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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 9, 2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the miscible polyester blend" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 10-12, 19 and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO 2022/003534 (Yu et al.).
Regarding claim 1, Yu discloses a dental appliance comprising a polymeric shell (102) comprising a plurality of cavities for receiving one or more teeth (104), wherein the polymeric shell comprises at least one layer including a polyester blend (see page 5, lines 27-29, Figure 1), the blend comprising:
A first, amorphous polyester (2,2,4,4-tetramethyl-1,3-cyclobutanediol modified polycyclohexylenedimethylene terephthalate) (see page 30, claim 8; which is described at paragraph 0036 of the instant specification as an option for the first polymer), and
A second, semi-crystalline polyester elastomer (PCTg or PETg or PCTA) (see page 30, claim 9, where it is stated that the polyester may be a mixture of said polyesters).
Yu does not necessitate the presence of a plasticizer in their disclosure, and thus it follows that the polyester blend does not include a substantial amount of plasticizer (less than 5% as defined at paragraph 0051 of the instant specification).
Yu also discloses that the shell has an expected haze of no greater than 10%, determined using ASTM D1003-13 (see page 22, lines 22-36), which is within the claimed range of no greater than 20%.
Regarding claim 2, Yu also discusses only a single glass transition temperature under DSC (see page 21, lines 7-12 where “the glass transition of the film” is mentioned, and page 14, lines 15-18 where measuring glass transition temperature by DSC is discussed), therefore they are miscible.
Regarding claim 3, Yu also discloses that the shell includes a multilayer film including a core layer, a skin layer and at least one inner layer disposed between the core and skin (see page 30, claim 6), and the inner layer (as well as the other layers “which may be the same”) includes the miscible polyester blend (see page 30, claims 7 and 8).
Regarding claim 10, Yu also discloses that the dental appliance may have an expected haze of no greater than 10% (see page 22, lines 22-36), as recited in the claim.
Regarding claim 11, Yu also discloses a film comprising at least one layer including a polyester blend (see page 5, lines 9-29, Figures 1 and 4), the blend comprising:
A first, amorphous polyester (2,2,4,4-tetramethyl-1,3-cyclobutanediol modified polycyclohexylenedimethylene terephthalate) (see page 30, claim 8; which is described at paragraph 0036 of the instant specification as an option for the first polymer), and
A second, semi-crystalline polyester elastomer (PCTg or PETg or PCTA) (see page 30, claim 9, where it is stated that the polyester may be a mixture of said polyesters).
Yu does not necessitate the presence of a plasticizer in their disclosure, and thus it follows that the polyester blend does not include a substantial amount of plasticizer (less than 5% as defined at paragraph 0051 of the instant specification).
Yu also discloses that the shell has an expected haze of no greater than 10%, determined using ASTM D1003-13 (see page 22, lines 22-36), which is within the claimed range of no greater than 20%.
Regarding claim 12, Yu also discusses only a single glass transition temperature under DSC (see page 21, lines 7-12 where “the glass transition of the film” is mentioned, and page 14, lines 15-18 where measuring glass transition temperature by DSC is discussed), therefore they are miscible.
Regarding claim 19, Yu also discloses a method of forming a shaped article, the method comprising
Providing a sheet of film comprising at least one layer (see page 20, lines 12-17) including a polyester blend comprising a first, amorphous polyester (2,2,4,4-tetramethyl-1,3-cyclobutanediol modified polycyclohexylenedimethylene terephthalate) (see page 30, claim 8; which is described at paragraph 0036 of the instant specification as an option for the first polymer), and
A second, semi-crystalline polyester elastomer (PCTg or PETg or PCTA) (see page 30, claim 9, where it is stated that the polyester may be a mixture of said polyesters).
Yu does not necessitate the presence of a plasticizer in their disclosure, and thus it follows that the polyester blend does not include a substantial amount of plasticizer (less than 5% as defined at paragraph 0051 of the instant specification).
Providing a first positive model (see page 20, lines 12-17);
Drawing the sheet over the model at a molding temperature (see page 20, lines 12-26); and
Cooling the sheet and model to atmospheric temperature to form an article (see page 20, line 26 through page 21, line 23), wherein the formed article has an expected haze of less than 10% (see page 22, lines 32-36), which is within the claimed range of less than 17%.
Regarding claim 20, Yu also discloses that the article is a tray aligner, and wherein the first positive model is representative of a patient’s dentition (see page 20, lines 12-17).
Claims 1-18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 2025/0215213 (Givens et al.).
