www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`16/043,065
`
`07/23/2018
`
`ChunhuaLI
`
`22773-826.303
`
`6436
`
`Align Technology, Inc. / WSGR
`650 Page Mill Road
`Palo Alto, CA 94304
`
`EIDE, HEIDI MARIE
`
`ART UNIT
`
`3772
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/15/2021
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`patentdocket @ wsgr.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Office Action Summary
`
`Application No.
`16/043,065
`Examiner
`HEIDI M EIDE
`
`Applicant(s)
`Lletal.
`Art Unit
`3772
`
`AIA (FITF) Status
`No
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133}.
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`
`
`1) Responsive to communication(s) filed on 4/29/2021.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)L) This action is FINAL. 2b)¥)This action is non-final.
`3)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4\0) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`30-31,36-37,39-40,48-49 58,62-63,69 and 71-88 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`Cj] Claim(s)
`is/are allowed.
`Claim(s) 30-31 ,36-37,39-40,48-49 58,62-63,69 and 71-88 is/are rejected.
`S)
`) © Claim(s)____is/are objected to.
`Cj) Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)(J accepted or b)() objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)1) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.2 Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20210610
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 2
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`The present application is being examined under the pre-AlA first to invent
`
`provisions.
`
`Information Disclosure Statement
`
`2.
`
`The information disclosure statement (IDS) submitted on September 18, 2020 is
`
`noted. The submission is in compliance with the provisions of 37 CFR 1.97.
`
`Accordingly, the information disclosure statement is being considered by the examiner.
`
`Specification
`
`1.
`
`The amendments to the specification received on April 29, 2021 are accepted
`
`and entered.
`
`Claim Rejections - 35 USC § 112
`
`2.
`
`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-AlA), second paragraph:
`The specification shall conclude with one or moreclaims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`3.
`
`Claim 71 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), 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.
`
`4.
`
`With respect to claim 71, the applicant claims the appliance comprises three
`
`polymer layers of alternating hardness, however, it is unclearif the claimed three layers
`
`include the claimed hard and soft layer or are in addition to the claimed layers for a total
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 3
`
`of 5 layers. For examination purposes, the claimed three layers of claim 71 are being
`
`interested as including the claimed 2 layers for a total of 3 layers.
`
`Claim Rejections - 35 USC § 103
`
`3.
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousnessrejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described
`as set forth in section 102, if the differences between the subject matter sought to be patented
`andthe prior art are such that the subject matter as a whole would have been obviousat the
`time the invention was madeto a person having ordinaryskill in the art to which said subject
`matter pertains. Patentability shall not be negatived by the manner in whichthe invention was
`made.
`
`4.
`
`Claims 30-31, 36, 40, 48-49, 58, 62-63, 74, 78-84, 88 is/are rejected under pre-
`
`AIA 35 U.S.C. 103(a) as being unpatentable over Kalili (2011/0020761) in view of
`
`DeSimone etal. (2008/0248438) in view of Stewart (2015/0374464)in view of Wheeler,
`
`deceasedet al. (5,335,675) as evidenced by TEXIN 990R.
`
`5.
`
`Kalili teaches with respect to claim 30, a multilayer dental appliance comprising
`
`teeth receiving cavities shaped to directly receive at least one of a patient’s teeth and
`
`apply a resilient positioning force to the patient’s teeth, the multiplayer dental appliance
`
`comprising a soft polymer layer comprising a thermoplastic polyurethane elastomer
`
`having an ultimate tensile strength of greater than about 5000 psi, an elongation at
`
`break of greater than about 200%, and a hardness of about 60 A to about 85D (see
`
`pars. 9, 69 and document TEXIN 990R for material properties, the hardness is about
`
`90A whichis within the claimed range, therefore, it meets the claimedlimitations) and a
`
`hard polymer layer (pars. 9, 69). Kalili teaches the invention as substantially claimed
`
`and discussed above, however, does not specifically teach the hard polymer layer
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 4
`
`comprising a co-polyester having a tensile modulus greater than 150,000 psi and a
`
`flexural modulus greater than about 150,000psi and the flexural modulus of the soft
`
`polymer is greater than about 35,000.
`
`6.
`
`DeSimone teaches a dental appliance comprising a hard polymer layer
`
`comprising a co-polyester having a tensile modulus greater than about 150,000 psi and
`
`a flexural modulus greater than about 150,000 psi (see abstract, pars. 5-7, 25-27).
