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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 8/27/2026 is acknowledged.
Claims 16-27 and 34-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/27/2026.
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 30-33 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.
Claim 30 recites the limitation "the occlusional cushioning region" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the impact protective region" in lines 1, 4, and 5. There is insufficient antecedent basis for this limitation in the claim.
The remaining claims are rejected due to their dependency.
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 28-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turkbas (WO 2018/063295 A1).
Regarding claim 28, Turkbas discloses a mouthguard (100) for a dental arch, said mouthguard being for protecting teeth of said dental arch from impact while also promoting biting-induced neck muscle activation, thus providing protection against brain injury (Abstract; Figure 1), said mouthguard comprising: an externally exposed impact protective region (110) defined by a first material property and configured to cover a front tooth of said dental arch (Figure 6; [0045]; [0052]); and an internally exposed occlusional cushioning region (166) defined by a second material property and configured to cover a molar tooth of said dental arch ([0052]; Figures 1 and 3 and 11); wherein said first and second material properties are different ([0052]); wherein said externally exposed impact protective region does not cover a molar tooth of said dental arch (Figure 1; [0045]).
Regarding claim 29, Turkbas discloses wherein at least one interface between regions comprises a mechanical interlocking portion, wherein the mechanical interlocking portion comprises an interlocking feature (172; Figure 11; [0052]); wherein the interlocking feature is configured to be positioned so as to reduce discomfort for the user (Figure 11; [0052]); and wherein the interlocking feature is configured to be positioned over an area between a first tooth of said dental arch and a second tooth of said dental arch (Figure 11; [0052]).
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.
Claims 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Turkbas (WO 2018/063295 A1).
Regarding claim 30, Turkbas discloses wherein the occlusional cushioning region comprises a material selected from an elastomeric material, a rubber-like material and a polymeric material ([0052], [0057]); and the occlusional cushioning region has a Shore hardness of 52 ([0052], [0057]). Turkbas does not specify wherein the occlusional cushioning region comprises a material that can resist at least 70% tensile strain; wherein the thickness of the occlusional cushioning region is from 2.0 to 5.0 millimetres; and wherein the hardness of the occlusional cushioning region is from 70 to 90 in Shore A scale. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to arrive at the claimed 70% strain, 2-5 mm thickness and 70-90 Shore A, since applicant has not disclosed that such values provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to criticality that such limitations provides an advantage, solves any stated problem, or is used for any particular purpose, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA). Furthermore, 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.
Regarding claim 31, Turkbas discloses wherein the impact protective region comprises a material selected from a thermoplastic material and a thermoset material ([0052]); wherein the impact protective region comprises a stress concentration feature (Figure 1; [0042]). Turkbas does not disclose wherein the Young's modulus of the impact protective region is from 1 to 3 GPa; and wherein the thickness of the impact protective region is from 0.9 to 2.0 millimetres. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to arrive at the claimed 1-3 GPa and 0.9-2 mm, since applicant has not disclosed that such values provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to criticality that such limitations provides an advantage, solves any stated problem, or is used for any particular purpose, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA). Furthermore, 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.
Regarding claim 32, Turkbas discloses wherein the mouthguard is configured to be anteriorly offset from a front tooth of said dental arch by at least 1 millimetre; and wherein said front tooth of said dental arch from which the mouthguard is configured to be anteriorly offset is selected from a central incisor tooth, a lateral incisor tooth and a canine tooth (intended use). Examiner further notes while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board' s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
Regarding claim 33, Turkbas discloses wherein the occlusional cushioning region is configured to cover two molar teeth of said dental arch (Figures 1, 6, and 11); and wherein the impact protective region is configured to cover two incisor teeth of said dental arch (Figures 1, 6, and 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
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