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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for domestic priority under 35 U.S.C. 119 (e)).
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or 35 U.S.C. 120 as follows:
Reinforcing materials are disclosed as fiber material or metallic alloys (refer to Paragraphs [0057]-[0058] of disclosure in applications 62624281 and 15914932), but particulate material is not disclosed. For the purpose of examination, the priority date for claims 1-14 is 01/25/2024.
Claim Objections
Claims 1, 8 and 9 are objected to because of the following informalities:
- Claim 1, line 2 states, "...the appliance exerting a continuous aligning force on a tooth or teeth...". This line should be corrected to, "…the orthodontic appliance configured for exerting a continuous aligning force on a tooth or teeth..." for consistency and to clarify the language as functional.
- Claim 1, lines 5-9 should be corrected to have line breaks at each “;” for readability.
- Claim 1, lines 7 and 8, should be corrected to include “the orthodontic appliance…” at the beginning of each limitation for clarity.
- Claim 1, line 9, “palatial surface” should be corrected to “palatal surface”.
- Claim 8, line 19, “palatial surface” should be corrected to “palatal surface”.
- Claim 9, line 10, “palatial surface” should be corrected to “palatal surface”.
Appropriate correction is required.
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 1-7 and 9-14 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 1, line 6 states, "the orthodontic appliance covering the entire surface of each tooth of the dental arch", which positively recites the body (surface of each tooth). This line should be modified to state, "configured for covering". Similarly, lines 7 and 8 should be modified to explicitly state "configured for covering...the gum surface" and "configured for covering...the entire sublingual surface".
Claim 9, line 7 states, "the orthodontic appliance covering the entire surface of each tooth of the dental arch", which positively recites the body (surface of each tooth). This line should be modified to state, "configured for covering". Similarly, lines 8 and 9 should be modified to explicitly state "configured for covering...the gum surface" and "configured for covering...the entire sublingual surface".
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) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. (US 20190231481 A1) in view of Hammar et al. (EP 0498558 A1); refer to the provided translation for Hammar et al.
Regarding claim 1, Moon et al. discloses an orthodontic appliance (Fig. 1) formed of a homogeneous composition comprising an elastic material and a reinforcing material (refer to Paragraphs [0060], [0069]; an orthodontic appliance formed of an elastic material, which further comprises a reinforcing material is disclosed),
the appliance (Fig. 1) exerting a continuous aligning force on a tooth or teeth along a dental arch (refer to Paragraph [0060]; the appliance exerts a continuous aligning force on a tooth or teeth),
wherein the orthodontic appliance (Fig. 1) comprises tooth sockets that correspond to and enclose each tooth on the dental arch, the orthodontic appliance (Fig. 1) covering the entire surface of each tooth of the dental arch (refer to Paragraph [0078], annotated Fig. 2 below; the appliance covers individual teeth of the dental arch);
covering and being configured for being in direct contact with the gum surface of each tooth (refer to annotated Fig. 2 below); and
covering and being configured for being in direct contact with the entire palatial surface or the entire sublingual surface of oral cavity (refer to annotated Fig. 2 below),
wherein the elastic material has an elasticity such that it is capable of being stretched at least 300% of its original length (refer to Paragraph [0070]; the elastic material can be stretched at least 300% of the original length).
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Moon et al. does not disclose wherein the reinforcing material is a particulate material.
Hammar et al. discloses an elastomeric orthodontic device in the same field of endeavor (refer to Paragraph [0001]), wherein a suitable material for the elastomeric orthodontic device is a homogeneous composition comprising an elastic material and a reinforcing material(refer to Paragraphs [0022], [0028], [0104], [0105]; the fluorosilicone elastomer comprises 10-90 parts per hundred resin (phr) methyl trifluoropropyl silicone, and 10-90 phr silica based filler, where the formulations are thoroughly mixed together, thereby forming a homogenous composition; the silica reinforces the molded device, acting as a reinforcing material), wherein the reinforcing material is a particulate material (refer to Paragraphs [0022], [0028]; a particulate material is defined as minute, separate particles (dictionary.com); hydrated, fumed, and precipitated silica are inherently particulate materials, existing as a powdery or granulated white material).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the material composition of the reinforcing material as taught by Moon et al. with silica particles as taught by Hammer et al., as this particulate material is taught as a suitable material to reinforce a molded elastic device (refer to Paragraph [0028]).