`
`It
`
`would have been obvious to one having ordinary skill in the art before the invention to
`
`modify the hard polymer layer with the hard polymer layer taught by DeSimone in order
`
`to provide an orthodontic appliance that is mechanically stable and less susceptible to
`
`degradation (see par. 16, 24, 31). It is noted that the hard polymer material taught by
`
`Kalili can be a polycarbonate which is a material also taught by DeSimone(par. 27).
`
`Kalili/DeSimone teachesthe invention as substantially claimed and discussed above,
`
`however, does not specifically teach the flexural modulus of the soft polymer layer is
`
`greater than about 35,000 psi.
`
`7.
`
`Stewart teaches a polymer with a flexural modulus of greater than about 35,000
`
`psi (par. 82, 1000Mpais 145038 psi).
`
`It would have been obvious to one having
`
`ordinary skill in the art at the time of the invention to modify Kalili/DeSimone with the
`
`flexural modulus taught by Stewart in order more the teeth as desired.
`
`Kalili/DeSimone/Stewart teaches the invention as substantially claimed and discussed
`
`above, including a soft polymer materials with the claimed material properties used in
`
`orthodontic devices to deliver the desired forces to the teeth to achieve the desired
`
`outcomes, however,itis noted that KaliliiDeSimone/Stewart does not specifically
`
`teachesa single soft polymer material with claimed material properties as discussed
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 5
`
`above with Kalili/DeSimone/Stewart in order to provide the material with the desired
`
`properties to movethe teeth in the desired manner.
`
`8.
`
`Wheeler teaches a soft polymer thermoplastic polyurethane elastomer used in
`
`medical device (see abstract, therefore, it is biocompatible) comprising a tensile
`
`strength of greater than about 5000 psi, an elongation at break of greater than about
`
`200%, a hardness of about 60A to about 85D and a flexural modulus of greater than
`
`about 35,000 psi (see col. 22, Il. 1-11). It would have been obvious to one having
`
`ordinary skill in the art before the invention was made to modify the soft material taught
`
`by KaliliiDeSimone/Stewart which teachesall of the material properties for use in
`
`provided desired forces to the teeth for orthodontic treatment with the single material. It
`
`is noted that all of the claimed material properties are taught by the prior art are known
`
`properties provided to materials to deliver the desired forces to the teeth to movethe
`
`teeth as desired. It is further noted it has been held that where the general conditions of
`
`a claim are disclosedin the prior art, discovering the optimum or workable ranges
`
`involves only routine skill in the art (/n re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235
`
`(CCPA 1955)).
`
`9.
`
`With respect to claim 31, Kalili teaches the applicant wherein the hard polymer
`
`layer has a hard polymer layer elastic modulus and the soft polymer layer has a soft
`
`polymer modulus less than the hard polymer layer elastic modulus (see par. 69).
`
`10. With respect to claim 36, Kalili teaches the appliance is clear (see par. 53),
`
`therefore, the soft polymer hasalight transmission between 400nm and 800nm of
`
`greater than about 75%.
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 6
`
`11. With respect to claim 40, Kalili teaches the invention as substantially claimed and
`
`discussed above, however, does not specifically teach the hard polymer layer further
`
`comprises a polymer selected from the list consisting of a polyester, a thermoplastic
`
`polyurethane, a polypropylene, a polyethylene, a polypropylene and polyethylene
`
`copolymer, an acrylic, a polyetheretherketone, a polyamide, a polyethylene
`
`terephthalate, a polybutylene terephthalate, a polyetherimide, a cyclic block copolymer,
`
`a polyethersulfone and a polytrimethylene terephthalate, or any combination thereof.
`
`12.
`
`DeSimone teaches with respect to claim 40, the appliance wherein the hard
`
`polymer layer further comprises a polyester, polybutylene terephthalate or polyethylene
`
`terephthalate (pars. 17, 32, claims 36, 52). It would have been obvious to one having
`
`ordinary skill in the art before the invention to modify the hard polymer layer with the
`
`hard polymer layer taught by DeSimone in order to provide an orthodontic appliance
`
`that is mechanically stable and less susceptible to degradation (see par. 16, 24, 31). It
`
`is noted that the hard polymer material taught by Kalili can be a polycarbonate whichis
`
`a material also taught by DeSimone (par. 27).
`
`13.
`
`With respectto claim 48, Kalili teaches the invention as substantially claimed
`
`and discussed above, however, does not specifically teach the hard polymer layer has a
`
`tensile strength at yield between 4000 and 6500psi.
