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 .
DETAILED ACTION
Response to Arguments
Applicant's arguments filed 03/26/2026 have been fully considered but they are not persuasive. Applicant has argued that Stewart fails to provide for the new limitation of claim 1 by asserting that the appliance of Stewart is used differently however Stewart is no longer relied up for teaching the method claims. Further the claims of 1 and its depending claims are directed to an apparatus itself and not the intended use of the apparatus. The cited layers of Stewart do provide for the claimed layers and their structural relations.
The new broader claims are now addressed by Chisti et al. for both the apparatus and method claims.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 10-12, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Stewart et al. (US 2019/0105881 A1).
Regarding claims 1 and 24, Stewart discloses a thermoformed orthodontic appliance (title, regarding the limitation of “thermoformed” This limitation is being viewed as a product by process claim of merely reciting a process to make the product as discussed above, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965), however Stewart does disclose that the appliance is made of thermoforming in paragraph [0074] lines 1-8) comprising two or more anchoring shells shaped to receive teeth and being stacked (abstract, paragraph [0016] disclosing the appliance conforms to one or more teeth, Fig.1b showing stacked shell layers), and
a mutable shell located between the two or more anchoring shells (Fig. 1b mutable shell a’ with anchoring shells a and any of b, b’, c’ and c) that comprises a first polymer material such as a thermoplastic polyurethane of Isoplast 2530 ( Layer A a’ comprising a polyurethane as in paragraph [0006], paragraph [0023] all disclosing layer A can be made of multiple layers and each layer comprised of one or more materials, and table 1 disclosing the polyurethane is Isoplast 2530 that can make up a component Layer A such as layer a’ as in Fig. 1b ) that is configured to decrease in elastic modulus so as to soften by exposure of the appliance to an environmental condition, the first polymer material enabling the mutable shell to decrease in elastic modulus so as to soften by exposure of the thermoformed appliance to the environmental condition that has a first glass transition temperature that is less than 90 degrees Celsius and such that exposure to heat between 60 degree Celsius and 100 degrees Celsius from room temperature would cause a state change so as to soften the mutable shell and wherein the onset of the softening temperature of the thermoplastic polyurethane material is between 40 degrees Celsius and 90 degrees Celsius (table 1 disclosing the Tg 85 degrees Celsius and thus would start softening at least at 84 degrees Celsius),
and wherein the two or more anchoring shells comprise a second polymer material that enables the two or more shells to not decrease in elastic modulus so as to not soften and remain harder than the mutable shell by exposure to the environmental condition, the second polymer material having a second glass transition temperature that is greater than the first glass transition temperature and wherein the second polymer is a polycarbonate material wherein the environmental condition would be heating the thermoformed orthodontic appliance from room temperature to a heating temp that meets both of the following conditions: 1) between 60 to 100 degrees Celsius and 2)at or above the first glass transition temperature and sufficiently below the second glass transition temperature so as to soften the first polymer material while the second polymer material does not soften and remains harder than the mutable shell when the orthodontic appliance is heated to the heating temperature outside of the oral cavity(Fig. 1b elements a and any of c’ or c being second polymer such as polycarbonate, paragraph [0006], paragraph [0075] lines 4-7 disclosing where a layer of the multilayers of A and C would have a Tg of significantly higher than the mutable layer, such as 100-160 C or 180 C and would thus not soften when exposed to an environment condition that would case the mutable shell to soften such as when the environmental condition would be heating the orthodontic appliance outside of the oral cavity at a heating temperature where the first polymer material would transitions towards a liquid state),
wherein at the heating temperature the first polymer material transitions toward a liquid state where the second polymer material is in a solid state (Fig. 1b elements a and any of c’ or c being second polymer such as polycarbonate, paragraph [0006], paragraph [0075] lines 4-7 disclosing where a layer of the multilayers of A and C would have a Tg of significantly higher than the mutable layer, such as 100-160 C or 180 C and would thus not soften when exposed to an environment condition that would case the mutable shell to soften such as when the environmental condition would be heating the orthodontic appliance outside of the oral cavity at a heating temperature where the first polymer material would transitions towards a liquid state)
and the second polymer would remain in a solid state and that meets both of the following conditions: 1) between 60 to 100 degrees Celsius and 2)at or above the first glass transition temperature and sufficiently below the second glass transition temperature so as to soften the first polymer material while the second polymer material does not soften and remains harder than the mutable shell when the orthodontic appliance is heated to the heating temperature outside of the oral cavity, wherein at the heating temperature the first polymer material transitions toward a liquid state where the second polymer material is in a solid state (as the Tg of the Isoplast 2530 is 85 degrees C then the heating between 60 C and 100 C that would be at 85 would cause the mutable Isoplast shell layer to soften while the other shells would not),
Regarding claim 10, Stewart further discloses wherein the first polymer material plastically softening when heating the orthodontic appliance would enable the mutable shell to plastically soften when heating the shells, and wherein the two or more anchoring shell are configured to remold the mutable shell into a pre-softened state by the first polymer material plastically hardening after heating the orthodontic appliance ceases (Due to their higher Tg the anchoring shells are configured to not change their shape when heated to 85 C and thus would remold the mutable shell after the mutable shell was plastically softened above its glass transition temperature while that temperature that softened the mutable/softened shell was below the outer/anchoring shells glass transition temperature).
