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
`
`17/553,590
`
`12/16/2021
`
`ChunhuaLI
`
`22773-826.309
`
`3538
`
`Align Technology, Inc. / WSGR
`650 Page Mill Road
`Palo Alto, CA 94304
`
`CHEN,VIVIAN
`
`PAPER NUMBER
`
`ART UNIT
`
`1787
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/15/2023
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`Thetime 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)
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 2
`
`DETAILED ADVISORY ACTION
`
`Status of Claims
`
`1.
`
`2.
`
`3.
`
`Claims 2-6, 10-30, 33 is/are pending.
`
`Claims 2-6, 10-30, 33 is/are rejected.
`
`Claims 1, 7-9, 31-32 is/are cancelled by Applicant.
`
`Notice of Pre-AIA or AIA Status
`
`4.
`
`The present application, filed on or after March 16, 2013, is being examined underthe
`
`first inventorto file provisions of the AJA.
`
`5.
`
`In the event the determination of the status of the application as subject to AIA 35 U.S.C.
`
`102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
`
`statutory basis for the rejection will not be considered a new groundofrejectionif the priorart
`
`relied upon, and the rationale supporting the rejection, would be the same undereitherstatus.
`
`Priority
`
`6.
`
`Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
`
`under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
`
`Claims 2-6, 10-30, 33 have an effective filing date of 05/14/2012 in view of the Claim
`
`Amendmentsfiled 02/01/2023.
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 3
`
`Claim Rejections - 35 USC § 112
`
`7.
`
`The rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph,in
`
`the previous Office Action mailed 10/05/2023 have been withdrawnin view of the Claim
`
`Amendmentsfiled 02/01/2023.
`
`Terminal Disclaimer
`
`8.
`
`The terminal disclaimerfiled on 02/01/2023 disclaiming the terminal portion of the
`
`statutory term which would extend beyond the expiration date of U.S. Patent Nos. 9,655,691 and
`
`9,655,693 and 10,052,176 and 10,973,613 and 11,154,384 has been reviewedandis accepted.
`
`The terminal disclaimer has been recorded.
`
`9.
`
`The terminal disclaimerfiled on 04/19/2023 disclaiming the terminal portion of the
`
`statutory term which would extend beyond the expiration date of any patents granted on U.S.
`
`Applications Nos. 16/043,065 and 16/264,420 and 16/382,918 and 17/858,825 has been
`
`reviewed and is accepted. The terminal disclaimer has been recorded.
`
`10.
`
`The terminal disclaimerfiled on 05/30/2023 disclaiming the terminal portion of the
`
`statutory term which would extend beyond the expiration date of any patents granted on U.S.
`
`Applications Nos. 17/510,276 and 18/107,736 and 18/107,742 has been reviewed andis
`
`accepted. The terminal disclaimer has been recorded.
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 4
`
`11.
`
`Applicant’s responsefiled 05/30/2023 implies that a Terminal Disclaimer wasfiled to
`
`address the nonstatutory double patenting rejections based on U.S. Patent Nos. 11,213,369 (LI
`
`ET AL) and 11,648,091 (LI ET AL).
`
`However, the two Terminal Disclaimers filed 05/30/2023 appear to be duplicates and
`
`only address copending U.S. Applications Nos. 17/510,276 and 18/107,736 and 18/107,742.
`
`Therefore, the nonstatutory double patenting rejections based on U.S. Patent Nos.
`
`11,213,369 (LIET AL) and 11,648,091 (LLET AL) arestill pending.
`
`Double Patenting
`
`12.
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
`
`improper timewise extension of the “right to exclude” granted by a patent and to prevent possible
`
`harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where
`
`the conflicting claimsare not identical, but at least one examined application claim is not
`
`patentably distinct from the reference claim(s) because the examinedapplication claim is either
`
`anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg,
`
`140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d
`
`2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van
`
`Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may
`
`be used to overcome an actual or provisional rejection based on nonstatutory double patenting
`
`provided the reference application or patent either is shown to be commonly ownedwith the
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 5
`
`examinedapplication, or claims an invention madeasa result of activities undertaken within the
`
`scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination
`
`underthe first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP
`
`$$ 706.02(1)(1) - 706.02(1)(3) for applications not subject to examination underthe first inventor
`
`to file provisions of the AJA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`1.321(b).