`
`14.|DeSimone teaches with respect to claim 48, the dental appalling wherein the
`
`hard polymer layer has a tensile strength at yield between 4000 and 6500 psi (see
`
`abstract, 6000 psi is within the claimed range). It would have been obvious to one
`
`having ordinary skill in the art before the invention to modify the hard polymer layer with
`
`the hard polymer layer taught by DeSimonein order to provide an orthodontic appliance
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 7
`
`that is mechanically stable and less susceptible to degradation (see par. 16, 24, 31). It
`
`is noted that the hard polymer material taught by Kalili can be a polycarbonate whichis
`
`a material also taught by DeSimone (par. 27).
`
`15.
`
`With respect to claim 49, Kalili teaches a plurality of incremental position
`
`adjustment appliances having teeth receiving cavities shaped to directly receive at least
`
`some ofa patient’s teeth and apply a resilient positioning force to the patient’s teeth,
`
`wherein the plurality of incremental positioning adjustment applies are shaped to move
`
`teeth form one arrangement to a successive arrangement when successively worn by
`
`the patient (par. 53), and wherein at least one of the plurality of incremental positioning
`
`adjustment appliances comprises a soft polymer layer comprising a thermoplastic
`
`polyurethane elastomer having an ultimate tensile strength of greater than about 5000
`
`psi, an elongation at break of greater than about 200%, and a hardnessof about 60 A to
`
`about 85D (see pars. 9, 69 and document TEXIN 990R for material properties, the
`
`hardness is about 85D, therefore, it meets the claimed limitations) and a hard polymer
`
`layer (pars. 9, 69). Kalili teaches the invention as substantially claimed and discussed
`
`above, however, does not specifically teach the hard polymer layer comprising a co-
`
`polyester having a tensile modulus greater than 150,000 psi and a flexural modulus
`
`greater than about 150,000psi and the soft polymer layer has a flexural modulus of
`
`greater than about 35,000 psi.
`
`16.
`
`DeSimone teaches a dental appliance comprising a hard polymer layer
`
`comprising a co-polyester having a tensile modulus greater than about 150,000 psi and
`
`a flexural modulus greater than about 150,000 psi (see abstract, pars. 5-7, 25-27).
`
`It
`
`would have been obvious to one having ordinary skill in the art before the invention to
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 8
`
`modify the hard polymer layer with the hard polymer layer taught by DeSimone in order
`
`to provide an orthodontic appliance that is mechanically stable and less susceptible to
`
`degradation (see par. 16, 24, 31). It is noted that the hard polymer material taught by
`
`Kalili can be a polycarbonate which is a material also taught by DeSimone(par. 27).
`
`17.
`
`Stewart teaches a polymer with a flexural modulus of greater than about 35,000
`
`psi (par. 82, 1000Mpais 145038 psi).
`
`It would have been obvious to one having
`
`ordinary skill in the art at the time of the invention to modify Kalili/DeSimone with the
`
`flexural modulus taught by Stewart in order more the teeth as desired.
`
`Kalili/DeSimone/Stewart teaches the invention as substantially claimed and discussed
`
`above, including a soft polymer materials with the claimed material properties used in
`
`orthodontic devices to deliver the desired forces to the teeth to achieve the desired
`
`outcomes, however,itis noted that KaliliiDeSimone/Stewart does not specifically
`
`teachesa single soft polymer material with claimed material properties as discussed
`
`above with Kalili/DeSimone/Stewart in order to provide the material with the desired
`
`properties to movethe teeth in the desired manner.
`
`18.|Wheeler teaches a soft polymer thermoplastic polyurethane elastomer used in
`
`medical device (see abstract, therefore, it is biocompatible) comprising a tensile
`
`strength of greater than about 5000 psi, an elongation at break of greater than about
`
`200%, a hardness of about 60A to about 85D and a flexural modulus of greater than
`
`about 35,000 psi (see col. 22, Il. 1-11). It would have been obvious to one having
`
`ordinary skill in the art before the invention was made to modify the soft material taught
`
`by KaliliiDeSimone/Stewart which teachesall of the material properties for use in
`
`provided desired forces to the teeth for orthodontic treatment with the single material. It
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 9
`
`is noted that all of the claimed material properties are taught by the prior art are known
`
`properties provided to materials to deliver the desired forces to the teeth to movethe
`
`teeth as desired. It is further noted it has been held that where the general conditions of
`
`a claim are disclosedin the prior art, discovering the optimum or workable ranges
`
`involves only routine skill in the art (/n re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235
`
`(CCPA 1955)).
