 22 and is provided with a forced discharger 24 at the extension destination. The suction portion 12 and the suction portion 12 are maintained in the suction state, or the forced discharger 24 is operated in the reverse direction) that communicates with the recess to apply a negative pressure to the closed space from an outside ([0021]; [0022]; NOTE: exhausting the air provides negative pressure to the opening of 12 and the closed space); a tongue suction portion material (NOTE: material of tongue suction portion 12 seen in annotated Fig. 3 with regard to the claim 1 rejection) that is attached to a back surface side of the recess (annotated Fig. 3; NOTE: the tongue suction portion material forms tongue suction portion 12 that is attached to a back surface of the recess via base 11) and that forms a tongue suction portion (12) (annotated Fig. 3; [0021]; [0022]; [0014]; NOTE: lower cup 12 in annotated Fig. 3 is a suction portion)) facing a tongue of the user (Fig. 3); and a lower fixing portion material (NOTE: material for forming lower fixing portion as described in [0032]) for forming a lower fixing portion ([0032], the accidental ingestion preventing portions 11a and 11c are all illustrated so as to face upward, but these elevation directions may be directed downward as well as upward. It can be moored on the lips or both lips and / or teeth or gingival area to prevent accidental ingestion) that is attached to a lower jaw side of the upper fixing portion ([0032], as described above portions 11a and 11c may be directed downward as well as upward and as they would thus be attached to a lower jaw side of the upper fixing portion 11a, 11c) and that covers and is fixed to a tooth of a lower jaw of the user ([0032], capable of intended use), wherein a suction hole (22a) communicating from the recess to the tongue suction portion (capable of intended use, [0020], One of the passages 22 is connected to the opening 22a of the suction portion so as to allow ventilation, and the other is connected to the ventilation opening /closing portion 22b. As a result, the outside air (air), saliva, etc. staying in the entire area of the opening 22a can be discharged and the adsorbing part can be adsorbed to the tongue 2 or palate part 3; [0021], [0022]; NOTE: as each of the suction portions 12 are connected to the opening/suction hole 22a the suction hole is communicating from the recess to the tongue suction portion) and a suction portion (22, 24) ([0022]) communicating with the recess to apply a negative pressure to the closed space (Fig. 3; [0020], air in the area of the opening can be discharged and the adsorbing part can be adsorbed to the tongue; capable of intended use) from an outside are formed (Fig. 2, shows suction portion 22, 24 are from an outside of the device).
Regarding claim 7, Masakatsu discloses the invention as described above with regard to claim 1.
Masakatsu further discloses wherein plural suction holes (22a, 22b) communicate with one recess ([0020]; ventilation hole and opening 22a are a plurality of holes that communicate with one recess of element 12/suction cup 12).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masakatsu (JP 2008183388A, English Translation Provided as NPL), as applied to claim 5 above, in further view of Thornton (US 5846082).
Regarding claim 6, Masakatsu discloses the invention as described above with regard to claim 5.
