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
`
`16/382,918
`
`04/12/2019
`
`ChunhuaLI
`
`22773-826.305
`
`8094
`
`Align Technology, Inc. / WSGR
`650 Page Mill Road
`Palo Alto, CA 94304
`
`MAI, HAO D
`
`PAPER NUMBER
`
`ART UNIT
`
`3772
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/03/2022
`
`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)
`
`

`

`Office Action Summary
`
`Application No.
`16/382,918
`Examiner
`HAO D MAI
`
`Applicant(s)
`Lletal.
`Art Unit
`3772
`
`AIA (FITF) Status
`No
`
`-- The MAILING DATEof this 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 01/20/2022.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)[¥) This action is FINAL.
`2b) (J 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*
`1,5,7,9-13,17,19-25 and 29-41 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 20-25 and 29-30 is/are withdrawn from consideration.
`[) Claim(s)__ is/are allowed.
`Claim(s) 1,5,7,9-13,17,19 and 31-41 is/are rejected.
`(1 Claim(s)__is/are objectedto.
`C] Claim(s)
`are subjectto restriction and/or election requirement
`“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:/Awww.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)() The drawing(s) filedon__ is/are: a)C) accepted or b)C) 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). Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`cc) None ofthe:
`b)L) Some**
`a)D) All
`1.(.) Certified copies of the priority documents have been received.
`2.1) Certified copies of the priority documents have been received in Application No.
`3.2.) 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)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20220214
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`The present application is being examined under the pre-AlAfirst to invent provisions.
`
`Priority
`
`2.
`
`The later-filed application mustbe an application for a patent for an invention
`
`which is also disclosed in the prior application (the parent or earlier-filed nonprovisional
`
`application or provisional application for which benefit is claimed). The disclosure of the
`
`invention in the parent application and in the later-filed application must be sufficient to
`
`comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35
`
`U.S.C. 112, except for the best mode requirement. See Transco Products,Inc. v.
`
`Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
`
`The originally-filed disclosures of the prior-filed applications, Application Nos.
`
`16/043,065, 15/476622, and 13/470,681, all fail to provide adequate support or
`
`enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first
`
`paragraph for one or moreclaims of this application.
`
`The prior-filed applications disclose a large Markush Group (#1) for:
`
`the
`
`properties of the soft layers (see Application 13/470681 specification paragraph 28
`
`provided herein below, emphasis added):
`
`[0028] The soft polymer layers of the appliances can have a variety of physical properties. For
`example, physical properties s uch as hardness, ultimate tensile strength, elongation at break, tensile
`modulus, compression set, flexural modulus, and light transmission can each bespecifically tailored
`fora particular application. insome embodiments, the soft polymerlayers of the appliances can
`independently have a physical property of at least one of a hardness of about 60A to about 85D, an
`ultimate tensile strength of greater than about 5000 psi, an elongation at break of greater than
`about 200 %, a compression set at about 70 °C of greater than 40% after 24 hours, a flexural
`modulus of greater than about 35,000 psi, and a light transmission between 400 nm and 800 nm of
`greater than about 75%.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 3
`
`The prior-filed applications disclose a large Markush Group (#2) for:
`
`the
`
`properties of the hard layer (see Application 13/470681 specification paragraph 26,
`
`provided herein below, emphasis added).
`
`[0026] The hard polymer layer of the appliances of the present invention can have a variety of physical
`
`properties that can, e.g.,improve treatment options for a practitioner. For example, physical
`
`propertiessuch as tensile strength, elongation at yield, elongation at break, tensile modulus, flexural
`
`modulus, stress relaxation over time, and light transmission can each be specifically tailored fora
`
`particular application. in some embodiments, the hard polymerlayer of the appliances can have a
`
`physical property of at least one of a tensile strength at yield of between about 4000 pounds per
`
`square inch (psi) and 6500psi, an elongation at yield of greater than about 4%, an elongation at
`
`break of greater than about 70%, a tensile modulus of greater 30 than about 150,000 psi, a flexural
`
`modulus greater than about 150,000 psi, a stress relaxation at 24 hours testing in a high humidity
`
`environment(e.g., between about 90%-100% relative humidity) is greater than 10%, and a light
`
`transmission between 400 nm and 800 nm of greater than about 75%.
