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
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/632157, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The bridge members of Claim 1 are not seen in the Figures or disclosed in the Specification of the prior-filed application.
Therefore, the priority date awarded is July 8, 2025.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 2, the limitation “being patient specific” should be recited as “configured to be patient-specific,” the limitation “an upper and a lower dental arch in lines 6-7 should be recited as “the upper and lower dental arch,” the limitation “teeth of an upper dental arch” in line 12 should be recited as “the teeth of the upper dental arch,” and the limitation “teeth of a lower dental arch” in line 17 should be recited as “the teeth of the lower dental arch”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the limitation “the upper and lower exterior prong members and the upper and lower interior prong members” in lines 1-2 should be recited as “the upper and lower set of exterior prong members and the upper and lower set of interior prong members”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: the limitation “the upper and lower exterior prong members and the upper and lower interior prong members” in lines 1-2 should be recited as “the upper and lower set of exterior prong members and the upper and lower set of interior prong members”. Appropriate correction is required.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because photographs are not ordinarily permitted in utility patent applications, and are only accepted if photographs are the only practicable medium for illustrating the claimed invention, such as photographs of electrophoresis gels or cell cultrures are accepted, thus new corrected drawings are required for this application. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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 1-3 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 1, it is unclear what is meant by “severable bridge members” in lines 22-23. The specification describes the bridge members as “severable” but does not provide any description as to what makes them severable or how they are to be severed. For the purpose of examination, any occlusal splint that meets the structural limitations of the claim will be considered “severable” as any splint can be severed. Additionally, the limitation “the exterior and interior prong members” in lines 18 and 19 is unclear, as it isn’t clear from the claim if this is referring to the upper set of exterior prong members, and/or the lower set of exterior prong members, and/or the upper set of interior prong members, and/or the lower set of interior prong members.
Claim 1 recites the limitation "the occlusal surface" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the exterior prong members" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the exterior prong members" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the material of composition" in line 18. There is insufficient antecedent basis for this limitation in the claim.
All claims not specifically addressed above are rejected based on their dependency on Claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over KIM (US 2023/0270527 A1) in view of Choi et al. (US 2016/0074207 A1, hereinafter “Choi”) in further view of Stapelbroek et al. (US 8,448,282 B2, hereinafter “Stapelbroek”).
Regarding claim 1, KIM discloses a self-retaining occlusal splint (Figure 12, 3 and 4) adapted to secure teeth in an upper and lower dental arch of a patient in a fixed, occluded relationship (see Figs. 12-13; the appliances 3, 4 make up a self-retaining occlusal splint as they are adapted to secure teeth in an upper and lower dental arch of a patient in a fixed, occluded relationship), the self-retaining occlusal splint (3, 4) being patient-specific (see [0103] and Figs. 12-13; the bite registration of a patient is taken and appliances 3,4 are fitted to the user’s upper and lower jaws and thus is patient-specific) comprising a horseshoe-shaped occlusal plate (10, 10D) having an upper surface and a lower surface (See Figs. 12-13; the base portion 10 and base portion 10D make up a horseshoe shaped occlusal plate, as although not shown in Figs. 12-13 due to the side angle of the figures, the shape of the base portions is U-shaped or horseshoe-shaped, better seen in Fig. 1 and [0070], and the upper most surface of base portion 10 is the upper surface and the lower most surface of base portion 10D is the lower surface), an upper set of exterior prong members (31, 41, 610) and an upper set of interior prong members (32, 42, 620) disposed on the upper surface of the occlusal plate (10, 10D) (see Figs. 12-13; the upper surface of the base portion 10, 10D is the upper most surface of base portion 10, and the upper surface of base portion 10 has fitting portion 20 which has the same construction as the embodiments described in Fig. 1, see [0099], thus the fitting portion 20 as described in Figs. 1-2 is made up of movement members 30, 40, and gripping member 60, and these movement members 30, 40 and gripping members 60 each are made up of tooth surface pads that contact the exterior and interior surfaces of individual teeth, and thus movement members 30, 40 have tooth surface pad 31 and 41 which contact the exterior or labial side of a tooth and