Appl. No.: 16/043,065
`Reply to Final Office Action of October 30, 2020
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`Attorney Docket No.: 22773-826.303
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`REMARKS
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`Upon entry of this Amendment, claims 30-31, 36-37, 39-40, 48-49, 58, 62-63, 69, and 71-
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`88 will be pending in the present application. Claim 1-29, 32-33, 35, 38, 41-47, 50-57, 59-60, 64-
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`68, and 70 were previously canceled without prejudice or disclaimer. Claims 34 and 61 are
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`presently canceled without prejudice or disclaimer. Applicant reserves the right to pursue any
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`canceled subject matter in a related, future application. Claims 30, 49 and 58 have been amended
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`herewith this Amendment. Support for these amendments can be found in the specification as
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`originally filed and now canceled claims 34 and 61. Accordingly, no new matter has been added.
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`Reconsideration is respectfully requested.
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`Specification
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`The specification is objected to for allegedly failing to provide proper antecedentbasis for
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`claimed subject matter. Specifically, the Office states the “specific range of the appliance is not
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`discussed in the specification; however, it is noted that the range was disclosed in the parent
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`application and original claims.” Applicant herewith has amendedthe specification. Support for
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`the amendments are provided above.
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`Claim Rejections — 35 USC § 103
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`Claims 30-31, 36, 40, 48-49, 58, 62-63, 74, 78-84, and 86-88
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`Claims 30-31, 36, 40, 48-49, 58, 62-63, 74, 78-84, and 86-88 stand rejected under 35
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`U.S.C. § 103(a) as allegedly unpatentable over Kalili (U.S. Pub. No. 2011/0020761, hereinafter
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`“Kalili’”), in view of DeSimoneet al. (U.S. Pub. No. 2008/0248438, hereinafter “DeSimone’”), as
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`evidenced by Bayer Corporation (TEXIN 990R,pages 1-4, November2002, Pittsburgh, PA (Year:
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`2002), hereinafter “Bayer”). Specifically, the Office alleges that Kalili/DeSimone teaches the
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`invention as substantially claimed and discussed above, however, does not specifically the soft
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`polymer layer has a flexural modulus of greater than about 35,000 psi .
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`.
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`. It would have been
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`obvious .. . to modify Kalili/DeSimone with the flexural modulus taught by Stewart in order to
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`[move] the teeth as desired.” (Office Action, p. 3). Applicant disagrees.
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`Without conceding on the basis of the rejection and solely to expedite prosecution of the
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`instant application, Applicant has amended independent claim 30 to recite in part, “a soft polymer
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`layer comprising a thermoplastic polyurethane elastomer having an ultimate tensile strength of
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`Appl. No.: 16/043,065
`Reply to Final Office Action of October 30, 2020
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`Attorney Docket No.: 22773-826.303
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`greater than about 5000 psi, an elongation at break of greater than about 200%, a hardness of
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`about 60 A to about 85 D, and aflexural modulus ofgreater than about 35,000 psi.” Independent
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`claims 49 and 58 have been analogously amended. Further,
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`the Office concedes that
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`“Kalili/DeSimone .
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`.
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`. does not specifically [sic] the soft polymerlayer has a flexural modulus of
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`greater than about 35,000 psi.” (Office Action, p. 11).
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`Neither of Kalili, DeSimone, and Bayer alone or in combination, teaches, discloses or even
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`suggests “a soft polymer layer comprising a thermoplastic polyurethane elastomer having an
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`ultimate tensile strength of greater than about 5000 psi, an elongation at break of greater than
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`about 200%, a hardness ofabout 60 A to about 85 D, and aflexural modulus ofgreater than about
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`35,000 psi.” Thus, the cited combination of Kalili, DeSimone, and Bayer, alone or in combination,
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`fails to teach or in any way suggest each and every element of independent claims 30, 49, and 58.
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`Moreover, as discussed below as to now cancelled claims 34 and61, the addition of Stewart fails
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`to remedy this deficiency.