`
`Claims 1 and 13 each recites: the first and second outer layers having a
`
`hardness of about 60 A to about 85D (only one subset of Markush Group #1).
`
`Claim 33 recites:
`
`the first and second soft outer layers each has a flexural
`
`modulus of greater than about 35,000 psi (only one subset of Markush Group #1); and
`
`“the inner polymer layer having an elongation at break of greater than about 70% (only
`
`one subsetof Markush Group #2).
`
`There is no support from theprior-filed applications for such specifically
`
`claimed subset(s) and/or the combination(s) of the subset(s) of the Markush
`
`Groups. See Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326, 56 USPQ2d
`
`1481, 1486 (Fed. Cir. 2000), and In re Ruschig 379 F.2d 990, 154 USPQ 118 (CCPA
`
`1967). The court noted that with respect to In re Ruschig that “Ruschig makes clear
`
`that one cannot discloseaforest in the original application, and then later pick a tree out
`
`of the forest and say “here is my invention”.
`
`In orderto satisfy the written description
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 4
`
`requirement, the blaze marks directing the skilled artisan to that tree must be in the
`
`originally filed disclosure.”
`
`In this case,
`
`the prior-filed applications fail to indicate blaze marks(e.g. an
`
`embodiment, preferred embodiment, or a testing example) directing the skilled artisan to
`
`the specifically claimed property and/or combination of properties of the layer(s).
`
`Therefore, all claims 1, 3-7, 9-13, 15-18, and 34-42, are not entitled to the
`
`priority benefit of any of said above listed parent applications. Accordingly, for purpose
`
`of examination under the prior art, all claims 1, 3-7, 9-13, 15-18, and 34-42, are
`
`considered to have earliestfiling date of 04/12/2019.
`
`Double Patenting
`
`3. The nonstatutory double patenting rejection is based onajudicially created doctrine groundedin
`
`public policy (a policy reflected in the statute) so as to prevent the unjustified or impropertimewise
`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 claims are 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., /n 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); [n re Longi, 759 F.2d 887, 225 USPQ 645
`(Fed. Gir. 1985); /n re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); /n re Vogel, 422 F.2d
`438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`A timelyfiled terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321(d) may be used to
`overcome an actualor provisional rejection based on nonstatutory double patenting provided the
`reference application or patent either is shown to be commonly owned with the examined application, or
`claims an invention madeas a result of activities undertaken within the scopeof a joint research
`agreement. See MPEP § 717.02 for applications subject to examination underthefirst inventorto file
`provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(I}(1) - 706.02(1)(3)for
`applications not subject to examination underthe first inventor to file provisions of the AIA. A terminal
`disclaimer must be signed in compliance with 37 CFR 1.321(b).
`The USPTO Internet website contains terminal disclaimer forms which may be used. Pleasevisit
`www.uspto.gowpatent/patents-forms. Thefiling date of the application in which the formisfiled
`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 maybefilled out completely online using web-screens. An eTerminal
`Disclaimer that meetsall requirements is auto-processed and approved immediately upon submission.
`For more information about eTerminal Disclaimers, refer to
`www. uspto.gowpatents/process/file/efs/quidance/eTD-info-l.jsp.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 5
`
`4.
`
`Claims 1, 5, 7, 9-13, 17, 19, and 31-41, are rejected on the ground of
`
`nonstatutory double patenting as being unpatentable over:
`
`- Claims 1-31 of U.S. Patent No. 9,655,691;
`
`- Claims 1-20 of U.S. Patent No. 9,655,693; and
`
`- Claims 1-14 of U.S. Patent No. 10,052,176.
`
`Although the claims at issue are notidentical, they are not patentably distinct
`
`from each other because the difference between the application claims and the patent
`
`claims lies in the fact that the patent claims include more elements and are thus much
`
`specific. Thus the invention of the patent claims are in effect a “species” of the “generic”
`
`invention of the application claims. It has been held that the generic invention is
`
`“anticipated” by the “species”. See In re Goodman, 29 USPQe2d 2010 (Fed. Cir. 1993).
`
`Since the application claims are anticipated by the patent claims, they are not
`
`patentably distinct from the patent claims.
`
`Claim Rejections - 35 USC § 112(a)
`
`5.
