INVENTOR(S)
`
`Chunhua Li, Yan Chen, Heinz Pudleiner, Klaus Meyer, and Joerg Nickel
`
`It is certified that an error appears or errors appear in the above-identified patent and that said Letters Patent
`is hereby corrected as shown below:
`In the Claims
`
`Column 9, line 15, Claim 1:
`
`Please delete the period in "70° C." to read:
`
`-- 70° C --
`
`Column 10, line 16, Claim 11:
`
`Please delete the period in "70° C." to read:
`
`PTO/SB/44 (09-07)
`Approved for use through 01/31/2020. OMB 0651-0033
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`Also Form PTO-1050
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`CERTIFICATE OF CORRECTION
`
`PATENT NO.
`
`: 9,655,693
`
`APPLICATION NO.: 15/132,171
`
`ISSUE DATE
`
`: May 23, 2017
`
`—— 70° c --
`
`MAILING ADDRESS OF SENDER (Please do not use Customer Number below):
`
`Wilson Sonsini Goodrich & Rosati
`
`650 Page Mill Road
`Palo Alto, California 94304-1050
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`FORMS To THIS ADDRESS. SEND TO: Attention Certificate of Corrections Branch, Commissioner for Patents, P.O. Box 1450, Alexandria,
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`

`

`I hereby certify that this correspondence is being filed via
`EFS-Wb 'thth U'tdStt Pt
`t
`dT d
`kOff'
`6 W1
`6
`“1 e
`a 65 a e“ a“
`“1 em“
`1“
`on:
`July 7: 2017
`
`WILSON SONSINI GOODRICH & ROSATI
`
`By:
`
`/Hillary Pratt/
`
`
`PATENT
`
`Attorney Docket No.: 22773—826301
`Align Reference No.2 1228.US.C1
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Group Art Unit: 3732
`
`Examiner: Hao D. Mai
`
`Confirmation No.: 5235
`
`In re the Patent Application of: Chunhua Li et a1.
`,
`,
`Applicant: Align Technology, Inc.
`
`Patent No.: 9,655,693
`
`Issue Date: May 23, 2017
`
`Serial No.:
`
`15/132,171
`
`Filed:
`
`April 18 , 2016
`
`Title:
`
`MULTILAYER DENTAL
`
`APPLIANCES AND RELATED
`
`METHODS AND SYSTEMS
`
`
`
`
`
`
`
`REQUEST FOR CERTIFICATE OF CORRECTION OF THE ISSUED PATENT
`
`FOR OFFICE MISTAKE (37 CFR §1.322)
`
`Commissioner for Patents
`
`Office of Patent Publication
`
`PO. Box 1450
`
`Alexandria, VA 22313—1450
`
`ATTN: Certificate of Corrections Branch
`
`Commissioner:
`
`It is noted that errors of a clerical nature appear in this patent due to mistakes on the part
`
`of the Office, as more fully described below. The Patentee believes that correction thereof does
`
`not involve such changes in the patent as would constitute new matter or would require re—
`
`examination of the patent. A certificate of correction is therefore requested. Attached hereto is
`
`Form PTO/SB/44 which is suitable for printing.
`
`The errors and reasons for which correction is requested is located at:
`
`
`Column 9 line 15 Claim 1: Please delete the period in “70° C.” to read: “70° C”
`
`

`

`Serial No.: 15/132,171
`Filed: April 18, 2016
`
`PATENT
`
`
`Column 10 line 16 Claim 11: Please delete the period in “70° C.” to read: “70° C”
`
`The term “70° C” was correctly listed on the Claims provided with the Response to Non—
`
`Final Office Action filed November 22, 2016, a copy of Which is attached hereto. Accordingly,
`
`Patentee believes the error is attributable to the Patent Office. No fees are required for the
`
`submission of this Request.
`
`FEE AUTHORIZATION
`
`The Commissioner is authorized to charge any additional fees which may be required,
`
`including petition fees, or credit any overpayment to Deposit Account No. 23—2415 (Docket No.
`
`22773-826301).
`
`Respectfully submitted,
`
`/Charles C. Hagadorn, III/
`
`Charles C. Hagadorn, III
`Registration No. 62,367
`
`Dated: August 72 2017
`
`WILSON SONSINI GOODRICH & ROSATI
`
`650 Page Mill Road
`Palo Alto, CA 94304—1050
`
`(206) 883—2500
`Tel.:
`Customer No. 107046
`
`