`
`19. With respect to claim 58, Kalili teaches a method of moving a patient’s teeth from
`
`an initial configuration towards a target configuration, the method comprising providing a
`
`removable orthodontic tooth positioning appliance having teeth receiving cavities
`
`shapedto directly receive at least some of the patient’s teeth and placing the removable
`
`orthodontic tooth positioning appliance on the teeth of the patient to apply a resilient
`
`positioning force to the patient's teeth and thereby movethe teeth toward the target
`
`configuration, (par. 53), wherein the removable orthodontic tooth positioning appliance
`
`comprises a soft polymer layer comprising a thermoplastic polyurethane elastomer
`
`having an ultimate tensile strength of greater than about 5000 psi, an elongation at
`
`break of greater than about 200%, and a hardness of about 60 A to about 85D (see
`
`pars. 9, 69 and document TEXIN 990R for material properties, the hardness is about
`
`85D, therefore, it meets the claimedlimitations) and a hard polymer layer (pars. 9, 69).
`
`Kalili teaches the invention as substantially claimed and discussed above, however,
`
`does not specifically teach the hard polymer layer comprising a co-polyester having a
`
`tensile modulus greater than 150,000 psi and a flexural modulus greater than about
`
`150,000psi and the soft polymer has a flexural modulus of greater than about 35,000
`
`psi.
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 10
`
`20.
`
`DeSimone teaches a dental appliance comprising a hard polymer layer
`
`comprising a co-polyester having a tensile modulus greater than about 150,000 psi and
`
`a flexural modulus greater than about 150,000 psi (see abstract, pars. 5-7, 25-27).
`
`It
`
`would have been obvious to one having ordinary skill in the art before the invention to
`
`modify the hard polymer layer with the hard polymer layer taught by DeSimone in order
`
`to provide an orthodontic appliance that is mechanically stable and less susceptible to
`
`degradation (see par. 16, 24, 31). It is noted that the hard polymer material taught by
`
`Kalili can be a polycarbonate whichis a material also taught by DeSimone (par. 27).
`
`21.
`
`Stewart teaches a polymer with a flexural modulus of greater than about 35,000
`
`psi (par. 82, 1000Mpais 145038 psi).
`
`It would have been obvious to one having
`
`ordinary skill in the art at the time of the invention to modify Kalili/DeSimone with the
`
`flexural modulus taught by Stewart in order more the teeth as desired.
`
`Kalili/DeSimone/Stewart teaches the invention as substantially claimed and discussed
`
`above, including a soft polymer materials with the claimed material properties used in
`
`orthodontic devices to deliver the desired forces to the teeth to achieve the desired
`
`outcomes, however,itis noted that KaliliiDeSimone/Stewart does not specifically
`
`teachesa single soft polymer material with claimed material properties as discussed
`
`abovewith Kalili/DeSimone/Stewart in order to provide the material with the desired
`
`properties to movethe teeth in the desired manner.
`
`22. Wheeler teaches a soft polymer thermoplastic polyurethane elastomer used in
`
`medical device (see abstract, therefore, it is biocompatible) comprising a tensile
`
`strength of greater than about 5000 psi, an elongation at break of greater than about
`
`200%, a hardness of about 60A to about 85D and a flexural modulus of greater than
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 11
`
`about 35,000 psi (see col. 22, Il. 1-11). It would have been obvious to one having
`
`ordinary skill in the art before the invention was made to modify the soft material taught
`
`by KaliliiDeSimone/Stewart which teachesall of the material properties for use in
`
`provided desired forces to the teeth for orthodontic treatment with the single material. It
`
`is noted that all of the claimed material properties are taught by the prior art are known
`
`properties provided to materials to deliver the desired forces to the teeth to movethe
`
`teeth as desired. It is further noted it has been held that where the general conditions of
`
`a claim are disclosedin the prior art, discovering the optimum or workable ranges
`
`involves only routine skill in the art (/n re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235
`
`(CCPA 1955).
`
`23. With respectto claim 62, Kalili teaches the invention as substantially claimed and
`
`discussed above, however, does not specifically teach the hard polymer layer has an
`
`elongation at yield of greater than about 4%.
`
`24.
`
`DeSimone teaches the method wherein the hard polymer layer has an elongation
`
`at yield of greater than about 4%(see abstract). It would have been obvious to one
`
`having ordinary skill in the art before the invention to modify the hard polymer layer with
`
`the hard polymer layer taught by DeSimonein order to provide an orthodontic appliance
`
`that is mechanically stable and less susceptible to degradation (see par. 16, 24, 31). It
`
`is noted that the hard polymer material taught by Kalili can be a polycarbonate whichis
`
`a material also taught by DeSimone (par. 27).