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`(a) INGENERAL.—The specification shall contain a written description of the
`invention, and of the manner and process of making and usingit, in such full, clear,
`concise, and exact terms as to enable any personskilled in the art to which it pertains, or
`with which it is most nearly connected, tomake and use the same, and shall setforth the
`best mode contemplated by the inventoror joint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AlA 35 U.S.C. 112:
`The specification shall contain a written description of the invention, and of the
`mannerand process of making and using it, in such full, clear, concise, and exact terms
`as to enable any person skilled in the art to whichit pertains, or with which it is most
`nearly connected, to make and use the same,and shall setforth the best mode
`contemplated by the inventorof carrying out his invention.
`
`6.
`
`Claims 1, 5, 7, 9-13, 17, 19, and 31-41, are rejected under 35 U.S.C. 112(a) or
`
`35 U.S.C. 112 (pre-AlA), first paragraph, as failing to comply with the written
`
`description requirement. The claim(s) contains subject matter which was not
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 6
`
`described in the specification in such a way as to reasonably conveyto one skilled in
`
`the relevant art that the inventor or a joint inventor, or for pre-AlA the inventor(s), at the
`
`time the application wasfiled, had possession of the claimed invention.
`
`The application discloses a large Markush Group (#1) for:
`
`the properties of the
`
`soft layers (Specification paragraph 29 provided herein below, emphasis added)
`
`[0029] The soft polymer layers of the appliances can havea variety of physical properties. For
`example, physical properties such as hardness, ultimate tensile strength, elongation at break,
`tensile modulus, compression set, flexural modulus, and light transmission can each be
`specifically tailored fora particular application. In some embodiments, the soft polymer layers of
`the appliances can independently have a physical property of atleast one of a hardnessof about
`60A to about 85D, an ultimatetensile strength of greater than about 5000psi, an elongation at
`break of greaterthan about 200%, a compression set at about 70°C of greater than 40% after 24
`hours, a flexural modulus of greater than about 35,000 psi, anda light transmission between 400
`nmand 800 nm of greater than about 75%.
`
`The application discloses a large Markush Group (#2) for:
`
`the properties of the
`
`hard layer (specification paragraph 27, provided herein below, emphasis added).
`
`[0027] The hard polymer layer of the appliances of the present invention can haveavariety of
`physical properties that can, e.g., improve treatment options for a practitioner. For example,
`physical properties suchas tensile strength, elongation at yield, elongation at break, tensile
`modulus, flexural modulus, stress relaxation over time, and light transmission caneachbe
`specifically tailored fora particular application. In some embodiments, the hard polymerlayer of
`the appliances can have a physical property of atleast one of a tensile strength at yield of between
`about 4000 poundspersquareinch (psi) and 6500 psi, an elongation atyield ofgreater than about
`4%, an elongation at break of greater than about 70%, a tensile modulus of greater thanabout
`150,000psi, a flexural modulus greater than about 150,000psi, a stress relaxation at 24 hours
`testing in a wet environment (e.g., between about 90%-100% relative humidity) is greaterthan
`10%, and a light transmission between 400nm and 800 nm of greater than about 75%.
`
`Claims 1 and 13 each recites: the first and second outer layers having a
`
`hardness of about 60 A to about 85D (only one subset of Markush Group #1).
`
`Claim 33 recites:
`
`the first and second soft outer layers each hasa flexural
`
`modulus of greater than about 35,000 psi (only one subset of Markush Group #1); and
`
`“the inner polymer layer having an elongation at break of greater than about 70% (only
`
`one subset of Markush Group #2).
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 7
`
`There is no support from the original disclosure of this instant application
`
`for such specifically claimed subset(s) and/or the combination(s) of the subset(s)
`
`of the Markush Groups. Such recitations thus are considered to be new matter. See
`
`Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326, 56 USPQ2d 1481, 1486
`
`(Fed. Cir. 2000), and In re Ruschig 379 F.2d 990, 154 USPQ 118 (CCPA 1967). The
`
`court noted that with respect to In re Ruschig that “Ruschig makes clear that one cannot
`
`disclose a forest in the original application, and then later pick a tree out of the forest
`
`and say “here is my invention”.
`
`In order to satisfy the written description requirement,
`
`the blaze marks directing the skilled artisan to that tree must be in the originally filed
`
`disclosure.”
`
`In this case, the original disclosure fails to indicate blaze marks(e.g. an
`
`embodiment, preferred embodiment, or a testing example) directing the skilled artisan to
`
`the specifically claimed property and/or combination of properties of the layer(s).
