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 with traverse of Group 1, Claims 1-17 in the reply filed on 05/28/2026 is acknowledged. The traversal is on the ground that there is no burden. This is not found persuasive because searching the two different groups would impose a search burden on the Office.
Claims 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group 2, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/28/2026
The requirement is still deemed proper and is therefore made FINAL.
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 1-5, 7-12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2013/0302742 A1) in view of DeSimone et al. (US 2011/0062609 A1).
Regarding Claim 1-3, Li teaches a multilayer polymer membrane as a dental appliance (Fig. 2; Abstract) comprising a hard core layer and soften skin layers located on both sides of the hard core layer. (Fig. 2; Claim 1 of Li; Paragraph 0024).
Li teaches the hard core layer comprises one or more polymer layers (Fig. 2; Paragraph 0024), where the hard core layer can comprise layers of polyamide. (Paragraph 0025). Li teaches the hard core layers can have a light transmission greater than about 75%, which would make the hard core material, polyamide, transparent. (Paragraph 0026).
Li teaches the soft skin layer can comprise one or more polymer layers (Fig. 2; Paragraph 0024), where the soft skin layer can comprise layers of polyamide elastomers or thermoplastic polyurethane. (Paragraph 0029). Li teaches the soft layers can have a Shore hardness of about 60 A to about 85 D. (Paragraph 0028). This overlaps the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (MPEP §2144.05).
Li does not specifically teach the transparent polyamide is amorphous transparent polyamide or microcrystalline transparent polyamide with the claimed glass transition temperature.
DeSimone teaches a dental appliance comprising a multilayer polymer membrane. (Abstract). DeSimone teaches the core layer can be transparent polyamide that is amorphous transparent polyamide or microcrystalline transparent polyamide with a glass transition temperature of at least 155 degree C. (Paragraph 0030-0033). This overlaps the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (MPEP §2144.05). DeSimone teaches this glass transition range allows for annealing, which improves the strength of the polymer and resulting dental appliance. (Paragraph 0005, 0034). DeSimone teaches these types of polyamides have the sufficient transparency and resistances to be used as dental appliances. (Paragraph 0030-0033) Thus, it would have been obvious to one with ordinary skill in the art to use the claimed polyamide with the claimed glass transition ranges in Li, as DeSimone teaches the polyamides have the sufficient physical properties, such as improved strength and resistances, to be used in dental appliances.
Regarding Claim 4, Li teaches the material used in the hard core layer, polyamide, should have a light transmittance of greater than 75%. (Paragraph 0026). Li does not specifically teach the hard core layer has a tensile yield of greater than 50 MPa, a yield strain greater than or equal to 5% and a tensile modulus greater than 1300 MPa.
DeSimone teaches a hard core layer that can comprise of transparent polyamide (Abstract; Paragraph 00333), where the hard core material layer should have a tensile yield strength of greater than 6000 psi, yield strain (elongation at yield) of greater than 4%, and a tensile modulus greater than 200,000 psi. (Paragraph 0005). This ranges overlap the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (MPEP §2144.05). DeSimone teaches the property ranges ensure the resulting dental appliance using these hard core layer will not undergo stress relaxation and creep, which will ensure the dental appliance can maintain its ability to reposition teeth. (Paragraph 0004-0005). Thus, it would have been obvious to one with ordinary skill in the art to ensure the transparent polyamide of Li have the claimed properties as taught by DeSimone to ensure the resulting dental appliance can continuously reposition teeth.
Regarding Claim 5, Li teaches the material used in the hard core layer, polyamide, should have a light transmittance of greater than 75%. (Paragraph 0026). This overlaps the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (MPEP §2144.05).
Regarding Claim 7-9, Li teaches the hard core layer can range from about 400 to about 1100 microns. (Paragraph 0024). Li teaches the soft skin layer can have a thickness from about 25 to about 100 microns. (Paragraph 0024). This overlaps the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (MPEP §2144.05).
Regarding Claim 10-11, Li teaches the total thickness of the layered structure comprising the hard core layer and soft skin layers on both sides can range from about 500 microns to about 1200 microns. (Paragraph 0024). This overlaps the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (MPEP §2144.05).
Regarding Claim 12, Li teaches the membrane is a diaphragm used to prepare a shell shaped dental appliance. (Paragraph 0021; Fig. 3).
Regarding Claim 14-15, Li teaches using the membrane of Claim 1 by hot pressing it into a molded body, where the molded boy is a shell-shaped dental instrument. (Fig. 3; Paragraph 0030-0031)
Regarding Claim 16-17, Li teaches using the membrane of Claim 1 by hot pressing it into a molded body, where the molded boy is a shell-shaped dental instrument. (Fig. 3; Paragraph 0030-0031)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Li and DeSimone, in further view of Hall (US 4,695,417 A)
Regarding Claim 6, Li and DeSimone do not specifically teach the polymer membrane is processed by grinding with one-sided rollers.
Hall teaches grinding a dental appliance polymer membrane on a grinding wheel, a one-sided roller, to trim of the dental appliance for a better fit. (Column 1-2). Thus, it would have been obvious to one with ordinary skill in the art to grind the multilayer polymer membrane to ensure ground the polymer membrane dental appliance of Li to ensure the dental appliance can fully fit properly in the user’s mouth.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Li and DeSimone in further view of Xia et al. (US 2022/0395355 A1)
Regarding Claim 13, Li and DeSimone do not teach the membrane is formed through thermal lamination, extrusion compound or co-extrusion. Li teaches lamination is suitable. (Fig. 2).
Xia teaches making multilayer dental aligners can be formed through hot or cold lamination, adhesive lamination, melt lamination, or coextrusion. (Abstract; Paragraph 0038). In KSR, the Supreme Court explained that when "there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp." Thus, as Xia teaches these methods are all suitable in yielding a multilayer dental aligner, it would have been obvious to one with ordinary skill in the art to select any of the finite and claimed methods taught by Xia to form the membrane of Li and DeSimone.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ZHANG whose telephone number is (571)270-0358. The examiner can normally be reached Monday through Friday: 9:30am-3:30pm, 8:30PM-10:30PM.
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/Michael Zhang/Primary Examiner, Art Unit 1781
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