`
`The USPTOInternet website contains terminal disclaimer forms which may be used.
`
`Please visit www.uspto.gov/patent/patents-forms. Thefiling date of the application in which the
`
`form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or
`
`PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may befilled out completely
`
`online using web-screens. An eTerminal Disclaimerthat meets all requirements is auto-
`
`processed and approved immediately upon submission. For more information about eTerminal
`
`Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-Ljsp.
`
`13.
`
`The rejections on the ground of nonstatutory double patenting based on U.S. Patent Nos.
`
`9,655,691 and 9,655,693 and 10,052,176 and 10,973,613 and 11,154,384 in the previous Office
`
`Action mailed 10/05/2023 have been withdrawn in view of the Terminal Disclaimerfiled
`
`02/01/2023.
`
`14.
`
`The provisional rejections on the ground of nonstatutory double patenting based on U.S.
`
`Applications Nos. 16/043,065 and 16/264,420 and 16/382,918 and 17/858,825 in the previous
`
`Office Action mailed 10/05/2023 have been withdrawn in view of the Terminal Disclaimerfiled
`
`04/19/2023 has been reviewed andis accepted.
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 6
`
`15.
`
`The provisional rejections on the ground of nonstatutory double patenting based on U.S.
`
`Applications Nos. 17/510,276 and 18/107,736 and 18/107,742 in the previous Office Action
`
`mailed 05/15/2023 have been withdrawn in view of the Terminal Disclaimerfiled 05/30/2023
`
`has been reviewed andis accepted.
`
`16.
`
`Claims 2-6, 10-13, 15-20, 22, 24-30, 33 remain/s rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over:
`
`* claims 1-15 of U.S. Patent No. 11,213,369 (LIET AL),
`
`in view of TADROS ET AL (US 2005/0100853),
`
`and in view of BEDARD ET AL (US 6,077,075),
`
`and in view of WO 2006/0996558 (WEN-WO‘558),
`
`and in view of DESIMONEET AL(US 2006/0078841),
`
`and in view of PHAN ET AL (US 6,454,565),
`
`and in view of KALILI (US 2011/0020761),
`
`and in view of TEXIN 990R,
`
`and in view of SHORE A HARDNESS SCALE,
`
`as stated in the previous Office Action mailed 05/15/2023.
`
`The above U.S. Patent claims a dental or orthodontic appliance for repositioning a
`
`patient’s teeth, wherein the appliance comprises a multilayer sheet, and/or methods of production
`
`related to using said multilayer sheet to form said dental or orthodontic appliances, wherein the
`
`multilayer sheet comprises:
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 7
`
`* at least one second layer containing a thermoplastic polyurethane (TPU)
`elastomer (correspondingto the recited “second layer”), wherein the at least one
`soft layer has physical properties (e.g., but not limited to: elongation at break,
`light transmission, and optionally tensile strength, etc.) as recited in present
`application claims 2, 10, 16, 30, etc.;
`
`* at least one first layer containing a copolyester (correspondingto the recited
`“first layer”), wherein the at least one first layer has physical properties (e.g., but
`not limited to: flexural modulus, light transmission, etc.) as recited in present
`application claims 2, 4-6, 24-29, etc.;
`
`* at least one additional layer (correspondingto the recited “third layer’), wherein
`the additional layer(s) can be:
`* a layer containing a copolyester;.
`
`Features not explicitly claimed in the above U.S. Patents are knownin thepriorart.