`
`All dependent claims are rejected herein based on dependency of the base
`
`claims 1, 13, and 33, rejected herein.
`
`Claim Rejections - 35 USC § 112(b)
`
`7.
`
`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 outand distinctlyclaiming the subject matter which the inventor or a jointinventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specifications hall conclude with one or more claims particulary pointing out and distinctly
`claiming the subject matter which the applicant regards ashis invention.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 8
`
`8.
`
`Claims 1, 5, 7, 9-13, 17, 19, and 31-41, are 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 pre-AIA the applicant regards as the invention.
`
`# Claims 1, 13, and 33, each is incomplete for omitting essential elements, such
`
`omission amounting to a gap between the elements, rendering the claim
`
`indefinite. See MPEP § 2172.01. The omitted element(s) are: the elastic
`
`modulus, stiffness or hardness property, or a comparison of elastic modulus,
`
`stiffness, or hardness thereof, between the first and second soft layers and the
`
`hard inner layer.
`
`As currently recited, the recited terms “soft” and “hard” are merely nominal terms
`
`since there is no numeric measurement and/or a comparison there between the
`
`“softness” or “hardness” of the soft and hard layers. For example, the current
`
`recitation allows for interpretation that the “soft layer’ may have a hardness
`
`greater than that of the “hard layer’.
`
`All dependent claims are rejected herein based on dependency of the base
`
`claims 1, 13, and 33, rejected herein.
`
`Claim Rejections - 35 USC § 103
`
`9.
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though theinvention is not identically disclosed or described as
`set forth in section 102 ofthistitle, if the differences betw een the subject matter sought to be
`patented and the prior art are such that the subject matter as a whole w ould have been obvious at
`the time the invention was made to a person having ordinary skill
`in the art to whichsaid subject
`matter pertains. Patentability shall not be negatived by the manner in which theinvention was
`made.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 9
`
`10.
`
`Claims 1, 5, 7, 9-13, 17, 19, and 31-41, are rejected under pre-AlA 35 U.S.C.
`
`103(a) as being unpatentable over Chen etal. (US 2009/0246724 A1) in view
`
`Hostettler (US 4,791,156) and DeSimoneetal. (US 7,641,828), as evidenced by
`
`Plastics (non-patent literature No. 108 in IDS filed 04/22/2019).
`
`Regarding claim 1, Chen discloses a removable orthodontic tooth positioning
`
`appliance 100 having teeth receiving cavities 102 shaped to directly receive at least
`
`some of a patient's teeth 114 and apply a resilient positioning force to the patient's teeth
`
`(Fig. 1, paragraph 4). The appliance 100 comprises: a first and second outer polymer
`
`layers 134 comprising first and second polymeric materials; and an inner polymerlayer
`
`132 comprising a third polymeric material (Fig. 4C; paragraphs 3, 32, 36).
`
`Regarding the first and second outer polymer layers as claimed in claims 1, 5,7,
`
`and 31, Chenis silent to its ultimate tensile strength, elongation at break, and hardness,
`
`as Claimed. However, note that Chen disclosesthatit is well known to use polymeric
`
`material such as thermoplastic polyurethane (paragraphs 3, 21-22). Hostettler teaches
`
`that it is well Known that multilayer polymeric dental appliance (column 2 lines 33-38),
`
`includes a hard layer of hardness about “60D-100D” (column 2 lines 22-26, 34-35), and
`
`a separate soft layer of polyurethane elastomer having a hardness of “not greater than
`
`about 65A” (column 2 lines 36-44) which at least overlaps with the claimed range of
`
`hardness of about 60A to about 85D.
`
`It would have been obvious to one of ordinary
`
`skill in the art at the time of invention to use soft polyurethane elastomerfor the soft
`
`polymer layers of Chen as taught by Hostettler in order to provide a soft layer which
`
`provides tissue relief, is inexpensive,
`
`trouble-free, and easy to keep clean (column1
`
`lines 40-41, 50-59). Hostettler also discloses the material having certain tensile
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 10
`
`strength and elongation %(Table 1), indicating that such variables are of result-effective
`
`variables. The Plastics document showsthat polyurethane elastomer has an elongation
`
`at break of 75 to 1400% which overlaps with the claimed range of greater than about
`
`200%, and a hardness of 14 to 96 D which overlaps with the claimed range of 60 A to
`
`about 85 D. Therefore, such claimed range would have been obvious to one having
`
`ordinary skill
`
`in art at the time the invention was madesince it has been held that
`
`discovering an optimum or workable ranges is well within the skill of an artisan via
`
`routine experimentation in order to improve upon whatis already generally known. See
`
`MPEP§§ 2144.05.
