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
Claim 12 is objected to because of the following informalities: the term “to repositioning” should read “to reposition” or the like. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 2-3, and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farrell (US 2013/0244195 A1).
Regarding claim 2, Farrell discloses a dental appliance (see Figs. 1-9) comprising: a shell (2/44/45) configured to receive a plurality of teeth, the shell comprising a sidewall (25/45) and an interproximal engagement structure (50 on labial wall) extending from the sidewall into a space of an interproximal region between a first tooth and a second tooth of the plurality of teeth (see Figs. 1-9), wherein the interproximal engagement structure is configured to contact the first tooth and the second tooth concurrently, and wherein the interproximal engagement structure is larger than the space of the interproximal region, such that the contact causes deformation of one or more of the interproximal engagement structure or the sidewall (see [0124]-[0129], [0134], [0137]-[0138], [0143]-[0146], [0148]-[0151], [0156]-[0157], [0159], [0161], [0163], [0165], [0171]).
Farrell further discloses wherein the interproximal engagement structure has a first stiffness (just material of 50) and the sidewall has a second stiffness different from the first stiffness (second stiffness includes stiffness from material of 45 and including stiffer material of 25, see citations above; per claim 3); wherein the second stiffness is greater than the first stiffness (see above per claim 5); wherein the interproximal engagement structure is fabricated from a first material having the first stiffness (see above, material of 50) and the sidewall is fabricated from a second material having the second stiffness (see above, material of 45 and material of 25; per claim 6); wherein the sidewall is a buccal sidewall or a lingual sidewall (buccal sidewall, see above; per claim 7); wherein the shell further comprises a second sidewall (44/30) and a second interproximal engagement structure (50 on lingual wall opposite of first structure) extending from the second sidewall into a second space of the interproximal region between the first tooth and the second tooth (e.g. lingual side of interproximal space; per claim 8); and wherein the interproximal engagement structure and the second interproximal engagement structure are located at opposite sides of the interproximal region (see Fig. 5-6 for example; per claim 9).
Regarding claims 10-11, the term “wherein the shell is composed of a plurality of additively manufactured layers” is a product by process limitation; that is the shell is formed by additive manufacturing using a layer by layer construction. Product by process limitations are not limited by the specific steps of the process (layer by layer additive manufacturing), but only by the structure imparted by the process (e.g. use of a material that can be additively manufactured for at least one part of the device). In the instant case, the claim limitations are met as Farrell discloses that the portion 2 can be formed of Nylon (see [0171]), while 44 and 45 are formed from silicone or PVC (see [0180] and [0182]). Accordingly, as the portions 44/45 and portion 2 are unitary pieces from a material that can be additively manufactured, the prior art reads on the claimed product by process limitation (see MPEP 2113).
Regarding claim 11, Farrell discloses wherein the sidewall (45/25) and the interproximal engagement structure (50) are integrally formed with each other (e.g. at least in part as material of 50 is also used to form part of sidewall 45) from the plurality of additively manufactured layers (see above regarding product by process limitation “from the plurality of additively manufactured layers”).
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.
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.
Claim(s) 4, 12-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Lai et al (US 2006/0099544 A1).
Regarding claim 4, Farrell does not teach wherein the first stiffness is greater than the second stiffness as required.
Lai, however, teaches an orthodontic repositioning device comprising buccal and lingual sidewalls (see buccal and lingual walls of 11b, Fig. 6) and polymeric engagement structures (18b) projecting therefrom, wherein the polymeric engagement structures are formed from a different material than that of the buccal/lingual sidewall, with a stiffness that is less or greater than the material of the sidewall as required (see [0074]-[0076]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Farrell to include Lai’s teaching of providing polymeric engagement structures formed of a different material with a different stiffness than the material of the walls of the appliance, including a stiffness that is greater or less than the stiffness of the sidewall, as such modification would allow for customized and more efficient application and control of forces applied to the teeth and optimized material properties therefor. Additionally, the Examiner notes that such modification would involve a selection of a known material based on its suitability for its intended use, which has been held to be within the skill of the ordinary artisan (see MPEP 2144.07).
Regarding claims 12-13, 15-19 and 21, Farrell discloses a dental appliance (see Figs. 1-9) comprising: a shell (2/44/45) configured to receive a plurality of teeth, the shell comprising a sidewall (25/45) and an interproximal engagement structure (50 on labial wall) extending from the sidewall into a space of an interproximal region between a first tooth and a second tooth of the plurality of teeth (see Figs. 1-9), wherein the interproximal engagement structure is configured to contact the first tooth and the second tooth, and wherein the interproximal engagement structure is larger than the space of the interproximal region, such that the contact causes deformation of one or more of the interproximal engagement structure or the sidewall (see [0124]-[0129], [0134], [0137]-[0138], [0143]-[0146], [0148]-[0151], [0156]-[0157], [0159], [0161], [0163], [0165], [0171]).