`
`25. With respect to claim 63, DeSimone further teaches the method comprising
`
`fabricating the removable orthodontic tooth positioning appliance (par. 53).
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 12
`
`26. With respect to claim 74, Kalili teaches the appliance wherein the hard polymer
`
`layer has a hard polymer layer elastic modulus and the soft polymer layer has a soft
`
`polymer modulus less than the hard polymer layer elastic modulus (see par. 69).
`
`27. With respect to claim 78, Kalili teaches the method wherein the hard polymer
`
`layer has a hard polymer layer elastic modulus and the soft polymer layer has a soft
`
`polymer modulus less than the hard polymer layer elastic modulus (see par. 69).
`
`28. With respect to claim 79, Kalili teaches wherein the soft polymer layer has a
`
`compression set greater than 40%after 22 hours at 70 degrees C (see cited TEXIN
`
`990R), however, does not specifically teach the compression set after 24 hours,
`
`however, it would have been obvious to one having ordinary skill in the art at the time of
`
`the invention that the compression set of the material taught by Kalili is about the same
`
`at 24 hours asit is at 22 hours.
`
`29. With respect to claim 80, Kalili teaches the applianceis clear (see par. 53),
`
`therefore, the soft polymer hasa light transmission between 400nm and 800nm of
`
`greater than about 75%.
`
`30. With respect to claim 81, Kalili teaches the invention as substantially claimed and
`
`discussed above, however, does specifically teach the hard polymer layer has an
`
`elongation at break of greater than about 70%.
`
`31.
`
`DeSimone teaches with respectto claim 81, the hard polymer layer has an
`
`elongation at break of greater than about 70%(see abstract). It would have been
`
`obvious to one having ordinary skill in the art before the invention to modify the hard
`
`polymer layer with the hard polymer layer taught by DeSimonein order to provide an
`
`orthodontic appliance that is mechanically stable and less susceptible to degradation
`
`

`

`Application/Control Number: 16/043,065
`Art Unit: 3772
`
`Page 13
`
`(see par. 16, 24, 31). It is noted that the hard polymer material taught by Kalili can be a
`
`polycarbonate which is a material also taught by DeSimone(par. 27).
`
`32. With respectto claim 82, Kalili teaches the invention as substantially claimed and
`
`discussed above, however, does not specifically teach the hard polymer layer has a
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`stress relaxation of greater than about 10%at 24 hours testing at a relative humidity of
`
`between 90-100%.
`
`33.
`
`DeSimone teacheswith respectto claim 82, the hard polymer layer has a stress
`
`relaxation of greater than about 10% (see abstract), however, does not teach that
`
`measure measurementis at 24 hours testing at a relative humidity of between 90-100%.
`
`However, it would have been obvious to one having ordinary skill in the art at the time of
`
`the invention that the material property of the stress relaxation is measured to be the
`
`value when in use, therefore, since the appliance is used for more than 24 hours and in
`
`the mouth which hashigh relative humidity, therefore it is noted that it would have been
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`obvious to one having ordinary skill in the art at the time of the invention that the stress
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`relaxation is greater than about 10%at 24 hours testing at a relative humidity of
`
`between 90-100%. It would have been obvious to one having ordinary skill in the art
`
`before the invention to modify the hard polymer layer with the hard polymer layer taught
`
`by DeSimonein order to provide an orthodontic appliance that is mechanically stable
`
`and less susceptible to degradation (see par. 16, 24, 31). It is noted that the hard
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`polymer material taught by Kalili can be a polycarbonate which is a material also taught
`
`by DeSimone(par. 27).
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`34. With respectto claim 83, Kalili teaches the invention as substantially claimed and
`
`discussed above, however, does not specifically teach the hard polymer layer has a
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`light transmission between 400 and 800 nm of greater than about 75%.
`
`35.
`
`DeSimone teachesthe hard polymer layer hasa light transmission between 400
`
`and 800 nm of greater than about 75%(see abstract). It would have been obvious to
`
`one having ordinary skill in the art before the invention to modify the hard polymer layer
`
`with the hard polymer layer taught by DeSimonein order to provide an orthodontic
`
`appliance that is mechanically stable and less susceptible to degradation (see par. 16,
`
`24, 31). It is noted that the hard polymer material taught by Kalili can be a
`
`polycarbonate which is a material also taught by DeSimone(par. 27).