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`Therefore, for the reasons stated above, the cited combination of Kalili, DeSimone, and
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`Bayer fail to establish a prima facie case of obviousness for independent claims 30, 49, and 59,
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`and are therefore allowable. Claims 31, 36, 40, 48, 86, and 88 depend from allowable claim 30 and
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`are therefore allowable at least for their dependence on claim 30 and their own merits. Claim 74
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`depends from allowable claim 49 and are therefore allowable at least its dependence on claim 49
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`and its own merits. Claims 62, 63, 78-84, and 87 depend from allowable claim 58 andare therefore
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`allowable at least for their dependence on claim 58 and on their own merits.
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`Accordingly, at least for the reasons set forth above, withdrawal of the rejection of claims
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`30-31, 36, 40, 48-49, 58, 62-63, 74, 78-84, and 86-88 under 35 U.S.C. § 103(a)is respectfully
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`requested.
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`Claims 34 and 61
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`Claims 34 and 61 stand rejected under 35 U.S.C. § 103(a) as allegedly unpatentable over
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`Kalili (U.S. Pub. No. 2011/0020761, hereinafter “Kalili”), in view of DeSimoneet al. (U.S. Pub.
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`No. 2008/0248438, hereinafter “DeSimone’), as evidenced by Bayer Corporation (TEXIN 990R,
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`pages 1-4, November2002, Pittsburgh, PA (Year: 2002), hereinafter “Bayer”) as applied to claims
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`30 and 58 above, and further in view of Stewart (U.S. Pub. No. 2015/0374464, hereinafter
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`Appl. No.: 16/043,065
`Reply to Final Office Action of October 30, 2020
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`Attorney Docket No.: 22773-826.303
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`“Stewart’). Specifically, the Office alleges that “Kalili/Desimone teaches the invention ...
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`however, does not specifically the soft polymer layer has a flexural modulus of greater than about
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`35,000 psi. (Office Action, pp. 11-12). The Office further alleges that “Stewart, teaches a polymer
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`with a flexural modulus of greater than about 35,000 psi (par. 82, 1000 MPa is 145038 psi). It
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`would have been obvious to one having ordinary skill in the art at the time of the invention to
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`modify Kalili/DeSimonewith the flexural modulus taught by Stewart in order moretheteeth [sic. ]
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`as desired.” /d. Applicant disagrees.
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`As provided above, former claims 34 and 61 have been amended into claims 30 and 58
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`respectively, with similar amendments to claim 49. Claims 34 and 61 have been cancelled, thus
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`the rejection is moot against claims 34 and 61. However, the relevancy of this rejection to
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`independentclaims 30, 49 and 58 are discussed herein. As previously discussedin detail, the cited
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`combination of Kalili, DeSimone, and Bayer, alone or in combination, fails to teach, disclose or
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`suggest “a soft polymer layer comprising a thermoplastic polyurethane elastomer having an
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`ultimate tensile strength of greater than about 5000 psi, an elongation at break of greater than
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`about 200%, a hardness ofabout 60 A to about 85 D, and aflexural modulus ofgreater than about
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`35,000 psi.” Thus, the cited combination including Stewart will be discussed.
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`The Office fails to address, and the art fails to establish a reason why a person skilled in
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`the art would look to modifying Kalili and DeSimone with Stewart. Kalili is drawn to a device
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`wherein the inner layer has a lower elastic modulus than the outer layer. ({ 0069). The Office
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`specifically relies on TEXIN 99Ras having a hardness within the claimed range. Stewart describes
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`the altering of optical properties of self-supporting shells in order to improve the appearance of
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`teeth. (J 0001). Stewart provides that “this invention provides a self-supporting shell whichfits
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`over one or more teeth and which is composed of a polymeric composition comprising a polymer
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`and one or more optical additives which cause the combination of the shell and the teeth to have a
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`desired appearance.” ({ 0006). Paragraph 82, relied upon by the Office, merely teaches that
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`“Tw]hen the shell is also used as part of an orthodontic procedure, the polymeric composition
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`preferably has a flexural modulus of more than 1000 MPa....” The shell of Stewart is a sheet of
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`a polymeric composition, and when multiple sheets are used, they are disclosed as having different
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`amounts of optical additives. (] 0017). Neither the art nor the Office established a reason as to why
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`the ordinary artisan, in view of the teachings of Kalili, which teaches a two layer device in which
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`Appl. No.: 16/043,065
`Reply to Final Office Action of October 30, 2020
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`Attorney Docket No.: 22773-826.303
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`the liner may be TEXIN 99R, which the Office specifically relies upon as having the required
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`hardness, would have looked at the teachings of Stewart, which is primarily drawnto a shell for
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`changing the perceived colorof the teeth, for a specific flexural modulus of the polymerto be used
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`in the device of Kalili. The deficiencies of Kalili and Stewart, alone or in combination, are not
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`remedied by DeSimone. Additionally, the deficiencies of Kalili, DeSimone, and Stewart, alone or
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`in combination, are not remedied by Bayer because Bayer merely provides evidentiary values for
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`the TEXIN 99R material.