`
`TADROS ET AL‘853 discloses thatit is well knownin the art to form dental appliances
`
`for adjusting the alignment of a patent’s teeth, wherein the appliance is formed from a multilayer
`
`sheet comprising:
`
`* at least one elastomerlayer (e.g., containing polyurethane elastomer);
`
`* at least one copolyester layer(s) (e.g., containing polyethylene terephthalate
`copolymerized with cyclohexanedimethanol (PETG), etc.);
`
`The dental appliance is formed by:
`
`* providing the above multilayer sheet;
`
`* providing a mold;
`
`* thermoforming the multilayer sheet over the mold to form a plurality of cavities
`designed to receive and reposition the patient’s teeth from a first position to a
`second position.
`
`(paragraph 0015, 0019, 0022-0023, 0067, 0073, 0087-0088, etc.)
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 8
`
`BEDARD ETAL ‘075 that it is well knownin the art to form laminates for dental
`
`appliances(e.g., for re-aligning teeth, etc.) comprising:
`
`(i) at least one flexible “soft” layer(s) (e.g., with an illustrative Shore A hardness
`of 60-90) which can provide a soft contact layer for a patient’s mouth, wherein a
`“soft” layer unit can be optionally formed by multiple “soft” sub-layers;
`
`(i1) at least one flexible “hard” layer(s) (e.g., with an illustrative Shore D hardness
`of 55-85) to provide strength and providestiffness, wherein the “hard” layer unit
`can be optionally formed by multiple “hard” sub-layers;
`
`(iii) optional additional layers;
`
`wherein the “hard” layer(s) can be in contact with dental tissue or gums, or alternatively can be
`
`separated from the dental tissue or gums bythe “soft” layer(s). The rigidity or stiffness of the
`
`laminate or dental appliance as a whole can be controlled by adjusting the thickness of the “hard”
`
`layer(s). (line 5-68, col. 3; line 22-26, col. 5; line 49-62, col. 6; line 22-28, col. 7; etc.)
`
`WEN-WO‘558 discloses that it is preferable for the materials used to form dental
`
`aligners to be transparent. The reference further discloses that it is well knownin the art to form
`
`dental aligners from multilayer materials, wherein the layers have different properties(e.g.,
`
`hardness, stiffness, elasticity, flexural modulus, tensile strength, compression modulus, etc.),
`
`wherein the outer layer can have: (i) a higher hardness than the inner layer(s) to provide
`
`durability and/or heat-resistance; or (ii) a lower hardness than the inner layer(s) to provide better
`
`contact with a patient’s teeth and/or to provide greater patient comfort. (paragraph 0189, 0197-
`
`0201, 0217, 0220,etc.)
`
`DESIMONEETAL ‘841 discloses that it is well knownin the art to use copolyesters
`
`having physical properties (e.g., flexural modulus, elongation at yield, tensile modulus, tensile
`
`strength at yield, elongation at break, light transmission,etc.) as recited in present application
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 9
`
`claims 2, 4-6, 24-29, etc., as components in dental appliances(e.g., appliances for repositioning a
`
`patient’s teeth). (paragraph 0023, 0027, 0030, 0044,etc.)
`
`PHAN ETAL ‘565 disclosesthat it is well known in the art to incorporate transparent
`
`materials with different elastic modulus values and/or hardness in different layers of a dental
`
`appliance in order to provide a beneficial combination of: (i) firm and secure positioning; and (11)
`
`ease of removal and replacement, and improved seating or compliance with respect to the
`
`patient’s teeth. (line 60, col. 1 to line 20, col. 2; line 53-58, col. 2; line 5-25, col. 3; line 5-32, col.
`
`5; line 20-45, col. 15; etc.)
`
`KALILI ‘761 discloses that it is well known in the art to use polyurethanes such as
`
`TEXIN 990Rto form layers in multilayer sheets for orthodontic repositioning appliances. The
`
`reference further discloses that it is well known in the art to position “soft” layers with relatively
`
`lower elastic modulus on the tooth-contacting side of multilayer sheets used in dental appliances
`
`for repositioning a patient’s teeth, in order to improve patient comfort, and also prevent tooth
`
`and/or root damage due to excessive localized stress. (paragraph 0002, 0007-0009, 0069-0072,
`
`etc.)