thus is an exterior prong member, and tooth surface pad 32, 42 contacts the interior or buccal side of a tooth and thus is an interior prong member, see Figs. 1-2 and [0046], and similarly, the gripping members 60 have tooth surface pad 610 that contacts the exterior or labial side of a tooth and thus is also an exterior prong member, and tooth surface pad 620 contacts the interior or buccal side of a tooth and thus is an interior prong member, see [0086]), where each of the exterior prong members (31, 41, 610) of the upper set of exterior prong members is paired with an interior prong member (32, 42, 620), such that in combination the paired exterior and interior prong members are adapted to receive teeth of an upper dental arch (see Figs. 2, 6, and 11 which shows that each of the exterior prong members 31, 41, 610 is paired with an interior prong member 32, 42, 620, such that in combination each of the pairs 31+32, 41+42, 610+620 are adapted to receive teeth of an upper dental arch, also see [0046] and [0086]), and a lower set of exterior prong members (31, 41, 610) and a lower set of interior prong members (32, 42, 620) disposed on the lower surface of the occlusal plate (10,10D) (see Figs. 12-13; the lower surface of the base portion 10,10D is the lower most surface of the base portion 10D, and the lower surface of the base portion 10D has fitting portion 20D which has the same construction as the embodiment discussed in Fig. 1, see [0100], thus the fitting portion 20D is the same as described above, and thus tooth surface pads 31, 41, 610 are all exterior prong members as they contact the exterior or labial side of a tooth, see [0046] and [0086], and see Figs. 1-2, 6, and 11, and tooth surface pads 32, 42, 620 are all interior prong members as they contact the interior or buccal side of a tooth, see [0046], [0086], and see Figs. 1-2, 6, and 11), where each of the exterior prong members (31, 41, 610) of the lower set of exterior prong members is paired with an interior prong member (32, 42, 620) of the lower set of interior prong members, such that in combination the paired exterior and interior prong members are adapted to receive teeth of a lower dental arch (see Figs. 2, 6, and 11 which shows that each of the exterior prong members 31, 41, 610 is paired with an interior prong member 32, 42, 620, such that in combination each of the pairs 31+32, 41+42, 610+620 are adapted to receive teeth of a lower dental arch dental arch, also see [0046] and [0086]). KIM further discloses that the material of composition of the exterior and interior prong members (31, 41, 610, 32, 42, 620) is such that the exterior and interior prong members (31, 41, 610, 32, 42, 620) are outwardly flexible under a bias into a flexed position, but will return towards an unflexed position when the bias is removed to retain the occlusal splint (3,4) on the teeth (see Fig. 12-13 and 1-2, 6, and 11, and see [0046] and [0053]-[0054]; the material of the tooth surface pads 31, 32, 41, 42 are formed of an elastic material and may conform to the shape of the tooth crown, and thus the material of composition of the exterior and interior prong members allows the exterior and interior prong members to be capable of outwardly flexing under a bias into a flexed position but will return towards an unflexed position when the bias is removed to retain the appliances 3,4 on the teeth, also see [0088]-[0089] which discusses how the tooth surface pad 610 and 620 are fixed to base portion 10,10D via a resilient member attachment portion 603, 604 and thus applies a resilient force to retain the appliances 3,4 on the teeth).
KIM discloses the occlusal splint substantially as described above, but does not disclose tooth recesses disposed on the upper and lower surfaces of the occlusal plate, with each of the tooth recesses adapted to receive and mate with the occlusal surface of an individual tooth in an upper and lower dental arch. However, Choi teaches an analogous occlusal plate (see Annotated Fig. 2 of Choi which has the occlusal plate labeled), and tooth recesses (300,400) disposed on the upper and lower surfaces of the occlusal plate (see Annotated Fig. 2 of Choi below; upper teeth recess 300 and lower teeth recess 400 are respectively disposed on upper and lower surfaces of the occlusal plate, which is labeled in Annotated Fig. 2, also see Fig. 1), each of the tooth recesses (300,400) adapted to receive and mate with the occlusal surface of an individual tooth in an upper and a lower dental arch (see Annotated Fig. 2 of Choi, see Figs. 1-4, and see [0062]-[0063], and [0066]; the upper teeth recess 300 may have a shape corresponding to each tooth UT and thus is adapted to receive and mate with the occlusal surface of an individual tooth in an upper dental arch, and the lower teeth recess 400 may have a shape corresponding to each tooth LT and thus is adapted to receive and mate with the occlusal surface of an individual tooth in a lower dental arch), providing a more comfortable fit for each user. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the upper and lower surfaces of the occlusal plate (10, 10D) in the device of KIM to have tooth recesses adapted to receive and mate with the occlusal surface of an individual tooth in an upper and a lower dental arch as taught by Choi in order to provide an improved self-retaining occlusal splint that provides a more comfortable fit for each user.