Regarding claim 11, Stewart further discloses wherein the first polymer material increases in flexibility from exposure of the orthodontic appliance to the environmental condition and enables the mutable shell to significantly increase in flexibility from exposure to the environmental condition, and wherein the two or more anchoring shell are configured to provide structural form to the mutable shell by the first polymer material decreasing in flexibility after cessation of the exposure of the orthodontic appliance to the environmental condition (Due to the Tg of the outer/anchoring shell that would not soften at the 85 degree Celsius exposure they are thus configured to provide structural form to remold the appliance and thus configured to remold the mutable/softened shell after the mutable shell was increased in flexibility above its glass transition temperature while that temperature that increased flexibility in the mutable/softer shell was below the harder/anchoring shells glass transition temperature and the outer/anchoring shell provides the structure to the mutable/softer shell upon cooling).
Regarding claim 12, Stewart further discloses wherein the orthodontic appliance has a working flexural modulus configured to therapeutically move teeth(paragraph [0034] the appliance can move teeth and thus its inherent flexural modulus would be enough to move the teeth) and wherein the mutable shell made of the first polymer material that is configured to cause the orthodontic appliance to have a transitory flexural modulus that is reduced from the working flexural modulus when the orthodontic appliance is exposed to the environmental condition (Due to the Tg of the mutable layer being lower than the anchoring layer any applied heat above its Tg would reduce the forces of the inner layer and thus reduce the working flexural modulus of the orthodontic appliance).
Regarding claims 1, 10-12, and 24, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex Parte Masham, 2 USPQ F.2d 1647 (1987).
Claims 1 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Chishti et al. (US 2002/0051951 A1)
Regarding claims 1, Chishti discloses a method comprising:
obtaining a thermoformed orthodontic appliance (title, paragraph [0042] all disclosing thermoforming the appliance) comprising two or more anchoring shells shaped to receive teeth (abstract, Fig.6 elements 152 being an outer and inner shell), and
a mutable shell located between the two or more anchoring shells (Fig. 6 elements 150),
the mutable shell comprises a first polymer material (paragraph [0050] disclosing the mutable shell 150 made of a polymer material) that is configured to decrease in elastic modulus so as to soften by exposure of the thermoformed appliance to an environmental condition during use, the first polymer material enabling the mutable shell to decrease in elastic modulus so as to soften by exposure to the environmental condition that has a first glass transition temperature that is less than 90 degrees Celsius such that exposure to heat between 60 degrees Celsius and 100 degrees Celsius from room temperature causes a state change so as to soften the mutable shell (table after paragraph [0046] the inner shell made of polyurethane and having a temperature phase below 90 degrees Celsius, paragraph [0014] lines 1-14 disclosing the softening of the shell when exposed to an environmental condition, as the temperature phase when the appliance would be at room temperature would be exposed to a temp of 60-100 C it would begin to soften and melt at at least 37 C and such as between 40-55 would when being heated towards 60 C would pass through 37C or 40-55C and thus would soften),
and wherein the anchoring shells comprise a second polymer material that is configured to not decrease in elastic modulus so as to soften by exposure of the orthodontic appliance to the environmental condition and having a second glass transition temperature that is greater than the first glass transition temperature and the second polymer material is a polycarbonate material (paragraph [0044] all, [0050] -[0051] all disclosing one of the layers of shells has a higher glass transition temperature than another of the layered shells and thus one shell layer can have a significant decrease in elastic modulus while the other “harder segment” would be used to control the shape of the dental appliance and thus not significantly decrease in elastic modulus when exposed to the same environmental condition as the mutable shell layer, paragraph [0043] lines 1-10 disclosing that the outer anchoring shells are made of polycarbonate and have a glass transition temperature of about 150 degrees Celsius),