Masakatsu further discloses a method of manufacturing a tongue suction restrainer by using the tongue suction restrainer manufacturing kit according to claim 5 (it is implied that the tongue suction restrainer manufacturing kit is used by a user; [0017]), comprising: a step of forming, by the upper fixing portion material ([00019]; NOTE: the upper fixing portion is formed of a material), an upper fixing portion (11a, 11c) (annotated Fig. 3 above with regard to the claim 5 rejection; per 112f analysis above an upper fixing portion includes an indentation for a tooth and Fig. 2 of the Masakatsu includes an indentation for a tooth thus the limitation is met) that covers and is fixed to a tooth of an upper jaw of the user (Fig. 3; [0028]); a step of forming, by the tongue suction portion material (NOTE: material of tongue suction portion 12 seen in annotated Fig. 3 with regard to the claim 5 rejection), a tongue suction portion (12) (annotated Fig. 3 with regard to the claim 5 rejection) facing a tongue of the user (Fig. 3) on a back surface side of the recess in the upper side fixing portion (annotated Fig. 3 with regard to claim 5; NOTE: the tongue suction portion material forms tongue suction portion 12 that is attached to a back surface of the recess via base 11 in the upper side fixing portion); a step of forming, by the lower fixing portion material (NOTE: material for forming lower fixing portion as described in [0032]), a lower fixing portion ([0032], the accidental ingestion preventing portions 11a and 11c are all illustrated so as to face upward, but these elevation directions may be directed downward as well as upward. It can be moored on the lips or both lips and / or teeth or gingival area to prevent accidental ingestion) that covers and is fixed to a tooth of the lower jaw of the user ([0032]) on a lower jaw side of the upper fixing portion ([0032], as described above portions 11a and 11c may be directed downward as well as upward and as they would thus be attached to a lower jaw side of the upper fixing portion 11a, 11c and when downward would be fixed to a tooth of the lower jaw of the user on a lower jaw side of the upper fixing portion); and a step of forming a suction hole (22a) communicating with the tongue suction portion from the recess ([0020], One of the passages 22 is connected to the opening 22a of the suction portion so as to allow ventilation, and the other is connected to the ventilation opening /closing portion 22b. As a result, the outside air (air), saliva, etc. staying in the entire area of the opening 22a can be discharged and the adsorbing part can be adsorbed to the tongue 2 or palate part 3; [0021], [0022]; NOTE: as each of the suction portions 12 are connected to the opening/suction hole 22a the suction hole is communicating with the tongue suction portion from the recess), and a suction portion (22, 24) ([0022]) communicating with the recess and applying a negative pressure to the closed space (22, 24) ([0022]) from an outside (Fig. 2, shows suction portion 22, 24 are from an outside of the device).
Masakatsu does not disclose an upper fixing portion that covers and is fixed to a tooth of an upper jaw of the user from a tooth mold.
Thornton teaches an analogous step of forming, by an upper fixing portion material (col, 2, lines 48-60, col. 4, lines 9-29; NOTE: a mold for the upper teeth is formed from an upper fixing portion material and the mold is repeatedly put in the user’s mouth to form the final mold(; upper fixing portion is a part of the mold that covers and is fixed to a tooth of an upper jaw of the user and that is from a tooth mold of the upper jaw of the user), an upper fixing portion that cover and is fixed to a tooth of an upper jaw of the user from a tooth mold of the upper jaw of the user (col. 2, lines 48-60; col. 4, lines 9-29).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that in the method of manufacturing a tongue section restrainer of Masakatsu that includes a step of forming an upper fixing portion includes forming an upper fixing portion that that covers and is fixed to a tooth of an upper jaw of the user from a tooth mold, as taught by Thornton, in order to provide an improved method that provides optimal fit, is efficient and is economically available (col. 2, lines 15-31).
Allowable Subject Matter
Claim 4 is allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 4, the prior art alone or in combination fails to teach or suggest a tongue suction restrainer, comprising: an upper fixing portion that is fixable to an upper jaw of a user when the tongue suction restrainer is attached to an oral cavity of the user; an annular abutment portion that abuts a hard palate of the user when the tongue suction restrainer is attached to the oral cavity; a recess that is formed at an inner side of the abutment portion to form a closed space with the hard palate in a state in which an entire circumference of the abutment portion abuts the hard palate; a suction portion that communicates with the recess to apply a negative pressure to the closed space from an outside; and a tongue suction portion that is formed at a position facing a tongue of the user when the tongue suction restrainer is attached to the oral cavity, that has a suction hole provided to communicate with the recess, and that sucks the tongue by the negative pressure, a lower fixing portion that is fixable to a tooth of a lower jaw of the user, and a protrusion that protrudes from an inner peripheral portion of the lower fixing portion to form a pocket for allowing a part of the tongue to enter between the protrusion and the tongue suction portion, wherein the suction hole is provided in a portion of the lower fixing portion which forms the pocket.