`

`I hereby certify that this correspondence is being filed Via
`EFS-Web with the United States Patent and Trademark Office
`on
`November 22 2016
`
`Attorney Docket N0_: 22773_826_301
`Client Ref N0 _ 1228 US Cl
`
`WILSON SONSINI GOODRICH & ROSATI
`
`By:
`
`/William D. TronVig/
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`Confirmation No.: 5235
`
`Examiner: Hao D. Mai
`
`Art Unit: 3732
`
`AMENDMENT
`
`Chunhua Li et al.
`
`Application No.: 15/132,171
`
`Filed: April 18, 2016
`
`For: MULTILAYER DENTAL
`
`APPLIANCES AND RELATED
`
`METHODS AND SYSTEMS
`
`Customer No.: 107046
`
`
`
`Mail Stop Amendment
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313—1450
`
`Commissioner:
`
`In response to the Office Action mailed June 22, 2016, please enter the following
`
`amendments and remarks. The fee for a Petition for Extension of Time of 2 months accompanies
`
`this response.
`
`Amendments to the Claims are reflected in the listing of claims which begins on page 2 of this
`
`paper.
`
`Remarks begin on page 6 of this paper.
`
`Page 1 of 16
`
`

`

`Appl. No. 15/132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Amendments to the Claims:
`
`Attorney Docket No.2 22773-826301
`
`This listing of claims will replace all prior versions, and listings of claims in the application:
`
`Listing of Claims:
`
`1.
`
`(Currently Amended) An orthodontic appliance for repositioning a patient’s teeth,
`
`the appliance comprising:
`
`a shell having a plurality of teeth receiving cavities shaped to apply a
`
`repositioning force to the patient’s teeth, wherein the shell is formed from a multilayer material
`
`configured to reduce degradation of the repositioning force over time when the shell is worn on
`
`the patient’s teeth, the multilayer material comprising:
`
`a first soft polymer layer and a second soft polymer layer each having a
`
`thickness in a range from 25 um to 100 um and a compression set greater than 40% after
`
`2 hours at 70 0C, wherein the first and second soft polymer layer each comprise a
`
`thermoplastieelastemer: a thermoplastic polyurethane elastomerra—bleeleeepel-ymer
`
`-
`
`.--- ,
`
`.
`
`--
`
`--=: .'
`
`.
`
`:= .-
`
`-
`
`-
`
`. =---
`
`=
`
`. =--:-. =-
`
`-- -= ;and
`
`a hard polymer layer disposed between the first and second soft polymer
`
`layers and having a thickness in a range from 400 um to 1100 um, a tensile modulus
`
`greater than 150,000 psi, and a tensile strength at yield between 4000 psi and 6500 psi,
`
`wherein the hard polymer layer comprises a—pel—yester: a co—polyesterra—thermeplastie
`
`
`
`
`
`
`
`2.
`
`(Original) The appliance of claim 1, wherein the first and second soft polymer
`
`layers each have a thickness in a range from 30 um to 90 um.
`
`3.
`
`(Original) The appliance of claim 1, wherein the hard polymer layer has a
`
`thickness in a range from 500 um to 900 um.
`
`8490730_l.docx
`
`Page 2 of 16
`
`