`
`TEXIN 990R discloses a commercially available thermoplastic polyurethane elastomer
`
`having physical properties (e.g., hardness, ultimate elongation, ultimate tensile strength,
`
`compressionset, etc.) as recited in present application claims 2, 10, 16, 30, etc., with superior
`
`toughness, flexibility, microbial resistance. etc. (page 1, 3, etc.)
`
`SHORE A HARDNESS SCALEprovides evidence that a material with a Shore A
`
`hardness of 90 exhibits a hardness which generally falls between Shore A 65 and Shore D 85.
`
`Regarding claims 2-6, 10-13, 15-20, 22, 24-30, 33, it would have been obvious to one of
`
`ordinary skill in the art before the effective filing date of the claimed invention to utilize a
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`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 10
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`multilayer sheet comprising transparent layers such as the one or morefirst layer(s) containing
`
`copolyester with high light transmission on one or both sides of a second layer containing TPU
`
`elastomer with high light transmission as claimed in U.S. Patent No. 11,213,369 in a known
`
`dental appliance production methodas disclosed in TADROS ET AL ‘853 in order to produce
`
`transparent dental aligner appliances as suggested by WEN-WO ‘558 with advantageous
`
`combinationsof high light transmission, durability, stiffness, teeth-aligning fit and force, and
`
`patient comfort (as suggested in BEDARD ET AL ‘075 and WEN-WO‘558 and PHAN ET AL
`
`‘565 and KALILI ‘761).
`
`Further regarding claims 2, 10, 16, 30, one of ordinary skill in the art would have used
`
`known and/or commercially available TPU elastomers similar to TEXIN 990R(as suggested in
`
`KALILI ‘761) with high light transmission to form the second TPU layer(s) in the multilayer
`
`sheet materials claimed in U.S. Patent No. 11,213,369 in order to produce attractive transparent
`
`dental retainers.
`
`Further regarding claims 2, 4-6, 24-29, one of ordinary skill in the art would have used
`
`known and/or commercially available copolyesters with high light transmission(e.g., but not
`
`limited to, copolyesters as suggested in DESIMONE ET AL ‘841, etc.) to form thefirst
`
`copolyester layer(s) in the multilayer sheet materials claimed in U.S. Patent No. 11,213,369 in
`
`order to produceattractive transparent dental retainers.
`
`Further regarding claims 2, 4-6, 10, 16, 24-30, one of ordinary skill in the art would have
`
`utilized: (i) TPU elastomers having physical properties which are substantially similar to the
`
`desired physical properties of the recited second layer(s); and (ii) copolyesters having physical
`
`properties which are substantially similar to the desired physical properties of the recited first
`
`layer(s); in the multilayer sheet materials claimed in U.S. Patent No. 11,213,369 in orderto
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 11
`
`simplify the production of dental appliances with the desired individual and overall physical and
`
`mechanical properties (e.g., transparency, as suggested by WEN-WO‘558.
`
`Further regarding claims 2, 16, it is conventional in the production of dental aligners and
`
`orthodontic appliances to trim excess material from thermoformedarticles after shaping in order
`
`to obtain the desired final product.
`
`Regarding claim 19, one of ordinary skill in the art would have used conventional
`
`methods of forming multilayer sheets (e.g., coextrusion, lamination, etc.) to form the multilayer
`
`sheet materials claimed in U.S. Patent No. 11,213,369.
`
`Regarding claims 3, 12-13, 16-20, 22, one of ordinary skill in the art would have utilized
`
`transparent copolyester layers formed from multiple transparent copolyester sub-layers and/or
`
`transparent TPU layers formed from multiple transparent TPU elastomer sub-layers as suggested
`
`by BEDARD ETAL ‘075 in the multilayer sheet materials claimed in U.S. Patent No.