Farrell further discloses wherein the interproximal engagement structure has a first stiffness (just material of 50) and the sidewall has a second stiffness different from the first stiffness (second stiffness includes stiffness from material of 45 and including stiffer material of 25, see citations above; per claim 13); wherein the second stiffness is greater than the first stiffness (see above per claim 15); wherein the interproximal engagement structure is fabricated from a first material having the first stiffness (see above, material of 50) and the sidewall is fabricated from a second material having the second stiffness (see above, material of 45 and material of 25; per claim 16); wherein the sidewall is a buccal sidewall or a lingual sidewall (buccal sidewall, see above; per claim 17); wherein the shell further comprises a second sidewall (44/30) and a second interproximal engagement structure (50 on lingual wall opposite of first structure) extending from the second sidewall into a second space of the interproximal region between the first tooth and the second tooth (e.g. lingual side of interproximal space; per claim 18); and wherein the interproximal engagement structure and the second interproximal engagement structure are located at opposite sides of the interproximal region (see Fig. 5-6 for example; per claim 19).
Farrell, however, does not teach a system comprising a plurality of polymeric shell appliances configured to be sequentially worn by a patient to reposition a plurality of the teeth from an initial arrangement toward a target arrangement, and wherein at least one shell of the plurality comprises the interproximal engagement structures as required.
Lai, however, teaches a system comprising a plurality of polymeric shell appliances configured to be sequentially worn by a patient to reposition a plurality of the teeth from an initial arrangement toward a target arrangement, and wherein at least one shell of the plurality comprises tooth engagement structures (abstract and [0009]). Lai further discloses wherein the plurality of polymeric shell appliances comprises a plurality of aligners (see citations above; per claim 21). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Farrell to include Lai’s teaching of providing a system of appliances/aligners to incrementally move the teeth from an initial to final position, as such modification would provide for controlled and efficient repositioning of the teeth, allowing for complex adjustments over a period of time. The Examiner notes that should the teachings of Lai be provided to the device of Farrell, as combined above, the resultant system would comprise a plurality of appliances to move the teeth, with at least one having the interproximal engagement structures as required.
Regarding claim 14, Farrell/Lai, as combined above, does not teach wherein the first stiffness is greater than the second stiffness as required.
Lai, however, teaches an orthodontic repositioning device comprising buccal and lingual sidewalls (see buccal and lingual walls of 11b, Fig. 6) and polymeric engagement structures (18b) projecting therefrom, wherein the polymeric engagement structures are formed from a different material than that of the buccal/lingual sidewall, with a stiffness that is less or greater than the material of the sidewall as required (see [0074]-[0076]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the system of Farrell/Lai to further include Lai’s teaching of providing polymeric engagement structures formed of a different material with a different stiffness than the material of the walls of the appliance, including a stiffness that is greater or less than the stiffness of the sidewall, as such modification would allow for customized and more efficient application and control of forces applied to the teeth and optimized material properties therefor. Additionally, the Examiner notes that such modification would involve a selection of a known material based on its suitability for its intended use, which has been held to be within the skill of the ordinary artisan (see MPEP 2144.07).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Farrell in view of Lai, as combined above in regards to claim 12, further in view of Andreiko et al (US 2013/0095446 A1).
Regarding claim 20, Farrell/Lai, as combined above, does not explicitly teach wherein the plurality of polymer shell appliances each comprise a plurality of layers of a photopolymerized resin as required.
Andreiko, however, further discloses that a photopolymerizable resin may be used to form aligners (see abstract, [0087] and [0091]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the system of Farrell/Lai, as combined above, to include Andreiko’s use of a photopolymerizable resin, as such modification would make use of an old and well known technique for forming aligners while improving efficiency in production thereof. Further, the Examiner notes that such modification would involve a selection of a known material based on its suitability for its intended use, which has been held to be within the skill of the ordinary artisan (see MPEP 2144.07).
The Examiner notes that the term “a plurality of layers of a photopolymerized resin” is a product by process limitation, that is the appliances are formed by a layer by layer photopolymerization construction. Product by process limitations are not limited by the specific steps of the process (layer by layer photopolymerization), but only by the structure imparted by the process (e.g. use of a material that can be layer by layer photopolymerized for at least one part of the device). In the instant case, the claim limitations are met as Farrell/Lai/Andreiko discloses that at least part of the device can be formed from a photopolymerizable material (see above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see attached PTO892 form.
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/EDWARD MORAN/Primary Examiner, Art Unit 3772
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