`
`Regarding the inner polymer layer as claimedin claims 1, 9-10, and 12, Chen
`
`fails to disclose the hard polymer layer comprising a co-polyester and having the
`
`specifically claimed characteristics. DeSimone et al. discloses a polymer orthodontic
`
`appliance 10 made of co-polyesters and blends (column 5 lines 66-67). DeSimone also
`
`teaches that polyester, thermoplastic polyurethane, acrylic, polyamide, or
`
`polyetherimide (col. 6 Il. 47-59), polyethylene terephthalate, or polybutylene
`
`terephthalate (col. 7 Il. 24-31) may be used for hard layers (col. 6 Il. 47-59: polymeric
`
`materials with high glass transition temperatures). It would have been obvious to one of
`
`ordinary skill
`
`in the art at the time of invention to utilize the materials taught by
`
`DeSimone to form Chen's hard layer since DeSimone teaches that such materials are
`
`suitable for the intended use of such hard layer with predictable results and/or
`
`reasonable expectation of success. DeSimonealso discloses such hard polymerlayer
`
`comprising tensile modulus greater than 200,000 psi, a tensile strength at yield of
`
`greater than 8,800 psi, elongation at yield of greater than 4%, elongation at break of
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 11
`
`greater than 80%,a flexural modulus of greater than 200,000 psi, stress relaxation of
`
`not more than 50%, and light transmission between 400 nm and 800 nm of greater than
`
`75%(column 2 lines 5-16), which ranges overlapping with or indicating that the claimed
`
`ranges are of result-effective variables. Therefore, such claimed range would have
`
`been obvious to one having ordinary skill in art at the time the invention was made since
`
`it has been held that discovering an optimum or workable rangesis well within the skill
`
`of an artisan via routine experimentation in order to improve upon whatis already
`
`generally known. See MPEP §§ 2144.05.
`
`As to claim 11, Chen discloses the appliance and the layers therein may have
`
`certain thicknesses (paragraphs 30-31), indicating that such thickness is of result-
`
`effective variable. Therefore, such claimed range of thickness would have been
`
`obvious to one having ordinary skill
`
`in art at the time the invention was madesince it
`
`has been held that discovering an optimum or workable rangesis well within the skill of
`
`an artisan via routine experimentation in order to improve upon whatis already
`
`generally known. See MPEP §§ 2144.05.
`
`Regarding claims 13, 17, 19, and 32, Chen discloses a plurality of such
`
`incremental tooth position adjustment appliances 100, where the appliances are
`
`successively worn by a patient to move teeth from one arrangement to a successive
`
`arrangement (paragraphs 14-15). Chen/Hostettler/DeSimone discloses the elements as
`
`claimed as detailed above with respect to claims 1-12).
`
`Regarding claims 33-41, Chen/Hostettler/DeSimone discloses the elements as
`
`claimed as detailed above with respect to claims 1, 5, 7, 9-12, and 31, as detailed
`
`above.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 12
`
`Response to Arguments
`
`11.
`
`Applicant's arguments filed 01/20/2022 have been fully considered.
`
`Regarding the 35 USC § 103 ground(s) of rejection underprior art, Applicant
`
`arguesthat (1) the cited references provide no reason to select a polymer of DeSimone
`
`for use in Chen, and (2) one of ordinary skill in the art would not have had reasonable
`
`expectation of success for combining the teachings of Chen, DeSimone, and Hostettler
`
`to produce the presently claimed orthodontic appliances.