wherein the environmental condition is heating the thermoformed orthodontic appliance from room temperature toa heating temperature that meets both of the following conditions: 1) between 600 and 100 degrees Celsius and 2 sufficiently below the second glass transition temperature so as to soften the first polymer material while the second polymer material does not soften and remains harder than the mutable shell when the thermoformed orthodontic appliance is heated to the heating temperature, wherein at the heating temperature the first polymer material transitions toward a liquid state where the second polymer is in a solid state (table after paragraph [0046] the inner shell made of polyurethane and having a temperature phase below 90 degrees Celsius, paragraph [0014] lines 1-14 disclosing the softening of the shell when exposed to an environmental condition, as the temperature phase when the appliance would be at room temperature would be exposed to a temp of 60-100 C it would begin to soften and melt at at least 37 C and such as between 40-55 would when being heated towards 60 C would pass through 37C or 40-55C and thus would soften while the second polymer of the anchoring shell would being made of polycarbonate and have a glass transition temperature of about 150 degrees Celsius would remain hard, paragraph [0043] lines 1-10).
Regarding claims 1, 10-12, and 24, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus.
Regarding claim 10, Chishti further discloses wherein the first polymer material plastically softening when heating the orthodontic appliance enables the mutable shell to plastically soften when heating the shells, and wherein the two or more anchoring shell is configured to remold the mutable shell into a pre-softened state by the first polymer material plastically hardening after heating the orthodontic appliance ceases (paragraph [0044]-[0045] the outer/anchoring shell remolds the appliance and thus remolds the mutable shell after the mutable shell was plastically softened above its glass transition temperature while that temperature that softened the mutable/softened shell was below the outer/anchoring shells glass transition temperature).
Regarding claim 11, Chishti further discloses wherein the firs polymer material increases in flexibility from exposure of the orthodontic appliance to the environmental condition and enables the mutable shell to significantly increase in flexibility from exposure to the environmental condition, and wherein the two or more anchoring shell are configured to provide structural form to the mutable shell by the first polymer material decreasing in flexibility after cessation of the exposure of the orthodontic c appliance to the environmental condition (paragraph [0044]-[0045] the outer/anchoring shell provides structural form to remold the appliance and thus remolds the mutable/softened shell after the mutable shell was increased in flexibility above its glass transition temperature while that temperature that increased flexibility in the mutable/softer shell was below the harder/anchoring shells glass transition temperature and the outer/anchoring shell provides the structure to the mutable/softer shell upon cooling).
Regarding claim 12, Chishti further discloses wherein the orthodontic appliance has a working flexural modulus configured to therapeutically move teeth(paragraph [0044] all, a combined modulus to reposition teeth), and wherein the mutable shell made of the first polymer material that is configured to cause the orthodontic appliance to have a transitory flexural modulus that is reduced from the working flexural modulus when the orthodontic appliance is exposed to the environmental condition (paragraph [0044]-[0045] applied heat will reduce the forces of the inner layers and thus reduce the working flexural modulus).
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.