`
`11,213,369 in order to produce 3-layer or 4-layer multilayer materials with high light
`
`transmission which allows for convenient modification of various performance properties
`
`(strength, thermoforming properties, rigidity, flexibility, etc.) and thereby provide the optimal
`
`combination of softness/elasticity and stiffness/strength needed to meet the repositioning,
`
`durability and/or comfort needs of specific patients -- for example: (i) incorporating an additional
`
`TPU elastomerlayer adjacent to a first copolyester layer and/or a second TPU elastomerlayerin
`
`order to further adjust the cushioning and compliance characteristics of the multilayer sheet
`
`material, thereby improving the appliance’s ability to conform to the patient’s teeth and mouth
`
`and/or improving patient comfort; and/or (ii) incorporating an additional copolyester layer
`
`adjacent to a first copolyester layer and/or a second TPU elastomerlayer in order to adjust the
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 12
`
`rigidity, stiffness, toughness, thermoforming properties of the multilayer sheet material, thereby
`
`improving the durability and/or thermoforming characteristics of the dental appliance’s.
`
`Regarding claims 2-3, 12-13, 15-20, 22, one of ordinary skill in the art would have
`
`selected the relative positions of the light transmissive copolyester layer(s) and the light
`
`transmissive TPU elastomerlayers (e.g., as outer layer(s) and/or inner layer(s)) in the multilayer
`
`sheet materials claimed in U.S. Patent No. 11,213,369 depending on the performance properties
`
`desired for particular applications and/or patients. (e.g., hard inner layer(s) which provide the
`
`required structural strength, shape-retention, as well as the necessary tooth-repositioning force
`
`for specific applications; hard outer layer(s) for improved durability and wear resistance; soft
`
`outer layer(s) which conform well to a patient’s teeth and/or provide comfortable mouth-
`
`contacting surfaces; soft inner layer(s) providing improved cushioning betweenteeth; etc.)
`
`Regarding claims 11, 33, since the elastic modulus is a measure ofthe rigidity or stiffness
`
`of a material, and commonlyalso the hardness of said material, one of ordinary skill in the art
`
`would have combined one or morelayer(s) of a relatively higher elastic modulus copolyester
`
`material and one or more layer(s) of a relatively lower elastic modulus TPU material in the
`
`multilayer materials claimed in U.S. Patent No. 11,213,369 in order to provide: (i) desirably
`
`“hard”orstiff layer(s) which provide the required structural strength, shape-retention, as well as
`
`the necessary tooth-repositioning force for specific applications; and (ii) desirably compliant or
`
`resilient “soft” or flexible layer(s) which conform well to a patient’s teeth (thereby avoiding
`
`localized force which might damageteeth) and optionally to provide comfortable mouth-
`
`containing surfaces; (as suggested in and BEDARD ET AL‘075 and WEN-WO‘558 and PHAN
`
`ET AL ‘565 and KALILI ‘761).
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 13
`
`17.
`
`Claims 2-6, 10-30, 33 remain/s rejected on the ground of nonstatutory double patenting
`
`as being unpatentable over:
`
`* claims 1-26 of U.S. Patent No. 11,648,091 (LIET AL),
`
`in view of TADROS ET AL (US 2005/0100853),
`
`and in view of BEDARD ET AL (US 6,077,075),
`
`and in view of WO 2006/0996558 (WEN-WO‘558),
`
`and in view of DESIMONEET AL(US 2006/0078841),
`
`and in view of PHAN ET AL (US 6,454,565),
`
`and in view of KALILI (US 2011/0020761),
`
`and in view of TEXIN 990R,
`
`and in view of SHORE A HARDNESS SCALE,
`
`as stated in the previous Office Action mailed 05/15/2023.
