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 Objections
Claims 3, 4, 7, 8, and 10 are objected to because of the following informalities:
“thermos-chromic” in claim 3, line 1 should be amended to recite --thermo-chromic--
“fit the front teeth” in claim 4, line 2 should be amended to recite --fit front teeth--
“a user’s” in claim 4, line 3 should be amended to recite --the user’s--
“the range” in claim 7, lines 2 and 3 should be amended to recite --a range--
“the sidewall” in claim 8, line 3 should be amended to recite --one of the sidewalls--
“a user’s” in claim 8, line 3 should be amended to recite --the user’s--
“configure” in claim 8, line 5 should be amended to recite --configured--
“at temperature” in claim 8, line 6 should be amended to recite --a temperature--
“; and the insert layer is formed of a foam material” in claim 10, line 2 should be deleted, as this is already claimed in claim 1
Appropriate correction is required.
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.
The claim limitation “a temperature visualization means” in claim 9, lines 1-2 is interpreted under 112(f) as thermo-chromic material, as described in the specification.
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 7 and 8 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.
Regarding claim 7, the claim recites the limitations “the thickness” in lines 2, and 3. There are insufficient antecedent bases for these limitations in the claim.
Regarding claim 8, the claim recites the limitation “exceeds at temperature within a range of 100-102 degrees F” in line 6. The term “exceeds” indicates that the temperature needs to surpass some value, but the term “within” requires it also to fall within the range. For example, it is unclear whether 102 degrees F meets the claimed limitation (because it technically exceeds 101 F, which is within the range), or if it does not meet the claimed limitation (because it does not exceed the claimed range). Thus, the scope of the claim is unclear, and clarification is required.
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.
Claim(s) 1, 5, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Enicks et al. US 3,089,487 in view of Shah US 2019/0091060 A1 further in view of Kamradt US 2013/0247922 A1.
Regarding claim 1, Enicks discloses a mouth guard 12 configured to be fitted to teeth of a user (fig. 1 and col. 1, lines 8-12), the mouth guard 12 comprising:
an outer layer 26 that forms a lowermost layer and side walls defining a U-shape (col. 2, lines 52-56, latex material 26; fig. 4, the layers of latex 26 that are underneath reinforcement 30 and form the outside layers of the mouthguard 12 are interpreted as the “outer layer”, as this “outer layer” forms the lowermost layer and sidewalls of the U-shaped mouthguard 12);
an insert layer 30 formed of a shock absorbing material disposed on an upper surface of the outer layer 26 and extending between the sidewalls of the outer layer 26 (col. 2, lines 60-72, reinforcement 30 may be a pad of textile material, which is capable of absorbing shock; fig. 4, the insert layer 30 is disposed above outer layer 26 and extends across the bottom of the U-shaped cross-section between the sidewalls of the mouthguard 12); and
an inner layer 24/28 formed on the insert layer 30 and extending between the sidewalls of the outer layer 26 (col. 2, lines 52-56, latex layers 24/28 being interpreted as the “inner layer”, which is above insert layer 30, as seen in fig. 4, and extends across the U-shaped cross section between the sidewalls of the mouthguard 12), the inner layer 24/28 comprising a sidewall portion that extends along and adjacent the sidewalls of the outer portion 26, and an outer surface portion forming a flat surface extending in a U-shape and running parallel to a surface of the insert layer 30 that is in contact with an inner surface of the inner layer 30 (please see annotated fig. A below, where the upstanding portions of the inner layer 24/28 are interpreted as the sidewall portions that extend along the sidewalls of the outer layer 26; further, the horizontal/flat portion of the inner layer 24/28 is interpreted as the outer surface portion that forms the flat surface for receipt of the occlusal surface of the teeth; the lower surface of the outer surface portion that abuts the insert layer 30 is interpreted as the inner surface of inner layer 24/28; thus, this horizontal/flat portion of the inner layer 24/28 (i.e., the outer surface portion) is horizontal and runs parallel to the surface of the insert layer 30 in contact with the inner surface of the inner layer 24/28, shown in annotated fig. A);
wherein the insert layer 30 is formed of a material softer than the outer layer 26 and the inner layer 24/28 to absorb forces exerted on the outer layer 26 and the inner layer 24/28 (as described previously, insert layer 30 is a pad of textile material, while layers 26 and 24/28 are solid latex, allowing insert layer 30 to absorb shock).