`

`Appl. No. 15/ 132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
`
`4.
`
`(Original) The appliance of claim 1 wherein the hard polymer layer has a
`
`thickness in a range from 550 um to 750 um.
`
`5.
`
`(Original) The appliance of claim 1, wherein the first and second soft polymer
`
`layers each comprise a hardness of 60A to 85 D, an ultimate tensile strength greater than 5000
`
`psi, an elongation at break greater than 200%, a flexural modulus greater than 35,000 psi, and a
`
`light transmission between 400 nm and 800 nm greater than about 75%.
`
`6.
`
`(Original) The appliance of claim 1, wherein the hard polymer layer comprises an
`
`elongation at yield greater than 4%, an elongation at break greater than 70%, a flexural modulus
`
`greater than 150,000 psi, and a light transmission between 400 nm and 800 nm greater than about
`
`75%.
`
`7.
`
`(Original) The appliance of claim 1, wherein the multilayer material has elastic
`
`properties configured to reduce degradation of the shape of the plurality of teeth receiving
`
`cavities over time when the shell is worn on the patient’s teeth.
`
`8.
`
`(Currently Amended) The appliance of claim 1, wherein the first and second soft
`
`polymer layers each comprise [[a]]th_e thermoplastic polyurethane elastomer in combination with
`
`a thermoplastic elastomer, a block copolymer elastomer, or a thermoplastic co—polyester
`
`elastomer.
`
`9.
`
`(Currently Amended) The appliance of claim 1, wherein the hard polymer layer
`
`comprises [[a]]th_e co—polyester in combination with a polyester, a thermoplastic polyurethane, a
`
`polypropylene and polyethylene copolymer, a cyclic block copolymer, a polyethylene
`
`terephthalate, a polybutylene terephthalate, a polyethersulfone, a polytrimethylene terephthalate.
`
`10.
`
`(Original) The appliance of claim 1, wherein the stress relaxation of the hard
`
`polymer layer is greater than 10% at 24 hours tested at between 90% to 100% relative humidity.
`
`8490730_l.docx
`
`Page 3 of 16
`
`

`

`Appl. No. 15/ 132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
`
`11.
`
`(Currently Amended) An orthodontic appliance for repositioning a patient’s teeth,
`
`the appliance comprising:
`
`a shell having a plurality of teeth receiving cavities shaped to apply a
`
`repositioning force to the patient’s teeth, wherein the shell is formed from a multilayer material
`
`configured to reduce degradation of the repositioning force over time when the shell is worn on
`
`the patient’s teeth, the multilayer material comprising:
`
`a first soft polymer layer and a second soft polymer layer each having a
`
`thickness in a range from 25 um to 100 um and a compression set greater than 40% after
`
`2 hours at 70 0C; and
`
`a hard polymer layer disposed between the first and second soft polymer
`
`layers and having a thickness in a range from 400 um to 1100 um, a tensile modulus
`
`greater than 150,000 psi, and a tensile strength at yield between 4000 psi and 6500 psi,
`
`wherein the first and second soft polymer layer each comprise a
`
`thermoplastic polyurethane elastomer and the hard polymer layer comprises a co—
`
`polyester.
`
`12.
`
`(Original) The appliance of claim 11, wherein the first and second soft polymer
`
`layers each have a thickness in a range from 30 um to 80 um.
`
`13.
`
`(Original) The appliance of claim 11, wherein the hard polymer layer has a
`
`thickness in a range from 500 um to 900 um.
`
`14.
`
`(Original) The appliance of claim 11, wherein the hard polymer layer has a
`
`thickness in a range from 550 um to 750 um.
`
`15.
`
`(Original) The appliance of claim 11, wherein the first and second soft polymer
`
`layers each comprise a hardness of 60A to 85 D, an ultimate tensile strength greater than 5000
`
`psi, an elongation at break greater than 200%, a flexural modulus greater than 35,000 psi and a
`
`light transmission between 400 nm and 800 nm greater than about 75%.
`
`8490730_l.docx
`
`Page 4 of 16
`
`

