Appl. No.: 16/382,918
`Reply to Office Action of October 20, 2021
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`Attorney Docket No.: 22773-826.305
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`REMARKS
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`Upon entry of this amendment, claims 1, 5, 7, 9-13, 17, 19, and 31-41 will be pending
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`and at issue in the present application. Claims 1, 5, 7, 9-10, 12-13, 17, 19, 31-39, and 41 are
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`currently amended. Claims 20, 23, 24, 29-30 were previously withdrawn and currently amended.
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`Support for the amendments can be found throughoutthe application as originally filed. No new
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`matter is introduced. Reconsideration is respectfully requested.
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`Claim Rejections — 35 USC § 103
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`Claims 1, 5, 7, 9-13,17,19, and 31-41 were rejected under 35 U.S.C. § 103 as allegedly
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`unpatentable over Chenet al. (U.S. Pub. No. 2009/0246724) in view of Hostettler (U.S. Patent
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`No. 4,791,156) and DeSimoneet al. (U.S. Patent No. 7,461,898) as evidenced by Plastics (non-
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`patentliterature No. 107). Applicant disagrees and respectfully submits that the pending claims
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`are patentably distinct over the cited references.
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`As explained in the Office Action Response of October 28, 2019 (“10/28/2019
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`Response’), the remarks for which are incorporated by reference in their entirety, there was no
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`expectation of success in making the modifications proposed by the Office Action, and the
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`recited features demonstrated unexpected results and commercial success. 10/28/2019 Response,
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`15-24. Such unexpected results and commercial success are demonstrated at least by the
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`Declaration of Chunhua Li under 37 C.F.R. §1.132 (‘Li Declaration’), filed October 28, 2019.
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`With respect to unexpected results, the Li Declaration explains that “the fact that the over
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`250 materials tested by my team did not provide results meeting the desired criteria, while the
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`SmartTrack material having alternating polymer layers comprising co-polyester and
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`thermoplastic polyurethane, as well as features of the instant claims was found to meet Align's
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`criteria for a multilayer appliance, itself suggests that there was no predictability and there would
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`have been no reasonable expectation of success in combining the teachings of Chen and
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`DeSimone. If anything, a person of ordinary skill in the art would have expected failure in light
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`of the above-described developmenthistory.” Li Declaration, 5.
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`With respect to unexpected benefits and commercial success, the Li Declaration explains
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`that “the Experimental Group (ST30) showed greater than 75% improvementin overall tooth
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`movementpredictability over the Control Group.” /d., 7. Indeed, “[t]he effectiveness of
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`Page 9 of 12
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`Appl. No.: 16/382,918
`Reply to Office Action of October 20, 2021
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`Attorney Docket No.: 22773-826.305
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`appliances made with multilayered materials combining alternating polymer layers comprising
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`co-polyester and thermoplastic polyurethane, as well as the material properties as described by
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`the current claims wassurprising, and a person of ordinary skill in the art would not have
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`predicted the improved performance demonstrated.” /d., 8.
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`Applicant respectfully submits that nothing in the record rebuts the lack of any
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`expectation of success in making the proposed modifications, or the unexpected results and
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`commercial success established by the Li Declaration. Rather, the Office Action states that “[i]t
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`is maintained that Chen, DeSimone, and Hostettler, are all directed to orthodontic shell
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`appliances. Thus it would have been obviousto one of ordinary skill in the art at the time of
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`invention to utilize the materials taught by DeSimone to form Chen's hard layer.” Office Action,
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`11. Applicant respectfully submits that such conclusion is not supported by the record, at least in
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`part because of the analysis provided in the Li Declaration.
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`The Office Action also remarked that the Li Declaration “fails to provide a nexusto the
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`claimed invention(s)” because the affidavit refers to a system with “a hard polymerlayer
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`between twosoft polymerlayers.” Office Action, 12-13. Applicant respectfully disagrees and
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`submits that the Li Declaration describes the unexpected results and commercial success of
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`alternating polymerlayers comprising co-polyester and thermoplastic polyurethane. Nonetheless,
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`solely in the interest of advancing prosecution, the pending claims have been herein amended. As
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`amended, independentclaim 1 recites in part “a first soft outer polymer layer ... a second soft
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`outer polymer layer ... a hard inner polymerlayer ... wherein the hard inner polymerlayeris
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`disposed between thefirst soft outer polymer layer and the second soft outer polymerlayer.”