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`Therefore, the cited combination of Kalili, DeSimone, Bayer, and Stewart fail to establish
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`a prima facie case of obviousness for independent claims 30, 49, and 59, and are therefore
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`allowable. Claims 31, 36-37, 39-40, 48, 71, 72, 86, and 88 depend from claim 30 andare allowable
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`at least for their dependency on claim 30 and on their own merits. Claims 74-77 depend from claim
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`49 and are allowable atleast for their dependency on claim 49 and on their own merits. Claims 62-
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`63, 69 73 78-85 and 87 depend from claim 58 andare allowable at least for their dependency on
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`claim 59 and on their own merits.
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`Accordingly, at least for the reasons set forth above, withdrawal of the rejection of claims
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`34 and 61 under 35 U.S.C. § 103(a) is respectfully requested. Additionally, for the reasonsset forth
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`above, Applicant respectfully submits that independent claims 30, 49, and 58 are not rendered
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`obviousby the cited combination of Kalili, DeSimone, Bayer, and Stewart.
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`Claims 34, 37, and 61
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`Claims 34, 37, and 61 stand rejected under 35 U.S.C. § 103(a) as allegedly unpatentable
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`over Kalili in view of DeSimoneas evidenced by Bayer, and further in view of Tadros (U.S. Pub.
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`No. 2005/0100853, hereinafter “Tadros”). Specifically, the Office alleges that “Kalili/DeSimone
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`teaches the invention as substantially claimed and discussed above, however, does not specifically
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`teach the soft polymer layer comprises a material selected from the group consisting of a silicone
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`rubber, an elastomeric alloy, a thermoplastic elastomer, a thermoplastic vulcanizate elastomer, a
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`block copolymerelastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer
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`and a thermoplastic polyamide elastomer or any combination thereof and the soft polymer layer
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`has a flexural modulus of greater than about 35,000 psi. Tadros teaches .
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`.
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`. a layer made from two
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`polymers including a thermoplastic polyurethane elastomer and block copolymer elastomer and
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`Appl. No.: 16/043,065
`Reply to Final Office Action of October 30, 2020
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`Attorney Docket No.: 22773-826.303
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`silicons. .
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`. [1]t would have been obviousto one having ordinary skill in the art before the invention
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`to modify the single material taught by Kalili/DeSimone with a blended/mixed material as taught
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`by Tadros in order to provide the desired properties of the material as taught by Tadros.” (Office
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`Action, p. 12-13).
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`The Office further states “Tadros teaches .
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`.
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`. a layered dental appliance comprising a layer
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`made from a two polymersincluding a thermoplastic polyurethane elastomer and block copolymer
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`elastomer and silicones wherein the material selected is ECDEL 996 which hasa flexural modulus
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`of about 35,000 psi and other material properties as claimed including the elongation of break and
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`the hardness (see cited material properties). It would have been obvious .
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`.
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`. to modify the single
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`material taught by Kalili/DeSimone with a blended/mixed material taught by Tadros in order to
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`provide the desired properties of the material as taught by Tadros.” /d. Applicant disagrees.