Claims 15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chishti et al. (US 2002/0051951 A1)
Regarding claim 15, Chishti discloses a method comprising:
obtaining a thermoformed orthodontic appliance (title, paragraph [0042] all disclosing thermoforming the appliance) comprising two or more anchoring shells shaped to receive teeth (abstract, Fig.6 elements 152 being an outer and inner shell), and
a mutable shell located between the two or more anchoring shells (Fig. 6 elements 150),
the mutable shell comprises a first polymer material (paragraph [0050] disclosing the mutable shell 150 made of a polymer material) that is configured to decrease in elastic modulus so as to soften by exposure of the thermoformed appliance to an environmental condition during use, the first polymer material enabling the mutable shell to decrease in elastic modulus so as to soften by exposure to the environmental condition that has a first glass transition temperature that is less than 90 degrees Celsius such that exposure to heat between 60 degrees Celsius and 100 degrees Celsius from room temperature causes a state change so as to soften the mutable shell (table after paragraph [0046] the inner shell made of polyurethane and having a temperature phase below 90 degrees Celsius, paragraph [0014] lines 1-14 disclosing the softening of the shell when exposed to an environmental condition, as the temperature phase when the appliance would be at room temperature would be exposed to a temp of 60-100 C it would begin to soften and melt at at least 37 C and such as between 40-55 would when being heated towards 60 C would pass through 37C or 40-55C and thus would soften),
and wherein the anchoring shells comprise a second polymer material that is configured to not decrease in elastic modulus so as to soften by exposure of the orthodontic appliance to the environmental condition and having a second glass transition temperature that is greater than the first glass transition temperature and the second polymer material is a polycarbonate material (paragraph [0044] all, [0050] -[0051] all disclosing one of the layers of shells has a higher glass transition temperature than another of the layered shells and thus one shell layer can have a significant decrease in elastic modulus while the other “harder segment” would be used to control the shape of the dental appliance and thus not significantly decrease in elastic modulus when exposed to the same environmental condition as the mutable shell layer, paragraph [0043] lines 1-10 disclosing that the outer anchoring shells are made of polycarbonate and have a glass transition temperature of about 150 degrees Celsius),
wherein the environmental condition is heating the thermoformed orthodontic appliance from room temperature toa heating temperature that meets both of the following conditions: 1) between 600 and 100 degrees Celsius and 2 sufficiently below the second glass transition temperature so as to soften the first polymer material while the second polymer material does not soften and remains harder than the mutable shell when the thermoformed orthodontic appliance is heated to the heating temperature, wherein at the heating temperature the first polymer material transitions toward a liquid state where the second polymer is in a solid state (table after paragraph [0046] the inner shell made of polyurethane and having a temperature phase below 90 degrees Celsius, paragraph [0014] lines 1-14 disclosing the softening of the shell when exposed to an environmental condition, as the temperature phase when the appliance would be at room temperature would be exposed to a temp of 60-100 C it would begin to soften and melt at at least 37 C and such as between 40-55 would when being heated towards 60 C would pass through 37C or 40-55C and thus would soften while the second polymer of the anchoring shell would being made of polycarbonate and have a glass transition temperature of about 150 degrees Celsius would remain hard, paragraph [0043] lines 1-10)
and exposing the orthodontic appliance to an environmental condition to reduce the flexural modulus of the orthodontic appliance (paragraph [0044] all, paragraph [0019] all disclosing the transition is repeatable for insertion and thus would be heated outside the mouth to a temperature that would allow for the softening of the mutable layer for reinsertion).
Chishti discloses structure substantially identical to the instant application as discussed above, and further discloses where the exposing to the environmental condition includes warming the orthodontic appliance to a temperature above the transition temperature of the mutable shell (paragraph [0056] lines 1-5 disclosing applying an external heat stimulus) and the that the temperature would be above at least 37 degrees and a preference for 55 degrees (paragraph [0041] lines 1-12 disclosing a temperature of above 37 degrees Celsius and a preference for at least 55 degrees Celsius, [0043] all ) and the transition temperature of the anchoring shell being 150 degrees C (paragraph [0043] lines 1-8), and reinserting the appliance (paragraph [0019] lines 11-12) but fails to explicitly disclose where the exposed temperature is between 60 and 100 degrees Celsius, nor cooling to prevent burning of the patient.