`

`Appl. No. 15/132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
`
`16.
`
`(Original) The appliance of claim 11, wherein the hard polymer layer comprises
`
`an elongation at yield greater than 4%, an elongation at break greater than 70%, a flexural
`
`modulus greater than 150,000 psi, and a light transmission between 400 nm and 800 nm greater
`
`than about 75%.
`
`17.
`
`(Original) The appliance of claim 11, wherein the multilayer material has elastic
`
`properties configured to reduce degradation of the shape of the plurality of teeth receiving
`
`cavities over time when the shell is worn on the patient’s teeth.
`
`18.
`
`(Currently Amended) The appliance of claim 11, wherein the first and second soft
`
`polymer layers each comprise the thermoplastic polyurethane elastomer in combination with a
`
`thermoplastic elastomerra—thermeplastiepel-w-rethaneelastemer, a block copolymer elastomer, a
`
`thermoplastic co—polyester elastomerrer—a—eembinatien—thereef.
`
`l9.
`
`20.
`
`(Canceled)
`
`(Currently Amended) The appliance of claim 11, wherein the hard polymer layer
`
`comprises the co—polyester in combination with a polyester, ace—polyester: a thermoplastic
`
`polyurethane, a polypropylene and polyethylene copolymer, a cyclic block copolymer, a
`
`polyethylene terephthalate, a polybutylene terephthalate, a polyethersulfone, a polytrimethylene
`
`terephthalate, or a combination thereof.
`
`21.
`
`(Canceled)
`
`22.
`
`(Original) The appliance of claim 11, wherein the stress relaxation of the hard
`
`polymer layer is greater than 10% at 24 hours tested at between 90% to 100% relative humidity.
`
`8490730_l.docx
`
`Page 5 of 16
`
`

`

`Appl. No. 15/132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
`
`REMARKS
`
`Upon entry of this Amendment, claims 1—18 will be pending in the present
`
`application. Claims 19 and 21 have been canceled without prejudice or disclaimer. Applicants
`
`reserve the right to pursue any canceled subject matter in a related, future application. Claims 1,
`
`8, 9, ll, 18, and 20 have been amended. Support for the amendments can be found in the
`
`specification as originally filed. Accordingly, no new matter has been added. Reconsideration is
`
`respectfully requested.
`
`Examiner Interview
`
`Applicants thank Examiners Mai and Rodriguez for participating in an in—person
`
`interview on October 26, 2016. Additional participants in the interview included Applicants’
`
`representatives, Melissa Harwood and Esther Kepplinger, as well as Arthur Hsieh and Chunhua
`
`Li. The Examiner’s rejections of the claims made in a Non—Final Office Action mailed on June
`
`22, 2016, and the submission of a declaration demonstrating the unexpected results of the present
`
`invention were discussed.
`
`Claim Re'ections — 35 U.S.C.
`
`112
`
`Claims 1—22 stand rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre—
`
`AIA), second paragraph, as allegedly being indefinite for failing to particularly point out and
`
`distinctly claim the subject matter which the inventor or a joint inventor, or for pre—AIA the
`
`applicant regards as the invention. In particular, the Examiner objects to the use of “hard” and
`
`“soft” in independent claims 1 and 11, asserting that “‘hard’ and ‘soft’ are relative terms” and
`
`that the claims should specify “soft or hard compared to which element of the invention.” Office
`
`Action at 2.
`
`Applicants respectfully disagree. Insofar as “hard” and “soft” are relative terms, it
`
`is at least understandable from the claims as written that the hard and soft layers define a
`
`relationship between each other. For example, the hard layer is hard compared to the soft layer.
`
`Accordingly, Applicants respectfully submit that the claims are clear as written.
`
`8490730_l.docx
`
`Page 6 of 16
`
`