`
`The above U.S. Patent claims a dental or orthodontic appliance for repositioning a
`
`patient’s teeth, wherein the appliance comprises a multilayer sheet, and/or methods of production
`
`related to using said multilayer sheet to form said dental or orthodontic appliances, wherein the
`
`multilayer sheet comprises:
`
`* at least one soft layer containing a thermoplastic polyurethane (TPU) elastomer
`(correspondingto the recited “second layer”), wherein the at least one soft layer
`has physical properties (e.g., but not limited to: hardness, elongation at break,
`light transmission, and optionally additionally ultimate tensile strength,
`compressionset, etc.) as recited in present application claims 2, 10, 16, 30, etc.;
`
`* at least one hard layer containing a copolyester (corresponding to the recited
`“first layer”), wherein the hard layer has physical properties (e.g., but not limited
`to: flexural modulus, elongation at break, light transmission, and optionally
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 14
`
`tensile strength at yield, elongation at yield, tensile modulus, etc.) as recited in
`present application claims 2, 4-6, 24-29, etc. wherein the copolyester hard layer
`has an elastic modulus greater than the elastic modulus of the TPU soft layer;
`
`* at least one additional layer (correspondingto the recited “third layer” and the
`recited “fourth layer”), wherein the additional layer(s) can be:
`* a layer containing a copolyester; and/or
`* a layer containing a thermoplastic polyurethane elastomer.
`
`Features not explicitly claimed in the above U.S. Patent are knownin thepriorart.
`
`TADROSET AL ‘853 discloses that it is well known in the art to form dental appliances
`
`for adjusting the alignment of a patent’s teeth, wherein the appliance is formed from a multilayer
`
`sheet comprising:
`
`* at least one elastomerlayer (e.g., containing polyurethane elastomer);
`
`* at least one copolyester layer(s) (e.g., containing polyethylene terephthalate
`copolymerized with cyclohexanedimethanol (PETG), etc.);
`
`The dental appliance is formed by:
`
`* providing the above multilayer sheet;
`
`* providing a mold;
`
`* thermoforming the multilayer sheet over the mold to form a plurality of cavities
`designed to receive and reposition the patient’s teeth from a first position to a
`second position.
`
`(paragraph 0015, 0019, 0022-0023, 0067, 0073, 0087-0088, etc.)
`
`BEDARD ETAL ‘075 that it is well knownin the art to form laminates for dental
`
`appliances(e.g., for re-aligning teeth, etc.) comprising:
`
`(i) at least one flexible “soft” layer(s) (e.g., with an illustrative Shore A hardness
`of 60-90) which can provide a soft contact layer for a patient’s mouth, wherein a
`“soft” layer unit can be optionally formed by multiple “soft” sub-layers;
`
`

`

`Application/Control Number: 17/553,590
`Art Unit: 1787
`
`Page 15
`
`(i1) at least one flexible “hard” layer(s) (e.g., with an illustrative Shore D hardness
`of 55-85) to provide strength and providestiffness, wherein the “hard” layer unit
`can be optionally formed by multiple “hard” sub-layers;
`
`(iii) optional additional layers;
`
`wherein the “hard” layer(s) can be in contact with dental tissue or gums, or alternatively can be
`
`separated from the dental tissue or gums bythe “soft” layer(s). The rigidity or stiffness of the
`
`laminate or dental appliance as a whole can be controlled by adjusting the thickness of the “hard”
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`layer(s). (line 5-68, col. 3; line 22-26, col. 5; line 49-62, col. 6; line 22-28, col. 7; etc.)
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`WEN-WO‘558 discloses that it is preferable for the materials used to form dental
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`aligners to be transparent. The reference further discloses that it is well knownin the art to form
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`dental aligners from multilayer materials, wherein the layers have different properties(e.g.,
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`hardness, stiffness, elasticity, flexural modulus, tensile strength, compression modulus, etc.),
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`wherein the outer layer can have: (i) a higher hardness than the inner layer(s) to provide
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`durability and/or heat-resistance; or (ii) a lower hardness than the inner layer(s) to provide better
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`contact with a patient’s teeth and/or to provide greater patient comfort. (paragraph 0189, 0197-
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`0201, 0217, 0220,etc.)