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Additionally, KIM does not disclose that the occlusal splint is an integral single-piece. However, the occlusal splint of Choi is an integral single-piece device (see Figure above). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the splint of KIM as an integral single-piece splint as taught by Choi as such a modification would simplify cleaning and sterilization of the device. Further, the Examiner notes that such modification would merely involve making a formerly separate structure integral, which has been held to be within the skill of the ordinary artisan. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of KIM to make the splint a single-piece, as taught by Choi, as such modification would merely involve making a formerly separate structure integral which has been held to be within the skill of the ordinary artisan (see MPEP 2144.04(V)(B)).
KIM in view of Choi disclose the invention substantially as claimed, but do not disclose that the self-retaining occlusal splint further comprises one or more gaps, the one or more gaps dividing the occlusal splint into segments, and one or more severable bridge members, the one or more bridge members connecting adjacent splint segments across each of the one or more gaps. In the same art orthodontic splints, Stapelbroek teaches a splint with one or more gaps (see Figures 1 and 2) that divide the splint into segments, and one or more severable bridge members (32 and 34) that connect adjacent splint segments across the gaps (as seen in Figures 1 and 2). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to construct the device of KIM in view of Choi with gaps and bridge members as taught by Stapelbroek in order to provide a more flexible and comfortable fit for the patient.
Regarding claim 2, Kim/Choi/Stapelbroek discloses the invention as discussed in claim 1. Kim/Choi/Stapelbroek further discloses wherein the upper and lower exterior prong members (31, 41, 610 of KIM) and the upper and lower interior prong members (32, 42, 620 of KIM) are positioned along the occlusal plate (10, 10D of KIM) whereby they are adapted to align with an interdental space between adjacent teeth such that a central portion of the tooth is exposed (see Figs. 11-13 of KIM; [0086]-[0087] of KIM discusses how the tooth pad surfaces 610, 620 of KIM are not each provided in form on independent single pad, but are respectively connected to tooth surface pads, as shown in Figs. 12-13 of KIM, and thus tooth surface pads 610, 620 of KIM are positioned along the base plate 10, 10D of KIM whereby they are adapted to align with an interdental space between adjacent teeth such that a central top portion (crown of a tooth) is exposed, as the front sides and back sides of the teeth are covered via the tooth pad surfaces 610, 620 that covers multiple adjacent teeth in a row).
Regarding claim 3, Kim/Choi/Stapelbroek discloses the invention as discussed in claim 1. Kim/Choi/Stapelbroek further discloses wherein the upper and lower exterior prong members (31, 41, 610 of KIM) and the upper and lower interior prong members (32, 42, 620 of KIM) are positioned along the occlusal plate (10, 10D of KIM) whereby they are adapted to align with a central portion of each tooth such that an interdental space between adjacent teeth is exposed (see Figs. 12-13, 1, 6, and 11 of KIM; [0046] and [0086] of KIM discusses how the tooth pad surfaces 31, 41, 610, 32, 42, 620 of KIM are to conform to the shape of the tooth crown so as to cover the tooth crown on the mesial and distal side, and thus all the prong members are positioned along the base portions 10,10D of KIM such that they are capable of being adapted to align with a central portion of each tooth such that an interdental space between adjacent teeth is exposed, like shown in Fig. 5 of KIM).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE L NELSON whose telephone number is (571)270-5368. The examiner can normally be reached M - F 9-5 ET.
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/CHRISTINE L NELSON/ Examiner, Art Unit 3772 /EDWARD MORAN/Primary Examiner, Art Unit 3772
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