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`Independentclaims 13 and 33 as amendedrecite similar subject matter. Thus, any alleged lack of
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`nexus between the pending claims and the unexpected results and commercial success
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`demonstrated by the Li Declaration has been rendered moot. Accordingly, Applicants
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`respectfully submits that independent claims 1, 13, and 33 are patentably distinct over Chen,
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`DeSimone, Hostettler, and Plastics, whether considered alone or in any combination thereof, for
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`at least the reasons above. See also 10/28/2019 Response, 15-24.
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`Dependentclaims 5, 7, 9-12,17,19, 31-21, and 34-41each depend from one of
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`independent claims 1, 13, or 33 and thus incorporate all the features recited therein. Forat least
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`the reasons above, these dependent claims are also patentably distinct over Chen, DeSimone,
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`Appl. No.: 16/382,918
`Reply to Office Action of October 20, 2021
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`Attorney Docket No.: 22773-826.305
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`Hostettler, and Plastics, whether considered alone or in any combination thereof. Accordingly,
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`withdrawal of the corresponding rejections under 35 U.S.C. § 103 is respectfully requested.
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`Statements Regarding Claimed Priority
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`The Office Action alleged that claims 1, 3-7, 9-13, 15-18, and 34-42 are not entitled to
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`the claimedpriority. In particular, the Office Action alleged that independent claims 1, 13, and
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`33 omit “(i) two distinguishable soft layers, (11) a distinguishable hard layer, and (iii) the
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`arrangementof the hard layer being positioned between twosoft layers.” Office Action, 2.
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`Applicant respectfully disagrees and submits that the claims as previously submitted find support
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`and enablementin the priority documents. Nonetheless, solely in the interest of advancing
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`prosecution, the pending claims have been herein amended. As amended, independentclaim 1
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`recites in part “a first soft outer polymerlayer ... a second soft outer polymer layer ... a hard
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`inner polymerlayer ... wherein the hard inner polymerlayeris disposed betweenthefirst soft
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`outer polymer layer and the second soft outer polymer layer.” Independent claims 13 and 33 as
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`amended recite similar subject matter. Further, the Office Action alleged that “the prior-filed
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`applications for such specifically claimed combination.” Office Action, 3. Applicant respectfully
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`disagrees and submits that the prior filed applications support the embodiments claimed. Support
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`can be found in the parent applicationsasfiled at, for example, paragraphs [0027]-[0029] of U.S.
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`Application No. 13/470,681 (now U.S. Patent No. 9,655,691). Accordingly, withdrawal of the
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`corresponding statements to the claimedpriority is respectfully requested.
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`Claim Rejections — 35 USC § 112
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`Claims 1, 5, 7, 9-13, 17, 19, and 31-41 were rejected under 35 U.S.C. § 112 as allegedly
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`failing to comply with the written description requirement and as allegedly indefinite for failing
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`to particularly point out and distinctly claim the subject matter. In particular, the Office Action
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`alleged that independent claims 1, 13, and 33 (and their corresponding dependentclaims)fail to
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`recite omitted features and omitted structural cooperative relationships. Office Action, 5-8.
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`Applicant respectfully disagrees. Nonetheless, solely in the interest of advancing prosecution, the
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`pending claims have been herein amended. As amended, independentclaim 1 recites in part “a
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`first soft outer polymerlayer ... a second soft outer polymerlayer ... a hard inner polymerlayer
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`Page 11 of 12
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`Appl. No.: 16/382,918
`Reply to Office Action of October 20, 2021
`
`Attorney Docket No.: 22773-826.305
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`... wherein the hard inner polymerlayer is disposed between thefirst soft outer polymerlayer
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`and the second soft outer polymerlayer.” Independent claims 13 and 33 as amendedrecite
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`similar subject matter. Accordingly, withdrawal of the corresponding rejections under 35 U.S.C.
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`§ 112 is respectfully requested.
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`Alleged Double Patenting
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`Claims 1, 5, 7, 9-13, 17, 19, and 31-41 were rejected on the ground of nonstatutory
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`double patenting as allegedly being unpatentable over: claims 1-31 of U.S. Patent No. 9,655,691;
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`claims 1-20 of U.S. Patent No. 9,655,693; and claims 1-14 of U.S. Patent No. 10,052,176. The
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`rejection is acknowledged. Applicant respectfully requests that the rejections be held in abeyance
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`until final resolution of the claims. At that time, Applicant mayfile a terminal disclaimer,if
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`necessary, to resolve the alleged double patenting rejection.
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`CONCLUSION
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`In view of the foregoing, Applicant believes all claims now pending in this Application
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`are 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
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`any 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 206-573-2274.
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`Dated: January 20, 2022
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`Respectfully submitted,
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`/Yahn-Lin CHU/
`Yahn-Lin (Franklin) Chu
`Registration No. 75,946
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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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