DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 2, and 4-8 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Abbatte et al (US 4755139).
Regarding claim 2, Abbatte et al discloses a method (see Figs. 5-13) comprising: fabricating an aligner (14) having a polymeric shell comprising a plurality of tooth-receiving cavities (tooth indentations in 14) shaped to reposition teeth of a patient (see abstract and col 4, lines 27-68, col 5, lines 19-57), wherein the polymeric shell is shaped to cover an occlusal surface of the teeth when the aligner is worn by the patient (see Figs. 1-13); and fabricating a mouth guard (12) shaped to protect the teeth (at least to some degree due to the increased thickness and material properties of 12), the mouth guard comprising a plurality of cavities shaped to receive the teeth (see tooth indentations in 12 as well as area corresponding to anterior teeth in 12) and accommodate the aligner when worn on the teeth (e.g. mouth guard accommodates the aligner as the outer surfaces of the cavities as they provide sufficient space for the aligner to fit thereon, and the cavity corresponding to the anterior teeth accommodates the anterior portion of the aligner therein), and an occlusal portion connected to the plurality of cavities (e.g. occlusal surfaces), wherein the occlusal portion is shaped to reduce impact forces on the teeth (at least to some degree by virtue of the material properties; reduced compared to areas without 12), wherein the mouth guard is configured to be removably coupled to the aligner (see abstract, col 3, lines 39-col 4, line 7; col 9, lines 30-35).
Abbatte et al further discloses wherein the mouth guard is not configured to apply repositioning forces to the teeth (see citations above; 12 does not apply repositioning forces; 14 does; per claim 4); wherein the occlusal portion comprises one or more interfacing surfaces (e.g. any portion of the occlusal surface of 12 which is capable of interfacing with another structure via contact through the aligner 14 is interpreted as an interfacing surface; per claim 5); wherein the one or more interfacing surfaces are configured to interface with second teeth on an opposite jaw of the patient (e.g. any of occlusal surfaces of 12 are configured to interface with second teeth on an opposite jaw via contact through aligner 14; per claim 6); wherein the one or more interfacing surfaces are configured to interface with a second mouth guard (e.g. any of occlusal surfaces of 12 are configured to interface with a second mouth guard via contact through aligner 14, if a second guard is provided; per claim 7); and wherein the impact forces comprise forces transmitted between a first dental arch and a second dental arch of the patient (e.g. occlusal portion of 12 is shaped and configured to reduce forces transmitted between a first and second arch of the patient, at least to some degree, compared to areas where it is not present, at least due to the increase thickness, rigidity and/or material properties thereof; per claim 8).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Abbatte et al in view of Martz et al (US 4793803).
Regarding claim 3, Abbatte et al discloses the use of providing devices for both the upper and lower jaw (see also Fig. 14), but does not explicitly teach the method also comprising fabricating a second mouth guard shaped to protect second teeth on an opposite jaw of the patient, the second mouth guard comprising: a second plurality of cavities shaped to receive the second teeth; and a second occlusal portion connected to the second plurality of cavities as required.
Martz, however, teaches a method of fabricating a first (device on upper jaw) and second (device on lower jaw) mouthguard shaped to protect second teeth on an opposite jaw of the patient (e.g. at least to some degree by virtue of the thickness or material properties of the device), the second mouth guard comprising a second plurality of cavities shaped to receive the second teeth (e.g. tooth depressions in device on lower jaw) and a second occlusal portion connected to the second plurality of cavities (e.g. occlusal surfaces thereof). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Abbatte to include Martz’ step of fabricating a second mouthguard for the opposite jaw, as such modification would provide improved protection for the teeth and/or allow treatment of both jaws concurrently.
Claims 9-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Abbatte et al in view of Kuo et al (US 6607382 B1).
Regarding claim 9, Abbatte et al does not teach wherein the mouthguard is fabricated from a multi-laminate material as required.
Kuo et al, however, teaches a similar mouth guard which is formed of a multi-laminate material (see col 5, line 1- col 6, line 42). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Abbatte to include a multi-laminate material, as taught by Kuo, as such modification would allow for the release of a drug to concurrently treat an oral condition, and adjust the material properties of the device as desired.
Regarding claims 10-11, Abbate et al does not teach receiving a digital representation of the teeth, and fabricating the aligner and the mouth guard based on the digital representation of the teeth, or further comprising determining an accommodation envelope for the plurality of cavities of the mouth guard, the accommodation envelope providing a swept volume that accommodates the aligner as required.
Kuo et al, however, teaches fabricating a similar dental device based on a received a digital representation of the teeth, encompassing determining an accommodation envelope for the plurality of cavities of the device, the accommodation develop providing a swept volume (see col 4, lines 5-24; the Examiner interprets the accommodation envelope to correspond to the area or volume of the cavities in the mouth guard model). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Abbatte to include Kuo’s digital representation and determine of an accommodation envelope, as such modification would provide for more accurate and efficient production. The Examiner notes that should the method of Abbatte be modified with the digital method of Kuo, as combined above, by forming the digital model of the teeth, the user would determine an accommodation envelope for the plurality of cavities of the mouth guard (e.g. the size and/or geometry thereof, which is based on the teeth), the accommodation envelope providing a swept volume that accommodates the aligner (e.g. at least at the anterior teeth cavity, the size of the teeth (accommodation envelope provides a swept volume to accommodate any tooth movement and the aligner therein)).
Claims 12, and 14-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zacco (US 6619290 B1) in view of Kuo et al.