Regarding claim 4, the closest prior art is Masakatsu (JP 2008183388A, English Translation Provided as NPL). Masakatsu discloses a tongue suction restrainer 1A) ([0001]; [0005]; capable of intended use), comprising: an upper fixing portion (11a, 11c) (per 112f analysis above an upper fixing portion includes an indentation for a tooth and Fig. 2 of the Masakatsu includes an indentation for a tooth thus the limitation is met) that is fixable to an upper jaw of a user when the tongue suction restrainer is attached to an oral cavity of the user ([0008]; capable of intended use); an annular abutment portion (12) ([0020]; Fig. 2; Fig. 3; NOTE: a rim of the suction portion 12 is annular as seen in Fig. 2 which abuts a hard palate as seen in Fig. 3) that abuts a hard palate of the user (Fig. 3 shows the rim of 12 abutting a hard palate of the user) when the tongue suction restrainer is attached to the oral cavity (Fig. 3; [0021]); a recess (annotated Fig. 3; spaced inside suction cup that is indented/recessed relative to the outer annular rim) that is formed at an inner side of the abutment portion to form a closed space with the hard palate (Fig. 2 shows opening 22a in an inner portion of each of the suction portion/cups 12) in a state in which an entire circumference of the abutment portion abuts the hard palate (Fig. 3; [0021]; FIG. 3 shows that in all embodiments of the tongue locking device of the present invention, the tongue locking device 1 and the other tongue locking devices 1A and 1B are locked to the tongue 2 and the palate portion 3); a suction portion (22) ([0021], The outside air (air), saliva, etc. staying in the entire area of the opening 22a through the air passage 22 are exhausted (see FIG. 2), and the adsorbing portion 12 and the base 11 are applied to the tongue portion 2 and the palate portion 3, respectively. By locking through the tongue locking device, the movement of the tongue 2 is prevented and the fall in the direction of the airway 5 is prevented; [0022], The air passage 22 also becomes the air passage 22 and is provided with a forced discharger 24 at the extension destination. The suction portion 12 and the suction portion 12 are maintained in the suction state, or the forced discharger 24 is operated in the reverse direction) that communicates with the recess to apply a negative pressure to the closed space from an outside ([0021]; [0022]; NOTE: exhausting the air provides negative pressure to the opening of 12 and the closed space); and a tongue suction portion (12) (NOTE: lower cup 12 in Fig. 3) that is formed at a position facing a tongue of the user (Fig. 3) when the tongue suction restrainer is attached to the oral cavity (Fig. 3), that has a suction hole (22a) provided to communicate with the recess (capable of intended use, [0020], One of the passages 22 is connected to the opening 22a of the suction portion so as to allow ventilation, and the other is connected to the ventilation opening / closing portion 22b. As a result, the outside air (air), saliva, etc. staying in the entire area of the opening 22a can be discharged and the adsorbing part can be adsorbed to the tongue 2 or palate part 3; [0021], [0022]), and that sucks the tongue by the negative pressure (Fig. 3; [0020], air in the area of the opening can be discharged and the adsorbing part can be adsorbed to the tongue; capable of intended use), a lower fixing portion that is fixable to a tooth of a lower jaw of the user ([0032], the accidental ingestion preventing portions 11a and 11c are all illustrated so as to face upward, but these elevation directions may be directed downward as well as upward. It can be moored on the lips or both lips and / or teeth or gingival area to prevent accidental ingestion).
Masakatsu does not disclose a protrusion that protrudes from an inner peripheral portion of the lower fixing portion to form a pocket for allowing a part of the tongue to enter between the protrusion and the tongue suction portion, wherein the suction hole is provided in a portion of the lower fixing portion which forms the pocket.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/G.M./ Examiner, Art Unit 3786
/OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786
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