Regarding claim 1, Givens discloses a dental appliance comprising a polymeric shell comprising a plurality of cavities for receiving one or more teeth, wherein the polymeric shell comprises at least one layer including a polyester blend (see paragraph 0178), the blend comprising a first amorphous polyester (Tritan copolyesters, see paragraph 0104; described at paragraph 0036 of instant specification as suitable first polyester PCTT); and
A second, semi-crystalline polyester elastomer (Neostar or Ecdel copolyesters, see paragraph 0104; described at paragraph 0041 of instant specification as suitable second polyesters PCCE).
Givens does not necessitate the presence of a plasticizer in their disclosure, and thus it follows that the polyester blend does not include a substantial amount of plasticizer (less than 5% as defined at paragraph 0051 of the instant specification).
Givens also discloses embodiments where the shell has an expected haze of no greater than 20% (see Table 1, EX 1-1, 1-2, 1-3, 1-4), as claimed. Although Givens does not expressly identify ASTM D1003-13 as the measurement method, Givens discloses a polymeric shell having the same composition as the presently claimed shell. Accordingly, there is a sound basis for concluding that the film of Givens would inherently exhibit the claimed haze when measured according to ASTM D1003-13. Where the prior art and the claimed products are identical or substantially identical, the burden shifts to Applicant to establish that the prior-art product does not possess the claimed property (see MPEP 2112.01).
Regarding claim 2, Givens does not necessitate the presence of a compatibilizer, and thus it follows that the blend is in the absence of a compatibilizer. While Givens does not specifically state that the blend is miscible, in that it exhibits a single glass transition temperature, the reference teaches all the claimed ingredients in the claimed amounts made by a substantially similar process. Moreover, the original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components in the claimed amounts. Therefore, the claimed miscibility with a single glass transition temperature would naturally arise and be achieved by a composition with all the claimed ingredients. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see MPEP 2112.01).
Regarding claim 3, Givens also discloses that the shell includes a multilayer film including a core layer, a skin layer, and at least one inner layer disposed between the core and the skin, wherein the inner layer includes the polyester blend (see paragraph 0170).
Regarding claim 4 and 5, while Givens does not state the Force Persistence exhibited by the appliance, the reference teaches all the claimed ingredients in the claimed amounts made by a substantially similar process. Moreover, the original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components in the claimed amounts. Therefore, the claimed Force Persistence would naturally arise and be achieved by a composition with all the claimed ingredients. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see MPEP 2112.01).
Regarding claim 6, Givens also discloses an embodiment where the blend comprises 50 wt% of the second polyester (see Table 1 and paragraphs 0214-0215), which is within the claimed range of 80 to 40 wt%, and 50 wt% of the first polyester (see Table 1 and paragraphs 0214-0215 and 0166), which is within the claimed range of 20 to 60 wt%.
Regarding claim 7, Givens also discloses that the first polyester comprises a Tritan polymeric component (see paragraph 0104), which is defined at paragraph 0036 of the instant specification as being a commercially available source of PCTT.
Regarding claim 8, Givens also disclose that the second polyester comprises Neostar or Ecdel (see paragraph 0104), which are defined at paragraph 0041 of the instant specification as being commercially available sources of PCCE or mPCCE.
Regarding claim 9, Givens also discloses embodiments where the blend comprises 50 wt% of Neostar (PCCE or mPCCE) (see Table 1 and paragraphs 0214-0215 and 0166), which is within the claimed range of 60 to 40 wt%, and 50 wt% of Tritan (PCCT) (see Table 1 and paragraphs 0214-0215 and 0166), which is within the claimed range of 40 to 60 wt%.
Regarding claim 10, Givens also discloses that the dental appliance has an expected haze of 1.2% or less (see Table 1), which is within the claimed range of no greater than 10%.
Regarding claim 11, Givens discloses a film comprising at least one layer including a polyester blend, the blend comprising a first, amorphous polyester (Tritan copolyesters, see paragraph 0104; described at paragraph 0036 of instant specification as suitable first polyester PCTT); and
A second, semi-crystalline polyester elastomer (Neostar or Ecdel copolyesters, see paragraph 0104; described at paragraph 0041 of instant specification as suitable second polyesters PCCE).
Givens does not necessitate the presence of a plasticizer in their disclosure, and thus it follows that the polyester blend does not include a substantial amount of plasticizer (less than 5% as defined at paragraph 0051 of the instant specification).
Givens also discloses embodiments where the shell has an expected haze of no greater than 20% (see Table 1, EX 1-1, 1-2, 1-3, 1-4), as claimed.