However it would have been obvious to one having ordinary skill in the art at the time the invention was made to have made the step of exposing the appliance to an environmental condition that was a temperature of between 60 and 100 degrees instead of 55 Celsius as Chishti disclose that the glass transition temperature needed to achieve the method of only having the soften/mutable layer to transition above its glass transition temperature would be to raise above its Tg and thus would be above the Tg of the inner polyurethane but below the Tg of the harder/anchoring shells polymer of 150C and thus it would be obvious to only go above the 80-85 degree enough to ensure the full transition of the softer/mutable layer only since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Further it would have been obvious to allow a device to cool to a temperature that would not burn a patient during the insertion since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 17, Chishti further discloses where the method includes cooling the surfaces of the appliance to a temperature less than 45 C that and thus would be at some point during its cooling would still be high enough to retain the mutable shell in a softened state when applied to a user (paragraph [0052] 13-16 allowing the appliance to cool below the glass transition Tg, paragraph [0041] disclosing the transition temperature can be below 40 degrees Celsius).
Regarding claim 18, Chishti further discloses wherein the first polymer material plastically softens when heating the orthodontic appliance to the heating temperature enabling the mutable shell to plastically soften, and wherein the two or more anchoring shell is configured to remold the mutable shell into a pre-softened state by the first polymer material plastically hardening after heating the orthodontic appliance ceases (paragraph [0044]-[0045] the outer/anchoring shell remolds the appliance and thus remolds the mutable shell after the mutable shell was plastically softened above its glass transition temperature while that temperature that softened the mutable/softened shell was below the outer/anchoring shells glass transition temperature).
Regarding claim 19, Chishti further discloses wherein the firs polymer material increases in flexibility from exposure of the orthodontic appliance to the environmental condition and enables the mutable shell to significantly increase in flexibility from exposure to the environmental condition, and wherein the two or more anchoring shell are configured to provide structural form to the mutable shell by the first polymer material decreasing in flexibility after cessation of the exposure of the orthodontic c appliance to the environmental condition (paragraph [0044]-[0045] the outer/anchoring shell provides structural form to remold the appliance and thus remolds the mutable/softened shell after the mutable shell was increased in flexibility above its glass transition temperature while that temperature that increased flexibility in the mutable/softer shell was below the harder/anchoring shells glass transition temperature and the outer/anchoring shell provides the structure to the mutable/softer shell upon cooling).
Regarding claim 20, Chishti further discloses wherein the orthodontic appliance has a working flexural modulus configured to therapeutically move teeth(paragraph [0044] all, a combined modulus to reposition teeth), and wherein the mutable shell made of the first polymer material that is configured to cause the orthodontic appliance to have a transitory flexural modulus that is reduced from the working flexural modulus when the orthodontic appliance is exposed to the environmental condition (paragraph [0044]-[0045] applied heat will reduce the forces of the inner layers and thus reduce the working flexural modulus).
Claims 23 are rejected under 35 U.S.C. 103 as being unpatentable over Chishti et al. (US 2002/0051951 A1) in view of Stewart et al. (US 2019/0105881 A1).
Regarding claim 23, Chishti discloses a method as discussed above but fails to explicitly disclose where the first polymer material that is a thermoplastic polyurethane is ISOPLAST TM 2530.
However, Stewart discloses a multi-layer orthodontic appliance with one of the multi layers being a thermoplastic polyurethane that has a glass transition temperature of 80-85 degrees Celsius that allows for being able to reversibly change shape (Fig. 1b inner layer a’ of A, para [0024] all disclosing the multi-layer A can reverse shape, paragraph [0015]/[0071] disclosing the polyurethane has a glass transition temperature of 80 or 85 Celsius), that is made of a thermoplastic polyurethane of ISOPLAST TM 2530 (Table I-Isoplast 2530).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the thermoplastic polyurethane to have been ISOPLAST 2530 into the thermoplastic polyurethane of Chisti, for the purpose of providing an improved flexibility and strength as taught by Stewart (paragraph [0084] all disclosing that the selected materials would provide for greater flexibility and user comfort and excellent cosmetics).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.P.S/Examiner, Art Unit 3772 06/08/2026
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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