Regarding claim 12, Zacco discloses a method (see abstract, Figs. 6a-d, Fig. 12) comprising: fabricating a dental appliance (22) having a shell comprising a plurality of tooth-receiving cavities (see tooth indentations in 22), wherein the shell extends over an occlusal surface of the teeth when the dental appliance is worn by the patient (see Figs. 1-6d); and fabricating a covering guard (32) comprising a plurality of cavities (left and right halves of 32) shaped to fit over the dental appliance when worn on the teeth (see Figs. and citations above; at least during fitting), and an occlusal portion connected to the plurality of cavities (occlusal surfaces of 32), wherein the occlusal portion is shaped to protect the teeth (at least to some degree due to the thickness and/or material properties of 32, compared to a device without such layer), wherein the covering guard is configured to be removably coupled to the dental appliance (see Figs. above).
Zacco further discloses wherein the mouth guard is not configured to apply repositioning forces to the teeth (see Figs above; 32 does not apply repositioning forces per claim 14); wherein the occlusal portion comprises one or more interfacing surfaces (e.g. any portion of the occlusal surface of 32 which is capable of interfacing with another structure is interpreted as an interfacing surface; per claim 15); wherein the one or more interfacing surfaces are configured to interface with second teeth on an opposite jaw of the patient (e.g. any of occlusal surfaces of 32 are configured to interface with second teeth on an opposite jaw; per claim 16); wherein the one or more interfacing surfaces are configured to interface with a second mouth guard (e.g. any of occlusal surfaces of 32 are configured to interface with a second mouth guard, if a second guard is provided; per claim 17); and wherein the impact forces comprise forces transmitted between a first dental arch and a second dental arch of the patient (e.g. occlusal portion of 32 is shaped and configured to reduce forces transmitted between a first and second arch of the patient, at least to some degree, compared to devices without such layer present, at least due to the increase thickness, rigidity and/or material properties thereof; per claim 18).
Zacco however, does not teach wherein the plurality of cavities of the shell are shaped to reposition teeth of a patient as required.
Kuo, however, teaches a similar dental appliance that protects the teeth (at least to some degree) and has cavities shaped to reposition the patient’s teeth (see abstract). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Zacco to include Kuo’s cavity shape which repositions teeth, as such modification would allow for concurrent orthodontic treatment of teeth, while providing other functions via the device, improving treatment efficiency and scope.
Regarding claim 19, Zacco/Kuo, as combined above, does not teach wherein the mouthguard is fabricated from a multi-laminate material as required.
Kuo et al, however, teaches a similar mouth guard which is formed of a multi-laminate material (see col 5, line 1- col 6, line 42). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Zacco/Kuo to further include a multi-laminate material, as taught by Kuo, as such modification would allow for the release of a drug to concurrently treat an oral condition, and adjust the material properties of the device as desired.
Regarding claims 20-21, Zacco/Kuo does not teach receiving a digital representation of the teeth, and fabricating the aligner and the mouth guard based on the digital representation of the teeth, or further comprising determining an accommodation envelope for the plurality of cavities of the mouth guard, the accommodation envelope providing a swept volume that accommodates the aligner as required.
Kuo et al, however, teaches fabricating a similar dental device based on a received a digital representation of the teeth, encompassing determine an accommodation envelope for the plurality of cavities of the device, the accommodation develop providing a swept volume (see col 4, lines 5-24; the Examiner interprets the accommodation envelope to correspond to the area or volume of the cavities in the mouth guard model). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Zacco/Kuo to further include Kuo’s digital representation and determine of an accommodation envelope, as such modification would provide for more accurate and efficient production. The Examiner notes that should the method of Zacco/Kuo be further modified with the digital method of Kuo, as combined above, by forming the digital model of the teeth, the user would determine an accommodation envelope for the plurality of cavities of the mouth guard (e.g. the size and/or geometry thereof, which is based on the teeth), the accommodation envelope providing a swept volume that accommodates the aligner (e.g. at least at the anterior teeth cavity, the size of the teeth (accommodation envelope provides a swept volume to accommodate any tooth movement and the aligner therein)).
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zacco in view of Kuo, as combined above, further in view of Martz et al (US 4793803).
Regarding claim 13, Zacco/Kuo, as combined above discloses the use of the device on both the upper and/or lower jaw (see Zacco col 4, lines 22-36), but does not explicitly teach the method also comprising fabricating a second mouth guard shaped to protect second teeth on an opposite jaw of the patient, the second mouth guard comprising: a second plurality of cavities shaped to receive the second teeth; and a second occlusal portion connected to the second plurality of cavities as required.
Martz, however, teaches a method of fabricating a first (device on upper jaw) and second (device on lower jaw) mouthguard shaped to protect second teeth on an opposite jaw of the patient (e.g. at least to some degree by virtue of the thickness or material properties of the device), the second mouth guard comprising a second plurality of cavities shaped to receive the second teeth (e.g. tooth depressions in device on lower jaw) and a second occlusal portion connected to the second plurality of cavities (e.g. occlusal surfaces thereof). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Zacco/Kuo, as combined above, to include Martz’ step of fabricating a second mouthguard for the opposite jaw, as such modification would provide improved protection for the teeth and/or allow treatment of both jaws concurrently, and/or improve the fit of the device, by providing a specific sized/shaped device for each jaw.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see attached PTO892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD MORAN whose telephone number is (571)270-5349. The examiner can normally be reached Monday-Friday 7 AM-4 PM EST.
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/EDWARD MORAN/Primary Examiner, Art Unit 3772
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