`

`Appl. No. 15/132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
`
`Accordingly, for the reasons set forth above, withdrawal of the rejection of claims
`
`1—22 under 35 U.S.C. § 112 is respectfully requested.
`
`Claim Re'ections — 35 USC 103
`
`Claims 1—8, 10—20, and 22 stand rejected under pre—AIA 35 U.S.C. § 103(a) as
`
`allegedly being obvious over US 2009/0246724 (hereinafter “Chen”) in view of US 7,641,828
`
`(hereinafter “DeSimone”), as evidenced by Boedekercom, “Polycarbonate specifications”
`
`(hereinafter “Boedeker”) and plastics.ides.com/generics/57/c/t/polyurethane—thermoset—
`
`elastomer—tsu—properties—processing (hereinafter “Plastics”).
`
`Independent claims 1 and 11 have been amended to incorporate material from
`
`claims 8 and 9, and 19 and 21, respectively. Claims 9 and 21 stand rejected under pre—AIA 35
`
`U.S.C. § 103(a) as allegedly being unpatentable over Chen in view of DeSimone et a1. (U.S.
`
`Patent No. 7,641,828, hereinafter “DeSimone”). In particular, the Examiner states that “Chen
`
`fails to disclose the hard inner polymer layer comprising a co—polyester as claimed” but that it
`
`“would have been obvious to one of ordinary skill in the art at the time of invention to utilize the
`
`co—polyesters and blends as taught by DeSimone to form Chen's hard layer.” Office Action at 6.
`
`As amended claims 1 and 11 recite that the hard layer comprises co—polyester, Applicants will
`
`address the rejection of claims 1 and 11 further in view of DeSimone as described with respect to
`
`claims 9 and 21.
`
`Applicants respectfully disagree with the Examiner’s assertions at least because
`
`(1) the cited references provide no reason to select a polymer of DeSimone for use in Chen; (2)
`
`one of ordinary skill in the art would not have had a reasonable expectation of success for
`
`combining the teachings of Chen and DeSimone to produce the presently claimed orthodontic
`
`appliances; (3) the presently claimed orthodontic appliances were found to exhibit unexpectedly
`
`good results when compared with the most relevant art; and (4) the presently claimed orthodontic
`
`appliances gave rise to considerable commercial success. These positions are supported by the
`
`present specification and further supported by the attached November 21, 2016 Declaration
`
`under 37 C.F.R. § 1.132 of Dr. Chunhua Li (“Li Declaration”), an expert in materials and
`
`8490730_1.docx
`
`Page 7 of 16
`
`

`

`Appl. No. 15/132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
`
`biomechanical engineering and a co—inventor of the present application. The Li Declaration
`
`describes the development history and clinical evaluation of appliances comprising material
`
`according to the present claims, which is referred to herein as ST30—a material that has soft
`
`outer layers comprising a thermoplastic polyurethane elastomer and a hard inner layer
`
`comprising a co—polyester—to the prior art, including a thermoplastic polyurethane referred to as
`
`EX30, which was the standard of care prior to the release of ST30.
`
`1. Obvious to Try Rejection—The Examiner Provides No Reason Why the
`
`Skilled Artisan Would Select a Polymer of DeSimone for use in Chen
`
`The Examiner improperly relies on Chen for teaching the use of a thermoplastic
`
`polyurethane elastomer as a soft outer layer; however, Chen does not teach the use of a
`
`thermoplastic polyurethane elastomer as a soft outer layer. The Examiner states that “Chen
`
`discloses an orthodontic appliance .
`
`.
`
`. formed from a multilayer material,” and further states that
`
`the “multilayer material comprises: a first soft polymer layer 134 and a second soft polymer
`
`layer 134, each comprises a thermoplastic polyurethane elastomer.” Office Action at 3. The
`
`Examiner cites to paragraphs 3, 32, and 35, as well as Fig. 4C for these elements. Id. However,
`
`Chen does not disclose a multi—layer material comprising a thermoplastic polyurethane
`
`elastomer. Chen paragraph [0003] describes that “[s]ome dental appliances are made using
`
`polymers, such as thermoplastic polyurethane.” As described in the Li Declaration, paragraph
`
`[0003] of Chen is referring to appliances made with a material called EX30, which was the
`
`standard of care prior to the development of the presently claimed appliances. Li Declaration at
`
`4. However, this material was not a multi—layer material, and Chen does not state as much.
`
`Instead, Chen paragraphs [0032] and [0035] describe a multi—layer material comprising
`
`polycarbonate and PVC, but do not explicitly describe the use of thermoplastic polyurethane, nor
`
`a thermoplastic polyurethane elastomer. Thus, contrary to the Examiner’s assertions, Chen fails
`
`to disclose the use of a thermoplastic polyurethane elastomer as a soft outer layer.
`
`Accordingly, Applicants interpret the Examiner’s rejection as asserting that it
`
`would have been obvious to modify the EX30 (thermoplastic polyurethane) appliance of Chen
`
`paragraph [0003] to comprise a multi—layer material as described in Chen paragraphs [0032] and
`
`8490730_l.docx
`
`Page 8 of 16
`
`