Regarding claims 2-6, the combination of Moon et al. and Hammer et al. discloses the orthodontic appliance according to claim 1, with Moon et al. further disclosing wherein the elastic material comprises at least 20 wt%/50 wt% /80 wt%/90 wt%/95 wt% of the combination of the elastic and reinforcing materials forming the appliance (refer to Paragraphs [0062]-[0066]).
Regarding claim 7, the combination of Moon et al. and Hammer et al. discloses the orthodontic appliance according to claim 1, with Moon et al. further disclosing wherein the elastic material is a silicone rubber (refer to Paragraph [0071]).
Regarding claim 8, Moon et al. discloses a method of aligning a tooth or teeth of target of a patient (refer to Paragraph [0111]), comprising:
forming an appliance (refer to Paragraph [0112], Fig. 1), and
applying the appliance (Fig. 1) to the patient to move the tooth or teeth of target from an original position(s) to a prescribed position(s) according to a prescription by a treating doctor (refer to Paragraph [0113])),
wherein forming the appliance (Fig. 1) comprises:
creating a dental model of a patient tooth and bite (refer to Paragraph [0088]), constructing individual teeth from the dental model (refer to Paragraph [0089]),
moving a tooth or teeth of target of alignment according to a prescription by a treating doctor to create an aligned dental model of the patient (refer to Paragraph [0090]), and
forming at least one appliance (Fig. 1) from the aligned dental model of the patient (refer to Paragraph [0091]),
wherein the appliance (Fig. 1) is formed of a homogeneous composition comprising an elastic material and a reinforcing material (refer to Paragraphs [0060], [0069]; an orthodontic appliance formed of an elastic material, which further comprises a reinforcing material is disclosed), the appliance (Fig. 1) exerting a continuous aligning force on a tooth or teeth along a dental arch (refer to Paragraph [0060]; the appliance exerts a continuous aligning force on a tooth or teeth),
wherein the orthodontic appliance (Fig. 1) comprises tooth sockets that correspond to and enclose each tooth on the dental arch, the orthodontic appliance (Fig. 1) covering the entire surface of each tooth of the dental arch (refer to Paragraph [0078], annotated Fig. 2 below; the appliance covers individual teeth of the dental arch);
covering and being configured for being in direct contact with the gum surface of each tooth (refer to annotated Fig. 2 below); and
covering and being configured for being in direct contact with the entire palatial surface or the entire sublingual surface of oral cavity (refer to annotated Fig. 2 below),
wherein the elastic material has an elasticity such that it is capable of being stretched at least 300% of its original length (refer to Paragraph [0070]; the elastic material can be stretched at least 300% of the original length).
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Moon et al. does not disclose wherein the reinforcing material is a particulate material.
Hammar et al. discloses an elastomeric orthodontic device in the same field of endeavor (refer to Paragraph [0001]), wherein a suitable material for the elastomeric orthodontic device is a homogeneous composition comprising an elastic material and a reinforcing material(refer to Paragraphs [0022], [0028], [0104], [0105]; the fluorosilicone elastomer comprises 10-90 parts per hundred resin (phr) methyl trifluoropropyl silicone, and 10-90 phr silica based filler, where the formulations are thoroughly mixed together, thereby forming a homogenous composition; the silica reinforces the molded device, acting as a reinforcing material), wherein the reinforcing material is a particulate material (refer to Paragraphs [0022], [0028]; a particulate material is defined as minute, separate particles (dictionary.com); hydrated, fumed, and precipitated silica are inherently particulate materials, existing as a powdery or granulated white material).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the material composition of the reinforcing material as taught by Moon et al. with silica particles as taught by Hammer et al., as this particulate material is taught as a suitable material to reinforce a molded elastic device (refer to Paragraph [0028]).