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`DESIMONEETAL ‘841 discloses that it is well knownin the art to use copolyesters
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`having physical properties (e.g., flexural modulus, elongation at yield, tensile modulus, tensile
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`strength at yield, elongation at break, light transmission,etc.) as recited in present application
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`claims 2, 4-6, 24-29, etc., as components in dental appliances(e.g., appliances for repositioning a
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`patient’s teeth). (paragraph 0023, 0027, 0030, 0044,etc.)
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`PHAN ETAL ‘565 disclosesthat it is well known in the art to incorporate transparent
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`materials with different elastic modulus values and/or hardness in different layers of a dental
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`appliance in order to provide a beneficial combination of: (i) firm and secure positioning; and (11)
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`Application/Control Number: 17/553,590
`Art Unit: 1787
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`Page 16
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`ease of removal and replacement, and improved seating or compliance with respect to the
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`patient’s teeth. (line 60, col. 1 to line 20, col. 2; line 53-58, col. 2; line 5-25, col. 3; line 5-32, col.
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`5; line 20-45, col. 15; etc.)
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`KALILI ‘761 discloses that it is well known in the art to use polyurethanes such as
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`TEXIN 990Rto form layers in multilayer sheets for orthodontic repositioning appliances. The
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`reference further discloses that it is well known in the art to position “soft” layers with relatively
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`lower elastic modulus on the tooth-contacting side of multilayer sheets used in dental appliances
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`for repositioning a patient’s teeth, in order to improve patient comfort, and also prevent tooth
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`and/or root damage due to excessive localized stress. (paragraph 0002, 0007-0009, 0069-0072,
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`etc.)
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`TEXIN 990R discloses a commercially available thermoplastic polyurethane elastomer
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`having physical properties (e.g., hardness, ultimate elongation, compressionset, etc.) as recited
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`in present application claims 2, 10, 16, 30, etc., with superior toughness, flexibility, microbial
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`resistance. etc. (page 1, 3, etc.)
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`SHORE A HARDNESS SCALEprovides evidence that a material with a Shore A
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`hardness of 90 exhibits a hardness which generally falls between Shore A 65 and Shore D 85.
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`Regarding claims 2-6, 10-30, 33, it would have been obvious to one of ordinary skill in
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`the art before the effective filing date of the claimed invention to utilize a multilayer sheet
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`comprising transparent layers such as the one or moresoft layer(s) containing TPU elastomer
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`with high light transmission on oneor both sides of the one or more hard layer(s) containing
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`copolyester with high light transmission as claimed in U.S. Patent No. 11,648,091 in a known
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`dental appliance production methodas disclosed in TADROS ET AL ‘853 in order to produce
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`transparent dental aligner appliances as suggested by WEN-WO ‘558 with advantageous
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`Application/Control Number: 17/553,590
`Art Unit: 1787
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`Page 17
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`combinationsof high light transmission, durability, stiffness, teeth-aligning fit and force, and
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`patient comfort (as suggested in BEDARD ET AL ‘075 and WEN-WO‘558 and PHAN ET AL
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`‘565 and KALILI ‘761).
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`Further regarding claims 2, 10, 16, 30, one of ordinary skill in the art would have used
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`known and/or commercially available TPU elastomers similar to TEXIN 990R(as suggested in
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`KALILI ‘761) with high light transmission to form the soft TPU elastomer layer(s) in the
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`multilayer sheet materials claimed in U.S. Patent No. 11,648,091 in order to produceattractive
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`transparentdentalretainers.
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`Further regarding claims 2, 4-6, 24-29, one of ordinary skill in the art would have used
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`known and/or commercially available copolyesters with high light transmission(e.g., but not
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`limited to, copolyesters as suggested in DESIMONE ET AL ‘841, etc.) to form the hard
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`copolyester layer(s) in the multilayer sheet materials claimed in U.S. Patent No. 11,648,091 in
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`order to produceattractive transparent dental retainers.