Enicks is silent on the shock absorbing material being foam.
However, Shah teaches an oral device 10 (fig. 1 and [0002]) comprising an analogous pressure-receiving pad 12 that is foam (fig. 1 and [0084], pad 12 can be styrene foam and be fiber-filled to facilitate an even distribution of pressure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Enicks’ fibrous shock absorbing material to be (fiber-filled) foam, as taught by Shah, as foam is a material well-known for its shock absorbing and protective properties, and a fiber-filled foam would comprise the positive properties of both the fibers and the foam.
Enicks in view of Shah is silent on the outer layer being formed of a material harder than the insert layer and the inner layer.
However, Kamradt teaches an analogous shock absorbing mouth guard (fig. 1 and [0001]) comprising an outer layer 1 that is formed of a material harder than an analogous inner layer 2 (fig. 1 and [0016], outer layer 1 is made of a hard resilient material and inner layer 2 is soft and rubber-like, similar to Enicks’ latex inner layer); therefore, the combination of Enicks, Shah, and Kamradt teaches the outer layer (Kamradt’s outer layer, which is harder than rubber/latex) being harder than the insert layer (Enicks in view of Shah’s fibrous foam)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the outer layer of Enicks in view of Shah to be formed of a material harder than the insert layer and the inner layer, as taught by Kamradt, to better protect the teeth from impact by providing a hard shield.
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Regarding claim 5, Enicks in view of Shah further in view of Kamradt discloses the claimed invention as discussed above.
Enicks further discloses the inner layer 24/28 being thicker in a bit direction than the outer layer 26 (fig. 4, the inner layer 24/28 is shown having many more plies than the outer layer 26, making it thicker).
Regarding claim 10, Enicks in view of Shah further in view of Kamradt discloses the claimed invention as discussed above.
Enicks in view of Shah further in view of Kamradt further teach in combination the outer layer and the inner layer being formed of an elastomeric polymer (Enicks’ inner layer 24/28 is latex, see col. 2, lines 52-56; the outer layer 1 as modified by Kamradt is urethane, see claims 2 and 3); and the insert layer is formed of a foam material (the insert layer 12 as modified by Shah is foam, see [0084]), to provide a combination of materials that can absorb force and protect the teeth from impact.
Claim(s) 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Enicks et al. US 3,089,487 in view of Shah US 2019/0091060 A1 further in view of Kamradt US 2013/0247922 A1 and Morgan et al. US 2006/0237020 A1.
Regarding claim 2, Enicks in view of Shah further in view of Kamradt discloses the claimed invention as discussed above.
Enicks in view of Shah further in view of Kamradt is silent on the outer layer comprising a thermo-chromic material configured to change color in response to the outer layer reaching a temperature in excess of 100 degrees F.
However, Morgan teaches a mouth guard 10 (fig. 1 and [0034]) comprising a layer comprising a thermo-chromic material configured to change color in response to the layer reaching a temperature in excess of 100 degrees F ([0079], the thermoplastic material of the mouth guard can include thermochromic elements that cause the mouth guard to display a first color under 100 degrees Fahrenheit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the outer layer of Ericks in view of Shah further in view of Kamradt to comprise a thermo-chromic material configured to change color in response to the outer layer reaching a temperature in excess of 100 degrees F, as taught by Morgan, to be indicative of the wearer’s body temperature, which may reflect the physical health of the wearer.
Regarding claim 9, Enicks in view of Shah further in view of Kamradt discloses the claimed invention as discussed above.
Enicks in view of Shah further in view of Kamradt is silent on a temperature visualization means for indicating a temperature change of the mouth guard.
However, Morgan teaches a mouth guard 10 (fig. 1 and [0034]) comprising a temperature visualization means for indicating a temperature change of the mouth guard ([0079], the thermoplastic material of the mouth guard can include thermochromic elements that cause the mouth guard to display a first color under specific temperature thresholds).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the provided the mouth guard of Ericks in view of Shah further in view of Kamradt with a temperature visualization means for indicating a temperature change of the mouth guard, as taught by Morgan, to be indicative of the wearer’s body temperature, which may reflect the physical health of the wearer.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Enicks et al. US 3,089,487 in view of Shah US 2019/0091060 A1 further in view of Kamradt US 2013/0247922 A1 and Manzo US 2011/0005531 A1.