Regarding claim 9, Moon et al. discloses an orthodontic aligner kit (refer to Paragraph [0084]), comprising a plurality of appliances (refer to Paragraph [0085], Fig. 1), the plurality of appliances (Fig. 1) being formed of a homogeneous composition comprising an elastic material and a reinforcing material (refer to Paragraphs [0060], [0069], [0085]; an orthodontic appliance formed of an elastic material, which further comprises a reinforcing material is disclosed), the appliance (Fig. 1) exerting a continuous aligning force on a tooth or teeth along a dental arch (refer to Paragraph [0060]; the appliance exerts a continuous aligning force on a tooth or teeth),
wherein the orthodontic appliance (Fig. 1) comprises tooth sockets that correspond to and enclose each tooth on the dental arch, the orthodontic appliance (Fig. 1) covering the entire surface of each tooth of the dental arch (refer to Paragraph [0078], annotated Fig. 2 below; the appliance covers individual teeth of the dental arch);
covering and being configured for being in direct contact with the gum surface of each tooth (refer to annotated Fig. 2 below); and
covering and being configured for being in direct contact with the entire palatial surface or the entire sublingual surface of oral cavity (refer to annotated Fig. 2 below),
wherein the elastic material has an elasticity such that it is capable of being stretched at least 300% of its original length (refer to Paragraph [0070]; the elastic material can be stretched at least 300% of the original length).
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Moon et al. does not disclose wherein the reinforcing material is a particulate material.
Hammar et al. discloses an elastomeric orthodontic device in the same field of endeavor (refer to Paragraph [0001]), wherein a suitable material for the elastomeric orthodontic device is a homogeneous composition comprising an elastic material and a reinforcing material(refer to Paragraphs [0022], [0028], [0104], [0105]; the fluorosilicone elastomer comprises 10-90 parts per hundred resin (phr) methyl trifluoropropyl silicone, and 10-90 phr silica based filler, where the formulations are thoroughly mixed together, thereby forming a homogenous composition; the silica reinforces the molded device, acting as a reinforcing material), wherein the reinforcing material is a particulate material (refer to Paragraphs [0022], [0028]; a particulate material is defined as minute, separate particles (dictionary.com); hydrated, fumed, and precipitated silica are inherently particulate materials, existing as a powdery or granulated white material).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the material composition of the reinforcing material as taught by Moon et al. with silica particles as taught by Hammer et al., as this particulate material is taught as a suitable material to reinforce a molded elastic device (refer to Paragraph [0028]).
Regarding claim 10, the combination of Moon et al. and Hammer et al. discloses the orthodontic aligner kit of claim 9, with Moon et al. further disclosing wherein the elastic material is a silicone rubber (refer to Paragraph [0071]).
Regarding claims 11-13, the combination of Moon et al. and Hammer et al. discloses the orthodontic aligner kit of claim 9, with Moon et al. further disclosing wherein the elastic material comprises at least 20 wt%/50 wt% /80 wt% of the combination of the elastic and reinforcing materials forming the appliance (refer to Paragraphs [0062]-[0064]).
Regarding claim 14, the combination of Moon et al. and Hammer et al. discloses the orthodontic aligner kit of claim 9, with Moon et al. further disclosing wherein the plurality of appliances has up to three appliances (refer to Paragraph [0086]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adriena J Webb Lyttle whose telephone number is (571)270-7639. The examiner can normally be reached Mon - Fri 8:00-5:00 EST.
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/ADRIENA J WEBB LYTTLE/Examiner, Art Unit 3772
/THOMAS C BARRETT/SPE, Art Unit 3799