Regarding claim 12, Givens does not necessitate the presence of a compatibilizer, and thus it follows that the blend is in the absence of a compatibilizer. While Givens does not specifically state that the blend is miscible, in that it exhibits a single glass transition temperature, the reference teaches all the claimed ingredients in the claimed amounts made by a substantially similar process. Moreover, the original specification does not identify a feature that results in the claimed effect or physical property outside of the presence of the claimed components in the claimed amounts. Therefore, the claimed miscibility with a single glass transition temperature would naturally arise and be achieved by a composition with all the claimed ingredients. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see MPEP 2112.01).
Regarding claim 13, Givens also discloses an embodiment where the blend comprises 50 wt% of the first polyester (see Table 1 and paragraphs 0214-0215 and 0166), which is within the claimed range of 5 to 60 wt%, and 50 wt% of the second polyester elastomer (see Table 1 and paragraphs 0214-0215 and 0166), which is within the claimed range of 95 to 40 wt%.
Regarding claim 14, Givens also discloses an embodiment where the blend comprises 50 wt% of the first polyester (see Table 1 and paragraphs 0214-0215 and 0166), which is within the claimed range of 20 to 60 wt%, and 50 wt% of the second polyester elastomer (see Table 1 and paragraphs 0214-0215 and 0166), which is within the claimed range of 80 to 40 wt%.
Regarding claim 15, Givens also discloses that the first polyester comprises a Tritan polymeric component (see paragraph 0104), which is defined at paragraph 0036 of the instant specification as being a commercially available source of PCTT.
Regarding claim 16, Givens also disclose that the second polyester comprises Neostar or Ecdel (see paragraph 0104), which are defined at paragraph 0041 of the instant specification as being commercially available sources of PCCE or mPCCE.
Regarding claim 17, Givens also disclose that the second polyester comprises Neostar or Ecdel (see paragraph 0104), which are defined at paragraph 0041 of the instant specification as being commercially available sources of mPCCE.
Regarding claim 18, Givens also discloses embodiments where the blend comprises 50 wt% of Neostar (PCCE or mPCCE) (see Table 1 and paragraphs 0214-0215 and 0166), which is within the claimed range of 80 to 40 wt%, and 50 wt% of Tritan (PCCT) (see Table 1 and paragraphs 0214-0215 and 0166), which is within the claimed range of 20 to 60 wt%.
Claim Rejections - 35 USC § 102/103
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 4 and 5 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2022/003534 (Yu et al.).
Yu discloses a dental appliance as discussed above.
Regarding claims 4 and 5, Yu also discloses that the appliance exhibits enhanced force persistence (see page 5, lines 24-26); however, this is not stated in any percentage. Based on this statement to enhance force persistence, it would have been obvious to one having ordinary skill in the art before the effective filing date to maximize the force persistence of the dental appliance. Since it is intended to apply corrective forces on the teeth, it is implicit that the dental appliance must have as high a force persistence level as possible as it must maintain its shape during the treatment to apply a corresponding force.
Alternatively, the Yu dental appliance and material is substantially the same as that disclosed in the specification of the instant application, and so it follows that because the material of the Yu dental appliance and the instant application appear to be the same, there is a reasonable basis to conclude that the force persistence would be at least 50% (claim 4), or at least 65% (claim 5). The reference teaches all the claimed ingredients made by a substantially similar process. Therefore, the physical property would naturally arise and be achieved by a material having all the claimed ingredients. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see MPEP 2112.01).
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.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2025/0215213 (Givens et al.) in view of WO 2022/003534 (Yu et al.).
Givens discloses a shaped article (dental appliance) provided from a sheet of film comprising at least one layer including a polyester blend comprising a first, amorphous polyester, and a second, semi-crystalline polyester elastomer, having an expected haze of less than 17%, as discussed above.
Regarding claim 19, Givens does not disclose the method steps of forming the shaped article; however, in the analogous field of dental appliances, Yu discloses a method of forming a dental appliance comprising the steps of providing a sheet of film;
Providing a first positive model (see page 20, lines 12-17);
Drawing the sheet over the model at a molding temperature (see page 20, lines 12-26); and
Cooling the sheet and model to atmospheric temperature to form an article (see page 20, line 26 through page 21, line 23).
It would have been obvious to one having ordinary skill in the art before the effective filing date to produce the Givens dental appliance according to the method taught by Yu. One of ordinary skill in would have been motivated to do so because Yu expressly teaches thermoforming polymeric films as an efficient technique for producing dental appliances having tooth-retaining cavities (see page 20, lines 3-8).
Regarding claim 20, Givens in view of Yu also discloses that the article is a tray aligner, and wherein the first positive model is representative of a patient’s dentition (see Yu page 20, lines 12-17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENDY L BOSS whose telephone number is (571)272-7466. The examiner can normally be reached 8:30-6:30.
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/WENDY L BOSS/Examiner, Art Unit 1749
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