Regarding claim 6, Enicks in view of Shah further in view of Kamradt discloses the claimed invention as discussed above.
Enicks in view of Shah further in view of Kamradt is silent on the insert layer being thicker than the inner layer and the outer layer in the bit direction.
However, Manzo teaches an mouth guard 10 (fig. 1 and [0002]) comprising an analogous insert layer 14 that is thicker than the inner layer and the outer layer in the bit direction (fig. 11 and [0029], impact absorbing members 14; as can be seen in the figure, members 14 are thicker in the biting direction than the layer forming the upper channel 30 and the layer forming the lower channel 32; the upper and lower layers are analogous inner and outer layers, since they sandwich the impact members 14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the insert layer of Enicks in view of Shah further in view of Kamradt to be thicker than the inner layer and the outer layer in the bit direction, as taught by Manzo, to provide ample shock absorption and prevent the teeth from grinding together.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Enicks et al. US 3,089,487 in view of Shah US 2019/0091060 A1 further in view of Kamradt US 2013/0247922 A1, Manzo US 2011/0005531 A1, Lesniak US 2008/0295850 A1, and McLaughlin US 6,274,122 B1.
Regarding claim 7, Enicks in view of Shah further in view of Kamradt and Manzo discloses the claimed invention as discussed above.
Manzo further teaches the thickness of the insert layer 14 being within the range of 3.5-4.4 mm ([0034], impact absorbing members 14 are about 3-10 mm in thickness), to provide ample shock absorption and prevent the teeth from grinding together.
Enicks in view of Shah further in view of Kamradt and Manzo is silent on the thickness of the outer layer being within the range of 1-2 mm.
However, Lesniak teaches interocclusal appliance 10 (fig. 1 and [0002]) comprising an analogous outer layer 12 with a thickness in the range of 1-2 mm (fig. 2 and [0069], base 12 has a thickness from 0.25-4 mm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the outer layer of Enicks in view of Shah further in view of Kamradt and Manzo to have a thickness within the range of 1-2 mm, as taught by Lesniak, to protect the teeth without adding bulk.
Enicks in view of Shah further in view of Kamradt, Manzo, and Lesniak is silent on the thickness of the inner layer being within the range of 3.3-3.8 mm.
However, McLaughlin teaches a dental tray 10 (fig. 1 and col. 2, lines 31-33) comprising an inner layer 5,6 with a thickness within the range of 3.3-3.8 mm (fig. 1 and col. 4, lines 53-58, inner layer 5, 6 can be thicker than 3 mm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the inner layer of Enicks in view of Shah further in view of Kamradt, Manzo, and Lesniak to have a thickness within the range of 3.3-3.8 mm, as taught by McLaughlin, to allow the teeth to be securely impressed and surrounded.
Allowable Subject Matter
Claims 3 and 8 recite allowable subject matter.
Regarding dependent claim 3, the prior art of record when applied alone or in combination neither anticipates nor renders obvious the thermo-chromic material is configured to change the color from a dark color to a transparent or semitransparent material, and the insert layer is formed of a bright color whereby the bright color is visible through the outer layer when semitransparent due to the temperature in excess of 100 degrees F. The rejection of claim 2 above provides the closest prior art combination based on the search to date. However, no other reference to date has been found in the prior art that would be able to properly modify Enicks, Shah US 2019/0091060 A1, Kamradt, and Morgan et al. US 2006/0237020 A1 to address their deficiencies. Dependent claim 4 would be allowable by virtue of its dependence on claim 3.
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding dependent claim 8, the prior art of record when applied alone or in combination neither anticipates nor renders obvious wherein the outer layer is configured to change from a dark color to a transparent color and has a thickness in the range of 1-1.5 mm along a front portion of the sidewall configured to face opposite a user's teeth, and the inner layer abuts the outer layer inside the front portion and has a bright color, and wherein the bright color and thickness of the front portion are configure to show the bright color when the temperature of the outer layer exceeds at temperature within the range of 100-102 degrees F. The rejection of claim 2 above provides the closest prior art combination based on the search to date. However, no other reference to date has been found in the prior art that would be able to properly modify Enicks, Shah US 2019/0091060 A1, Kamradt, and Morgan et al. US 2006/0237020 A1 to address their deficiencies.