`
`36. With respect to claim 84, Kalili teaches the invention as substantially claimed and
`
`discussed above, however, does not specifically teach the hard polymer layer has a
`
`tensile strength at yield between 4000 and 6500 psi.
`
`37.|DeSimone teaches with respectto claim 84, the dental appalling wherein the
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`hard polymer layer has a tensile strength at yield between 4000 and 6500 psi (see
`
`abstract, 6000 psi is within the claimed range). It would have been obvious to one
`
`having ordinary skill in the art before the invention to modify the hard polymer layer with
`
`the hard polymer layer taught by DeSimonein order to provide an orthodontic appliance
`
`that is mechanically stable and less susceptible to degradation (see par. 16, 24, 31). It
`
`is noted that the hard polymer material taught by Kalili can be a polycarbonate whichis
`
`a material also taught by DeSimone (par. 27).
`
`38. With respect to claim 88, Kalili teaches wherein the soft polymer layer has a
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`compression set greater than 40%after 22 hours at 70 degrees C (see cited TEXIN
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`990R), however, does not specifically teach the compression set after 24 hours,
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`however, it would have been obvious to one having ordinary skill in the art at the time of
`
`the invention that the compression set of the material taught by Kalili is about the same
`
`at 24 hours asit is at 22 hours.
`
`39.
`
`Claims 37 and 86-87 are rejected under pre-AlA 35 U.S.C. 103(a) as being
`
`unpatentable over Kalili (2011/0020761) in view of DeSimone etal. (2008/0248438)in
`
`view of Stewart (2015/0374464) in view of Wheeler, deceased etal. (5,335,675) as
`
`evidenced by TEXIN 990R asapplied to claims 30 and 58 above, and further in view of
`
`Tadros et al. (2005/0100853).
`
`40.__Kalili/DeSimone/Stewart/Wheeler teaches the invention as substantially claimed
`
`and discussed above, however, does not specifically teach the soft polymer layer
`
`comprises a material selected from the group consisting of a silicone rubber, an
`
`elastomeric alloy, a thermoplastic elastomer, a thermoplastic vulcanizate elastomer, a
`
`block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester
`
`elastomer and a thermoplastic polyamide elastomer or any combination thereof and the
`
`method and appliance wherein the hard polymer layer comprises more than one
`
`polymer.
`
`41.—Tadros teaches with respect to claim 37, a layered dental appliance comprising a
`
`layer made from a two polymersincluding a thermoplastic polyurethane elastomer and
`
`block copolymer elastomer and silicones (pars. 22, 73) and with respect to calims 86-87
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`the appalince and the appliance used in the method of moving comrpsing the hard
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`polymer layer with more than one polymer layer (see par. 73, such thatthe soft layer is
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`the first layer in contact with the teeth and the hard layer is the polymeric mixture and
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`the secondlayer).
`
`It would have been obvious to one having ordinary skill in the art
`
`before the invention was made to modify the single material taught by
`
`Kalili/DeSimone/Stewart/Wheeler with a blended/mixed material as taught by Tadrosin
`
`order to provide the desired properties of the material and forces to the teeth as taught
`
`by Tadros.
`
`42.
`
`Claims 39, 69, 71-73, 75-77 and 85is/are rejected under pre-AlA 35 U.S.C.
`
`103(a) as being unpatentable over over Kalili (2011/0020761) in view of DeSimone et
`
`al. (2008/0248438) in view of Stewart (2015/0374464) in view of Wheeler, deceased et
`
`al. (5,335,675) as evidenced by TEXIN 990R asapplied to claims 30, 49, and 58 further
`
`in view of Schwartz (2009/0298006).
`
`43. —KaliliiDeSimone/Stewart/Wheeler teaches the invention as substantially claimed
`
`and discussed above, however, does not specifically teach wherein the soft polymer
`
`layer comprises more than one polymer layer, wherein the multilayer dental appliance
`
`comprises three polymer layer of alternating hardness, the appliance has a thickness
`
`between 500 um and 1200 um, wherein the appliance comprises three polymer layer
`
`wherein the three polymer layers comprise the soft polymer layer and hard polymer
`
`layer.
`
`44.
`
`Schwartz teaches an orthodontic appliance with respect to claims 39 and 69,
`
`wherein the soft polymer layer comprises more than one polymer layer (par. 26, the two
`
`layers of the soft polymer, i.e. the polymer contacting the teeth and an outer layer
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`embedding the hard polymer layer), with respect to claims 71, 76 and 85, wherein the
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`multilayer dental