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`As provided above, former claims 34 and 61 have been amended into claims 30 and 58
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`respectively. Claims 34 and 61 have been cancelled, thus the rejection is moot against claims 34
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`and 61. However, the relevancy ofthis rejection to independentclaims 30, 49, and 58 are discussed
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`herein. As previously discussed in detail, the cited combination of Kalili, DeSimone, and Bayer,
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`alone or in combination, fails to teach, disclose or even suggest “a soft polymer layer comprising
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`a thermoplastic polyurethane elastomer having an ultimate tensile strength ofgreater than about
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`5000 psi, an elongation at break ofgreater than about 200%, a hardness of about 60 A to about
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`85 D, and a flexural modulus of greater than about 35,000 psi.” Thus, the cited combination
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`including Tadros and will be discussed.
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`A person of ordinary skill in the art would have had no reasonable expectation of success
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`in introducing the Office’s proposed combination of materials while achieving the claimed
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`material properties. The Office states that “it would have been obviousto one having ordinary skill
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`in the art to modify the material to have the flexural modulus as claimed in order to provide the
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`desired properties since it has been held that discovering an optimum or workable range involves
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`only routine skill
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`in the art.” (Office Action, p. 13). Applicant disagrees with the Office’s
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`assessment of the material properties disclosed by the cited portions of Tadros. Tadros describes
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`the use of ECDEL 9966 as a material purportedly having a tensile modulus less than or equal to
`about 1,000 N/mm?. (4 0073) However, ECDEL 9966 does not have a flexural modulus greater
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`than about 35,000 psi—it has a flexural modulus of approximately 21,800 psi. See Ecdel™ 9966
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`Appl. No.: 16/043,065
`Reply to Final Office Action of October 30, 2020
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`Attorney Docket No.: 22773-826.303
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`data sheet, provided herewith. It also does not have an ultimate tensile strength greater than about
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`5000 psi (its tensile strength at yield is 2030 psi; tensile strength at break is 3190 psi).
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`Further, Tadros fails to remedy the deficiencies of Kalili, DeSimone, and Bayer, either
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`alone or in combination. The Office concedesthat “Tadros does not specifically teach the flexural
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`modulusgreater than 35,000 psi.” (Office Action, p. 13). Neither of Kalili, DeSimone, Bayer, and
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`Tadros, alone or in combination,
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`teaches, discloses or even suggests “a soft polymer layer
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`comprising a thermoplastic polyurethane elastomer having an ultimate tensile strength ofgreater
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`than about 5000 psi, an elongation at break ofgreater than about 200%, a hardness ofabout 60
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`A to about 85 D, and a flexural modulus of greater than about 35,000 psi.” Thus, the cited
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`combination of Kalili, DeSimone, Bayer, and, Tadros, alone or in combination,fails to teach or in
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`any way suggest each and every element of independent claims 30 and 58.
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`Therefore, the cited combination of Kalili, DeSimone, Bayer, and Tadrosfail to establish
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`a primafacie case of obviousness for claims independent claims 30, 49, and 58. Claims 31, 36-37,
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`39-40, 48, 71, 72, 86, and 88 depend from claim 30 and are allowable at least for their dependency
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`on claim 30 and on their own merits. Claims 74-77 depend from claim 49 andare allowable at
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`least for their dependency on claim 49 and on their own merits. Claims 62-63, 69 73 78-85 and 87
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`depend from claim 58 andare allowable at least for their dependency on claim 59 and on their own
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`merits.
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`Accordingly, at least for the reasons set forth above, withdrawal of the rejection of claims
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`34, 37, and 61 under 35 U.S.C. § 103(a) is respectfully requested. Additionally, for the reasonsset
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`forth above, Applicant respectfully submits that independentclaims 30, 49, and 58 are not rendered
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`obviousby the cited combination of Kalili, DeSimone, Bayer, and Tadros.
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`Claims 39, 69, 71-73, 75-77, and 85
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`Claims 39, 69, 71-73, 75-77, and 85 stand rejected under 35 U.S.C. § 103(a) as allegedly
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`unpatentable over Kalili in view of DeSimone as evidenced by Bayer, and in further view of
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`Schwartz (U.S. Pub. No. 2009/0298006). Specifically, the Office alleges that “Kalili/DeSimone
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`teaches the invention as substantially claimed and discussed above, however, does not specifically
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`teach wherein the soft polymer layer comprises more than one polymer layer, wherein the
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`multilayer dental appliance comprises three polymerlayer of alternating hardness, the appliance
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`Appl. No.: 16/043,065
`Reply to Final Office Action of October 30, 2020
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`Attorney Docket No.: 22773-826.303
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`has a thickness between 500 um and 1200 um, wherein the appliance comprises three polymer
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`layer wherein the three polymer layers comprise the soft polymer layer and hard polymerlayer. .