Kuo et al. US 6,607,382 B1 and Castaldi US 5,031,638 are additional references that are the most relevant prior art to date for the above claimed subject matter. Kuo discloses in col. 14, lines 14-20 a dental appliance 42 that is more transparent when heated, and more visibly colored when cooled. Castaldi discloses in col. 4, lines 18-28 a rigid core that has a color, while the outer layers are transparent. However, Kuo and Castaldi do not teach in combination the thermo-chromic material configured to change the color from a dark color to a transparent or semitransparent material, and the insert layer is formed of a bright color whereby the bright color is visible through the outer layer when semitransparent due to the temperature in excess of 100 degrees F. One would not have been motivated to modify Castaldi’s outermost layer to have a color that transitions to transparency when warmed, because Castaldi states that the visible color allows officials to quickly determine if athletes are abiding by the rules governing mouthguards (col. 4, lines 24-28). An outer layer (and, even more, a dark outer layer) that requires time to transition to transparency or semitransparency would jeopardize the ability for officials to quickly make these evaluations. Further, even if a combination of Kuo and Castaldi (or Enicks, Shah, Kamradt, Kuo, and Castaldi) was made, the combined references do not specify that the outer layer specifically transitions from a dark color to semitransparency or transparency while the insert layer is formed of a bright color that is visible through the outer layer. The usage of “dark” and “bright” to describe the respective layers links the two colors in a way that requires relative darkness/brightness, which cannot be taught by any combination of these references.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements (including the Double Patenting issues detailed below) or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 9, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,357,900 B2 (first interpretation) in view of Enicks et al. US 3,089,487.
Regarding claim 1, the patent claims all imitations of the claim except the inner layer comprising a sidewall portion that extends along and adjacent the sidewalls of the outer portion, and an outer surface portion forming a flat surface extending in a U-shape and running parallel to a surface of the insert layer that is in contact with an inner surface of the inner layer (see claim 1).
However, Enicks teaches a mouth guard 12 configured to be fitted to teeth of a user (fig. 1 and col. 1, lines 8-12), the mouth guard 12 comprising: an inner layer 24/28 (col. 2, lines 52-56, latex layers 24/28 being interpreted as the “inner layer”, which is above insert layer 30, as seen in fig. 4, and extends across the U-shaped cross section between the sidewalls of the mouthguard 12), the inner layer 24/28 comprising a sidewall portion that extends along and adjacent the sidewalls of the outer portion 26, and an outer surface portion forming a flat surface extending in a U-shape and running parallel to a surface of the insert layer 30 that is in contact with an inner surface of the inner layer 30 (annotated fig. A, where the upstanding portions of the inner layer 24/28 are interpreted as the sidewall portions that extend along the sidewalls of the outer layer 26; further, the horizontal/flat portion of the inner layer 24/28 is interpreted as the outer surface portion that forms the flat surface for receipt of the occlusal surface of the teeth; the lower surface of the outer surface portion that abuts the insert layer 30 is interpreted as the inner surface of inner layer 24/28; thus, this horizontal/flat portion of the inner layer 24/28 (i.e., the outer surface portion) is horizontal and runs parallel to the surface of the insert layer 30 in contact with the inner surface of the inner layer 24/28, shown in annotated fig. A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the inner layer of the patent with a sidewall portion that extends along and adjacent the sidewalls of the outer portion, and an outer surface portion forming a flat surface extending in a U-shape and running parallel to a surface of the insert layer that is in contact with an inner surface of the inner layer, as taught by Enicks, so that all the layers of the mouthguard abut and are in close parallel contact with each other, such that the mouthguard is compact and comfortable.
Regarding claim 2, the patent in view of Enicks discloses the claimed invention as discussed above.
The patent claims the entirety of this claim (claim 1).
Regarding claim 3, the patent in view of Enicks discloses the claimed invention as discussed above.
The patent claims the entirety of this claim (claim 1).
Regarding claim 4, the patent in view of Enicks discloses the claimed invention as discussed above.