`

`Appl. No. 15/132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
`
`[0035], but with soft layers comprising a thermoplastic polyurethane elastomer and a hard layer
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`between comprising a co—polymer from DeSimone. Each embodiment relied on by the examiner
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`provides only one element of the proposed combination, and the Examiner fails to identify any
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`reason why one of ordinary skill would have selected these elements in combination with one
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`another and the cited references themselves fail to provide such guidance.
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`The Examiner improperly uses an “obvious to try” approach and fails to provide
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`any reason why one of ordinary skill in the art would select a co—polyester material from
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`DeSimone for use in the multi—layer material of Chen. In fact, DeSimone lists hundreds of
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`materials, from which the Examiner points to a single reference of “co—polyester.” (DeSimone,
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`col. 5). Notably, neither Chen nor DeSimone provide any sort of guidance suggesting why one
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`might select any one of these numerous materials of DeSimone over any other disclosed
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`material. The references do not provide a finite number of identified, predictable solutions to the
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`problem and one of ordinary skill in the art could have pursued these known potential solutions
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`with a reasonable expectation of success. The obvious to try rationale is improper when what
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`would have been obvious to try would have been to vary all parameters and try each of numerous
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`possible choices until one possibly arrived at a successful result and where the prior art gave no
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`indication of which parameters were critical or no direction as to of which of many possible
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`choices is likely to be successful. In re Kubin (Fed. Cir. 2009). There is no guidance in the
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`references about which of many choices might be successful. There is no indication that the hard
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`layers described in DeSimone would have the properties recited in Chen nor any other basis for
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`selecting them from the list of hundreds of materials. In the absence of any such guidance, the
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`selection of the co—polyester material from DeSimone for use in Chen represents nothing more
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`than an “obvious to try” rationale or impermissible hindsight bias.
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`2. N0 Expectation of Success
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`One of ordinary skill in the art would not have had a reasonable expectation of
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`success in combining the teachings of Chen and DeSimone to yield the presently claimed
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`orthodontic appliances at least because of the high level of unpredictability in the art and the lack
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`Appl. No. 15/132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
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`of guidance provided in Chen and DeSimone suggesting which material combinations should be
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`used to produce a sufficient multi—layer orthodontic appliance.
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`Over the course of more than seven years, Applicants worked diligently to
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`develop a suitable, improved appliance that would meet various criteria for effective orthodontic
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`treatment. Li Declaration at ‘][4. This development process was neither easy nor straightforward.
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`During the development process, Applicants evaluated, in an iterative fashion, more than 250
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`distinct materials and/or material combinations for possible use in an improved appliance device.
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`After years of development, Applicants produced the SmartTrackTM material (also referred to
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`herein as “ST30”), which is a product according to the instant claims comprising a layered
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`material with a hard co—polyester layer between two soft layers of thermoplastic polyurethane
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`elastomer. The intent of this testing was to identify a suitable replacement for Align
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`Technology’s single—layer, thermoplastic polyurethane appliance product (referred to herein as
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`“EX30”), which was the standard of the care for plastic tooth moving appliances at the time of
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`filing, and the materials were evaluated on this basis. Id. at ‘JI‘JI4—6. From among those over 250
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`materials tested, only the materials of the present claims met Align’s criteria for a multi—layer
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`orthodontic appliance. Id. at ‘JI‘JI4—5. The tested materials included many multi—layer (e.g., three—
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`layer) materials, yet of those tested only the materials of the present claims proved capable of
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`performing at a level sufficient to meet Align’s criteria for an orthodontic appliance, and thus as