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`Further regarding claims 2, 4-6, 10, 16, 24-30, one of ordinary skill in the art would have
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`utilized: (i) TPU elastomers having physical properties which are substantially similar to the
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`desired physical properties of the soft layer(s); and (11) copolyesters having physical properties
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`which are substantially similar to the desired physical properties of the hard layer(s); in the
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`multilayer sheet materials claimed in U.S. Patent No. 11,648,091 in order to simplify the
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`production of dental appliances with the desired individual and overall physical and mechanical
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`properties (e.g., transparency, as suggested by WEN-WO‘558.
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`Further regarding claims 2, 16, it is conventional in the production of dental aligners and
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`orthodontic appliances to trim excess material from thermoformedarticles after shaping in order
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`to obtain the desired final product.
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`Application/Control Number: 17/553,590
`Art Unit: 1787
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`Page 18
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`Regarding claim 19, one of ordinary skill in the art would have used conventional
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`methods of forming multilayer sheets (e.g., coextrusion, lamination, etc.) to form the multilayer
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`sheet materials claimed in U.S. Patent No. 11,648,091.
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`Regarding claims 3, 12-15, 17-23, one of ordinary skill in the art would have utilized
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`transparent hard layers formed from multiple transparent hard copolyester sub-layers and/or
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`transparent soft layers formed from multiple transparent soft TPU elastomer sub-layers as
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`suggested by BEDARD ET AL ‘075 in the multilayer sheet materials claimed in U.S. Patent No.
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`11,648,091 in order to produce 3-layer or 4-layer multilayer materials with high light
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`transmission which allows for convenient modification of various performance properties
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`(strength, thermoforming properties, rigidity, flexibility, etc.) and thereby provide the optimal
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`combination of softness/elasticity and stiffness/strength needed to meet the repositioning,
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`durability and/or comfort needs of specific patients -- for example: (i) incorporating an additional
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`TPU elastomerlayer adjacent to a first hard copolyester layer and/or a second soft TPU
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`elastomerlayer in order to further adjust the cushioning and compliance characteristics of the
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`multilayer sheet material, thereby improving the appliance’s ability to conform to the patient’s
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`teeth and mouth and/or improving patient comfort; and/or (11) incorporating an additional
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`copolyester layer adjacentto a first hard copolyester layer and/or a second soft TPU elastomer
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`layer in order to adjust the rigidity, stiffness, toughness, thermoforming properties of the
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`multilayer sheet material, thereby improving the durability and/or thermoforming characteristics
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`of the dental appliance’s.
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`Regarding claims 2-3, 12-23, one of ordinary skill in the art would haveselected the
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`relative positions of the light transmissive hard copolyester layer(s) and the light transmissive
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`soft TPU elastomerlayer(s) (e.g., as outer layer(s) and/or inner layer(s)) in the multilayer sheet
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`Application/Control Number: 17/553,590
`Art Unit: 1787
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`Page 19
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`materials claimed in U.S. Patent No. 11,648,091 depending on the performance properties
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`desired for particular applications and/or patients. (e.g., hard inner layer(s) which provide the
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`required structural strength, shape-retention, as well as the necessary tooth-repositioning force
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`for specific applications; hard outer layer(s) for improved durability and wear resistance; soft
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`outer layer(s) which conform well to a patient’s teeth and/or provide comfortable mouth-
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`contacting surfaces; soft inner layer(s) providing improved cushioning betweenteeth; etc.)
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`Claim Rejections - 35 USC § 103 (AIA)
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`18.
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`The rejections under 35 U.S.C. 103 based on TADROS ET AL (US 2005/0100853) as
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`primary reference in the previous Office Action mailed 10/05/2022 have been withdrawn in view
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`of the Claim Amendmentsfiled 02/01/2023.
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`19.
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`Applicant’s arguments filed 05/30/2023 have been considered but they are not
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`Response to Arguments
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`persuasive.
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`(A) As discussed above, Applicant has not yet submitted a Terminal Disclai