The patent claims the entirety of this claim (claim 5).
Regarding claim 5, the patent in view of Enicks discloses the claimed invention as discussed above.
The patent claims the entirety of this claim (claim 2).
Regarding claim 6, the patent in view of Enicks discloses the claimed invention as discussed above.
The patent claims the entirety of this claim (claim 3).
Regarding claim 7, the patent in view of Enicks discloses the claimed invention as discussed above.
The patent claims the entirety of this claim (claim 4).
Regarding claim 9, the patent in view of Enicks discloses the claimed invention as discussed above.
The patent claims the entirety of this claim (claim 1, wherein thermochromic material is a temperature visualization means for indicating a temperature change of the mouth guard).
Regarding claim 10, the patent in view of Enicks discloses the claimed invention as discussed above.
The patent claims the entirety of this claim (claim 6, where the insert layer being a foam material is already claimed in claim 1).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,357,900 B2 (second interpretation) in view of Enicks et al. US 3,089,487.
Regarding claim 1, the patent claims all imitations of the claim except the inner layer comprising a sidewall portion that extends along and adjacent the sidewalls of the outer portion, and an outer surface portion forming a flat surface extending in a U-shape and running parallel to a surface of the insert layer that is in contact with an inner surface of the inner layer (see claim 7).
However, Enicks teaches a mouth guard 12 configured to be fitted to teeth of a user (fig. 1 and col. 1, lines 8-12), the mouth guard 12 comprising: an inner layer 24/28 (col. 2, lines 52-56, latex layers 24/28 being interpreted as the “inner layer”, which is above insert layer 30, as seen in fig. 4, and extends across the U-shaped cross section between the sidewalls of the mouthguard 12), the inner layer 24/28 comprising a sidewall portion that extends along and adjacent the sidewalls of the outer portion 26, and an outer surface portion forming a flat surface extending in a U-shape and running parallel to a surface of the insert layer 30 that is in contact with an inner surface of the inner layer 30 (annotated fig. A, where the upstanding portions of the inner layer 24/28 are interpreted as the sidewall portions that extend along the sidewalls of the outer layer 26; further, the horizontal/flat portion of the inner layer 24/28 is interpreted as the outer surface portion that forms the flat surface for receipt of the occlusal surface of the teeth; the lower surface of the outer surface portion that abuts the insert layer 30 is interpreted as the inner surface of inner layer 24/28; thus, this horizontal/flat portion of the inner layer 24/28 (i.e., the outer surface portion) is horizontal and runs parallel to the surface of the insert layer 30 in contact with the inner surface of the inner layer 24/28, shown in annotated fig. A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the inner layer of the patent with a sidewall portion that extends along and adjacent the sidewalls of the outer portion, and an outer surface portion forming a flat surface extending in a U-shape and running parallel to a surface of the insert layer that is in contact with an inner surface of the inner layer, as taught by Enicks, so that all the layers of the mouthguard abut and are in close parallel contact with each other, such that the mouthguard is compact and comfortable.
Claims 2 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,357,900 B2 (second interpretation) in view of Enicks et al. US 3,089,487 further in view of Morgan et al. US 2006/0237020 A1.
Regarding claim 2, the patent in view of Enicks discloses the claimed invention as discussed above.
The patent in view of Enicks is silent on the outer layer comprising a thermo-chromic material configured to change color in response to the outer layer reaching a temperature in excess of 100 degrees F.
However, Morgan teaches a mouth guard 10 (fig. 1 and [0034]) comprising a layer comprising a thermo-chromic material configured to change color in response to the layer reaching a temperature in excess of 100 degrees F ([0079], the thermoplastic material of the mouth guard can include thermochromic elements that cause the mouth guard to display a first color under 100 degrees Fahrenheit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the outer layer of the patent in view of Enicks to comprise a thermo-chromic material configured to change color in response to the outer layer reaching a temperature in excess of 100 degrees F, as taught by Morgan, to be indicative of the wearer’s body temperature, which may reflect the physical health of the wearer.
Regarding claim 8, the patent in view of Enicks further in view of Morgan discloses the claimed invention as discussed above.
The patent claims the entirety of this claim (claim 7).
Conclusion
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786
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