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`a suitable replacement for EX30. Id. at ‘][6.
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`Data obtained by Applicants during the development of the SmartTrack material
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`provides significant evidence of the unpredictability in the art and the unexpected effectiveness
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`of the presently claimed orthodontic appliances. Li Declaration at ‘][7. As mentioned above, the
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`presently claimed multi—layer, multi—material orthodontic appliances were developed during
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`more than seven years of diligent evaluation of over 250 materials, including numerous iterations
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`in which materials were tested and compared, with the results used to design new materials. Id.
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`at 4. It was clear from many of the materials tested, including those from the Chen and
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`DeSimone, that such materials were not effective alone or in combination to provide the
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`improvements sought. Id. at ‘][5. During those evaluations, Applicants determined that only the
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`Appl. No. 15/132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
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`combinations of materials of the instant claims met Align’s development criteria. Id. It was not a
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`simple or predictable process to identify those materials that would work together to create the
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`multi—layer apparatus which provided the unexpectedly good results. Among those 250 materials
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`tested were more than 180 materials either generically or specifically described in Chen and/or
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`DeSimone, including various copolymers (see, e.g., Chen at [0036]) and unblended polysulfones
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`(DeSimone at 6:47—59), as well as styrenic polymer materials such as acrylonitrile—butadiene—
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`styrene (ABS) (id. at 6:24—37). Li Declaration at ‘][5. Specifically, none of the 23 co—polymers
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`that were tested during the iterative development process met Align’s criteria. Id. Similarly, none
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`of the styrenic polymers nor unblended polysulfones tested met Align’s criteria. Id. Thus none of
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`these materials would have yielded an orthodontic device having sufficient modulus of elasticity,
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`elongation, time stress—relaxation, durability, and thermoform ability. Id.
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`Inventor Li had extensive knowledge of the teachings of Chen and DeSimone at
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`the time of filing, and yet it still took her team many years to identify a suitable material.
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`Inventor Li is also listed as a co—inventor of Chen, and thus she was thus intimately familiar with
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`the teachings of Chen during the development of the presently claimed orthodontic appliances.
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`Inventor Li also collaborated closely with Joseph M. DeSimone and Robert E. Tricca (the
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`inventors listed on DeSimone) while they were developing and patenting the technology
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`described in DeSimone. Li Declaration at ‘][9. She was thus very aware of the teachings of
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`DeSimone during the development of the presently claimed orthodontic appliances. Even with
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`her extensive knowledge of the teachings of Chen and DeSimone, it took her team over seven
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`years to identify a suitable combination of polymers for use in the claimed multi—layer
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`orthodontic appliances. Id. Thus, one of ordinary skill in the art having far less knowledge of the
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`teachings of Chen and DeSimone would not have had a reasonable expectation of success in
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`producing the presently claimed orthodontic appliances based on the teachings of Chen,
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`DeSimone and Hostettler. Id. at ‘][10.
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`During the course of their evaluations, Applicants determined that merely
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`combining the materials into multiple layers was insufficient to improve performance relative to
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`the EX30 material. Id. at ‘][6—7. In fact, many three—layer materials tested proved inferior to the
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`Appl. No. 15/132,171
`Amdt. dated November 22, 2016
`Reply to Office Action of June 22, 2016
`
`Attorney Docket No.2 22773-826301
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`EX30 material. These three—layer materials included combinations of materials disclosed in Chen
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`and/or DeSimone. Id. In particular, the sole exemplified multi—layer material described in Chen
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`would not be expected to show improved performance relative to EX30. For example, Chen
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`paragraph [0032] describes a material containing polycarbonate and polyvinyl chloride (PVC);
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`however, PVC was later evaluated by Applicants and found to be unsuitable for use in
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`or