`
`It is maintained that Chen,
`
`DeSimone, and Hostettler, are all directed to orthodontic shell appliances. Thusit
`
`would have been obvious to oneof ordinary skill
`
`in the art at the time of invention to
`
`utilize the materials taught by DeSimone to form Chen's hard layer since DeSimone
`
`teaches that such materials are suitable for the intended use of such hard layer with
`
`predictable results and/or reasonable expectation of success. And as Hostettler
`
`teachesthatit is well known that a multilayer polymeric dental appliance (column 2 lines
`
`33-38),
`
`includes a hard layer of hardness about “60D-100D” (column 2 lines 22-26, 34-
`
`35), and a separate soft layer of polyurethane elastomer having a hardness of “not
`
`greater than about 65A” (column 2 lines 36-44), indicating that such claimed ranges of
`
`properties are of result-effective variables. Thus, such claimed range would have been
`
`obvious to one having ordinary skill
`
`in art at the time the invention was made since it
`
`has been held that discovering an optimum or workable rangesis well within the skill of
`
`an artisan via routine experimentation in order to improve upon whatis already
`
`generally known. See MPEP §§ 2144.05.
`
`Furthermore, Applicant argues that (3) the presently claimed appliances were
`
`found to exhibit unexpectedly beneficial results, and (4) the presently claimed
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 13
`
`appliances gave rise to considerable commercial success. Regarding the hard polymer
`
`layer, Applicant argues that there is no reason provided for why one of ordinary skill in
`
`the art would select a co-polyester material from DeSimonefor the hard polymerlayer
`
`because DeSimonelists hundreds of materials. Applicant cites unexpected results for
`
`the specifically claimed material of co-polyester for the hard polymer layer. However,
`
`Applicant fails to provide evidence for such cited unexpected result or criticality of using
`
`specifically co-polyester for the hard polymerlayer.
`
`In fact, similar to DeSimonelisting
`
`co-polyester among the list of many suitable material, Applicant also discloses co-
`
`polyester amonga list of many materials that can be used for the hard polymer layer:
`
`“For example, the hard polymerlayer can include several polymerlayers
`laminated togetherto form the hard polymer layer. The laminated hard
`polymerlayer can includeat least two layers of any combination of the
`following polymer materials: a polyester, a co-polyester, a polycarbonate, a
`thermoplastic polyurethane, a polypropylene, a polyethylene, a
`polypropylene andpolyethylene copolymer, an acrylic, a cyclic block
`copolymer, a polyetheretherketone, a polyamide, a polyethylene
`terephthalate, a polybutylene terephthalate, a polyetherimide, a
`polyethersulfone, and a polytrimethylene terephthalate.”
`(Specification paragraph 30).
`
`Applicant cites the affidavit/declaration by co-inventor ChunhuaLi, filed
`
`10/28/2019, as to provide evidences for the unexpected results and commercial
`
`success. However, note that the affidavit only refers to the system, i.e. SmartTrack™
`
`(ST30) as a multilayered material with a hard polymer layer between twosoft polymer
`
`layers, and not to the individual claims of the application, particularly “a first outer
`
`polymer layer, a second outer polymer layer, and an inner polymerlayer” . The affidavit
`
`fails to provide a nexus to the claimed invention(s).
`
`In view of the foregoing, whenall of the evidence is considered, the totality of the
`
`rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 14
`
`Regarding the priority and the ground(s) of rejection under U.S. 35 112(a),
`
`Applicant's remarks pointing out to the prior-filed and the instant applications disclosing
`
`a specific example for the soft layer comprising thermoplastic polyurethane and the hard
`
`layer comprising co-polyester, are persuasive.
`
`However, Applicant fail to show support from the prior-filed and the instant
`
`applications for the specifically claimed property or a combination of properties for the
`
`soft and hard layers. See statement regarding priority and ground(s) of rejection under
`
`U.S. 35 112(a) above.
`
`Note the new ground(s) of rejection under 35 USC 112(b).
`
`Conclusion
`
`12.
`
`Applicant's amendment necessitated the new ground(s) of rejection presented in
`
`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
`
`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
`
`CFR 1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`
`
`MONTHSfrom the mailing date of this action. In the eventafirst reply is filed within
`
`TWO MONTHSof the mailing date of this final action and the advisory action is not
`
`mailed until after the end of the THREE-MONTH shortened statutory period, then the
`
`shortened statutory period will expire on the date the advisory action is mailed, and any
`
`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
`
`the advisory action.
`
`In no event, however, will the statutory period for reply expire later
`
`than SIX MONTHS from the date of this final action.
`
`

`

`Application/Control Number: 16/382,918
`Art Unit: 3772
`
`Page 15
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to HAO D MAI whosetelephone numberis (571)270-3002.
`
`The examiner can normally be reached on Mon-Fr