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`. It would have been obvious .
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`.
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`. to modify the two layer appliance taught by Kalili/DeSimone
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`with the three layer appliance taught by Schwartz as an obvious matter of design choice.” (Office
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`Action, p. 13-14).
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`As Applicant has indicated above, the cited combination of Kalili, DeSimone, and Bayer,
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`either alone or in combination, fail to teach or suggest each and every element of independent
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`claims 30, 49 and 58. The cited portions of Schwartz do not teach, disclose or suggest “a soft
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`polymer layer comprising a thermoplastic polyurethane elastomer having an ultimate tensile
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`strength of greater than about 5000 psi, an elongation at break of greater than about 200%, a
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`hardness ofabout 60 A to about 85 D, and aflexural modulus ofgreater than about 35,000 psi.”
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`Schwartz does not cure deficiencies of Kalili, DeSimone, and Bayer, alone or in combination.
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`Therefore, the cited combination of Kalili, DeSimone, Bayer, and Schwartz, either alone or in
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`combination, fails to teach, or in any way suggest each and every element of independentclaims
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`30, 49, and 58.
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`For the reasons stated above, the cited combination of Kalili, DeSimone, Bayer, and
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`Schwartz fail to establish a prima facie case of obviousness for independent claim 30, 49 and 58
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`and are therefore allowable. Claims 39, 69, 71-73, 75-77, and 85 depend from one of allowable
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`claims 30, 49 and 58, and are therefore allowable at least for their dependence on these claims and
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`on their own merits.
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`Accordingly, at least for the reasons set forth above, withdrawal of the rejection of claims
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`39, 69, 71-73, 75-77, and 85 under 35 U.S.C. § 103(a) is respectfully requested.
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`Previously Submitted Declaration under 37 C.F.R. § 1.312
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`Applicant thanks the Office for their consideration of the declaration filed under 37 C.F.R.
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`§ 1.312 on September 18, 2020. Applicant does not concede that the Office’s characterization or
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`statements regarding the declaration are correct or accurate.
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`Page 15 of 17
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`Appl. No.: 16/043,065
`Reply to Final Office Action of October 30, 2020
`
`Attorney Docket No.: 22773-826.303
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`Double Patenting
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`Claims 30-31, 34, 36, 37, 39, 40, 48, 49, 58, 61-63, 69, 71-86, and 88 are rejected on the
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`groundof nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7, 10-15, and
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`23-25 of U.S. Patent No. 10,052,176. (Office Action, pp. 14-38).
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`The rejection is acknowledged and will be addressed upon final resolution of the claims
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`by, e.g., filing a terminal disclaimer, if necessary.
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`Page 16 of 17
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`Appl. No.: 16/043,065
`Reply to Final Office Action of October 30, 2020
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`Attorney Docket No.: 22773-826.303
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`CONCLUSION
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`In view of the foregoing, Applicant believes all claims now pendingin this Application are
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`in condition for allowance. The issuance of a formal Notice of Allowance at an early date is
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`respectfully requested.
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`Further, the Commissioner is hereby authorized to charge any additional fees or credit any
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`overpayment in connection with this paper to Deposit Account No. 23-2415.
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`If the Examiner believes a telephone conference would expedite prosecution of this
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`application, please telephone the undersigned at 206-883-2500.
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`Dated: April 29, 2021
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`/Luis Perla/
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`Respectfully submitted,
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`Luis G. Perla, PhD
`Registration No. 77,556
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`WILSON SONSINI GOODRICH & ROSATI
`650 Page Mill Road
`Palo Alto, CA 94304-1050
`Tel: 650-493-9300
`Fax 650-493-6811
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`Page 17 of 17
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